Antitrust Law Daily Wrap Up, ANTITRUST NEWS: Generic Drug Maker Asserts Antitrust Claims Against Brand-Name Manufacturer for Refusal to Sell Drug for Bioequivalence Testing, (Apr 2, 2013)

By Tobias J. Gillett, J.D., LL.M.

Generic pharmaceutical manufacturers Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (“Accord”) have filed a complaint in the federal district court in Fort Lauderdale, Florida, asserting that brand-name drug manufacturer Acorda Therapeutics and drug distributor H.D. Smith Wholesale Drug Co. violated the Sherman Act and the Florida Antitrust Act by refusing to permit Accord to purchase samples of Acorda’s multiple sclerosis medication for use in bioequivalence testing necessary to produce a generic version of the medication (Accord Healthcare, Inc. v. Acorda Therapeutics, Inc., April 1, 2013).

As part of the Food and Drug Administration’s approval process for a generic drug equivalent, the manufacturer must submit an abbreviated new drug application (ANDA) that demonstrates that the generic drug is bioequivalent to the brand-name drug. According to Accord’s complaint, providing proof of bioequivalence requires access to samples of the brand-name drug in order to perform testing to prepare the ANDA.

The Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act facilitate this process by requiring brand-name drug manufacturers to submit their patents for approved drugs for inclusion in the FDA’s Approved Drugs with Therapeutic Equivalence Evaluations. The Patent Code permits generic manufacturers to perform research on drugs in that publication without infringing the patents.

The FDA also has authority to require Risk Evaluation and Mitigation Strategies (REMS) from manufacturers regarding their drugs. The FDCA prohibits brand-name manufacturers from using a REMS “to block or delay approval of” an ANDA.

Acorda produces the only drug approved by the Food and Drug Administration that contains the active ingredient dalfampridine, called Ampyra. According to Accord’s complaint, Accord intends to produce a generic version of Ampyra, and must perform bioequivalence testing in order to prepare an ANDA for submission by January 22, 2104, the earliest date one can be submitted. Without samples of Ampyra, the complaint alleges, Accord will not be able to perform that testing, and therefore access to Ampyra is “an essential facility” wholly controlled by Acorda.

The complaint alleges that Accord sent letters to both Acorda and Acorda’s authorized distributor, H.D. Smith, attempting to obtain those samples and assuring them that Accord would implement all necessary controls under the REMS, but that those requests were denied. Accord alleges that the companies did not have valid business justifications for their refusals.

By refusing to sell samples of Ampyrato, Accorda “has unlawfully and willfully maintained its monopoly power” over the market for dalfampridine in the United States, in violation of Section 2 of the Sherman Act and the Florida Antitrust Act, Accord asserted. Acorda’s actions would prevent or delay access to the market by competitors, according to Accord.

Acorda’s refusal deprived Accord of access to an essential facility in the control of Acorda, the lawsuit maintained. Acorda has allegedly used this essential facility to maintain its monopoly power in the dalfampridine market, in violation of the Sherman Act and the Florida Antitrust Act. Accord asserts that it cannot obtain samples of Ampyrafrom any other sources.

Accord claims that Acorda’s refusal will restrain competition, permit Acorda to obtain monopoly profits on the drug, and force patients to pay artificially high prices. Accord seeks an injunction requiring Acorda to sell Ampyra to Accord at market prices for bioequivalence testing, a declaration of Acorda’s obligation to sell Ampyra at market prices for testing, treble damages under the antitrust laws, and an award of attorneys’ fees.

The case is No. 0:13-cv-60742.

Attorneys: Devang Desai (Gaebe, Mullen, Antonelli, & DiMatteo, PA) for Accord Healthcare, Inc.

Companies: Accord Healthcare, Inc.; Intas Pharmaceuticals, Ltd.; Acorda Therapeutics, Inc.; H.D. Smith Wholesale Drug Co.

News: Antitrust FloridaNews