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
One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al. 1:15-cv-00756; filed August 27, 2015 in the District...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
On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...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
On May 28, the Federal Trade Commission (“FTC”) announced it had reached a $1.2 billion settlement with Teva Pharmaceuticals, which acquired Cephalon in 2012, over reverse payment for its narcolepsy drug, Provigil. The...more
On May 28, 2015, the Federal Trade Commission (FTC) announced the settlement of its 2008 lawsuit against Cephalon, Inc. (now owned by Teva Pharmaceutical Industries, Ltd.), which alleged that Cephalon had made “reverse...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
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
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