Eurand, Inc. et al. v. Impax Laboratories, Inc. et al.


Docket No. 2012-1280

NEWMAN, O’MALLEY, REYNA
February 1, 2013

Non-precedential

Summary: Impax appealed USDC DE decision adding it to May, 2011 preliminary injunction related to generic versions of Cephalon’s AMRIX® (for more information on action: In re Cyclobenzaprine Hydrochloride Extended Release Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012)). On the last day of trial with Impax and others, Cephalon and Impax settled, with Cepahlon granting Impax a non-exclusive license to the patents-in-suit and controlling the timing of Impax’s entry into the market (“License Effective Date”). The settlement agreement provided five different “triggering events” (one year prior to expiration of ‘793 patent, if Cephalon licenses a third party entitled to first-to-file exclusivity, if Cephalon authorizes another party (not first-to-file) to sell a generic product, if another party enters the market “at-risk”, or if another party invalidates Cephalon’s Orange Book patents); Impax was allowed to enter the market with its own product or an authorized generic supplied by Cephalon upon the earliest of any of these events. Cephalon also made its own plans to launch a generic in case a competitor entered the market, entering into a sales agreement with Watson. After the May 11 trial, the DC issued an order finding the patents-in-suit invalid and obvious, Mylan launched “at-risk”, and Cephalon instructed Watson to begin selling an authorized generic. But the DC enjoined all parties (including Impax) from selling the generic to maintain the status of any appeals, and Cephalon subsequently appealed the obviousness decision. Impax knew of but did not appear at a subsequent hearing regarding which parties were covered by the injunction, and did not timely appeal (within 30 days). The FC panel concluded that Impax did not timely appeal the injunction issue and reviewed why none of the five triggering events had actually occurred.

This entry was posted in Generics / ANDA. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s