Tonight, Merck and Pfizer (from whom Kenilworth has an in-license for the mature branded Type-2 diabetes drug called Steglatro®) have affirmatively sued in the federal courts of Delaware, to prevent/delay the generic manufacturers at right. . . from entering the market with unbranded but equivalent offerings.
Post Martin Shkreli's FTC loss in federal court in Manhattan two months ago, I predict these suits may face tougher sledding -- in preventing generic entrants on mature brands. We shall see -- but to be clear, this is a patent suit (alleging the so-called '580 patent is being infringed under 35 U.S.C. § 271(e)(2)(A); typical in such suits), not just a naked restriction on API source gambit by the big branded houses. Do stay tuned, but here is a bit:
. . .Merck & Co. and Pfizer Inc. filed lawsuits alleging copycats of Steglatro proposed by three generic-drug makers infringe a patent for the diabetes drug that Pfizer licenses to Merck.
The companies filed complaints Wednesday against Aurobindo Pharma Ltd. and Hetero Labs Ltd. and another Thursday against Cambrex Corp.’s Zenara Pharma Private Ltd., all in the U.S. District Court for the District of Delaware. In the complaints, Merck and Pfizer allege that Aurobindo, Hetero, and Zenara each intend to launch a cheaper version “immediately and imminently upon the approval” of its respective application. . . .
Grinning, as we crank out these "catch up" power-alley posts, while watching St. Peter's try to slay. . . mighty Purdue tonight. Yep -- they've kept it close, going into the half. . . . C'mon you Peacocks! Onward, into the intermittent snows, tonight. . . .
नमस्ते
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