Bristol Myers Squibb v. DRL/Lupin — Representing BMS in Hatch-Waxman patent infringement litigation regarding cancer therapy Sprycel® (dasatinib).
Boehringer Ingelheim Pharmaceuticals Inc., et al. v. [16 Defendants] — Representing Boehringer Ingelheim in Hatch-Waxman litigation arising from Defendants’ submissions of ANDAs seeking approval to manufacture and sell generic versions of Boehringer’s Jardiance® (empagliflozin) products used to treat type II diabetes.
Galderma v. Teva — Represented Teva Pharmaceuticals in Hatch-Waxman litigation against Galderma concerning Teva’s ANDA on topical rosacea formulation. Following a bench trial at which Ashley took a witness, the Delaware District Court sided with Teva, finding all asserted patents invalid. The parties settled following Galderma’s appeal.
Represented a leading provider of oil and gas technologies in writing successful inter partes review petition to invalidate challenger patent.
Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. HEC Pharmaceuticals Inc. et al. — Representing Boehringer Ingelheim in patent infringement suit arising from numerous 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. Zydus Pharmaceuticals (USA) Inc. et al. — Represented Impax against Defendants in Hatch-Waxman litigation regarding Impax’s Rytary® (Levodopa/Carbidopa) capsules. The case was resolved by settlement on favorable terms for Impax.
Duchesnay Inc. v. Actavis Laboratories FL, Inc., et al. — Represented Actavis and Teva in a patent infringement suit regarding ANDA covering doxylamine succinate/pyridoxine hydrochloride tablets for the treatment of morning sickness. Obtained favorable settlement.
Microspherix v. Merck — Represented Microspherix in patent litigation regarding implantable contraceptive device, and successfully defended Microspherix’s patent in inter partes review proceedings.
Impax v. Lannett — Represented Impax Laboratories and AstraZeneca in District Court ANDA patent litigation related to nasal spray for treatment of migraines at trial, obtaining judgment that all asserted patent claims were valid and infringed, and successfully defended the District Court’s decision at the Federal Circuit.
Butamax v. Gevo — Represented Butamax Advanced Biofuels LLC against Gevo, Inc. in district court patent litigation related to enzymes used in the production of biofuels. Ashley worked on all aspects of the case, including trial preparation, at which point the parties entered into a favorable cross-license agreement.
Baxter v. Ethicon — Represented Baxter in co-pending ITC Investigation and stayed District Court litigation, asserting infringement of Baxter patents covering hemostatic devices and their use in surgery. Ashley was part of the team representing Baxter at a 5-day hearing before the ITC, after which Baxter obtained a favorable settlement.
Regeneron v. Merus — Represented Merus B.V. against plaintiff Regeneron’s claims that Merus infringed its patents related to genetically modified mice. Ashley was part of the trial team which brought Merus’s counterclaims in the Southern District of New York. The Judge concluded that Regeneron had purposefully withheld information from the USPTO and found Regeneron’s patent unenforceable.
Veitch v. Virgin Cruises — Represented Virgin Cruises against Colin Veitch in Mr. Veitch’s claim that Virgin Cruises misappropriated trade secrets related to the launch of a Virgin-branded cruise line, alleging $300 million in damages. Virgin Cruises denied these allegations, highlighting the fact that Virgin Cruises’ planned entry into the industry uses a fleet of mid-sized ships, substantially different from the “Ultra Ships” that Mr. Veitch proposed. A settlement was reached and Veitch dismissed the claims in February 2016.
Cipher v. Actavis — Represented Cipher, Galephar and Ranbaxy in an ANDA litigation against Actavis relating to Actavis’ efforts to gain FDA approval to market generic Absorica®, a product used to treat recalcitrant nodular acne.