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In , the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug Administration (FDA)  (Approved Drug Products with Therapeutic Equivalence Evaluations), and decided that the “device” patents at issue were not properly listable. The decision follows recent action in this space by the Federal Trade Commission (FTC), including a general policy statement issued in late 2023, and challenges to more than related to inhaler devices, multidose eyedrop bottles, and autoinjectors.

The Patents at Issue

The patents at issue were five patents Teva had listed in the Orange Book for its ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents are described in the Federal Circuit opinion as relating to “improvements in the device parts of inhalers—specifically, the dose counter.” According to the Federal Circuit opinion, “None of the claims … explicitly require the presence of an active drug” as an element of the claimed product.

The ANDA Proceedings and Delisting Counterclaim

Amneal filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Teva’s ProAir® HFA product. Amneal’s ANDA included a paragraph IV certification against the Orange Book-listed patents at issue. After Teva sued for infringement, Amneal filed a counterclaim seeking delisting of the patents at issue. The district court agreed that the patents should not be listed in the Orange Book, but its delisting order was stayed pending Teva’s appeal to the Federal Circuit.

The Federal Circuit Opinion

The Federal Circuit opinion was authored by Judge Prost and joined by Judges Taranto and Hughes.

The Federal Circuit opinion includes a lengthy background section that touches on the origins of the Hatch-Waxman Act, basic principles of the ANDA framework, and statutory and regulatory provisions governing the listing of patents in the Orange Book. For those not familiar with Orange Book listings, it is important to understand that New Drug Application (NDA) holders are required to list certain patents in the Orange Book, but the FDA does not substantively review whether a patent submitted for listing meets the statutory and regulatory listing requirements. In effect, the listing process operates on an honor system, although ANDA filers can challenge Orange Book listings in a counterclaim in paragraph IV litigation as Amneal did here.

Prior to 2021, NDA holders were required to list “any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” In 2021, the Orange Book Transparency Act (OBTA) was enacted to clarify the types of patents that could be listed and codify existing FDA guidance. As amended by the OBTA, an NDA holder must list:

… 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.

The Federal Circuit opinion walks through a lengthy analysis to conclude that the patents at issue are not listable because they do not “claim[] the drug for which the applicant submitted the application,” which the court determined was the active ingredient (albuterol sulfate). At the end of its opinion, the court acknowledges but does not “adopt or reject” Amneal’s additional arguments that the patents are not listable because they are not “drug substance” or “drug product” patents under the OBTA.

The Federal Circuit rejected Teva’s arguments that a patent “claims the drug” if the NDA product infringes the claims, explaining in a nine-page analysis that “claiming” and “infringing” have distinct meanings. The court also rejected Teva’s arguments that a patent “claims the drug” if it claims any part of the NDA product, concluding after an eight-page analysis that just because a drug-device combination product was “approved with an NDA” does not mean every part of the product is a “drug.” Rather, according to the Federal Circuit, for drug-device combination products, “the drug for which the application was submitted and approved” is only “the part of the drug-device combination that made it regulatable as a drug in the first place,” i.e., “the active ingredient.”

Using the Definiteness Requirement as a Touchstone For Listability

The definiteness requirement of 35 USC § 112 requires the claims of a patent to “particularly point[] out and distinctly claim[] the subject matter which the inventor … regards as the invention.” Throughout its analysis, the Federal Circuit opinion invokes this definiteness requirement when interpreting the Orange Book listing requirement that the patent “claims the drug for which the applicant submitted the application.” For example, the court emphasizes:

[A] patent claims the drug when it particularly points out and distinctly claims the drug as the invention.

In rejecting Teva’s arguments that the patents would be listable if its claims were construed as requiring the presence of “an active drug,” the court reasoned:

[T]o claim something, a patent must particularly point out and distinctly claim what it purports to be the invention. See 35 U.S.C. § 112(b). And to qualify for listing, a patent must claim at least the active ingredient in the application and the approved drug product. …

In language that may open the door to Orange Book-listing scrutiny of generic claims, the court stated:

A claim requiring the presence of “an active drug” is far too broad to particularly point out and distinctly claim the drug approved in Teva’s NDA. Teva’s construction permits the presence of any active ingredient in any form. As a matter of law, Teva’s construction does not particularly point out and distinctly claim what was approved—the ProAir® HFA with albuterol sulfate as the active ingredient.

Taking Care With Orange Book Listings

In its policy statement, the FTC characterized improper Orange Book listings as potentially anti-competitive behavior, and “put market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.” As noted in the Federal Circuit opinion, Amneal also filed antitrust counterclaims, alleging that the improper listings delayed FDA approval of its generic product. Thus, even though Judge Prost opined that “[t]he attractiveness of the thirty-month stay might arguably provide an NDA holder significant incentives to improperly list patents in the Orange Book,” there are good reasons for taking care with Orange Book Listings.

Attorneys at �鶹ֱ�� have extensive experience counseling clients on issues affecting Orange Book listings. Members of our Chemical, Biotechnology & Pharmaceutical practice and FDA Regulatory team frequently collaborate to address regulatory, patent, and litigation considerations. Contact your �鶹ֱ�� attorney or the author for more information.