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As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8, 2024, before the panel of Judges Prost, Taranto, and Hughes. The Federal Circuit is reviewing a district court decision that ordered Teva to delist five patents from the Orange Book for Teva’s ProAir® HFA inhaler product.

Teva had sued Amneal, alleging that Amneal’s ANDA infringed five Orange Book-listed patents. Amneal filed counterclaims seeking, among other things, an order that Teva remove five patents from the Orange Book. Supported by an amicus brief filed by the FTC, Amneal prevailed, and Teva appealed.

The Federal Circuit case focuses on whether Teva’s patents, directed to the device aspects of the inhaler combination product, but not expressly reciting the active ingredients, are properly listed in the Orange Book. During oral argument, Teva focused on the Combination Product Statute (21 U.S.C. § 353(g)(1)) and the Orange Book Listing Statute (21 U.S.C. § 355(b)(1)(A)(viii)). Teva argued that its combination product should be considered a drug product. In response, Judge Taranto stated that the Combination Product Statute explicitly provides that the FDA can review combination products as if they were drug products, but it does not logically follow that combination products are to be considered drug products for all purposes.

Teva provided a proposed statutory test under which a patent claiming a component of a drug product is listable. Teva argued that in this situation, the medicament is administered via a metered dose inhaler, and because a drug product is defined to include all of its components, all aspects of the metered dose inhaler are components of the drug product and patents directed to such components are listable.

Amneal argued, in turn, that the device patents do not satisfy the Listing Statute’s requirements that (1) the patent be a drug product patent, and (2) the patent claim the drug for which the applicant submitted the application. Amneal argued that the active ingredient (albuterol sulfate) is “the drug,” and that its interpretation is consistent with Congressional intent. Amneal also emphasized that the issue for the court is not whether these device patents can be asserted, but whether they qualify for listing in the Orange Book and, thus, receive the special treatment that Orange Book listed patents receive under the Hatch-Waxman Act, which Amneal characterized as “superpowers.”

Teva’s opening appellate brief emphasized that the district court had not engaged in claim construction but nevertheless concluded that the patents at issue do not claim or even mention the drug active ingredient. On November 4, 2024, just four days before the oral argument, the district court issued a formal claim construction order finding that Teva’s five device patents do not require a drug active ingredient.

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