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Nicholas Mitrokostas

Partner

Boston

Image of Nicholas Mitrokostas
Nicholas Mitrokostas

Partner

Boston

Nick, a partner in the Intellectual Property practice, is 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 (D. 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 in Review Committee. He also serves on a leadership committee for the non-profit Science Club for Girls. At Allen & Overy, Nick is 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 Associates Development Committee.

Speaking engagements:

  • Speaker, Boston Bar Association Webinar, IP Year in Review, January 26, 2022
  • Speaker, MJH Life Sciences News Network Center for Biosimilars, How COVID-19 FDA Rule Changes Are Shaping the Biosimilar Market, June 23, 2020

  • Speaker, FDA News, Biosimilars on the Rise: The Latest on FDA’s Guidelines and Guidances, June 3, 2020

  • 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

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Experience highlights

Expertise

Practices

Intellectual Property

Sectors

Life Sciences

Office

Boston

One Beacon Street
Boston
MA 02108

View office →

Qualifications

Professional

Admitted: State Bar of Massachusetts, 2003

Admitted: State Bar of New York, 2006

US Court of Appeals for the Federal Circuit 

Academic

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

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

Other noteworthy experience

Advising:

  • 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.

Recognition

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

Awards & accolades

Leading Life Sciences Lawyer

LMG Life Sciences, 2022

Acritas Star

2018 – 2020

Stand-out Lawyer

Thompson Reuters, 2021