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

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