Thursday, October 02, 2014

Pharmaceutical Patents and the Dawn of a New Era

In a piece in the Indian Express a couple of days ago, I expressed some apprehension about the latest round of licensing agreements signed between Gilead and seven Indian generic companies. And argued that since many of our generic majors are now partnering with western multinationals and foregoing the option to challenge their patents, the government must play a stronger role in public health and access. It cannot simply continuing relying on these generic majors and the competition that they helped unleash earlier through strong patent challenges. For those interested, here are excerpts from the piece. The full text is available here.
"Prime Minister Narendra Modi’s US visit is likely to throw up highly contentious intellectual property rights issues. Indeed, for the last several years, US drug majors and their European counterparts have lobbied hard to demonise the Indian patent regime. But the government must continue to defend the law and stand its ground. Particularly since our own industrial moguls have caved in and are less vocal about their opposition to a global patent paradigm scripted by Western industrial interests.
It is against this backdrop that one must view the latest deal between Gilead, a leading US pharmaceutical company, and seven Indian generic firms, to manufacture and distribute an important antiviral in several low- and middle-income countries. The deal pertains to the licencing of Sovaldi, a patented hepatitis C drug that revolutionised treatment but is priced at a whopping $84,000 for a three-month course. Faced with mounting pressure from patient groups and strong patent opposition in India, Gilead announced that it would sell Sovaldi for $900. Immediately thereafter, it announced the licencing arrangement.
The announcement of Gilead’s licencing agreement generated consternation among public health activists, who believe that its patent is vulnerable under India’s stringent patent standard, which was upheld by the Supreme Court in the famous Novartis case.
...What does all of this mean? Are we seeing a new phase in pharmaceutical history? Does this have to do with a gradual whittling away of the sharp innovator-versus-generic divide? A divide that is often considered a defining feature of the pharmaceutical industry, distinguishing it from most other technology sectors. Notably, while the high technology sector routinely sees a fluid innovator versus infringer dynamic, with Microsoft and Google suing as much as they are sued, the pharmaceutical industry is different. Patent positions are more ossified, with alleged innovators, typically MNCs, suing generic copycats, typically Indian companies. However, it would appear that this dividing line is now blurring, with generic companies aspiring to jump on to the innovation bandwagon, and drug innovators waiting to acquire generic divisions.
.....All of this means that public health and affordable access will take a severe beating. We can no longer expect our home-grown generic companies to guard this turf. Growing partnerships between them and global innovators will mean fewer patent challenges. As such, the government cannot remain content with relying on free-market competition from the generic sector to bring drug prices down. It has to play a more active role to foster affordable healthcare and revive its once-prominent public sector units. It is this new dynamic that Modi must bear in mind as he negotiates with a partner that is all too keen to collaborate on the IP front, but mostly on its own terms."
In the immediate aftermath of Prime Minister Modi's rockstar visit to the US, we've had an announcement by the Indian and US governments of a high level working group on IP.  We've also had a hard hard hitting editorial in the HT from Raj Dave and Srividya Ragavan here. Responding very well to the continued cacophonic outbursts against India's IP regime. Also some weeks ago, Yogesh Pai wrote a thoughtful piece on the likely direction of the Modi government when it comes to IP policy. Since then, the Minister of Commerce announced that an IP policy was in the offing. 
Post a Comment