The patents being challenged are for inhalers – those aren’t the same as vaccines necessary to solve their advantages.

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 Seemingly Focusing on Certain Patents Claiming Devices or Device Components

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.