Patent

The Gilead Licenses and a New Drug Era?


dawnIn 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.”

The above piece draws on an earlier piece that I’d written in the wake of the Ranbaxy Daichi merger in 2008, where I reflected on the emergence of an Ardhnarishwar type pharma entity (half man: half woman).

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. Thomas will reflect on this a bit more in a post that we will bring to you soon. 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. For  those interested, here is a podcast from Niticentral where I reflect on this attempt to formulate a policy and on why our government should continue to resist the US pressure to succumb to a low threshold patent regime that suits US corporate interest.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

One comment.

  1. AvatarAnon.

    Mr. Basheer, what is the problem with these arrangements? There is no under the table, bad faith settlement that your blog has complained of before. In fact the gilead arrangements may help increase access and may drive down price. I think it’s an excellent example of partnership in this acrimonious industry.

    Or are you against a free market system? While I understand the other concerns raised by your bloggers like Mr Baruah about access to medicine and public interest, I fail to see the point of this post or your article in the Indian Express.

    Reply

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