Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS…
A district court found that a defective complaint still a triggers 30-month stay. The District of Delaware recently issued an opinion holding that a defective complaint in which the plaintiff did not have standing could still trigger a thirty-month stay. The case arose out of Mylan’s ANDA seeking approval to manufacture a generic version of…
Momenta Pharmaceutica and Sandoz recently petitioned the Supreme Court to review the Federal Circuit’s interpretation of the 35 U.S.C. § 271(e)(1) safe harbor provisions. The petition was filed in response to a Federal Circuit decision, issued in August 2012, overturning a Preliminary Injunction that prevented Amphastar from selling its generic version of enoxaparin, a low…
Last week, Carlson Caspers was represented at the GPhA Conference. Partners Mark Schuman and Sam Lockner attended the 2013 Generic Pharmacuetical Association’s (GPhA) Annual Meeting in Orlando Florida from February 20-23, 2013. According to the GPhA’s website: [vision_pullquote style=”3″ align=”center”] The Generic Pharmaceutical Association (GPhA) is the nation’s leading trade association for manufacturers and distributors of…
This much is clear: Proving lack of enablement requires more than an expert saying it would be “complex” or “difficult” to practice the claimed invention. So said the Federal Circuit recently in Cephalon, Inc. et al. v. Watson Pharmaceuticals, Inc. et al. This appeal resulted from an opinion following a bench trial on the validity and…
On February 11, 2013, the District Court of Delaware ruled that U.S. Patent No. 5,206,244 patent to entecavir (the active ingredient in Bristol-Myers Squibb’s Baraclude, which treats hepatitis B viral infections) is invalid for obviousness. This case marks the first instance where a court has invalidated a molecule patent based on obviousness. The lead compound…
A recent case is a reminder of a claim construction lesson that all litigants should keep in mind. Last Friday, Novartis AG’s Alcon Inc. subsidiary asked the Supreme Court to reverse a Federal Circuit decision in favor of Apotex relating to Alcon’s Patanol (olopatadine) ophthalmic formulation. The case is interesting because of its unusual procedural…