Judge Partially Dismisses FTC Complaint Alleging Shire Used Fraudulent Petitions to Stifle Generics

A federal judge granted Shire’s motion to dismiss a Federal Trade Commission action against its citizen petitions relating to potential generic competitors, saying the FTC had not met a prerequisite for bringing the lawsuit.

In a February 2017 complaint, the FTC claimed Shire subsidiary ViroPharma filed sham petitions to delay market entry for generics of its drug Vancocin. ViroPharma submitted 43 petitions between 2006 and 2012 and filed three lawsuits against the FDA, the commission said. Without these petitions, the lawsuit claimed, a generic would have been approved by 2010 or earlier rather than in April 2012.

Judge Richard G. Andrews of the U.S. District Court for Delaware ruled against the FTC on procedural grounds, finding that the FTC’s authority to seek a permanent injunction depends on it having reason to believe a company is “violating, or about to violate” a law the commission enforces.  “There does not appear to be any dispute that the FTC has not alleged that ViroPharma ‘is violating’ a law enforced by the FTC,” he wrote.