Olga Berson, Ph.D.

With a focus on intellectual property (IP) due diligence, Olga conducts patent portfolio and patent landscape analyses, evaluates IP licensing and technology agreements, and assesses the financial and operational risks associated with patent disputes and potential litigation. Her advice is frequently sought for due diligence investigations related to mergers, acquisitions, collaborations, divestitures, recapitalizations, and bankruptcies. She serves a diverse client base, from multinational corporations to emerging startups and venture capital firms.

Olga also undertakes patent audits and internal evaluations, helping clients identify either licensing opportunities or strategic patent abandonments. She guides clients in preparing for product launches and provides valuable counsel on freedom-to-operate strategies and patent validity. She understands the intricate relationship between US Food and Drug Administration (FDA) regulations and patent issues. Olga’s considerable litigation background, including Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA) matters, not only enhances her IP due diligence practice but also enables her to proactively mitigate potential litigation risks for clients.

Olga’s recent work involved the commercialization of a COVID-19 vaccine, the acquisition of an immunology company, and the evaluation of patent portfolios in areas including immunology, oncology, and neurodegenerative diseases. She has also conducted patent landscape analyses to facilitate the launches of biosimilar versions of blockbuster monoclonal antibodies.

Beyond her IP due diligence practice, Olga assists clients with strategic patent portfolio development. She also handles Hatch-Waxman, BPCIA, and biologics patent litigation, as well as US Patent and Trademark Office proceedings. With her wide-ranging technical and legal capabilities, Olga serves as an invaluable asset for clients requiring comprehensive and insightful IP solutions.

Patent Due Diligence Investigations

• 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

• 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

• 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