Jeanna M. Wacker, P.C.

Bristol Myers Squibb v. Apotex, Inc./DRL/Lupin — 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 against Apotex was resolved by settlement on favorable terms for BMS.

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. — Represented 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. The cases against all parties were resolved by settlement on favorable terms for Impax.

Merck Sharp & Dohme Corp v. Teva Pharmaceuticals USA, Inc. et al. — Represented 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. Obtained favorable settlement.

Janssen Biotech, Inc., et al. v. Celltrion Healthcare Co., Ltd., et al. — Representing Hospira (now Pfizer) and Celltrion in a multi-billion dollar litigation brought by Janssen which filed suit to block the Defendants from selling INFLECTRA®, a lower-cost biosimilar version of REMICADE®. Successfully invalidated the patent covering infliximab, the active ingredient in REMICADE®, under a doctrine prohibiting one company from holding multiple patents on essentially the same invention. However, Janssen continued to allege that the Defendants infringe a second patent on cell culture media. Shortly before trial, won summary judgment of noninfringement regarding the second patent based on a rarely used doctrine called ensnarement. Unanimously affirmed on appeal by the Federal Circuit.

Par Pharmaceutical, Inc., et al. v. Eagle Pharmaceuticals, Inc. — Representing Eagle Pharma in patent litigation brought by Par Pharma companies, involving Eagle Pharma's Abbreviated New Drug Application (ANDA) for the generic version of Par's Vasostrict® (vasopressin injection) for the treatment of hypotension/low blood pressure in patients experiencing vasodilatory shock. After a bench trial, the Court found that Eagle’s ANDA product did not infringe Par’s asserted patent.

Eli Lilly and Co. v. Eagle Pharmaceuticals, Inc. — Represented Eagle Pharma in a patent infringement suit arising from Eagle Pharma’s submission of an ANDA to the FDA seeking approval to manufacture and sell a generic pemetrexed injection, a chemotherapy drug used for the treatment of non-small cell lung cancer. The client sought Golden Flag’s assistance one month before trial was scheduled to begin. Following a four-day bench trial in 2019, the parties entered into a settlement agreement.

Duchesnay Inc. v. Actavis Laboratories FL, Inc., et al. — Represented Actavis and Teva in a patent infringement suit arising from an ANDA to the FDA seeking approval to manufacture and sell generic doxylamine succinate/pyridoxine hydrochloride tablets for the treatment of morning sickness. Obtained favorable settlement.

Janssen Pharmaceuticals, Inc., et al. 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 a generic version of paliperidone palmitate for the treatment of schizophrenia and schizoaffective disorder.

Genzyme Corp., et al. v. Apotex, Inc.; Teva Pharmaceuticals USA, Inc. — Representing Teva in a patent infringement suit arising from an ANDA to the FDA seeking approval to manufacture and sell generic eliglustat capsules for the treatment of Gaucher’s disease.

Novo Nordisk Inc., et al. v. Teva Pharmaceuticals USA, Inc. — Represented Teva in a patent infringement suit arising from Teva’s submission of an ANDA to the FDA seeking approval to manufacture and sell a generic liraglutide injection, a non-insulin injection prescribed for the treatment of type II diabetes. Before the bench trial was to commence, the parties reached a confidential settlement and license agreement.

Onyx Therapeutics, Inc. v. InnoPharma, Inc. — Represented Pfizer subsidiary InnoPharma in a patent infringement suit arising from an ANDA to the FDA seeking approval to manufacture and sell a generic carfilzomib injection for the treatment of multiple myeloma. The case was resolved by settlement favorable to InnoPharma.

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, Golden Flag 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 N.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.

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.

Rafael Serrano v. Jessica Lopez — Represented a New York-area musician pro bono in a trademark dispute with a competitor who misappropriated and unlawfully obtained a federal trademark registration to the client’s stage name. Won summary judgment that directed the USPTO to cancel the registration due to fraud. After developing a strong evidentiary record on the Plaintiff's remaining claims, a favorable settlement was secured.