US: FTC submits amicus brief in no-authorized-generic case

The US Federal Trade Commission submitted a proposed amicus brief regarding a patent settlement case in the US District Court for the District of New Jersey that includes a “no-authorized-generic” commitment.

The FTC is now asking the judge in the case, In re Effexor XR Antitrust Litigation, to accept the amicus brief that, according to an FTC press release, involves the application of the Supreme Court’s recent pay-for-delay ruling to the settlement.

In the case of Effexor XR, the plaintiffs challenged the patent settlement agreement between Wyeth and Teva Pharmaceuticals due to the no-authorized-generic agreement the two had made. The press release offered by the FTC Monday explained that such a no-authorized-generic commitment means that a brand name drug company has agreed to not launch its own generic alternative when a competing generic drug maker launches its own. But a study spearheaded by the FTC found that such agreements lead to higher revenues for the generic drug maker, “and consumers pay higher prices for the generic product.”

It’s a case similar to so-called pay-for-delay, in which a brand name pharmaceutical company pays a generic drug maker to keep its competition off the shelves; the Supreme Court ruled in FTC v. Actavis that such agreements can be subject to legal scrutiny. According to the FTC, the watchdog’s amicus brief says that the settlement in the New Jersey case presents “an issue with significant implications for American consumers,” and that the no-authorized-generic commitment “raise[s] the same type of antitrust concern that the Supreme Court identified in Actavis.”

The regulator voted 4-0 in favor of approving the amicus brief, which was submitted to the court on August 14 of this year. A decision on whether the FTC is to participate as amicus is expected next month, said the press release.

Full Content: Fierce Pharma

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