James H. Velema
James Velema leads the firm's biotech patent prosecution team. His practice includes 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.
- U.S. District Court for the District of Massachusetts
- U.S. Patent and Trademark Office
Selected among the Intellectual Asset Management (IAM) Patent 1000 – The World’s Leading Patent Professionals, 2016
Chambers USA, Massachusetts Intellectual Property, 2015-2016
Selected for Massachusetts Super Lawyers “Rising Stars,” 2013-2019
Recipient, Postgraduate A Scholarship from the National Sciences and Engineering Research Council (NSERC) of Canada, 1999
- American Intellectual Property Law Association
- Boston Bar Association
- Boston Patent Law Association
- Massachusetts Bar Association
- Moderator, "Clinical Trials: Successes & Failures of Nucleic Acid Drugs Discovery & Development," UMASS Medical School RNA Therapeutics Institute, RNA Therapeutics Conference, June 29, 2018
- Speaker, "CRISPR vs. RNAi - A Guide to Patenting Small RNAs," UMASS Medical School RNA Therapeutics Institute, RNA Therapeutics Conference, June 29, 2018
- Speaker, “Patenting of Antibodies,” presented to the NRC Biotechnology Research Institute, Montreal, Canada, August 30, 2010
- Speaker, “An Overview of the Antibody Glycosylation Landscape and Patent Strategies,” presented to the NRC Institute for Biological Sciences, Ottawa, Canada, May 27, 2010
- Speaker, “How Secure is your IP?” at TiE Ottawa, Canada Meeting, June 24, 2008
- Author, “Biological Polymers for use in Tissue Engineering,” book chapter in Advances in Biotechnology and Biochemical Engineering, eds. Kaplan et al., 102:187-238. (2006)
- October 17, 2019
- June 3, 2016
- October 23, 2015
- May 20, 2015
- October 17, 2014
- October 21, 2013
- January 24, 2011
28 State StreetSuite 700Boston, MA 02109
Suffolk University School of Law, J.D., cum laude, Dean’s List
Tufts University, M.S., Biology/Biotechnology
Queen’s University, B.Sc., Biology