A Norwegian Court Has Ruled That Gilead May Never Owe Merck Royalties On Sovaldi® (Sofosbuvir) -- Due To Merck's Patent Invalidity

Patent lawsuits are pending in the United Kingdom, Germany, Norway, France, Canada, Australia and of course, on both coasts here in the United States, related to Merck's claims for as much as a 10 per cent royalty on sales of Gilead's Sovaldi^® -- the most successful drug launch in history. [That's potentially a $5 billion claim, by the way.]

However, it is beginning to look like Merck's very expensive global patent lawsuit juggernaunt may amount to. . . very little. Consider that in Oslo, Norway, a patent court has held some of the Merck patents invalid because they don't teach how to make the chemical substances -- without undue random experimentation, by someone skilled in the art. That alone could be fatal (even taking into account the slightly differing patenet standards in Europe, compared to the US); but then add to that, that some US governmental patent authorities have opined that Merck's claims should not be considered as prior in time, or prior in right, to Gilead's. OF course we will keep watching, but we learned all of this from an amended answer, and set of counterclaims (full 25 page PDF here) filed this past Monday in the federal District courthouse in Wilmingon, Delaware -- here's a bit:

. . . .The Norwegian District Court summarized the origins of this litigation as “a disagreement between the parties to the case as to who are the rightful owners of chemical substances of the pattern 2’-methyl-up, 2’-fluorine-down nucleosides with a natural N-bonded base.” (Norwegian Opinion, attached hereto as Exhibit 6, at 3). . . .

. . . .On March 21, 2014, the Oslo District Court (a three-member panel consisting of one legal judge and technical expert judges in nucleoside chemistry and medicine) issued a judgment holding NO330,755 [the Merck/Idenix patent] invalid because “the description in patent NO ‘755 is not sufficiently clear and complete as to enable a skilled person, as at the application date of 27 June 2003, to carry out the invention without undue burden or experimentation.” (Norwegian Opinion, attached hereto as Exhibit 6, at 34.) The court simultaneously upheld the validity of NO330,700. (Id., at 38).. . .

The claims of the ’600 [the Merck/Idenix] patent are invalid for lack of enablement under 35 U.S.C. § 112 because the ’600 patent fails to enable one of ordinary skill in the art to make and use the full scope of the claims without undue experimentation for at least the reasons set out in the ’871 interference, the ’981 interference, and Norwegian Opinion, including that the patent does not disclose how to synthesize a compound with a fluorine down and a methyl group up in the 2’ position, and [Merck and Idenix] Counterclaim Defendants themselves were not able to successfully synthesize such a compound until long after the filing date of the ’600 patent. (See, e.g., March 22, 2013, Decision on Motions, Paper 426 at 25, attached hereto as Exhibit 1; Clark Substantive Motion 7 and 8, Papers 154 and 155, attached hereto as Exhibits 3 and 4; Norwegian Opinion, attached hereto as Exhibit 6, at 33-34). . . .

Finally, it elsewhere appears in the moving papers that the US patent authorities have ruled that at least some of the Merck/Idenix patent claims are not prior in right to those through which Gilead claims (the legacy-Pharmasset patents). So the burden of proof here in the US is pretty firmly fixed on the shoulders of Merck and Idenix. While there will be quite a bit of wrangling to go, around the globe, I'd say that, on balance, it is starting to look like Merck will get nothing like a 10 per cent running royalty on any of Gilead's sofosbuvir sales.