United Kingdom Office of Fair Trading: Accuses GlaxoSmithKline for Pay for Delay

In January of this year, we noted that the U.S. Supreme Court agreed to hear a case to decide whether agreements between brand-name pharmaceutical companies and generic makers to delay the entry of generic drugs to the market—so called “pay for delay” deals—violate antitrust laws.  “In a typical case, a generic rival challenges the patent of a brand-name competitor, which then pays the rival a sum of money to drop its challenge,” reported Reuters.   A study by RBC Capital Markets Corp. of 371 cases during 2000-2009 found brand-name companies won 89 at trial compared to 82 won by generic drugmakers.  Another 175 ended in settlement deals, and 25 were dropped, reported TimesNews.net. Oral arguments for the case—FTC v. Actavis—were heard in late March of this year, and there was significant coverage of the case by industry and various stakeholders.  A decision against the pharmaceutical industry would further shorten the patent protection period on many branded drugs.  Below is a summary of oral arguments and comments from various lawyers and stakeholders. Forbes reported that while the Supreme Court case is considering the legality of such agreements, AstraZeneca entered into a new agreement with Actavis and its partner Egis Pharmaceuticals, to begin selling a generic copy of Crestor in May 2016, and Actavis will have to pay AstraZeneca a 39 percent royalty on net sales until the end of pediatric exclusivity in July 2016. Pay-for-Delay Ban in the U...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs