In a significant ruling affecting pharmaceutical patent practices, the Federal Circuit has upheld a lower court decision requiring Teva Pharmaceuticals to remove several patents related to its ProAir HFA inhaler from the FDA's Orange Book. The decision stems from a patent infringement lawsuit filed by Teva against Amneal Pharmaceuticals in October 2023, concerning Amneal's generic version of the inhaler.
Patent Dispute Background
The controversy began when Teva asserted five patents (U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889) against Amneal's generic product. This triggered a 30-month stay under the Hatch-Waxman Act, potentially delaying FDA approval of Amneal's generic inhaler until February 2026. Amneal responded with counterclaims, including antitrust violations, seeking to remove Teva's patents from the Orange Book.
Key Legal Findings
Judge Stanley Chesler of the U.S. District Court for the District of New Jersey examined the "Listing Statute" (21 U.S. Code § 355(b)(1)(A)(viii)) and determined that Teva's patents failed to meet the statutory requirements. The court emphasized that Orange Book-listable patents must claim either the drug itself or its method of use. Teva's patents, which covered the inhaler device components rather than the active ingredient albuterol sulfate, did not qualify under these criteria.
Federal Circuit's Decisive Ruling
The Federal Circuit's December 2024 decision reinforced the district court's interpretation, establishing a clear precedent for Orange Book listings. The court rejected Teva's argument that patents covering drug delivery device components should qualify for listing, emphasizing that the statute requires patents to claim the drug's active ingredient specifically.
FTC Involvement and Industry Impact
The Federal Trade Commission played a significant role by submitting an amicus brief supporting the removal of Teva's patents. The agency had previously issued warning letters to ten pharmaceutical companies regarding potentially improper Orange Book listings, highlighting broader concerns about patent practices in the industry.
Current Status and Industry Response
On January 22, 2025, the Federal Circuit temporarily stayed the delisting order pending consideration of Teva's request for an en banc rehearing. Major pharmaceutical companies including AstraZeneca and Sanofi-Aventis have filed supporting briefs, expressing concerns about the ruling's potential impact on patent dispute resolution processes in the pharmaceutical industry.
The case represents a pivotal moment in pharmaceutical patent law, potentially affecting how companies approach patent protection for drug-device combination products. The outcome could significantly influence future strategies for both branded and generic pharmaceutical companies in protecting and challenging drug delivery technologies.
