Innovation Patent

Solving Sovaldi: Whose Drug is it Anyway?

solving sovaldi

As I’d mentioned in yesterday’s post, a very interesting development is brewing in the US in relation to the Gilead “Sovaldi” controversy.

As some may be aware, the key prior art relied on by opponents to challenge Gilead’s patent application is a published patent by Merck. Merck sued Gilead (claiming that Sovaldi infringes upon this patent) and won in the US (at least at the initial stage, with the jury awarding Merck 200 million dollars, after the patent was found to be valid. Gilead conceded on the issue of infringement). It now turns out that Gilead has submitted evidence that this patent by Merck may have been built upon confidential disclosures by Pharmasset researchers to a Merck scientist.

judge found prima facie merit in this contention by Gilead and permitted them to bolster this claim by submitting additional evidence. Remember that the Sovaldi patent initially belonged to Pharmasset which was then taken over by Gilead.

I haven’t studied this US case in detail, but here is a hypothetical: what if Gilead is able to prove that Merck’s patent effectively drew on this confidential disclosure by Pharmasset researchers to Merck (apparently the disclosures were made since Merck had expressed interest in licensing the relevant molecule from Pharmasset). Would the patent then be compulsorily assigned to Gilead?

Secondly, if Gilead claims that Pharmasset was never going to patent the relevant invention so early in the game, can it still constitute prior art? In other words, if Gilead proves that this was in the nature of “confidential” information and should never have been made public, much less through a patent application, can it then constitute prior art against Gileads’ own patent application  (later in time) to cover Sovaldi? And if this comes to pass, will Gilead have a strong claim to a patent, even in India? Interesting questions! Or perhaps I’m just way off the mark.

ps: Image from here

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's 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 Prof. Basheer joined Anand 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. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

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