Abstract

AbstractPre-grant and post-grant oppositions filed in India by civil society and generic companies have been instrumental in visibly increasing access of drugs to the public—both in terms of earlier generic entry and also cheaper prices due to such generic competition. This paper looks at the significant pharmaceutical patent oppositions in India during the last 15 years. It focuses on some unique aspects connected to each of these oppositions and tracks how these oppositions helped in securing earlier access to generic drugs. The last part of the paper analyses patent opposition pendency statistics and notes that increasing pendency numbers, over the last few years, is a matter of deep concern as it could impact access to drugs, in future.

Highlights

  • Patent oppositions by civil society organisations and generic pharmaceutical companies have been instrumental in increasing access of drugs to the public—by preventing patent evergreening and bringing in earlier generic drug entry as well as increasing competition in the pharmaceutical sector leading to cheaper prices due to such generic entry

  • Indian Network of People Living with HIV/acquired immunodeficiency syndrome (AIDS) (INP+) Delhi Network of People Living with HIV/AIDS (DNP+) Cipla Ltd

  • Drug: Therapeutic area: Application # Opponent: Expiry, if granted: Copy of decision: Unique point: Abacavir Sulphate Anti-HIV 872/CAL/98 Indian Network of People Living with HIV/AIDS (INP+) 14/May/2018 Image, here

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Summary

Introduction

Patent oppositions by civil society organisations and generic pharmaceutical companies have been instrumental in increasing access of drugs to the public—by preventing patent evergreening and bringing in earlier generic drug entry as well as increasing competition in the pharmaceutical sector leading to cheaper prices due to such generic entry. Cancer Patients Aid Association (CPAA) Companies: Hetero, Cipla, Natco Evidence submission, obviousness, disclosure versus claim scope and S.3(d) is a Novartis drug used in treatment of certain cancers (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors etc.) This opposition battle went all the way up to the Supreme Court of India where besides looking at the S.3(d) interpretation, the Court made way for some very interesting case-law on inventive step, rejecting Novartis’ arguments on disclosure v/s claim scope. (i) S.3(d) framework for assessing patentability arguments for new forms of a known substance and (ii) the law of obviousness for pharmaceutical inventions— theoretically, the EMR and subsequent product patent would have sustained and possibly blocked generic launch until July 2018 While this opposition used S.3(d) extensively, the jurisprudence that developed from the Patent Office all the way up to the Supreme Court went a lot beyond the plain S.3 (d) argument. Became the cornerstone for India’s pharmaceutical patent opposition/drug access saga

Valcyte Opposition
Herceptin Opposition
Original
Zykadia Opposition
The Viread Oppositions
Kaletra Opposition
Reyataz Opposition
Combivir Opposition
Trizivir Opposition
2.10 Ziagen Opposition
2.11 Isentress Opposition
2.12 Sanofi TB Drugs Oppositions
2.13 Veklury Opposition
Pre-grant Oppositions
Post-grant Oppositions
Pendency at the Intellectual Property Appellate Board (IPAB)
Impact of Pendency
Findings
Conclusion
Full Text
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