Olga Berson’s practice spans a wide range of technical areas, including biopharmaceuticals (small and large molecules), drug delivery systems, medical devices, analytical technologies, skincare and cosmetics, foods and nutraceuticals, and specialty chemicals. Olga collaborates closely with inventors and scientific experts, translating complex technical concepts into practical, effective legal strategies.

Clients turn to Olga for intellectual property (IP) due diligence, patent portfolio analysis, licensing, and technology agreements. She is often involved in high-stakes transactions such as mergers, acquisitions, collaborations, divestitures, recapitalizations, and bankruptcies. Whether advising multinational corporations, venture capital firms or emerging startups, Olga is always focused on safeguarding IP assets and aligning legal strategies with business goals.

Olga also helps clients uncover licensing opportunities, streamline portfolios, and plan for product launches through internal patent audits and patent landscape analyses. With a nuanced understanding of the interplay between patent law and U.S. Food and Drug Administration (FDA) regulations, she provides actionable advice on freedom-to-operate strategies. Her litigation experience, including Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA) cases, empowers her to anticipate and mitigate potential litigation risks proactively.

Recent highlights of Olga’s work include advising on the commercialization of a COVID-19 vaccine, supporting the acquisition of an immunology company, and evaluating patent portfolios in fields such as immunology, oncology, and neurodegenerative diseases. She has conducted patent landscape analyses to facilitate the launch of biosimilar versions of blockbuster monoclonal antibodies.

Throughout her career, Olga has guided clients in building robust patent portfolios, navigating complex litigation, and succeeding in proceedings before the U.S. Patent and Trademark Office. Her unique blend of technical and legal skills makes her an indispensable partner for clients seeking comprehensive and forward-thinking IP strategies.

experience

Patent Due Diligence Investigations, Representing:

  • A global pharmaceutical company in connection with IP due diligence relating to a potential acquisition of a biosimilar candidate.
  • A global pharmaceutical company in connection with collaboration and supply agreements for the clinical development, regulatory approval, supply, and distribution of a COVID-19 vaccine in Japan, analyzing IP issues in Japan and Europe and developing IP risk mitigation strategies.
  • A global pharmaceutical company in its acquisition of an immunology company, analyzing the patent portfolio covering a norovirus vaccine.
  • A global pharmaceutical company in IP due diligence in connection with an Alzheimer’s disease treatment.
  • A private investment bank in connection with investment opportunities in biotechnology, chemical, material science, and electronics areas.
  • A global manufacturer of skincare and rejuvenation products in a patent landscape analysis for several cosmetic formulations.
  • A global pharmaceutical company in the evaluation of a target patent portfolio for a type 2 diabetes drug.
  • A global pharmaceutical company in IP due diligence for the acquisition of two biosimilar products, including an assessment of the risks associated with the BPCIA litigation.
  • A global pharmaceutical company in conducting a patent landscape analysis and preparing noninfringement and invalidity opinions in connection with manufacturing a monoclonal antibody product for prophylaxis of hereditary angioedema.

Strategic Patent Portfolio Development and Counseling, Representing:

  • An emerging biotech company in drafting and prosecuting patent applications and managing its worldwide patent portfolio covering peptide vaccines, high-throughput methods for production of vaccines, and therapeutic compositions for treating anthrax infections.
  • A global leader in handheld and portable 3D scanners in developing and managing its worldwide patent and trademark portfolio.
  • A global pharmaceutical company in preparing invalidity and freedom-to-operate opinions in connection with the licensing of a small molecule drug for treatment of insomnia.
  • A European company developing a skin substitute product in connection with the experimental use exemption under Hatch-Waxman.
  • An innovative medicines company in conducting an assessment of patents covering a neuroendocrine tumor diagnostic agent for listing in the Orange Book.
  • A global pharmaceutical company in rendering validity and freedom-to-operate opinions in connection with peptides for the treatment of cell proliferative disorders.
  • A global pharmaceutical company in rendering invalidity and noninfringement opinions in connection with small molecule compounds and spectroscopic methods for their characterization.
  • A Japanese electronics company in rendering invalidity and noninfringement opinions in connection with micro-electromechanical system inkjet printhead assemblies.
  • A global leader in medical devices and surgical products in rendering a noninfringement opinion in connection with the design of a portable endoscope.

Patent Litigation and Post-Grant Proceedings, Representing:

  • An Asian company in high-stakes patent information exchanges, litigation, and settlement negotiations under the Biologics Price Competition and Innovation Act (BPCIA) for the U.S. market, as well as in global settlement negotiations in connection with the launch of biosimilars of blockbuster recombinant monoclonal antibodies produced through sophisticated multi-step processes.
  • A pioneering medical inventor, in a multi-faceted legal battle involving both litigation and Inter Partes Review (IPR) over his ground-breaking patent for a multibeam laser skin therapy device.
  • A biopharmaceutical company in a patent infringement litigation involving Factor IX/IXa activating antibodies for treatment of hemophilia.
  • A global biopharmaceutical company in a royalty dispute concerning a peptide product for treatment of hyperparathyroidism, securing a significant settlement payment for the client.
  • A pharmaceutical company in cross-suits for patent infringement involving small molecule inhibitors of tyrosine kinase used in treatment of leukemia.
  • A branded pharmaceutical company in multiple Hatch-Waxman cases related to a market-leading pharmaceutical for ulcerative proctitis, ensuring continuing market exclusivity for the client.
  • A pharmaceutical company in a patent infringement litigation targeting its billion-dollar cancer drug and winning summary judgment of noninfringement on both asserted patents
  • An innovative biopharmaceutical company in high-stakes inventorship dispute over 37 US and international patents concerning peptides that mimic activity of erythropoietin (EPO) and phage display methods utilized in their discovery.
  • A manufacturer of a biosimilar antibody medicine for rheumatoid arthritis and other chronic inflammatory disorders in invalidating key blocking patents, navigating the BPCIA patent information exchange process, and launching its biosimilar product several years ahead of schedule.

  • Loyola Law School, Los Angeles, J.D., 2003
  • California Institute of Technology (Caltech), Ph.D., environmental science (bioremediation and microbiology) and chemistry, 1996
  • California Institute of Technology (Caltech), M.S., environmental science and chemistry, 1992
  • D. Mendeleyev University of Chemical Technology of Russia, B.S., chemical engineering and environmental engineering, 1989

Admissions

Bar Admissions

  • California, 2003
  • Texas, 2024

Court Admissions

  • U.S. District Court, Central District, California, 2003
  • U.S. District Court, Southern District, California, 2012
  • U.S. Court of Appeals, Federal Circuit, 2004
  • United States Patent and Trademark Office, 2004

Russian (fluent)

  • ChIPs, Orange County chapter, co-leader and strategic advisor
  • American Bar Association
  • American Chemical Society

  • LMG Life Sciences Life Sciences Star
    • Patent Strategy & Management, 2024
    • Intellectual Property, 2022
  • Law360 Practice Group of the Year member, Intellectual Property, 2019
  • The American Lawyer Litigation Department of the Year member, Intellectual Property, 2019
  • Listed in Super Lawyers Rising Stars, Intellectual Property and Intellectual Property Litigation, 2005, 2008

  • “Hsu Untied interview with Olga Berson”
    Hsu Untied podcast, November 4, 2024
  • Speaker, “Generative AI: Understanding Basics, Unraveling IP Complexities, and Establishing Robust AI Policies”
    California Lawyers Association IP Section Webinar, 2023

Outside the office, I channel my energy into Latin dance competitions, where I’ve progressed from a beginner (bronze level) in May of last year to winning mid-level (silver) competitions by December. Competing in Cha-Cha, Samba, Rumba, Jive, and Paso Doble has been an exhilarating journey, providing a creative outlet and a vibrant balance to my desk-focused career.