John C. Serio

Partner

Boston, MA
D: 617.345.3314
Overview
Bar Admissions

Massachusetts

U.S. Patent and Trademark Office

Education

J.D., Western New England College School of Law

B.S.P.S., University of Rhode Island College of Pharmacy

John Serio is a partner in the Firm, Chair of the Food & Drug Law practice, and member of the Intellectual Property and Life Sciences groups. He focuses on intellectual property related to biotechnology, pharmaceuticals, medical devices, chemistry, health care and analytic scientific equipment. His practice involves the drafting and prosecution of patents, right to use and patentability opinions, patent litigation, licensing of technology, and trademark issues. He has extensive experience in Food and Drug Administration regulatory issues.

Throughout his intellectual property law career, Mr. Serio has gained experience advising clients on IP issues and strategy related to the acquisition, collaboration and licensing of life science technologies. In addition to his experience with patent law, he provides strategic legal oversight in order to mitigate business risk when evaluating potential product candidates for development or acquisition. He regularly assists foreign-based life science companies and is qualified to provide assessment and counsel concerning cross border transactional matters related to pharmaceutical and medical device patent portfolios and regulatory strategy.

Mr. Serio regularly assists clients whose products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act concerning all aspects of product development and approval of drugs and medical devices. He represents manufacturers and distributors in obtaining approval to market drugs, medical devices, over-the-counter products, foods, dietary supplements and cosmetics. Mr. Serio counsels on all aspects of marketing of FDA products, including providing advice on labeling, advertising, manufacturing and distribution. He has extensive experience in the recall of products regulated by the FDA. He also negotiates and prepares clinical trial, distribution, supply, contract manufacturing and quality agreements. Mr. Serio is a thought leader on the state regulation of clinical trials and the use of social media in direct-to-consumer advertising of pharmaceuticals.

He is an accredited speaker with the American College of Pharmaceutical Education and has extensive experience writing and presenting on a wide variety of FDA and patent-related topics. Prior to joining Burns & Levinson LLP, Mr. Serio was a partner with the Boston office of a large, international law firm.

Experience

Experience

  • 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.

Memberships

Greater Boston Chamber of Commerce Life Sciences Alliance

Boston Patent Law Association

Boston Bar Association

Speaking Engagements

Speaking Engagements

“Food & Drug Administration (FDA) Overview,” Speaker, Chilean Entrepreneurial Summit, October 2014

“FDA Food Labeling," Presenter, Québec New Exporters Trade Mission, July 2014

John Serio has also spoken at various conferences, including the American Conference Institute's Pharmaceutical Conference and EyeforPharma's e-Communication and Online Marketing Conference.

Articles & Publications

Articles & Publications

articles

“FDA Approval and Licensing as Intellectual Property,” Chapter in MCLE publication, Intellectual Property Law, January 2016

“The ABC’s of a Product Recall,” Focus Newsletter, December 2014

“State-by-State Clinical Trial Requirements Reference Guide 2013," Barnett Educational Services, 2013

Mr. Serio has also written articles for publications such as the Life Sciences Law & Industry Report and CHEManager

quotes

“Flurry of Supreme Court Decisions Keeps Local IP Bar Busy,” Massachusetts Lawyers Weekly, July 2014

“Burns & Levinson nabs four IP attorneys and patent agent from Pierce Atwood,” Boston Business Journal, April 2014

Resources
John C. Serio
Practices
  • Intellectual Property & IP Litigation
  • IP Transactions
  • Food & Drug Law
  • Life Sciences
Education

J.D., Western New England College School of Law

B.S.P.S., University of Rhode Island College of Pharmacy

Admissions

Massachusetts

U.S. Patent and Trademark Office

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