Theresa Kavanaugh is a senior partner in the firm’s nationally recognized Life Sciences group, and the co-chair of Goodwin’s Late Stage Drug Development practice. Dr. Kavanaugh 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, especially for therapeutics in phase 3 clinical trials or with recent regulatory approval. Her practice includes patent portfolio management in anticipation of product approval, company partnering, M&A, and financing events, including public offerings. Dr. Kavanaugh has developed patent strategies for many therapeutics that have ultimately been approved by the FDA and other regulatory agencies.
Experience
Dr. Kavanaugh has significant experience in developing patent strategies throughout the developmental life cycle of chemical therapeutics, with a special focus on small molecule, antisense, and peptide therapies, as well as biologic therapeutics including engineered foods, diagnostics, and nutraceuticals. She has shepherded early stage patent development for discovery programs, including preparation and IP diligence for investors and for company investment rounds, through post FDA approval patent strategy and litigation challenge. Her strategic patent counseling has helped her clients achieve significant funding from acquisitions, public market offerings, and private investments, extension of market exclusivity for approved therapeutics, includes patentability, freedom to operate analyses, FDA Orange Book listing strategy, and ANDA preparation for small molecules, biosimilar strategy for biologics, patent term extension strategy, and preparing for and conducting post grant patent review procedures, including Inter Partes Review (IPR) proceedings at the USPTO. She has 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. Clients also benefit from her experience on IP matters as part of initial public offerings and venture investments.
Representative Matters
- Pre-ANDA strategy for extending patent term and exclusivities relating to several marketed small molecule therapeutic
- New antibody patent strategy and third party patent/freedom to operate strategy
- 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
- Aptinyx on patent matters relating to NMDA small molecule modulators for brain and nervous system disorders, including patent matters leading to its IPO
- Ascentage Pharma on patent matters relating U.S. patent strategy and its $53 million initial public offering on the Hong Kong Stock Exchange
- 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 for an equity value of approximately $1.1 billion
- Full life cycle patent strategy on behalf of a pharmaceutical company with a recently approved orphan drug
- Early stage platform and discovery stage patent strategies for several pharmaceutical and biological therapeutic companies
- Preparation of the published 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
Dr. Kavanaugh 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
Masters in Library Information Science1997
Simmons College
MSChemistry1987
The University of Texas at Austin
BSChemistry1986
University of California
Admissions
Bars
- Massachusetts
- U.S. Patent and Trademark Office (USPTO)
Recognition & Awards
Ms. Kavanaugh has been recognized by The Best Lawyers in America Best Lawyers for her work in Patent Law, Biotechnology and Life Sciences Practice 2022-2023.
Ms. Kavanaugh was recognized for her work in MA – Prosecution in 2021 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