Antitrust claim for improper Orange Book listing of auto-injector patent dismissed at pleadings stage.

It’s not often that an antitrust complaint is dismissed before the defendant is required to answer the complaint, but it happened recently in the United States District Court for Massachusetts, and should come as great comfort to any company considering whether to list a drug delivery device patent in the Orange Book.  In re Lantus Direct Purchaser Antitrust Litig., 2018 U.S. Dist. LEXIS 4503 (D. Mass. January 10, 2018).

The drug product at issue, Lantus SoloSTAR®, is an insulin glargine auto-injector marketed by Sanofi Aventis US, LLC (“Sanofi”). In addition to a compound patent for insulin glargine, which expired on February 12, 2015 with pediatric exclusivity, Sanofi had listed an auto-injector patent (U.S Patent No. 8,556,864, expiring in 2025 with pediatric exclusivity) in the Orange Book when Eli Lilly and Company (“Lilly”) filed a 505(b)(2) application seeking approval to market a competitive insulin glargine auto-injector.  Sanofi sued Lilly under the Hatch Waxman Act based on the ‘864 patent and, on the eve of trial, settled with Lilly.  The settlement agreement required Lilly to pay a royalty to Sanofi under the ‘864 patent, and precluded Lilly from launching its product until December 15, 2016.

The plaintiffs in the case are purchasers of insulin glargine, and alleged that they would have purchased Lilly’s less expensive product had it been marketed sooner.  According to the plaintiffs, the ‘864 patent was not eligible for listing in the Orange Book, and Sanofi unlawfully monopolized the market for insulin glargine auto-injectors when it listed the ‘864 patent in the Orange Book.

Sanofi’s filed a motion to dismiss shortly after receiving the complaint.  The motion turned primarily on the distinction between “packaging” patents, which are not supposed to be listed in the Orange Book, and “drug product” patents, which should be listed. As explained by the Court, FDA’s

“21 C.F.R. § 314.53 (b)(1) dictates which patents applicants must list in the Orange Book when filing an NDA. The regulation provides that applicants should list ‘patent[s] that claim[] the drug or a method of using the drug . . . [which] consist of drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method-of-use patents.’ Section 314.53 also identifies those patents applicants should exclude, explaining that ‘[p]rocess patents [and] patents claiming packaging . . . are not covered by this section, and information on these patents must not be submitted to FDA.’”

While the regulation does not expressly state that a delivery device patent is a “drug product” patent, an appendix to the Orange Book lists current dosage forms for approved drug products, and specifically lists metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems as approved dosage forms.

To counter this evidence, the Plaintiffs argued that the ‘864 patent did not cover the drug product because the claims did not specifically recite insulin glargine.  In response, Sanofi cited seven letters industry had written to FDA asking FDA to clarify whether a patent that claims a drug delivery device such as an auto-injector or an inhaler would qualify as a “drug product” patent, even though the claims of the patent did not recite the drug substance. As told by the Court:

“Since at least 2005, drug manufacturers have sought to determine whether patents directed to drug delivery systems that do not recite the approved active ingredients or formulation should be listed in the Orange Book. … Thus, by the time of Lilly's Paragraph IV Certification, the FDA had been informed that a number of drug manufacturers were listing their drug delivery systems in the Orange Book, even if the relevant patents did not claim ‘the finished dosage form of the approved drug product,’ but had not indicated that such a listing was improper.

FDA’s lack of a response to these industry letters was fatal to the Plaintiff’s claims because, to violate the antitrust laws, Sanofi’s actions must at a minimum have been unreasonable or objectively baseless. As explained by the Court,

“it is clear from these requests that the issue whether the '864 patent should have been listed is an open question in the industry. …The plaintiffs have pled no other facts that lead to the conclusion that Sanofi knew or should have known that its listing of the '864 patent was incorrect. Therefore, the Sherman Act [antitrust] claims, insofar as they rely on the improper Orange Book listing of the '864 patent, are dismissed.”

The decision should give great comfort to innovators considering whether to list a patent for a drug delivery device in the Orange Book, even if the device was not designed specifically for the drug substance approved by FDA, and the patent does not claim the drug substance specifically.