Michael H. Brodowski is a partner in Goodwin’s nationally recognized Life Sciences group and a member of its Intellectual Property practice. Dr. Brodowski advises companies, investors, and academic and research institutions on patent and other IP related matters. He has extensive experience in strategic development and implementation of complex patent portfolio and market exclusivity strategies in the US and abroad for Life Sciences companies.
Experience
Dr. Brodowski primarily advises clients in connection with the protection and exploitation of patent and other IP rights to support their business objectives. He has significant experience and knowledge in developing and managing domestic and foreign patent portfolios including post-grant proceedings such as patent reexamination, reissue and foreign opposition proceedings. Dr. Brodowski has obtained protection for various FDA approved products and advises on patent life cycle management including patent term extension (PTE) and other exclusivities. He analyzes patent landscapes to evaluate patentability and freedom-to-operate. Dr. Brodowski counsels on the Bayh-Dole Act and its impact on inventions made with federal government funding, actions under the Act, and related matters. He conducts IP due diligence for public and private business transactions such as investments in public and privately-held companies, public offerings, licensing transactions, and mergers and acquisitions. He prepares patent opinions regarding infringement and invalidity; and advises on patent license and other technology-related agreements.
Dr. Brodowski counsels clients in a diverse range of technologies in the fields of chemistry including small molecules and pharmaceuticals, plastics and polymers, drug delivery technologies, specialty chemicals and chemical manufacturing; materials science and nanotechnology including composite materials; energy including petroleum processing, fuel cells, solar cells and biofuels; biotechnology; environmental remediation; and health care including diagnostic assays, medical devices and personal care products.
Representative Matters
- Aptinyx in the development of its worldwide patent estate relating to its drug product candidates and its $117 million IPO and follow-on offerings
- AVEO Pharmaceuticals in the preparation and filing of multiple patent term extension applications for its FDA approved product, Fotivda®
- Esperion Therapeutics in the development of its worldwide patent estate relating to its FDA approved drug products, Nexletol® and Nexlizet®, and its second generation product candidates including multiple accelerated patent application examinations to issue U.S. patents covering the products, issuing a PTE Certificate for a five-year term extension and securing corresponding SPCs in 24 European countries, and related Orange Book listings
- Fresenius Kabi in its opposition of European patents to AbbVie relating to its drug product, Humira® (adalimumab)
- Macrogenics in the preparation and filing of a patent term extension application for its FDA approved biologic product, Margenza® (margetuximab-cmkb), and issuing a PTE Certificate for the full requested term
- Nogra Pharma in the development of its worldwide patent estate relating to its small molecule drug product candidates including licensing and diligence matters including its exclusive license agreement with Torii Pharmaceuticals Co., Ltd.
- QED Therapeutics in the development of its worldwide patent estate related to its FDA approved drug product, Truseltiq®, and other indications, securing patent term extensions in Australia and filing applications in Canada and the U.S., and related Orange Book listings
- scPharmaceuticals in the establishment and development of its worldwide patent estate relating to its FDA approved drug formulation product, Furoscix®, and its $90 million IPO and follow-on offerings as well as multiple accelerated patent application examinations to issue patents covering its second generation product, and Orange Book listings
- Watt Fuel Cell in the establishment and development of its worldwide patent estate relating to solid oxide fuel cells and related systems and its $67 million financing among other capital raises including investment by Generac Power Systems
- Zydus Lifesciences Limited in the prosecution of its patent estate in the United States relating to its fast tracked drug product candidate saroglitazar magnesium including accelerated patent application examination to successfully issue U.S. patents covering the product and its uses
- Representation of the above and other various privately held and public companies including Corium Innovations, DrinkSavvy, Glycadia, NanoIntegris Technologies, Onkos Surgical, Ratio Therapeutics, TriGlobal IP, and Waters Corporation
- Representation of underwriters during initial public offerings, follow-on offerings, and other financial transactions
- Representation of issuers during initial public offerings, follow-on offerings, and other financial transactions including for Aptinyx, BridgeBio Pharma, EpicentRx, Esperion Therapeutics, Galecto, QED Therapeutics, and scPharmaceuticals
- Representation of asset management firms in connection with their investments in portfolio companies
Professional Activities
Dr. Brodowski is a member of the Massachusetts Bar Association, the Boston Intellectual Property Law Association, and the American Chemical Society (Division of Chemistry and the Law).
Professional Experience
Prior to joining Goodwin in 2016, he was a partner in the patent and IP practice groups at Burns Levinson LLP, K&L Gates LLP and Testa, Hurwitz & Thibeault LLP. Prior to entering the legal profession, Dr. Brodowski was a Project Chemist developing toiletries technology with The Gillette Company. He is the first named inventor on issued US and foreign patents. His doctorate studies included the multistep synthesis of a macrolide antibiotic, chlorothricolide, starting with vitamin C.
Credentials
Education
JD1996
Suffolk University Law School
PhDOrganic Chemistry1990
The State University of New York at Buffalo
BAChemistry1985
University of Rochester
Admissions
Bars
- Massachusetts
- U.S. Patent and Trademark Office (USPTO)
Courts
- U.S. District Court for the District of Massachusetts
- U.S. Court of Appeals for the Federal Circuit
- U.S. Supreme Court
Recognition & Awards
Dr. Brodowski has been recognized by The Best Lawyers in America for his work both in Biotechnology and Life Sciences Practice and in Patent Law 2022-2024.
Dr. Brodowski was selected for inclusion in The Best Lawyers in America (2013 - 2022) for his work in Biotechnology and Life Sciences Practice.
Publications
Dr. Brodowski has also authored numerous articles, including:
- “Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for Pharmaceutical and Medical Technology Companies,” Client Alert (December 12, 2023)
- “Biden Executive Order Puts Focus on Domestic Manufacturing of Inventions Created Using Federal Funding,” Client Alert (August 29, 2023)
- “NIH Again Refuses to Exercise March-In Rights to Control Drug Price,” Goodwin Life Sciences Perspectives (March 27, 2023)
- “USPTO Director Issues Precedential Review Decision Regarding Multiple Dependent Claims,” Goodwin Life Sciences Perspectives (March 23, 2023)
- “USPTO Launches the Cancer Moonshot Expedited Examination Pilot Program,” Goodwin Client Alert (January 18, 2023)
- “USPTO Announces Cancer Moonshot Expedited Examination Program,” Goodwin Life Sciences Perspective blog (December 15, 2022)
- “USPTO and FDA Continue to Focus on Patent Quality in the Pharmaceutical Industry,” Goodwin Life Sciences Perspective blog (November 23, 2022)
- “USPTO Doubles Down Calling Out Pharmaceutical Industry,” Goodwin Life Sciences Perspective blog (October 19, 2022)
- “USPTO Publishes Notice Calling Out Pharmaceutical Industry,” Goodwin Life Sciences Perspective blog, August 1, 2022
- “Changes to March-In Rights Under Bayh-Dole and More?,” Goodwin Client Alert, March 16, 2021
- “Compliance with New Bayh-Dole Act Regulations Becomes Critically Important,” Goodwin Client Alert, August 2, 2018
- “Changes to Bayh-Dole Act Regulations Impacting Ownership of Patent Rights,” Goodwin Client Alert, April 10, 2017
- “An unbroken chain: the importance of securing patent ownership,” World Intellectual Property Review, February 4, 2016
- “Personalized Medicine: A Dynamic Patent Landscape,” The National Law Journal, IP Supplement Online, December 12, 2011
- “Inadequate assignments can imperil patent rights,” The National Law Journal, November 30, 2009
- “Managing Risks Associated with IP,” The Metropolitan Corporate Counsel, July 2008
Dr. Brodowski is a frequent speaker and panelist at industry and legal conferences. His speaking engagements include:
- “Forfeiting Patent Rights for Failure to Comply with the Bayh-Dole Act,” Association of University Technology Managers (AUTM) Compliance Course, November 2017
- “IP Agreement Challenges: Keep the Big Picture in View,” Association of Corporate Counsel (ACC) Northeast, Intellectual Property Transactions Master Class: Practical Guidance for the Non-Intellectual Property Specialist, March 2016
- “IP Licensing Agreements,” Technology Transfer Program for Universidad de la Frontera, July 2015
- “Licensing of IP in the U.S.,” Chilean Entrepreneurial Summit, October 2014
- “Protect Your IP: A Guide to the Newly Implemented Patent Laws,” American Chemical Society Webinar, April 2013
- “New Year and New Patent Laws That Scientists Should Know,” American Chemical Society’s ACS Small and Medium Business Webinar™ Series, January 2012
- “Global Patent Protection and International Business Strategies,” American Chemical Society’s ACS Small and Medium Business Webinars™ Series, September 2010
- “A Global IP and Business Strategy,” Sino-American Pharmaceutical Professionals Association – New England, SAPA-NE 10th Annual Conference 2008, June 2008