Sec.3(d) pivots a health revolution

Ten years ago, on April 4, 2005, the President of India gave his assent to the Patents (Amendment) Act, 2005. And with it, Section 3(d) came into India’s law lexicon. Within six months, in September 2005, the Cancer Patients Aid Association (CPAA) with legal aid and representation from the Lawyers Collective, filed the first public interest pre-grant opposition challenging Novartis’ patent application for a new form (beta crystalline) of Imatinib Mesylate. Section 3(d) was a key argument in that challenge. Little could anyone have known that this case and Section 3(d) would go on to capture the imagination of the world and become the epicentre in the global fight for access to affordable medicines.

Recognising the problems of patent evergreening (the practice of pharmaceutical companies to file multiple, successive patents on known medicines attempting to extend their monopolies), Section 3(d) allows patents for new forms of known medicines only on the demonstration of a significant increase in efficacy. On April 1, 2013, the Supreme Court held that Novartis’ patent application failed the Section 3(d) standard. They also rejected Novartis’ attempt to weaken its interpretation stating: “With regard to the genesis of Section 3(d), and more particularly the circumstances in which Section 3(d) was amended to make it even more constrictive than before, we have no doubt that the “therapeutic efficacy” of a medicine must be judged strictly and narrowly.”

Even as the Imatinib Mesylate case progressed through the courts, networks of people living with HIV filed multiple patent oppositions; Section 3(d) featured prominently as a majority of molecules used in first- and secondline HIV treatment were invented before 1995. For newer molecules, the provision features in challenges to ensure that the monopoly even if granted is not extended.

At the time, Novartis’ challenge was considered the most serious threat to Section 3(d). But the last few years have presented far greater challenges. The US has ratcheted up its pressure on India’s patent regime; Section 3(d), their favourite whipping boy. In the Regional Comprehensive Economic Partnership Agreement negotiations, Japan’s proposals reportedly include a reversal of Section 3(d). An intense ongoing effort to introduce data exclusivity would mean that medicines that remain off patent could, nevertheless, be covered by a monopoly.

But the increasingly shrill opposition to India’s balanced patents law, particularly Section 3(d), hides the quiet revolution that the provision is inspiring across the developing world. The Philippines introduced their version of Section 3(d) in 2008. Argentina introduced regulations in 2012 that improved on the spirit and intent of Section 3(d) through detailed provisions prohibiting patents on new uses and new forms of known substances. In Brazil, patent law reform proposals feature versions of Section 3(d).

There is good reason for this. One that is immediately visible to those working directly with patients. Since the judgment, CPAA has provided over a 1,000 patients suffering from chronic myloid luekemia with generic versions of Imatinib Mesylate free of cost. Section 3(d), along with other provisions of India’s patent law, has been pivotal in the rejections or withdrawals of patent applications on key first- and second-line HIV medicines. It is increasingly being used in challenging patent applications on medicines necessary to treat diabetes, cancer and hepatitis C treatment. Every victory means that generic companies can freely manufacture and supply generic versions of these critical medicines. Every victory means one less hurdle for patients in India and developing countries in accessing safe, effective and affordable generic medicines.

Every victory provides a chance to fight off the restrictive voluntary licences that are increasingly binding generic production. Multinational companies are luring India’s biggest generic manufacturers into deals that may be sweet for their collective bottomlines, but that are creating significant hurdles, including grave privacy violations for patients accessing the drugs. For patients in countries excluded from these deals, the future is bleak. In exchange for these unconscionable deals, generic companies are shying away from or backing out of critical patent oppositions. This leaves the burden of challenging questionable patent applications squarely on the shoulders of patients and public interest groups. Gilead’s voluntary licences on the critical hepatitis C treatment, Sofosbuvir, is the worrying case in point. Multiple patent oppositions based on Section 3(d), among other grounds, by people living with HIV and hepatitis C, now pending before the patent office hope to stem the tide of such devil’s bargains.

There are several other pro-public interest provisions in the patent law amendments that were signed into effect 10 years ago. But for the detractors of India’s balanced legal regime, for the supporters of corporate monopolies and for the developed country governments lobbying for even greater profits for their companies, Section 3(d) has been used as a symbol of all that they argue is wrong with India’s approach to foreign investment and innovation. But for many patients and public interest groups, it is a symbol of all that is right with India’s approach in balancing its international obligations to the WTO, its obligations to patients in India and abroad and its obligations to push the research and development world towards true innovations, away from minor tinkering with existing molecules to extract the longest possible monopoly.

So this month, April 2015, we are celebrating 10 years of Section 3(d), 10 years of hope, 10 years of hard-fought and hard-won battles. We have a long way to go and there are tough days ahead. Section 3(d) may not be the perfect solution to the problem of patent evergreening and of the abuse of the patent system, but in our books, it’s an efficacious one. And it is one that we will defend, like our lives depend on it. Loon Gangte is with the Delhi

Network of Positive People (DNP+). Anand Grover is the former UN Special Rapporteur on Health and the director of the

Lawyers Collective. Y.K. Sapru is the founder-chairman and CEO of the Cancer

Patients Aid Association.