On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents related to FDA-approved drug/device combination products. Patentees and sponsors of New Drug Applications (NDAs) directed to drug/device combinations should review this decision to ensure that their OB listing processes comply with the standards outlined by the Federal Circuit. In particular, patents that claim the device or its components but that do not include any claim reciting the active pharmaceutical ingredient (aka active ingredient or API) included in the approved drug must not be listed. This decision is of particular importance because of the risk of antitrust claims for improper OB listings, both from private litigants and the Federal Trade Commission, which has recently taken a more public and outspoken role in policing the OB. However, questions regarding the OB listability of patents related to drug/device combinations remain.
Orange Book Background
The Orange Book (so named for the orange cover of the FDA publication, which is actually titled Approved Drug Products with Therapeutic Equivalence Evaluations) provides a list of drug products approved by FDA on the basis of safety and effectiveness, along with corresponding exclusivity and “patent information” for those products. Sponsors of NDAs must submit this “patent information” (patent number and expiration date) to FDA for any patent that claims the drug that is the subject of the application (or a method of using the drug) for which a claim of patent infringement could reasonably be asserted for unlicensed manufacturing, use, or sale of the product. While submission of patent information for OB listing is mandatory, FDA does not substantively review listing requests, viewing its role as purely “ministerial.”
Orange Book listing is important because, under the Hatch-Waxman framework, OB listing of a patent can trigger an automatic 30-month stay preventing FDA from approving a proposed generic version of the relevant approved product under certain circumstances. Improper OB listing can accordingly give rise to claims for antitrust violations where it results in an unjustified delay in generic product approval.
Background of the Teva v. Amneal Litigation
Teva holds an approved NDA for its ProAir® HFA Inhalation Aerosol product, which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate. Teva listed several patents in the OB for ProAir® HFA, including several claiming components of the device portion of the approved drug product (such as the metered dose inhaler dose counter and inhaler canister). Amneal filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market a generic version of ProAir® HFA, providing a “paragraph IV notice” to Teva alleging that its proposed generic product would not infringe Teva’s OB-listed patents. Teva sued Amneal based on certain OB-listed patents, invoking an automatic 30-month stay prohibiting FDA from approving Amneal’s ANDA during that time. In response, Amneal filed counterclaims, including for antitrust violations, and requested court ordered delisting of Teva’s patents from the OB as being impermissibly listed.
The district court agreed with Amneal that Teva’s asserted patents were not properly listed in the OB because they did not “claim the drug” for which the NDA was submitted, as no claim in any asserted patent recited the API albuterol sulfate. The court accordingly ordered Teva to delist those patents. Teva appealed, and the Federal Circuit stayed the district court’s order.
The Federal Circuit’s Decision
On appeal, the Federal Circuit lifted the stay and affirmed the district court’s order for Teva to delist its patents from the OB. In particular, the appeals court held that, in order to list a patent in the OB, “the patent must claim at least the active ingredient.” Because none of Teva’s asserted patents included a claim reciting the API albuterol sulfate, they were improperly listed.
Outstanding Questions for Orange Book Listings for Drug/Device Combinations
Assuming the Supreme Court does not disturb the Federal Circuit’s decision, this case makes clear that patents that fail to recite the API of the product that is the subject of an NDA cannot be listed in the OB. However, additional challenges to OB listing of drug/device combination patents may exist.
In particular, the Federal Circuit expressly declined to address Amneal’s separate argument that Teva’s patents should not be listed in the OB because they are not “drug-substance or drug-product patents” as required by the Hatch-Waxman statute as amended by the Orange Book Transparency Act of 2021. There thus remains a risk that patents directed to the device portion of a drug/device combination, even those that include a dependent claim reciting the API, could be alleged to be barred from OB listing.