Nicholas Mitrokostas, a partner in Goodwin’s IP Litigation Group, focuses his practice on intellectual property, with an emphasis on patent litigation and inter partes review proceedings in the Patent Trial and Appeal Board (PTAB). Mr. Mitrokostas has extensive trial and PTAB experience representing clients in the pharmaceutical and biotechnology industries in patent and antitrust litigation. Mr. Mitrokostas has a wide-ranging pharmaceutical practice representing both innovator and challenger entities, including filers of 501(b)(1), 505(b)(2), 505(j) and aBLAs. He also has experience counseling and representing higher educational institutions in these matters. In addition to his IP work, Mr. Mitrokostas also served as one of several Goodwin attorneys working on matters related to the criminal investigation and prosecution following the July 2006 Central Artery Tunnel collapse in Boston.  Mr. Mitrokostas is an editor of the firm’s Biosimilars Reference Guide and co-leads the biosimilars blog, www.bigmoleculewatch.com, which provides resources, information and analysis on biologics, biosimilars and the Biologics Price Competition and Innovation Act (BPCIA).  He also devotes significant time to representing pro bono clients in criminal and immigration matters.

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

Some of Mr. Mitrokostas’ recent representations include:

  • Teva Pharmaceuticals, Inc. v. Sandoz, Inc.: Representing Teva Pharmaceuticals in a significant patent litigation involving Teva’s blockbuster branded product, Copaxone®, the most prescribed treatment for relapsing forms of multiple sclerosis. 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.
  • Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania: Representing patent owner the Trustees of the University of Pennsylvania 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.
  • In re Bendamustine Consolidated Litigation: Representing Cephalon, Inc. in patent litigation against 18 defendants involving Cephalon’s branded cancer drug, Treanda®, which is indicated for the treatment of certain lymphomas. The U.S. District Court for the District of Delaware (Judge Gregory M. Sleet) issued a final decision in favor of Cephalon, upholding the validity and finding infringement of all patents-in-suit following a six-day bench trial. The case is now on appeal.
  • Mass. Inst. Tech. v. Shire: Representing M.I.T. in litigation involving infringement of patents relating to novel cellular-scaffolds discovered by Professors Bob Langer and Jay Vacanti. The action is pending in the U.S. District Court for the District of Massachusetts. Based on the favorable decision from the District of Massachusetts court, which was affirmed on appeal, the defendant stipulated to the infringement and validity of the patent-in-suit.
  • Mylan Pharmaceuticals, Inc. v. Yeda Research and Development: Representing patent owner Yeda Research and Development in an inter partes review proceeding involving patents directed to the treatment of multiple sclerosis with a novel dosing regimen for the drug glatiramer acetate.  The case is on appeal to the U.S. Court of Appeals for the Federal Circuit.
  • Teva Branded Pharmaceutical Products R&D, Inc. v. Perrigo, Inc.: Represented Teva Branded Pharmaceutical Products R&D, Inc. in patent litigation involving its inhaler, ProAir® HFA, the most widely prescribed albuterol sulfate metered-dose inhaler. The case was settled favorably.
  • Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin, Inc.: Represented Teva Branded Pharmaceutical Products R&D, Inc. in patent litigation involving its inhaler, ProAir® HFA, the most widely prescribed albuterol sulfate metered-dose inhaler. The case was settled favorably.
  • Valeant et al. v. Actavis, LLC.: Representing ANDA-filer Actavis LLC in patent litigation involving injectable methylnaltrexone products. The case is pending in the U.S. District Court for the District of New Jersey.
  • Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.: Represented Teva Pharmaceuticals USA as ANDA-defendant in patent litigation involving Pfizer’s products, Detrol® and Detrol® LA. The case was settled favorably.
  • Cephalon, Inc. v. Celgene, Corp.: Represented Cephalon, Inc. in patent infringement litigation involving a paclitaxel drug formulation in the U.S. District Court for the District of Massachusetts.
  • Genzyme, Inc. v. Anika Therapeutics, Inc.: Represented medical device company, Anika Therapeutics, Inc., which was sued for patent infringement relating to its proposed hyaluronic acid injection therapy, Monovisc®, in the U.S. District Court for the District of Massachusetts.
Professional Activities

Mr. Mitrokostas is a member of the American Intellectual Property Law Association, IPO, and the Boston, Massachusetts and American Bar Associations, among other organizations.

Professional Experience

From March to September 2008, Mr. Mitrokostas served 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.

Mr. Mitrokostas has served as an adjunct professor teaching Patent Law at Northeastern University School of Law and has guest-lectured in other courses.

Recognition

Mr. Mitrokostas has been named a Super Lawyers’ Rising Star for 2011-2017. During law school, Mr. Mitrokostas served as Editor in Chief of Law & Policy in International Business (renamed Georgetown Journal of International Law).

In The News

MELDUNGEN

ACTUALITÉS

在新闻中

Credentials

WERDEGANG

RÉFÉRENCES

专业资格

Education

J.D., 2003
Georgetown University Law Center

(magna cum laude, Order of the Coif)

A.B., 1999
Harvard College

(magna cum laude)

Clerkships

2003 to 2004 Massachusetts Supreme Judicial Court, Honorable Judith A. Cowin

Admissions

Bar

Massachusetts
New York

Courts

U.S. District Court for the District of Massachusetts
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