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Mark James FitzGerald, Ph.D.



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.

What do you focus on?

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.

What do you see on the horizon?

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.

Representative Engagements

  • 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.

Speaking Engagements

  • “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

Litigator of the Week shout outs and runners-up

The AmLaw Litigation Daily | May 07, 2021

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.

Good bacteria: The microbiome, its vast therapeutic potential, and the challenges ahead

STAT Reports | April 26, 2021

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.

Chancery awards biopharm company $38M for fraud-tainted deal

Law360 | April 23, 2021

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.

Microbiome therapeutics and patent protection

Nature Biotechnology | July 08, 2020

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.

Gut Check: Microbiome Patent Update

Intellectual Property & Technology Law Journal | May 01, 2020

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.

Validity Attack on US Patent for Bifidobacetrium Combo-Therapy: What can we learn?

Microbiome Times | April 29, 2020

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.

Patent opportunities and dangers in the microbiome revolution

IAM | April 02, 2020

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.

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Contact

Mark James FitzGerald, Ph.D.

Partner

Boston

Phone: 617-345-1058


Fax: 866-741-1546

Suffolk University Law School, J.D., cum laude

Brown University, Ph.D.

Worcester Polytechnic Institute, B.S., with high distinction

Massachusetts

U.S. Patent and Trademark Office

  • IAM Strategy 300—Ranked as one of the world’s leading IP strategists in the IP management consultancy and technology transfer sectors (2020-2021)
  • IAM Patent 1000—Ranked as one of the world’s leading patent practitioners (2021)

Mark is a member of the Massachusetts Bar Association, the American Bar Association, and the American Intellectual Property Law Association.

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