Research Results Based on the Query


ACT
ARG
SCJ
HCJ

Query: A pharmaceutical company, my client is embroiled in a legal dispute with a competitor over patent infringement allegations. The plaintiff alleges that my client's new drug formulation infringes on their patented technology and seeks damages for lost profits and royalties. My client maintains that their product is based on original research and does not violate any existing patents. They counterclaim, accusing the plaintiff of engaging in anti-competitive practices to stifle competition in the market. As legal counsel for the pharmaceutical company, I am responsible for defending against these claims and protecting my client's intellectual property rights.



Likely Arguments


Analysis of Potential Arguments by Opposing Counsel

1. Allegation of Patent Infringement
- Argument: The plaintiff will argue that your client's drug formulation utilizes a patented process or compound, thus constituting infringement under Section 48 of the Patents Act, 1970, which grants patent holders exclusive rights to their inventions.
- Counterargument: Your client can assert that their formulation is based on original research and does not utilize any of the patented claims. Under Section 3(d) of the Patents Act, 1970, the plaintiff must demonstrate that the formulation is not merely a new form of an existing drug but a novel invention.

2. Proof of Infringement
- Argument: The plaintiff may present evidence of similarities between the two formulations, arguing that these similarities indicate infringement.
- Counterargument: Your client can argue that the similarities are superficial and that the formulations differ significantly in composition and mechanism of action. Additionally, Section 104A of the Patents Act allows for the presumption of validity of a patent, which your client can challenge by providing evidence of prior art.

3. Damages for Lost Profits and Royalties
- Argument: The plaintiff will seek damages based on lost profits and potential royalties, arguing that the infringement has caused significant financial harm.
- Counterargument: Your client can contest the calculation of damages, arguing that the plaintiff has not adequately demonstrated a direct correlation between the alleged infringement and the claimed losses. Under Section 135 of the Patents Act, damages must be proven with reasonable certainty.

4. Anti-Competitive Practices
- Argument: The plaintiff may argue that your client's counterclaim of anti-competitive practices is a mere distraction from the infringement allegations.
- Counterargument: Your client can substantiate their counterclaim by providing evidence of the plaintiff's actions that may constitute abuse of market dominance under Section 4 of the Competition Act, 2002, such as filing frivolous lawsuits to stifle competition.

5. Public Interest and Access to Medicines
- Argument: The plaintiff may argue that enforcing their patent rights is in the public interest, as it encourages innovation and investment in drug development.
- Counterargument: Your client can argue that their formulation provides a more affordable or effective alternative, thus serving the public interest better. This aligns with the objectives of the Patents Act, which aims to balance patent rights with public health needs.

Optimal Strategy to Defend Your Client

1. Conduct a Thorough Patent Analysis
- Review the plaintiff's patent claims in detail to identify any weaknesses or prior art that may invalidate the patent. This includes conducting a freedom-to-operate analysis to ensure that your client's formulation does not infringe on existing patents.

2. Gather Evidence of Original Research
- Compile comprehensive documentation of your client's research and development process, including lab notes, experimental data, and expert testimonies to demonstrate the originality of the formulation.

3. Challenge the Plaintiff's Damages Claims
- Engage a financial expert to analyze the plaintiff's claims for lost profits and royalties, ensuring that any damages sought are substantiated and reasonable.

4. Prepare a Strong Counterclaim
- Develop a robust counterclaim against the plaintiff for anti-competitive practices, gathering evidence of their actions that may violate the Competition Act, 2002. This could include instances of market manipulation or attempts to monopolize.

5. Leverage Public Interest Arguments
- Frame your client's product as beneficial to public health, emphasizing its affordability or effectiveness compared to the plaintiff's product. This can be a persuasive argument in court, especially in the context of access to medicines.

6. Engage in Settlement Discussions
- Consider the possibility of settlement negotiations to avoid protracted litigation. This could involve licensing agreements or other arrangements that allow both parties to benefit without further legal conflict.

7. Prepare for Trial
- If the case proceeds to trial, ensure that your legal team is well-prepared with a clear strategy, including expert witnesses, compelling arguments, and a strong narrative that highlights your client's commitment to innovation and public health.

By employing these strategies, you can effectively defend your client against the patent infringement allegations while also protecting their intellectual property rights and countering any anti-competitive claims made by the plaintiff.


Relevant Supreme Court Judgments
Year From: 1950, Year To: 2024

Result 1
Supreme Court of India
(ID::2015 SCP 647)
Neon Laboratories Ltd vs Medical Technologies Ltd. & Ors
Honourable Judges Shiva Kirti Singh, Vikramajit Sen
Date of Judgment: 05 Oct 2015
Segment Number (Approximate Page Number): 1
Relevancy Score: 61.67
   
   
   

REPORTABLE IN THE SUPREME COURT OF INDIA CIVIL APPEALLATE JURISDICTION CIVIL APPEAL NO. 1018 OF 2006 Neon Laboratories Ltd. ... Appellant Versus Medical Technologies Ltd. & Ors. ... Respondents J U D G M E N T VIKRAMAJIT SEN, J. 1 This Appeal assails the Judgment dated 19.12.2005 of the Learned Single Judge of the High Court of Gujarat at Ahmedabad, who returned the opinion that the Trial Court had rightly granted an injunction in favour of the Plaintiffs (Respondents before us) till the disposal of the suit. 2 Briefly stated, the Plaintiff-Respondents 1 & 2 had filed a suit for injunction, damages and account of profits. The Plaintiff-Respondents are engaged in the business of manufacture and marketing of pharmaceutical products and medicinal preparation, and as pleaded by them, have acquired high reputation and goodwill in the market. Hematal Biologicals Ltd. or Core Health Care Ltd., the predecessor-in-title of Plaintiff-Respondents is stated to have introduced the molecular preparation and generic drug “Propofol” in India, in respect of which an application had been filed before the Drug Controller of India on 22.4.1998. Product Permission was received on 2.5.1998 from the Commissioner of Food and Drugs Control Administration. It has been pleaded that the predecessor-in-title of Plaintiff-Respondent No.1 had coined and invented the trademark PROFOL in April 1998 and not applied for registration of the said trademark on 24.5.1998 in Class V. However, it seems to us that this claim may not find acceptance inasmuch as PROFOL is almost an anagram of and is phonetically almost indistinguishable from the molecular compound, namely “Propofol”. In our opinion, to claim exclusivity of user, the trademark should normally partake of a new creation, or if an existing word, it should not bear descriptive characteristics so far as the product is concerned, nor should it be of an extolment or laudation. It would be surprising if exclusivity is given to marks such as ‘bestsoap’ etc. Having said this, we must accept the reality that in the pharmaceutical industry it is commonplace that trademarks reproduce and resonate the constituent composition. While this aspect and feature may be a good ground for declining registration of the trademark, it may nevertheless remain a favourable determinant in a passing- off action. So far as the subject trademarks are concerned, not only do their names constitute part of the generic drug “Propofol”, but they are also so similar that even the concerned medical practitioner/anaesthesiologist could fail to discern the difference between them. It has been pleaded in the plaint that the said predecessor-in-title has been openly employing this mark since April 1998. After amalgamating with its predecessor-in-title on 17.2.2000, Plaintiff-Respondent No. 1 became the owner of the trademark PROFOL, and has been using it since 2000, when it also applied for its registration.

Result 2
Supreme Court of India
(ID::2012 SCP 742)
Cipla Ltd vs Union Of India & Ors
Honourable Judges Dipak Misra, K.S. Radhakrishnan
Date of Judgment: 27 Nov 2012
Segment Number (Approximate Page Number): 1
Relevancy Score: 56.95
   
   
   

REPORTABLE IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION CIVIL APPEAL NO(s).8479-8480 OF 2012 (arising out of SLP(C)No(s).34504-34505/2012 ) CIPLA LTD. Appellant(s) VERSUS UNION OF INDIA AND OTHERS Respondent(s) O R D E R Leave granted. Sugen Inc. USA and Pharmacia and Upjohn Company USA filed an application on 9.8.2002 for the grant of patent. The application was recommended for grant of patent on 23.8.2007 and was finally alloted the patent No.209251, which was published in the Patent Office Journal under Section 43(2) of the Patents Act, 1970 (for short. “the Act”). Cipla Ltd. filed an application under section 25(2) of the Act on 1.9.2008 for revocation of the said patent, before the Assistant Controller of Patent and Design (in short, “the Controller”), who vide his order dated 24th September, 2012 revoked the patent which gave rise to this litigation. Heard Mr. Harish Salve, learned senior counsel appearing for the appellant and Mr. T.R. Andhyarujina, learned senior counsel appearing for Respondent Nos.2 and 3 at length. Detailed arguments were addressed with regard to the correctness or otherwise of the order passed by the Controller as well as by the High Court and the consequences thereof. We find it unnecessary to examine all those contentions since we are sending this matter back to the Controller for fresh consideration in accordance with law. The main controversy raised in the case is on the non-furnishing of the copy of the recommendation of the Statutory Board constituted under Section 25(4) of the Act to the parties. Chapter V of the Patents Act, 1970 (for short, “the Act”) deals with the Opposition Proceedings to grant of patents. Section 25(1) of the Act enables any person to represent by way of Opposition to the Controller against the grant of patent, but before a patent has not been granted. Sub-section (2) of Section 25 enables any person interested to give notice of opposition to the Controller at any time after the grant of patent, but before the expiry of period of one year from the date of publication of grant of the patent. Clauses (a) to (k) of this sub-section are the grounds which can be taken by any person. It is specifically made clear that in sub-sections (1) and (2) of Section 25 of the Act that no other grounds are available to be taken by any person. Section 25(3)(b) of the Act deals with the constitution of the Opposition Board for examination and submission of its recommendations to the Controller. Clause (c) of Section 25(3) says that every Opposition Board constituted under clause (b) shall conduct examination in accordance with such procedure as may be prescribed. Chapter VI of the Patent Rules, 2003 (for short, “the Rules”) deals with the Opposition proceedings to grant of patents. Rule 56 deals with the constitution of Opposition Board and its proceeding.

Result 3
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 5
Relevancy Score: 56.31
   
   
   

Before the application for patent was taken up for consideration, the appellant made an application (Application No. EMR/01/2002) on March 27, 2002, for grant of exclusive marketing rights (EMR) for the subject product under section 24A of the Act, which was at that time on the statute book and which now stands deleted. The Patent Office granted EMR to the appellant by order dated November 10, 2003. 13. The appellant’s application for patent was taken out of the “mailbox” for consideration only after amendments were made in the Patents Act, with effect from January 1, 2005. But before it was taken up for consideration, the patent application had attracted five (5) pre-grant oppositions[6] in terms of section 25(1) of the Act. And it was in response to the pre-grant oppositions that the appellant had filed the affidavits on the issue of bioavailability of Imatinib Mesylate in beta crystalline form. 14. The Assistant Controller of Patents and Designs heard all the parties on December 15, 2005, as provided under rule 55 of the Patent Rules, 2003, and rejected the appellant’s application for grant of patent to the subject product by 5 (five) separate, though similar, orders passed on January 25, 2006 on the 5 (five) opposition petitions. The Assistant Controller held that the invention claimed by the appellant was anticipated by prior publication, i.e., the Zimmermann patent; that the invention claimed by the appellant was obvious to a person skilled in the art in view of the disclosure provided in the Zimmermann patent specifications; and further that the patentability of the alleged invention was disallowed by section 3(d) of the Act; and also that July 18, 1997, the Swiss priority date, was wrongly claimed as the priority date for the application in India and hence, the alleged invention was also anticipated by the specification made in the application submitted in Switzerland. 15. At that time, the appellate authority under the Act had yet to become functional. The appellant, therefore, challenged the orders passed by the Assistant Controller in writ petitions filed directly before the Madras High Court. Apart from challenging the orders of the Assistant Controller, the appellant also filed two writ petitions (one by the appellant and the other by its Indian power of attorney holder) seeking a declaration that section 3(d) of the Act is unconstitutional because it not only violates Article 14 of the Constitution of India but is also not in compliance with “TRIPS”. After the formation of the Intellectual Property Appellate Board, the five writ petitions challenging the five orders of the Assistant Controller were transferred from the High Court to IPAB by order dated April 4, 2007, where these cases were registered as appeals and were numbered as TA/1 to 5/2007/PT/CH.

Result 4
Supreme Court of India
(ID::1999 SCP 1062)
M/S Aristo Pharmaceuticals Ltd. vs M/S. Wockhardt Ltd.
Honourable Judges B.N. Kirpal, D.P. Mohapatra, R.P. Sethi
Date of Judgment: 24 Nov 1999
Segment Number (Approximate Page Number): 1
Relevancy Score: 56.14
   
   
   

ORDER 1. Leave granted. 2. We have heard counsel for the parties at length. The question involved in this case is whether in the suit for injunction filed by the respondent herein alleging violation of its trademark the Division Bench of the High Court should have reversed the finding of the Single Judge and granted temporary injunction. 3. In view of the fact that the suit is still pending and taking in to consideration then nature of dispute between the parties and the state of evidence, we do not think it proper and appropriate to deal with the matter in any great detail and to express opinion on the merits of the dispute because that may prejudice the parties at the time of trial of the suit. 4. We are here dealing with a case where the respondent, who manufacturing a drug under the name 'SPASMO-PROXYVON', registered in his favour, filed a suit for injunction against the appellant herein who was manufacturing and selling a drug called 'SPASMO-FLAXON'. The Single Judge of the Madras High Court by a reasoned order vacated the ex-parte injunction in his favour which had been granted. The said decision was challenged and the Division Bench allowed the appeal of the respondent and granted an injunction in his favour. 5. It is the case of the appellant herein that this is not a case where the trade-mark of 'SPASMOP-ROXYVON' is being violated by the appellant. According to the appellant the respondent is manufacturing the drug called 'PROXYVON'and also amilder form of that drug called'SPASMO-PROXYVON'. Similarly, the appellant is manufacturing the drug called 'FLEXON' and milder version of that called 'SPASMO-FLEXON'. According to the appellant the use of the word 'SPASMO' is meant to indicate that the drug is meant for the soft tissues. It is also the case of the appellant that the word 'SPASMO', which is being objected to by the respondent herein, has been used for several drugs since long before and after the respondent got its trade mark registered in the year 1977. 6. The respondent, on the other hand, submits that the words 'SPASMO-PROXYVON' having been registered in its name the appellant cannot use the word 'SPASMO' in the drug which is manufactured by it.

Result 5
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 72
Relevancy Score: 55.97
   
   
   

Needless to say that in regard to the tablet as well the reference is to the Zimmermann patent. [36] Not an “inventive step”! A “manipulative step” may or may not be an “inventive step”, which is the requirement under Indian law. [37] Imatinib. [38] Imatinib Mesylate. [39] There is a factual error in the submission in as much as in the Drug Approval application before the US FDA the drug Gleevec is represented as Imatinib Mesylate. Before the US FDA there is no reference to the beta crystalline form of Imatinib Mesylate. [40] Blocking Patents! [41] Recall that it is on the basis of this provision that the U.S. Board of Patent Appeals had held in the case regarding the appellant’s claim for patent for beta crystalline form of Imatinib Mesylate that “in light of 35 U.S.C. § 282, therefore, we may presume that the specification of the Zimmermann patent teaches any person skilled in the art how to use Imatinib, or a pharmaceutically acceptable salt thereof,…”. [42] [1992] R.P.C. 131 [43] [2009] EWHC 1916 (Pat) [44] 559 F.2d 595 [45] The following discussion on the Hogan decision is partially based on the article “Allocating Patent Rights Between Earlier and Later Inventions” by Charles W Adams, Professor of Law at the University of Tulsa College of Law, published in the Saint Louis University Law Journal (Vol. 54-55, 2009, pp 56-112). [46] Apart from the Hogan Decision, Mr. Subramanium also relied upon the relevant passage under the heading “Enablement and the Temporal Paradox” from the book “Patent Law and Policy: Cases and Materials” (Fifth Edition) by Robert Patrick Merges and John Fitzgerald Duffy…at pg. 298- [47] 315 F. 3d 1335, 1341 (Fed. Cir. 2003) [48] 363 F. 3d 1247, 1257 (Fed. Cir. 2004) [49] (1986) 1 SCC 642 [50] The New Oxford Dictionary of English, Edition 1998. [51] Prof. Basheer traced the origins of the amended part of section 3(d) in Article 10(2)(b) of European Drug Regulatory Directive, 2004 which defines a “generic medicinal product” as: “a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.

Result 6
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 70
Relevancy Score: 55.88
   
   
   

Section 14- Term of Patent. (1)The term limited in every patent for the duration thereof shall, save as otherwise expressly provided by this Act, be sixteen years from its date. [10] The Bakshi Tek Chand Committee’s (also called Patents Enquiry Committee I) report and the Ayyangar Committee’s report are important milestones in the development of the patent law in the country. [11] The different tables compiled in the Justice Ayyangar’s report are put together at one place at the end of this judgment in Appendix I. [12] Michel on Principal National Patent Systems, Vol. I, P.15 [13] The provisions quoted here are as those were enacted in the 1970 Act and before those provisions underwent the amendments with effect from January 1, 2005. [14] Chaudhuri, Sudip, The WTO and India’s Pharmaceuticals Industry (Patent Protection, TRIPS, and Developing Countries) (Oxford University Press, 2005). [15] For the purposes of Articles 3 and 4, “protection” shall include matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as those matters affecting the use of intellectual property rights specifically addressed in this Agreement. [16] For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively. [17] This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6. [18] Section 5 of the Act as before it was amended: Section 5. Inventions where only methods or processes of manufacture patentable.– In the case of inventions – a) claiming substances intended for the use, or capable of being used, as food or as medicine or drug, or b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds), no patent shall be granted in respect of claims for the substances themselves, but claims for the methods of processes of manufacture shall be patentable. [19] During this brief period, 125 applications for product patents were received and filed. [20] Excepting all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances referred to in sub-clauses (i) to (iv) of section 2 (1) (l) of the Parent Act. [21] Here it will be unfair not to state that in course of hearing of the case when the Court expressed its bewilderment over the price of the drug, it was strenuously stated on behalf of the appellant that they also ran a huge charitable programme under which the drug was supplied free to the needy persons.

Result 7
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 50
Relevancy Score: 55.63
   
   
   

It is, of course, a fundamental principle that the construction of a claim is the same whether validity or infringement is to be considered; no patentee is entitled to the luxury of an “elastic” claim which has a narrow meaning in the former case but a wide meaning in the latter. Under English procedure, infringement and validity are normally litigated at the same time and therefore the court is astute to avoid such a result. …” (emphasis added) 144. Chisum on Patents: A Treatise on the Law of Patentability, Validity, and Infringement (Vol. 3, June 2007) in Chapter: “Adequate Disclosure” notes: “§ 7.03 – The Enablement Requirement Since 1790, the patent laws have required that the inventor set forth in a patent specification sufficient information to enable a person skilled in the relevant art to make and use the invention. The “invention” that must be enabled is that defined by the particular claim or claims of the patent or patent application. This is consistent with the general principle of patent law that the claim defines the invention for purposes of both patentability and infringement.” 145. Nevertheless, both Mr. Andhyarujina and Mr. Subramanium strenuously argued that the coverage or the claim, and the disclosure or the teaching, have different parameters in a patent, and that the former may have an extended boundary within which disclosure or teaching may be confined to a narrower extent. In support of the submission, Mr. Andhyarujina relied upon a decision of the Court of Appeal in A.C. Edwards Ltd. v. Acme Signs & Displays Ltd.[42] and another of the High Court of Justice Chancery Divisions Patent Court in Astellas Pharma Inc v. Comptroller-General of Patents[43]. 146. Mr. Gopal Subramanium strongly relied upon the decision of United States Court of Customs and Patent Appeals in In re Hogan[44] in support of his contention. 147. In Hogan, the Court of Customs and Patent Appeals held that a patent application that disclosed and enabled a method of making the crystalline form of polymer was entitled to a claim for the method of making a solid polymer, because the only known method for making a solid polymer at the time was the applicants’ method of making the crystalline form. 148. The Hogan decision was rendered in a jurisdiction that has the historical background of Blocking Patents.

Result 8
Supreme Court of India
(ID::2001 SCP 367)
Cadila Healthcare Limited vs Cadila Pharmaceuticals Limited
Honourable Judges Doraswamy Raju, British Kumar
Date of Judgment: 26 Mar 2001
Segment Number (Approximate Page Number): 1
Relevancy Score: 55.28
   
   
   

CASE NO.: Appeal (civil) 2372 of 2001 Special Leave Petition (civil) 15994 of 1998 PETITIONER: CADILA HEALTHCARE LIMITED Vs. RESPONDENT: CADILA PHARMACEUTICALS LIMITED DATE OF JUDGMENT: 26/03/2001 BENCH: B.N.Kripal, Doraswamy Raju, British Kumar JUDGMENT: KIRPAL,J. L.....I.........T.......T.......T.......T.......T.......T.......J Leave granted. Appellant and respondent are pharmaceutical companies manufacturing various pharmaceutical products. The two companies had taken over the assets and business of the erstwhile Cadila Group after its restructuring under Sections 391 & 394 of the Companies Act. One of the conditions in the scheme of restructuring of the Cadila Group was that both the appellant and the respondent got the right to use the name CADILA as a corporate name. The present proceedings arise from the suit for injunction which had been filed by the appellant against the respondent in the District Court at Vadodara. The suit related to a medicine being sold under the brand name Falcitab by the respondent which, according to the appellant, was a brand name similar to the drug being sold by it under its brand name Falcigo The case of the appellant was that its drug Falcigo contains Artesunate for the treatment of cerebral malaria commonly known as Falcipharum. After the introduction of this drug, the appellant on 20th August, 1996 applied to the Trade Marks Registry, Ahmedabad for registration in Part-A, Class-5 of the Trade and Merchandise Marks Act. On 7th October, 1996 the Drugs Controller General (India) granted permission to the appellant to market the said drug under the trade mark of Falcigo. It is, thereafter, that since October, 1996 the appellant claimed to have started the manufacture and sale of drug Falcigo all over India. The respondent company is stated to have got permission on 10th April, 1997 from the Drugs Controller General (India) to manufacture a drug containing Mefloquine Hydrochloride. The respondent was also given permission to import the said drug from abroad. According to the appellant, it came to know in April, 1998 that the said drug, which was also used for the treatment of Falcipharum Malaria, was being sold by the respondent under the trade mark of Falcitab.

Result 9
Supreme Court of India
(ID::2003 SCP 703)
Secretary, Ministry Of Chemicals & ... vs M/S. Cipla Ltd. & Ors
Honourable Judges S. Rajendra Babu, P.Venkatarama Reddi, Arun Kumar
Date of Judgment: 01 Aug 2003
Segment Number (Approximate Page Number): 11
Relevancy Score: 55.25
   
   
   

The High Court observed that the particulars furnished by the petitioner were not effectively controverted, there being only a bald denial. It was therefore held that the drug ought not to have been brought under price control. As per the statement furnished by the learned Solicitor General at the time of hearing, the fact that there were more than five bulk drug producers, was accepted but the number of formulators was given as seven. Therefore, the dispute is confined to the number of formulators, the term 'formulator' being understood in the sense in which the Government of India explained in its clarificatory letter dated 6-4-1998. 7.4 Cloxacillin : The writ petitioners concerned are said to be the manufacturers of formulations made out of Cloxacillin. There is no dispute that the annual turnover at the relevant time was much more than 400 lacs. The writ petitioners claimed exclusion of the drug Cloxacillin on the basis of clause (iii) of para 22.7.2. According to them, there were as many as 16 bulk drug producers and 23 formulators in respect of Cloxacillin and none of the formulators had more than 40% market share as per the ORG figures for the year 1989-90 (upto March 1990). The High Court accepted the case of the petitioners on the ground that the factual particulars were not controverted, but there was only a bald denial in the counter affidavit filed by Union of India. The counter-affidavit of Union of India is not found either in S.L.P. paper books or the original record of High Court. However, the stand of Union of India, as is clear from the reply dated 6.4.1998 of the NPPA sent to the Bulk Drug Manufacturers' Association as well as the Grounds of SLP is that the number of single ingredient formulators of the drug was less than 10. According to the statement furnished by the learned Solicitor General in the course of the arguments, the number of formulators were only two. The NPPA clarified the position thus: "The Association has claimed that the highest market share of single formulator is 21.89%. This claim is based on consideration of sale values of both single ingredient and combination products of Cloxacillin. However, the highest market share of single drug ingredient formulation of a particular formulator works out to 93.07% which is more than the stipulated level of 40%." Thus, there is controversy regarding the number of formulators and their market share. 7.5 Cyproflaxacin: The 2nd petitioner in writ petition No. 3449 of 1996, namely, Ranbaxy Laboratories Ltd. produced the said bulk drug during the relevant period and captively consumed the same in the manufacture of formulations marketed under the brand name of Cifran both in India and foreign countries. The petitioner in W.P.No. 1974 of 2000 is Cipla Ltd. Inter alia, it is engaged in the manufacture and sale of formulations of the drug Cyproflaxacin.

Result 10
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 47
Relevancy Score: 54.7
   
   
   

136. Mr. Subramanium further submitted that the scope of coverage is distinct from the scope of disclosure in a patent. Imatinib Mesylate could be said to be not new and known from the Zimmermann patent only in case there was a complete disclosure of the method of its preparation in the Zimmermann patent. The learned counsel strongly contended that coverage under a patent of the Markush kind cannot lead to any presumption of disclosure, much less any enabling disclosure of all the compounds within the genus. The learned counsel further contended that coverage that is granted in respect of a patent is not always coextensive with what is disclosed in that patent. In certain circumstances, where it is a pioneering invention (as in the case of the Zimmermann invention), the patent may be entitled to larger coverage than what is specifically disclosed in it. The learned counsel argued that coverage cannot be used to presume an enabling disclosure of the beta crystalline form of Imatinib Mesylate in the Zimmermann patent. Disclosure in a specification can never be presumed, and that is a question of the clear teaching contained in the specification. The teaching of a patent lies in the disclosure/specification that supports the claim. The disclosure describes the invention. The claim defines through language the various ways the invention could be used, i.e., possible but not actualized products. This is the scope of protection granted under the patent. For the purpose of prior art, it is the disclosure in the specification supporting the claim and not the written description or the claims themselves, that must be assessed. The claim can never be the teaching. He further contended that it would be wrong to say that the appellant’s claims for beta crystalline form of Imatinib Mesylate is a case of double or repeat patenting, that is, the same invention is being sought to be patented twice. The claim for patent for beta crystalline form of Imatinib Mesylate relates to a second and different invention. Though the invention in the first part (Imatinib) may be necessary to arrive at the invention in the second part, the final product does not come into existence without inventions. The principle is that if a product is covered, it means that it infringes a patent. Whether the patent infringed disclosed every aspect of the product in its specification is a separate inquiry. 137. Mr. Subramanium maintained that the boundary of the Zimmermann patent was extended up to Imatinib Mesylate but the enablement or disclosure made therein ended at Imatinib. He submitted that it was possible for Zimmermann himself, or for anyone else, to invent Imatinib Mesylate starting from Imatinib.

Result 11
Supreme Court of India
(ID::2019 SCP 32)
Monsanto Technology Llc Thru The ... vs Nuziveedu Seeds Ltd. Thru The Director
Honourable Judges Navin Sinha, Rohinton Fali Nariman
Date of Judgment: 08 Jan 2019
Segment Number (Approximate Page Number): 3
Relevancy Score: 54.3
   
   
   

8. Dr. Abhishek Manu Singhvi contended that the plaintiffs’ suit was for injunction restraining infringement of an existing and valid patent. The lack of patentability was never an issue in the suit. The defendants argued lack of patentability to invalidate the primary issue relating to infringement only. The counter claim for revocation of the patent as unpatentable, was neither argued nor adjudicated by the learned Single Judge. Only notice was issued on the counter claim bearing no.51 of 2016 while counter claim bearing no.50 of 2016 challenging the termination of sub­ licence agreement was withdrawn. The issue for existence of the patent, patent exclusion under Section 3(j) of the Act was a heavily mixed question of law and facts requiring formal proof and expert evidence, to be considered at the hearing of the suit, as rightly observed by the Single Judge. The defendants in their memo of appeal themselves contended that the issue regarding existence of the patent and/or its revocation could not have been decided summarily by the learned Single Judge as these were matters which required evidence and could be adjudicated only at the final trial of the suit. The plaintiffs’ claims were under 25­27 only. The process claims 1­24 was never an issue in consideration before the Single Judge and yet the Division Bench delved into the same and held the process claims to be bad also. 9. The plaintiffs had never consented to a summary adjudication regarding the validity of its patent. The consent referred to by the Division Bench, had been given only to decide whether the plaintiffs’ patent had been infringed or not, as also the scope of the patent, so as to allow or disallow the relief of injunction. It is incomprehensible that the plaintiffs holding a valid registered patent under the Act nonetheless would have agreed to a summary consideration and validation/invalidation of the patent. The patent comprises of a DNA construct or nucleotide sequence in claim 25­27 comprising of three different components, i.e. (i) a promoter (ii) a man­made gene for the production of Cry2Ab 5­endotoxin and, (iii) a third component for the production of a transit peptide 6. The DNA construct so created did not exist in nature and upon insertion into a plant confers insect tolerant trait. A plant is next produced as a “fusion protein” which comprises the Cry2Ab S­endotoxin 7 bonded with the transit peptide. The subject patent claims use of bacillus thuringiensis strain and the development of two genes designated Cry2Aa and Cry2Ab. Each gene sequence is known for its ability to synthesize proteins with pesticidal properties. The NAS is not a living organism but a chemical created in a laboratory. The “event” which is the positioning of the NAS at a unique location in the genome of a plant cell is a separate, subsequent and entirely different invention for which the plaintiffs have obtained a different patent no.

Result 12
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 52
Relevancy Score: 54.15
   
   
   

The rationale on which the decision is based is described by Professors Merges and Duffy as the “temporal paradox”[46]. The professors explain that, approached in this way, the description and enablement requirements for the genus are determined as of the date of filling the patent, and the patentee gets the benefit of any addition to the genus discovered later. 154. It needs to be noted here that even in the US, Hogan represents a decision given in the context of the special set of facts and circumstances of the litigation over polypropylene. In later decisions, the Federal Circuit appears to have drastically narrowed Hogan’s scope as a precedent. In Plant Genetics System, N.V. v. DeKalb Genetics Corp,[47] the effect of Hogan was considerably constricted and its effect is virtually eliminated in Chiron Corp. v. Genentech, Inc[48]. Since Chiron, the Federal Circuit has not referred to Hogan in any of its cases that involve claims to a genus where a single species was enabled. 155. Mr. Subramanium refers to the Hogan decision in order to support his contention that the Zimmermann patent is a patent covering a genus with certain known species, and many other species that were unknown at that time, but which are equally covered by the patent, even though there is no enabling disclosure in the patent in respect thereof. But it is already found and held earlier that Imatinib Mesylate is a known substance from the Zimmermann patent. The finding that Imatinib Mesylate is a known substance from the Zimmermann patent is not based on the conduct of the appellant alone, as objected to by Mr. Andhyarujina, but the finding has been arrived at on an objective consideration of all the material facts and circumstances. In view of that finding, we fail to see any application of the Hogan decision to the facts of the case. We have also considered the two decisions relied upon by Mr. Andhyarujina. Those two decisions also have no application to the facts of the present case, for the same reason as in case of Hogan. 156. However, before leaving Hogan and proceeding further, we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent. 157. In light of the discussions made above, we firmly reject the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent.

Result 13
Supreme Court of India
(ID::2014 SCP 418)
Dr. Aloys Wobben And Another vs Yogesh Mehra And Others
Honourable Judges Jagdish Singh Khehar, A.K. Patnaik
Date of Judgment: 02 Jun 2014
Segment Number (Approximate Page Number): 14
Relevancy Score: 54.09
   
   
   

Therefore, no interpretation can be placed on Section 64 of the Patents Act, which will be in conflict with, any other provision(s) of the Patents Act. 18. If any proceedings have been initiated by “any person interested”, under Section 25(2) of the Patents Act, the same will eclipse the right of the same person to file a “revocation petition” under Section 64(1) of the Patents Act. And also, to invoke the right granted under Section 64(1) of the Patents Act, to file a “counter-claim” (in response to an “infringement suit”, to seek the revocation of a patent). This, in our view, would be the natural effect of the words, “Subject to the provisions contained in this Act…..”, appearing at the beginning of Section 64(1) of the Patents Act. And if, the above meaning is not to be assigned to the words “Subject to the provisions of this Act…..”, they would be redundant and superfluous. It is however not necessary to pay a serious thought to the situation referred to above. The above situation, in our considered view, is unlikely to ever arise. This is because, Section 25 of the Patents Act, inter alia, provides for the procedure, for the grant of a patent. The procedure commences with the filing of an application. The second step contemplates publication of the details of the patent sought. The next step envisages, the filing of representations by way of opposition (to the grant of the patent). This advances into a determination by the “Controller”, to grant or refuse the patent. The decision of the “Controller”, leads to the publication of the grant (of the patent). This process finalises the decision of the grant of the patent. All the same, it does not finally crystalise, the right of the patent holder. After the grant is published, “any person interested”, can issue a notice of opposition, within one year of the date of publication of the grant of a patent. If and when, challenges raised to the grant of a patent are disposed of favourably, to the advantage of the patent holder, the right to hold the patent can then and then alone, be stated to have crystallized. Likewise, if no notice of opposition is preferred, within one year of the date of publication of the grant of a patent, the grant would be deemed to have crystallized. Thus, only the culmination of procedure contemplated under Section 25(2) of the Patents Act, bestows the final approval to the patent. Therefore, it is unlikely and quite impossible, that an “infringement suit” would be filed, while the proceedings under Section 25(2) are pending, or within a year of the date of publication of the grant of a patent. 19. The defendant party to a suit for infringement, who seeks to repudiate the charge of infringement, is allowed to raise a “counter-claim”, so as to enable him to raise a challenge, to the validity of the patent assigned to the author of the suit (under Section 64 of the Patents Act).

Result 14
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 6
Relevancy Score: 54.05
   
   
   

16. The appellant’s appeals against the orders passed by the Assistant Controller were finally heard and dismissed by the IPAB by a long and detailed judgment dated June 26, 2009. 17. The IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness. It held that the appellant’s invention satisfied the tests of novelty and non-obviousness, and further that in view of the amended section 133, the appellant was fully entitled to get July 18, 1997, the date on which the patent application was made in Switzerland, as the priority date for his application in India. The IPAB, however, held that the patentability of the subject product was hit by section 3(d) of the Act. Referring to section 3(d) the IPAB observed: “Since India is having a requirement of higher standard of inventive step by introducing the amended section 3(d) of the Act, what is patentable in other countries will not be patentable in India. As we see, the object of amended section 3(d) of the Act is nothing but a requirement of higher standard of inventive step in the law particularly for the drug/pharmaceutical substances.” 18. The IPAB also referred to the judgment of the Madras High Court, dismissing the appellant’s writ petitions challenging the constitutional validity of section 3(d) where the High Court had observed: “We have borne in mind the object which the amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of the country to life saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.”  19. In light of the High Court’s observation, the IPAB also referred to the pricing of the drug Gleevec by the appellant while it enjoyed EMR over it, and held that the patentability of the subject product would also be barred by section 3(b) of the Act and in this regard observed as follows: “We are fully conscious of the Appellant’s benevolent GIPAP program for free distribution of GLEEVEC to certain cancer patients.  But as per information furnished in its written counter–argument by R 3 that when the Appellant was holding the right as EMR on GLEEVEC it used to charge Rs.1,20,000/- per month for a required dose of the drug from a cancer patient, not disputed by the Appellant,  which in our view is too unaffordable to the poor cancer patients in India.  Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective.  This will have disastrous effect on the society as well.

Result 15
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 37
Relevancy Score: 53.65
   
   
   

According to the appellant, beginning with Imatinib, the subject product, i.e., Imatinib Mesylate in beta crystalline form, was brought to being by not one but two inventions. 106. The first invention lies in selecting example 21 out of the 37 examples given in the Zimmermann patent and then choosing methanesulfonic acid to produce the methanesulfonic acid addition salt of the free base Imatinib, called Imatinib Mesylate. It was emphasized by both Mr. Gopal Subramanium and Mr. Andhyarujina, Senior Advocates appearing for the appellant, that the Zimmermann patent did not teach or suggest to a person skilled in the art to select example 21 in preference to other compounds of which examples were given in the Zimmermann patent. Further, even if example 21 was selected, the Zimmermann patent did not teach a person to select one particular salt. The Zimmermann patent did not teach a person how to prepare Mesylate salt of example 21. Hence, the coming into being of Imatinib Mesylate from Imatinib in free base was the result of an invention that involved technical advance as compared to the existing knowledge and brought into existence a new substance. 107. In the second invention, the appellant arrived at the beta crystal form of methanesulfonic acid addition salt of Imatinib. It was contended on behalf of the appellant that once the salt form of Imatinib was arrived at, the inventors had to further research to be able to ensure that that particular salt form of Imatinib is suitable for administration in a solid oral dosage form. This research further required defining the process parameters that brought into being the beta crystalline form of Imatinib Mesylate. It was argued on behalf of the appellant that there is certainly no mention of polymorphism or crystalline structure in the Zimmermann patent. The relevant crystalline form of the salt that was synthesized needed to be invented. There was no way of predicting that the beta crystalline form of Imatinib Mesylate would possess the characteristics that would make it orally administrable to humans without going through the inventive steps. It was further argued that the Zimmermann patent only described, at most, how to prepare Imatinib free base, and that this free base would have anti-tumour properties with respect to the BCR ABL kinase. Thus, arriving at the beta-crystalline form of Imatinib Mesylate for a viable treatment of Chronic Myeloid Leukemia required further invention – not one but two, starting from Imatinib in free base form, as stated above. 108. The subject product admittedly emerges from the Zimmermann patent.

Result 16
Supreme Court of India
(ID::2024 SCP 388)
M/S Sun Pharmaceutical Industries Ltd vs Union Of India Department Of Chemicals ...
Honourable Judges Sanjay Kumar
Date of Judgment: 15 Jul 2024
Segment Number (Approximate Page Number): 5
Relevancy Score: 53.41
   
   
   


However, that would not be sufficient to exclude the appellant from the ambit of Paragraph 13 of the DPCO. The intent and purpose thereof are to control the prices at which medicinal drug formulations are made available to the common man by holding out the threat of recovery of the higher prices charged for such drug formulations by those involved in their manufacture and marketing. Given the laudable objective underlying the provision, it cannot be subjected to a restricted or hidebound interpretation. 12. Pertinent to note, the agreement, if any, between the manufacturer and the appellant in relation to the purchase and sale of Roscilox was never produced. This failure was explicitly raised before the Division Bench by the respondent authorities, stating that the appellant had not made complete disclosure, despite sufficient opportunity, as to its arrangement with Oscar Laboratories Pvt. Ltd. for the distribution of the drug formulation. Significantly, before the Division Bench of the High Court, the appellant came up with a new version that it had purchased the drug formulation from Delta Aromatics Pvt. Ltd. from September, 1999. This story was not accepted by the Division Bench as it was an altogether new story that was introduced afresh. 13. Given its own inconsistent versions and in the absence of a firm factual foundation being built up by the appellant with proper documentation as to its status, it was not open to it to baldly claim that it was not a €˜distributor€™ but only a €˜dealer€™. 14. We, therefore, find no error committed by the High Court in rejecting the claim of the appellant. The appeal is devoid of merit and is accordingly dismissed. Order of status quo dated 10.11.2014 shall stand vacated. Pending applications, if any, shall also stand dismissed. Parties shall bear their own costs. ................................, J Sanjay Kumar ................................, J Augustine George Masih July 15, 2024; New Delhi.

Result 17
Supreme Court of India
(ID::1986 SCP 13)
Monsanto Company By Their Patent Agent, ... vs Coramandal Indag Products (P) Ltd
Honourable Judges O. Chinnappa Reddy, E.S. Venkataramiah
Date of Judgment: 14 Jan 1986
Segment Number (Approximate Page Number): 8
Relevancy Score: 53.34
   
   
   

We must begin with the statement in the plaint that "THE ACTIVE INGREDIENT MENTIONED IN THE CLAIM IS CALLED 'BUTACHLOR'" which suggests that Butachlor was covered by the Plaintiffs' patents and the circumstance now admitted that no one, neither the plaintiff nor any one else, has a patent for Butachlor. The admission was expressly made by PW-2, the power of attorney holder of the first plaintiff and Director of the second plaintiff company. The learned counsel for the plaintiffs also admitted the same before us. PW-1, Dr. Dixon, Chemist of the first plaintiff company, after explaining the use of an emulsifying agent, in answer to a direct question, whether his company claimed any patent or special knowledge for the use of any particular solvent or particular emulsifying agent, in the formulation in their patent, had to admit that they had no such patent or special knowledge. He further admitted that the use of solvent and emulsifying agent on the active ingredient was one of the well-known methods used in the pesticide industry to prepare a marketable product. He also expressed his inability to say what diluents or emulsifying agents the defendant used in their process. PW-2 admitted that Butachlor was a common name and that the Weed Science Society of America had allotted the common name. He stated that "Machete" was the brand name under which their company manufactured Butachlor. He also stated that there could be a number of concerns all over the world manufacturing Butachlor, but he was not aware of them. He admitted that they did not claim a patent for Butachlor. He stated that though his company did not claim a patent for Butachlor, they claimed a patent for the process of making a Butachlor emulsifiable concentrate to be used as a Herbicide composition for rice. Pursued further in cross-examination, he was forced to admit that they used kerosene as a solvent for Butachlor and an emulsifier manufactured by a local Indian company as an emulsifying agent. He then proceeded to state that he claimed secrecy with regard to the manufacture of their formulation. When he asked further whether the secrecy claimed was with regard to the solvent or with regard to the stabilizer, he answered in the negative. He finally admitted that his secret was confined to the active ingredient Butachlor about which as we know there is no secret.

Result 18
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 43
Relevancy Score: 52.94
   
   
   

However, the Board of Patent Appeals held that the teaching in the Zimmermann patent did not go beyond Imatinib Mesylate and did not extend to beta crystalline form of Imatinib Mesylate, which represented a manipulative step[36] in a method of treating tumor disease in a patient. 125. Further, NATCO Pharma Ltd., one of the Objectors to the grant of patent to the appellant in this country, had marketed a drug called VEENAT 100 (capsules) in the UK. A legal notice on behalf of the appellant was given to NATCO Pharma Ltd. on February 13, 2004. The notice stated that the appellant was the proprietor of European patent EP-A- 0 564 409 (the Zimmermann patent) and that this patent claimed, among other things, the compound Imatinib and acid addition salts of that compound such as the Mesylate salt. In the notice it was pointed out that NATCO Pharma Ltd. was selling, in the UK market, VEENAT 100 capsules, the active pharmaceutical ingredient of which was Imatinib Mesylate as claimed in the Zimmermann patent. The importation, sale and offer to sell VEENAT 100 capsules in the UK market infringed the Zimmermann patent and NATCO Pharma Ltd. was therefore warned to immediately cease the importation, sale and promotion of VEENAT 100 capsules and other pharmaceutically substances containing “Imatinib”. The matter was finally settled out of court, we are told, at considerable expense to NATCO Pharma Ltd. which of course had to stop marketing its drug VEENAT 100 capsules in the UK. 126. From the above discussion it would be clear that the drug Gleevec directly emanates from the Zimmermann patent and comes to the market for commercial sale. Since the grant of the Zimmermann patent, the appellant has maintained that Gleevec (that is, Imatinib Mesylate) is part of the Zimmermann patent. It obtained drug approval for Gleevec on that basis. It claimed extension of the term of the Zimmermann patent for the period of regulatory review for Gleevec, and it successfully stopped NATCO Pharma Ltd. from marketing its drug in the UK on the basis of the Zimmermann patent. Not only the appellant but the US Board of Patent Appeals, in its judgment granting patent for beta crystalline form of Imatinib Mesylate, proceeded on the basis that though the beta crystal form might not have been covered by the Zimmermann patent, the Zimmermann patent had the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. This finding was recorded by the US Board of Patent Appeals, in the case of the appellant itself, on the very same issue that is now under consideration. The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea. 127. We have looked, so far, at the Zimmermann patent and the developments that have taken place on its basis. We now propose to take a look at certain publications.

Result 19
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 46
Relevancy Score: 52.93
   
   
   

133. We thus find no force in the submission that the development of Imatinib Mesylate from Imatinib is outside the Zimmermann patent and constitutes an invention as understood in the law of patent in India. 134. Mr. Andhyarujina and Mr. Gopal Subramanium, learned Senior Advocates appearing for the appellant, strenuously argued that the patent information furnished by the appellant before the US FDA, or its Patent Term Extension Application, or the legal notice given at its behest to NATCO Pharma Ltd. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann patent. Mr. Andhyarujina submitted that the Zimmermann patent did not disclose Imatinib Mesylate. The Zimmermann patent did not describe any working method for converting Imatinib to Imatinib Mesylate. It only stated that a salt may be formed by acid without disclosing any method, but simply calling the method to be “per se”. The Zimmermann patent mentioned multiple choices of compounds including Imatinib free base but not any salt of any compound, much less Imatinib Mesylate. Mr. Andhyarujina further submitted that it is well settled that the disclosure of an invention must be in a manner clear enough and complete enough for the invention to be performed by a person skilled in the art (Terrell on Law of Patents 16th edition, page no. 51, para 3.2/7). The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann patent but not disclosed therein. He further submitted that, in any case, in patent law subsequent conduct of the patentee is irrelevant in construing the patent (Terrell on Law of Patent 16th edition, page no. 192 citing Glaverbel vs. British (1993) RPC 80). Referring to the two articles in Cancer Research and Nature Medicine, Mr. Andhyarujina submitted that though in the first article there was a reference to Imatinib Mesylate, there was no teaching as to how it is to be prepared. In the Nature Medicine article there was no reference to Imatinib Mesylate but only to Imatinib. 135. Mr. Gopal Subramanium submitted that the Zimmermann patent is a patent for “Pyrimidine Derivatives and Processes for the Preparation thereof”. The patent is related to a genus of compounds, and each of the compounds within the genus shares a common chemical structure (Markush structure) and common properties with respect to the inhibition of certain tyrosine kinases (there being a total of 518 kinases in existence). Mr. Subramanium further submitted that the appellant in its application before the US Food and Drug Administration Authority had made a reasonable assertion that the Zimmermann patent covers the product that was made out of the beta crystalline form of Imatinib Mesylate, i.e., Gleevec[39].

Result 20
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 42
Relevancy Score: 52.4
   
   
   

Claim 21 claims a composition containing a compound or compounds which include the approved product, imatinib mesylate. Claim 22 claims a method of treating tumors in warm-blooded animals with a compound or compounds which include the approved product, imatinib mesylate.” 122. The application was accepted and the term of the patent, which was due to expire on May 28, 2013, was extended for the period of 586 days. 123. It is noted above that the appellant had made an application no. 09/463,097 in the USA for grant of patent for beta crystalline form of Imatinib Mesylate. The application was rejected by the examiner and, against the examiner’s decision, the appellant preferred an appeal (that is, appeal no. 2003-0919) before the Board of Patent Appeals and Interferences. The Board of Patent Appeals, by its judgment and order dated November 23, 2003, allowed the appellant’s appeal and reversed the examiner’s decision, rejecting claims 1 through 8, 10, and 13 through 16. Dealing with the examiner’s rejection of appellant’s claim 14 under 35 USC § 112, the Board of Patent Appeals referred to claims 21 and 22 of the Zimmermann patent. With reference to those claims in the Zimmermann patent, the Board of Patent Appeals observed and held as under: “Under the provisions 35 U.S.C. § 282, a patent shall be presumed valid; and each claim of a patent shall be presumed valid independently of the validity of other claims. Accordingly, claims 21 and 22 of the U.S. Patent No.5,521,184 (the Zimmermann patent), shall be presumed valid. We may presume, therefore, that claims 21 and 22 are based on an enabling disclosure; and that the specification of the Zimmermann patent teaches any person skilled in the art how to use a compound of formula I, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. In claim 23, Zimmermann recites imatinib, a specific compound within the scope of formula I, or a pharmaceutically acceptable salt thereof. In light of 35 U.S.C. § 282, therefore, we may presume that the specification of the Zimmermann patent teaches any person skilled in the art how to use imatinib, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. On these facts, we disagree that the examiner has set forth adequate reasons or evidence to doubt the objective truth of statements in applicants’ specification that an effective amount of the ß-crystal form of imatinib mesylate may be administered to a patient as the manipulative step in a method for treating tumour disease in a patient.

Result 21
Supreme Court of India
(ID::2003 SCP 706)
Secretary, Ministry Of Chemicals & ... vs M/S. Cipla Ltd. & Ors
Honourable Judges S. Rajendra Babu, P.Venkatarama Reddi, Arun Kumar
Date of Judgment: 01 Aug 2003
Segment Number (Approximate Page Number): 14
Relevancy Score: 51.73
   
   
   

Moreover, the High Court was under an apparent misapprehension that the Writ Petitioner sought the benefit of exclusion under clause (iii) also. The core controversy, as already noticed, is regarding the quantum of turnover. The Union of India took the stand that the turnover was above 400 lacs. In the statement filed by the learned Solicitor-General at the time of argument, the figure was given as 471.77 lacs. However, the appellant did not furnish any details as to the calculation of turnover. 7.8 Glipizide: The writ petitioner—USV Limited is a manufacturer of the bulk drug 'Glipizide' which is sold under the brand name of Glynase. It does not appear that there was any other producer of bulk drug during the relevant period. It is the case of the writ petitioner that the annual turnover for the year ending 31st March, 1990 was only Rs. 82 lacs and that clause (ii) is not therefore attracted. The writ petitioner estimated the turnover figure by arriving at the consumption of the bulk drug in various formulations and by multiplying the same by the MRP (Maximum Retail Price). The ORG data relating to sales of formulations was furnished. The stand of the Central Government is that production data was not available for the year 1989-90 and the turnover of the bulk drug was determined by the expert group on the basis of the landed cost of imports during the year to the tune of Rs.322.50 lacs. As there was only one formulator as reported in ORG survey of March, 1990, monopoly situation was considered to be existing "since one formulator was having 100% market share as on 31.3.1990". Disputing the assertion of the writ petitioner that as per ORG data furnished in Ext.F to the writ petition, there was no single formulator having 90% or more market share in retail trade, it is pointed out in Paragraph (iv) of the counter-affidavit that Ext.F includes formulations based on the bulk drugs other than Glipizide. It is further stated in the same para of the counter that there is only one formulation, namely, Glynase based on Glipizide and in respect of that, the writ petitioner had 100% market share. Thus, the dispute mainly centers round the quantum of turnover. The High Court observed that "even assuming that the petitioners were the sole manufacturers of the said drug, as the turnover was below Rs.100 lacs, the monopoly situation, as envisaged in para 22.7.2 (ii) of Drug Policy, 1994 does not apply and as such the said drug ought to be kept out of the purview of DPCO, 1995". The plea of discrimination between this drug and another anti- diabetic drug known as Insulin also found favour with the High Court.

Result 22
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 23
Relevancy Score: 51.71
   
   
   

We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. 7. We reaffirm the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.” 65. In the course of the hearing, we were told that the Doha Declaration effectively reflected and addressed the deep disquiet of the developing and the least-developed countries regarding their obligation under TRIPS to grant patent protection for pharmaceutical and agricultural chemical products and the likelihood of its highly adverse consequence on public- health. Dr. Dhawan, appearing for Cipla (one of the Objectors), was particularly severe in his criticism of the TRIPS Agreement and called it a “predatory and coercive” agreement. The other counsel, though, appearing for the different Objectors, were more muted in their criticism of the TRIPS Agreement. Mr. Kuhad, the learned Additional Solicitor General appearing for the Union of India, and Mr. Grover, Senior Advocate, appearing on behalf of the M/s. Cancer Patients Aid Association (one of the Objectors), especially adapted their submissions, taking the TRIPS Agreement as a fact that cannot be simply wished away. However, all the counsel representing the Union of India and the different Objectors unanimously took the stand that the TRIPS Agreement has sufficient flexibility (vide Articles 7, 8 and 27), which was further reaffirmed by the Doha Declaration (in paragraphs 4 to 6), to enable the member States to control the patent rights in a manner as to avoid any adverse impact on public-health. It was contended on behalf of the Union of India and the Objectors that the TRIPS Agreement coupled with the Doha Declaration leaves it open to the member States to adjust their respective patent systems by regulating the grant of patents and to set up higher standards for patent protection for pharmaceutical and agricultural chemical products. The Union of India and all the Objectors maintained that the patent law in India, as it stands to-day after major changes were brought about in the Patents Act, 1970 in 2005, is fully TRIPS compliant.

Result 23
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 24
Relevancy Score: 51.67
   
   
   

66. We have referred to the TRIPS Agreement and certain developments arising from it not to comment upon the fairness or otherwise of the Agreement nor to examine the correctness and wisdom of the decision of the Government of India to subscribe to the Agreement. That is farthest from our mind. We have referred to the Agreement as being the main reason behind the basic changes brought about in the patent law of the country by legislative action. We have also referred to the Agreement as being the cause of a good deal of concern not only in this country but also (as we shall see presently) in other parts of the world; the concern being that patent protection to pharmaceutical and agricultural chemical products might have the effect of putting life-saving medicines beyond the reach of a very large section of people. In the following lines we shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). 67. We have seen above that, simultaneously with the TRIPS coming into force, the Government of India had brought an Ordinance to comply with the provisions of Article 70 (8) and (9), but the Ordinance lapsed without being replaced by any enactment. Complaints were then filed on which pronouncements were made against India. On the complaint filed by the USA, the decision of the Appellate Body was rendered on December 19, 1997; and on the complaint filed by the European Communities, the report of the Panel came on August 24, 1998. Thus faced with the threat of trade sanctions, Parliament passed the Patents (Amendment) Act 1999 (Act No. 17 of 1999) on March 26, 1999, which amended the provisions of the Patents Act 1970 retrospectively, with effect from January 1, 1995, the date when the TRIPS Agreement came into force. By the Amendment Act of 1999, section 5 of the Parent Act was amended to provide for making “a claim for patent of an invention for a substance itself intended for use or capable of being used, as medicine or drug”[20]. The Amendment Act further incorporated in the Parent Act, Chapter IVA, which contained provisions for grant of exclusive marketing rights in respect of pharmaceutical substances for which a claim for patent was made under section 5 of the Act. The Amendment Act of 1999 thus complied with Article 70(8) and (9) of the TRIPS Agreement.

Result 24
Supreme Court of India
(ID::2019 SCP 32)
Monsanto Technology Llc Thru The ... vs Nuziveedu Seeds Ltd. Thru The Director
Honourable Judges Navin Sinha, Rohinton Fali Nariman
Date of Judgment: 08 Jan 2019
Segment Number (Approximate Page Number): 2
Relevancy Score: 51.64
   
   
   

The NAS was a chemical composition incapable of reproducing itself and was thus not a micro­organism. Only on insertion into a plant, a living organism, it imparts Bt.trait (insect resistance) to the living organism. The defendants also filed a counter claim no.51 of 2016 seeking revocation of the patent under Section 64 of the Act, as being in violation of Section 3(j) of the Patents Act (hereinafter referred to as “the Act”) in respect of plants and seeds that contained DNA sequences, denying any infringement. 5. The learned Single Judge on 28.03.2017, while deciding the plaintiffs’ application for injunction, observed that the issues arising in the suit necessarily required formal proof, particularly expert opinion, which in complicated matters like that of patent were crucial for ascertaining the breadth of the monopoly granted by the specifications of a patent claim. The nature and extent of the patent claim was more properly a matter to be examined after pleadings were complete and evidence adduced on the issues arising, which did not merit comments at the stage of interim injunction. Considering the existing patent registered under Section 48 of the Act, it was ordered that during the pendency of the suit, the parties shall remain bound by their respective obligations under the sub­licence agreement and that the licence fee/trait value payable by the defendant shall be governed by the laws in force. The learned Single Judge simultaneously only issued notice on the counter claim no.51 of 2016. The order of injunction dated 28.03.2017, therefore did not deal with or consider the counter claim. It was prima facie observed that the defendants having had the advantage of a sub­licence ever since 2004, appeared unjustified in contending that they were not bound by the obligations under the agreement in view of the claimed statutory protections vis­à­vis the suit patent or the registered trademarks. Prima facie opining that the termination of the sub­licence agreement by the plaintiffs on 14.11.2015 appeared unjustified in view of the statutory price restrictions, the termination was held not to be of any consequence. 6. Aggrieved, both the Plaintiffs and the defendants preferred appeals. The Division Bench dismissed the plaintiffs’ appeal upholding the defendants’ contention with respect to patent exclusion under Section 3(j) of the Act and that the plaintiffs were at liberty to claim registration under the PPVFR Act, as the two Acts were not complementary, but exclusive in the case of all processes and products falling under Section 3(j) of the Act. Consequentially, the defendants’ counter claim succeeded. The suit was, however, permitted to continue with regard to the claim for damages and other reliefs. The plaintiffs were required to continue with their obligations under the sub­licence agreement including payment of licence fee/trait value by the defendants in accordance with law.

Result 25
Supreme Court of India
(ID::2003 SCP 706)
Secretary, Ministry Of Chemicals & ... vs M/S. Cipla Ltd. & Ors
Honourable Judges S. Rajendra Babu, P.Venkatarama Reddi, Arun Kumar
Date of Judgment: 01 Aug 2003
Segment Number (Approximate Page Number): 13
Relevancy Score: 51.5
   
   
   

It is, therefore, contended that the twin conditions of a minimum of five bulk drug producers and at least 10 formulators are not satisfied. The High Court accepted the plea of the writ petitioner on the ground that there was only a bald denial in the counter-affidavit and no specific particulars were given to controvert the contention of the petitioner. In the order passed by NPPA in response to the representation of Bulk Drug Manufacturers' Association, it is stated that as per the records available, there were only three bulk drug manufacturers in the country during 1989-90. However, the names were not furnished either in this document or the counter affidavit. As per the ORG data, the market share of the formulation sold by the petitioner-Company was 39.56% (vide annexure at page 38 of the original writ petition record) which, as pointed out by NPPA, is technically lower than 40%. We may add that it is perilously close to 40%. It should also be noted that the writ petitioner did not furnish any details of production to show that the bulk drug manufacturers mentioned by it or at least five amongst them actually produced the bulk drug. 7.7 Doxycycline : It is the case of the writ petitioner that it manufactures and sells single ingredient formulation containing the bulk drug Doxycycline in a concentration of 100 mg per capsule under the brand name of Doxy-1. The annual turnover of the bulk drug Doxycycline, according to the writ petitioner, was Rs. 316 lacs. It is seen from the tabular statement appended to Annexure-A to the writ petition at pages 85-86 of the original record, the petitioner arrived at the total domestic consumption of the bulk drug with reference to the ORG data pertaining to sales of formulations in the market. It is the further case of the writ petitioner that as per ORG data, there were at least 19 formulators producing Doxycycline based formulations and none of them had more than 40% of market share in retail trade. Therefore, the petitioner claimed that the bulk drug Doxycycline should have been excluded from the purview of price control in terms of under clause (i) & (iii) and that monopoly situation contemplated by clause (ii) has no application because no single manufacturer had 90% or more market share in retail trade. The stand of the Government has been that the turnover of Doxycycline was above 400 lacs during the relevant period and therefore it comes under price control. Further, it is their case that clause (ii) has no application because the turnover is above 400 lacs. It is also averred in the counter affidavit that the retail trade sale data is not relevant since the need to calculate market share does not arise. Moreover, since undisputably, there is only one manufacturer of the bulk drug, i.e., Ranbaxy Limited, the exclusion criteria laid down in clause (iii) of para 22.7.2 is not applicable.

Result 26
Supreme Court of India
(ID::2011 SCP 84)
Madley Pharmaceuticals Ltd vs Commnr Of Central Excise&Customs;, ...
Honourable Judges H.L. Dattu, D.K. Jain
Date of Judgment: 14 Jan 2011
Segment Number (Approximate Page Number): 9
Relevancy Score: 51.36
   
   
   

This choice made by the pharmaceutical companies in terms of Rule 96 (1) (ix) of the Drugs Rules by overprinting words `Physician's sample- Not to be sold' on the label of the drugs will not come in the way of the Revenue from levying excise duty on the drugs so manufactured. 28) We agree with Shri Ganesh, learned senior counsel for the appellant, that the manufacture of patent and proprietary drugs is completed only after the labelling is completed, for the purpose of levy of excise duty. However, on a perusal of the labelling provisions in the Drug Rules, we find that they deal with the name of drug, contents of the drug, name and address of manufacturer, a distinctive batch number (details of manufacture of drug is recorded and available for inspection as a particular batch), preparation of drug, date of manufacture and date of expiry of drug, its storage conditions, etc., which are in aid of the object of the Act, viz. promoting the use of good quality drugs, and ensuring that drugs that do not live upto quality do not find their way into the market. Rule 96 (1) (ix) of the Drug Rules on which Shri Ganesh heavily relies in support of his submission, states that while complying with the labelling provisions under clauses (i) to (viii) of Rule 96 (1), the manufacturer must further overprint on the label `Physician's Sample - Not to be Sold', in case they are to be distributed free of cost as physicians samples. Further, the bare perusal of Rule 96 shows that its heading bears `Manner of Labelling' and clause 1 of this Rule contemplates or govern the manner of labelling in a way that the particulars on the label of the container of a drug shall be either printed or written in indelible ink and shall appear in conspicuous manner. This gives ample clarification that the process of labelling is distinct or different from the overprinting on the label of a physician's sample, and hence we are unable to agree with him that the manufacture for the purpose of the Central Excise Tariff Act is not completed until `Physicians Sample - Not to be Sold' is printed on the label. 29) The primary reason of distributing free physician samples by the manufacturer of pharmaceutical drugs to us appears to be only for the purpose of advertising of the product and thereby enhancing the sale of the product in the open market. It has been shown by research that the market of a pharmaceutical company is enhanced substantially by the distribution of free physician samples. In other words, the distribution of such physician samples serves as a marketing tool in the hands of the pharmaceutical companies [See Sarah L. Cutrona et al., Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis, 98 Am. J. Pub. Health 284 (2008)]. 30) Before we conclude, in our view, the issue raised in these appeals is no more res-integra.

Result 27
Supreme Court of India
(ID::2013 SCP 268)
Novartis Ag vs Union Of India & Ors
Honourable Judges Ranjana Prakash Desai, Aftab Alam
Date of Judgment: 01 Apr 2013
Segment Number (Approximate Page Number): 61
Relevancy Score: 51.22
   
   
   

If a drug product is not bio-available, it cannot be regarded as effective. However a determination that a drug product is bio-available is not in itself a determination of effectiveness.” (emphasis added) 189. Thus, even if Mr. Grover’s submission is not taken into consideration on the question of bioavailability, the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model. 190. Thus, in whichever way section 3(d) may be viewed, whether as setting up the standards of “patentability” or as an extension of the definition of “invention”, it must be held that on the basis of the materials brought before this Court, the subject product, that is, the beta crystalline form of Imatinib Mesylate, fails the test of section 3(d), too, of the Act. 191. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment. 192. Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind”[53]. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation. 193. Coming back to the case of the appellant, there is yet another angle to the matter. It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form.

Result 28
Supreme Court of India
(ID::2011 SCP 77)
Madley Pharmaceuticals Ltd vs Commnr Of Central Excise&Customs, ...
Honourable Judges H.L. Dattu, D.K. Jain
Date of Judgment: 14 Jan 2011
Segment Number (Approximate Page Number): 9
Relevancy Score: 51.21
   
   
   

This choice made by the pharmaceutical companies in terms of Rule 96 (1) (ix) of the Drugs Rules by overprinting words `Physician's sample- Not to be sold' on the label of the drugs will not come in the way of the Revenue from levying excise duty on the drugs so manufactured. 28) We agree with Shri Ganesh, learned senior counsel for the appellant, that the manufacture of patent and proprietary drugs is completed only after the labelling is completed, for the purpose of levy of excise duty. However, on a perusal of the labelling provisions in the Drug Rules, we find that they deal with the name of drug, contents of the drug, name and address of manufacturer, a distinctive batch number (details of manufacture of drug is recorded and available for inspection as a particular batch), preparation of drug, date of manufacture and date of expiry of drug, its storage conditions, etc., which are in aid of the object of the Act, viz. promoting the use of good quality drugs, and ensuring that drugs that do not live upto quality do not find their way into the market. Rule 96 (1) (ix) of the Drug Rules on which Shri Ganesh heavily relies in support of his submission, states that while complying with the labelling provisions under clauses (i) to (viii) of Rule 96 (1), the manufacturer must further overprint on the label `Physician's Sample - Not to be Sold', in case they are to be distributed free of cost as physicians samples. Further, the bare perusal of Rule 96 shows that its heading bears `Manner of Labelling' and clause 1 of this Rule contemplates or govern the manner of labelling in a way that the particulars on the label of the container of a drug shall be either printed or written in indelible ink and shall appear in conspicuous manner. This gives ample clarification that the process of labelling is distinct or different from the overprinting on the label of a physician's sample, and hence we are unable to agree with him that the manufacture for the purpose of the Central Excise Tariff Act is not completed until `Physicians Sample - Not to be Sold' is printed on the label. 29) The primary reason of distributing free physician samples by the manufacturer of pharmaceutical drugs to us appears to be only for the purpose of advertising of the product and thereby enhancing the sale of the product in the open market. It has been shown by research that the market of a pharmaceutical company is enhanced substantially by the distribution of free physician samples. In other words, the distribution of such physician samples serves as a marketing tool in the hands of the pharmaceutical companies [See Sarah L. Cutrona et al., Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis, 98 Am. J. Pub. Health 284 (2008)]. 30) Before we conclude, in our view, the issue raised in these appeals is no more res-integra.

Result 29
Supreme Court of India
(ID::2019 SCP 1228)
M/S Genentech Inc. vs Drugs Controller General Of India
Honourable Judges Hrishikesh Roy, A.S.Bopanna, R.Banumathi
Date of Judgment: 17 Dec 2019
Segment Number (Approximate Page Number): 2
Relevancy Score: 51.19
   
   
   

6. Prior to the Reliance suit filed against respondent no.3, the appellants had filed the suit being CS (OS) No. 355/2014 against F. Hoffmann-La Roche, AG, their associate Mylan Inc, seeking similar The Act Page 3 of 21 restraint against purported biosimilar version of the appellants drug, “Trastuzumab”. Biocon and Mylan were however already in the market by selling their products “Trastuzumab’ - ‘CANMab’ and ‘Trastuzumab’-‘HERTRAZ’ in the market. 7. The High Court of Delhi passed respective orders on 5.12.2014,14.2.2014 and 28.02.2014 in the Biocon’s suit and permitted Biocon and Mylan to market their drugs subject to the conditions that they would not claim bio similarity with the appellants’ product HERCEPTIN, HERCLON and BICELTIS. However, in the Reliance suit, the learned Single Judge was of the prima facie view that the approval by the DCGI for the biosimilar drug of respondent no.3, was far more egregious than in the case of the drug marketed by Biocon. Accordingly, an interim order was passed on 2.11.2015 in the Reliance suit whereby respondent no.3 was restrained from launching and selling their product ‘TrastuRel’ in India, until the next date of hearing. In the Biocon and the Reliance suits, the appellants had claimed that the biosimilar version of the appellants ‘Trastuzumab’, were being launched without the required test and studies under the applicable laws requiring conducting of tests and obtaining of appropriate approval from the regulatory authority including the DCGI. The appellants’ injunction application was ordered Page 4 of 21 by the learned Single Judge on 25.04.2016. The Court recorded the prima facie finding that ‘TrastuRel was approved by the DCGI under applicable law. The learned Single Judge observed that the approvals granted to ‘TrastuRel’ product are not on the basis of the adherence of the Guidelines 2012 and rules framed under the Drug Act. However, it was observed that the final finding in this respect is yet to be arrived after the suit is heard and completion of the trial. Accordingly, while permitting respondent no.3 to launch and market ‘TrastuRel’ on the basis of the approval from the DCGI, certain conditions were imposed by the learned Judge to safeguard public health and safety as also to protect the innovator of the biosimilar drug ‘Trastuzumab’. The relevant stipulations of the learned Single Judge are noted as follows: “262. I am of the view that the approvals granted to TrastuRel product are not on the basis of the adherence of the Guidelines of 2012 and rules framed under the Drug Act. The final finding in this respect is yet to be arrived after the present suit is heard upon completion of the trial.

Result 30
Supreme Court of India
(ID::2014 SCP 418)
Dr. Aloys Wobben And Another vs Yogesh Mehra And Others
Honourable Judges Jagdish Singh Khehar, A.K. Patnaik
Date of Judgment: 02 Jun 2014
Segment Number (Approximate Page Number): 13
Relevancy Score: 50.82
   
   
   

Whereas “any person” can “represent by way of opposition”, to an application for the grant of a patent (under Section 25(1) of the Patents Act), only a “person interested” can challenge the grant of a patent by issuing a “notice of opposition” (under Section 25(2) of the Patents Act). On the subject of locus, therefore, Section 25(2) and Section 64(1), are alike, inasmuch as, the locus to raise a challenge to a patent granted, lies with “any person interested” in both of these provisions. A challenge to the grant of a patent can also be raised by a defendant in a “patent infringement suit”. This can be done by the defendant by filing a “counter-claim” in a “patent infringement suit”. 16. When a challenge is raised at the pre-grant stage, under Section 25(1) of the Patents Act, the same is liable to be determined at the hands of the “Controller”. An order passed by the “Controller” can be assailed by way of an appeal before the “Appellate Board”. When a challenge is raised under Section 25(2), it must be raised within one year of the publication of the grant (of patent). The same has to be examined, in the first instance, by an “Opposition Board” contemplated under Section 25(3). The recommendations made by the “Opposition Board” are then to be placed before the “Controller” for consideration. After issuing notice to the patent-holder, and after affording an opportunity of hearing to the patent-holder, the “Controller” is required to pass the final order, on a notice of opposition filed under Section 25(2). Such order passed by the “Controller” is assailable by way of an appeal, before the “Appellate Board”. A challenge raised by “any person interested”, under Section 64(1), is liable to be adjudicated, at the very first instance, by the “Appellate Board”. If in response to an “infringement suit”, the defendant files a “counter-claim” seeking the revocation of the concerned patent, the said process of adjudication would lie before the jurisdictional High Court (see, the proviso to Sections 64(1) and 104 of the Patents Act). 17. Having heard learned counsel, and having examined the different provisions of the Patents Act, relating to revocation of patents, we shall now endeavour to examine the controversy in hand. In our considered view, Section 64 of the Patents Act needs a close examination. Section 64 aforementioned, is prefaced by the words “Subject to the provisions contained in this Act,…..”. And not by the words, “Without prejudice to the provisions contained in this Act…..”, or “Notwithstanding the provisions contained in this Act…”.

Relevant High Court Judgments
Year From: 1950, Year To: 2024

Result 1
Himachal Pradesh High Court
(ID::2024 HHIMP 224)
Thrugh Its Power Of Attorney Holder vs (1) Eris Lifesciences Limited
Honourable Judges Ajay Mohan Goel
Date of Judgment: 30 May 2024
Segment Number (Approximate Page Number): 7
Relevancy Score: 65.35
   
   
   

According to the plaintiffs, there is a complete misreading of the statutory provisions of the Patents Act by the defendant and onus to prove the credible challenge to the validity of the subject patent was squarely on the defendant and the plaintiffs had already . demonstrated that there was a valid patent in its favour, which was being infringed by the defendant. Further, according to the plaintiffs, the price of the drug was not relevant for the purpose of the adjudication of the application for the reason that defendant had copied the patented product of the plaintiffs and taken undue advantage of the R&D of the said party and copied the product at lower price to gain undue sympathy at the cost of someone else's intellectual property rights, which cannot be allowed to continue. According to the plaintiffs, they have been able to make out a clear case for the grant of interim relief, as they have proved that they have a valid patent in their favour, which is being infringed by the defendant and that the patented drug has a large market and, therefore, if the infringing product will be permitted to be sold at a lower price, the ill effect upon the plaintiffs will be long term and unqualifiable. It is also the contention of the plaintiffs that manufacturing of the drug by the defendant without the consent of the plaintiff is good enough to establish the violation of the Section 48 of the Patents Act, more so, in the light of the fact that there was no denial of infringement. It is also mentioned in the rejoinder that the suit patent has been granted in favour of the plaintiffs by more than 70 countries worldwide. The corresponding patent was granted in China and was invalidated, wherein a re-trial petition has been filed before the Supreme People's Court of the People's Republic of . China, which is pending. It is also the stand of the plaintiffs that the prior art relied upon by the defendant has been part of examination proceedings in all countries, including before the major Patent Offices. The grant of a suit patent is based on technical expertise of the patent examiners, who have not casted any doubt on the validity and inventiveness of the suit patent. The patent protection is territorial and governed by respective patent laws of each of the countries.

Result 2
Telangana High Court
(ID::2022 HTELP 329)
Msn Laboratories Pvt. Ltd vs Novartis Ag
Honourable Judges Satish Chandra Sharma, N.Tukaramji
Date of Judgment: 14 February 2022
Segment Number (Approximate Page Number): 10
Relevancy Score: 63.99
   
   
   

But, during the subsistence of patent, the patentee is entitled to enjoy the monopoly. It is a reward for innovation and experimentation and hard work put into bringing a better therapeutic medicine which will save lives of millions. Suit patent is set to expire in 2023 and patent infringement suits especially with a counter claim for revocation take a considerable amount of time to be determined. In the meanwhile, if the defendant is allowed to launch his drug it will cause irreparable damage to the plaintiffs. 29. It is appropriate to note that plaintiffs were granted patent in the year 2009, operative retrospectively from 2003. There was no opposition at pre-grant stage or within one year after grant of patent. Plaintiffs have been enjoying the patent rights for more than a decade successfully. The product received wide acceptance. While so, in the recent past other pharmaceutical companies came out with their own drugs which are bio-equivalent of the tested drug, the one made by plaintiffs, and plaintiffs are fighting litigation against them alleging violation of its patent. In the suits pending in Delhi High Court either the Court restrained the defendants from launching the product or the defendants gave an undertaking not to launch the product. This suit is instituted as a quia timet injunction suit to prevent similar drug being introduced into the market by the defendant. Though, defendant claims to be doing research to make a viable drug to treat heart failure by using Valsartan and Sacubitril, defendant never challenged the validity of the patent granted to plaintiffs. For the first time he raised objection to the plaintiff's patent as a counter claim that too, after receiving regulatory approvals. 30. Primarily, the contention of defendant against granting injunction to plaintiff is that Valsartan and Sacubitril are known pharmaceutical components/ compounds and therefore there is no 'novelty' and 'inventive step' and is obvious to person skilled in the art. Thus granting patent itself was illegal. By using known compounds when defendant makes a drug it does not amount to infringement of patent. The defendant further justifies his product by contending that the methodology adopted by him to make his drug is different from one adopted by plaintiffs.

Result 3
Himachal Pradesh High Court
(ID::2024 HHIMP 222)
Thrugh Its Power Of Attorney Holder vs (1) Eris Lifesciences Limited
Honourable Judges Ajay Mohan Goel
Date of Judgment: 30 May 2024
Segment Number (Approximate Page Number): 4
Relevancy Score: 62.28
   
   
   

It is also the contention of the plaintiffs that they have been vigilant in protecting their rights in the medicinal produce covered by the subject patent and have initiated the legal proceedings against various parties who have infringed their patent and details thereof are given in Para-28 of the application. It is mentioned in this para that this Court in three Civil Suits filed by the plaintiffs, has passed restraint orders against the infringers therein and in favour of the plaintiffs. Reference has also been made to the orders passed by the District Court of Vadodara and the Court of learned Additional District Judge (Commercial) Dehradun at Uttarakhand, which Courts as per the applicants, have passed orders in favour of the plaintiffs. 6. It is further averred in the application that if defendant/non-applicant is allowed to manufacturer and/or sell the drug in issue, it will not only infringe the subject patent, but also completely defeat the purpose of subject patent. It is further averred in the application that the companies who incur huge investments will be left bereft of protection, if the infringers who do not carry out . R & D on their own, are allowed to indulge in dishonest practices. As per the plaintiffs/applicants, w.e.f. 18.09.2015, the plaintiffs/applicants have an exclusive right to make, use, offer for sale, sell, import and/or export the product covered by the subject patent and the act of the defendant/non-applicant of infringing the subject patent was causing a substantial financial hardship to the plaintiffs/applicants and as they were having a prima facie case in their favour, therefore, non-grant of injunction in their favour during the pendency of the Civil Suit would cause irreparable harm and injury to the applicants. 7. Defendant/non-applicant opposes the prayers made in the application. According to the defendant, plaintiffs/applicants have failed to discharge the burden to establish a prima facie case of infringement of subject patent by the defendant. As per the defendant, there is no presumption of validity of old patent and for a granted patent in India, be it a new or old patent, there is no presumption of validity. Third party Dr. Reddys Laboratories is stated to have filed a revocation petition against the suit patent, which belies the contention of the plaintiffs that the suit patent is unchallenged.

Result 4
Delhi High Court
(ID::2016 HDELP 95)
Roche Products (India) Pvt Ltd & Ors vs Drugs Controller General Of India And ...
Honourable Judges Manmohan Singh
Date of Judgment: 25 April 2016
Segment Number (Approximate Page Number): 10
Relevancy Score: 62.01
   
   
   

Hence the defendant No.2's drugs cannot create confusion regarding the nature of the drug and cause patients and medical practitioners to use the drug incorrectly. 12.5 There is a bar to the jurisdiction of Civil Court for monitoring and governing the process and procedure for obtaining requisite approvals in relation to the drug in dispute once the remedy to challenge the approvals as granted is available with the plaintiffs. Rule 122 DC of the Drugs Rules provides for a remedy to any person aggrieved by an order of the Licensing Authority/ Approving Authority to challenge the grant of approvals. The suit for injunction is not maintainable. The plaintiffs in the present suit with the sole motive of stifling competition under the garb of public safety and health for an illegitimate and mischievous attempt to retain monopoly by the plaintiffs over sale of its drug(s) HERCEPTIN, HERCLON and BICELTIS. 12.6 The reason behind the present suit is that for many years the plaintiffs had been the only manufacturer for the drug used in the treatment of HER2 positive metastatic breast cancer and therefore enjoyed a monopoly over the pharmaceutical industry in this segment. But soon after the defendant No.2's announcement on a similar drug, the plaintiffs realized that they will no longer enjoy the monopoly and control over the treatment of HER2 metastatic breast cancer, therefore, in order to maintain the monopoly and restrict the entry of the defendant's drug, the plaintiffs filed the present suit under the garb of lack of approvals. The defence as per written statement of defendants No.3 and 4 13. In addition to the written statement of defendants No.1 and 2, it is alleged that the entire suit is entirely speculative and nothing more than a fishing expedition, the plaintiffs do not have any locus standi to initiate and prosecute the present civil action before a court of law. It is submitted that the Drugs and Cosmetics Act, 1940 ("Drugs Act") does not create any civil right of action in the plaintiffs. The present suit is barred by law. 13.1 Defendant No.3 is one of the world's leading generics and specialty pharmaceutical companies and defendant No.4 is its Indian subsidiary. The defendant No.2 is a company engaged in the business of manufacturing biotechnological products that cater to the healthcare segment.

Result 5
Bombay High Court
(ID::2004 HBOMP 61)
Novartis Ag And Anr. vs Mehar Pharma And Anr.
Honourable Judges D.K. Deshmukh
Date of Judgment: 23 December 2004
Segment Number (Approximate Page Number): 9
Relevancy Score: 61.82
   
   
   

In India, approximately 3000 patients are enrolled under the programme till date. On the other hand, the Defendant is not pleading the interest of the public. It is a manufacturer who has stolen the Intellectual Property of the Plaintiffs. Plaintiff No. 1 has spent millions of dollars to research and invent the drug. The Defendant No. 2 is pleading a private, commercial interest without any basis in law or equity. The balance of convenience lies in favour of the Plaintiffs. If the reliefs prayed for by the Plaintiffs are granted by this Hon'ble Court, the EMR will remain a paper right. Rather, this Court by granting the specific reliefs as prayed for will honour the TRIPS Agreement and the provisions of the Patents Act in consonance with India's obligations under the TRIPS Agreement and the provisions of the Patents Act without jeopardising public interest. 15. The defendants oppose grant of reliefs sought by the plaintiffs by this Notice of Motion. At the outset, it is submitted that the suit filed by the plaintiffs relates to a specific form of intellectual property, viz. exclusive marketing rights which is like a patent. A patent right is different is nature, scope and legal effect from other forms of intellectual property such as trade marks and copyright. A patent can be granted for an industrially useful invention, which is novel and not part of the public domain. Once granted a patent confers on the patentee, the exclusive right to prevent others from making, using, offering for sale or importing the patented product in India. No product patent for a medicine can be granted under the law at present, although an application may be filed. 16. Whilst registration of trade marks and copyright in one country has a persuasive value in another, patent and design rights are statutory creatures, territorial in nature and dependent only on specific registration in each country. Registration of patent rights in one country does not automatically confer protection in other countries nor does it have any persuasive value. Registration in each country may be obtained only after passing the tests prescribed in each country. Without registration, the invention or design in question enters the public domain in that country and the public would be free to copy and use the same.

Result 6
Delhi High Court
(ID::2019 HDELP 238)
Eisai Co. Ltd. & Anr. vs Satish Reddy & Anr.
Honourable Judges J.R. Midha
Date of Judgment: 6 May 2019
Segment Number (Approximate Page Number): 17
Relevancy Score: 61.72
   
   
   

The philosophy of the company is to ensure that affordable medicines are made available with convenience and ease so that patients do not suffer either due to lack of availability of medicines or due to high prices of innovator drugs. Towards this end, the company has established 9 (nine) research centers globally and more than 1200 (one thousand two hundred) research scientists working on various projects. In financial year 2018 alone, the defendant company invested 13% of its sales revenue i.e. approximately USD 281 million, in research and development activities. As per the Biospectrum Report published in November, 2018, this is the highest investment in research and development activities among Indian companies. Wherever the defendant company believes that a product is covered by a patent; it has entered into a license with the patent owner. For example, defendants have acquired the molecule XP-23829 from XenoPort. This drug is a clinical stage new oral entity that has the potential for the treatment of plaque psoriasis and may even be developed for relapsing forms of multiple sclerosis. The defendants have also acquired a license with the plaintiff No.1 for its molecule E7777, which is an anti-cancer agent. Defendant No.2 has also filed pre-grant oppositions to the 311 application on 29th October, 2018, 2296 application on 06th November, 2018 and the 1208 application on 11th October, 2018. Thus, the defendants have the highest respect for patent rights and are very conscious of ensuring that its products do not infringe any patent. 42. Defendant No.2 has undertaken considerable effort and expenses to conduct clinical trials, and has obtained marketing approvals for their product, as against the plaintiffs who are a foreign patent owner/foreign licensee and who have failed, despite passage of more than 15½ years of the life of the patent (almost 11 years from the date of grant of the suit patent) to even file for regulatory approvals, let alone marketing approvals to work or commercially launch the Lorcaserin free base or its enantiomers, or even LH or the hemihydrate form of LH in India. For obtaining marketing approvals for India, clinical trials have to be conducted on Indian patients.

Result 7
Madras High Court
(ID::2004 HMADP 49)
Novartis Ag, Rep. By It'S Power Of ... vs Adarsh Pharma And Anr.
Date of Judgment: 28 April 2004
Segment Number (Approximate Page Number): 5
Relevancy Score: 61.09
   
   
   

The sum and substance of the plaintiffs' case at this interlocutory stage is as follows: "The first plaintiff is a "Swiss" company and the second plaintiff is its subsidiary in India; the first plaintiff invented a particular form of Methanesulphonic acid addition salt of a particular pyrmidineamine derivatives (Imatinib Mesylate in crystal form), hereinafter referred to as the "invention"; the crystals are in two forms namely, "Alpha" and "Beta"; in the manufacture of the drug in question, "Beta" crystalline form is used; the product so invented is "Beta Crystalline form of Imatinib Mesylate", hereinafter referred to as the "product"; the first plaintiff had filed applications in 1997 to 2000 for the said product patent in several countries and in some countries, patent had been granted and in the other countries, patent is still pending; India, as a member of World Trade Organisation and by virtue of its agreement on trade related aspects of intellectual property rights (TRIPS AGREEMENT), is under an obligation to consider granting product patent in all fields, including medicines and drugs with effect from 1.1.2005; by way of an interim measure, till the product patent application is taken up for consideration, provision is made in the Patents' Act for granting Exclusive Marketing Rights ("EMR"); the first plaintiff filed a patent application in India on 17.7.1998 for the product patent referred to above; the first plaintiff filed an application in a convention country i.e., Australia on 16.7.1998 claiming patent for the identical product; marketing approval to sell the identical product was granted in Australia on 13.8.2001 followed by the proceedings dated 28.2.2002, by which, the patent product was granted in Australia; on 4.12.2001, marketing approval for an identical product was granted in India in favour of the second plaintiff by the Drug Controller General; on 27.3.2002, the plaintiff filed an application with the patent office Kolkota for an "EMR" for the patent product and "EMR" was granted on 10.11.2003; "EMR" confers an exclusive right to sell or distribute the drug referred to earlier for a period of five years or till an order is passed in the patent claim in India either way, whichever is earlier; the Drug Controller of India had given marketing approval to the second plaintiff for the drug in question by order dated 5.12.2002 valid for the period from 1.1.2003 to 31.12.2005 and the defendants, either in their capacity as the manufacturer or distributor, are infringing the rights of the plaintiffs, given under the "EMR", by dealing with the same drug."

Result 8
Delhi High Court
(ID::2009 HDELP 174)
F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd.
Honourable Judges Chief Justice, S.Muralidhar
Date of Judgment: 24 April 2009
Segment Number (Approximate Page Number): 41
Relevancy Score: 60.98
   
   
   

Indeed, in the plaint, the plaintiffs have worked out loss suffered by them and have in fact sought a monetary decree in relation thereto. In my opinion, the aspect of balance of convenience has also to be answered in favour of the defendants, especially because the drug in relation to which EMR is granted is a anti-cancer drug, is a life saving drug and the plaintiffs do not manufacture the drug in India but import it from foreign country. The defendants have stated that the demand of capsules is over 30,00,000 per month. This does not appear to have been disputed by the plaintiffs. It is clear that the demand of this drug in India is very large, it is a life saving drug. The defendants manufacture the drug in India. The plaintiffs do not manufacture the drug in India. They state that they will import required quantity of the drug from a foreign country. Therefore, the plaintiffs will rely entirely on the international transport system for making the drug available in India in required quantity. In case interim injunction is granted in favour of the plaintiffs, the manufacturing and marketing network of the defendants so far as the drug is concerned would be dismantled. If due to any problem, the plaintiffs cannot make available the drug in required quantity in India, it obviously will be disastrous for the patients. This consequence is foreseeable, therefore in my opinion, the Court should not pass any interim order which may possibly lead to such a situation. In my opinion, the aspect of the difference in price of the product of the plaintiffs and the defendants also cannot be ignored, especially at the stage of considering the question whether the plaintiffs are entitled to any interim relief." 79. In Roussel Uclaf the plaintiffs were a company which held a licence under a patent which gave them exclusive rights to sell in the United Kingdom two drugs, an amide base and a phosphate salt, both giving rise to the same active ingredient in the body. The first defendants began to sell the phosphatic salt in July 1976 and the plaintiffs sought, inter alia, an interlocutory injunction to restrain the sale. The plaintiff€Ÿs sale of the amide base represented 2.2 per cent of their total U.K. sales. They did not market the phosphate salt though they had plans to do so.

Result 9
Delhi High Court
(ID::2021 HDELP 140)
Novartis Ag & Anr. vs Natco Pharma Limited & Anr.
Honourable Judges C. Hari Shankar
Date of Judgment: 13 December 2021
Segment Number (Approximate Page Number): 72
Relevancy Score: 60.52
   
   
   

The patentability of products would then have to be assessed, for determination of their patentability on the basis of Section 2(1)(j) read with Section 2(1)(j)(a).51 (g) A mere claim, without enabling disclosure, as would enable a person skilled in the art to work the invention, is not patentable.52 (h) The role of the complete specification accompanying a patent application is to teach what the invention was, how it was to be made, and how it was to be used.53 (i) One invention is entitled only to one patent. One patent may, however, cover more than one invention, provided all inventions involved the same inventive steps.54 Refer Novartis9 Refer Roche v. Cipla Ltd17 Refer Merck v. Glenmark16 Refer Merck v. Glenmark16 Refer Astrazeneca v. Intas20 (j) Grant of repeated patents for the same invention results in the malaise of evergreening of a patent beyond its life, which is impermissible.55 (ii) Mere grant of a patent is not necessarily a prima facie indicator of its validity.56 (iii) Infringement: (a) Examination of any claim of infringement requires (i) determination of the meaning and scope of the claims in the suit patent and (ii) comparison of the claim so interpreted with the allegedly infringing product of the defendants. The comparison has to be of the defendants' product vis-a-vis the plaintiffs' patent and not product-to- product.57 (b) This has to be determined on the basis of claim construction. The plea of a defendant that the plaintiff may have itself applied for grant of patent in respect of the allegedly infringing product, and abandoned the claim later, was held, in Merck v. Glenmark16, to be irrelevant. In a visible departure, however, where the claim of the plaintiff was rejected, Roche v. Cipla held this to be an indicator, prima facie, that the defendant's product infringed the suit patent. Refer Astrazeneca20 Refer Merck v. Glenmark16 Refer Roche v. Cipla Ltd17 (iv) Section 3(d) (a) Once a patent was granted to an Active Pharmaceutical Ingredient (API), Section 3(d) protects all products of such API, in any form, from grant of a subsequent patent. The manufacture or marketing by any third party of any product-derivative of a patented API would amount to infringement.58 The API is the molecular entity which exerts the therapeutic effect of medicine and is biologically active.

Result 10
Delhi High Court
(ID::2008 HDELP 113)
F. Hoffmann-La Roche Ltd. And Anr. vs Cipla Limited
Honourable Judges S. Ravindra Bhat
Date of Judgment: 19 March 2008
Segment Number (Approximate Page Number): 16
Relevancy Score: 59.86
   
   
   

31. Learned Counsel relied heavily on the decision reported as American Cyanamid Co -v- Ethicon Ltd, 1975 (1) All. ER 504 to say what are the guiding principles which courts have to adopt in cases involving infringement of patent and copyright cases. Learned Counsel submitted, by placing reliance on the decision of the Supreme Court in Midas Hygiene Industries (P) Ltd v. Sudhir Bhatia , that in cases of infringement either of trade mark or of copyright, normally an injunction must follow. Mere delay in bringing action is not sufficient to defeat grant of injunction in such cases. The grant of injunction becomes necessary if it prima facie appears that the adoption of the mark was itself dishonest. 32. It was contended next by Dr. Singhvi that the amendments to the Act deleted Section 5 of the Act, which had specified that only methods or processes of manufacture are patentable for certain inventions, so as to allow product patent protection in all fields of technology including areas of foods, medicines and drugs. The compulsion for amendments to the Act was primarily to introduce product patents for all inventions as mandated by the TRIPS Agreement. Therefore, ifThis Court were to refuse granting injunction, even after a clear case of infringement and prima facie merits for relief were made out, the legislative will, and the country's resolve to integrate with a global patent friendly regime, affording protection to inventions would be thwarted. 33. Dr. Singhvi submitted that the arguments sought to be raised, about comparative cost of the product, are dangerous. This would render Section 108, nugatory. The Defendant's argument that the Plaintiff's drug costs more and therefore balance of convenience would lie in refusing injunction is 'jingoistic'; it is also unacceptable in view of the country's signaling acceptance of the TRIPS mandated patent regime, through the new amendments to the Patent Act. The Plaintiff's drug, inclusive of the cost of research and development and clinical trials, is marketed at Rs. 3,200/- while the Defendant's drug is marketed at Rs. 1,600/- without these costs. It is also to be noted that plaintiff price for patented drug includes the import duty of 32% (i.e. approx 850/- which is included in Rs. 3200/-).

Result 11
Delhi High Court
(ID::2019 HDELP 238)
Eisai Co. Ltd. & Anr. vs Satish Reddy & Anr.
Honourable Judges J.R. Midha
Date of Judgment: 6 May 2019
Segment Number (Approximate Page Number): 8
Relevancy Score: 59.82
   
   
   

19. Grant of a subsequent patent, which is an improvement invention, does not take the said forms out of the first/basic patent, which in the present case is the suit patent. If the subsequent patent is granted, the pharmaceutical product in such a case gets covered by two patents and an infringer making the pharmaceutical patent would infringe two patents. For this, reliance is placed upon Extract from Pharmaceutical Patent Law by John R, Thomas. 20. The plaintiffs further rely on the decision of the Court of Appeals for England and Wales in Dr. Reddy's Laboratories (UK) Ltd. v Eli Lily, 2010 RPC 9. In this case, Dr.Reddy sought revocation of Eli Lily€Ÿs patent from Olanzapine drug, stating that the patent of Eli Lily was not novel on the ground that it was disclosed in a previous patent which disclosed a general formula. The Court while rejecting the revocation petition of Dr.Reddy held the following: "First then, the a priori considerations apart from case- law. An old question and answer runs as a follows: "Where does a wise man hide a leaf? In a forest." It is, at least faintly, ridiculous to say that a particular leaf has been made available to you by telling you that it is in Sherwood Forest. Once identified, you can of course see it. But if not identified you know only the generality: that Sherwood Forest has millions of leaves." 21. The above passage shows that even though a genus patent exists, a second subsequent patent can be granted for a "species€Ÿ present in the genus patent. Reliance is placed on Merck v. Glenmark (Supra) and Roche v. Cipla (65) PTC 1 (Del) (DB). 22. The plaintiffs€Ÿ pleadings before the Patent Office have been reproduced/relied upon by the defendants in their written submissions in a misleading manner. 23. As regards the second contention of the defendants that the plaintiffs have not worked out the suit patent in India, it is submitted that the said contention is fallacious for the following reasons: (i) In case of non-working, the remedy provided under Sections 83 and 84 of the Patents Act, 1970 is for the defendants to seek a compulsory License.

Result 12
Himachal Pradesh High Court
(ID::2022 HHIMP 59)
) Boehringer Ingelheim Pharma vs Vee Excel Drugs And Pharmaceuticals ...
Honourable Judges Ajay Mohan Goel
Date of Judgment: 2 June 2022
Segment Number (Approximate Page Number): 20
Relevancy Score: 59.64
   
   
   

One patent may, however, cover more than one invention, pro- vided all inventions involved the same inventive steps. (j) Grant of repeated patents for the same invention re- sults in the malaise of evergreening of a patent beyond its life, which is impermissible.55 (ii) Mere grant of a patent is not necessarily a prima fa- . cie indicator of its validity.56 (iii) Infringement: (a) Examination of any claim of infringement requires (i) determination of the meaning and scope of the claims in the suit patent and (ii) comparison of the claim so interpreted with the allegedly infringing product of the defendants. The comparison has to be of the defendants' product vis-a-vis the plaintiffs' patent and not product-to- product.57 (b) This has to be determined on the basis of claim construction. The plea of a defendant that the plaintiff may have itself applied for grant of patent in respect of the allegedly infringing product, and abandoned the claim later, was held, in Merck v. Glenmark16, to be irrelevant. In a visible departure, however, where the claim of the plaintiff was rejected, Roche v. Cipla held this to be an indicator, prima facie, that the defendant's product infringed the suit patent. (iv) Section 3(d) (a) Once a patent was granted to an Active Pharmaceu- tical Ingredient (API), Section 3(d) protects all products of such API, in any form, from grant of a subsequent patent. The manufacture or marketing by any third party of any product-derivative of a patented API would amount to in- fringement.58 The API is the molecular entity which exerts the therapeutic effect of medicine and is biologically active. Patent protection is ordinarily granted to the API59. (b) In the case of pharmaceutical products, the deriva- tives envisaged by Section 3(d) would include (a) pro- drugs, which are not active, but are metabolized in the body so as to result in pharmaceutically active substances, (b) combinations of more than one APIs or the combina- tion of an API with an inert carrier and (c) drug delivery systems, which are compositions enabling the constituents to be administered in a particular fashion.60 (c) In Novartis9, examining the vulnerability of Imatinib Mesylate to invalidity on the ground of Section 3(d), the Supreme Court held that (i) the obtaining of Refer Roche v. Cipla Ltd17 Refer Roche v. Cipla Ltd17 Refer Roche v. .

Result 13
Delhi High Court
(ID::2019 HDELP 238)
Eisai Co. Ltd. & Anr. vs Satish Reddy & Anr.
Honourable Judges J.R. Midha
Date of Judgment: 6 May 2019
Segment Number (Approximate Page Number): 24
Relevancy Score: 59.56
   
   
   

There are five cases relating to patent in which the defendant company is a party. I can produce the list of those five cases and also copies of the relevant orders. The defendant company€Ÿs policy is to examine the patent of a medicine and to launch the medicine if the patent of the patentee is not valid." (Emphasis supplied) (iii) Statement of Girish Parhate, S/o Sh. Sadashiv Parhate, aged about 40 years, R/o D0601, Sunway Opus Grand Neville, 3A, Sy. No. 162 P, 164,, Ameenpur, Hyderabad-502032: "I am the Director of the defendant for Indian Drug Regulations Affairs of the defendant company since December, 2015. I am not aware who took the decision to develop the medicine named Lorcaserin Hydrochloride Hemihydrate (herein after referred as "LHH€Ÿ). In June 2016, I was instructed by Business Strategic Unit of the defendant to apply for grant of permission for manufacture and marketing of LHH where upon I prepared and submitted an application dated 29th June, 2016 before the Drugs Controller General of India, Directorate General of Health Services. I produce the copy of the application dated 29th June, 2016 which is marked as Ex.C1. Q.1 In para 3 of the application (Ex.C1) you have stated that the defendant has developed the drugs substance LHH. Please tell who developed this drug substance and when was it developed? Ans. The drug substance LHH was developed by the Research Development Unit of the defendant during the period 2013 to 2016. Q.2 Did you disclose to the Drug Controller that the plaintiff already has a patent on this salt? Ans. I did not disclose in the application that the plaintiff is holding the patent in respect of the drug substance because there is no provision for such disclosure in the application form. Earlier, there was a column in the application form to disclose the patent but the same was removed in the format of the application and therefore such disclosure was not made. The drug substance LHH is different from the drug substance in respect of which the plaintiff is having patent. I can produce the earlier form showing the requirement of the patent disclosure as well as the amended format in which the said requirement was omitted. However, I am not technical qualified to tell the difference. I can produce the documents relating to the drug substance namely LHH by the defendant.

Result 14
Himachal Pradesh High Court
(ID::2022 HHIMP 56)
) Boehringer Ingelheim vs Tvs Motor Company
Honourable Judges Ajay Mohan Goel
Date of Judgment: 11 March 2022
Segment Number (Approximate Page Number): 5
Relevancy Score: 59.28
   
   
   

Learned Senior Counsel stressed that admittedly the defendant neither has any patent in its name nor did it lay any challenge at the time when the plaintiffs had applied for the 'subject patent' or even after the patent was granted in favour of the plaintiffs. They further submitted that the filing of revocation petition by the defendant, in close proximity with the launch of the infringing product was nothing but an afterthought to hold out that in lieu of its having filed a revocation petition, it has laid a . credible challenge to the 'subject patent'. 10. Opposing the prayer of the plaintiffs, learned Counsel for the defendant submitted that in the present case, the defendants have filed a revocation petition against the 'subject patent', as would be evident from the averments also made in the application filed by it under Order XXXIX, Rule 4 of the Code of Civil Procedure, perusal whereof would demonstrate that there is a credible challenge which has been laid by it to the 'subject patent'. Learned Counsel have submitted that it is settled law that mere grant of patent does not lend a presumption of validity to the patent. The scheme of the Patents Act is to provide multi-layer challenges, which are available to a non-patentee to challenge and question the validity of a patent at any time and such validity has to be tested on the anvil of the provisions of the The Patents Act, 1970. It was argued that the provisions of Section 13(4) of the The Patents Act expressly set out the absence of any presumption of validity due to mere grant and further, as there has been non- compliance of the statutory provisions of Sections 8 and 64 of the Patents Act, therefore, the patent in issue is not a valid patent and the defendant has laid a credible challenge to the same. They have also argued that in the case of pharmaceutical patents, which have been recognized as a specific species of patent infringement litigation, the overwhelming factor is that of public interest-namely . the need to provide for affordable and accessible healthcare products.

Result 15
Delhi High Court
(ID::2008 HDELP 113)
F. Hoffmann-La Roche Ltd. And Anr. vs Cipla Limited
Honourable Judges S. Ravindra Bhat
Date of Judgment: 19 March 2008
Segment Number (Approximate Page Number): 17
Relevancy Score: 59.05
   
   
   

To include the price as a criterion for denial of injunction would mean that any generic producer would successfully avoid the injunction by offering a lower price. Thus, Dr. Singhvi submitted that the lower price of an infringing drug is irrelevant, in an action for infringement of a pharmaceutical patent. 34. Learned Counsel submitted, in the context of balance of convenience, that the working of a patent only means 'accessibility' of the invention to its customers and its use in the territory. The drug is available in India and has been used since April 2006. No Indian law mandates that patents can be only worked thorough manufacture in the territory; it can equally be used through imports. An identical argument about non-working of patent in the context of import of the product, was repelled by the Division Bench in Schneider (supra). IV Submissions of the Defendant 35. Mr. Arun Jaitley, learned senior counsel for the defendant contends that the patent was wrongly granted to the plaintiff and is liable to be revoked. He submitted that the test of Section 3(d) has not been satisfied as all documents of efficacy relied upon by plaintiff are post 2002 and it is not clear as to whether the drug dealt with in those publications is as per U.S. 5747498 or 6900221. It was also submitted that the invention claimed in patent No. 196774 is obvious to persons skilled in the art and the patent lacks an inventive step. 36. According to counsel, two elements attaching to any patent can invalidate it, that is, i) Obviousness and Lack of inventive step. ii) Section 3(d) Under Section 3(d) of the Patent Act, the applicant for a patent for a derivative substance has to show significant differences in properties with regard to efficacy.

Result 16
Himachal Pradesh High Court
(ID::2022 HHIMP 61)
) Boehringer Ingelheim vs Tvs Motor Company
Honourable Judges Ajay Mohan Goel
Date of Judgment: 11 March 2022
Segment Number (Approximate Page Number): 4
Relevancy Score: 59.02
   
   
   

Learned Senior Counsel stressed that admittedly the defendant neither has any patent in its name nor did it lay any challenge at the time when the plaintiffs had applied for the 'subject patent' or even after the patent was granted in favour of the plaintiffs. They further submitted that the filing of revocation petition by the defendant, in close proximity with the launch of the infringing product was nothing but an afterthought to hold out that in lieu of its having filed a revocation petition, it has laid a credible challenge to the 'subject patent'. 9. Opposing the prayer of the plaintiffs, learned Counsel for the defendant submitted that in the present case, the . defendants have filed a revocation petition against the 'subject patent', as would be evident from the averments also made in the application filed by it under Order XXXIX, Rule 4 of the Code of Civil Procedure, perusal whereof would demonstrate that there is a credible challenge which has been laid by it to the 'subject patent'. Learned Counsel have submitted that it is settled law that mere grant of patent does not lend a presumption of validity to the patent. The scheme of the Patents Act is to provide multi-layer challenges, which are available to a non-patentee to challenge and question the validity of a patent at any time and such validity has to be tested on the anvil of the provisions of the The Patents Act, 1970. It was argued that the provisions of Section 13(4) of the The Patents Act expressly set out the absence of any presumption of validity due to mere grant and further, as there has been non- compliance of the statutory provisions of Sections 8 and 64 of the Patents Act, therefore, the patent in issue is not a valid patent and the defendant has laid a credible challenge to the same. They have also argued that in the case of pharmaceutical patents, which have been recognized as a specific species of patent infringement litigation, the overwhelming factor is that of public interest-namely the need to provide for affordable and accessible healthcare products.

Result 17
Delhi High Court
(ID::2009 HDELP 174)
F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd.
Honourable Judges Chief Justice, S.Muralidhar
Date of Judgment: 24 April 2009
Segment Number (Approximate Page Number): 10
Relevancy Score: 58.91
   
   
   

The plaintiff has also suppressed the fact that it has made two further Patent Applications for the same compound, i.e. hydrochloride salt of N(3 ethynylphenyl)-6, 7-bis (2-methoxyethoxy)-4 quinazolinamine in B-Polymorph form. The defendant has already filed pre-grant oppositions against the said patent applications. Copy of the said pre-grant oppositions for patent application No. IN/PCT/2002/00507 and Patent application No.IN/PCL2002/00497 are annexed as Annexure E-6 and Annexure E-7. For ready reference the defendant is annexing herewith copies of the US Patent Nos. 5747498 and 6900221 downloaded from the USPTO. The said patent no. 5747498 corresponds to Indian Patent No.196774 which is the alleged equivalent of the patent which is subject matter of the present suit, while US Patent No.6900221 corresponds to the two aforesaid applications against which the opposition is filed by the defendant. The patent specification of Patent application No.IN/PCT/2002/00507 is annexed as annexure E-8 and the patent specification of Patent application No. IN/PCT/2002/00497 is annexed as Annexure E-9. 15. It is, thus, submitted that the entire case of the plaintiff is based on a false premise. The plaintiff is obviously not marketing the drug which is allegedly covered by the patent which is already granted. The drug which is being marketed is a drug which is related to the subsequent patent applications in India which are pending. These facts ought to have been disclosed by the plaintiff before this Hon'ble Court. The plaintiff has deliberately claimed in its pleadings that the sales of the patented drug are approx Rs.13.91 crores when it was well aware that the drug which is being manufactured and marketed by it is still pending for patent protection. Therefore, there has been no sale of the product form patented under No.196774." (emphasis supplied) 23. However, while notice was directed to issue in the application on 31st January 2008, on that very date the arguments in the injunction application I.A. No.642/2008 were concluded before the learned Single Judge and orders reserved. Thus in the impugned judgment the learned Single Judge did not advert to I.A. No.1272/2008 although a reference was made in the passing to the facts concerning polymorph-B.

Result 18
Delhi High Court
(ID::2008 HDELP 112)
Eureka Forbes Ltd. And Anr. vs Hindustan Unilever Ltd.
Honourable Judges T.S. Thakur, Veena Birbal
Date of Judgment: 8 February 2008
Segment Number (Approximate Page Number): 7
Relevancy Score: 58.61
   
   
   

If the plaintiff company does have a patent in its favor which fact is admitted even by the defendant appellant before us, the question whether the defendant appellant is committing any infringement of the said patent would give rise to a friable issue, no matter the defendant appellant may in its defense claim the right to manufacture its water purifying apparatus by reference to the patent granted in its favor. Whether or not the two designs are similar and if so, whether the grant of a patent in favor of the defendant would entitle it to use the said design for manufacture and marketing of its product are serious questions of fact and law that would require adjudication by the Court trying the suit. The learned Single Judge has examined, at some length, the nature of the right which a patentee has in regard to its patent and come to the conclusion that the right of a patentee is an exclusionary right. The Court has in that regard placed reliance upon the following passage appearing in "Patents For Chemicals, Pharmaceuticals and Bio Technology" (IV Edition) by Phillip W. Grubb: Exclusionary Right It is important to realise that the rights given by the patent do not include the right to practice the invention, but only to exclude others from doing so. The patentee's freedom to use his own invention may be limited by legislation or regulations having nothing to do with patents, or by the existence of other patents. For example, owning a patent for a new drug clearly does not give the right to market the drug without permission from the responsible health authorities, nor does it give the right to infringe an earlier existing patent. In the very common situation where A has a patent for a basic invention and B later obtains a patent for an improvement to this invention, then B is not free to use his invention without the permission of A, and A cannot use the improved version without coming to terms with B. A patent is not a seal of government approval, nor a permit to carry out the invention. We very often hear 'This patent allows Company X' to do something or other. It does not, it only allows them to stop someone else from doing it.

Result 19
Delhi High Court
(ID::2019 HDELP 238)
Eisai Co. Ltd. & Anr. vs Satish Reddy & Anr.
Honourable Judges J.R. Midha
Date of Judgment: 6 May 2019
Segment Number (Approximate Page Number): 7
Relevancy Score: 58.2
   
   
   

Importantly, prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or "hit") during the interim, which may take some time. The victory for the patentee therefore should not be pyrrhic but real." (Emphasis Supplied) 16. The defendants have taken three main defenses in the Written Statement. The first contention of the defendants is that they are not infringing the suit patent as the patent does not cover LHH, which is what the defendants have obtained a marketing approval for. The defendants€Ÿ primary argument is that the plaintiffs have made certain admissions in reply to oppositions filed by a third party against the plaintiffs€Ÿ subsequent patent applications concerning LHH, which show that the plaintiffs€Ÿ patent does not disclose LHH. 17. According to the plaintiffs, the above contention is completely fallacious as it ignores the well-established concepts of basic and improvement patents. The plaintiffs rely on I. G. Farbenindustrie A.G.'s Patents; (1930) 47 RPC 289 at page 321: "It may be observed that chemicals patents in recent years have consisted of two sharply divided classes. The first class is that of patents based on what may be described as an originating invention, that is, the discovery of a new reaction or a new compound. Such patents may be called for brevity "originating patents". The second class comprises patents (the so-called selection patents) based on a selection of related compounds such as the homologues and substitution derivatives of the original compounds which presumably have been described in general terms and claimed in the originating patent." 18. The suit patent is in the nature of an originating/genus patent and the various subsequent patent applications were for improvement/selection inventions, which specifically discloses and claims a particular "species€Ÿ of the genus patent, i.e. the hydrochloride hemihydrate form. Merely because the plaintiffs have applied for a patent separately for a specific species of the genus disclosed in the suit patent, does not mean that the species patent cannot be granted or that the species patent would not fall within the coverage of the genus patent (i.e. the suit patent in the present case).

Result 20
Delhi High Court
(ID::2009 HDELP 174)
F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd.
Honourable Judges Chief Justice, S.Muralidhar
Date of Judgment: 24 April 2009
Segment Number (Approximate Page Number): 3
Relevancy Score: 58.19
   
   
   

The plaintiffs state that from such news report they learnt for the first time of Cipla€Ÿs plans to infringe and violate the plaintiffs€Ÿ rights. According to the plaintiffs the drug Tarceva (Erlotinib) has been developed after a long sustained research and after incurring enormous expenditure inter alia on the tests which are mandatorily conducted for its efficacy and safety. It was alleged that the said innovation was duly protected under law and that no person except those legally authorized to exercise legal rights associated with the aforementioned patented drug could be allowed or permitted to simulate, re-create it in any manner or in any other name. It was alleged that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva (Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the legal rights of the plaintiffs. 7. In para 20 of the plaint it was asserted that the plaintiffs were under imminent threat of violation of their patent rights inter alia at New Delhi. It was further asserted that "the application for the patent of the drug and process of manufacture of Tarceva (Erlotinib) was made and the patent was granted at New Delhi". It was argued that, therefore, this Court has territorial jurisdiction to adjudicate the suit. The suit was valued at Rs. 20 lakhs and for the relief of damages, it was tentatively valued at Rs.1 crore. 8. The suit was filed on 15th January, 2008. Along with the suit the plaintiffs filed an application under Order XXXIX Rule 1 Code of Civil Procedure 1908 (CPC), I.A. No. 642/2008, seeking ad-interim injunction restraining the defendant from infringing the plaintiffs patent in respect of Tarceva (Erlotinib).The two important points to be noted at this stage are that the plaintiffs asserted in the plaint that plaintiff No.2 was granted a patent for Tarceva (Erlotinib) jointly with Pfizer Products Inc. It was stated that the certificate bearing patent No. 196774 dated 23rd February, 2007 recorded in the Register of Patents on 6th July, 2007 pertained to Erlotinib Hydrochloride which was marketed as Tarceva.

Result 21
Delhi High Court
(ID::2024 HDELP 401)
Natco Pharma Limited vs Novartis Ag And Anr
Honourable Judges Vibhu Bakhru
Date of Judgment: 24 April 2024
Segment Number (Approximate Page Number): 12
Relevancy Score: 58.01
   
   
   

In a visible departure, however, where the claim of the plaintiff was rejected, Roche v. Cipla held this to be an indicator, prima facie, that the defendant's product infringed the suit patent. (iv) Section 3(d) (a) Once a patent was granted to an Active Pharmaceutical Ingredient (API), Section 3(d) protects all products of such API, in any form, from grant of a subsequent patent. The manufacture or marketing by any third party of any product-derivative of a patented API would amount to infringement. The API is the molecular entity which exerts the therapeutic effect of medicine and is biologically active. Patent protection is ordinarily granted to the API. (b) In the case of pharmaceutical products, the derivatives envisaged by Section 3(d) would include (a) prodrugs, which are not active, but are metabolized in the body so as to result in pharmaceutically active substances, (b) combinations of more than one APIs or the combination of an API with an inert carrier and (c) drug delivery systems, which are compositions enabling the constituents to be administered in a particular fashion. (c) In Novartis, examining the vulnerability of Imatinib Mesylate to invalidity on the ground of Section 3(d), the Supreme Court held that (i) the obtaining of approval for Imatinib Mesylate on the basis of Zimmerman patent, (ii) the obtaining of patent term extension for the Zimmerman patent on the ground of pendency of regulatory approval for Imatinib Mesylate, (iii) the obtaining, by Novartis, of injunction against marketing of Imatinib Mesylate by any third party on the basis of the Zimmerman patent and (iv) the view of the Board of Patent Appeals that the Zimmerman patent had the teaching to convert Imatinib to Imatinib Mesylate, in conjunction, indicated that Imatinib Mesylate was not a "new product", within the meaning of Section 3(d), vis-à-vis the Zimmerman patent, but merely a "known substance". (d) "Efficacy" in Section 3(d) refers to the function, utility and purpose of the product under consideration. Hence, for pharmaceutical products, "efficacy" would mean "therapeutic efficacy". "Therapeutic efficacy" was required to be judged strictly and narrowly. (e) Enhanced properties, which were inherent to the forms of the known substance, visualized in the explanation to Section 3(d) would not imply enhanced efficacy.

Result 22
Delhi High Court
(ID::2015 HDELP 229)
Bristol-Myers Squibb Company & Anr vs Mr.D. Shah & Anr.
Honourable Judges Manmohan Singh
Date of Judgment: 29 June 2015
Segment Number (Approximate Page Number): 60
Relevancy Score: 57.93
   
   
   

94. The object of the injunction in patent matters is to protect the patentee against the injury by violation of right for which he could not be adequately compensated in damages recoverable in the action if ultimately a decree for damages is passed. There is no rule in the patent matters that a plaintiff must make out a prima-facie case. No doubt, the Court must be satisfied that the claim(s) is not frivolous or vexatious. An interim injunction may be granted if the defendant has applied for a compulsory licence but he infringes the patent. The interim injunction may also be passed in respect of single claim which is valid even though other claims in the specific actions are not prima facie valid. 95. The patent law in India is governed by Patents Act, 1970 as amended in the year 2005. What constitutes infringement of a patent is not denied in the Act. Thus, one has to gather the meaning of infringement from the scope of the monopoly rights conferred on the patentee for infringement is the violation of those rights. Section 48 confers on the patentee, his agents and licensees the exclusive rights to make, use, exercise or distribute invention in India. The rights of the patentee are infringed if anyone makes and supplies or commercially uses and the patentee may be granted interim order, subject to the condition if the patent is valid. It is not incumbent upon the plaintiff in case of infringement to show that the plaintiff has suffered commercial loss. 96. In the present case, as per the conduct of the defendants, prima-facie no credible challenge has been made, rather they have admitted infringement in their pleadings. The defendants in both the matters are connected with others, hence it is immaterial if two companies are different entity. Their main intent is to manufacture and sell the product in question. 97. In view of the above said reasons if defendants would be allowed to commence the infringement in full knowledge of the patentee invention, the plaintiffs would suffer injury and irreparable harm. 98. On the balance of convenience in a quia timet action the House of Lords, in American Cyanamid Company v. Ethicon Limited [1975 FSR (1) 101], held that: "Where other factors appear to be evenly balanced it is a counsel of prudence to take such measures as are calculated to preserve the status quo.

Result 23
Delhi High Court
(ID::2009 HDELP 174)
F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd.
Honourable Judges Chief Justice, S.Muralidhar
Date of Judgment: 24 April 2009
Segment Number (Approximate Page Number): 9
Relevancy Score: 57.54
   
   
   

Since the admitted position of the plaintiffs was that patent No.196774 was not a preferred form for manufacture of tablets, the defendant was curious to know how the plaintiffs were still importing and selling tablets of the said Hydrochloride compound under the brand "Tarceva". It sought to determine the actual crystalline structure of the tablets and accordingly purchased some manufactured in August 2006 from the local market. The x-ray diffraction data of Tarceva sold in India showed that it was "B-Polymorph of the Hydrochloride". This was confirmed by the defendant€Ÿs expert Mr. Manish G. Gangrade who performed the technical evaluation. On an analysis of the X-ray diffraction pattern he came to the follwoing conclusion: "Tarceva tablets are wholly B polymorph of the hydrocholoride salt of N-(3-ethynylphenyl)-6, 7 bis(2-methoxyethoxy)-4-quinazolinamine. I further say that the X-ray powder diffraction of Tarceva clearly goes to show that it is not A polymorph or a mixture of A and B polymorph but is wholly B polymorph of the said compound." 22. It was stated in paras 12, 14 and 15 of the application as under: "12. The plaintiff in its various pleadings has claimed that the patented drug has been sold by it in India since April, 2006, meaning thereby the drug which is sold in India is the drug for which the patent has already been granted, i.e., Patent No.196774. However, an analysis of the drug which is sold in India and the patent which is registered as also the patent which is pending in India reveals that the case of the plaintiff is completely false. The drug sold by the plaintiff in India appears to relate to the said pending patent applications and not the granted patent No.196774. ...... 14. It is, thus, obvious that the plaintiff has come to this Hon€Ÿble Court with a completely false and incorrect case. The plaintiff has deliberately failed to file the patent specification in the first place by claiming confidentiality. When the defendant showed that as per the statute a patent specification is a public document the plaintiff was forced to reveal the same. Now it has come to light that the drug which is marketed by the plaintiff is not at all the product for which the alleged patent has been obtained. The patent application for the drug which is marketed by the plaintiff is still pending in the patent office.

Result 24
Delhi High Court
(ID::2023 HDELP 683)
F Hoffmann-La Roche Ltd & Others vs Drugs Controller General Of India & ...
Honourable Judges Jyoti Singh
Date of Judgment: 11 September 2023
Segment Number (Approximate Page Number): 3
Relevancy Score: 57.47
   
   
   

This order was challenged before the Division Bench by Cadila and on 04.03.2021 the Division Bench in FAO(OS)(COMM) No. 120/2020 while adjudicating the appeal permitted Cadila to prefer an application under Order VII Rule 11 CPC, if so advised, within two weeks. It was further directed that if an application is preferred, the same shall be decided by the learned Single Judge, after giving an opportunity to the Plaintiffs herein, to file reply(ies), uninfluenced by the observations in the impugned order. It is pursuant to the said liberty that the present application has been filed by Cadila. CONTENTIONS ON BEHALF OF CADILA:- 7. No cause of action arises in favour of the Plaintiffs and they have no locus standi to file the present suit. Plaintiffs have no statutory or common law rights or any other intellectual property rights in the drug 'Trastuzumab' and in the absence of any valid and subsisting rights the plaint deserves to be rejected. It is an admitted position that the drug 'Trastuzumab' does not enjoy patent protection since 03.05.2013, when the Plaintiffs' patent lapsed and the drug is in the public domain. Therefore, no suit can be filed for patent infringement. 8. In the absence of patent protection, no monopoly can be exercised by the Plaintiffs on 'Trastuzumab'. The data relating to 'Trastuzumab' is publicly available and Indian law does not recognize any data exclusivity provisions as the same are considered TRIPS-Plus provisions and India only follows TRIPS. In any event, admittedly Plaintiffs are not claiming data exclusivity or data protection and Drugs Act itself provides an applicant to rely on the data to the extent required for obtaining statutory approvals for a biosimilar. 9. 'Trastuzumab' is an International Non-Proprietary Name (INN) which is globally recognized and no proprietary rights can be sought by the Plaintiffs by virtue of Section 13 of the Trade Marks Act, 1999 (hereinafter referred to as the '1999 Act'). Allowing an ex-patentee to claim any form of ownership in an INN as a result of 'goodwill/ reputation' obtained by it during the period the patent was valid will entirely destroy the patent regime and provide an easy route to patentees to 'evergreen' their patent and file passing off suits against manufacturers of generics/biosimilars.

Result 25
Delhi High Court
(ID::2009 HDELP 167)
Bayer Corporation & Ors. vs Uoi & Ors.
Honourable Judges S. Ravindra Bhat
Date of Judgment: 18 August 2009
Segment Number (Approximate Page Number): 1
Relevancy Score: 57.43
   
   
   

* 1. The writ petitioner, a pharmaceutical company manufacturing various kinds of drugs, (hereafter "Bayer") seeks directions to, inter alia, restrain grant of drug license in regard to an application by the third Respondent for the license to manufacture, sell and distribute its drug "Soranib". Bayer claims that the said drug is an imitation of, or substitute for its (the first petitioner's) patented drug. It is submitted that the said drug "Soranib", being a "spurious drug" WP(C) No.7833/2008 Page 1 as defined in Section 17B of the Drugs and Cosmetics Act, (hereafter called "the Drugs Act") and the second respondent Drugs Controller (hereafter "the Controller" and "DGCI") would be exceeding his jurisdiction, and deciding in contravention of Chapter IV of the Drugs Act, if the application for marketing license is processed. 2. Bayer is a corporation organized and incorporated under the laws of Indiana, USA; the second petitioner is its Indian subsidiary. It is owner of Indian Patent number 215758 (hereinafter referred to as "the subject patent") which was granted by the Patent Office on March, 3, 2008. Therefore, by virtue of section 48 of the Act, Bayer has exclusive right to prevent third parties who do not have its consent from the acts of making, using, offering for sale, selling or importing the patented product in India. Bayer relies on Sections 43, 48 and 53 of the Patents Act, 1970 to say that the said provisions clarify that upon grant of a patent, a patentee secures, for a term of twenty years from the date of filing of the application, the exclusive right to prevent third parties who do not have its consent from making, using, offering for sale, selling or importing patented product in India. 3. Bayer submits that in the present case the application of the third Respondent ("Cipla") is for the license to manufacture, sell and distribute its drug "Soranib" which is an imitation of and/or substitute for the patented drug under its (Bayer's) patent.

Result 26
Delhi High Court
(ID::2009 HDELP 167)
Bayer Corporation & Ors. vs Uoi & Ors.
Honourable Judges S. Ravindra Bhat
Date of Judgment: 18 August 2009
Segment Number (Approximate Page Number): 4
Relevancy Score: 57.42
   
   
   

Generic drugs can only be legally produced for drugs which are free of patent protection. The expiration or invalidation of the patent removes the monopoly of the patent holder on drug sales or licensing patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires or to revive it after it is invalidated. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug for a fraction of the original cost of testing and developing that particular drug; in essence, says Bayer, this is a "generic" product. Therefore, a product for which CIPLA has applied for the grant of marketing approval is not generic drug but "spurious drug" as defined under Section 17B of the Drugs Act for which marketing approval cannot be granted as per Section 18 of the Drugs Act. In view of the aforesaid submissions, it is submitted that "generic drug" and "spurious drug" are two different concepts and cannot be interpreted in the manner sought to WP(C) No.7833/2008 Page 4 be canvassed by CIPLA, in its opposition to the present proceeding. Bayer's product is protected by a patent; it is not "generic"; CIPLA's products are "spurious". 8. Mr. Shanti Bhushan, Bayer's Senior counsel, besides reiterating the combined effect of Section 2, 17-B and 18 of the Drugs Act read with provisions of the schedule (which oblige an applicant to disclose particulars relating to patent in respect of the drug for which marketing license is sought) also submitted that this court should interpret Section 2 purposively to further legislative intent, rather than otherwise. He contended that with amendments to the Patents Act in 2005, pursuant to India's commitment to be part of the WTO regime, the court had to recognize the need for patent linkage with the drug licensing mechanism. He contended that a patent is granted after elaborate examination, scrutiny and inspection of the product and process, for ensuring its efficacy, novelty, existence of inventive step and industrial application. It can even be challenged by persons aggrieved, after its grant.

Result 27
Madras High Court
(ID::2015 HMADP 162)
Novartis Ag vs Union Of India
Honourable Judges Sanjay Kishan Kaul, T.S.Sivagnanam
Date of Judgment: 28 July 2015
Segment Number (Approximate Page Number): 1
Relevancy Score: 57.41
   
   
   

The Hon'ble The Chief Justice and T.S.SIVAGNANAM, J. The Petitioner M/s.Novartis AG a company, carrying on business of research, development, manufacturing and marketing of Pharmaceutical preparations, has approached this Court by way of this Writ Petition being aggrieved by an order dated 11.03.2015, passed by the Intellectual Property Appellate Board (hereinafter referred to as 'IPAB') in M.P.No.68 of 2014 and M.P.No.50 of 2014, in ORA/21/2013/PT/CH. 2. The petitioner is the Patentee of the Indian Patent No.212815 titled N-Substituted 2-Cyanopyrrolidines which pertains to the pharmaceutical product and New Chemical Entity (NCE), assigned International Non-Proprietary Name (INN) Vildagliptin. The petitioner is said to operate in India through its subsidiary which markets patented product Vildagliptin in India. The petitioner claims to have spent substantial financial resources on pharmaceutical research and development in order to invent new products. The petitioner filed the subject Patent Application on 04.06.2001, as National Phase Entry of Patent Cooperation Treaty International Application, dated 09.12.1999 claiming priority from US Application dated 10.12.1998. The Patent Application was published in the official gazette on 09.03.2007 inviting pre-grant opposition and it appears that no opposition was filed within the prescribed period and the petitioner was granted the suit patent as Indian Patent No.212815 as of 17.12.2007 and the same was published in the official gazette of Patent office as of 15.02.2008. The post grant opposition period expired on 15.02.2009 and it is stated that there was no opposition filed within the statutory period. Thus, the petitioner claims that they have a valid suit patent (hereinafter referred to as the subject patent). 3. The second respondent M/s.Wockhardt Limited applied for revocation of the subject patent granted to the petitioner by filing an application under Section 64 of the Patents Act before the IPAB on 30.04.2013 and notice of such application was received by the counsel for the petitioner on 08.01.2014. Thereafter, the petitioner filed a Suit before the High Court of Delhi in CS(OS) No.646 of 2014 and an order of interim injunction was granted on 05.03.2014, restraining the second respondent from manufacturing, importing, selling, offering for sale the formulations or combinations containing Vildagliptin.

Result 28
Delhi High Court
(ID::2008 HDELP 113)
F. Hoffmann-La Roche Ltd. And Anr. vs Cipla Limited
Honourable Judges S. Ravindra Bhat
Date of Judgment: 19 March 2008
Segment Number (Approximate Page Number): 1
Relevancy Score: 57.37
   
   
   

This order disposes of IA 642/2008, an application seeking ad-interim injunction, restraining the defendant from manufacturing, offering for sale, selling and exporting the drug Erlotinib, for which the plaintiff holds a patent. Emergent notice was issued, and the parties filed their pleadings as well as documents in support of their contentions, in the suit and the interlocutory proceedings. The application was heard finally for disposal. I The suit 1. The Plaintiffs in this suit seek permanent injunction restraining infringement of their patent rights in the drug Erlotinib, rendition of accounts, damages and delivery up of the infringing goods. 2. The first Plaintiff is a company organized and existing under the laws of Switzerland and has its principal office at Grenzacherstrasse, 124 CH 4070, Basel Switzerland. The second Plaintiff is a company organized and incorporated under the laws of the United States with its registered office at 41, Pinelawn Road, Melville, New York 11747, USA. It jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule, medically termed as a 'Human Epidermal Growth Factor Type-1/Epidermal Growth Factor Receptor' (Her/Egfr) inhibitor, popularly known as 'Erlotinib'. It is claimed that this drug marked a major breakthrough and innovation in the treatment of cancer; it is used to destroy some types of cancer cells while causing little harm to normal human cells. This drug is administered in the form of a tablet. The tablet formulation of Erlotinib is sold by the plaintiff under the trademark and name of 'Tarceva', which is registered in the name of the first plaintiff. It is averred that the drug Erlotinib and its formulation 'Tarceva' has been approved by the U.S. Food and Drug Administration in the year 2004 and thereafter by the European Union in the year 2005. 3. The second Plaintiff, along with M/s. Pfizer Products, Inc had applied for grant of a patent in respect of Erlotinib and its process by application No. 537/Del/1996 on 13.3.1996. The Controller General of Patents, Trademarks and Designs, New Delhi granted a certificate bearing Patent No. 196774 dated 23.02.2007, which was recorded in the Register of Patents on 06.07.2007. The molecular name of patent is 'A Novel [6,7-BIS(2-Methoxyethoxy) Quinazolin-4-YL] (3-Ethynylphenyl) Amine Hydrochloride'.

Result 29
Delhi High Court
(ID::2009 HDELP 167)
Bayer Corporation & Ors. vs Uoi & Ors.
Honourable Judges S. Ravindra Bhat
Date of Judgment: 18 August 2009
Segment Number (Approximate Page Number): 12
Relevancy Score: 57.37
   
   
   

Cipla's submissions 15. Cipla contests this proceeding, arguing that Bayer's claim for patent linkage, based on an interpretation of Section 2 of the Drugs Act is misleading, because i) The grant of drug regulatory approval by the DCGI cannot, by itself amount to a patent infringement ii) The existence of patent infringement cannot be assumed merely because the patentee states so, but has to be clearly established before a court of law in accordance with the infringement provisions mentioned under the Patents Act, 1970. Such an assessment is beyond the statutory powers of the DCGI, which is institutionally incapable of dealing with complex issues of patent scope, validity and infringement. 16. Cipla says that Section 48 of the Patents Act, spells out the various exclusive rights of a patentee and includes the acts of "making, using, offering for sale, selling or importing" the patented product or process as the case may be. It is submitted that grant of a drug regulatory approval by the DCGI to Cipla on the basis that its drug is safe and effective does not amount to an act of "making, using, offering for sale, selling or importing" the petitioners' patented product. Cipla states that Section 107A of the Patents Act, clearly exempts from patent infringement any of acts of making, using or even selling a patented invention, in so far as such acts are necessary to obtain information for the filing of a drug regulatory application before the DCGI. It is highly illogical to argue that when all acts leading upto the stage of drug approval are exempt from patent infringement, the very act of approval itself amounts to an infringement. 17. It is argued that Section 107A (a) of the Patents Act, commonly referred to as the WP(C) No.7833/2008 Page 11 "Bolar" provision permits any drug manufacturer to experiment with any patented drug with a view to generating data that could then be submitted to a drug control authority. The aim of this section is to ensure that generic drugs are introduced into the market as soon as the patent expires or is invalidated, so that consumers may benefit from this early entry of affordably priced drugs.

Result 30
Madras High Court
(ID::2004 HMADP 49)
Novartis Ag, Rep. By It'S Power Of ... vs Adarsh Pharma And Anr.
Date of Judgment: 28 April 2004
Segment Number (Approximate Page Number): 3
Relevancy Score: 57.3
   
   
   

On the above stated facts, the plaintiffs sought for an injunction and it was accordingly granted ex parte on 20.1.2004, which underwent a slight modification on 26.2.2004. 3. The defendants' case is summarised as hereunder: "The first plaintiff filed a patent claim in "US" on 28.4.1994 titled "Pyrmidine derivatives and processes for the preparation thereof; priority for this application was claimed from "Swiss" patent application filed on 1.4.1992; this patent was granted by "US" on 28.5.1996 disclosing "Mesylate Salt of Imatinib"; for the same invention, the plaintiff filed a patent claim in "Canada" on 1.4.1993 basing again the priority on the "Swiss" patent application referred to earlier; "Canada" granted patent on 26.11.2002; no patent for "Imatinib Mesylate" was ever filed in India and therefore there is no question of the plaintiffs being entitled to any protection on the basis of any patent that may still subsist abroad for "Imatinib" per se or for the "Mesylate Salt of Imatinib"; no patent can be granted, if the said subject matter was claimed else where, before the priority date claimed in India; the first plaintiff filed a patent application in India on 17.7.1998 titled "Crystal modification of a N-Pheny-2-Pyrimidineamine derivative process for its manufacture and it's use"; for this application, the priority date is 18.7.1997 Switzerland; on the date of filing the patent application in India, Switzerland was not a convention country and it was notified as a convention country only on 28.9.1998; therefore no patent can ever be granted in India to the invention referred to above; the first plaintiff obtained a patent in Australia based on the priority on the "Swiss" patent application of July 18, 1997; the "EMR" issued in this case does not disclose the specific substance claimed in the Australian patent, on which it is based; the "EMR" granted is vague and indefinite; the first plaintiff is trying to create a monopoly and to take the entire profits out of the sale of drugs covered under the "EMR", adversely affecting the interest of the patients in India; the cost of one capsule marketed by the plaintiffs is Rs. 1,700 whereas the cost of the drug in question sold by the Indian manufacturer averages less than Rs. 100 per capsule; taking the price tag, the cost of the plaintiffs' product per year would be approximately Rs. 25 lakhs while the same would be Rs. 1-1/2 lakhs for an Indian drug; India being a poor country, many cannot afford to buy the plaintiffs' product and ultimately, they would die untreated; the plaintiffs have to establish that the "EMR" was validly granted and it is being infringed; the plaintiffs are lacking in good faith; the "EMR" is not validly granted for the reasons stated in paragraph Nos. 43 to 50 of the written statement; the marketing approval in Australia for the drug in question was not given to the first plaintiff but to M/s. Novartis Pharmaceuticals Australia Private Limited, hereinafter referred to as "Novartis


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