Published on Nov 15, 2023
On November 7, the FTC disputed more than 100 patents on asthma inhalers, EpiPens and other drug products that the agency claimed were improperly listed in the Orange Book, a publication of FDA-approved drugs and drug products and their patent protections.
The FTC sent letters to 10 brand-name drug manufacturers: Teva Branded Pharmaceuticals, Norton Limited, Mylan Specialty, Kaleo Inc., Impax Labs, GlaxoSmithKline (GSK), Glaxo Group, Boehringer Ingelheim, AstraZeneca (AZN) and AbbVie (ABBV). Per the FDA’s Orange Book dispute process, the companies have thirty days to amend, withdraw or recertify the flagged patents. Those who recertify run the risk of an FTC lawsuit or criminal referral.
The FTC’s move relies on a 2020 ruling in a case called In re Lantus Direct Purchaser Antitrust Litigation. The case, which concerns Sanofi’s injectable insulin glargine product, branded as Lantus, established that Orange Book patents, including ones related to devices, must claim the drug for which the company submitted its application for FDA approval.
“They’re only supposed to list patents covering active drug ingredients, so the substance of the drug that helps your body heal,” FTC Chair Lina Khan said in a recent interview with NPR. “Instead, we have found that firms are listing device patents that have absolutely nothing to do with the active ingredient, so patents that are instead covering the dispenser cap on a multidose eye dropper or the cap strap on an inhaler, which just keeps the inhalers in place.”
Khan added, “We’ve identified patents covering these components of devices that we think are improperly listing and that may in fact be resulting in Americans having to pay hundreds, if not thousands, of dollars more than they should be.”
In the policy statement that alerted the industry to the FTC’s focus on improper Orange Book listings, the FTC cited the Lantus ruling to establish that improper Orange Book listings may constitute an improper means of competition.
“A number of factors influenced the FTC’s recent actions, including the Lantus decision, which clearly states the law,” an FTC spokesperson told The Capitol Forum. “We also focused on device patents because inhalers and EpiPens are not affordable for so many Americans who rely on them.”
An in-depth look at Lantus. In 2017, a group of direct insulin glargine purchasers filed an antitrust lawsuit against Sanofi for allegedly restricting competition for Lantus insulin injectables—keeping prices high. The plaintiffs alleged that over two dozen of Sanofi’s patents were improperly listed and that Sanofi had abused patent litigation to block competition.
The FDA requires patents in the Orange Book to claim a drug substance, a drug product, or a method of use. According to the plaintiffs, the patents at issue failed to meet these criteria.
A district court dismissed the lawsuit, arguing that Sanofi’s listings were reasonable. The plaintiffs appealed specifically on a patent claiming the drive mechanism of the Lantus SoloSTAR insulin pen.
Reversing the district court’s decision, the First Circuit found that the patent was improperly listed because it did not claim the drug for which the New Drug Application (NDA) was submitted.
“The statute and regulations clearly require that only patents that claim the drug for which the NDA is submitted should be listed in the Orange Book,” the ruling said.
The First Circuit pointed specifically to the FDA’s regulatory text in its decision, stating, “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.’”
A drug product, according to the FDA’s definition, is a finished dosage form of a drug substance—meaning the active ingredient.
Even if the SoloSTAR injector itself separately qualified as a “drug product”—an argument that indeed “finds support in FDA guidance”—the patent on the drive mechanism for that injector wasn’t valid, the court said.
“We see nothing in the statute or regulations that welcomes such a further expansion of the already stretched statutory terms, whereby an integral part of an injector pen becomes the pen itself, and in turn is a drug,” the ruling said.
The case was returned to the district court for further proceedings.
The 2020 Lantus ruling has been followed by more litigation on Sanofi’s (SFNY) alleged patent thicket around Lantus injections. In a lawsuit filed against Sanofi in May 2023, Mylan, now merged with Viatris (VTRS), alleged that Sanofi established a series of patents between 2011 and 2017 that were all “improperly listed in the Orange Book for the sole purpose of delaying competition.” Mylan alleged that none of these patents, which related to injectors, claimed insulin or insulin glargine.
Viatris did not respond to a request for comment by press time. Sanofi provided the following statement: “Sanofi has not submitted any patents to FDA for the purpose of blocking competition. As with any patent we hold, we take steps to defend our patents against infringement. When we do so, we hold ourselves to the highest ethical and legal standards.”