Irena Royzman, head of Life Sciences at Kramer Levin, handles pharmaceutical and biotech patent litigation and proceedings before the Patent Trial and Appeal Board. Irena holds a Ph.D. in biology from MIT and the Whitehead Institute, where she was an NSF fellow. She represents plaintiffs and defendants in some of the most complex pharmaceutical and biotech patent cases.
Irena has litigated a wide range of subject matters, including small molecules, biologics, recombinant DNA technology, gene therapy, gene editing, manufacturing processes, formulations and drug-eluting medical devices. She has significant experience in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.
For plaintiffs, Irena has successfully defended generic challenges to patents protecting blockbuster medical therapies, including a multibillion-dollar anti-psychotic drug and a best-selling HIV protease inhibitor. She has also represented an innovator in some of the first cases under the BPCIA, including the first involving an antibody. For defendants, she recently defeated a $530 million claim of patent infringement of a competitor’s biotech patent, obtaining dismissal of all claims and discovery sanctions against the patent owner. In another high-stakes case, she obtained summary judgment of noninfringement and exclusion of plaintiff’s experts under Daubert as well as a full award of attorneys’ fees.
A registered patent attorney, Irena also handles inter partes review proceedings. For patent owners, she has obtained denial of IPR for patents protecting blockbuster drugs, and has leveraged IPR for defendants to obtain freedom to operate.
Irena also coordinates U.S. proceedings with parallel ex-U.S. litigation and proceedings in foreign patent offices. She provides strategic counseling in the area of biologics and pharmaceuticals and advises clients on their IP portfolios and transactions. She also represents clients in high-stakes license disputes involving biotech patents, and, in a dispute concerning the use of a recombinant protein as an enzyme replacement therapy, obtained one of the largest settlement awards over the life of the contract.
Irena has been principal counsel on amicus briefs to the United States Supreme Court in some of the most important life sciences cases. She is frequently quoted on patent-related issues, including in the Washington Post, Nature Biotechnology and Pink Sheet.
Updated Sep 2021