Goodwin

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100 Northern Avenue
Boston, MA 02210, United States
Phone: 617.570.1000
Fax: 617.523.1231
Areas of Practice
  • Antitrust & Trade Regulation
  • Appellate Practice
  • Art, Entertainment, & Sports Law
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Other U.S. Locations
  • California
  • D.C.
  • Massachusetts
  • New York
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  • France
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Number of Attorneys
800+ Attorneys

Issue Four: PTAB Trial Tracker

Parallel District Court and PTAB Proceedings - In Douglas Dynamics, LLC v. Meyer Prods. LLC, No. 3:14-cv0886-JDP (W.D. Wis. April 18, 2017), the district court for the Western District of Wisconsin drew a clear line regarding…more
 /  Civil Procedure, Intellectual Property

Financial Services Weekly News - April 2017 #4

Editor's Note - State Regulators Sue OCC Over Federal FinTech Charter. On April 26, the Conference of State Bank Supervisors (CSBS) sued the Office of the Comptroller of the Currency (OCC) in the U.S. District Court for the…more
 /  Civil Procedure, Consumer Protection, Elections & Politics, Finance & Banking, Real Estate - Residential

Pfizer Files for IPR of Two Biogen Patents Directed to Rituximab

In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the…more
 /  Intellectual Property, Science, Computers, & Technology

Apotex Citizen Petition Seeks to Heighten Regulatory Requirements for Biosimilar Competition

Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that FDA…more
 /  Intellectual Property, Science, Computers, & Technology

Fresenius Kabi Acquires Merck KGaA’s Biosimilars Business

On Monday, April 24, 2017, Fresenius Kabi and Merck KGaA announced that Fresenius will be acquiring Merck KGaA’s biosimilars business. According to Merck KGaA’s press release, Merck KGaA’s biosimilar portfolio focuses on…more
 /  Business Organizations, Mergers & Acquisitions, Science, Computers, & Technology

Analysis: Supreme Court Oral Argument in Sandoz v. Amgen

The transcript of the April 26 Supreme Court oral argument in Sandoz v. Amgen has been posted online. As we covered briefly, the questioning during today’s argument focused primarily on three points…more
 /  Civil Procedure, Intellectual Property, Science, Computers, & Technology

Glenmark Pharmaceuticals Begins Clinical Investigation for Omalizumab Biosimilar

In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a…more
 /  Health, Science, Computers, & Technology

Reminder: Supreme Court Arguments on April 26th in Amgen v. Sandoz

As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the…more
 /  Civil Procedure, Intellectual Property, Science, Computers, & Technology

Supreme Court Oral Argument in Sandoz v. Amgen

The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting…more
 /  Civil Procedure, Intellectual Property, Science, Computers, & Technology

CFPB Director Cordray Testifies Before House Financial Services Committee

On April 5, 2017, Consumer Financial Protection Bureau (CFPB) Director Richard Cordray testified before the U.S. House of Representatives Financial Services Committee to present the CFPB’s semi-annual report, which is available…more
 /  Commercial Law & Contracts, Consumer Protection, Elections & Politics, Finance & Banking, Securities Law

Sandoz’s Biosimilars Rituximab and Etanercept are Recommended for Approval in Europe

On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be…more
 /  Health, International Law & Trade, Science, Computers, & Technology

FDA Advisory Committee to Hold Public Meeting on Hospira’s Proposed Epogen/Procrit Biosimilar

The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer…more
 /  Administrative Law, Science, Computers, & Technology

Legislative Update: State Biosimilar Substitution Laws

More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and…more
 /  Health, Science, Computers, & Technology

HUD Resolves Allegations of Discrimination Against California Lenders

?On April 19, the U.S. Department of Housing and Urban Development (HUD) announced that it had entered an agreement with a group of California mortgage lenders to resolve allegations that they discriminated against a mortgage…more
 /  Administrative Law, Civil Rights, Finance & Banking, Real Estate - Residential

Supreme Court Hears Oral Argument on Scope of FDCPA

On April 18, 2017, the United States Supreme Court, once again with nine justices sitting on the bench, heard oral arguments in Henson v. Santander Consumer USA, Inc., No. 16-349, concerning the scope of the Federal Debt…more
 /  Civil Procedure, Finance & Banking
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