Federal Circuit Affirms that Medical Devices are Only Listable in the Orange Book if They Claim the Active Drug Ingredient

The Court of Appeals for the Federal Circuit (CAFC) affirmed the decision by the U.S. District Court in New Jersey, which ordered the delisting of five U.S. Patents owned by TEVA on the ground “that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate,” but instead “are directed to components of a metered inhaler device.” Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964, — F. Supp. 3d –, 2024 WL 2923018, at *6, *7 (D.N.J. June 10, 2024) (“Delisting Order”). Accordingly, moving forward, patents for a medical device product are only Orange Book listable in the U.S. if they include claims directed to the active drug ingredient.

 The Court of Appeals for the Federal Circuit (CAFC) affirmed the decision by the U.S. District Court in New Jersey, which ordered the delisting of five U.S. Patents owned by TEVA on the ground “that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate,” but instead “are directed to components of a metered inhaler device.” Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964, — F. Supp. 3d –, 2024 WL 2923018, at *6, *7 (D.N.J. June 10, 2024) (“Delisting Order”). Accordingly, moving forward, patents for a medical device product are only Orange Book listable in the U.S. if they include claims directed to the active drug ingredient.

In its decision, the CAFC gave a thorough background explaining how the U.S. Food and Drug Agency (FDA) approves applications to market drugs and how the Orange Book is used. The CAFC then discussed TEVA’s New Drug Application (NDA) for ProAir® HFA Inhalation Aerosol, described in NDA No. 021457, Amneal’s Abbreviated New Drug Application (ANDA) with a Paragraph IV certification indicating Amneal’s belief their proposed generic product would not infringe any claim of any patent listed in the Orange Book for this product, and the District Court’s delisting order.

TEVA listed patents for a metered dose inhaler that can be used with albuterol sulfate in the Orange Book. However, none of the patents listed by TEVA specifically claim an active ingredient, only a medicament canister. Amneal submitted an ANDA to obtain approval for a similar device with a Paragraph IV certification, arguing that the nine patents listed by TEVA would not be infringed by their proposed generic device. TEVA then sued Amneal for infringement on, ultimately, five of the Orange Book listed patents.  Amneal, in turn filed counterclaims against Teva, including a request for an order that TEVA be required to delist the five patents, which did not include claims for an active ingredient as required for listing in the Orange Book.

The CAFC performed a statutory interpretation de novo as an issue of law. In the review, the CAFC focused on the language of the relevant statute and the broader context of drug approval to determine the meaning in the relevant statute.

TEVA argued that their patents were properly listed in the Orange Book because the patents “claim the drug” by reading on, or referring generally to, the drug. In other words, TEVA argued that a patent claims a drug if the patent would be infringed by use of the drug.  The CAFC rejected this interpretation.  The CAFC explained that TEVA’s interpretation would allow far more patents to be listed in the Orange Book and goes directly against the plain language of the relevant statute.  The CAFC pointed out that the listing provision of the relevant statute identifies “infringing” and “claiming” as two distinct requirements. The CAFC asserted that it would have been redundant of Congress to include two different clauses for the same requirement.  The Court also referred to the patenting statutes, specifically 35 U.S.C. § 112, which defines the written description and claim requirements in a patent application.  When the claims and specification are read together the claims define the invention. Therefore, the Court concluded that claims are of primary importance and identify the “invention”.

Infringement, on the other hand, is governed by a different statute (35 U.S.C. § 251) and occurs when someone other than the inventor makes, uses, sells, or imports the claimed invention without authorization. Claims are given their ordinary meaning based on the words used inside the patent document itself. Further, someone can infringe a patent without meeting all the claim elements when there is equivalence between the elements of the accused product or process and the claimed elements of the patented invention. A product that infringes a patent claim can also include more than the elements of the claim.

Referring again to the written description requirement with respect to the relevant patents, the CAFC gave an example from oral arguments to illustrate the difference between claims and infringement. A large item such as a car can infringe a patent for a steering wheel even if the patent application did not describe the car itself.

Lastly, the CAFC described that the interpretation outlined in the opinion contrasts with the Patent Term Extension (PTE) provisions of the Hatch-Waxman Act, which extends the term of a patent that “claims a product.” 35 U.S.C. § 156(a)(4). The CAFC concluded its statutory analysis by stating that both relevant statutory provisions and case law establish that what a patent claims and what infringes a patent are distinct concepts. What is claimed in TEVA’s patents are distinct from what may infringe TEVA’s patents.

Next, the CAFC discussed whether the device itself was a drug, or whether an actual chemical must be claimed in the patent. The CAFC again turned to statutes and case law to determine that medical devices and chemical compounds, or drugs, have distinct approval pathways under U.S. law and cannot be conflated as the same thing.  Patents listed in the Orange Book are required to include at least one claim directed to an active ingredient, while all TEVA’s asserted patents for a metered dose inhaler device do not include any claims for the active drug ingredient, albuterol sulfate.

Accordingly, the CAFC affirmed that Teva is required to delist the patents at issue from the Orange Book for the ProAir® HFA Inhalation Aerosol, and lifted the stay, thereby permitting Amneal to launch their generic product.