Irena Royzman concentrates on biotech and pharmaceutical litigation and is Co-Chair of the firm’s Biotechnology Practice. She has successfully represented biotech, pharmaceutical and medical device companies as plaintiffs and defendants in patent litigation on a wide variety of subject matters, such as small molecules, biologics, crystal forms, manufacturing processes, analysis of polymerase chain reaction (PCR) products, genetic transformation techniques, and drug-eluting coatings. Ms. Royzman has significant experience litigating cases brought under the Hatch-Waxman Act and is also representing an innovator pharmaceutical company in one of the first cases under the legislation for biosimilars (BPCIA). She is experienced in all aspects of patent litigation, from pre-suit investigation to Markman hearings, bench and jury trials and appeals. In addition to patent infringement litigation, Ms. Royzman, a registered patent attorney, represents clients in AIA trial proceedings, including one of the first IPRs involving a biotech therapy, and obtained the denial of a petition for IPR of a patent to a crystal form of a blockbuster drug. She also has successfully represented biotech and pharmaceutical clients in high-stakes license disputes involving biotech patents. In addition, Ms. Royzman provides strategic counseling and opinions in the area of biologics and pharmaceuticals and advises clients on contractual issues.
Ms. Royzman holds a Ph.D. in Biology from the Massachusetts Institute of Technology, where she was a NSF fellow and studied the regulation of DNA replication and amplification. Through her research at MIT and the Whitehead Institute, Ms. Royzman has hands-on experience in recombinant DNA technology, cell biology and genetics.
Ms. Royzman writes and lectures widely on patent issues impacting the biotech and pharmaceutical industry. She is also a frequent contributor to the firm’s BiologicsBlog.com, which tracks and analyzes developments in intellectual property law related to biotechnology and biologic medical products as well as regulatory and legislative changes. In addition, Ms. Royzman is Co-Chair of the Amicus Briefs Committee for the New York Intellectual Property Law Association.
- U.S. Supreme Court
- U.S. Patent and Trademark Office
- U.S. Court of Appeals, Federal Circuit
- U.S. District Court, Southern and Eastern Districts of New York
- U.S. Court of International Trade
- New York
American Chemical Society; New York Intellectual Property Law Association (Co-Chair of Amicus Briefs Committee); Intellectual Property Owners Association (Pharmaceutical and Biotechnology Issues Committee); American Intellectual Property Law Association (Biotechnology, Professional Programs and Women in IP Law Committees); Super Lawyers in the area of Intellectual Property Litigation