Tag: Prescription Drugs

The FTC filed a complaint in federal district court in September 2014 charging that AbbVie Inc. and its partner Besins Healthcare Inc. illegally blocking American consumers’ access to lower-cost alternatives to Androgel by filing baseless patent infringement lawsuits against potential generic competitors. In a June 2018 decision, the U.S. District Court for the Eastern District of Pennsylvania ruled that AbbVie used sham litigation to illegally maintain its monopoly over the testosterone replacement drug Androgel, and ordered $448 million in monetary relief to consumers who were overcharged for Androgel as a result of AbbVie’s conduct.

In September 2020, the Third Circuit affirmed the district court’s finding of liability on the FTC’s sham litigation claim, and reinstated the reverse payment claim, two important legal victories that protect competition in pharmaceutical markets.

While handing the Commission important legal victories, the Third Circuit reversed the district court’s nearly half-billion dollar monetary judgment for consumers, holding that the FTC is not entitled to disgorgement under 13(b) of the FTC Act. This determination was effectively affirmed by the Supreme Court’s decision in AMG Capital Management v. FTC.

Since the initial filing of the lawsuit, generic AndroGel products have entered the market, so that patients now benefit from competition among multiple suppliers. AbbVie and Teva are also now subject to Commission orders preventing them from entering into certain reverse-payment settlements. On July 30, 2021, the Commission announced that it has withdrawn its reverse-payment claim from federal district court, ending its litigation against AbbVie.

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 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.

Pharmaceutical companies AbbVie Inc. and Allergan plc have agreed to divest assests to settle Federal Trade Commission charges that AbbVie's proposed $63 billion acquisition of Allergan would violate federal antitrust law. On Sept. 4, 2020, the Commission announced the final consent agreement in this matter.