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News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • May 1 2014

The U.S. Food and Drug Administration (FDA) seeks input "on the design and conduct of the postmarketing requirements (PMRs) for the class-wide


Federal Circuit applies patent issuance date to laches claim in inventorship correction suit
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

The Federal Circuit Court of Appeals has ruled that a claim for correction of inventorship under 35 U.S.C. 256 accrues when the patent issues and not when the allegedly omitted inventors purportedly knew or should have known that they were not named inventors on the patent application


IOM publishes report on the effects of falsified and substandard medicines
  • Shook Hardy & Bacon LLP
  • Global, USA
  • February 21 2013

At the request of the U.S. Food and Drug Administration (FDA), national think tank the Institute of Medicine (IOM) has published a report that


FDA considers changes to generic drug labeling rules
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

A footnote in an amicus brief filed by the U.S. Department of Justice (DOJ) in a case involving whether a design-defect claim asserted against a


U.S. Supreme Court to consider just one question in Myriad Genetics
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

The U.S. Supreme Court has agreed to review a Federal Circuit Court of Appeals ruling on the patentability of human genes and limited its grant of certiorari to the question “Are human genes patentable?”


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

The Food and Drug Administration makes available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support abbreviated new drug applications


New biotech jobs in Massachusetts outpace hiring in other industries
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

According to a new Massachusetts Biotechnology Council report, while hiring in the biotech industry has not fully recovered from the recession, the industry is adding jobs faster in Massachusetts than the state’s economy as a whole, and the state has added more jobs in biotechnology research than any other state between 2007 and 2011


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


Comments sought on guidelines for nanotoxicology research papers
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

Nature Nanotechnology editors have initiated an effort to develop guidelines that would apply to researchers submitting papers on the toxicity of various nanomaterials


Science publishers voluntarily dismiss part of copyright infringement case against law firm
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

The companies that claim law firms violate their copyrights in scientific articles when the firms submit copies of the articles with patent applications to the U.S. Patent and Trademark Office have sought leave to amend their complaint by withdrawing these claims but will move forward with claims that additional copies the firms make infringe the companies’ copyrights