Boehringer Ingelheim Pharmaceuticals Inc., et al. v. [16 Defendants] — Representing Boehringer Ingelheim in a patent infringement suit arising from defendants’ submissions of Abbreviated New Drug Applications (“ANDA”) to the Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of Boehringer’s Jardiance® (empagliflozin) products used to treat type II diabetes.
Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. HEC Pharmaceuticals Inc. et al. — Representing Boehringer Ingelheim in a patent infringement suit arising from defendants’ submissions of ANDAs to the FDA seeking approval to manufacture and sell generic versions of Boehringer’s Tradjenta® (linagliptin) and Jentadueto® (linagliptin and metformin hydrochloride) tablets used to treat type II diabetes.
Impax Laboratories, Inc. v. Actavis Laboratories Fl, Inc. and Actavis Pharma Inc; Sandoz Inc.; Zydus Pharmaceuticals (USA) Inc. et al. — Representing Impax in an action for patent infringement arising under the Food and Drug Laws and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively, arising from Defendants’ submissions of ANDAs to the FDA seeking approval to manufacture and sell generic versions of Plaintiff’s Rytary® (Levodopa/Carbidopa) capsules. The cases against Actavis and Sandoz were resolved by settlement on favorable terms for Impax.
Merck Sharp & Dohme Corp v. Teva Pharmaceuticals USA, Inc. et al. — Representing Teva in a patent infringement suit arising from Teva’s submission of an ANDA to the FDA seeking approval to manufacture and sell generic alvimopan capsules.
Par Pharmaceutical, Inc. et al v. Eagle Pharmaceuticals Inc. — Representing Eagle in a patent infringement suit arising from Eagle’s submission of an ANDA to the FDA seeking approval to manufacture and sell a generic vasopressin product.
Amgen, Inc., et al. v. Sandoz, Inc., et al. — Represented Sandoz Inc. in patent litigation regarding a biosimilar version of Amgen’s blockbuster drug Neulasta® (pegfilgrastim). In July 2016, Kirkland succeeded in obtaining an order dismissing Amgen’s related declaratory judgment action in the U.S. District Court for the District of New Jersey.
Regeneron Pharmaceuticals, Inc. v. Merus B.V. — Represented Merus in patent infringement litigation concerning genetically engineered animals used in making human biopharmaceutical therapeutics.
Cipher Pharmaceuticals Inc. v. Actavis — Represented Cipher, Galephar and Ranbaxy in a Hatch-Waxman patent litigation against Actavis relating to Actavis’ efforts to gain FDA approval to market generic Absorica®. Absorica® isotretinoin capsules are used for the treatment of recalcitrant nodular acne. The case was resolved by settlement on favorable terms for Cipher, Galephar and Ranbaxy.
Bristol Myers Squibb v. Apotex, Inc. — Represented BMS in Hatch-Waxman patent infringement litigation regarding Sprycel® (dasatinib) tablets. Sprycel® is a cancer drug used to treat patients with chronic myelogenous leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. The case was resolved by settlement on favorable terms for BMS.
Pfizer Inc. v. Apotex, Inc. — Represented Plaintiffs in Hatch-Waxman patent litigation against Teva regarding linezolid, which Pfizer markets under the brand name Zyvox®. Zyvox® is a first-in-class antibiotic to treat vancomycin resistant bacterial infections. The case was resolved by settlement on favorable terms for Pfizer.
Pfizer Inc. v. Sandoz Inc. — Represented Plaintiffs in Hatch-Waxman patent litigation against Sandoz regarding temsirolimus, which Pfizer markets under the brand name Torisel®. Torisel® is indicated for the treatment of renal cell carcinoma. The case was resolved by settlement on favorable terms for Pfizer.
Seattle Children’s Hospital and Novartis v. Teva Pharmaceuticals Industries — Represented Seattle Children’s Hospital and Novartis in Hatch-Waxman patent litigation regarding TOBI®, an inhalable antibiotic formulation for treatment of cystic fibrosis patients.
Witness Systems Inc. v. Nice Systems Ltd. — Represented Nice Systems in a patent infringement action brought by Witness Systems and tried before a jury in the U.S. District Court for the Northern District of Georgia relating to technology systems for monitoring and extracting particular information from recorded telephone communications.
Amgen Inc. v. F. Hoffmann-La Roche Ltd. — Represented Roche in a patent infringement action brought by Amgen and tried before a jury in the U.S. District Court for the District of Massachusetts relating to Roche’s new synthetic drug for treating anemia. On September 15, 2009, the Federal Circuit affirmed in part and reversed and remanded in part the district court’s ruling in favor of Amgen and the two companies subsequently entered into a settlement agreement.
