The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response to Amneal’s ANDA filing seeking to make and sell a generic version of ProAir HFA (albuterol sulfate) Inhalation Aerosol (“ProAir”). Teva holds an approved NDA for ProAir in addition to five patents listed in the Orange Book as covering the product, all of which were asserted in the lawsuit. The patents claim variations of a metered dose inhaler and dose counter.

In its answer, Amneal asserted counterclaims requesting delisting of all five asserted patents in the Orange Book for failure to comply with the statutory requirements under the FD&C Act. Amneal cited 21 U.S.C. § 355(b)(1)(A)(viii), which governs new drug applications to the FDA. The statute states that among other things, applicants must include:

(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—

(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

    (II) claims a method of using such drug for which approval is sought or has been granted in the application.

    (emphasis added).

    Amneal moved for partial judgment on the pleadings under Rule 12(c), arguing that none of the five asserted patents claims an active ingredient, drug product, or a method of using the drug and is therefore improperly listed. Teva responded that the patents are correctly listed because they cover drug products, relying on their NDA acceptance from the FDA and the definition of the word “drug” as defined in 21 U.S.C. § 321(g)(1):

    The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

    Notably, the FTC simultaneously but independently got involved, sending Teva a letter stating concerns that the asserted patents (among others) were improperly listed in the Orange Book. The FTC explained that its investigation was spurred by a lack of genetic competition among inhaler products, and asserted that improper listing of patents may undermine the competitive process and constitute illegal monopolization. The FTC was granted leave to file an amicus brief supporting Amneal at the district court and in the Federal Circuit appeal.

    In June 2024, the District Court of New Jersey found that the patents were improperly listed and ordered Teva to correct the Orange Book listings. The Court found that Teva’s inhaler patents were “directed to components of a metered inhaler device, but do not claim or even mention albuterol sulfate for the ProAir HFA.” Teva Branded Pharm. Prod. R&D, Inc. v. Amneal Pharms. of New York, LLC, No. CV 23-20964 (SRC), 2024 WL 2923018, at *7 (D.N.J. June 10, 2024). Therefore, the patent does not claim the drug for which the applicant submitted the application as required by the statute. Id.

    On appeal, Teva argued that the district court erred by failing to use the ordinary meaning of the word “claim” or the statutory meaning of the word “drug.” Teva further argued that removal of its patents from the Orange Book would in turn affect patents that claim inactive ingredients or a genus that generically includes the active ingredient. Specifically, Teva argued that in the asserted patents, there are a limited number of possible ingredients that may be contained in the inhaler’s medicament cannister, which is essentially equivalent to claiming a genus of active ingredients. As the claimed inhaler components are part of the approved drug product, they are listable patents in the Orange Book.

    Amneal maintained that adhering to the statute’s definitions and requirements means Orange Book listed patents must claim the drug for which the NDA request was submitted, rather than cover a potential drug that may be used (i.e., albuterol sulfate rather than another inhalant). Therefore, Amneal argued, the statutory definition of “drug” on which Teva relies is irrelevant because the only relevant drug is albuterol sulfate.

    The Federal Circuit panel consisted of Judges Taranto, Prost, and Hughes. Initially, the panel focused on identifying what can and cannot be considered a drug product under the FD&C Act and the Orange Book Transparency Act of 2020. The judges also pressed Teva on the practicality of the FDA’s inclusion of the inhaler as part of a drug product for ease of review as opposed to defining the inhaler itself as a drug.

    Turning to Amneal, the judges asked counsel to address Teva’s genus claims concern. Amneal agreed that a patent claiming albuterol sulfate among a list of other potential inhalants would be “closer” to a listable patent. Amneal maintained, however, that a patent generally claiming an active ingredient in a medicament cannister without naming an ingredient is not enough, nor can the ingredients be mentioned solely in the specification. To be listed, according to Amneal, the patent must recite the specific active pharmaceutical ingredient in the claims. Amneal added that companies would continue to enjoy patent protection for their genus claims; they simply would not benefit from the 30-month stay of FDA approval provided by the statute in connection with litigation of Orange Book listed patents.

    As the parties await an opinion, the case continues at the district court level. The Court recently issued a claim construction ruling on November 4th, finding that the asserted patents do not require the presence of an active drug. Teva Branded Pharm. Prod. R&D, Inc. v. Amneal Pharms. of New York, LLC, No. CV 23-20964 (SRC), 2024 WL 4664096, at *6 (D.N.J. Nov. 4, 2024).

    The Federal Circuit’s decision should bring much-needed clarity on the issue of whether pure device patents can properly be listed in the Orange Book. We will provide further updates as the case progresses.