James Velema, a partner in our Boston office, focuses his practice on patent preparation and prosecution, due diligence and opinion work in all areas of biotechnology, including biologic therapies, research tools, screening assays, bioprocessing and purification. A particular focus of his work has involved representing clients in the fields of RNA silencing and antibody technology. He assists a wide variety of clients ranging from start-ups and emerging biotechnology companies to large academic research institutions and Fortune 500 biotechnology companies. In addition, James has considerable research experience in industry and academia. He previously served as the IP manager and patent agent at a pharmaceutical company and research associate at a biotech company, and is an inventor who holds several U.S. patents.
His notable experience includes:
- Prosecuting and procuring a portfolio of fundamental patents related to the Nobel-prize winning RNA interference (RNAi) technology of a top, research-oriented medical school.
- Coordinating and implementing worldwide patent strategies for Bapineuzumab, a humanized antibody developed by two large biopharmaceutical companies for the treatment of Alzheimer’s Disease.
- Preparing and filing the underlying petitions which led to Wyeth v. Kappos, a landmark decision overturning the narrow interpretation of the laws concerning patent term adjustment (PTA).
- Assisting in the opposition of a European patent at the European Patent Office in Munich, Germany.
- Crafting a patent portfolio for an emerging Swiss antibody company and participating in due diligence activities which resulted in its acquisition by a U.S. opthalmology giant for over $400 million USD.
- Preparing and prosecuting a complex patent portfolio of antibody engineering technologies developed across multiple research sites of one of the largest biotech companies in the U.S.
- Performing Freedom-to-Operate (FTO) and clearance analyses of proposed manufacturing processes for the biological products of several large biopharmaceutical companies.
- Analyzing the patent landscape relating to antibodies including: antibody glycobiology, antibody Fc variants, alternative binding scaffolds, and discovery platform technologies.
