Michael K. Nutter

Mike is a first-chair trial lawyer and registered patent attorney who focuses on small-molecule pharmaceutical patent litigation within the framework of the Hatch Waxman Act and biosimilar patent litigation within the Biologics Price Competition and Innovation Act (BPCIA). The depth of his experience in this space has been recognized by IAM Patent 1000, which notes that he is a “star of the pharmaceutical circuit.”

Mike’s clients are primarily generic drug companies facing patent infringement cases involving Abbreviated New Drug Applications (ANDAs) that include a Paragraph IV certification to one or more Orange Book-listed patents. He works closely with his clients to resolve ANDA-related issues before the FDA, including labeling issues, issues with API, patent listing disputes, and issues pertaining to new drug and marketing exclusivities. As a complement to his ANDA litigation practice, Mike provides clients with strategic counseling in developing long-term legal and business strategies for developing and launching generic pharmaceutical products.

Mike holds a Bachelor of Science in Chemical Engineering from the University of Illinois.

Mike represents leading pharmaceutical companies in patent infringement actions, including:

• A pending action in the District of New Jersey regarding client’s ANDA to make a generic version of the oral solution Xywav^® (calcium, magnesium, potassium, and sodium oxybates).
• Pending actions in the District of Delaware regarding client’s ANDA to make a generic version of the type-2 diabetes drug Jardiance^® (empagliflozin).
• Pending action in the District of New Jersey regarding client’s ANDA to make a generic version of the vaginal insert Imvexxy^® (estradiol). No trial date has been set.
• An action regarding client’s ANDA to make a generic version of the Parkinson’s disease drug Nuplazid^® (pimevanserin).
• An action in the District of Delaware regarding client’s ANDA to make a generic version of the overactive bladder drug Myrbetriq^® (mirabegron).
• An action in the District of Delaware regarding client’s 505(b)(2) application to make a generic version of the drug Elcys^® (cysteine hydrochloride), which is indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN). The case was settled on terms favorable to the client.
• An action in the Southern District of Indiana regarding client’s ANDA to make a generic version of the low-testosterone drug Axiron^® (testosterone topical solution). All patents found invalid and/or not infringed after a multi-week trial.
• An action in the District of New Jersey regarding client’s ANDA to make a generic version of the topical solution Jublia^® (efinaconazole). The case was settled on terms favorable to the client.
• An action in the District of New Jersey regarding client’s ANDA to make a generic version of the bipolar depression drug Latuda^® (lurasidone HCL). The case was settled on the first day of trial.
• An action in the District of Delaware regarding client’s ANDA to make a generic version of the severe acne drug Doryx^® MPC (doxycycline hyclate). The case was settled on terms favorable to the client.
• An action before the Texas Judicial Branch regarding client’s ANDA to make a generic version of the eczema cream Locoid® (hydrocortisone butyrate). The case was settled on terms favorable to the client.
• An action in the District of Delaware regarding client’s ANDA to make a generic version of the opioid dependence buccal tablet Bunavail^® (buprenorphine and naloxone). The case was settled on terms favorable to the client.
• An action in the District of New Jersey regarding client’s ANDA to make a generic version of the pulmonary arterial hypertension drug Orenitram^® (treprostinil). The case was settled on terms favorable to the client.
• An action in the District of New Jersey regarding client’s ANDA to make a generic version of the drug Dificid^® (fidaxomicin), indicated for the treatment of Clostridium difficile-associated diarrhea (CDAD). The case was settled on terms favorable to the client.

• Speaker, “The Practice of Hatch-Waxman Litigation: Town Hall with the Magistrate Judges,” 16th Annual Paragraph IV Disputes Conference, November 9, 2021