On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of patents” in the Food and Drug Administration’s (“FDA”) “Orange Book.” The FTC also stated that it had submitted patent listing dispute letters to the FDA challenging the “accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products.” The FDA has publicly expressed its support for the FTC’s recent efforts in its press release.
According to the FTC, warning letters were sent last week to companies manufacturing injectable obesity and type-2 diabetes drugs, asthma and COPD inhalers, and a nasal spray to treat severe hypoglycemia in type-1 diabetics. The patent listing dispute letters are confidential, and these patent listing disputes have not yet been listed on the FDA’s database.
Branded drug manufacturers must continue to carefully evaluate their Orange Book patent listings for approved products and those with pending new drug applications (NDAs). As described in greater detail below, particular attention should be paid to any patents listed on the basis of claims covering devices or device components of drug-device combination products.
FTC CONTINUES TO RAMP UP SCRUTINY OF ORANGE BOOK PATENT LISTINGS
The FTC’s patent listing dispute letters are not publicly available, and the published “warning letters” are silent on the legal basis for these challenges. Nevertheless, each of the patents identified by the FTC announcement is listed in the Orange Book as a “Drug Product” (DP) patent. Specifically, the FTC appears to be focusing on patents that claim devices, or components of devices, listed in the Orange Book with drug-device combination products, such as inhalers or injectors. In particular, the FTC appears to have challenged only patents that claim devices or device components and that do not disclose the approved active ingredient in the patent claims.
The FTC made this point more explicitly in an amicus brief filed in March 2024, in which it asserted that “[i]n the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted.
FTC CONTINUES TO RAMP UP SCRUTINY OF ORANGE BOOK PATENT LISTINGS
These patent listing challenges are just the latest step by the FTC, which has taken an increasingly assertive role in recent months to scrutinize branded drug manufacturers’ patent listings in the Orange Book.
September 2023 Policy Statement: The FTC issued a policy statement on “Brand Pharmaceutical Manufacturers’ Improper Listing of Patents” in the FDA’s Orange Book. At that time, the FTC announced that it would carefully scrutinize brand drug manufacturers’ patent listing practices, and consider enforcement action against any improper patent listings. For a full analysis of the September 2023 Policy Statement, see our Legal Update.
November 2023 Patent Listing Dispute Letters: The FTC initially followed up on its Policy Statement by sending “warning letters” to 10 branded drug manufacturers, alleging that they had improperly listed more than 100 patents in the Orange Book. In addition, the FTC submitted patent listing dispute letters to FDA seeking removal or correction of these Orange Book listings. The products at issue in these disputes included 13 inhaler products and four epinephrine injector-pen products. According to the FTC, several companies delisted 14 patents across six NDAs in response to the FTC’s letters.
November 2023 Amicus Brief: The same month, the FTC also filed an amicus brief in Mylan Pharms., Inc., et al., v. Sanofi-Aventis U.S. LLC.1 In that case, Mylan alleged that Sanofi-Aventis had improperly listed several patents in the Orange Book, which delayed the regulatory approval of Mylan’s follow-on version of Sanofi-Aventis’s product. The FTC’s amicus brief asserted that improper patent listings “can cause substantial harm to competition and to consumers,” but took no position on the patents at issue in that case.
March 2024 Amicus Brief: The FTC filed an amicus brief in Teva Branded Pharmaceutical Products R&D, Inc.. et al., v. Amneal Pharms. of New York, LLC, et al.2 This is a Hatch-Waxman patent litigation case, brought by Teva as NDA holder against Amneal as an abbreviated new drug application (ANDA) applicant. Amneal filed a counter-claim, asserting that certain of the asserted patents were improperly listed in the Orange Book. As noted above, the FTC explicitly asserted in this amicus brief that “device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted.”
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In conclusion, branded drug manufacturers and NDA holders must continue to carefully evaluate all of their patent listings in light of the FTC’s continued scrutiny—especially those patents that claims devices or device components. Collaboration between patent counsel and FDA regulatory counsel has always been essential, and the increasing role of the FTC and private antitrust litigation means that antitrust counsel review should also be considered.
1 Mylan Pharms., Inc., et al., v. Sanofi-Aventis U.S. LLC, Civil Action No. 23-836 (W.D.Pa. 2023).
2 Teva Branded Pharmaceutical Products R&D, Inc.. et al., v. Amneal Pharms. of New York, LLC, et al., Civil Action No. 23-20964 (D.N.J. 2023).
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