Note: Following a request from Teva, the Federal Circuit judges in this case stayed their ruling on January 22, thereby delaying any delisting of patents.
In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey's order to delist from the FDA Orange Book Teva's five patents claiming just device components of a drug product without reciting any active ingredient.
These patents were listed in the Orange Book for Teva's ProAir HFA Inhalation Aerosol under NDA No. 021457, used in treating or preventing bronchospasm with reversible obstructive airway diseases. The NDA product combines albuterol sulfate as the active ingredient with a propellant, ethanol, and an inhaler device. The patents are directed to the inhaler, with claims focusing on device components, particularly an improved dose counter and a canister, without reciting any active drug or specific active ingredient. In 2023, Amneal filed an abbreviated new drug application (ANDA), and Teva sued Amneal for infringement of the five patents. Amneal counterclaimed noninfringement and invalidity and sought delisting of all five patents. In 2024, the District Court held that Teva's patents "do not claim the drug for which the applicant submitted the application" because the patents do not claim or even mention albuterol sulfate or the ProAir HFA, and thus ordered Teva to delist the five patents. Teva appealed.
The Federal Circuit reviewed the Federal Food, Drug and Cosmetic Act (FDCA) and the Hatch-Waxman Act. As enacted in 1984, the Hatch-Waxman Act requires an NDA holder 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." (Emphasis added.) The court noted that the FDA does not police the listing process, and in 2003 Congress authorized a generic company to bring a counterclaim in an ANDA litigation to seek an order requiring the NDA holder to correct or delete the listing if the patent does not claim either the drug for which the application was approved or an approved method of using the drug. In 2021, Congress further amended the listing provision in the Orange Book Transparency Act (OBTA). The OBTA requires an NDA holder to list "each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed 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.)
In response to Teva's arguments, the Federal Circuit analyzed the statues and case laws by focusing on the two words "claim" and "drug" in determining whether a patent "claims the drug." First, the court rejected the argument that a patent "claims the drug" if the claim "reads on" the approved drug—that is, if the NDA drug product infringes that claim. The court notes that "in order to be listed, a patent must both claim the drug and be infringed by the NDA product," and infringing a claimed invention is different from claiming the invention. Second, the court rejected Teva's reliance on the FDCA's definition of "drug," which may include the device components of the NDA product approved as a drug. The court reasoned that the presence of an active ingredient that is safe and effective is what makes a product approvable as a drug. Therefore, the court concludes that:
To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.
Applying the laws to this case, the court stated that the fact ProAir HFA as a drug-device combination was approved as a drug does not make its device parts also a drug because it is the active ingredient that made the combination regulatable as a drug. Therefore, the five patents claiming the device components only should be delisted.
Without further need to address, the court neither adopted nor rejected Amneal's additional argument that the patents should be delisted because they are not drug-substance or drug-product patents per the OBTA. How much of a drug in an NDA product a patent must claim to be listed is still a question not fully answered. If a continuation of the patents at issue specifically claims the device components while reciting the active ingredient, which is trivial to patentability, such a patent would arguably be listable—or is it a question that needs to be answered in the future? Before the laws are further clarified, patent drafting and continuation strategies may be used for possibly listable patents.
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