Actavis, FTC Butt Heads Over Handing Over Public Report Documents

The FTC is fighting to keep secret the reports drugmakers must file with the commission on patent infringement litigation in an ongoing and closely watched pay-for-delay lawsuit with Actavis.

The generics maker has urged a federal judge to force the commission to turn over the reports or, alternatively, to prohibit the FTC from using them to support its case that the company illegally agreed to delay generic entry of Solvay Pharmaceuticals’ AngdroGel (testosterone gel). The company maintains that it needs the documents to adequately counter any legal arguments the agency uses in court.

The FTC’s defense comes in its latest filing in the U.S. District Court for the Northern District of Georgia. While the reports themselves are public, the documents from which they derive are largely confidential materials from patent infringement settlements that drugmakers must hand over under the 2003 Medicare and Modernization Act, the commission says.

The FTC says it does not plan on citing the studies in the lawsuit.  

The nearly five-year-old lawsuit hinges on allegations that Solvay Pharmaceuticals engaged in illegal and anticompetitive deals with Actavis predecessor Watson and other generics makers to put off generic entry of Solvay until this year.

The lawsuit, Federal Trade Commission v. Actavis, went all the way to the Supreme Court in 2013, where the justices voted 5-3 to reverse an appellate decision dismissing the lawsuit and send it back to the lower courts. — Bryan Koenig