Senate’s Pay-For-Delay Bill Would Weaken Drug Patents

This month several U.S. senators introduced the Preserve Access to Affordable Generics Act. The bill would expand Federal Trade Commission powers and alter the legal test governing drug patent settlements. See Preserve Access to Affordable Generics Act, S. 214, 113th Cong., 1st Sess. (2013). This bill is the most recent iteration of such legislation, and, aside from updated data, it mirrors bills introduced in 2009 and 2011. See S. 27, 112th Cong., 1st Sess. (2011); S. 369, 111th Cong., 1st Sess. (2009).

Key Points

• There is no similar bill pending in the U.S. House.
• The act revives legislative efforts to wipe out the majority court standard by treating “reverse payment” drug patent settlements as presumptively illegal.
• The FTC would enforce the act in administrative litigation and collect penalties valued at three times the violators gains.
• Drug manufacturers would have to notify the FTC of additional agreements relating to patent settlements.

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