Dr. Janet McNicholas is noted for her patent-related achievements as a life sciences attorney with more than 30 years of practice, including serving biotech clients with products and platforms for antibody, gene/gene editing, and cell-based products.
Janet advises clients in the development, management, and enforcement of worldwide patent portfolios. She writes and prosecutes patent applications for a broad range of life science technologies, advises clients in licensing and agreement matters, and is experienced in biopharma litigation and opposition matters. Her practice regularly includes conducting patentability, patent landscape, freedom-to-operate, infringement, and validity assessments; conducting IP audits; evaluating intellectual property portfolios in connection with acquisitions, licensing, financings, collaborations, and/or partnering deals; and mining both developing and mature patent portfolios covering products and platforms for opportunities to maximize value.
Prior to practicing law, Janet conducted research in immunology, molecular biology, biochemistry, and genetics at the University of Illinois as a pre-doctoral student and then at Stanford University and at the California Institute of Technology as a post-doctoral fellow of the Arthritis Foundation.
Janet has spoken at national and international scientific, business, and legal conferences on patent matters relating to recombinant biologicals, therapeutic antibodies, next generation biotherapeutics, bioprocessing/bioproduction, biofuels, biosimilars/biobetters, pharmaceuticals, Hatch-Waxman Act, branded and generic drug development, medical devices, patent and regulatory exclusivities, partnering/outsourcing, translational research, bio-entrepreneurship, development of innovative gene/gene editing/cell-based therapeutics, and product commercialization strategies.
Janet is a member of the American Bar Association (ABA), American Intellectual Property Law Association (AIPLA), Biotechnology Innovation Organization (BIO), BIOCOM, Chinese American Biopharmaceutical Society (CABS), Churchill Club, and TiE Silicon Valley.
180-Day Notice of Commercial Marketing Mandatory Even When Biosimilar Applicants Do the "Patent Dance"
FDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars
- October 2015
The Rise of the PTAB and Its Implications for Biopharma Patents
- May 2015
Biosimilars 2014 in Review and What to Expect in 2015, The Biotech Connection in Boston
- May 16, 2018
Women in IP Speaker Series: Developing and Commercializing New Medicines: Do Patents Still Matter?
- March 4, 2015
Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker
- The University of Chicago (J.D. cum laude 1986); University of Illinois (Ph.D. in Microbiology/Immunology 1980; Milan Novak Award for Excellence in Microbiology; M.S. 1976); Rosary College (B.A. 1973)
- California, Illinois, U.S. Patent and Trademark Office, and U.S. District Court for the Northern District of Illinois