Replies to post #128304 on Biotech Values

[biomaven0]

and even if Defendants were found to be using the claimed methods, Plaintiffs’
infringement claims would be barred by the safe harbor provisions of the Hatch-Waxman Act, 35
U.S.C. § 271(e)(1).

Seems they finally got round to pointing out this defense to infringement...

Peter

[mouton29]

There is something about the pace of the filings in this case that strikes me as a little odd. On Friday, the TRO was issued, now late Wednesday, 5 days later, Amphastar files an "emergency motion" to modify the TRO on the ground they are facing gigantic and immeidate damages. And how long did it take MNTA to file their motion for a TRO? It seems to me that if you want to argue you are facing irreparable damage and want emergency relief, you need to move with lightning speed.

Here is an excerpt from the memo filed by Sandoz in opposition to the TRO that Sanofi-Aventis sought when the sued the FDA:

Having waited almost four full days to even seek an injunction – when sanofiaventis itself concedes that large quantities of the generic are shipped immediately by a new entrant (see Durso Decl. ¶ 12) – sanofi-aventis is in no position to seek an emergency injunction
to protect against loss of market share. Much of the lost sales sanofi aventis fears already occurred while it sat on its hands. See Graceway Pharms., LLC v. Perrigo Co., 697 F. Supp. 2d
600, 607 (D.N.J. 2010) (denying injunction barring drug launch where plaintiff delayed in seeking relief and defendant incurred substantial costs “associated with its putting its product in the stream of commerce”).

www.fdalawblog.net/files/lovenox---sandoz-tro-pi-opp-brief.pdf

Of course, just because Sandoz made the argument in another case does not mean it is a winning argument and even if it were in that case, circumstances are different here.