Kristen Buteau, whose practice is complemented by her years of experience as a research scientist in the pharmaceutical industry, assists pharmaceutical and biotech companies in the strategic development of patent portfolios and product lifecycle management. Her practice focuses on all areas of drug discovery, from proof-of-concept through drug design, development, and product launch. She manages global patent portfolios for sophisticated pharmaceutical companies, while facilitating investment acquisitions and licensing through due diligence and freedom-to-operate analyses. Ms. Buteau also works with universities and research institutions to provide focused patent protection for innovative discoveries.
Intellectual Property Protection: counsels global pharmaceutical companies, mid-to-large biotechnology companies, venture-backed start-up companies, research institutions and universities, and investor groups in the crafting and development of IP protection strategies for pharmaceutical products.
Prepares and prosecutes patent applications relating to a wide variety of pharmaceutically-relevant inventions, including portfolios protecting novel chemical matter, metabolites and prodrugs, deuterated analogs and derivatives, pharmaceutical formulations, methods of treatment and dosing regimens, patient stratification, and combination therapies.
Advises clients on license agreements, manufacturing and supply agreements, and consulting agreements.
Complex Intellectual Property Disputes: works closely with litigation teams to develop strategies pertaining to technical scientific concepts and patent prosecution issues.
Advises clients on Hatch-Waxman product exclusivity timelines.
Due Diligence: renders validity/invalidity opinions.
Analyzes and advises clients on freedom-to-operate positions.
Provides focused and strategic advice in support of due diligence to facilitate merger and acquisition, initial public offering and in-licensing opportunities.
- Advises clients on worldwide portfolio management and filing strategies.
- Counsels start-up clients on developing IP strategies and portfolio creation.
- Assists clients in determining inventorship of patents/applications.
- Conducts freedom-to-operate and competitive landscape analyses.
- Prepares applications for Hatch-Waxman patent term extensions.
- Conducted IP due diligence in support of Tesaro’s in-licensing and prosecution of a patent estate protecting rolapitant, a novel NK1 antagonist now approved for the treatment and prevention of delayed nausea and vomiting associated with repeated courses of emetogenic cancer chemotherapy.
- Represented Tesaro during IP due diligence in support of its $87M initial public offering.
- Represented Tesaro in several rounds of follow-on financing, totaling more than $400 million.
- Represented Celgene Corporation in IP due diligence in support of its $1.1 billion acquisition of Impact Biomedicines.
- Represented Momenta Pharmaceuticals in a patent infringement action relating to innovative methods of processing therapeutic polysaccharides.
Momenta v. Amphastar et al.
- Represented Celgene Corporation in a breach of contract litigation regarding exclusive license agreement related to Revlimid and Pomalyst.
Children’s Medical Center Corporation v. Celgene Corporation, D Mass
Publications and Presentations
- “The design, synthesis and structure-activity relationships of novel isoindoline-based histone deacetylase inhibitors,” co-author, Bioorganic & Medicinal Chemistry Letters, 2011.
- “Deuterated Drugs: Unexpectedly Nonobvious?” author, Journal of High Technology Law, 2009.
Professional and Community Involvement
Ms. Buteau is a member of the American Chemical Society and the Boston Patent Law Association.
Education & Credentials
- Suffolk University Law School
- JD, 2010, magna cum laude Intellectual Property, with distinction
- Northeastern University
- MS, 2005
- Boston University
- BA, 2000
US Patent & Trademark Office