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Results: 1-10 of 113

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

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

News bytes

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

The U.S. Patent & Trademark Office (USPTO) selects 19 law schools to join its Law School Clinic Certification Pilot Program. Four of the law schools

Stakeholders provide input on FDA review standards for biosimilars

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 18 2010

The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics

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

Parties to gene patent dispute change course by seeking U.S. Supreme Court review

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 20 2011

After filing petitions for rehearing before the Federal Circuit Court of Appeals panel that split over whether genetic discoveries can be patented, the parties have apparently changed course and indicated their intent to petition the U.S. Supreme Court for review

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

Federal Circuit says certain human genes may be patented

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 4 2011

In a ruling likely to be appealed to the U.S. Supreme Court, a divided Federal Circuit Court of Appeals panel has determined that genetic discoveries may, to a certain extent, be patented