More Post Trial Subsequent Authority — In Gilead/Merck Hep C Patent Fight — In Delaware Federal Court…

As we discussed last week, on Tuesday — the post trial wrangling is now well-underway, here.

At stake is as much as a series of payments totaling perhaps $2.54 billion — to Merck. I suspect that amount (and the ongoing royalty, if any) will be substantially reduced, as the appeals process proper takes its course. However, as of Friday night, Merck’s lawyers were citing a newly decided appellate case, for the notion that Merck’s win ought to stand undisturbed in Delaware. [Recall though that Merck lost in a similar patent spat in California, involving these same patents (and w as ordered to pay Gilead’s legal fees), due to Kenilworth’s “unclean hands“.] Here’s a bit — from the latest six pager — but we will have to wait a tic. for rulings, now:

. . . .Gilead says that Wyeth stands for the principle that, if extensive screening is required, a patent claim “lacks enablement as a matter of law.” (D.I. 536 at 6.) As Judge Bryson explained, that is an incorrect understanding of Wyeth. Rather, the inquiry turns on the specific facts of each case. Quoting Wyeth, Judge Bryson reiterated that “‘[u]ndue experimentation is a matter of degree. Even a considerable amount of experimentation is permissible as long as it is merely routine or the specification provides a reasonable amount of guidance regarding the direction of experimentation.’” UroPep at 45 (quoting Wyeth v. Abbott Labs., 720 F.3d 1380, 1385-86 (Fed. Cir. 2013)).

For extensive experimentation to be “undue,” the defendant must provide clear and convincing evidence such as “a disclosure and a field that provides no guidance, [and requires] aimless plodding through systematic experimentation of a single compound that would take weeks.” Id. Those facts were present — and undisputed — in Wyeth. But such facts were not present in UroPep, and they are not present here, either: The jury heard copious evidence that contradicted Gilead’s “undue experimentation” claim, including that Pharmasset scientists read and understood the value of the ’597 patent disclosure and that Mr. Clark, with the ʼ597 disclosure in hand, was able to practice the invention with ease. This case, like UroPep, has a rich trial record on enablement that is far removed from the undisputed record in Wyeth. . . .

Now you know. . . and with sweet Cassini now only one full orbit away from its final plunge, and obliteration — in the thickening, burning and toxic atmosphere of Saturn. . . I find myself reflecting — in the now cold, clear dawn glow — on the passing of the last five years, with some wonderment. . . Smile.



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