Court specifies terms of injunction order enjoining "at risk" generic launch
In Re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, C.A. No. 09-MD-2118-SLR, May 24, 2011.
Robinson. J. On May 24, 2011, the court entered an injunction order specifying the terms of the TRO enjoining the post-trial generic launch by the parties.
This is an ANDA litigation involving generic extended release cyclobenzaprine products. From September 29 to October 7, 2010, a bench trial was held on infringement, invalidity, and inequitable conduct. On May 12, 2011, the court issued its opinion finding that defendants’ generic extended release cyclobenzaprine products infringed the patents-in-suit, and that the patents-in-suit were obvious. After trial, one defendant began selling its generic products in the market, thus triggering its 180-day exclusivity period under the Hatch-Waxman Act. Plaintiffs moved for a TRO to enjoin the defendant from continuing to manufacture, use, offer to sell, or sell generic extended release cyclobenzaprine products during the pendency of plaintiffs’ appeal to the Federal Circuit. The court granted plaintiffs’ motion for a TRO on the condition that plaintiffs seek an expedited appeal and remove their authorized generic from the market. The court held a hearing to consider a motion for reconsideration on May 23, 2011, and issued an order denying the motion the following day. The court then entered an order specifying the terms of the injunction to maintain the status quo. In summary fashion, the terms are as follows: (1) the generic launcher is enjoined from commercializing or using the generic extended release cyclobenzaprine products; (2) plaintiffs and those in concert with them shall not commercialize or use an authorized generic of the product; (3) the generic launcher shall recall generics they launched “at risk” and shall issue a letter explaining the terms of the TRO; (4) plaintiffs shall post a bond in the amount of $10 million in the event defendants prevail on appeal; (5) plaintiffs shall seek an expedited appeal; (6) plaintiffs and all defendants in this multidistrict litigation are required to give 10 days notice of any intended launch of their respective generic cyclobenzaprine extended-release products; and (7) the injunction shall remain in place until the earliest of a further order from this court, an order from the Federal Circuit, or affirmance of the court’s invalidity opinion.
