Dr. Kavanaugh has significant experience in developing patent strategies throughout the developmental life cycle of chemical and biologic therapeutics. She has shepherded patent strategies from early stage patent development for discovery programs through post approval patent strategy for FDA-approved therapeutics and then successfully through post grant and litigation challenge. Her strategic patent counseling, which has helped her clients achieve significant funding from acquisitions, public market offerings and private investments, 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; 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.
- Aptinyx on patent matters relating to NMDA small molecule modulators, including patent matters leading to its $65 million Series A financing, and its recent IPO.
- Assembly Biosciences on patent matters relating to its HBV and microbiome programs and its $69 million public follow-on offering
- Zafgen Inc. on patent portfolio strategy and patent matters relating to its MetAP-2 inhibitor small molecule program and its $96 million public offering and subsequent $137 million follow-on public offering
- Nogra Pharma Ltd. (Ireland) on patent portfolio strategy and patent matters relating to small molecule therapeutics including PPARg modulators; IL-34 technology; and SMAD7 antisense therapy.
- AMAG Pharmaceuticals on patent matters relating to its marketed products, including Feraheme®, and its $201 million follow-on and $225 convertible note offerings
- Aegerion Pharmaceuticals on 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
- Proteostasis Therapeutics on patent prosecution matters and strategy relating to its cystic fibrosis transmembrane regulator small molecule program, including patent matters leading to its $50 million initial public offering and $65 million and $40 million follow-on public offerings
- 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
- Post grant review challenges on patents relating to approved products
- 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
- BridgeBio Pharma, for its new subsidiary, QED Therapeutics
- Nogra Pharma Ltd. (Ireland) on patent portfolio strategy and patent matters relating to its agreement with Celgene Corporation for an oral, SMAD7 antisense therapy for Crohn’s disease; the agreement includes one of the largest upfront payments for a licensing deal in the last 10 years
- Aegerion Pharmaceuticals on patent matters leading to its merger with Novelion (QLT)
- Naurex Inc. on patent portfolio development and patent matters relating to its NMDA small molecule and peptidyl programs and in connection with its recent $560 million merger with Allergan PLC
- BIND Therapeutics on patent matters relating to its nanomedicine platform, its initial public offering on the NASDAQ Stock Market and its subsequent acquisition by Pfizer
Dr. Kavanaugh is a member of the American Intellectual Property Law Association, the Boston Patent Law Association and the American Chemical Society.