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Rob Cerwinski, managing partner, is a seasoned patent litigator and IP strategist with 20+ years of experience at premier U.S. law firms helping international clients launch biopharma products into the highly-competitive U.S. market.
Mr. Cerwinski specializes in helping companies devise cost-effective strategies to navigate the complex and intertwined legal, regulatory and financial hurdles that can delay or prevent product launch. His successes in pre-litigation strategy and in the courtroom have driven the launch of 20+ biopharma products in the U.S. and Europe.
Mr. Cerwinski holds a Master of Science Degree in molecular biology and has a deep understanding of the science, business and regulation of biopharma product development, manufacture and marketing.
Mr. Cerwinski co-founded the industry-leading biosimilars practice at Goodwin Procter LLP and is a recognized global authority on biosimilars. He is Senior Editor of the leading legal treatise in the field, Guide to Biosimilars Litigation and Regulation in the U.S. (published by Thomson-Reuters) and founded Goodwin’s award-winning biosimilars blog, Big Molecule Watch and its companion blog, Big Molecule Watch China.
Mr. Cerwinski was recognized by Chambers in New York for Intellectual Property: Patent in 2024 and 2025. He was named an IAM Global Leader in Intellectual Property Law in 2021 and is ranked in the Gold Tier of the IAM Patent 1000.
- Celltrion in BPCIA litigation concerning Celltrion’s biosimilar to Herceptin. Genentech v Celltrion (D. Del.)
- Celltrion in BPCIA litigation concerning Celltrion’s biosimilar to Rituxan. Genentech v Celltrion (D.N.J.)
- Celltrion in Inter Partes Review proceedings in the USPTO concerning patents relating to trastuzumab and rituximab.
- Fresenius in Inter Partes Review proceedings in the USPTO concerning patents relating to filgrastim and pegfilgrastim.
- Fresenius in Post Grant Review proceedings in the USPTO concerning a patent relating to adalimumab.
- Actavis in Hatch-Waxman patent infringement litigation concerning Actavis’s generic equivalent to Noxafil®, an antibiotic. A favorable settlement was obtained after trial. Merck v. Fresenius (D. Del.)
- Dr. Reddy’s in Hatch-Waxman patent infringement litigation concerning DRL’s generic equivalent to Suboxone®, an anti-addiction product. A judgment of non-infringement was obtained after trial. Indivior v. DRL (D. Del.)
- Fresenius in Hatch-Waxman patent infringement litigation concerning Fresenius’s generic equivalent to Cubicin®, an antibiotic. A favorable settlement was obtained before trial. Cubist v. Fresenius (D. Del.)
- Actavis in Hatch-Waxman patent infringement litigation concerning Actavis’s generic equivalent to Staxyn®, an ED medication. A judgment of patent invalidity was obtained after an appeal to the Federal Circuit. Bayer v. Actavis (D. Del.)
- Teva in Hatch-Waxman patent infringement litigation concerning Teva’s generic equivalent to Pfizer’s Atelvia®, an osteoporosis medication. Warner Chilcott v. Teva Pharmaceuticals (D.N.J.)
- Teva in Hatch-Waxman patent infringement litigation concerning Teva’s generic equivalent to Pfizer’s Neurontin®, an epilepsy medication. A favorable settlement was obtained during jury trial. Warner-Lambert v. Teva Pharmaceuticals (D.N.J.)
- Teva in Hatch-Waxman litigation concerning Teva’s generic equivalent to OxyContin®, an opioid pain medication. A judgment of patent invalidity was obtained after trial. A favorable settlement was obtained prior to trial. Purdue Pharma v. Teva Pharmaceuticals (S.D.N.Y.)
- Teva in a patent infringement action concerning Teva’s generic equivalent to Biaxin®, an antibiotic. A favorable settlement was obtained while summary judgment motion was pending. Abbott Laboratories v. Teva Pharmaceuticals (N.D. Ill.)
- Teva in patent infringement action concerning Teva’s generic equivalent to Biaxin XL®, an antibiotic. A favorable settlement was obtained after the Federal Circuit vacated a preliminary injunction. Abbott Laboratories v. Teva Pharmaceuticals (N.D. Ill.)
- Teva in a patent infringement action concerning Teva’s generic equivalent to Augmentin®, an antibiotic. Seven patents were invalidated in two summary judgment motions and a bench trial. Teva Pharmaceuticals v. GlaxoSmithKline (E.D. Va.)
- Teva in a patent infringement action involving Teva’s equivalent to Wellbutrin®, an antidepressant. A favorable settlement was obtained. Glaxo Wellcome v. Teva Pharmaceuticals (D. Del.)
- Teva in Hatch-Waxman litigation concerning Teva’s equivalent to Zithromax®, an antibiotic. A favorable settlement was obtained while summary judgment motions were pending. Teva Pharmaceuticals v. Pfizer (S.D.N.Y.)
- Breckenridge in a patent infringement action involving Breckenridge’s sulfatol acne medication. A favorable settlement was obtained. Bradley Pharmaceuticals v. Breckenridge Pharmaceutical (D.N.J.)
- Teva in Hatch-Waxman litigation concerning generic equivalents to Allegra® and Allegra-D 12 Hour® allergy medications. The case settled after a preliminary injunction was denied and summary judgments of non-infringement and invalidity were obtained. Aventis and AMR v. Teva Pharmaceuticals (D.N.J.)
- Estée Lauder in a patent infringement litigation concerning cosmetic emulsions. A favorable settlement was obtained. Revlon v. Estée Lauder (S.D.N.Y.)
- Faulding in patent infringement litigation concerning Cardizem CD®, a hypertension medication. A favorable settlement was obtained. Hoechst Marion Roussel v. Faulding (D.N.J.)
- American Home Products and Takeda Chemical Industries in a patent infringement litigation concerning acellular pertussis vaccines. Summary judgment of non-infringement was obtained. Evans Medical v. American Cyanamid (S.D.N.Y.)
Prior to forming Gemini, Mr. Cerwinski was a partner at Goodwin Procter LLP in New York City. Before joining Goodwin in 2014, Mr. Cerwinski was a partner at Kenyon & Kenyon LLP. Before pursuing a career in law, he worked for a major Japanese pharmaceutical company in Tokyo assisting with intellectual property matters concerning biotechnology products.
- J.D., Boston University School of Law (cum laude), 1997
- M.S., Cellular and Molecular Biology, Roswell Park Cancer Institute, 1993
- B.S., Biology, Rensselaer Polytechnic Institute, 1991
- New York City Bar Association
- New York State Bar Association
- New York Intellectual Property Law Association
- American Intellectual Property Law Association
- American Bar Association
- Chambers, New York, Intellectual Property: Patent, 2024 and 2025.
- Gold Tier of the IAM Patent 1000 – The World’s Leading Patent Professionals as one of the world’s leading patent litigators (2017, 2019-2022, 2024-2025) and as an IAM Global Leader in 2021, 2022 and 2023.
- Legal 500 USA – IP Litigation (2018).
Mr. Cerwinski has been interviewed extensively by Dow Jones, Forbes, the Center for Biosimilars, Bloomberg, SCRIPS, The Pink Sheet, and other publications. Thought leadership highlights include:
- Speaker, “Top of Mind Issues for Global Life Sciences Companies in the Era of COVID-19,” Goodwin Webinar, April 2020
- Co-author, “INSIGHT: Why the Illegality Doctrine Shouldn’t Apply to Cannabis Patents”, Bloomberg Law, January 2020
- Speaker, “Goodwin Lawyers Give a Look at Biosimilar Litigation,” Not So Different: A Podcast from the Center for Biosimilars, January 2020
- Senior Editor, Guide to Biosimilars Litigation and Regulation in the U.S., published by Thomson Reuters, November 2019
- Co-author, “Protect At All Costs: How the Maker of the World’s Bestselling Drug Keeps Prices Sky-High”, Fortune, July 2019
- “The US’s First All Biosimilar Patent Suit Shows New Pharma IP Landscape is Emerging,” IAM Global, February 2019 [Subscription Required]
- Speaker, “Current Infliximab Litigation,” The Center for Biosimilars, September 2017
- Speaker, “Recent Trends in PTAB Decisions on Biologics, Biosimilars,” The Center for Biosimilars, September 2017
- Speaker, “The Potential for an Executive Order on Drug Pricing,” The Center for Biosimilars, September 2017
- Speaker, “Shall we Dance: Mastering the “Steps” of the BPCIA While Avoiding Common Pitfalls,” American Conference Institute 8th Annual Biosimilars Summit, June 2017
- Speaker, “Biosimilar Investment Landscape in 2017,” Goodwin Seminar, January 2017
- Speaker, “Biosimilars: Annual Market Review,” Goodwin Seminar, January 2016
- Speaker, “Analysis of Amgen v. Sandoz Federal Circuit Decision,” Goodwin Webinar, August 2015
- Speaker, “Declining to Dance? Lessons Learned from Early BPCIA Cases on Whether the Pathway is Mandatory” American Conference Institute 6thAnnual Biosimilars Summit, June 2015
- Co-author, “Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions,” Goodwin Alert, March 2015
- Speaker, “Understanding Biosimilars: Intellectual Property Challenges,” Goodwin Seminar, January 2015