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Results:1-10 of 33

Medical Devices and the Intersection between FDA and Patent Law
  • Mintz
  • USA
  • October 5 2018

Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the


FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
  • Mintz
  • USA
  • December 18 2017

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and


Federal Circuit Thoroughly Reverses District Court Findings of Velcade Patent Obviousness
  • Mintz
  • USA
  • July 26 2017

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v


SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
  • Mintz
  • USA
  • June 14 2017

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological


Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling
  • Mintz
  • USA
  • June 14 2017

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price


Federal Circuit Clarifies the On-Sale Bar under AIA
  • Mintz
  • USA
  • May 9 2017

Last week the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals clarified the scope of the on-sale bar rule under the America Invents Act


Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA
  • Mintz
  • USA
  • April 27 2017

On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has


New State Substitution Laws, and a Busy Spring for Biosimilars
  • Mintz
  • USA
  • April 19 2017

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total


Federal Circuit Limits Claim to Single Embodiment Because Only Enabling Description Provided in the Patent
  • Mintz
  • USA
  • April 12 2017

On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for


BPCIA Helps Amgen Gain Dismissal of Genentech Complaint
  • Mintz
  • USA
  • March 20 2017

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act