Wednesday, May 4, 2022

Minor Power Alley Update: Zenara Has Answered Merck's Patent Complaint; Says Merck "Double Patented" -- And Thus Merck... Loses.


This battle will take at least two more years to sort out in Delaware's federal district courts.

Merck here tries to keep Zenara's generic version of ertugliflozin off market for as long as it can. Zenara continues to march toward FDA approval, and an "at risk" launch, as it is unlikely that Merck will show that Zenara doesn't qualify under Hatch-Waxman. Here's the full answer, filed exactly a month ago, today -- and a bit, of the salient conclusions:

. . .Zenara has not infringed, is not infringing, will not infringe, will not induce to infringe, and will not contribute to infringement of, literally or under the doctrine of equivalents, any valid and enforceable claims of the ’580 patent against Zenara. . . .

The claims of the ’580 patent against Zenara are invalid and/or unenforceable for failure to satisfy the requirements of Title 35 of the United States Code, including, without limitation one or more of 35 U.S.C. §§ 101, 102, 103, 112, 116, and/or for double patenting. . . .


Now you know. Onward, grinning -- with kindergarten "concert/graduation" now complete. . . a very rare rib-eye treat, with wilted lemon spinach. . . and some back to back Jedi stuff, tonight awaits. . . .

नमस्ते

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