John Serio

Partner | Boston

John is a partner in the US intellectual property team, based in our Boston office.

He focuses his practice 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. John has expertise in prosecuting patents domestically and worldwide. He has prosecuted a significant number of patents that have been successfully enforced and/or licensed. He has extensive experience in Food and Drug Administration regulatory issues.

Throughout his intellectual property law career, John 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.

John 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. John counsels on all aspects of marketing of FDA products, including providing advice on labeling, advertising, manufacturing and distribution. John’s expertise in FDA regulation extends to the regulation and labeling of food, 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. John is a thought leader on the state regulation of clinical trials and the use of social media in direct-to-consumer advertising of pharmaceuticals.

John also advises companies on the labeling, packaging and testing of textiles, toys and consumer products. He further assists clients with regulatory requirements of the USDA, EPA and state regulatory requirements such as Proposition 65.

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.

Track record

Admissions

Publications

Memberships

Talks

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.

Massachusetts

United States District Court for the District of Massachusetts

U.S. Patent and Trademark Office

"FDA’s Pfizer Vaccine Approval Adds Fuel to Biden Booster Plan; Bloomberg Law, August 25, 2021, featured

"Regulatory Actions for May 19, 2021; BioWorld, May 19, 2021, featured

Greater Boston Chamber of Commerce Life Sciences Alliance

Boston Patent Law Association

Boston Bar Association

“State Laws Governing Clinical Trial Regulatory Compliance Interactive Web Seminar,” Barnett International, April, 2021

“CMC Patent Opportunities,” Global Regulatory Affairs CMC; Chemistry, Manufacturing & Controls Conference, Philadelphia, PA, October 2019

“Patent Basics for the CMC Professional,” Global Regulatory Affairs CMC; Chemistry, Manufacturing & Controls Conference, Philadelphia, PA, October 2016

Education


Languages


  • English

Dates


Joined

2021

Boston

245 First Street,

18th Floor,

Cambridge,

MA 02142

View Office

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