Mark J. FitzGerald, Ph.D.
Senior Counsel / Co-Lead, Microbiome IP Team
Introduction
Mark FitzGerald concentrates his practice on intellectual property and patent law, representing industry and academic/nonprofit institution clients from the U.S. and abroad for the strategic development of patent portfolios, analyses of freedom to operate, patent validity and infringement and associated opinion preparation, transactional due diligence and associated client counseling.
My focus
A major focus of my work relates to the biotechnology patent arena, working with clients to secure meaningful patent protection for their own technology as well as assisting them in charting a course through the patent protection shoals of their competitors.
Representative areas of technical experience include:
- Therapeutics, including the “anti’s”—e.g., antibiotics, antivirals, antifungals, antiangiogenics, anti-tumor agents—as well as other nucleic acid, peptide and protein based therapies.
- Immunology, including antibodies and therapies based upon them, as well as manipulation of immune pathways for treatment of inflammation, autoimmune diseases and cancer.
- Diagnostics, including diagnostic devices and the underlying techniques they employ.
- Stem cells, including embryonic and adult stem cells and therapies based upon them.
- Molecular biology and genetics, including RNA interference, cloning methods and vectors, gene expression analyses, genotyping and mutation detection as well as diagnostics based upon them.
In addition to strategic patent portfolio development, I also work with clients to evaluate the patent landscape regarding their technology, and the strengths and weaknesses of their competitors’ patent positions, consulting on design-around options as well as providing reasoned opinions regarding patent invalidity and non-infringement where necessary.
Representative experience
- Currently building and managing a portfolio of domestic and international patents and applications covering technology from a number of investigators for a major academic research institution; interacting with licensees’ management and counsel to facilitate licensing of university IP in the portfolio.
- Recently conducted IP due diligence, on behalf of a large pharma client, related to the acquisition of a large patent portfolio of a company in bankruptcy.
- Currently assisting a startup diagnostic device company in the development of its domestic and international patent portfolio, evaluating and charting a course regarding freedom to operate, and providing support during rounds of investor IP due diligence.
- Developed and implemented a strategic plan regarding options to better tailor claims of a large existing patent application portfolio acquired by a pharmaceutical company client to fit the technological and business goals of the company.
Looking ahead
I’m focusing on the ways that patent strategy relating to biomolecules will shift to a more application-oriented approach that will be shaped by the ongoing tension between the Federal Circuit and the Supreme Court regarding patent-eligible subject matter.
/Insights
- “Under the Microscope: Microbiome IP Protection,” La BioSpace Meet and Greet, Los Angeles, CA, November 17, 2022
- “Achieving IP on a Microbiome Therapeutics,“ Hanson & Wade’s 6th Microbiome Movement - Drug Development Summit, July 1, 2021
- “Patent Protection for Bacteriophage Therapeutics: Issues & Approaches,“ Bacteriophage Therapy Summit, March 25, 2021
- “Patent Issues Relating to Agricultural Application of Microbiome Technology,“ Hanson & Wade’s 5th Annual Microbiome Movement - AgBiotech Summit, February 22, 2021
- “Patent Protection and the Microbiome,” Hanson & Wade’s 5th Annual Microbiome Movement – Drug Development Europe, Webinar, January 27, 2021
- “Patents in the Microbiome Arena: Status and Trends,” 3rd Annual Microbiome Summit: Regulatory, Quality Developments and Commercialization, Berlin, Germany, October 17, 2019
- “IP due diligence as it relates to microbiome investment,” Microbiome Invest, London, UK, May 23, 2019
- “Workshop II: Patenting in the Microbiome Arena,” Translational Microbiome Conference, Boston, MA, April 16, 2019
- “Scoping Out Patents in the Microbiome Arena,” 4th Annual Translation Microbiome Conference, Boston, MA, April 18, 2018
- “Gut Check, Scoping Out Patents and the Microbiome,” 4th Annual Translation Microbiome Conference, Boston, MA, April 20, 2018
- “Microbiome-Related IP: Challenges and Strategies,” Microbiome Think-Tank at Mass General Hospital, November 2017
- “Privilege and Confidentiality in Freedom to Operate Opinions: When are they Preserved and When are they Waived?” American Conference Institute’s 6th National Tactical and Practical Guide to Freedom to Operate, Philadelphia, July 2012
In the news
- Microbiome Times
Ferring v Finch: Ripples from the decision
Aug 14, 2024Boston Intellectual Property partner Mark FitzGerald co-authored this article with Craig Thomson of HGF Limited, discussing the impact of a jury verdict which found that Ferring Pharmaceuticals infringed on patent claims of Finch Therapeutics Group, awarding $25 million in damages and future royalties to Finch. Mark and Craig discuss how these court proceedings will likely have relevance to a large number of businesses in the therapeutic microbiome field.
- Law360
A Watershed moment for microbiome-based therapy
May 31, 2023Boston Intellectual Property partner Mark FitzGerald and patent specialist Alissa Young, co-leaders of the IPPG Microbiome team, contributed this article discussing recent FDA approvals of microbiome-based therapies and an anticipated increase in patent enforcement litigation that could follow.
- The AmLaw Litigation Daily
Litigator of the Week shout outs and runners-up
This article recognizes the full NP team that secured a major damages win on behalf of Takeda subsidiary Millennium Pharmaceuticals. Litigation Department vice chair and partner Ethan Trull and partner John Ruskusky, both of the Complex Commercial Disputes group in Chicago, led the damages trial team. The NP team also included partner Lisa Sullivan, associate Katie Burnett, e-discovery specialist Anders van Marter, and paralegal Donna Long, all of the Complex Commercial Disputes group in Chicago. In addition, Intellectual Property partner Mark FitzGerald and Complex Commercial Disputes associate Tarae Howell, both of the Boston office, played integral roles in the initial fraud win for Millennium in 2020.May 7, 2021 - STAT Reports
Good bacteria: The microbiome, its vast therapeutic potential, and the challenges ahead
This long-form report examining the science behind the nascent microbiome industry quotes Boston Intellectual Property partner Mark FitzGerald on patents in this area as the field begins to mature.April 26, 2021 - Law360
Chancery awards biopharm company $38M for fraud-tainted deal
This article, covering the Delaware Chancery Court’ s $38.2 million damages judgment in favor of Takeda subsidiary Millennium Pharmaceuticals for its fraud claim against Harpoon Therapeutics, mentions Chicago Complex Commercial Disputes partners Ethan Trull, John Ruskusky and Lisa Sullivan; associate Katie Burnett; senior e-discovery specialist Anders van Marter; and paralegal Donna Long for representing Millennium. Intellectual Property partner Mark FitzGerald, Complex Commercial Disputes associate Tarae Howell, and Intellectual Property patent specialist Angela Hafner, all in Boston, have also played integral roles in the matter.April 23, 2021 - Nature Biotechnology
Microbiome therapeutics and patent protection
Boston Intellectual Property partner Mark FitzGerald co-authored this journal article on microbiome therapeutics, and how two U.S. Supreme Court decisions have redefined the scope of which natural phenomena—including microbiome therapeutics—are patent eligible.July 8, 2020 - Intellectual Property & Technology Law Journal
Gut Check: Microbiome Patent Update
Intellectual Property partner Mark FitzGerald in Boston and associate Matt Kitces in Washington, D.C. contributed this article examining the post-grant review challenge of a U.S. patent related microbiomes and the treatment of cancer. The result could provide an indication of how microbiome-related patents will fare when challenged for validity. Click here for the full article.May 2, 2020 - Microbiome Times
Validity Attack on US Patent for Bifidobacetrium Combo-Therapy: What can we learn?
Boston Intellectual Property partners Mark FitzGerald and David Resnick co-authored this article analyzing a recent decision by the U.S. Patent Trial and Appeal Board to invalidate a University of Chicago U.S. microbiome patent. The authors note some positive aspects of that decision within the microbiome community, as it provides increased definition around what they can protect with patents.April 29, 2020 - IAM
Patent opportunities and dangers in the microbiome revolution
Boston Intellectual Property partner Mark FitzGerald discusses how the microbiome—the collection of microbes that occupy the human body—has become an increasingly fruitful source of insights for life sciences researchers looking to develop new therapeutics.April 2, 2020 - Law360
You Say 'Insolubly Ambiguous,' I Say 'Reasonably Certain'
Boston partners Maia Harris and Mark FitzGerald and associate Shayne Huff authored this column discussing the U.S. Supreme Court’s unanimous decision in Nautilus Inc. v. Biosig Instruments Inc.June 4, 2014
Admitted to practice
Massachusetts
U.S. Patent and Trademark Office
Education
Suffolk University Law School, J.D., cum laude
Brown University, Ph.D.
Worcester Polytechnic Institute, B.S., with high distinction
Professional activities
- Massachusetts Bar Association
- American Bar Association
- American Intellectual Property Law Association.
Recognition
- IAM Patent 1000—Ranked as a leading Massachusetts lawyer for patent prosecution (2021–2024)
- IAM Strategy 300—Ranked as one of the world’s leading IP strategists in the IP management consultancy and technology transfer sectors (2020-2021)
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