Sofosbuvir Metabolites: Now, We Offer Merck's Side Of The Gilead Sovaldi® Patent Spat

As we have repeatedly indicated -- billions hang in the balance here. Sovaldi^®, by Gilead, is largely a wonder cure for Hep C. But it costs $84,000 a patient. So, Merck. . . wants. . . some.

And Merck says the therapeutic effect of Sofosbuvir, in humans, comes solely via metabolite variants. And Merck's patents teach the methods of synthesizing those metabolites, it says. All methods patents (more on that, another day) -- and thus, this fight. Idenix (soon to be part of Merck) shared those patents with Whitehouse Station. Cozy. In any event, here is Merck's side of their claim (via PDF Answer and Counterclaims) to a running royalty on those billions:

. . . .[Merck and Idenix affiliates] are the owners of the ‘499 patent, entitled “Nucleoside Derivatives as Inhibitors of RNA-Dependent RNA Viral Polymerase,” which the United States Patent and Trademark Office duly and legally issued on September 12, 2006 to [a Merck affiliate's] predecessor in interest. . . .

[Merck and Idenix affiliates] are the owners of the ‘712 patent, entitled “Nucleoside Derivatives as Inhibitors of RNA-Dependent RNA Viral Polymerase,” which the United States Patent and Trademark Office duly and legally issued on July 9, 2013 to [Merck and Idenix affiliates]. . . .

Sofosbuvir is a pro-drug that, following administration to human subjects, is converted into a series of metabolites, including compounds designated as PSI-7411, PSI-7410 and PSI-7409 [Pharmasett and Gilead properties under patent]. . . .

The therapeutic benefit of sofosbuvir depends on its metabolism to PSI-7411, PSI-7410 and PSI-7409 following administration to human subjects. . . . The claims of the ’499 [and '712] patents encompass methods of treating HCV infection by administering sofosbuvir to a human patient. Upon commercialization of sofosbuvir, end users of sofosbuvir who administer the drug to HCV-infected human patients in the United States following FDA approval and prior to expiration of the ‘499 [and '712] patents or any additional patent exclusivity accorded thereto will directly infringe the ‘499 [and '712] patents. . . .

On information and belief, when it filed its Complaint in this action Gilead had knowledge that sofosbuvir, upon administration to human subjects, is converted into metabolites, including PSI-7411, PSI-7410 and PSI-7409, and that the therapeutic benefit of sofosbuvir depends on such conversion. . . .

Gilead will have knowledge of any ruling by this Court that human patients to whom sofosbuvir is administered in the United States in accordance with the directions in the product label will directly infringe the ‘712 patent. Gilead’s commercialization of sofosbuvir in the United States following such a ruling and prior to expiration of the ‘712 patent or any additional patent exclusivity accorded thereto will induce and contribute to infringement of the ‘712 patent. . . .

An actual controversy exists between Gilead and Counterclaimants concerning whether Gilead’s threatened commercial sale and offer for sale of sofosbuvir in the United States will induce or contribute to infringement of the ‘712 patent. . . .

Unless it settles, this will have a mid-2015 trial date in the Northern District of California's federal courts. We will follow it closely. Trust that. And we are talking very high stakes patent trolling here.