By Kurt R. Karst –
A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the latest salvo in a bigger battle between generic drug and brand-name drug manufacturers over access to drug product for purposes of bioequivalence testing and ANDA submission. This time the drug involved is AMPYRA (dalfampridine) Extended-release Tablets, which FDA approved on January 22, 2010 with 5-year New Chemical Entity (“NCE”) exclusivity and 7-year orphan drug exclusivity under NDA No. 022250 to improve walking in individuals with multiple sclerosis. Although AMPYRA is approved with a Risk Evaluation and Mitigation Strategy (“REMS”), the REMS does not include Elements To Assure Safe Use (“ETASU”) that requires restricted distribution of the drug product. Rather, the AMPYRA REMS, which is intended to address the risk of seizures, originally consisted of a Medication Guide, a communication plan, and a timetable for submission of assessments of the REMS. The REMS was subsequently modified – here and here – and now includes only a communication plan. Notwithstanding the absence of an FDA ETASU REMS for AMPYRA, the drug is available only through certain distributors, such as H.D. Smith, under a restricted distribution program adopted and implemented by Acorda.
The controversy over restricted distribution products and generic competition has been heating up over the last several months. As we previously reported, in 2012, Actelion Pharmaceuticals preemptively sued generic drug manufacturers seeking declaratory relief that Actelion is under no affirmative duty or obligation to supply prospective ANDA applicants with its brand-name drug product TRACLEER (bosentan) Tablets, which is under an ETASU REMS. The generic defendants in the case, which added another drug that is under a restricted distribution program but not an ETASU REMS – ZAVESCA (miglustat) Capsules – filed counterclaims alleging that Actelion abused its monopoly power in violation of Sections 1 and 2 of the Sherman Act and the New Jersey Antitrust Act by refusing to provide sample of the drugs. In March, the Federal Trade Commission filed an amicus brief (see our previous post here) saying that the allegations in the case “highlight a troubling phenomenon: the possibility that procedures intended to ensure the safe distribution of certain prescription drugs may be exploited by brand drug companies to thwart generic competition.” More recently, Actelion filed a Reply Brief in the case saying, among other things, that the company’s restricted distribution programs are protected from antitrust attack under the First Amendment and the Noerr-Pennington doctrine, because they are submissions to FDA that constitute petitioning. In addition, another company, Johnson Matthey, Inc., has entered the case as a defendant/counterclaim plaintiff (see the briefs here and here).
Accord Healthcare alleges in its Complaint that both Acorda and H.D. Smith refused to provide sample of AMPYRA in violation of federal and state antitrust laws, and that such refusals have caused significant delay in Accord Healthcare’s efforts to prepare an ANDA for generic AMPYRA. According to Accord Healthcare, in order to conduct the bioequivalence studies outlined by FDA in draft guidance on dalfampridine in time to submit an ANDA on the so-called “NCE-1” date of January 22, 2014 (i.e., when the first ANDA can be submitted to FDA containing a Paragraph IV certification to an Orange Book-listed patent covering AMPYRA) and, therefore, qualify for 180-day exclusivity, bioequivalence studies must begin in May 2013. “If samples are not obtained in time to begin the necessary clinical trials the central commercial incentive for preparing and filing an ANDA, the ability of Accord Healthcare to file an ANDA for approval of its generic product will be eviscerated,” says Accord Healthcare. The company continues, saying that “Ampyra® is therefore an essential facility.” This is a reference to the “essential facilities doctrine,” which is an exception to the general rule that a company has no obligation to deal with its competitors.
Accord Healthcare alleges that Acorda violated Section 2 of the Sherman Act, the Florida Antitrust Act, and tortiously interfered with a prospective business relationship by refusing to sell the company sample of AMPYRA at market prices for ANDA submission purposes, and is seeking preliminary and permanent mandatory injunctive relief and declaratory relief. Specifically, Accord Healthcare requests that the Florida district court compel Acorda to immediately sell Accord Healthcare sufficient quantities of AMPYRA at market prices so that the company can conduct bioequivalence testing, and declare that
Acorda is required to sell Accord Healthcare sufficient samples of the drug.