Olga Berson, Ph.D.

Olga advises multinational and emerging companies, research institutions, startups, venture capital firms, and individual investors on intellectual property issues that arise in due diligence investigations, including in connection with mergers, acquisitions, divestitures, recapitalizations, and bankruptcies. She counsels clients on patentability of inventions, freedom to operate strategies, third-party patent landscape analyses, and patent validity issues. Olga also advises biopharmaceutical clients on the interplay between regulatory (FDA) and patent issues both in product life cycle management and in litigation.

Olga’s diverse practice includes Hatch-Waxman and biologics patent litigation, Biologics Price Competition and Innovation Act (BPCIA) proceedings and litigation, and US Patent and Trademark Office proceedings. She represents clients in patent disputes before various federal district and appellate courts, including the US Court of Appeals for the Federal Circuit, arbitration panels, the International Trade Commission, and the US Patent and Trademark Office. With a solid technical foundation, she quickly develops a sophisticated understanding of her clients’ technologies, works effectively with inventors and scientific experts, and distills complex technical issues into compelling legal arguments.

Educated in the United States and Russia, Olga holds a Ph.D. in environmental science (bioremediation and microbiology) and chemistry from California Institute of Technology (Caltech) and an undergraduate degree in chemical and environmental engineering from D. Mendeleyev University of Chemical Technology of Russia. A native Russian speaker, Olga assists her clients in the United States with IP due diligence involving technologies developed in Russia. She also counsels Russian venture capital firms and other Russian clients on IP issues in connection with their investment into and acquisitions of technologies developed in the United States.

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 drug developed in Russia
• A Russian private investment bank in connection with investment opportunities in biotechnology, chemical, material science, and electronics areas
• A global pharmaceutical company in evaluation of a target patent portfolio for a type II diabetes drug

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
• 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 of the Hatch-Waxman Act
• A global pharmaceutical company in conducting a patent landscape analysis and preparing non-infringement and invalidity opinions in connection with manufacturing of a monoclonal antibody product for prophylaxis of hereditary angioedema
• An innovative medicines company in conducting an assessment of patents covering a neuroendocrine tumor diagnostic agent for listing in the Orange Book
• A global manufacturer of skin care and rejuvenation products in a patent landscape analysis for several cosmetic formulations
• 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 relating to 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 non-infringement 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