These lethal changes in India’s patent rules

Nearly 20 years ago, India passed a Patents (Amendment) Act that permitted product patents on food items, chemicals and pharmaceuticals to comply with the World Trade Organization (WTO)’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) regime. India’s Patents (Amendment) Act, 2005, however, was unique in many ways by balancing the WTO demand on IPRs with special safeguards to protect public health. It ensured there were provisions for issuing compulsory licences to meet public health emergencies and an opportunity to anyone—individuals or patient associations, among others—to freely mount pre-grant opposition if they felt the patent application, specially for drugs, was being made on specious or shaky grounds.

These are some of the critical aspects of the law that the Narendra Modi government is seeking to undermine in a way that some IP experts say could alter the Indian patent landscape in a significant manner. The changes have not been debated in Parliament or in any public fora. The law itself is not being amended, just the rules that govern the patent law. It is a kind of backdoor way of bringing about major changes. What the Department for Promotion of Industry and Internal Trade (DPIIT), which deals with patent matters, has done is notify the Draft Patents (Amendment) Rules and allow a month for comments. That ended on September 25. Were any stakeholders consulted? None, except the corporate sector, it would seem. Among public health activists, campaigners for access to medicines and patient groups, there is shock and dismay.

The rationale DPIIT offers for the amendments is the need to streamline the working of the Patent Office so that applications are processed faster. The Union Minister for Commerce and Industry Piyush Goyal sets great store on increasing the number of patents and has been consistently saying that he will amend the patent law to spur innovation and research and development. But that is all of a piece with the government’s statements on the patent law since it came to power in 2014. Modi’s first Minister of Commerce and Industry, Nirmala Sitharaman, startled a business meeting in October of that year when she claimed that India did not have an IPR policy and that this had “really curbed us from establishing our rights in a forceful way”. What was needed was a nationalist policy, she stated. This showed little understanding of how India had formulated its patent laws over the decades to meet the country’s economic interests at different stages of its development. The 2005 Patents Act, in fact, had been formulated by the Manmohan Singh government, based on a draft prepared by the outgoing ministry of Atal Bihari Vajpayee and by seeking inputs from different segments of society. Singh ensured that the law would not allow patent holders a free run on the patent system by including several safeguards to protect public interests. This is the reason why rich nations, led by the US and its business organisations, particularly the pharma lobby, have kept up relentless pressure on India’s policymakers, its courts and the patent system to get unique sections of the law excised or diluted to suit their interests.

The pressure appears to have finally worked. In the past couple of years, New Delhi has been whittling away at some of the critical aspects of the safeguards in the patent law by the insidious method of amending the rules, all in the name of ensuring better working of the Patent Office. One such amendment with wide ramifications relates to Form 27, which this column has flagged earlier. Form 27 is a local working requirement that needs to be filed by patent holders every year to disclose whether their patents are being worked in India and to what extent. Apparently, this was too onerous a requirement for drug majors although they are required to file similar information with the relevant authorities in their home countries. Form 27 provides vital information for Indian companies when applying for compulsory licences. The draft rule proposes to remove the need for patent holders to explain why the patent was not worked in India or to provide details of the approximate revenue earned in India through the patent. That’s not all. Patent holders can file this abridged, and very likely meaningless, form just once in three years instead of annually. In essence, this amendment would also spell the death knell of compulsory licences, not that any are being issued by the government.

There are other concessions to patent applicants. They no longer have to disclose to the Patent Office information on the status of their patent applications for the same invention in other countries. The DPIIT argument is that such information would be in the public domain and that the Patent Office should be able to access it. Why bother the companies to provide such detailed information when the inundated Patent Office could spend long hours of its working days searching the data bases of patent offices the world over? One wonders if the Patent Office was consulted at all in the process of formulating the new system.

But the most lethal blow is aimed at pre-grant opposition. Those challenging patent applicants will have pay hefty dynamic fees, which was not the case earlier. Patients groups say they would be unable to fork out such sums. And it will no longer be open to everyone to file a patent challenge; it needs the approval of the Controller of Patents. Giving such discretionary powers to officials is a hallmark of this government, but in this instance, it’s a violation of not just the patent law but also of several court rulings that have upheld the right of patient groups and others to file pre-grant opposition petitions. In 2006, patients scored a landmark victory against Swiss multinational Novartis when the Chennai Patent Office rejected its patent application for an incremental improvement on its anti-cancer drug Glivec based on an opposition suit filed by the Cancer Patients’ Aid Association. That is when India sent out a strong signal that patients and access to medicines mattered as much patent protection.

It is difficult to fathom where this government’s priorities lie. Recall another signal victory a few months ago when two TB patients, both women, stopped Johnson & Johnson’s claim for a secondary patent on its tuberculosis drug bedaquiline with their pre-grant opposition. Following the rejection in India, the drug giant announced it would not be enforcing these patents in 134 other low- and middle-income countries. Normally, one would have expected New Delhi to celebrate such a major victory by strengthening the pre-grant opposition system. Instead, the government appears set on crippling it with restrictive new rules.

This was first published in the 16-31 October, 2023 print edition of Down To Earth

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