Delaware Patent Litigation Report : Delaware Intellectual Property Lawyer & Attorney : Morris James Law Firm : Delaware Patent Litigation Report

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 the generic extended release cyclobenzaprine products infringed the patents-in-suit, and that the patents-in-suit were obvious.  After trial, one defendant began selling their generic products in the market, i.e., the defendant engaged in an “at risk” launch of their product, thus triggering their 180-day exclusivity period under the Hatch-Waxman Act. Plaintiffs moved for a temporary restraining order to enjoin the continued manufacture, use, offer to sell, or selling of the 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 generic launcher then moved for reconsideration.  The court held a hearing on the motion for reconsideration on May 23, 2011, and issued an order denying the motion the following day.  The generic launcher argued that it was error for the court to grant a TRO while concluding that the likelihood of success on the merits weighed equally for both parties.  The court agreed that in the normal course, i.e., at the start of the case, that a showing of likelihood of success is a prerequisite to entry of a TRO.  However, the court disagreed that this factor controlled the analysis in the post-trial setting of the current dispute between the parties.  The court reasoned that here “this factor switches from having a gate-keeping function to simply being one of the four factors to be considered when granting or denying an injunction.”  The court reasoned further that, at minimum, plaintiffs demonstrated a “substantial case on the merits,” which the Federal Circuit has found sufficient for an injunction pending appeal.  The court also dismissed the generic launcher’s contention that the balance of harm favored it by reasoning, inter alia, that it brought the harm on itself by launching “at risk” even though it could have preserved the180 day exclusivity period throughout the appeal to the Federal Circuit by not launching and because the court required the posting of a bond should the generic launcher prevail on appeal.