Categories & Search

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus and Lantus SoloSTAR, which use the insulin product glargine to treat Type I and Type II diabetes.  The plaintiffs in the multi-district litigation, a group of purchasers of the Lantus products, alleged that Sanofi unlawfully prolonged its monopoly for the glargine products after the expiration of the relevant patent in two ways.  First, the plaintiffs alleged that Sanofi improperly listed six patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).  Second, the plaintiffs alleged that Sanofi pursued sham litigation against Eli Lilly in which Sanofi asserted claims of patent infringement without any reasonable basis. That litigation was settled by Sanofi and Lilly shortly before trial.

The District Court held that plaintiffs did not present a plausible case for relief under the Sherman Act on either claim.  As to the Orange Book claim, FDA regulations provide that, when filing a New Drug Application (“NDA”) the applicant should include “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.”  The applicant should exclude “[p]rocess patents [and] patents claiming packaging.” 21 C.F.R. § 314.53 (b)(1). In 2007, when seeking approval for the Lantus SoloSTAR, Sanofi included a patent relating to its injector pen device, sold preloaded with a dosage of insulin glargine. 

Plaintiffs alleged that the inclusion of the injector-pen patent in the Orange Book listing was an attempt to maintain or acquire monopoly power by improper means because it was a packaging patent which should not have been listed, rather than a drug patent.  The Court found that the “FDA has expressly interpreted ‘drug products’ which must be listed in the Orange Book to include "pre-filled drug delivery systems” and the plaintiffs conceded that the Lantus SoloSTAR was “sold as a pre-filled drug delivery system.”  According to the Court, “while it may be debatable whether the Lantus SoloSTAR fits neatly into the category of patents that must be disclosed, it does not fit into the category of patents that must not be disclosed.”  Thus, the plaintiffs could not use the allegedly improper Orange Book listing as a basis for an antitrust claim.

As to the sham litigation claim, plaintiffs alleged that Sanofi’s patent infringement litigation against Lilly was objectively baseless and concealed an attempt to interfere directly with the business relationships of a competitor, and therefore not immune from antitrust scrutiny under the Noerr-Pennington doctrine.  According to the plaintiffs, Sanofi knew that Lilly’s competitive product did not infringe the asserted patent.

The District Court held that the facts as alleged did not establish that the patent litigation was objectively baseless.  The Court explained that other than “repeatedly stating” that the Lilly products would not infringe, “[t]he plaintiffs have offered no facts in support of these conclusions.”  The Court also found that other factors supported the conclusion that the suit was not objectively baseless. The asserted patents had never been invalidated or found unenforceable, the suit went on for a year and was “heavily contested” and the parties’ settlement included a payment of royalties on the sale of Lilly products.

The Court’s decision provides additional clarity on the circumstances under which an Orange Book listing can conceivably lead to antitrust liability, requiring that the antitrust plaintiff to show clearly that the patent is one the regulation requires be excluded, rather than forcing the patentholder to prove that it is one the regulation clearly allows.  It also further maps the contours of the Noerr-Pennington doctrine.  In doing so, the Court appears to have been trying to limit speculative claims surrounding prior litigation.