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FDA Advisory Committee Materials Qualify as 102(b) Prior Art
  • Morrison & Foerster LLP
  • USA
  • August 20 2018

In this consolidated appeal from decisions invalidating as obvious certain claims in six IPRs, appellant argued that the PTAB erroneously found


FDA Releases Biosimilar Action Plan; Solicits Stakeholder Input; Public Hearing on September 4th
  • Morrison & Foerster LLP
  • USA
  • August 20 2018

On July 18, the FDA released its Biosimilar Action Plan, which focuses on "four key areas:" improving efficiency of the biosimilar and interchangeable


Hatch-Waxman and BPCIA Developments in May 2018
  • Morrison & Foerster LLP
  • USA
  • June 6 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA


Round One Goes to Roundup: Court Temporarily Enjoins Proposition 65 Warnings for Glyphosate and Glyphosate Residues in Foods
  • Morrison & Foerster LLP
  • USA
  • March 5 2018

Last Monday, a federal judge temporarily barred California from requiring cancer warnings on products that contain detectable amounts of


3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
  • Morrison & Foerster LLP
  • USA
  • January 16 2018

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The


FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims
  • Morrison & Foerster LLP
  • USA
  • July 11 2017

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn


The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?
  • Morrison & Foerster LLP
  • USA
  • June 12 2017

On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to


Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule
  • Morrison & Foerster LLP
  • USA
  • March 30 2017

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate


Judge Koh Issues First Blow to “Added Sugars” Plaintiffs
  • Morrison & Foerster LLP
  • USA
  • March 24 2017

The Big Picture: On Tuesday, Judge Koh granted Kellogg’s Motion to Dismiss in its entirety in Hadley v. Kellogg Sales Company, No. 5:16-cv-04955-LHK


California Court Denies Stay of Consumer Class Action Challenging “Natural Cheese”
  • Morrison & Foerster LLP
  • USA
  • January 6 2017

On December 6, 2016, United States District Judge John A. Kronstadt for the Central District of California denied a motion to stay a class action