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. She represents both early stage and mature life science companies worldwide on development and implementation of complex patent and market exclusivity strategies. She has substantial 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; her strategic patent counseling has helped her clients achieve significant acquisition valuation and early stage funding.
Theresa has led patent portfolio strategy for many therapeutics that have gained FDA and worldwide regulatory approval.
Experience
Theresa has developed patent portfolio strategy for both therapeutics and diagnostics, including new chemical entities, biologics and 505(b)(2) products.
In particular Theresa has extensive experience 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, including actives developed by machine learning and/or artificial intelligence.
She has extensive technical expertise with pharmaceutical and small molecule therapeutics; protein, antisense and other biologic therapies, diagnostic and drug discovery platform technologies (including AI and machine learning), microbiome modulator technology, polymer chemistry; alternative food and nutraceutical technologies, drug delivery and extended release formulations, materials science, and chemical process technologies.
Representative Matters
- Deciphera Pharmaceuticals on its global patent strategy, including patent strategy related to QiNLOCK® and its approval worldwide, and Deciphera’s acquisition by ONO Pharmaceuticals for $2.4 billion.
- BridgeBio Pharma and subsidiary companies on patent portfolio strategy for orphan genetic diseases, including patent strategy for QED Therapeutics
- Flagship Pioneering and its spin off companies, including companies focusing on diagnostics, small molecules, and AI drug discovery
- Antibody and other protein therapeutics patent strategy for a “hub and spoke” biotech company and its spin out companies
- Nogra Pharma Ltd. (Ireland) on patent portfolio strategy and patent matters relating to SMAD7 antisense therapy and other small molecule and protein therapeutics
- Europe based therapeutic companies on U.S. IP and regulatory matters in advance of partnering/finance activities
- Alkermes on patent matters related to its LYBALVITM (samidorphan and olanzapine) product patent term extension, and Orange Book patent strategy
- Acadia Pharmaceuticals on patent matters related to its Nuplazid® (pimavanserin) product, patent term extension, and Orange Book patent strategy
- 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
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 since 2013.
Theresa was recognized for her work in MA – Prosecution by The IAM Patent 1000.
REPRESENTATIVE PUBLICATIONS
- Lead author, “Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence and Life- Science Related Machine Learning ( June 2024)
- Co-author, “Strategic Considerations for Seeking Patent Term Extension (PTE) and its Scope for Drug Products,” Goodwin Insights, May 2020