New York
With a Ph.D. in biology from MIT and the Whitehead Institute, where she was a NSF fellow, Irena represents plaintiffs and defendants in their most complex pharmaceutical and biotech patent cases. Over the last 20 years, pharmaceutical and biotechnology innovators have relied on Irena again and again for cases involving small molecules, biologics, recombinant DNA technology, gene therapy, gene editing, manufacturing processes, formulations and drug-eluting medical devices, including numerous multi-billion dollar cases involving many of the world’s best-selling drugs.
Irena has significant experience in litigation under the Hatch-Waxman Act (ANDA and 505(b)(2) actions) and the Biologics Price Competition and Innovation Act (BPCIA), as well as inter partes review (IPR) proceedings, license disputes and matters with parallel ex-U.S. litigation and proceedings in foreign patent offices. Irena also helps life sciences companies and organizations develop the law in the most important cases for the biopharma industry. She has been principal counsel on numerous amicus briefs to the United States Supreme Court and the Federal Circuit in key biopharma cases.
For plaintiffs, Irena has successfully defended generic challenges to patents protecting blockbuster medical therapies, including multi-billion dollar cancer, antiviral, diabetes and anti-psychotic drugs, including recently obtaining attorneys’ fees in a hard-fought ANDA action. She also represents innovators in biosimilar litigation from its outset, including in some of the first cases under the BPCIA involving antibodies. Irena also represents clients in innovator vs innovator disputes. For defendants, she 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 (IPR) 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, recently obtaining freedom to operate for a biotech innovator’s gene therapy. She provides strategic counseling in biologics and pharmaceuticals and advises clients on their IP portfolios and transactions. Irena 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.
Chambers USA has recognized Irena as a leading lawyer in intellectual property, where clients have described her as “excellent,” “knowledgeable, aggressive,” “knows the science forward and backward” and “an incredibly smart lawyer.” Benchmark Litigation named her one of the “Top 250 Women in Litigation” for the last eight years and a litigation star in intellectual property. Irena was also named to the Crain’s New York Business list of “Notable Women in Law.” She is also recognized as a leading lawyer by Legal 500. Irena writes and lectures widely on biopharma patent issues and biosimilar litigation. Irena also is frequently quoted on patent-related issues, including in the Washington Post, Financial Times, Nature Biotechnology, Bloomberg and Pink Sheet.