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Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions
  • Cozen O'Connor
  • USA
  • October 15 2018

The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often


First CBD Drug Receives FDA Approval
  • Knobbe Martens
  • USA
  • October 11 2018

The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the


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


The Priority Review Voucher: An Untapped Asset
  • Dilworth IP
  • USA
  • October 3 2018

Typically, we think of patents as the main tool that allows for product exclusivity in the pharmaceutical industry. However, exclusivity has a


New Arguments in Momenta On Standing to Appeal IPR Loss Before Filing a Biosimilar Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 12 2018

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal


FDA Releases Policy on Risk-Based Inspections
  • Morgan Lewis
  • USA
  • September 10 2018

The policy sheds light on risk factors but does not provide inspection predictability. Manufacturers should therefore continue to ensure inspection


Safe Harbor Provision of 35 U.S.C. 271(e)(1) - Implications of Intent and Continued Use
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 7 2018

The safe harbor defense has been of issue in two recent cases in which the bounds of the protection has been analyzed. Section 271(e)(1) carves out an


FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites
  • Hogan Lovells
  • USA
  • September 5 2018

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug


FDA advisory committee meeting materials were “printed publications” after notice of meeting and link to location of materials were published in the Federal Register
  • Winston & Strawn LLP
  • USA
  • September 4 2018

This was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB) finding patent claims relating to a drug distribution system for


FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic
  • Knobbe Martens
  • USA
  • September 4 2018

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s