03/24/26 | Court Issues Order Regarding Summary Judgment
On Mar. 24, 2026, U.S. District Judge Leo T. Sorokin issued an order on summary judgment, adopting the report and recommendation of Chief Magistrate Judge Jennifer Boal. The court rejected Sanofi’s motion for summary judgment in its entirety and granted the purchasers’ summary judgment in part. The court agreed with the purchasers that Sanofi improperly submitted the Lantus SoloStar device patents to the FDA for Orange Book listing and granted summary judgment on that issue. Meanwhile, the court found there were genuine disputes of the material fact with respect to causation and Sanofi’s affirmative defense. The purchasers’ claims will proceed to trial at a date yet to be determined.
In 2017, Hagens Berman filed a federal antitrust class action on behalf of a class of direct purchaser plaintiffs against Sanofi alleging the company engaged in a multifaceted scheme to unlawfully extend its monopoly over its multibillion-dollar per-year injectable insulin glargine product, Lantus.
At the center of that scheme, the suit alleges, is Sanofi’s decision to improperly submit more than two dozen patents claiming mechanical aspects of an injection pen in the FDA’s Orange Book—a list in which only patents claiming a drug or a method of using a drug may be listed. The complaint alleges that this enabled Sanofi to sue would-be competitors over those ineligible pen patents, securing a 30-month delay in the FDA’s ability to approve competing products.
The direct purchasers allege Sanofi did this solely for the purpose of delaying the availability of affordable alternatives to Sanofi’s expensive Lantus product, forcing purchasers to pay hundreds of millions of dollars, if not billions, more for life-saving insulin.
CASE TIMELINE
Although the district court initially dismissed the case, in February 2020, the direct purchasers secured a victory on appeal. The First Circuit Court of Appeals held that Sanofi had improperly submitted its pen patent for listing in the Orange Book and, accordingly, the company is potentially liable under the antitrust laws.
The case has been returned to the district court to proceed into discovery and toward trial.
