“The needle has moved,” declares Anil Matai, director general of the Organization of Pharmaceutical Producers of India (OPPI), describing India’s evolving intellectual property rights regime, which saw the enactment of some key amendments last year. The OPPI essentially represents the interests of foreign firms in India.
In this audio interview/podcast with Scrip, Matai outlines how things are playing out on the ground in areas like pre-grant oppositions and also discusses some of the long-standing sticking points including restrictions on patent-eligible subject matter under Section 3(d) of India’s patent regulations.
Section 3(d) was at the core of a 2013 Supreme Court ruling in India that turned down a patent for Novartis’s cancer drug Glivec (imatinib mesylate).
Matai, who’s worked in leadership roles across both Indian and foreign pharma multinationals, also underscored the need for regulatory data protection (RDP). “RDP to me is a no-brainer,” Matai asserted, citing how China has been able to draw global pharma investment and also moved way ahead of India in the biologics space.
China’s National Medical Products Administration, for the first time, recently outlined specific time periods of data exclusivity for different drug categories, opening up the draft proposal to public comment. While China’s Regulations for the Implementation of the Drug Administration Law included provisions for the protection of drug regulatory data in 2002, it lagged behind in implementation and lacked detailed guidelines, experts at the American multinational law firm Arnold & Porter observed in a recent advisory note.
Data exclusivity (DE) has been contentious issue in India, with innovator firms long interpreting obligations under Art 39.3 of the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement as requiring member states to provide DE, with flexibility only to determine the period of exclusivity.
Art 39.3 essentially binds member states to protect undisclosed data required to be submitted for approval of pharmaceutical and agricultural chemical products against unfair commercial use, when such products are new chemical entities. India, though, sees DE as a TRIPS-plus measure (DE is not currently provided for in Indian regulations), with generic industry and public health experts, among other arguments, asserting that the obligation referred to is confidentiality and data protection, not exclusivity.
Big pharma chiefs like Eli Lilly’s CEO, David Ricks have recently underscored that India will need to rethink certain historical positions in areas like IPR and also transform the regulatory environment to “join the globe as a leader in life sciences.”
Both Section 3(d) and concerns around protecting against the unfair commercial use, and unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products, are part of the United States Trade Representative’s Special 301 report, where India remains on the Priority Watch List in 2025, as does China.
The US and India hope to negotiate the first tranche of a multi-sector Bilateral Trade Agreement (BTA) by fall of 2025 and it will be interesting to see if any of the contentious IPR issues feature therein.
Time Stamps
00:09 Introduction
04:32 Drug discovery journey, sustained financial/scientific investment & effective IP framework
06:27 Global and India product launch timeline gap
09:04 Amended Patent rules & changes brought about in pre-grant opposition process
09:50 Hope India’s IPR rules get further amended
10:56 Statutory situation with respect to compulsory license remains onerous
13:12 Need more IPR benches in courts
15: 56 Section 3(d)… now’s the time that India must open up
17:19 ‘RDP is not a patent issue’
19:24 EU- patents are enforced in a meaningful manner
20:25 India doesn’t stand chance to catch up with China in biologics, RDP is a ‘no brainer’
22:12 Bolar provision -past experience of member companies
24:24 AI and IP requirements
28:30 Geopolitical shifts reshaping business strategies
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