Antitrust Law Daily Wrap Up, ANTITRUST NEWS: Pharmaceutical company sued for denying access to drug for bioequivalence testing, (Nov 17, 2014)

By Linda O’Brien, J.D., LL.M.

Pharmaceutical company Gilead Sciences, which manufactures ambrisentan under the brand name Letairis, has refused to allow a competitor access to samples of Letairis for the purpose of conducting bioequivalence testing of its proposed generic version of the drug, according to a complaint filed in the federal district court in Trenton, New Jersey (Zydus Pharmaceuticals Inc. v. Gilead Sciences, Inc., November 11, 2014).

Gilead Sciences, Inc. is the manufacturer of ambrisentan oral tablets, marketed under the brand name Letairis, which is used for the treatment of pulmonary arterial hypertension (PAH). Zydus Pharmaceuticals, the U.S. division of Cadila Healthcare Limited, develops, manufactures, and sells generic pharmaceuticals. Zydus intends to seek Food and Drug Administration (FDA) approval to market a generic version of ambrisentan. Currently there are no generic alternatives to Letairis.

Zydus has attempted to purchase ambrisentan tablets for bioequivalence testing through commercial suppliers but was unable to do. Ambrisentan is distributed exclusively by specialty pharmacies, which dispense medications for certain conditions that require ongoing patient education and counseling.

In June 2014, Zydus contacted Gilead requesting to purchase Letairis for use in bioequivalence testing as part of the development of its product. Zydus offered to pay Gilead the wholesale acquisition costs for the sample in addition to any shipping and handling. Gilead failed to respond to Zydus’ June 2014 letter or to Zydus’ follow up correspondence in July 2014. To date, Gilead has refused to sell samples of Letairis to Zydus, the complaint alleges.

According to the complaint, Gilead has a 100 percent market share in the market for ambrisentan. Gilead’s actions have caused significant delays in Zydus’ development of a generic alternative.

Letairis is not reasonably interchangeable with other drugs used to treat PAH in the United States as physicians do not view other drugs approved by the FDA to treat PAH to be close substitutes for Letairis. Through its anticompetitive conduct, Gilead was able to charge above competitive prices for Letairis while increasing sales at the same time, according to the complaint.

The plaintiff asserts claims for tortious interference with economic advantage, and monopolization and attempted monopolization in violation of the Sherman Act and New Jersey Antitrust Act. The action seeks declaratory and injunctive relief, compensatory and treble damages, costs of suit, attorney fees, and any other just and proper relief.

The case is No. 3:14-cv-07080-FLW-LHG.

Attorneys: Eric I. Abraham and Christina L. Saveriano (Hill Wallack LLP) and Michael J. Gaertner, Randall A. Hack, and Andy J. Miller (Locke Lord LLP) for Zydus Pharmaceuticals Inc. and Cadila Healthcare Limited.

Companies: Zydus Pharmaceuticals Inc.; Cadila Healthcare Limited; Gilead Sciences, Inc.

News: Antitrust NewJerseyNews