Monday, October 26, 2015

In 2002, Did Pharmasset Scientists Stealthily Use A Merck Patented Chemical Composition/Pro-Drug -- To "Create" What Later Became Gilead's Sovaldi®?

That is the deeply intriguing question posed by some photos that have just come to light in the ongoing global litigation between Kenilworth and Gilead -- over who owns various parts of the chemical technology "embedded in" Gilead's HCV mega-blockbuster Sovaldi® (sofosbuvir). In an unusual Saturday filing, Merck has asked that the federal trial court sitting in the Northern District of California order Gilead to produce both (i) the photographs of these vials (at right, from an iPhone 5), and (ii) the vials themselves -- as it seems they might contain pro-drugs created using a Merck-patented method or chemical compound. [It was earlier averred that the vials had been lost -- in the sands of time. That no longer seems to be so.]

Below in blue is a bit from the filing -- more, as soon as I make sure that the filing is not subject to any sort of gag order. One of my many prior background pieces on this litigation is linked here, but do search "Sovaldi" in the box above to see them all. Apparently, the existence of these vials -- or at least photos of them -- first came to light in the Canadian proceedings. Now, however, Merck asserts that Gilead has disclosed that the vials themselves still exist, and may be in the possession of someone that Gilead could reasonably convince to deliver the same, to Merck.

If the liquid in the vial is in fact accurately labeled (i.e., a chemical with molecular weight of 259.23 g/mol), Merck would probably be right in saying that Gilead in fact agrees (ever since 2002!) that Merck's patents "taught" the Pharmasset scientists (a company Gilead later acquired) how to make what became Sovaldi. If so, materially good news, for Merck; bad news for Gilead's positions, in each of the pending suits in the EU, Canada and in the federal District courts in Delaware and Northern California. Here is a bit of (and a link to) the latest filing which I will release in full (as a 24 page PDF file), now later this afternoon/tonight:

. . . .If PSI-6130 was present in any one of the tubes sent on or around October 28, 2002, this is strong evidence that one of ordinary skill in the art was enabled by the disclosure of Merck’s specification to make and then test compounds falling within the claims of the patents-in-suit. It is also further proof that there was adequate written description in the specification of the patents-in-suit to allow one of ordinary skill in the art to make and then test compounds covered by the patents-in-suit for treating HCV infection in a mammal. . . .

Onward, and awaiting the arrival of BHO 44 here -- in the City of Big Shoulders, tomorrow -- as military style fixed wing vertical takeoff maneuvers are being practiced, right outside my lakefront-facing windows now. . . . Cool.

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