Overview
John Serio is Of Counsel in the Intellectual Property and Technology group at Day Pitney. He focuses his practice on intellectual property matters involving biotechnology, pharmaceuticals, medical devices, chemistry, health care, and analytical scientific equipment.
With deep experience in patent law, John advises clients on the drafting and prosecution of U.S. and international patents, as well as on right-to-use and patentability opinions, enforcement and licensing strategies, and intellectual property litigation. He has prosecuted a significant number of patents that have been successfully enforced or licensed, particularly in the life sciences sector.
John also counsels clients on strategic IP issues related to the acquisition, collaboration, and licensing of life sciences technologies. He frequently advises foreign-based life sciences companies on cross-border transactions involving pharmaceutical and medical device patent portfolios and regulatory compliance.
In addition to his intellectual property practice, John has extensive experience with regulatory matters involving the U.S. Food and Drug Administration (FDA). He assists clients in obtaining FDA approval for drugs, medical devices, over-the-counter products, dietary supplements, foods, and cosmetics. He provides guidance on product labeling, advertising, manufacturing, distribution, and recalls, and regularly prepares and negotiates clinical trials, distribution, supply, contract manufacturing, and quality agreements. His regulatory work also includes counseling on compliance with USDA, EPA, and state regulations, including California's Proposition 65.
John is recognized as a thought leader in FDA regulatory issues, including the use of social media in pharmaceutical advertising and the state regulation of clinical trials. He is an accredited speaker with the American College of Pharmaceutical Education and frequently writes and presents on FDA and patent-related topics.
Experience
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Managed and directed litigation, including oversight of junior litigation team, on behalf of a Fortune 500 client related to enforcement of its medical device portfolio, resulting in a successful settlement prior to trial
Assisted a medical imaging company in the preparation and filing of a 510(k) application for a radiological imaging device, resulting in FDA approval. Developed a strategy and presentation related to Hatch-Waxman patent term extension for a pharmaceutical company in negotiations with a potential partner
Has rendered freedom to operate opinions involving pharmaceuticals and medical devices, resulting in successful product launches
Coordinated and negotiated with the FDA on behalf of client related to recall of pharmaceutical product without any further administrative action against client
Assisted pharmaceutical company in successfully negotiating clinical trial agreements related to international clinical trials
Represented a pharmaceutical company in litigation involving False Claims Act counts, resulting in successful dismissal of matter on all counts
Assisted numerous multi-national food companies in compliance with the Food Modernization Act and its related foreign verification requirements
Developed an extensive patent portfolio for a laboratory robotics company acquired by a leading multi-national diagnostic company
Represented a member country in a CERN Research Consortium in an inter-agency arbitration proceeding resulting in a successful outcome
Education and Credentials
Education
- Western New England University School of Law, J.D.
- University of Rhode Island College of Pharmacy, B.S.
Admissions
- Commonwealth of Massachusetts
- U.S. District Court, District of Massachusetts
- U.S. Patent and Trademark Office
Affiliations
- Boston Bar Association
- Boston Patent Law Association
Recognition and Community
No aspect of this advertisement has been approved by the highest court of any state. Prior results do not guarantee a similar outcome. See Awards Methodology.
Recognitions
Chosen for inclusion as "Go To" Life Sciences Lawyer, by Massachusetts Lawyers Weekly, 2022-2024
Chosen for inclusion in the Top Recommended, Life Sciences, by THE SPEAR'S 500, 2023
News & Insights
In The Media
Publications
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Outsourcing Strategies for Maximizing Drug Exclusivity, Outsourced Pharma, December 19, 2022 -
Quality Concerns to Resurface as FDA Resumes Foreign Inspections, Bloomberg Law, March 17, 2022 -
Biden's FDA Chief Confirmed by Senate With Republicans' Help, Bloomberg Law, February 15, 2022 -
U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time, Reuters News, February 15, 2022 -
Patent Filing By Former Employees Leads Pfizer To File Trade Secret Suit, Pink Sheet, February 3, 2022 -
FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages, Medtech Insight, January 11, 2022 -
FDA's Pfizer Vaccine Approval Adds Fuel to Biden Booster Plan, Bloomberg Law, August 11, 2021
Speaking Engagements
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"Private Practice and In-House Counsel: Managing Expectations, Fee Structures and Budget Pressures," Life Sciences Patent Network (LSPN) Conference, Webinar, May 3, 2023 -
"State Laws Governing Clinical Trial Regulatory Compliance Interactive Web Seminar," Barnett International, April 2021