Overnight, Zenara formally answered the Merck and Pfizer (Steglatro®) complaint, in Delaware US District Court.
Of course, the goal of the branded manufacturers is to prevent/delay the entry in the US, of generic manufacturers at right. . . to the market with unbranded but equivalent offerings. And the generics simply deny that any patent infringement has transpired -- at least not one that is not specifically authorized by Hatch-Waxman. Under that statute, the first generic to market gets 180 days of exclusivity. So the prize is substantial.
Post Martin Shkreli's FTC loss in federal court in Manhattan two months ago, I've previously predicted that 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 (i.e., the Martin gambit -- now definitively ruled to be violations of the Sherman and Clayton Acts, at least in the ham-handed way Martin went about it).
There are lawful ways to reach much the same endpoints, and smart people advise big pharma on how to do that... all day, every day.
But still -- I expect we will see new push-back, from the bench -- in this matter, since it is the first really high profile one, involving the two of the top four public pharma concerns (by market cap) on the planet. It will draw much (mostly-withering) attention, Condor bets.
Onward. Smiling on a sunny, warming midday here. . . out for a long walk. . . .
नमस्ते
No comments:
Post a Comment