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Conflict Between Granting a Preliminary Injunction and Staying the Case Pending Appeal of the Injunction
  • Foley & Lardner LLP
  • USA
  • June 5 2017

In Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, et al., Case No. 15-3654 (D.N.J.) the district court recently denied Fresenius’s motion to

Third Circuit Affirms Dismissal of FCA Suit Against Genentech Based on Supreme Court’s Materiality Standard
  • McDermott Will & Emery
  • USA
  • May 10 2017

On May 1, 2017, the US Court of Appeals for the Third Circuit affirmed the dismissal of United States ex rel. Petratos, et al. v. Genentech, Inc., et

Par’s Hatch-Waxman Claims Too Speculative and Discovery Requests Too Broad
  • Foley & Lardner LLP
  • USA
  • May 4 2017

The recent decision from the New Jersey District Court in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Civ. No. 16-02290 (WHW)(CLW) (D

Ninth Circuit Affirms Class Decertification Order But Reverses Summary Judgment in "All Natural" Foods Label Case
  • Jones Day
  • USA
  • October 5 2016

On September 30, 2016, in a closely watched case, the Ninth Circuit affirmed a district court's decertification ruling based on a faulty damages

Off-Label Promotion And The First Amendment Updates
  • Reed Smith LLP
  • USA
  • September 22 2016

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and

Petitioner Avoids One-Year Time Bar by Acquiring ANDAs after Filing IPR Petition
  • Marshall Gerstein & Borun LLP
  • USA
  • September 8 2016

A PTAB decision denying a patent owner's motion for discovery concerning privity illustrates what may be a carefully-structured business transaction

Guest Post Marion Even with a Road Map, Only One Dubious Claim Navigates Preemption
  • Reed Smith LLP
  • USA
  • August 17 2016

Here's another guest post, this time from Reed Smith's Elizabeth Graham Minerd. This post concerns PMA preemption, and a second opinion largely

Muffin-Mix Manufacturer Burned By “Natural” Labeling
  • Weil Gotshal & Manges LLP
  • USA
  • August 11 2016

As we previously reported, the food industry is currently awaiting formal guidance from the FDA on the meaning of the word “natural.” The agency

Amgen Can Enforce Notice of Commercial Marketing for Epogen Biosimilar
  • Fish & Richardson PC
  • USA
  • August 8 2016

Hospira's motion to dismiss Count I of Amgen's complaint has been denied, and Amgen will be able to seek declaratory judgment relief in the form of

Right to be Smoke-Free Coalition and E-Vapor Industry Trade Associations file Motion for Summary Judgment in Lawsuit Challenging FDA's Deeming Regulation and the Tobacco Control Act
  • Keller and Heckman LLP
  • USA
  • July 28 2016

On July 25, 2016, Keller and Heckman LLP, on behalf of the Right to be Smoke Free Coalitionand ten national and state e-vapor industry trade