FTC Weighs In on Orange Book Listing of Drug-Device Patents

In Short

The Situation: On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the District of New Jersey ("Teva v. Amneal"), stating that the court should grant Amneal's motion for judgment on the pleadings to compel Teva to de-list certain patents in the U.S. Food and Drug Administration's ("FDA") Orange Book for Teva's ProAir HFA product. 

Background: For many years, FDA has failed to respond substantively to requests from drug makers for clarity regarding which types of patents that cover drug-device combination products should be listed in the "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book"). Recently, the FTC filed an amicus brief in the Teva v. Amneal dispute, advocating a narrow view of the Orange Book listing rules that would not allow listing of five Teva patents covering the devices that are used to administer the ProAir HFA product.

Looking Ahead: Companies need to be thoughtful when deciding whether to list drug-device patents in the Orange Book. Companies also are advised to carefully monitor district court litigations and FTC challenges in this space.

The federal Hatch-Waxman Act instructs companies that submit a New Drug Application ("NDA") to FDA to include information regarding each patent with claims that recite the drug substance (the active ingredient), the finished drug product, and/or an approved method of using the drug that is the subject of the NDA. See 21 USC 355(b)(1)(A)(viii); see also 21 C.F.R. § 314.53(a).

In its 2003 rulemaking, the FDA clarified that the "drug product" for purposes of patent listing refers to the "finished dosage form," which the FDA stated includes "metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems." See Applications for FDA Approval to Market a New Drug; Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 68 Fed. Reg. 36,676, 36,680 (June 18, 2003).

Beyond this statement, which included a number of drug-device combination products, the FDA has not explained how the rules for Orange Book listings should be applied to patents claiming drug-device combination products where the finished dosage form given to the patient includes the drug substance in a device for administration. Pharmaceutical companies have been requesting additional FDA guidance on this issue for years. As required by the Orange Book Transparency Act of 2020, the FDA solicited public comments regarding the types of patent information that should be listed in the Orange Book, and received numerous comments regarding drug-device patent listing. To date, however, FDA has not provided any more guidance about whether or to what extent such patents are properly listable in the Orange Book. FDA will list such patents, but the NDA applicants who list them are increasingly subject to challenge.

This issue arose recently in the Teva v. Amneal matter. Amneal filed an Abbreviated New Drug Application ("ANDA") seeking approval of a generic version of Teva's ProAir HFA product, an albuterol drug indicated for treatment of bronchospasm. Amneal's ANDA included a Paragraph IV certification directed to Teva's Orange-Book listed patents. When Teva brought suit under the Hatch-Waxman Act, Amneal lodged a counterclaim seeking de-listing from the Orange Book of five of Teva's patents, which claimed aspects of the metered-dose inhaler that is used to administer precise amounts of the active ingredient in ProAir HFA with each use. Amneal takes the position that those patents do not cover the "drug product," and thus are not properly listable.

On March 22, 2024, the FTC filed an amicus brief in the case, urging the court to grant Amneal's motion for judgment on the pleadings and to compel Teva to de-list the patents. The FTC takes a narrow view of the "drug product" definition in the Hatch-Waxman Act, stating that "drug manufacturers cannot lawfully list device patents that are not limited to either the active ingredient or the approved product." In addition, the FTC quoted the FDA in its 2003 rulemaking on patent submissions and listing requirements, where the FDA clarified that the "key factor is whether the patent being submitted claims the finished dosage form of the approved drug product." Accordingly, in the FTC's view, "a device or device component patent that does not mention any drug in its claims is not a 'drug product (formulation or composition) patent,'" and "brand drug manufacturers may list as 'drug product (formulation or composition) patents' only those that claim the finished dosage form containing the drug substance of the relevant NDA." Furthermore, the FTC stated that even if a patent claims a part of a drug, "under the statutory text, it is not a sufficient condition for proper listing that the patent 'claims the drug.'"

FTC's narrow view is shared by certain members of Congress, who have targeted NDA holders and demanded that drug-device patents be de-listed from the Orange Book. FDA has consistently viewed its own role in Orange Book listings as ministerial only. On April 11, 2024, the FDA Commissioner Robert Califf suggested during testimony before the House Oversight Committee that Congress should "tighten up the laws" if it wanted to address perceived Orange Book abuses. 

Three Key Takeaways

1. There are unanswered questions regarding whether and to what extent patents that claim drug-device combination products should be deemed to claim the "drug product" for purposes of Orange Book listings.

2. FDA has not provided clear guidance, despite repeated requests from industry.

3. FTC takes a narrow view, arguing that only those patents which specifically claim the finished dosage form containing the drug substance are properly listable in the Orange Book; claims drawn to a device component for administering a drug are not.

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