Kramer Levin Launches Biologics Law Blog

Kramer Levin Naftalis & Frankel LLP have launched their  Bio Law Blog, which provides insights into intellectual property law and regulatory developments for biologic medicines. The blog is edited by Kramer Levin partners Irena Royzman, Ph.D.Jonathan S. Caplan and Hannah Lee.

“We started this blog to engage in a conversation about the rapidly developing US biosimilars pathway and the recent surge in approvals for cutting-edge biologic products, such as cell-based and gene therapies,” said Ms. Royzman. “These new biologic products are changing medicine and posing important intellectual property questions and challenges. We are excited to share with you our perspective as trial lawyers immersed in biology and biotech patent law during these transformative times for biologic medicines.”

The blog’s initial post, Biosimilar Litigation Trends and Lessons Learned in 2019, addresses biosimilar litigation trends and the current state of this dynamic area of law. Other topics the blog will cover include the:

  • New biologic products such as small interfering RNA (siRNA), and cell-based and gene therapies
  • Developments in written description and enablement law for antibodies
  • Impact of Section 101 on biotech discoveries
  • Increasing role of the Patent Trial and Appeal Board (PTAB) in reviewing biotech patents

Along with Royzman, Caplan and Lee, contributors to the blog will include the Kramer Levin life sciences team.

Irena Royzman, Ph.D., represents pharmaceutical, biotech and medical device companies in patent litigation, advising both plaintiffs and defendants in every stage of the litigation process from pre-suit investigation through trials and appeals. Irena litigates a wide range of subject matters including antibodies, recombinant DNA technology, small molecule drugs, manufacturing processes, point-of-care diagnostics, gene-editing technology, gene therapies and drug-eluting medical devices. She has particular depth of experience in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA). In addition, Irena represents clients in inter partes reviews and high-stakes license disputes. She also provides strategic counseling in the area of biologics and pharmaceuticals and advises clients on contractual and licensing issues.

Jonathan S. Caplan represents clients in patent litigation, counseling and prosecution, as well as in general corporate matters involving the acquisition, sale or licensing of intellectual property rights. Jonathan litigates patent infringement actions in federal district courts across the country, and in the Court of Appeals for the Federal Circuit, both representing patent owners seeking to enforce their rights and defending companies against allegations of infringement. His litigation work includes patent infringement actions in the Southern District of New York, the District of Delaware, the Northern District of California and the District of Nebraska, involving technologies from immuno-assay kits and analyzers to wireless communications. He also handles inter partes review and ex parte re-exam proceedings before the Patent and Trademark Office.

Hannah Lee litigates high-stakes patent litigation disputes for clients in the life sciences and technology sectors. Hannah has substantial trial experience, including conducting direct and cross-examination of fact and expert witnesses in several trials that resulted in damages and settlements of over $90 million for her clients. She has defended and taken over 70 depositions in the United States, Europe and East Asia, and she practices in multiple districts throughout the United States, and before the U.S. Patent Trial and Appeal Board and the U.S. International Trade Commission.

About Kramer Levin Naftalis & Frankel LLP

Kramer Levin provides its clients proactive, creative and pragmatic solutions that address today’s most challenging legal issues. The firm is headquartered in New York, with offices in Silicon Valley and Paris, and fosters a strong culture of involvement in public and community service. For more information, visit