Mark James FitzGerald, Ph.D.

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

• “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,” 4^th Annual Translation Microbiome Conference, Boston, MA, April 18, 2018
• “Gut Check, Scoping Out Patents and the Microbiome,” 4^th 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