Theresa Kavanaugh is a senior partner in the firm’s nationally recognized Life Sciences group, and the co-founder of Goodwin’s Late Stage Drug Development practice. Theresa has been consistently recognized as a leading life science patent attorney by numerous legal guides including selection for yearly inclusion since 2013 in U.S. News-Best Lawyers, as a LMG Life Science star, and recognition in The IAM Patent 1000. Her practice focuses on developing and implementing complex patent and market exclusivity strategies for the life sciences, with a focus on extending exclusivity for chemical and biologic therapeutics and positioning IP strategy for M&A and other financing activities, especially for therapeutics in phase 3 clinical trials or with recent regulatory approval. Theresa has led patent portfolio strategy for many therapeutics that have gained FDA and worldwide approval.
Experience
Theresa has developed patent portfolio strategy for many therapeutics, including new chemical entities, biologics and 505(b)(2) products, that have gained FDA and worldwide regulatory approval. She has significant experience and a deep understanding of preparing for and positioning patent and regulatory strategy for M&A, company partnering, and financing events including public offerings and her strategic patent counseling has helped her clients achieve significant funding.
In particular Theresa has extensive expertise in FDA Orange Book listing strategy, patent term extension, and preparing for ANDA or biosimilar competition, including preparing for and conducting post grant patent proceedings such as Inter Partes Review (IPR) proceedings at the USPTO. She has a special focus on small molecule, antisense, and peptide therapies, as well as biologic therapeutics including engineered foods, diagnostics, and nutraceuticals, and extensive technical expertise with pharmaceutical and small molecule therapeutics; protein, antisense and other biologic therapies, diagnostic and drug discovery platform technologies, microbiome modulator technology, polymer chemistry; alternative food and nutraceutical technologies, drug delivery and extended release formulations, materials science, and chemical process technologies.
Representative Matters
- Pre-ANDA strategy for extending patent term and exclusivities relating to marketed small molecule therapeutics
- New antibody patent strategy and third party patent/freedom to operate strategy for fast follower approval
- BridgeBio Pharma and subsidiary companies on patent portfolio strategy for orphan genetic diseases, including patent strategy for QED Therapeutics for TruseltiqTM (infigratinib), approved for certain kinds of cholangiocarcinoma
- Nogra Pharma Ltd. (Ireland) on patent portfolio strategy and patent matters relating to SMAD7 antisense therapy and other small molecule and protein therapeutics
- Alkermes on patent matters related to its LYBALVITM (samidorphan and olanzapine) product
- Acadia Pharmaceuticals on patent matters related to its Nuplazid®(pimavanserin) product
- AMAG Pharmaceuticals on patent matters relating to its marketed products, including Feraheme®, and its $201 million follow-on and $225 convertible note offerings
- Patent matters relating to the approved small molecule lomitapide and BLA approved product metreleptin; including representing the licensor/patent owner in an inter partes review involving patents directed to a novel dosing regimen for lomitapide, with Final Written Decisions upholding the validity of the patents (Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania)
- Neuroderm Ltd. (Israel) on patent matters relating to its CNS small molecule therapeutics, its U.S. IPO and later acquisition by Mitsubishi Tanabe Pharma Company
- Early stage strategy on behalf of venture backed platform companies developing biologics and new chemical entities
- Prepared the patent application that includes the CAS Registry 100 millionth substance, (4S)-6-(4-chlorophenyl)-N-ethyl-8-[2-[[4[hydroxydimethylsilyl)-methyl]benzoyl]amino]ethoxy]-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine-4-acetamide
Professional Activities
Theresa is a member of the American Intellectual Property Law Association, the Boston Patent Law Association, and the American Chemical Society.
Credentials
Education
JD2005
Northeastern University School of Law
Masters in Library Information Science1997
Simmons College
Doctor of PhilosophyChemistry1992
Massachusetts Institute of Technology
MSChemistry1987
The University of Texas at Austin
BSChemistry1986
University of California
Admissions
Bars
- Massachusetts
- U.S. Patent and Trademark Office (USPTO)
- Vermont
Recognition & Awards
Theresa has been recognized by The Best Lawyers in America Best Lawyers for her work in Patent Law, Biotechnology and Life Sciences Practice 2022-2023.
Theresa was recognized for her work in MA – Prosecution by The IAM Patent 1000.
Publications
- Co-author, “Strategic Considerations for Seeking Patent Term Extension (PTE) and its Scope for Drug Products,” Goodwin Insights, May 2020