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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

Analysts predicts biosimilars boom as biologics reach new patent cliff

  • Shook Hardy & Bacon LLP
  • -
  • Global
  • -
  • August 7 2014

A new Allied Market Research (AMR) report predicts that the global biosimilars market, which accounted for $1.3 billion in 2013, will generate $35

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

SCOTUS sides with FTC in reverse payment deals

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 20 2013

A divided U.S. Supreme Court has determined that patent-infringement settlement agreements requiring the patentee to pay the claimed infringer

Pharma trade group seeks biologics data exclusivity for international trade

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 19 2011

PhRMA has reportedly called for the U.S. Trade Representative to go outside provisions in the Korea-U.S. trade deal (KORUS) and press for a 12-year period of exclusivity for biologics in ongoing Trans-Pacific Partnerships (TPP) negotiations

Fractured Myriad Genetics ruling follows SCOTUS remand

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 30 2012

Ruling that one plaintiff had standing to seek a declaratory judgment as to the patent eligibility of certain genetic discoveries, the Federal Circuit Court of Appeals has once again reversed in part and affirmed in part a lower court’s determination that isolated DNA molecules and methods of comparing molecules to determine whether a patient’s genes have mutations that could cause breast and ovarian cancer were not patent eligible

Genetic technologies settles infringement suit over non-DNA coding technology

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 2 2013

Genetic Technologies Ltd. (GTG) has reportedly settled a patent infringement lawsuit filed in late 2012 against PreventionGenetics. While the terms

EU Court of Justice Advocate General issues ruling on Stem Cell patentability

  • Shook Hardy & Bacon LLP
  • -
  • European Union, United Kingdom
  • -
  • August 7 2014

In a non-binding ruling, Advocate General Cruz Villalón of the EU Court of Justice has determined that unfertilized human ova whose division

FTC reports “pay-for-delay” deal trend continuing

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 3 2011

The Federal Trade Commission (FTC) has found that the ongoing trend of drug companies settling claims filed by rival generic manufacturers with “pay-for-delay” deals is proceeding unabated

FTC report on Authorized Generic Drugs generates comment and concern

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 22 2011

The Federal Trade Commission has released a report titled “Authorized Generic Drugs: Short-Term Effects and Long-Term Impact,” in which the agency concludes that “pay-for-delay” agreements between name-brand drug manufacturers and generic drug makers is “a practice that causes substantial consumer harm” by keeping drug prices high