Maryland Class Action Lawsuit Contends Pharmaceutical Company Unlawfully Barred Generic Version Of Its Drug

On November 20, 2018, a proposed federal class action lawsuit was filed in the United States District Court for the District of Maryland against Actelion Pharmaceuticals Ltd., Actelion Clinical Research, Inc., and Actelion Pharmaceuticals US, Inc. (“Actelion”) alleging that Actelion engaged in an “illegal scheme to maintain its monopoly over the prescription drug bosentan.”

Bosentan is a dual endothelin receptor antagonist that Actelion sells as a treatment for pulmonary artery hypertension (“PAH”) under the brand name “Tracleer.” PAH is a relatively rare, but chronic, and potentially fatal disorder in which elevated blood pressure in the arteries of the lungs causes the heart to work harder than normal. It affects between 10,000 and 20,000 people in the U.S. — most of them women. PAH is a progressive condition. Without treatment, only about 70% of patients survive a year after diagnosis. PAH is also an extremely expensive condition to treat. In 2016, America’s Health Insurance Plans, an industry organization of health insurers, estimated that average drug spending for PAH patients was between $103,464 and $196,560 per year.

The proposed class action lawsuit alleges that while Tracleer is a highly profitable drug (billions in sales for Actelion) and Actelion’s regulatory and patent exclusivity over the use of bosentan to treat PAH expired by November 20, 2008 and November 20, 2015, respectively, no generic manufacturer has brought a generic bosentan to market. At least four manufacturers started the process of bringing a generic bosentan to market, but Actelion allegedly unlawfully blockaded the regulatory process for generic manufacturers to proceed and, thereby, illegally maintained its monopoly over bosentan.

The proposed class action lawsuit alleges that Actelion blocked would-be generic bosentan manufacturers from obtaining samples of Tracleer. This prevented a generic version of bosenten coming to market because in order to obtain FDA approval of a generic drug application, a generic manufacturer must run comparison tests to establish that the brand and the generic are bioequivalent — that is, that the generic is absorbed in the body at the same rate and to the same extent as the brand. Doing so requires samples of the brand product. Without these samples, generic manufacturers cannot complete the regulatory process and cannot bring a competing generic to market.

The proposed class action lawsuit alleges that Actelion prevented would-be generic bosentan competitors from purchasing samples of Tracleer by forbidding its distributors from selling Tracleer to those generic manufacturers and refusing to sell Tracleer directly to the manufacturers as well. By doing both, Actelion allegedly blocked every path generic manufacturers had to obtain samples of Tracleer.

The proposed class action lawsuit alleges that, unable to get samples of Tracleer from distributors as they usually would, at least
four generic manufacturers requested samples directly from Actelion, offering to pay the market price for the samples. Actelion refused, allegedly offering subterfuge for its reason. Tracleer carries risks of serious liver damage and birth defects if taken during pregnancy. Therefore, the FDA approved Actelion’s New Drug Application (“NDA”) for Tracleer subject to two restrictions: (1) a “black box” warning on Tracleer’s packaging, and (2) Actelion’s implementation of a Risk Evaluation and Mitigation Strategy (“REMS”) for Tracleer. Actelion cited its REMS as the reason it would not sell to would-be generic competitors.

The proposed class action lawsuit alleges that Actelion cited the safety protocols imposed by FDA as the reason it refused to sell Tracleer samples to generic manufacturers (and the reason it prevented its distributors from selling them as well). Congress has specified however, that REMS may not be used to delay generic competition. The FDA has also expressly indicated that REMs do not prevent distributors from selling samples to generics nor empower the NDA holder to veto such sales. Indeed, the FDA has repeatedly confirmed that allowing the generics to buy samples does not run afoul of the FDA’s required safety protocols, both generally and with respect to Tracleer specifically.

The proposed class action lawsuit alleges that Actelion wanted to keep its competitors out of the market in order to prevent competition and prolong its monopoly well past its period of legitimate exclusivity, and this is the only logical explanation for Actelion foregoing potential sales, but it is allegedly illegal: the FTC, the FDA, courts, and commentators all agree that the antitrust laws do not tolerate such exclusionary conduct.

The proposed class action lawsuit alleges that Actelion’s anticompetitive scheme has been 100% effective. To date, no generic Tracleer is available in the U.S. nearly three years after the expiration of the Tracleer patent. Actelion’s alleged scheme has forced Plaintiff and other purchasers to pay higher prices for bosentan for far longer than they otherwise would have. Absent Actelion’s years-long blockade, one or more generics would have been available at or around the expiration of Tracleer’s patent protection in November 2015. Actelion’s alleged unlawful conduct has prevented generic manufacturers from entering the market with competing generic bosentan products and has cost purchasers hundreds of millions of dollars in overcharge damages.

GOVERNMENT EMPLOYEES HEALTH ASSOCIATION V. ACTELION PHARMACEUTICALS LTD, ET AL., Case 1:18-cv-03571-CCB.

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