In re Lantus Direct Purchaser Antitrust Litig., 18-2086, 2020 WL 728628 (1st Cir. Feb. 13, 2020)
This class-action antitrust decision from the 1st Circuit reversed a lower court dismissal — holding that consumers had alleged sufficient injury based upon Sanofi’s improper listing of patents in the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations).
The court explains:
The principal questions posed on this appeal are whether Sanofi improperly submitted a patent for listing in the Orange Book and, if so, whether Sanofi is potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi’s monopoly. We answer “yes” to both questions and vacate the dismissal of the plaintiffs’ complaint to the extent that the district court held otherwise.
The FDA statute calls for listing of patents “which claim[ ] the drug for which [an application is submitted] or which claim[ ] a method of using such drug.” 21 U.S.C. § 355(b)(1).
Here, the listed patent at issue is US Patent 8,556,864 which covers the drive mechanism for Sanofi’s SoloSTAR Insulin Pen. The Orange Book listing is important because it can be used to trigger a 30-month stay of FDA approval of a competitor’s product. The drive mechanism is apparently part of the SoloSTAR pen thus it appears that a generic knock-off competitor would infringe the patent. But, the appellate panel still held that it was improperly listed in the orange book since the patent does not claim the drug or a method of using the drug. The court writes:
[B]ecause the claims of the ‘864 patent do not mention the drug for which the sNDA was submitted, the patent does not “claim the drug,” and it was improper for Sanofi to have submitted it for listing in the Orange Book as a drug claiming either insulin glargine or the Lantus SoloSTAR. The regulations clearly require a patent not to be submitted if it does not claim the drug for which the application was filed: “For patents that claim a drug product, the applicant must submit information only on those patents that claim the drug product, as is defined in § 314.3, that is described in the pending or approved NDA.” 21 C.F.R. § 314.53(b)(1) (emphasis added).
On remand, the district court will take-up the case again and likely focus on whether the improper listing actually caused harm to consumers.