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Teva v. Sandoz: Supreme Court Makes "Clear Error" the Standard for Claim Construction Factual Findings


Speaker(s): Nicholas K. Mitrokostas, William M. Jay
Recorded on: Feb. 13, 2015
PLI Program #: 135507

Nicholas Mitrokostas, a partner in Goodwin Procter’s IP Litigation Group, focuses his practice on commercial litigation, with a particular emphasis on intellectual property and patent litigation. Mr. Mitrokostas has extensive trial experience representing clients in the pharmaceutical and biotechnology industries in patent and antitrust litigation. He also has experience counseling and representing higher educational institutions in litigation. Mr. Mitrokostas also devotes a significant amount of time representing pro bono clients in criminal and immigration matters.

Work For Clients:

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 remitting 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 on October 15, 2014.
  • 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.
  • Cephalon, Inc. v. Eagle Pharmaceuticals, Inc. (and related cases): Representing Cephalon, Inc. in patent litigation against 18 defendants involving Teva’s branded cancer drug, Treanda®, which is indicated for the treatment of certain lymphomas. The actions are pending in the U.S. District Court for the District of Delaware before Judge Gregory M. Sleet.
  • 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.
  • Teva Pharmaceuticals USA, Inc. v. Pfizer, 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. The action is pending before the U.S. Court of Appeals for the Federal Circuit.
  • 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.

Mr. Mitrokostas also served as one of several attorneys at Goodwin Procter working on matters related to the criminal investigation and prosecution following the July 2006 Central Artery Tunnel collapse in Boston.


Willy Jay is a partner in the firm’s Litigation Department and a co-chair of its Appellate Litigation Practice. A former Assistant to the Solicitor General, Mr. Jay has extensive experience with litigation in the U.S. Supreme Court and U.S. Courts of Appeals. He has argued 11 cases before the Supreme Court, briefed more than 20 cases on the merits and briefed more than 150 cases at the certiorari stage. He also has significant experience with cases in the Court’s original jurisdiction.

Mr. Jay has handled cases in every federal court of appeals as well. He has personally briefed or argued more than 30 appellate cases, both in private practice and on behalf of the U.S. Department of Justice’s Environment, Criminal and Civil Divisions, and he has participated in numerous appellate matters involving government appeals or amicus participation.

Mr. Jay has particular experience in cases involving federal preemption of state law, environmental law, class action practice, and the First Amendment, including those involving campaign finance regulation, election law and constitutional challenges to public-corruption prosecutions.

WORK FOR CLIENTS

Since joining Goodwin Procter, Mr. Jay has handled complex litigation matters in the Supreme Court; in the First, Second, Third, Fourth, Fifth, Eighth, Ninth, Eleventh, D.C., and Federal Circuits; and in various trial courts and administrative agencies. His recent significant representations include:

  • Successfully winning rehearing en banc in the First Circuit on behalf of a national bank in a putative nationwide class action, and co-authoring briefs that won a complete victory on rehearing en banc.
  • Briefing and orally arguing several significant issues of standing and timeliness under the Securities Act in the Fourth Circuit.
PROFESSIONAL EXPERIENCE

Prior to joining Goodwin Procter in 2012, Mr. Jay served for five years as Assistant to the Solicitor General at the U.S. Department of Justice. In that capacity, he handled Supreme Court and appellate matters for a wide variety of federal agencies, including every Cabinet Department and numerous executive and independent agencies. Previously, he was a litigation associate with Gibson, Dunn & Crutcher in its Appellate and Constitutional Law Practice Group.

BAR AND COURT ADMISSIONS

Mr. Jay is admitted to practice in the District of Columbia, in Virginia (inactive), and before numerous federal appellate courts.

RECOGNITION

As Assistant to the Solicitor General, Mr. Jay received the Attorney General’s Distinguished Service Award for his work on litigation arising from the bankruptcy of Chrysler, as well as a Special Commendation from the DOJ’s Environment and Natural Resources Division for his work on litigation involving oil drilling, invasive species and interstate water rights.

While in law school, Mr. Jay was executive editor of the Harvard Law Review.

EDUCATION
J.D., 2001
Harvard Law School
(magna cum laude)

A.B., 1998
Government
Harvard College
(magna cum laude)

CLERKSHIPS

2004-2005 U.S. Supreme Court, Honorable Antonin Scalia

U.S. Court of Appeals for the Ninth Circuit, Honorable Diarmuid F. O'Scannlain