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The US Food and Drug Administration ("FDA") has issued long-awaited draft guidance addressing the standards for demonstrating interchangeability of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

News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • June 12 2014

The U.S. Food and Drug Administration (FDA) issues a final rule amending its "postmarketing safety reporting regulations for human drug and

Top 10 steps global life sciences companies should take in 2014
  • Sidley Austin LLP
  • USA
  • February 24 2014

Prepare now for difficult-to-defend challenges to biological patents. Most innovative biological product companies have little experience with the

Bric-a-brac: January 31, 2014
  • Michael Best & Friedrich LLP
  • USA, Nigeria, Russia
  • January 31 2014

An interesting article in Pharmaexec.com discusses Russia's focus on developing a "world class" biopharmaceutical sector. The article states that