Sunday, April 19, 2015

Sovaldi® Patent Battle Twists -- Northern California Federal District Court Edition

At the outset, I'll note that -- in general -- when a company files a New Drug Application with the US FDA, it does so assuming that all the supporting materials will remain private, except for certain limited portions, which the FDA makes public during its Advisory Committee proceedings, as well as the label copy and related product data. Of course, for the last few years at least, the candidate's clinical trial results are made available on [Some fascinating background, here.]

But other than those truncated bits, drug companies use the NDA submission process to help FDA staffers understand how it is thought the drug works in humans, its safety profile, and why it is novel enough to warrant approval. The NDA also covers how the company plans to ensure uniformity, sterility and purity in large scale drug dose manufacturing.

So it was with great interest that I reviewed recent letters between the lawyers in the Merck v. Gilead patent fight over how sofosbuvir (branded as Sovaldi®) is metabolized in each human's system, as their bodies absorb the drug, this past week. To greatly oversimplify, Merck claims that its prior patents teach that metabolization process. Gilead replies that what all human bodies do naturally -- when sofosbuvir is introduced to their systems -- cannot properly be patentable, let alone patented by Merck. And so the battle rages, across at least seven countries, and about 12 court-rooms, globally. Most recently, a letter dated April 9, 2015, from Merck's lawyers makes it clear that Kenilworth wants Gilead to disclose all "the secret stuff" in Gilead's FDA NDA -- about Solvaldi (and Harvoni®, too apparently). Slick.

Truly, billions are at stake. And to be fair, the NDA might well indicate that Gilead was aware of Merck's likely claims on metabolization patents. But being aware of a patent that one (Gilead) believes was improvidently granted -- is not the same as being liable for billions in patent infringement royalties. Not even remotely. So, Merck has been able to compromise with Gilead, and learn about module 3 of Gilead's NDA. Perhaps that is what Kenilworth scientists were after, right along. We shall see. [But as I've said, I do not foresee Merck receiving billions from Gilead -- not by a long shot, here.]

So here is the back-door language intended to get Merck a peek, under Gilead's FDA NDA kimono (click to embiggify):

. . . . As we explained, disclosure in [Gilead's FDA NDA submission] Module 3 that synthetic techniques that were known in the art before January 18, 2002 are used for Gilead's synthesis of the "methyl-up, fluoro-down 2"-Me-F moiety in sofosbuvir would serve to rebut Gilead's contention that Merck's specification did not enable the synthesis of that structure as of January 18, 2002. . . .

Fascinating. Now go out and enjoy a beautiful Spring Sunday, one and all! I certainly plan to do so.

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