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A U.S. Perspective on Global Strategy
  • Sterne Kessler Goldstein & Fox PLLC
  • USA, Taiwan
  • April 13 2018

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms

Innovation in Hatch-Waxman and ANDA Litigation
  • Seyfarth Shaw LLP
  • USA
  • March 12 2018

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation
  • Morgan Lewis
  • USA
  • December 7 2017

There have been two interpretations of the "acts of infringement" language in the patent venue statute regarding ANDA submissions in Hatch-Waxman

Canada’s new linkage litigation scheme: a comparison to Hatch-Waxman
  • Smart & Biggar/Fetherstonhaugh
  • USA, Canada
  • December 1 2017

The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme

Spotlight on Upcoming Oral Arguments - November 2017
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • November 3 2017

In this appeal, the Federal Circuit will consider whether it has jurisdiction to review a PTAB decision to terminate an IPR and enter an adverse

Frequent Participation in Hatch-Waxman Litigation in a Forum May Be Relevant to Whether a Defendant Can Be Sued in That Forum for Patent Infringement
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 19 2017

Submitting an Abbreviated New Drug Application (ANDA) and subsequent prospective infringement can be sufficient to show an act of infringement under

Senator Orrin Hatch Comments on Patent Reform
  • Dilworth IP
  • USA
  • October 9 2017

Senator Orrin Hatch (R-UT), Chairman of the Senate Republican High-Tech Task Force and Former Chairman of the Senate Judiciary Committee, recently

ANDA & Biosimilar and the Law
  • Foley & Lardner LLP
  • USA
  • July 10 2017

Welcome to Foley & Lardner’s Summer 2017 edition of ANDA & Biosimilar and the Law. In our Legal Developments section, we report on a number of

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court
  • Baker & Hostetler LLP
  • USA
  • June 16 2017

On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics

Pharmaceutical patents in Canada: key issues for life sciences companies
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 13 2017

There are some key distinctions between the US and Canadian drug approval systems and patent laws. This can create very different and unexpected