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District court finds patent covering Cephalon’s wakefulness improving drug Nuvigil, valid in ANDA litigation
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 4 2018

The U.S. District Court for the District of Delaware ruled in favor of Finnegan clients Cephalon Inc., Cephalon France, and Teva Santé SAS, finding

Procedures and strategies for pharmaceutical brands: United States
  • Baker McKenzie
  • USA
  • March 13 2018

Clearing and registering pharmaceutical trademarks in the United States are often more complex and challenging than in other countries. This is due in

Patent Term Extension Considerations for BioPharma Patents
  • Sterne Kessler Goldstein & Fox PLLC
  • USA
  • August 15 2017

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the

Metallizing Forfeiture Post-Helsinn
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • June 13 2017

In Helsinn Healthcare S.A. V. Teva Pharmaceuticals USA, Inc., the Federal Circuit had its first opportunity to address the impact of the

The Emergent Microbiome: Rebounding after a Series of Challenging Events
  • Dilworth IP
  • USA
  • April 6 2017

Over the past two years, we have been reviewing and reporting on technology and IP issues related to the emerging field of microbiome research. In

FDA Issues Guidance on Interchangeable Biosimilars
  • Mayer Brown
  • USA
  • January 25 2017

The US Food and Drug Administration ("FDA") has issued long-awaited draft guidance addressing the standards for demonstrating interchangeability of

Intellectual Property Linkage: Connecting IP Offices with Regulators
  • Tilleke & Gibbins International Ltd
  • Thailand
  • November 30 2016

Intellectual property (IP) linkage refers to connecting an IP office, through open communication lines and complementary processes, to other

MoFo IP newsletter
  • Morrison & Foerster LLP
  • USA, United Kingdom, European Union
  • November 28 2016

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act

  • Shook Hardy & Bacon LLP
  • USA
  • October 2 2014

The U.S. Patent and Trademark Office extends the deadline for applications under its Patents for Humanity Program, "which recognizes patent holders

Selling your FDA-regulated product - 11 tips for an effective international distribution agreement
  • Arnall Golden Gregory LLP
  • USA
  • March 12 2013

If your company is a producer of FDA-regulated products, either in the U.S. or abroad, an international distribution network can be an effective and