With a population of about 1,2 billion, India counts for about 17,5% of the world population. The Indian population is growing at a sustained rate, as do its economy of the country. Therefore, while the growth of the western drug market is slowing down, Indian has become a market of primary importance for the pharmaceutical industry.
India has still many peculiar rules of Intellectual Property, especially for drug patents. Such type of patents was forbidden for decades, particularly for allowing the development of a domestic generic industry, which has reached today a significant size. To be specific, the Indian Patent and Design Acts from 1911 had provisions for both product and process patents, including pharmaceuticals. In practice, these provisions benefited primarily to foreign companies. On the other side, India did not have established yet a proper public health insurance, rendering the access to medicine for most of the population very difficult.
To remedy to this problem, one of the solutions was limiting drug patents to process patents for a maximum of 7 years – as enacted the Amended Act from 1970. From this point, the Indian pharmaceutical industry has grown exponentially to become one of the largest manufacturers of generic medicines, especially for under developed/development countries. However, after becoming a member of the World Trade Organization in 1995 and signing the TRIPs (Trade Related aspects of Intellectual Property) Agreement, India was pushed to change its patent policy and put it in line with international standards. Accordingly, India cancelled the Amendment from 1970, allowing again therefore product patent, including pharmaceuticals. This new system – which is now in place since 2005 – still comprises however strong restrictions to drug patent granting and broad criteria for compulsory licensing, leading to long judicial battles between India and the big pharma concerns.
For illustration, let’s keep in mind the decision from 2013 of the Indian Supreme Court in the case Novartis A.G. vs Union of India1.The decision dealt with a dispute about a patent application, relating to a specific salt of the otherwise patented compound Imatinib®. This specific salt (here-after Gleevec®) exhibits an interesting anti-tumoral activity. However, Imatinib®, its salts as well as their anti-tumoral properties were already covered by the scope of a previous patent. In addition, the US market authorization for Gleevec® was granted on the basis of the Imatinib® patent. As a consequence, the Indian Supreme Court considered that Novartis admitted by filing the market authorization application that the particular salt Gleevec® was already covered by the previous patent, and therefore not patentable anymore under section 3(d) of the 2005 Patent Act. In return, Novartis attempted arguing – in vain – that Gleevec® was indeed generically covered but not specifically disclosed by the Imatinib® patent, that the Indian Supreme court did not correctly interpreted the inventive step criteria as set up in the TRIPs Agreement, and that it should be considered that sister patents had been already granted in both Europe and the US for Gleevec®. Hence, one of the key issues of the dispute related to the legality of the corresponding section 3(d) in view of the TRIPs Agreement.
Considering the debate following the issuance of this decision, in which Novartis’arguments had not been backed up by the Supreme Court, the Indian Intellectual Property Office issued in October 2014 Guidelines for the examination of patent applications in the field of pharmaceuticals. These Guidelines outline general principles on patentability, quite similar to those contained in the EPO Guidelines. However, unfortunately, these Guidelines do not provide clarification on specific issues, as those debated in the Novartis dispute. These days, some legal uncertainty still remains as per drug patents in India, and it is expected that in the coming years further judicial disputes would make headlines.
1 Civil Appeal n°2706-2716 of 2013, Novartis A.G. vs Union of India & Others: All India Reporter 2013 SC 1311.