On Friday April 19 the Federal Circuit, in a divided decision, emphasized the importance of adhering to the appeal rules by establishing that if a patent infringer does not appeal a trial court’s validity decision, then that infringer/defendant cannot challenge the validity of the claims on subsequent appeals. On its face, this seems quite logical;…
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…
Every Paragraph IV certification is a potential trial. But this simple fact is often ignored until just before trial, when the attorneys rush to figure out how to present the case. The most effective and efficiently runs case, however, is one in which every aspect of the case—from beginning to end—revolves around a case story.…
The Federal Circuit recently heard oral arguments in Allergan’s appeal of its second patent infringement action seeking to preclude Apotex from launching a generic version of Zymar, a pinkeye treatment. Allergan initially sued Apotex back in 2007 under the Hatch-Waxman Act. Apotex prevailed in that action, with the District Court finding that the asserted claims…
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…