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Nicholas Mitrokostas

Partner

Email

nicholas.mitrokostas@aoshearman.com

Phone

+1 857 353 4503

Offices

Boston

V-CARD
Nick is Managing Partner of Boston and an experienced Life Sciences trial attorney who focuses on representing innovator companies in intellectual property, trade secret, licensing and antitrust disputes.

A litigator known for his trial skills, Nick has extensive experience representing clients in the pharmaceutical, biotechnology, and medical device industries in federal and state courts as well as before the Patent Trial and Appeal Board (PTAB). He has a wide-ranging pharmaceutical experience in the biologics and small molecule space.

Nick has expertise in counseling emerging and small and mid-cap Life Sciences companies in late stage drug development (i.e., Phase III clinical trials) on issues pertaining to patent and regulatory exclusivities including patent term extension (PTE), patent listing requirements, and pre-commercial and launch assessments and litigation risks. Having previously represented generic and biosimilar companies in litigation, as part of his counseling practice, Nick works with companies to develop strategies for maximizing regulatory and patent exclusivity as well as mitigating risks associated with product launch in the United States.
 
Nick also has experience counseling and representing higher educational institutions in intellectual property matters. He also devotes significant time to representing pro bono clients in criminal and immigration matters. Nick also has expertise on emerging issues relating to digital health, artificial intelligence and machine learning in the Life Sciences space.
 
Earlier in his career, Nick served for seven months as a Special Assistant District Attorney for Middlesex County (Mass) where he prosecuted more than 200 cases, tried more than 15 jury and non-jury misdemeanor and felony cases, and argued numerous dispositive and evidentiary motions.
 
Nick serves on the Boston Bar Association’s IP Committee and chairs the IP Year in Review Committee. He also serves on a leadership committee for the non-profit Science Club for Girls. At A&O Shearman, Nick serves on the firm’s Global Tech Board and co-leads the firm’s AI/ML, Digital Health, and MedTech initiatives. He is also a member of the firm’s U.S. Pro Bono Committee and co-chairs the IP Litigation Associate Development Committee.

Expertise

Industries

Experience

Representative matters

  • A multinational pharmaceutical corporation on its defence of the validity of its U.S. Patent No. 9,220,631 (pre-filled syringe drug product patent) before the Patent Trial and Appeal Board.
  • Trustees of the University of Pennsylvania patent owner representing in connection with asserting infringement of U.S. Patent No. 7,625,558 (methods of treating cancer tumors) by Genentech's Herceptin, Perjeta, and Phesgo products.
  • Innovator pharmaceutical client Cephalon, Inc.'s lead trial counsel in a successful verdict in patent litigation against 18 defendants involving its branded cancer drug, TREANDA®.
  • Innovator life sciences company representation in licensing dispute related to its intellectual property rights in an arbitration under the AAA.
  • Teva Pharmaceuticals successful representation in a significant patent litigation involving Teva’s blockbuster branded multiple sclerosis product, Copaxone®. The court ruled that Teva’s nine patents were valid, enforceable and infringed by the defendants’ ANDAs, which was partially upheld on appeal. The case was heard by the U.S. Supreme Court and in January 2015, the Court delivered a precedent-setting decision in favor of Teva.
  • The Trustees of the University of Pennsylvania successful representation in an inter partes review proceeding involving patents directed to the treatment of hypercholesterolemia and hyperlipidemia with a novel dosing regimen for the drug lomitapide. The PTAB issued Final Written Decisions upholding the validity of the two patents at issue.
  • Nektar Therapeutics patent owner representation in invalidity challenge brought by licensee. The matter involved coordinating invalidity challenges in multiple foreign jurisdictions, including Switzerland and Germany, in addition to the U.S. proceeding. The matter was successfully resolved through a settlement agreement.
  • Boston Biotech Company representation in connection with advice regarding potential trade secrets violation case against a university.
  • AI Drug Discovery Company representation in a cross-border licensing transaction and related with another biotech company. Our work includes IP due diligence.

Published Work

  • Quoted (July 2022), "A Supreme Court review of a contentious patent issue would change the way pharma claims discoveries" , STAT News
  • Co-Author (July 1, 2021), “Patent and Regulatory Challenges in AI’s Use in Life Sciences”, MedTech Intelligence
  • Co-Author (March 2019) “Increasing Biosimilar Competition: Trends in Government Responses”, BioprocessOnline

Speaking Engagements

  • Speaker, ACI Summit on Biosimilars & Innovator Biologics, The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies, June 28, 2022
  • Speaker, Boston Bar Association Webinar, IP Year in Review, January 26, 2022
  • Speaker, FDANews Webinar on Recent Developments at FDA re: Biosimilars, June 1, 2020 Speaker, BBA Webinar: The Experts Speak: Best Practices on Selecting and Working with Expert Witnesses, May 27, 2020
  • Speaker, MIT Enterprise Forum: Athens, Greece Webinar on Key IP Considerations for Emerging Companies, May 13, 2020

Recognition

“He put together a really fantastic team for a matter in which they represented us…the team was successful, and we had a great result. He is a nice guy and I always enjoyed working with him.”
Acritas

Awards

  • Leading Life Sciences Lawyer, LMG Life Sciences, 2022
  • Acritas Star, 2018 – 2020
  • Stand-out Lawyer, Thompson Reuters, 2021
  • Rising Star and Super Lawyers, 2011-2022

Qualifications

Admissions

 Admitted to the State Bar of Massachusetts, 2003 
 
Admitted to the State Bar of New York, 2006 
 
United States Court of Appeals for the Federal Circuit, 2010 
 
United States Court of Appeals, Ninth Circuit, 2017 
 
United States Court of Appeals, Eleventh Circuit, 2023 
 
United States District Court for the District of Massachusetts, 2004 
 
United States District Court for the Southern District of New York, 2023 
 
Registered Foreign Lawyer, England and Wales, 2024 

 
 

Academic

J.D, magna cum laude, Order of the Coif, Georgetown University Law Center, 2003

A.B., magna cum laude, Harvard College, 1999

Disclaimer
A&O Shearman was formed on May 1, 2024 by the combination of Shearman & Sterling LLP and Allen & Overy LLP and their respective affiliates (the legacy firms). Any matters referred to above may include matters undertaken by one or more of the legacy firms rather than A&O Shearman.