Irena Royzman concentrates on pharmaceutical and biotech patent litigation and is Co-Chair of the Firm's Biotechnology Practice. She holds a Ph.D. in Biology from the Massachusetts Institute of Technology and the Whitehead Institute, where she was a National Science Foundation fellow. Ms. Royzman successfully represented plaintiffs and defendants in some of the most complicated pharmaceutical and biotech patent cases.
She has represented pharmaceutical, biotech and medical device companies in patent litigation on a wide range of subject matters, including small molecules, biologics, crystal forms, manufacturing processes, polymerase chain reaction (PCR) products, genetic transformation techniques, and drug-eluting coatings. Ms. Royzman has significant expertise in litigation 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.
For plaintiffs, Ms. Royzman has successfully defended generic challenges to patents protecting blockbuster medical therapies, including a multi-billion dollar anti-psychotic drug and a best-selling HIV protease inhibitor. For defendants, in a case with a damages claim in the hundreds of millions, she obtained summary judgment of noninfringement based on a series of antibody tests. In another high-stakes case involving a damages claim of more than $150 million, she obtained summary judgment of noninfringement and exclusion of plaintiff's experts under Daubert as well as a full award of attorneys' fees.
Ms. Royzman, a registered patent attorney, also 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. In addition, she has successfully represented biotech and pharmaceutical clients in high-stakes license disputes involving biotech patents. Ms. Royzman also provides strategic counseling and opinions in the area of biologics and pharmaceuticals and advises clients on contractual issues.
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. In addition, Ms. Royzman is on the Board of the New York Intellectual Property Law Association and Board Liaison for the Amicus Briefs Committee. She has been principal counsel on amicus briefs to the Supreme Court in some of the most important cases for the biotech industry. She also is frequently quoted on patent-related issues, including in the Washington Post, Pink Sheet, and Law360.
- 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
HONORS: Recognized as a Future Star in Euromoney Institutional Investor PLC’s Benchmark: America's Leading Litigation Firms and Attorneys; named in Super Lawyers in the area of Intellectual Property Litigation
MEMBERSHIPS: American Chemical Society; New York Intellectual Property Law Association (Board Member, Board Liaison for Amicus Briefs Committee, Co-Chair of Amicus Briefs Committee 2015-2017); American Intellectual Property Law Association (Amicus and Biotechnology Committees); Intellectual Property Owners Association (Pharmaceutical and Biotechnology Issues Committee)