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 defendants’ generic extended release cyclobenzaprine products infringed the patents-in-suit, and that the patents-in-suit were obvious.  After trial, defendants began selling their generic products in the market, i.e., defendants 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 defendants 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 “agree to seek an expedited appeal and remove their generic product from the market.”   The Court reasoned that (1) plaintiffs and defendants were equally likely to prevail on appeal; (2) plaintiffs would be irreparably harmed, as defendants admitted, and, despite defendants' assertion that the “at risk” launch already harmed plaintiffs, plaintiffs could recover some of their monopoly pricing if the court enjoined the defendants and plaintiffs removed their generic product from the market; (3) harm to the defendants is minimal even though, as defendants assert, that their “at risk” launch triggered the 180-day exclusivity period because the defendants launched despite a finding of infringement at trial and knowing they bore a risk of a TRO from the court and the Federal Circuit; and (4) the public interest fact was neutral.   The parties were then ordered to submit a proposed form of order on May 23, 2011.