Purchasers of a diabetes drug can pursue antitrust claims based on allegations that drugmaker Sanofi-Aventis wrongfully extended its monopoly by improperly listing a patent in the US Food & Drug Administration’s (FDA) “Orange Book,” the 1st US Circuit Court of Appeals has determined.
The “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, known in the pharmaceutical industry as the Orange Book, identifies drug products approved by the FDA and includes related patent and exclusivity information. The listing of a patent in the Orange Book enables the patent holder to later trigger an automatic 30-month suspension of the FDA’s approval of competing products.
The plaintiffs in the case argued that Sanofi improperly listed in the Orange Book a patent for a pen injector used to administer Lantus to diabetes patients. According to the plaintiffs, the improper listing was designed to extend Sanofi’s monopoly and thereby keep cheaper generic drugs off the market.
In reversing a dismissal by US Magistrate Judge Judith Dein in Boston, the 1st Circuit concluded that the plaintiffs stated a plausible claim for antitrust liability.
“We … hold that the facts and reasonable inferences found in the complaint describe an improper submission of the ‘864 patent for listing in the Orange Book [and] that the defenses to antitrust liability as a result of such an improper submission include proving that the submission was the result of a reasonable, good-faith attempt to comply with the Hatch-Waxman [Amendments] scheme,” Judge William J. Kayatta Jr. wrote for the unanimous 1st Circuit panel.
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