In the EU, the number of so-called pay-for-delay settlements between brand-name drugmakers and generics companies has dropped to 3 percent of the industry’s patent settlements last year, as opposed to 10 percent in 2009. The Commission is concerned that such deals designed to delay the release of a generic drug in return for a payment from the brand-name drugmaker can pose competition concerns and harm consumers by keeping cheaper drugs off the market.
The European Commission’s report contrasts sharply with a similar study released by the U.S. Federal Trade Commission in May, which found that the number of pay-for-delay deals monitored by that agency jumped by 60 percent in 2010 to 31 such deals. Of those 31 pay-for-delay deals, 26 involved generics makers that were the first to file for FDA approval to market their own version of the branded drug. The FTC views such deals as particularly dangerous to customers because they often block other generic drug companies from entering the market under the U.S. pharmaceutical patent regulatory scheme. U.S. appellate courts have repeatedly upheld the settlements against antitrust attack when they do not foreclose other generics from attempting to enter the market.