By Jeffrey May, J.D.
The Noerr-Pennington doctrine barred claims against Sandoz Inc. and Momenta Pharmaceuticals, Inc. for restraining competition in the market for generic enoxaparin, an anticoagulant used to prevent blood clots, because the injuries alleged by a complaining drug maker were the result of a Food and Drug Administration (FDA) action and not the conduct of the defending firms. Consequently, the federal district court in Boston dismissed Amphastar Pharmaceuticals, Inc.‘s antitrust claims based on the firm’s inability to compete in the market (Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., July 27, 2016, Gorton, N.).
Amphastar claimed that shortly after it received FDA approval to sell generic enoxaparin, the defendants, who until that point were the sole source of generic enoxaparin, took steps to prevent Amphastar from competing and driving down the cost of the drug. The defendants filed suit against Amphastar for infringing a patent during the course of its manufacture and sale of generic enoxaparin products. Amphastar apparently violated the patent when using a method for establishing a drug standard to test enoxaparin products selected by the U.S. Pharmacopeial Convention (USP) and as required by the FDA.
According to Amphastar, as part of the alleged scheme, the defendants entered into a collaboration agreement to develop, market, and sell "enoxaparin sodium injection" in the United States. The agreement granted an exclusive license to Sandoz for the so-called ‘886 patent, which concerned the testing process used in manufacturing enoxaparin. Amphastar also alleged that the defendants abused the standard setting process by violating their duty to disclose conflicts of interest to the USP when it was establishing the standard to test enoxaparin products. Amphastar contended that, as a result of this conduct, it was prevented from competing in the market.
Noerr-Pennington doctrine. Noerr-Pennington immunity from an antitrust attack applies when the anti-competitive restraint on trade results directly from government action and not from private action seeking to elicit government action, the court explained. Amphastar’s antitrust injuries included "damaged reputation, reduced financing upon IPO, and lost profits on sales" suffered as a result of the injunction in the patent infringement case, which precluded it from selling generic enoxaparin. The court concluded that the asserted injuries arose from the FDA’s purported adoption of the test method and not from the defendants’ execution of the collaboration agreement or the USP’s adoption of the test method. While the Noerr-Pennington doctrine would not bar antitrust claims for anticompetitive effects resulting from the collaboration agreement or the purported failure to disclose conflicts to the USP, the court noted that Amphastar did not claim federal antitrust injuries under those theories of antitrust liability.
Moreover, because Amphastar failed to show how Momenta’s purported misconduct fell within the sham exception to the Noerr-Pennington doctrine, the court found conclusory assertions that the sham exception applied unpersuasive. Lastly, Amphastar’s failure to assert a federal antitrust claim required dismissal of its California Cartwright Act as well.
The case is No. 1:16-cv-10112-NMG.
Attorneys: Anna Rachel Dray-Siegel, Office of the Attorney General, for Momenta Pharmaceuticals, Inc. Alison L. Nadel (McDermott, Will & Emery LLP) for Sandoz Inc. Douglas H. Carsten (Wilson Sonsini Goodrich & Rosati) and Jennifer A. Mauri (Michelman & Robinson, LLP) for Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd. and Actavis, Inc.
Companies: Momenta Pharmaceuticals, Inc.; Sandoz Inc.; Amphastar Pharmaceuticals, Inc.; International Medication Systems, Ltd.; Actavis, Inc.
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