Pointers from the Gilead patent win in India

A good 14 years after it sought patent in India for its blockbuster Hepatitis C drug, marketed as Sovaldi, the approval, by the Deputy Controller of Patents & Designs, must have come as a big relief to Gilead Sciences. The approval order said the "claimed compounds are novel, inventive and patentable under the Patents Act. Accordingly, the instant application is allowed to proceed for grant." Though, due to the delay, only eight years of the patent term are left.

Gilead had first filed an application under the Patent Cooperation Treaty, or PCT, on April 21, 2004. PCT is an international patent law treaty, concluded in 1970, which provides a uniform procedure for filing of patent applications to protect inventions in each of its contracting states. A patent application filed under the PCT is called an international application or a PCT application. This included India. In 2005, the company also applied for a patent to the Indian Patent office.

The approval has several implications, as is apparent from talking to those who have looked at the case closely over the years. Prathiba M. Singh, Senior Advocate in the case for Gilead, says: "This case shows that Section 3 D (of the Indian Patent Act) is not a hindrance to patentability in India," Second, she says, it also shows that India is serious about protecting patents provided it is not ever-greening." Singh had appeared on behalf of Indian generic companies in the Novartis case on Glivec in the Supreme Court in April 2013. Novartis lost the case on account of Section 3D (very loosely, this is a provision that is read as a measure to avoid companies from extending the monopoly by getting second or third patents and ever-greening  (adopting technological and other strategies to extend a patent's life). Third, she says, it re-enforces the licensing model of Gilead in India, which is more about access and affordability (for instance, the $1,000-pill of the company may get right-priced for India through its licensing model). Finally, it is not as if the company is getting a monopoly for 20 years with this patent. The licensing model of Gilead allows the 11-odd licensees (the likes of Cipla, Biocon, Natco and others) to make the generic version of the drug and sell it at a price that works for them in India and select countries abroad. The grant of patent now is apparently re-enforcing this because without patent there is really no incentive for a licensee company to seek a license. It also ensures the patent is not infringed by others.

But then, not everyone is happy. There is an argument that there could be makers of APIs (active pharmaceutical ingredients for this drug) , not all licensed by Gilead, who will now not be able to make and supply these outside India and, therefore, to that extent access to the drug could get impacted. But then, there is lack of clarity on the players doing this as also on volumes involved since most major companies are already licensees in this case.

There is also the argument that the patent win by Gilead has also to be seen in the context that Hardev Karar, the patent official who had earlier rejected the patent application, was replaced by another official.