KEI comments on the Novartis decision

There is so much that one could say about today’s decision, it is hard to know where to start.

By presenting the India patent law from a historical perspective, including long passages from Sudip Chaudhuri’s book titled, The WTO and India’s Pharmaceuticals Industry, documents and developments relating to the WTO Doha Declaration on TRIPS and Public Health, WTO disputes over the India patent law, various amendments to the patent act and the debates over those amendments, and political statements by various public health officials (including Dr. Jim Yong Kim when he was director of HIV/AIDS for the WHO) and groups like MSF, the court made a deliberate decision to recognize and present the decision to the world in a broader context, rather than focus entirely on the technical issues regarding patent validity.

The Indian drug company NATCO has now figured into two major precedent setting cases, including not only this case, but the earlier compulsory licensing case involving Bayer’s patents on the cancer drug sorafenib (Nexavar). Both cases involved drugs for cancer– a growing battle ground for access to medicine in developing countries.

By making extensive references to the WTO dispute resolution understanding, the Court has drawn attention to the fact that the EU and the US have not challenged section 3(d) of the Patents Act at the WTO itself, a fact that weakens the claims that India is operating outside of global norms.

The New York Times quoted Dr. Yusuf K. Hamied, chairman of Cipla, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, Leena Menghaney of Médecins Sans Frontières, and Anand Grover, described as the lawyer for the Cancer Patients Aid Association of India.

On page 2 of the Judgement, the court set out in broad strokes its task:

4. These questions were debated at the bar intensely and at great length. The debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world”. The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India. We will advert to these and a number of other arguments at their proper place but we must first take note of the facts that give rise to the above questions and provide the context for the debate.

The decision is about one important issue for India and other countries, can a WTO member eliminate many of the “evergreening” patents on new medicines, not eliminating patent protection for new drugs, but eliminating all sorts of patents on new delivery mechanisms, doses, and new formulations of older drugs? The answer, by the court, was yes. This is a hugely significant decision, but there will still be battles over patents on new medicines that are not affected by this judgement.