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News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • October 30 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry titled "Circumstances that Constitute Delaying, Denying, Limiting


Study shows rise in biotech patent litigation
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

PricewaterhouseCoopers LLP has released its “2012 Patent Litigation Study,” which shows that the 4,105 patent lawsuits filed in 2011 marked a high point and a 22-percent increase from the previous year


Argument on remand scheduled in Myriad Genetics
  • Shook Hardy & Bacon LLP
  • USA
  • May 17 2012

The Federal Circuit Court of Appeals has scheduled briefing and oral argument in Association for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad Genetics), which the U.S. Supreme Court remanded for reconsideration in light of the Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012


News bytes 17052012
  • Shook Hardy & Bacon LLP
  • USA
  • May 17 2012

The Food and Drug Administration conducts a public hearing on draft guidances pertaining to a pathway to approval for biosimilar products


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • October 3 2012

U.S. Health and Human Services Secretary Kathleen Sebelius delegates authority to the Food and Drug Administration (FDA) to determine whether clinical trial information was not submitted to the Clinical Trial Registry and Results Data Bank as required by law or “was submitted but is false or misleading in any particular.”


Moody’s claims “the worst is over” for pharmaceutical companies facing patent cliff
  • Shook Hardy & Bacon LLP
  • USA
  • October 3 2012

Moody’s Investor Services has reportedly revised its outlook for the global pharmaceutical industry and upgraded it to stable, apparently anticipating that earnings will rebound in 2013 with the slowdown in patent expirations, characterized by many industry observers as the “patent cliff.”


Eleventh Circuit turns aside FTC challenge to pay-for-delay deal
  • Shook Hardy & Bacon LLP
  • USA
  • May 3 2012

The Eleventh Circuit Court of Appeals has dismissed an antitrust action filed by the Federal Trade Commission (FTC) against a name-brand prescription drug manufacturer (the patent holder) and generic drug companies that entered into pay-for-delay agreements to settle patent infringement claims filed against the generic drug companies


News bytes 03052012
  • Shook Hardy & Bacon LLP
  • USA
  • May 3 2012

The Government Accountability Office issues a report indicating that the Food and Drug Administration has met most of its performance goals when reviewing prescription drug applications, including new drug applications and biologic license applications, received from fiscal year (FY) 2000 through FY 2010


Federal Circuit refuses to consider standingmootness issue in Myriad Genetics
  • Shook Hardy & Bacon LLP
  • USA
  • June 21 2012

The Federal Circuit Court of Appeals has issued a non-precedential order declining Myriad Genetics’ invitation to revisit whether the plaintiff has standing, that is, a redressable legal interest in maintaining the lawsuit, and will thus consider, on remand from the U.S. Supreme Court, whether isolated DNA claims and method claims are patent-eligible under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012


NGOs request march-in rights for patented drug
  • Shook Hardy & Bacon LLP
  • USA
  • November 1 2012

Four non-governmental organizations (NGOs) have filed a petition with the National Institutes of Health (NIH) requesting that it grant march-in rights under the Bayh-Dole Act for a patented drug that they claim is “a federally funded invention that is much more expensive in the United States than in Canada, Europe or other high-income countries.”