As 2012 draws to a close, Madhulika Vishwanathan brings us a concise review of the year that was, for the Indian pharmaceutical landscape. Madhulika is a qualified patent agent, with a Masters in Pharmacology from UDCT, Mumbai. She has previously worked in the patent cell of a Mumbai based biotech company. This is Madhulika's second post in our SpicyIP Fellowship application series. Her previous post is available here.
Year 2012 in retrospection: Cases which changed the Indian pharmaceutical patent landscape
As 2012 fades into memory, here is a brief review of some of the cases which transformed Indian pharmaceutical patent landscape. In 2012, India saw a lot of firsts, right from the grant of first compulsory license to the first post-trial pharma patent ruling.
In a pathbreaking judgment which has been exhaustively and comprehensively covered here and here, the Controller General of patents granted a compulsory license to NATCO pharma to manufacture sorafenib tosylate (patented by pharmaceutical multinational Bayer). On observing that: (i) reasonable requirements of the public were not satisfied (the drug was accessible only to a little above 2% of eligible patients) (ii) drug was not "reasonably affordable" to the public (priced at ₹2.8 lakh for a month’s treatment) (iii) Non-Working of the Patent (working of patent was construed as local working i.e. manufactured to a reasonable extent within the territory of India), a compulsory license was issued under section 84 of Indian patent act. While this decision raised many eyebrows and was widely debated in the United States, it appears to be a case of the pot calling the kettle black, since compulsory licensing has been used there as an effective anti-trust remedy against patent abuses since long.
Sunitinib, patented by Pfizer/Sugen, a drug used to treat abnormal protein kinase activity was revoked by Indian patent office in a post grant opposition by Cipla on the grounds of obviousness. However careful scrutiny revealed that the decision may have been tainted by hindsight bias. This case is covered extensively here and here .
Roche vs. Cipla patent infringement suit was India’s first pharmaceutical patent litigation in the Post TRIPS era. The verdict was a much awaited one and was closely observed by one and all. While the verdict was in favour of generics and affordable healthcare, it was flawed in the sense that it blurred the distinction between two separate issues of validity and infringement. An excellent analysis of the article can be found here.
India’s first pharmaceutical product patent pegylated interferon alfa-2a (a medicine used to treat Hepatitis C patented by Roche) which survived a post grant opposition was ultimately revoked by the Intellectual Property Appellate board (IPAB) on the grounds of obviousness and not meeting the criteria set out in Section 3(d), much to the delight of patient groups and public health activists. The decision also held that patient groups fall within the purview of the term “person interested” as noted in the Indian patent act. This interesting decision has been covered here.
Meanwhile, 2012 saw the rest of the world trending towards harmonization of patent laws. In one of major changes to patent law in the past 6 decades in US, Leahy Smith America Invents act (patent reform act) was signed into law on September 16, 2011, with a majority of the changes coming into effect in 2012 and 2013. The act brings US laws in alignment with the practice of rest of the world. Major changes include switching from first to file system to first inventor to file thereby eliminating interference proceedings, and the introduction of post grant review amongst others.
After forty years of striving, EU has finally taken a giant stride towards a unified patent system recognized automatically in 25 EU countries except Spain and Italy. The Unitary patent system which is likely to come into effect in 2014 will be overseen by a unified patent court and will most probably do away with the need for cumbersome patent translations.
Year 2013 could pave the way to some important developments as well; the US Supreme court has granted certiorari and will hear the Myriad genetics case limited to a specific question “Are human genes patentable?” Also, the final verdict of the Indian Supreme court on Novartis Gleevec/Glivec case is also expected in 2013. As we wait with bated breath for the verdicts on these cases which would have powerful implications for pharma-biotech industry, it would be very interesting to see how 2013 shapes up.