I'm out for a bit -- having my weekend fun -- but will report in full, with complaint analysis included -- later today.
UPDATED | 3 PM EDT: It seems Merck previously brought -- and lost -- a proceeding to declare BMS patents related to the receptor cover useful in anti PD-1 monoclonal antibodies like nivolumab (belonging to BMS via license from Ono Pharmaceuticals, its co-marketing partner in Japan) invalid in Europe earlier this year.
This multi-faceted IP rights battle is raging across the EU, the UK, Japan and now the US. Into the high teens of billions of dollars at stake.
More later. Here is
BMS's full complaint at law, a nine page affair of a PDF file. In the complaint, BMS seeks a ruling that Merck cannot make Keytruda
® (Pembrolizumab) without paying a very substantial patent license fee annually to BMS. Alternatively, BMS asks the court to rule (with the aid of jury --to find the facts) that Merck must be enjoined from selling Keytruda in the US. To get there, BMS quite cleverly makes much of the fact that Merck recently challenged the validity of the EU equivalent of the central anti PD-1 cover-structure patent, and. . . lost. That was a trial level holding in the EU -- but it did hold that BMS's patent -- on the anti PD-1 monoclonal antibody structural invention -- was valid. Thus, Merck is clearly aware that, in the US, BMS might well assert the sale of Keytruda violates that same central patent. This is important because it may go to establish willfulness, on Merck's part -- and thus a tripling of any damages the jury might award. Ouch. Here it is, then:
. . . .BMS has announced that it expects to complete submission of its Biologics License Application (BLA) for nivolumab’s use in treating non-small cell lung cancer [a high burden cancer] by the end of 2014. . . .
Merck is planning to exploit the invention of the 474 patent with an anti-PD-1 antibody called pembrolizumab. On information and belief, Merck started developing pembrolizumab after Plaintiffs had made and started testing nivolumab, and Merck has since been engaged in efforts to meet the FDA regulatory requirements for marketing, distributing offering for sale, and selling pembrolizumab for the treatment of cancer. According to Merck, pembrolizumab is a PD-1 antibody that works by blocking the PD-1 checkpoint to treat cancer. . . .
Merck has had knowledge of the family of patents that includes the 474 patent for many years and has instituted legal proceedings seeking to invalidate the corresponding patents in Europe. Merck initiated an opposition proceeding against European Patent EP 1537878 (“EP 878 patent”), a European counterpart of the 474 patent, in the European Patent Office on June 20, 2011. Merck made numerous submissions in that opposition proceeding and an oral hearing was held on June 4, 2014. On information and belief, Merck’s outside counsel referred to the 474 patent during the oral hearing. That same day, the panel hearing oral argument rejected Merck’s opposition and held the EP 878 patent valid. . . .
On May 22, 2014, Merck filed a revocation action in the United Kingdom seeking to revoke the U.K. patent corresponding to the EP 878 patent. BMS has filed a counterclaim alleging infringement by pembrolizumab in that action. . . .
Separately,
OncLive is reporting that BMS's Opdivo (nivolumab) is already deep into many more clinical trials -- for additional cancers, here in the US: ". . .
Bristol-Myers Squibb has advanced development of the compound as monotherapy and in combinations across various tumor types in clinical trials that have enrolled an estimated 7000 patients. The FDA has designated nivolumab as a breakthrough therapy in lymphoma and has granted the compound fast track status in non-small cell lung cancer, melanoma, and renal cell carcinoma. The company has said it plans to submit an application to the FDA for nivolumab in melanoma during the third quarter of this year. . . ."
Thanks go to my commenters, for the heads up, here! Namaste.
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