Overview
Michael Sitzman is an accomplished first-chair trial lawyer in high-stakes biologic and drug patent litigation. He represents biotechnology and innovator pharmaceutical companies in patent litigation, including abbreviated new drug application (ANDA) litigation under the Hatch-Waxman Act, and other intellectual property matters across the life sciences industry.
Over the course of 30 years, Michael has litigated patent cases involving heavy-chain antibodies, recombinant DNA, chimeric antigen receptor technology (CAR-T), glycobiology, antisense technology, protein synthesis and regulation, and immunological markers for Allergan, Inc.; Alza Pharmaceuticals; Depomed; Genentech, Inc.; Janssen Pharmaceuticals; Medicis Pharmaceutical; Merck Serono; Novo Nordisk; Taiho Oncology; Taiho Pharmaceutical; and Ultragenyx. Notably, he was one of the chief architects of the strategy for Novo Nordisk that culminated in the Supreme Court of the United States’ first substantive review of the Hatch-Waxman Act.
Michael is a member of the patent bar and has extensive experience in courts that are key to life sciences clients, including the district courts for New Jersey, Delaware, Maryland, and New York, and the US Court of Appeals for the District of Columbia Circuit and the Federal Circuit.
Recognized as a leading lawyer in the patent litigation space, Michael is a frequent speaker at industry conferences on biotechnology and pharmaceutical patent law issues.
Results
- Secured a significant win for Taiho Oncology and Taiho Pharmaceutical in Hatch-Waxman Act litigation against four generic companies seeking to launch generic versions of the oncology drug LONSURF®*
- Secured complete relief for Acorda Therapeutics in arbitration and before the US District Court for the Southern District of New York against Alkermes plc for charging royalties in contravention of the Supreme Court’s ruling in Brulotte*
- Successfully represented Allergan before the International Trade Commission in a high-profile IP dispute over the genetic origin of C. botulinum, a toxin strain, and the process parameters used to manufacture BOTOX® that resulted in a broad exclusionary order against Daewoong Pharmaceutical and Evolus, Inc.*
- Successfully represented Genentech in a licensing dispute over patents claiming the use of monoclonal antibodies with high levels of fucose to decrease antibody-dependent cellular cytotoxicity activity and corresponding levels of inflammation*
- Represented a biopharmaceutical company in biologic patent litigation involving CAR-T for T-cells targeting CD19 and the US Food and Drug Administration’s (FDA) first approved CAR-T, YESCARTA™, for the treatment of non-Hodgkin lymphoma*
- Secured a win for Depomed in ANDA litigation against generic applicants for various dosage forms of NUCYNTA® for the treatment of polyneuropathic pain and diabetic peripheral neuropathy*
- Successfully defended Ultragenyx in trade secret litigation involving the ultra-rare disease mucopolysaccharidosis VII and its first treatment, MEPSEVII™*
- Represented Takeda Pharmaceutical Company and its lead investor in litigation against the FDA for its improper approval of Colcrys without requiring certification for the method-of-use patent*
- Successfully defended Allergan against patent infringement allegations concerning the structural elements of an improved inframammary breast prosthesis*
- Successfully represented Medicis Pharmaceutical in patent litigation against a 505(b)(2) competitor using the patented formulation for Medicis’s Ziana*
- Secured a significant win for Medicis Pharmaceutical in ANDA litigation against a generic applicant for a clindamycin phosphate/tretinoin topical gel for dermatological applications*
- Obtained favorable results for Novo Nordisk in litigation and appeals concerning the change in use code narrative associated with Novo Nordisk’s Prandin*
- Successfully represented Novo Nordisk in ANDA litigation against generic applicants for Prandin and PrandiMet when used in combination with metformin for the treatment of type 2 diabetes*
- Successfully defended Merck Serono against patent infringement allegations arising from the production of interferon-β in Chinese hamster ovary cells under the biologics license granted by the FDA*
- Obtained dismissal for clients in a follow-on antitrust suit arising from ANDA litigation concerning generic oxybutynin for the treatment of urological disorders*
- Successfully represented Arizona Heart Institute in patent litigation arising from inventorship and ownership claims to original patented stent technology*
- Successfully defended Endomed, Inc. in a patent infringement and trade secret misappropriation suit arising from the design of polytetrafluoroethylene vascular grafts*
*Matter handled prior to joining McDermott.
Recognitions
- Legal 500 US, Recommended, Patent Litigation: Full Coverage, 2020-2021 and 2023-2024
- Legal 500 US, Recommended, Patents: Litigation (International Trade Commission), 2023-2024
Community
- Federal Circuit Bar Association, Global Fellow
Credentials
Education
University of the Pacific, McGeorge School of Law, JD, Order of the Coif, 1991
University of California, Davis, BS, Molecular Genetics, 1986
Admissions
California
Courts / Agencies
Supreme Court of the United States
US Patent and Trademark Office
US Court of Appeals for the Ninth Circuit
US Court of Appeals for the Federal Circuit
US Court of Appeals for the District of Columbia Circuit
US District Court for the Northern District of California
US District Court for the Central District of California
US District Court for the Eastern District of California
US District Court for the Southern District of California
