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 to 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 21: 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: Judge Gajarsa, for the 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 . . .