McDermott Will & Schulte, a global law firm

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.

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• 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 the firm.

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