District Court Finds that a Defective Complaint Still Triggers a 30-Month Stay

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 […]

What’s your story ?…

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. […]

Federal Circuit Hears Argument On Allergan’s Second Attempt To Stop Generic Zymar

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 […]

An International Survey of Gene Patents

The Supreme Court will hear oral arguments next month in Association for Molecular Pathology v. Myriad Genetics, Inc. and will consider whether to permit isolated human genes patents. Much has been written about the Myriad case, but little attention has been paid to the potential international consequences of the decision. Dissimilarities in patent rights in […]

Will the Supreme Court Review Safe Harbor Provisions for Post-Approval Activity?

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 […]

Carlson Caspers partners Mark Schuman and Sam Lockner attended the Annual GPhA Conference in Orlando Florida

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 […]

Little clarity around lack of enablement

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 […]

Good news for companies patenting self-replicating technology?

While predicting a Supreme Court decision is never a safe bet, the oral argument in Bowman v. Monsanto suggests that the result will be welcome news for companies patenting self-replicating technology (like the biotechnology industry). On Tuesday, the Supreme Court heard oral argument on Bowman v. Monsanto, which we told you about on February 12. The […]

Lead Compound Requirement: Not so rigid after all?

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 Claim Construction Lesson – Be Careful What You Ask For

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 […]