In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 2011–1399 (Fed. Cir. 2011)
This case has an unusual history. Here is a brief summary of recent events:
- April 8: U.S. District Court for the District of Delaware enjoins Mylan from launching its generic AMRIX until the court issues its opinion on the patent infringement and validity issues in the case
- April 17: 30–month stay of FDA approval of Mylan's cyclobenzaprine ANDA expires
- April 18: FDA grants final approval of Mylan's ANDA
- May 12: District court issues its opinion (following seven-day bench trial held in September and October of 2010), finding asserted claims of the patents-in-suit invalid for obviousness (link)
- May 13: Mylan launches its generic AMRIX with 180–day exclusivity
- May 20: District court grants Cephalon's motion for a temporary restraining order, explaining that “plaintiffs' success on appeal is just as likely as not” (link)
- May 24: District court issues an Injunction Order, enjoining Mylan's further sales of generic AMRIX; enjoining Cephalon's licensing of an authorized generic version of AMRIX; and ordering Mylan and Cephalon to recall any already-sold generic AMRIX from the market
- May 25: Federal Circuit issues an Order (1) directing Cephalon to file a response to Mylan's motion for a stay, pending appeal, of the district court injunction; and (2) granting “Mylan's request for an immediate stay . . . to the extent that the injunction is temporarily stayed pending the court's receipt of the response and the court's consideration of the papers submitted.”
In an Order issued today, the Federal Circuit granted Mylan's motion for a stay, pending appeal, of the district court's injunction—but only in part. Citing a 1987 Supreme Court case, the Federal Circuit stated the standard for obtaining a stay:
The party requesting a stay bears the burden of showing that the circumstances justify an exercise of that discretion based on consideration of four factors, the first two of which are the most critical: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.
In view of these factors, the court concluded:
Based on the arguments in the motions papers, and without prejudicing the ultimate disposition of this case by a merits panel, we determine that Mylan has met their burden to obtain a stay, pending appeal, of the district court's injunction in part. We deem it proper to stay the injunction as to Paragraph 3 of the Injunction Order only. Mylan's motion to stay the remainder of the injunction provisions is denied.
Paragraph 3 of the Injunction Order directed Mylan and Cephalon to “take all reasonable steps to recall their respective generic cyclobenzaprine extended-release products promptly from the market. . . .” It is not clear why, if “Mylan has met their burden to obtain a stay,” the Federal Circuit lifted only that part of the injunction requiring Mylan to recall its generic AMRIX from the market, and not also the part ordering Mylan to stop selling its generic AMRIX.
In any event, it appears that Mylan must now stop selling its generic AMRIX. Presumably Mylan has been selling its generic AMRIX since it launched on May 13, meaning that it has received the benefit of 56 days of its 180–day exclusivity period. Due to the Federal Circuit's calendar for oral argument, however, the appeal won't be heard until September at the earliest. Meanwhile, Mylan's 180–day exclusivity period will continue to run. Thus, it is unclear whether, even if Mylan prevails on appeal, it will have any exclusivity remaining by the time the Federal Circuit issues its opinion in the case.