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Opportunity - FDA encouraging manufacture and distribution of new generic drugs
  • Innofy
  • USA
  • July 21 2017

The U.S. Food and Drug Administration (FDA) are desperately seeking to increase competition for prescription drugs. The reasons for this are of no

FDA Increases Priority Review Opportunities for Drug Products with Limited Competition
  • Duane Morris LLP
  • USA
  • July 18 2017

The FDA hopes to increase market competition for prescription drugs and facilitate entry of lower-cost alternatives. Following the Drug Competition

Major U.S. court decisions change patent landscape for Canadian companies
  • Osler Hoskin & Harcourt LLP
  • Canada, USA
  • July 6 2017

For many Canadian technology companies, the United States market is the most commercially important, yet it can be fraught with the risk of being sued

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen
  • Baker & Hostetler LLP
  • USA
  • June 28 2017

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?
  • Foley & Lardner LLP
  • USA
  • June 27 2017

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC 262(l)(9)(C) sets forth the exclusive federal

Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval
  • Jones Day
  • USA
  • June 21 2017

Intended to provide a faster route to approval for generic biologics, the Biologics Price Competition and Innovation Act, was the basis for a

Third Circuit Declines to Send Pay-for-Delay Litigation to Federal Circuit
  • McDermott Will & Emery
  • USA
  • May 25 2017

Addressing questions of federal jurisdiction, the US Court of Appeals for the Third Circuit ruled that it, and not the US Court of Appeals for the

Commission Holds Oral Argument on Dismissal of Antitrust Claims in Section 337 Case
  • Hogan Lovells
  • USA
  • May 2 2017

On April 20, 2017, the Commission held an oral argument in connection with its review of an Administrative Law Judge’s decision to grant Chinese

McDermott's Reverse Engineered Podcast The Intersection of Antitrust & Intellectual Property
  • McDermott Will & Emery
  • USA
  • April 28 2017

The exclusivity provided through patent protection has never wandered far from the long shadow cast by antitrust regulations and concerns. In this

A Hitchhiker’ s Guide to Antitrust and Intellectual Property Guidelines
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • China, USA
  • April 10 2017

Almost 22 years ago, the U.S. antitrust enforcement agencies issued their Antitrust Guidelines for the Licensing of Intellectual Property (IPG