The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
THE COURT FOUND THAT DEFENDANTS HAD NOT MET THEIR CLEAR-AND-CONVINCING BURDEN OF PROVING THAT FORMULATION AND METHOD-OF-TREATMENTS PATENTS-IN-SUIT WERE OBVIOUS. Case Name: Cephalon, Inc. v. Slayback Pharma Ltd., No....more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Case Name: In re Bendamustine Consolidated Cases, Civ. No. 13-2046-GMS, 2015 U.S. Dist. LEXIS 55963 (D. Del. Apr. 29, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Treanda® (bendamustine HCl); U.S. Patents Nos....more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Millennium Pharmaceuticals Inc. v. Dr. Reddys Laboratories, Ltd. et al. 1:15-cv-00539; filed June 25, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Idenix Pharmaceuticals LLC et al. v. Gilead Pharmasset LLC 1:15-cv-00416; filed May 21, 2015 in the District Court of...more
Recently, the FTC announced that it reached a settlement in its pay-for-delay lawsuit, FTC v. Cephalon Inc. in the U.S. District Court for the Eastern District of Pennsylvania, with Teva Pharmaceuticals Industries, Ltd.,...more
Nature of the Case and Issue(s) Presented: The issue in this case is not whether the validity of the ’516 patent should be litigated in the antitrust trial, but rather, how the court’s previous finding of invalidity and...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al. 1:14-cv-00777; filed June 19, 2014 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Breckenridge Pharmaceutical Inc. et al. 1:14-cv-00671; filed May 27, 2014 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alza Corp. et al. v. Mylan Pharmaceuticals Inc. et al. 1:14-cv-00085; filed May 15, 2014 in the Northern District of...more
On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more
In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s...more
On February 14, 2013, in, the U.S. Court of Appeals for the Federal Circuit (Reyna, Bryson, Wallach*) reversed-in-part and affirmed-in-part the district court's judgment following a bench trial that Watson did not infringe...more
Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more