People: John C. Serio, Partner

John C. Serio

Partner

Boston
Direct: (617) 946-4831
Fax: (617) 946-4801
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Mr. Serio, a partner in the Boston office of Seyfarth Shaw LLP, is a registered patent attorney concentrating his practice in the area of intellectual property concerning biotechnology, pharmaceuticals, medical devices, chemistry, and analytical scientific equipment. His practice involves drafting and prosecution of patents, right to use and patentability opinions, patent litigation, licensing of technology, and trademark issues.

Mr. Serio also has significant expertise in Food and Drug Law involving both pharmaceuticals and medical devices and in particular the FDA approval and marketing of therapeutic products and labeling of food and dietary supplements. He advises companies on a wide variety of regulatory issues, including, the national and international conduct of clinical studies, manufacturing, and FDA enforcement matters. He is a recognized expert on Direct to Consumer advertising of pharmaceuticals. He further assists clients in the preparation and filing of regulatory documents related to new drug applications, abbreviated new drug applications and 505(b)(2) applications. 

As a licensed pharmacist, Mr. Serio has a multilateral understanding of complex scientific principles and drug development within the pharmaceutical industry. He is an accredited speaker with the American College of Pharmaceutical Education and has written and lectured extensively on a variety of FDA and patent related topics. 

Mr. Serio, a partner in the Boston office of Seyfarth Shaw LLP, is a registered patent attorney concentrating his practice in the area of intellectual property concerning biotechnology, pharmaceuticals, medical devices, chemistry, and analytical scientific equipment. His practice involves drafting and prosecution of patents, right to use and patentability opinions, patent litigation, licensing of technology, and trademark issues.

Mr. Serio also has significant expertise in Food and Drug Law involving both pharmaceuticals and medical devices and in particular the FDA approval and marketing of therapeutic products and labeling of food and dietary supplements. He advises companies on a wide variety of regulatory issues, including, the national and international conduct of clinical studies, manufacturing, and FDA enforcement matters. He is a recognized expert on Direct to Consumer advertising of pharmaceuticals. He further assists clients in the preparation and filing of regulatory documents related to new drug applications, abbreviated new drug applications and 505(b)(2) applications. 

As a licensed pharmacist, Mr. Serio has a multilateral understanding of complex scientific principles and drug development within the pharmaceutical industry. He is an accredited speaker with the American College of Pharmaceutical Education and has written and lectured extensively on a variety of FDA and patent related topics. 

Education

  • J.D., Western New England College School of Law (1986)
  • B.S., University of Rhode Island (1980)
    School of Pharmacy

Affiliations

  • Boston Patent Law Association
  • Boston Bar Association
  • Massachusetts Bar Association

Representative Engagements

  • 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.
  • Prepared appeals brief and appeared before United States Patent Office Board of Appeals.
  • Negotiated consulting agreement with leading pharmaceutical expert on behalf of pharmaceutical client resulting in significant savings to the client.
  • Assisted pharmaceutical company in successfully negotiating clinical trial agreements related to international clinical trials.

Presentations

  • “A Guide to Electronic Submission of Pharmaceutical Product Applications,” Webinar (September 28, 2007)
  • “Connecting with Patients, Overcoming Uncertainty,” eCommunication and Online Marketing Conference, presented by Eyeforpharma, Philadelphia, PA (2007)
  • “Regulatory Approval Strategies for Drug Delivery Platforms, “ Pharmaceutical Education Associates, Philadelphia, PA (October 2007)
  • “Categorizing and Complying with Regulatory Nuances when Conducting Clinical Trials in Emerging Nations,” International Clinical Trials Conference, presented by American Conference Institute, Boston, MA (September 27, 2007)
  • “Freedom to Operate Assessments in Biotechnology, Analysis, Opinions and More,” Advanced Forum on Biotech Patents, Analysis, Insights and Strategies for New Challenges in Biotech Practice, presented by American Conference Institute (September 27, 2007)
  • American Conference Institute 7th Annual Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials (July 16-17, 2007)
  • “Reaching the Promised Land: FDA Approval of New & Improved Drugs,” Regulatory Approval Strategies for Drug Delivery Platforms, presented by Pharmaceutical Education Associates (June 6-8, 2007)
  • “Best Practices and Strategies for Carrying out Clinical Trials in the EU and US,” presented by C5’s US FDA Regulation for European Bio-Pharma Industry Players, London, UK (December 2006)
  • “New And Improved 505(b)(2) — Facilitating Approval for Enhanced Drug Delivery,” 11th Annual Drug Delivery Technologies & Deal-Making Conference (September 25-27, 2006)
  • “India and China: New Waves and Undertows,” Strategic Research Institute’s 10th Anniversary Pharmaceutical of Discovery Chemistry, presented by Advanced Intermediates & API’s Conference (2006)
  • “The Litigation Landscape in Clinical Trials: Plaintiff and Defense Theories and Federal and State Requirements,” Managing Legal Risks in Conducting and Promoting Clinical Trials Conference (February 27-28, 2006)
  • “State-By-State Clinical Trial Requirements,“  presented by Washington Source Expert (October, 2005)
  • “Implications of Merck v. Integra,”Recent Legal Developments in the Pharmaceutical Sector, presented by William Fry Life Sciences, Dublin, Ireland  (October 11, 2005)
  • “Outsourcing and Growth Opportunities in India,” presented by Tie International, MIT, Boston, MA (February 17, 2005)
  • “State Regulations of Clinical Trials,” presented by BioPharm International (2005)
  • “Advertising Promotion of Medical Devices,” Suffolk University, Boston, MA (2005)
  • “FDA Regulation of Functional & Wellness Beverage,” WorldNutra Fifth International Conference and Exhibition on Nutraceuticals and Functional Foods, San Francisco, CA (November 2004)
  • “Current Issues in Liability for the Pharmacist,” presented by Northeastern School of Pharmacy Continuing Education Series (2003)
  • “Emerging Issues of Liability and COBRA Compliance,” Maine State Pharmaceutical Association’s Annual Meeting

Publications

  • “Pharma and Social Media: The Leaders and Followers,” A FirstWord Market Intelligence Report (August 2009)
  • “Connecting with Patients, Overcoming Uncertainty,” Regulatory Issues in Social Media for Pharmaceutical Marketers (2008)
  • State-by-State Clinical Trial Requirements Reference Guide 2007, Barnett Educational Services (2007)
  • “India and China: New Frontiers in Pharma,” CHEManager (October 2006)
  • “State Laws and Clinical Trials: Liability Risks Associated With Failure to Comply With State Requirements,” Food and Drug Law Institute's Update Magazine (March/April 2006)
  • “State Regulation of Clinical Trials,” BioPharm International (November 2005)
  • “The Regulation of Clinical Trials under State Laws,” BioResearch Monitoring Alert (September 2005)
  • “Ignorance is No Excuse,” Successful Clinical Trials Management: Supplement to Pharmaceutical Executive (June 2005)