Tag: pay for delay

The FTC is suing Endo Pharmaceuticals, Inc., Endo International plc, Impax Laboratories, LLC, and Impax’s owner, Amneal Pharmaceuticals, Inc., alleging that a 2017 agreement between Endo and Impax violated the antitrust laws by eliminating competition in the market for oxymorphone ER. The complaint charges the defendants with violating Sections 1 and 2 of the Sherman Act, which constitutes unfair methods of competition in violation of Section 5 of the FTC Act. Specifically, Endo, Impax, and Amneal are charged with entering into an illegal agreement in restraint of trade, and Amneal is charged with monopolization of the oxymorphone ER market. The complaint was filed in the U.S. District Court for the District of Columbia on Jan. 25, 2021.

The FTC's administrative complaint against Impax charges that in 2010, Impax and Endo Pharmaceuticals Inc. illegally agreed that Impax would not compete by marketing a generic version of Endo’s Opana ER until January 2013. In exchange, Endo paid Impax more than $112 million.

Endo agreed to settle these charges in a stipulated order entered in federal court. See FTC v. Allergan plc, and Watson Laboratories, Inc. et al.

The Commission’s 2019 opinion held that the FTC staff had proven that the agreement between Impax and Endo Pharmaceuticals Inc. violated Section 5 of the Federal Trade Commission Act. The Commission’s opinion reversed Chief Administrative Law Judge D. Michael Chappell’s initial decision.

In April 2021, the U.S. Court of Appeals for the Fifth Circuit upheld the Commission’s opinion.

The FTC's complaint alleges that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Lidoderm.  The agreement not to market an authorized generic – often called a “no-AG commitment” – is the form of reverse payment.  The FTC’s complaint alleges that Endo paid the first generic companies that filed for FDA approval – Watson Laboratories, Inc. – to eliminate the risk of competition for Lidoderm, in violation of the Federal Trade Commission Act.  Lidoderm is a topical patch used to relieve pain associated with post-herpetic neuralgia, a complication of shingles.  Under federal law, the first generic applicant to challenge a branded pharmaceutical’s patent, referred to as the first filer, may be entitled to 180 days of exclusivity as against any other generic applicant upon final FDA approval. But a branded drug manufacturer is permitted to market an authorized generic version of its own brand product at any time, including during the 180 days after the first generic competitor enters the market. According to the FTC, a no-AG commitment can be extremely valuable to the first-filer generic, because it ensures that this company will capture all generic sales and be able to charge higher prices during the exclusivity period.  The FTC is seeking a court judgment declaring that the defendants’ conduct violates the antitrust laws, ordering the companies to disgorge their ill-gotten gains, and permanently barring them from engaging in similar anticompetitive behavior in the future.

Endo agreed to settle the charges in a proposed stipulated order to be entered by the court.

On 2/13/2008, the Commission filed a complaint in federal district court charging Cephalon, Inc. with preventing competition to its branded drug Provigil. The conduct under challenge includes paying four firms to refrain from selling generic versions of Provigil until 2012. Cephalon’s anticompetitive scheme, according to the Commission, denies patients access to lower-cost, generic versions of Provigil and forces consumers and other purchasers to pay hundreds of millions of dollars a year more for Provigil. According to the complaint, Cephalon entered into agreements with four generic drug manufacturers that each planned to sell a generic version of Provigil. Each of these companies had challenged the only remaining patent covering Provigil, one relating to the size of particles used in the product. The complaint charges that Cephalon was able to induce each of the generic companies to abandon its patent challenge and agree to refrain from selling a generic version of Provigil until 2012 by agreeing to pay the companies a total amount in excess of $200 million. In so doing, Cephalon achieved a result that assertion of its patent rights alone could not. In 2008, this case was transferred from the District Court of District of Columbia to the District Court for the Eastern District of Pennsylvania.