Antitrust Law Daily Wrap Up, ANTITRUST—Fed. Cir.: Orange Book delisting of Teva's ProAir® HFA patents affirmed on appeal, (Jan 3, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

District court correctly ruled that asserted patents did not claim the active drug, albuterol sulfate, or its formulation, making them ineligible for Orange Book listing under federal law.

In a lawsuit under the Hatch-Waxman Act, the U.S. Court of Appeals for the Federal Circuit affirmed a federal district court order requiring Teva Branded Pharmaceutical Products R&D, Inc. to delist five patents from the Orange Book. The appellate court held that the patents, relating to device components of a metered dose inhaler, did not “claim the drug for which the applicant submitted the application” under 21 U.S.C. § 355(b)(1)(A)(viii), as they lacked claims for the active ingredient, albuterol sulfate, or its formulation. Further, it rejected Teva’s argument that listing should include device components, clarifying the provision applies only to patents claiming the therapeutic drug. Additionally, the court denied Teva’s request for remand, concluding that the patents were ineligible for listing under Teva’s proposed claim construction (Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals LLC, No. 2024-1936 (Fed. Cir. Dec. 20, 2024)).

Background. The plaintiff/appellant, Teva, is a leading pharmaceutical company that specializes in developing and marketing branded and generic drugs, including inhalation therapies for respiratory conditions. The defendant/appellee, Amneal Pharmaceuticals LLC, is a pharmaceutical company that manufactures and markets generic drugs, including alternatives to branded inhalation therapies. Both companies are active players in the highly competitive pharmaceutical market.

Five of Teva’s Orange Book listed patents for its ProAir® HFA Inhalation Aerosol were relevant for this appeal. The asserted patents included U.S. Patent Nos. 8,132,712 (the ’712 patent), 9,463,289 (the ’289 patent), 9,808,587 (the ’587 patent), 10,561,808 (the ’808 patent), and 11,395,889 (the ’889 patent). These patents primarily concern device components of the inhaler, particularly dose counters designed to track the number of remaining doses accurately. The ’712 patent addresses issues such as undercounting doses, while the ’289 patent provides solutions to avoid dose counters registering doses incorrectly. The ’587, ’808, and ’889 patents share similar specifications and address improvements in dose counter mechanisms. Although some patents reference albuterol sulfate in the background, none include claims directly addressing the active ingredient or its formulation.

Amneal filed an Abbreviated New Drug Application (ANDA) to market a generic version of Teva's ProAir® HFA inhaler containing the active ingredient albuterol sulfate. Amneal included a Paragraph IV certification, asserting non-infringement or invalidity of the patents listed in the Orange Book for ProAir® HFA.

Teva, holding nine listed patents for ProAir® HFA, filed a lawsuit in the district of New Jersey under 35 U.S.C. § 271(e)(2), alleging infringement of six patents. Teva later narrowed its claims to five patents related to the inhaler’s dose counter and other device components. Amneal responded with counterclaims, including a request to delist the five patents, arguing they did not “claim the drug” as required under 21 U.S.C. § 355(b)(1)(A)(viii) and were improperly listed. Amneal also alleged that Teva’s listings caused a 30-month FDA approval delay for its generic product.

The district court sided with Amneal during claim construction, ruling that the patents did not claim albuterol sulfate or its formulation but were instead directed to device components. In June 2024, the court ordered Teva to delist the patents and rejected Teva’s arguments that the device components were integral to the drug. Teva’s other infringement claims and Amneal’s antitrust counterclaims remained pending. Teva appealed, and the Federal Circuit stayed the delisting order during the pendency of the appeal.

Statutory interpretation. The Federal Circuit analyzed the statutory language of 21 U.S.C. § 355(b)(1)(A)(viii), which governs the listing of patents in the Orange Book. It noted that the provision requires listed patents to "claim the drug for which the applicant submitted the application." The court emphasized that "claiming" a drug requires the patent to explicitly and distinctly claim the therapeutic drug or its formulation, as defined under 35 U.S.C. § 112(b). The court rejected Teva's argument that a patent claims a drug if it is infringed by any part of the drug product, reasoning that such an interpretation would render parts of the statute redundant and conflict with the statutory scheme. The court cited Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756 (Fed. Cir. 1997), to emphasize the distinction between claiming a drug and infringement, explaining that the latter involves broader considerations of equivalency and additional product features, which are irrelevant to the listing requirements.

Active ingredient requirement. The court clarified that for a patent to be eligible for Orange Book listing, it must claim at least the active ingredient, the therapeutic component responsible for the drug's primary mode of action. Teva's patents, however, focused on device features such as dose counters and canisters without claiming albuterol sulfate or its formulation. The court highlighted that the statutory framework under the Hatch-Waxman Act differentiates between drugs and devices, with Orange Book listings intended only for patents directly tied to the drug's therapeutic action. Citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012), the court reinforced the principle that Orange Book listings are restricted to patents claiming components essential to the drug's approval.

Rejection of Teva’s broad interpretation. Teva argued that its device patents were eligible for listing because they covered components integral to delivering the drug, such as dose counters and inhaler canisters. The court dismissed this argument, finding that the statutory language requires patents to claim the drug itself, not ancillary features. It explained that extending eligibility to such patents would conflict with the statutory intent of limiting Orange Book listings to therapeutic components. The court noted that while device components might support drug delivery, they do not meet the statutory definition of “claiming the drug for which the application was submitted.” Referencing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the court affirmed that patents for non-therapeutic components fall outside the scope of the Orange Book.

Procedural discretion. Teva requested a remand to the district court for claim construction, arguing that its patents might qualify for listing under a broader interpretation. The Federal Circuit rejected this request, concluding that even under Teva’s proposed construction, the patents did not meet the statutory requirements for listing. The court emphasized that the asserted patents lacked claims directed to albuterol sulfate or its formulation and thus were ineligible for listing regardless of claim interpretation. The court's refusal to remand underscored its focus on efficient resolution and reinforced that statutory eligibility for Orange Book listing does not depend on speculative claim construction but on clear compliance with statutory criteria.

Conclusion. Thus, the Federal Circuit affirmed the district court’s order requiring Teva to delist five of its patents from the Orange Book, finding that the patents, which were directed to device components, did not meet the statutory requirements of claiming the active drug, albuterol sulfate, or its formulation. Rejecting Teva’s arguments for a broader interpretation of the statutory provisions, the court reinforced the principle that Orange Book listings must directly pertain to the therapeutic components of a drug to facilitate competition while protecting legitimate patent rights.

Federal Trade Commission statement. The FTC welcomed the Federal Circuit’s decision to delist Teva’s ProAir® HFA patents, calling it a victory for competition and lower drug prices. The agency, which had filed amicus briefs urging the delisting, highlighted the decision’s role in removing improper “junk patent listings” that delay generic competition. FTC official Hannah Garden-Monheit noted the ruling’s broader impact, paving the way for fairer competition in markets for other critical medications. The decision aligns with the FTC’s 2023 policy to scrutinize improper Orange Book submissions that harm consumers by keeping generic alternatives off the market.

The Case is No. 2024-1936.

Attorneys: William M. Jay (Goodwin Procter LLP) for Teva Branded Pharmaceutical Products R&D, Inc., Norton [Waterford] Ltd., and Teva Pharmaceuticals USA, Inc. Steven Arthur Maddox (Procopio) for Amneal Pharmaceuticals of New York, LLC, Amneal Ireland Limited, Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals, Inc.

Companies: Teva Branded Pharmaceutical Products R&D, Inc.; Norton (Waterford) Ltd.; Teva Pharmaceuticals USA, Inc.; Amneal Pharmaceuticals of New York, LLC; Amneal Ireland Limited; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals, Inc.

Judge: Prost, S.

Cases: Antitrust NewJerseyNews