Pharmaceutical Business review

FTC, Teva reach global settlement to resolve reverse-payment charges

Image: FTC and Teva agree to settle reverse-payment charges. Photo: courtesy of Carol M. Highsmith/Wikipedia.org.

Subject to approval by various courts, the stipulated order from the FTC will block Teva from engaging in reverse-payment patent settlement agreements that would hinder consumer access to lower-priced generic drugs.

The FTC has agreed to dismiss its claims against the Israeli pharma company and its affiliates in the FTC v. AbbVie, FTC v. Actavis and FTC v. Allergan cases.

The competition authority and Teva will also modify some of the terms in their 2015 consent decree while the pharma company will not have to pay any additional amount to the competition watchdog as part of the settlement.

FTC Chairman Joe Simons said: “This settlement represents another milestone in the Commission’s unwavering commitment to put an end to harmful reverse-payment agreements.

“This broad settlement prevents the world’s largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market.”

In the FTC v. Actavis case, the FTC filed its complaint in 2009 alleging a reverse-payment agreement between Solvay and Watson, now a subsidiary of Teva to delay the release of a generic version of AndroGel, a commonly used testosterone replacement drug.

In the FTC v. AbbVie case, the FTC filed its complaint in 2014 alleging a reverse-payment agreement between AbbVie and Teva to delay the launch of lower-priced versions of AndroGel.

In the FTC v. Allergan case, the Commission filed its complaint in 2017 alleging that Endo Pharmaceuticals paid generic manufacturers, including Watson, to delay launching a generic version of Lidoderm, which is a topical patch used to relieve pain resulting from a complication of shingles.

Teva North America commercial EVP and Head Brendan O’Grady said: “We are very pleased to put these litigations against the FTC behind us.

“We also appreciate the FTC’s willingness to modify our consent decree to eliminate certain administrative burdens that will make it easier for us to navigate the patent issues that are critical to our business.”