Proposed PTO Rules Could Threaten Patent Practice and Stifle Innovation

Dr. Irena Roizman Partner

new york

Irena, who holds a PhD in Biology from MIT and the Whitehead Institute and was an NSF Fellow, represents plaintiffs and defendants in the most complex pharmaceutical and biotechnology patent litigation. Over the past two decades, pharmaceutical and biotechnology innovators have repeatedly engaged her in litigation involving small molecules, biologics, recombinant DNA technology, gene therapy, gene editing, manufacturing processes, formulations, and drug-eluting medical devices, including many multi-billion dollar cases involving many of the world's best-selling pharmaceuticals.

Irena has extensive experience in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA), as well as matters involving inter partes review (IPR) proceedings, licensing disputes, parallel litigation outside the U.S. and proceedings before foreign patent offices. Irena also helps life sciences companies and organizations develop law in some of the most significant litigation for the biopharmaceutical industry. She has served as lead counsel on numerous amicus briefs filed before the U.S. Supreme Court and Federal Circuit Courts in major biopharmaceutical litigation.

On the plaintiffs' side, Irena has successfully defended generic drug challenges to patents protecting multi-billion-dollar blockbuster medical therapies, including cancer, antiviral and antipsychotic drugs. She also represented innovators in some of the first cases under the BPCIA, including the first case involving antibodies. On the defense side, she defeated a $530 million patent infringement lawsuit against a competitor's biotechnology patents, obtaining dismissal of all claims and discovery sanctions against the patent owner. In another high-stakes case, she obtained a summary judgment of non-infringement and exclusion of the plaintiff's expert under Daubert, as well as an award of all attorneys' fees.

A registered patent attorney, Irena also practices inter partes review (IPR) proceedings, and has used IPR to defeat IPRs on patents protecting blockbuster pharmaceuticals for patent owners, enabling defendants to gain freedom to operate.

Irena also coordinates parallel non-U.S. litigation and litigation before foreign patent offices, most recently obtaining gene therapy freedom for a biotechnology innovator. She provides strategic counseling for biologics and pharmaceuticals and advises clients on their IP portfolios and transactions. Irena has also represented clients in high-stakes licensing disputes involving biotechnology patents, obtaining the largest settlement during her engagement in a dispute concerning the use of recombinant proteins as enzyme replacement therapy.

Chambers USA has recognized Aileena as a leading intellectual property attorney, and her clients describe her as a highly qualified, knowledgeable, aggressive, and incredibly smart attorney. Benchmark Litigation has named her one of the top 250 women in litigation for the past six years, making her a star in New York intellectual property litigation. Aileena has also been named to Crains New York Business' 2021 list of “Notable Women in Law.”

Irena has written and spoken extensively on biopharmaceutical patent issues and biosimilar litigation and is frequently quoted on patent-related issues in publications including The Washington Post, Financial Times, Nature Biotechnology and the Pink Sheets.

Sources 1/ https://Google.com/ 2/ https://www.orrick.com/en/Insights/2024/06/Proposed-PTO-Rule-Poses-Threat-to-Patent-Practice-and-Could-Stifle-Innovation The mention sources can contact us to remove/changing this article

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