In Re: Cyclobenzaprine Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR (D. Del. 2011)
In a strange turn of events, the district court that just eight days earlier found the asserted claims of the patents on Amrix invalid, granted a motion for a temporary restraining order against Mylan.
As we previously reported, on May 12, following a seven-day bench trial conducted last September and October, the U.S. District Court for the District of Delaware held that the asserted claims of U.S. Patent Nos. 7,387,793 and 7,544,372 are invalid due to obviousness. This decision cleared the way for Mylan, the first paragraph IV filer, to launch its generic version of Amrix. As we reported, Mylan did so on May 13, triggering its 180-day exclusivity period.
Notwithstanding that they lost after trial, on May 15 the plaintiffs filed a motion for a temporary restraining order. This was followed by three rounds of briefs by each side--including briefs filed each day last week--until the district court granted the motion last Friday.
Given that one of the legal requirements for granting a TRO is a "likelihood of success on the merits," and the district court previously found after a full trial that the plaintiffs lost on the merits, it is very surprising that the court granted the TRO. Did the court, after reconsideration, find that its decision was wrong on the merits? No--in its Memorandum Order, the court defended each of the findings that plaintiffs asserted to be erroneous. But inexplicably, the court concluded that "plaintiffs' success on appeal is just as likely as not," and therefore "this factor marginally supports a temporary restraining order."
Later on Friday, Mylan filed an Emergency Motion for Reconsideration, stating that the court "committed fundamental, material errors of law." Specifically, according to Mylan, the court "did not find that Plaintiffs were likely to succeed on the merits but rather that 'plaintiffs' success on appeal is just as likely as not.' As a matter of law, this sort of 50-50 assessment is insufficient to establish a likelihood of success and destroys the basis for the TRO." Mylan, of course, is concerned that its 180-day exclusivity period will tick away while it's prevented from marketing.
While the court granted the plaintiffs' motion, it has not yet entered an order enjoining Mylan. The court has scheduled a hearing for tomorrow at 9:00 am, and presumably will hear argument on Mylan's emergency motion.
- On May 24, Mylan filed a supplemental brief in support of its Emergency Motion for Reconsideration
- Later on May 24, in this Order, the district court denied Mylan's Emergency Motion for Reconsideration
- Also on May 24, in this Order, the district court entered an injunction against Mylan
- Still later on May 24, Mylan filed a Notice of Appeal to the Federal Circuit
- On May 25, in this Order, the Federal Circuit stayed the district court's May 24 injunction