A senior official of the US Federal Trade Commission (FTC) has said she hopes that, this year, one of the “pay-for-delay” pharmaceutical patent suits being pursued by the FTC will yield a “billion-dollar settlement.”
“That is one of the biggest priorities we have,” Deborah Feinstein, director of the FTC’s Bureau of Competition, told an American Bar Association meeting. “The consumer harm there is extremely significant, and so we have a tremendous amount of resources there and hope to come out with a victory one way or another in those cases,” she added.
Commission chair Edith Ramirez also released the FTC’s Annual Highlights report for 2013 at the conference, which was the spring meeting of the American Bar Association’s Section of Antitrust Law, held in Washington DC.
Last year, the healthcare and pharmaceutical industries continued to be a priority area for the FTC for competition enforcement, she said. One “significant victory” for the Commission was the Supreme Court’s ruling that lay-for-delay agreements are subject to antitrust scrutiny, thus reversing a lower court dismissal in FTC vs Actavis.
“The FTC will proceed with its litigation against the maker of the drug Androgel, and two generic drug manufacturers, charging that the companies agreed that the generic manufacturers would abandon their patent challenges relating to AndroGel and delay for nine years the marketing of a generic formulation of the testosterone replacement drug in return for payments,” said the Commission.
Also last year, the FTC continued to review pharmaceutical mergers “with an eye to preserving competition for generic medications as well as emerging treatments,” it says. One such example was the Commission’s challenge to Mylan’s proposed $1.85 billion acquisition of Agila Specialties.
The FTC alleged that the acquisition would likely reduce competition substantially for 11 generic injectable drugs used to treat various conditions - including several types of pediatric cancers, autoimmune diseases, severe hypertension and urinary tract damage - and required Mylan and Agila Specialties to divest these generics before allowing the merger to proceed.
In another example, the FTC required Actavis to sell all rights and assets to four generics to resolve charges that the firm’s proposed $8.5 billion acquisition of Warner Chilcott would be anticompetitive.
“The hallmark of our work has been, and will continue to be, our ability to adapt established tools – law enforcement, policy initiatives and education – to address economic challenges and technological advances that Congress could never have imagined when it created the FTC,” Chairwoman Ramirez told the meeting.