February 2013

Looking Ahead

On March 25, 2013, the Supreme Court will hear oral argument in Federal Trade Commission v. Actavis, Inc., Supreme Court No. 12-416, opinion below, 677 F.3d 1298 (11th Cir. 2012), an ANDA “reverse payment” settlement case.   Although not on appeal from the Federal Circuit, this case is related to patent law in that it concerns agreements between (1) the manufacturer of a brand name drug on which the manufacturer assertedly holds a patent; and (2) potential generic competitors who, in response to patent infringement litigation brought against them by the manufacturer, defended on the grounds that their products would not infringe the patent and that the patent was invalid.  The patent litigation culminated in a “reverse payment” settlement through which the seller of the brand name drug agreed to pay its would-be generic competitors tens of millions of dollars annually, and those competitors agreed not to sell competing generic drugs for a number of years.  

The specific question presented is:  “Whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held).”  A decision is expected by the end of June 2013.