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From Antitrust Law Daily, January 11, 2018

Monopoly claims based on Orange Book lists, sham litigation fail

By Nicole D. Prysby, J.D.

Purchasers of the insulin glargine products Lantus and Lantus SoloSTAR, which are used in the treatment of Type I and Type II diabetes, failed to allege monopoly claims against Sanofi-Aventis U.S. LLC based on purported improper listing of patents in the Food and Drug Administration (FDA) Orange Book or pursuing alleged sham litigation, held a federal district court in Boston. It was not clear from FDA guidance whether drug delivery devices such as pen injectors should be listed in the Orange Book. Therefore doing so was not objectively unreasonable. In addition, the litigation to enforce to patent was not sham litigation, based on the protracted length of the case and the details of the settlement, which provided royalty payments to the patent holder and delayed the entry into market for the competing product (In re Lantus Direct Purchaser Antitrust Litigation, January 10, 2018, Dein, J.).

Monopoly claims. The plaintiffs were two corporations that purchased insulin-glargine products from Sanofi, the manufacturer. They claimed Sanofi had improperly delayed the market entry of a competitive product marketed by Eli Lilly by improperly listing patents in the Orange Book and by pursuing sham patent infringement litigation against Lilly.

Sanofi is the holder of the original patent for insulin glargine, a patent that expired in 2015. Sanofi also obtained a patent for an injector pen (‘864) which expires in 2024 and relates to a "pre-drug-filled delivery device." It does not mention insulin glargine. Sanofi listed the pen patent in the FDA’s Orange Book.

Lilly developed a competing injector-pen product for insulin glargine, which it planned to market as soon as Sanofi’s patent for insulin glargine expired in 2015. Just prior to FDA approval for Lilly’s injector-pen product, Sanofi filed a lawsuit, claiming infringement. Lilly and Sanofi settled their claims.

Orange Book listing. One purpose of the Orange Book was to provide generic manufacturers with notice of any patent rights implicated by a brand-name drug. The plaintiffs argued that Sanofi improperly listed patent ‘864 in the Orange Book, as it was merely a package change. But the court found it was not unreasonable for Sanofi to have listed patent ‘864 in the Orange Book, because the FDA had interpreted the Orange Book requirement to include pre-filled drug delivery systems. The plaintiffs also argued that the ‘864 patent should not have been listed, because it did not claim the finished dosage form of the approved drug product. But the court found that it was not clear whether FDA regulations contain that requirement, and even if so, Sanofi’s decision to list the ‘864 patent in the Orange Book was not objectively baseless. On a number of occasions, a drug manufacturer had asked the FDA whether patents directed to drug delivery systems that do not recite the approved ingredients or formulation should be listed in the Orange Book, and the FDA has failed to provide guidance on the issue. Therefore, Sanofi’s interpretation of the requirement was not unreasonable.

Sham litigation. The court noted the high standard to prevail on a claim of sham litigation. The filing of a lawsuit was generally protected activity under the First Amendment, as recognized by the Noerr-Pennington doctrine, and the immunity was lost only if the litigation was a sham. The plaintiffs had to establish that Sanofi had no reasonable basis to believe that its patent claims were valid or that they were infringed. The court found that the plaintiffs failed to present sufficient facts to meet this standard; the only allegations were that Sanofi had information in its possession regarding the ingredients in Lilly’s product and the type of delivery device to be used. These facts were insufficient to show that that Sanofi knew Lilly’s product would not infringe any of Sanofi’s claims.

As further proof that Sanofi’s actions in protecting the ‘864 patent were not objectively unreasonable, the court looked to the litigation between Lilly and Sanofi. In that litigation, Lilly and Sanofi engaged in a claim construction dispute in which the court adopted and rejected some of each of the parties’ suggestions about how the ‘864 patent should be interpreted. The fact that the case was heavily contested for a period of time, combined with the details of the settlement (which delayed Lilly’s entry into the market until 2016 and provided some royalty payments to Sanofi) provide further support for the conclusion that it was not sham litigation. Therefore, the court found, the complaint should be dismissed.

The case is No. 16-12652-JGD.

Attorneys: David P. Germaine (Vanek Vickers & Masini PC) for FWK Holdings LLC. Bradley J. Demuth (Nussbaum Law Group, PC) for Cesar Castillo, Inc. Alisha M. Crovetto (Jones Day) for Sanofi-Aventis U.S., LLC.

Companies: Sanofi-Aventis U.S., LLC

MainStory: TopStory Antitrust MassachusettsNews

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