Michael B. Cottler

Mr. Cottler advises clients in the pharmaceutical and biotechnology industries on a number of intellectual property matters. His experience includes patent litigation, client counseling (including invalidity and clearance opinions), and due diligence. Mr. Cottler has extensive experience handling all aspects of patent litigation, including overseeing fact and expert discovery, examining witnesses at trial, preparing pretrial motions and briefs, and arguing in Court relating to discovery disputes, claim construction, Daubert motions, and motions in limine. The following are a representation of Mr. Cottler’s matters:

• Prometheus Laboratories Inc. v. Roxane Laboratories, Inc., et al., No. 2:11-cv-01241 (D.N.J.)

Mr. Cottler is a member of the team representing Roxane and Cipla in a patent infringement litigation filed by Prometheus under the Hatch-Waxman Act in response to Roxane’s filing of an abbreviated new drug application seeking approval to market a generic version of Prometheus’s IBS treatment drug, LOTRONEX® (alosetron hydrochloride). After a bench trial, the District Court found Prometheus’s patent invalid, enabling Roxane to launch the first generic version of LOTRONEX®. Judgement was affirmed on appeal.

• Cadence Pharmaceuticals, Inc., et al. v. Fresenius Kabi USA, LLC, No. 13-cv-00139 (S.D. Cal.)

Mr. Cottler was a member of the team representing Fresenius in a patent infringement litigation filed by Cadence under the Hatch-Waxman Act in response to Fresenius’s filing of a 505(b)(2) application seeking approval to market a generic version of Cadence’s pain medication, OFIRMEV® (acetaminophen). The case settled favorably before trial.

• Teva Pharmaceuticals USA, Inc. v. Amgen, Inc., No. 09-cv-5675 (E.D. Pa.)

Mr. Cottler was a member of the team representing Teva  in a declaratory judgment action filed by Teva regarding its Biologics License Application seeking approval to market its recombinant G-CSF product, a version of Amgen Inc.’s drug, NEUPOGEN®. The case settled favorably before trial, enabling Teva to launch, prior to patent expiration, the first G-CSF product in the U.S. market in over ten years.

• Novartis Pharmaceuticals Corporation, et al. v. Roxane Laboratories, Inc., No. 1:14-cv-01508 (D. Del.)

Mr. Cottler is a member of the team representing Roxane in an ongoing patent infringement litigation filed by Novartis under the Hatch-Waxman Act in response to Roxane’s filing of an abbreviated new drug application seeking approval to market a generic version of Novartis’s anti-cancer product, AFINITOR® (everolimus).

• Tris Pharma, Inc. v. Actavis Laboratories FL, Inc.,  No. 1:14-cv-01309 (D. Del.)

Mr. Cottler is a member of the team representing Actavis in an ongoing patent infringement litigation filed by Tris under the Hatch-Waxman Act in response to Actavis’s filing of an abbreviated new drug application seeking approval to market a generic version of Pfizer’s ADHD product, QUILLIVANT® (methlyphenidate).

• Genzyme Corporation, et al. v. Teva Pharmaceuticals USA, Inc., et al., No. 1:13-cv-01506 (D. Del.)

Mr. Cottler is a member of the team representing Teva in an ongoing patent infringement litigation filed by Genzyme under the Hatch-Waxman Act in response to Teva’s filing of an abbreviated new drug application seeking approval to market a generic version of Genzyme’s stem cell mobilizing agent, MOZOBIL® (plerixafor). The case is now on appeal.