Antitrust Law Daily Wrap Up, ANTITRUST NEWS: Gilead Sciences alleged to have blocked access to Letairis for bioequivalence testing, (Aug 26, 2014)

By Linda O’Brien, J.D., LL.M.

Gilead Sciences, which manufactures the pharmaceutical ambrisentan under the brand name Letairis, has refused to allow a competing pharmaceutical company access to samples of Letairis for the purpose of conducting bioequivalence testing of its proposed generic version of Letairis, according to a complaint filed in the federal district court in St. Paul, Minnesota (Natco Pharma Ltd. v. Gilead Sciences, Inc., August 22, 2014).

Gilead Sciences, Inc. is the manufacturer of ambrisentan, marketed under the brand name Letairis, which is used for the treatment of pulmonary hypertension. Express Scripts is a distributor of Letairis. Natco Pharma intends to seek Food and Drug Administration (FDA) approval to market a generic version of ambrisentan.

The complaint states that, before marketing a new drug in the United States, a manufacturer must obtain FDA approval for its new drug application. The application must contain data on the composition of the drug, along with evidence that the drug is safe and effective for its proposed uses. A manufacturer demonstrates that its generic drug is as safe and effective as the approved brand name drug, or reference listed drug (RLD), by showing that the generic drug is bioequivalent to the RLD.

A generic drug is a version of a brand name drug that contains the same active ingredient as the brand name drug but typically sells at a lower cost. Accordingly, generic drugs are frequently prescribed in an effort to control health care costs and represent an increasing portion of the medicines used in the United States. Natco has experience in the development, manufacture, sale, marketing, and distribution of pharmaceutical products, including the development and products of drug products from concept to FDA approval. Natco identified a need for a generic version of Letairis and developed a generic drug that it believes is bioequivalent to Letairis, the complaint states.

In June 2014, Natco attempted to purchase samples of Letairis for bioequivalence testing through normal wholesale channels but was unable to do. Natco also tried to purchase samples of Letairis from Gilead. However, Gilead declined to provide the samples and responded that Natco should attempt to purchase the sample through normal distribution channels. Natco then contacted Express Scripts, one of Gilead’s approved distributors of the drug, and requested to purchase Letairis samples. To date, Express Scripts has failed to respond to Natco’s requests, the complaint charges.

According to the complaint, Gilead is the holder of several patents for Letairis that are scheduled to expire in July 2018. Letairis is an extremely profitable drug for Gilead and has an average monthly whole price of over $2,000. Gilead currently controls 100 percent of the commercial market for pharmaceutical ambrisentan and has used its monopoly power to keep prices for ambrisentan drug products artificially high and quantities artificially low. Gilead has also raised the cost of entry into the market by blocking access to Letairis for the purpose of bioequivalence testing.

The plaintiff asserts claims for restraint of trade, monopolization, attempted monopolization, conspiracy to monopolize, and violations of Sections 1 and 2 of the Sherman Act and Minnesota Antitrust Act. The action seeks declaratory and injunctive relief, treble damages, interest, costs of suit, attorney fees, and any other just and proper relief.

The case is No. 0:14-cv-03247-DWF.

Attorneys: Jeffer Ali, Peter Kohlhepp, Christopher A. Pinahs (Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.) for Natco Pharma Ltd.

Companies: Natco Pharma Ltd.; Gilead Sciences, Inc.; Express Scripts Holding Co.

News: Antitrust MinnesotaNews