Friday, October 28, 2011

Finding from the latest FTC report - Pay for delay settlements between brand and generic companies are on a risepanies

  1. During the fiscal year 2011 (October 1, 2010 to September 30, 2011), the Federal Trade Commission received 156 final resolutions of patent disputes between a brand and a generic
    • 28 final settlements contain both compensation to the generic manufacturer and a restriction on the generic manufacturer’s ability to market its product
    • These settlements involve 25 different branded pharmaceutical products with combined annual U.S. sales of more than $9 billion.
  2. 100 final settlements restrict the generic manufacturer’s ability to market its product, but contain no explicit compensation
  3. 28 final settlements have no restrictions on entry
Final Settlements Involving First Filers
  1. 54 settlements involve generics eligible for 180-day first-filer exclusivity.
    • 18 settlements contain both compensation to the generic manufacturer and a restriction on the generic manufacturer’s ability to market its product.
    • 10 of these settlements include an agreement by the brand not to competewith an authorized generic or an exclusive license for the generic to market an authorized generic.
    • 29 settlements restrict the generic manufacturer’s ability to market its product, but contain no explicit compensation.