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Personalized Medicine: Insights Into Current Legal Issues
  • Foley & Lardner LLP
  • USA
  • September 18 2016

In his January 20, 2015 State of the Union Address, President Obama brought to the nation’s attention the promise of personalized medicine when he

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs
  • Foley & Lardner LLP
  • USA
  • July 5 2016

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced

Suspected off-label infringing uses do not equal inducement
  • McDermott Will & Emery
  • USA
  • July 30 2015

On May 6, 2015, the U.S. Court of Appeals for the Federal Circuit issued its full opinion affirming the U.S. District Court for the District of

How the new multi-party patent infringement rulings will affect pharmaceutical treatment claims
  • Hamilton Brook Smith & Reynolds PC
  • USA
  • July 26 2011

The very recent and continuing focus by the U.S. Supreme Court and the Federal Circuit sitting en banc on multi-party infringement issues namely, induced infringement and divided, or joint, infringement portends daunting new challenges for brand pharmaceutical companies that attempt to assert method of treatment claims in Hatch-Waxman litigation against generic competitors.

FDA hears testimony on approval pathway for biosimilar and interchangeable follow-on biologics
  • Locke Lord LLP
  • USA
  • November 10 2010

On November 2-3, 2010, the FDA held an important hearing relating to a new piece of legislation intended to allow for market entry of "follow-on" biologic drug products.

Andy Leck
  • Baker McKenzie