16 February 2022 - In The Press
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.
United States District Court for the District of Massachusetts
U.S. Patent and Trademark Office
‘Quality Concerns to Resurface as FDA Resumes Foreign Inspections,’_ Bloomberg Law - March 17, 2022, quoted
‘U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time,’_ Rueters News - February 15, 2022, quoted
‘Biden’s FDA Chief Confirmed by Senate With Republicans’ Help,’_ Bloomberg Law - February 15, 2022, quoted
‘Patent Filing By Former Employees Leads Pfizer To File Trade Secret Suit,’ Pink Sheet - February 3, 2022, quoted
‘FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages,’ Medtech Insight - January 11, 2022, quoted
‘FDA’s Pfizer Vaccine Approval Adds Fuel to Biden Booster Plan,’ Bloomberg Law - August 25, 2021, featured
‘Withers Picks Red-Hot Kendall Square For New Mass. Office,’ Law360 - July 8, 2021, featured
‘Regulatory Actions for May 19, 2021,’ BioWorld - May 19, 2021, featured
‘Withers Launches Venture Capital and Life Sciences Team in Boston,’ Intellectual Property Magazine - April 20, 2021, featured
‘News Digest: On the Move,’ World Trademark Review - April 20, 2021, featured
’6 Important Elements Of The New STRONGER Patents Act,’ Biosimilar Development - January 2020
‘FDA Approval and Licensing as Intellectual Property,’ Chapter in MCLE publication, Intellectual Property Law - January 2020
‘Working the Busy Intersection of Law, Science and Business,’ Corporate Counsel Business Journal - March 2019
‘The ABCs of a Product Recall,’ Focus Newsletter - December 2014
‘Maybe it’s not the real thing,’ Pom Wonderful LLC v Coca-Cola Co (Supreme Court of the US) Case Analysis: Intellectual Property Magazine - July/August 2014
‘State-by-State Clinical Trial Requirements Reference Guide 2013,’ Barnett Educational Services, 2013
‘Flurry of Supreme Court Decisions Keeps Local IP Bar Busy,’ Massachusetts Lawyers Weekly, July 2014, quoted
‘Managing the Risks and Regulatory Issues Associated with Successful Pharmaceutical Social Media Monitoring and Marketing,’ White Paper, September 2007
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
“GLOBAL LICENSING – EYEGATE – CASE STUDY,” ACC CCI Panel Discussion, February 2016
“Maintaining CMC Due Diligence During Licensing Activities,” Global Regulatory Affairs CMC; Chemistry, Manufacturing & Controls Conference, Philadelphia, PA, November 2015
FDA Social Media Guidance Panel, October 2014
“Food & Drug Administration (FDA) Overview,” Speaker, Chilean Entrepreneurial Summit, October 2014
“FDA Food Labeling," Presenter, Québec New Exporters Trade Mission, July 2014
InsightView all Firm insight
14 January 2022 - In The Press
John Serio featured in Medtech Insight's "FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages"
21 April 2021 - Article