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News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • November 13 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry and staff titled "Molecular Diagnostic Instruments with Combined


Federal court upholds glaucoma drug patents and enjoins generics
  • Shook Hardy & Bacon LLP
  • USA
  • September 1 2011

A federal court in Texas has determined that four combination glaucoma drug patents held by Allergan Inc. were valid and that generic drug makers infringed the patents by seeking Food and Drug Administration (FDA) approval to sell their generic versions under an abbreviated new drug application


Do DNA patents affect genetic sequencing and testing advances?
  • Shook Hardy & Bacon LLP
  • USA
  • November 15 2012

University of Missouri-Kansas City School of Law Professor Christopher Holman writes in the most recent issue of Nature Technology that while DNA sequencing technology has spawned a myriad of patent-related lawsuits, “aggressive patent acquisition and enforcement practices” show no signs of abating and may not necessarily be hindering the development of next-generation DNA sequencing and analysis technologies


Federal Courts of Appeals conflict over validity of pay-for-delay deals
  • Shook Hardy & Bacon LLP
  • USA
  • August 2 2012

The Third Circuit Court of Appeals issued a ruling in mid-July that found “any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market must be treated by a factfinder as prima facie evidence of an unreasonable restraint of trade,” thus supporting the Federal Trade Commission’s (FTC’s) view that pay-for-delay deals that settle patent disputes between name-brand pharmaceutical companies and their generic drug competitors violate antitrust law


Myriad Genetics, gene by gene settle BRCA infringement dispute
  • Shook Hardy & Bacon LLP
  • USA
  • February 13 2014

According to a joint news release, Myriad Genetics, Inc. and other owners of the BRCA1 and BRCA2 gene patents have settled patent infringe- ment


Biosimilar development costs may affect savings potential
  • Shook Hardy & Bacon LLP
  • USA
  • January 30 2014

According to Pharm Exec Senior Editor Ben Comer, the biosimilars that were supposed to save consumers and taxpayers money as "the first wave of


Australian court finds human gene mutation to be patentable
  • Shook Hardy & Bacon LLP
  • Australia, USA
  • September 11 2014

A full panel of the Federal Court of Australia has upheld its earlier ruling that an isolated but naturally occurring nucleic acid, BRCA1, can be


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • September 11 2014

The U.S. Patent and Trademark Office (USPTO) seeks comments on the estimated time burdens of revisions to a currently approved information collection


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • July 17 2014

The U.S. Food and Drug Administration issues guidance titled "Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal, Food


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