Biopharmaceutical

News & Analysis as of

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

Considerations for Biopharma Under a First-Inventor-to-File Regime [Video]

The America Invents Act brings many significant changes to US patent law, the most fundamental of which is the shift from a first-to-invent system to a first-inventor-to-file system. Kenley K. Hoover, Ph.D., a director at the...more

GEN Compiles List of Top Biopharma R&D Spenders

Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012"). The biotech...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

Recent Insider Trading Case Sparks Concerns Over Leaked Clinical Trial Results

What you need to know: The Martoma insider trading case is the latest in, and largest of, a string of actions brought by the Securities and Exchange Commission related to the alleged misuse of confidential clinical trial...more

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