Judge Robinson recently granted the plaintiffs’ motion for a temporary restraining order pending appeal in an ANDA case, enjoining the defendants “from manufacturing, using, offering to sell, or selling generic extended release cyclobenzaprine products” as long as “plaintiffs agree to seek an expedited appeal and remove their generic product from the market.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 09-MD-2118-SLR (D. Del. May 20, 2011).
First, Judge Robinson found that “plaintiffs’ success on appeal is just as likely as not,” and therefore the “[likelihood of success] factor marginally supports a temporary restraining order.” Id. at 6. Second, the Court stated that “[i]n every ANDA case there is a likelihood of irreparable harm for the name brand manufacturer as the generics have a ready-made market to flood as soon as they receive approval to release their products[,]” and therefore the “[irreparable harm] factor favors plaintiffs.” Id. Third, Judge Robinson found that “[t]he harm to the defendants from a temporary restraining order is minimal[,]” and therefore the “[harm to defendants] factor favors plaintiffs” despite the fact that the defendants “claim that they have already launched their products[.]” Id. at 6. “Defendants bore the risk of a restraining order both from this court and the Federal Circuit.” Id. at 7. Fourth, the Court found that “[t]he public interest factor is neutral[,]” stating that “[t]he public has both an interest in strong patent protection that encourages innovation as well as the ability to purchase inexpensive drugs.” Id. at 7. Thus, Judge Robinson granted the temporary restraining order pending appeal as long as the plaintiffs agreed “to seek an expedited appeal and remove their generic product from the market.” Id.