Michael Sitzman is a partner in the firm’s Intellectual Property and Life Science Practice Groups. Mr. Sitzman has extensive litigation experience in the pharmaceutical and biotechnology fields; he has handled many high-profile cases for Allergan, Alza, Depomed, Genentech, Gilead, Janssen Pharm., Medicis, Merck Serono, Novo Nordisk and Ultragenyx. Mr. Sitzman represents brand-name pharmaceutical companies in biologic and drug patent litigation, including ANDA litigation. Mr. Sitzman was one of the chief architects of the strategy for Novo Nordisk that culminated in the Supreme Court’s first substantive review of the Hatch-Waxman Act. Mr. Sitzman also represents a broad array of biotechnology companies in high stakes patent litigation involving recombinant DNA, CAR-T technology, antisense technology, protein synthesis and regulation and immunological markers.
Mr. Sitzman received a Bachelor of Science degree from the University of California at Davis in the field of molecular genetics. Before becoming an attorney, he worked at the U.C. Davis Plant Growth Laboratory and Biogenex Labs, combining the fields of immunology, histology and general chemistry. Mr. Sitzman earned his Juris Doctor, with distinction, from the University of the Pacific in 1991, where he was elected Order of the Coif.
Mr. Sitzman is a member of the State Bar of California and is registered to practice before the United States Patent and Trademark Office. He is admitted to all Federal and State courts in California, the United States Court of Appeals for the Federal Circuit and the United States Supreme Court. Mr. Sitzman regularly appears pro hac vice in the District Courts of New Jersey, Delaware, Maryland and the Southern District of New York. Mr. Sitzman is a Global Fellow of the Federal Circuit Bar Association and speaks regularly at PLI and ACI conferences on issues of biotechnology and pharmaceutical patent law.
Select Representative Matters
- Takeda, Millennium Pharm. v. Genentech, Inc. (Del. Ch. 2018) – licensing dispute over patents claiming the use of monoclonal antibodies with high levels of fucose in order to decrease ADCC activity and corresponding levels of inflammation.
- Juno Therapeutics & Memorial Sloan Kettering v. Kite Pharma (C.D. Cal. 2017) – biologic patent litigation involving chimeric antigen receptor technology (CAR-T) for T-cells targeting CD19 and FDA’s first approved CAR-T, axicabtagene ciloleucel (YESCARTA™), for the treatment non-Hodgkin lymphoma.
- Depomed v. Actavis, Roxane & Alkem (Fed. Cir. 2017; D.N.J. 2016) — ANDA litigation against generic applicants for various dosage forms of tapentadol hydrochloride (NUCYNTA®) for the treatment of polyneuropathic pain and diabetic peripheral neuoropathy.
- Shire Pharm. v. Ultragenyx Pharm. (D.Mass. 2017) – trade secret litigation involving the ultra-rare disease of mucoplysaccharidosis VII (MPS VII) and the first treatment, MEPSEVII.
- Oakwood Labs v. Aurobindo Pharma. (D.N.J. 2017) – trade secret litigation involving formulation of peptide-based microspheres encapsulating leuprolide and octreotide for injectable devices.
- Takeda v. Burwell (D.D.C. 2014; D.C. Cir. 2016) – challenging FDA’s improper approval of 505(b)(2) generic colchicine drug (Colcrys®) without requiring patent certification to method of use patents.
- Almha v. Allergan (D. Kan. 2013) – defense of patent infringement allegations concerning structural elements of an improved inframammary breast prosthesis.
- Medicis v. GlaxoSmithKline & Stiefel (W.D. Tex. 2012, D.N.J. 2012) – patent litigation against 505(b)(2) competitor using the patented formulation for Ziana® product.
- Medicis v. Actavis (D. Del. 2012) – ANDA litigation against generic applicant for drug combination clindamycin phosphate/tretinoin topical gel for dermatological applications.
- Novo Nordisk v. Caraco Labs & Sun Pharm. (S.Ct. 2011; Fed. Cir. 2010; E.D. Mich. 2009) – litigation and appeals concerning the change in use code narrative associated with Novo Nordisk’s Prandin® product.
- Novo Nordisk v. Caraco, Sun, Mylan, Paddock, Sandoz & Aurobindo, (Fed. Cir. 2012; E.D. Mich. 2011 & 2012; D.N.J. 2009; D. Minn. 2011) – ANDA litigation against generic applicants for repaglinide (PRANDIN®) for the treatment of Type 2 diabetes when used in combination with metformin.
- Novo Nordisk v. Actavis, Sandoz & Lupin (S.D.N.Y. 2011) — ANDA litigation against generic applicants for the single dose combination product repaglinide/metformin (Prandimet®)for the treatment of Type 2 diabetes.
- Isis Pharmaceutical v. Santaris Pharma A/S (S.D. Cal. 2012) – defense of patent infringement allegations arising out of the development of antisense oligonucleotides (LNAs) for the treatment of various diseases and medical conditions.
- Biogen IDEC MA v. Merck Serono (D.N.J. 2011) – defense of patent infringement allegations arising out of the production of interferon-β in CHO cells under the biologics license granted by FDA.
- In re: Ditropan Litigation (N.D. Cal. 2008) – defense of antitrust claims arising out of ANDA litigation concerning generic oxybutynin for the treatment urological disorders.
- Thoratec v. Bodycote – defense of patent infringement allegations concerning the biocompatible coating used in cardiovascular implantable devices.
- C.R. Bard v. AHI Cardiovascular Surgeons, Inc. (D. Ariz.) – patent litigation arising out of inventorship and ownership claims to original patented stent technology.
- Impra, Inc. v. Endomed (D. Ariz.) – defense of patent infringement and trade secret misappropriation allegations arising out of the design of polytetraflouroetheylene (PTFE) vascular grafts.