Thoughts on the Gleevec Controversy

We have borne in mind the object which the Amending Act wanted to achieve, namely…to provide easy access to the citizens of this country to live saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.

With these words a Division Bench of the Madras High Court dismissed the petitions filed by multinational drug company Novartis against a key provision of the Indian Patents Act, 1970. The provision in question, called section 3(d) seeks to promote public access to affordable drugs by restricting the granting of frivolous patents on medicines.

Before I dive into the fascinating story of the politics behind public health let me briefly give a backgrounder to the ‘Gleevec issue’.

Gleevec is a drug used to treat a form of cancer called chronic myeloid leukemia. The drug was invented by the Swiss multinational drug company Novartis which has a patent for it. However, the Indian Patents Act of 1970 has provisions that grant ‘process patents’ and not ‘product patents’ (I shall explain the legalese later in this text). What this basically means is that companies could only obtain a patent for the process of manufacture and not on the final product itself. This enabled Indian pharmaceutical companies to reverse engineer the final products and discover new processes to manufacture them, thus giving rise to the generic industry. What this meant in practical terms is that India – thanks to domestic pharma companies that made generic versions of many of the multinational companies’ drugs – went from a net importer of drugs to a net exporter. By the same token, drugs which were overall expensive post-independence became cheap by the 1980s. In fact, global NGO’s working in the field of public health procure affordable drugs from India to use them in Africa, Asia and Latin America.

However, as a member of the WTO and a co-signatory of the TRIPS agreement India had to bring her domestic laws in compliance with international laws. It is in this context that the Gleevec controversy has to be examined.

It is an indictment of our media and society that important issues are given short shrift in favour of fluff and floss. The gleevec issue barely got a passing mention in the mainstream media.

And now we dive headlong into the chemical sludge…

In May 2006 Novartis AG and its Indian subsidiary, Novartis India (henceforth Novartis) filed a bunch of writ petitions before the Madras High Court claiming that section 3(d) of the Indian Patents Act was contrary to the requirements of the TRIPS agreement and article 14 of the Indian constitution as it is vague and ambiguous. But what is section 3(d) about?

In a nutshell, 3(d) aims to prevent the practice called ‘evergreening’ by which drug companies seek to extend monopoly on their drugs by patenting minor variations of that chemical entity. Suppose a drug company has a patent on a chemical entity that is about to expire. What they will do is tweak the drug slightly and patent the new product(s). This guarantees that generics cannot be manufactured and that the patent is extended by another 20 years.

Section 3(d) was introduced into the 1970 Patents Act (the bedrock of Indian patents law and a progressive piece of legislation) via the Patents Amendment Act of 2005. This was done to meet India’s WTO obligations to grant product patents. Now, the 1970s Act granted only ‘process patents’ to agricultural and pharmaceutical products. Only the manufacturing process could be patented for 7 years and not the end product.