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Andrx Pharmaceuticals, Inc., Plaintiff-Cross v. Biovail Corporation v. Tommy G. Thompson, Secretary of Health and Human Services, Bernard A. Schwetz, Acting Principal Deputy Commissioner, U.S. Food and Drug Administration, and U.S. Food and Drug Administration, Biovail Laboratories, Inc., Plaintiff/counterclaim and Biovail Corporation, Counterclaim v. Andrx Pharmaceuticals, Inc., Defendant/counter Claimant-Cross

Citation: 276 F.3d 1368Docket: 02-1025

Court: Court of Appeals for the Federal Circuit; January 16, 2002; Federal Appellate Court

Narrative Opinion Summary

The case involves Biovail Corporation's appeal against a district court's decision to reduce the statutory thirty-month delay for FDA approval of Andrx Pharmaceuticals' Abbreviated New Drug Application (ANDA). The legal dispute centers on the interpretation of the Hatch-Waxman Amendments, which aim to balance the development of new drugs with the introduction of generics. Under these provisions, Biovail had listed its patent in the FDA's Orange Book, triggering a statutory stay on Andrx's ANDA. The district court initially shortened this stay, arguing Biovail failed to cooperate in expediting proceedings. However, the Federal Circuit vacated this ruling, finding the district court exceeded its authority under 21 U.S.C. § 355(j)(5)(B)(iii). Additionally, the case highlights the complex interplay between patent listings and FDA regulatory processes, with Andrx unsuccessfully attempting to challenge the FDA's actions under the Administrative Procedure Act. The decision underscores the significant impact of patent listings in delaying generic drug market entry, a practice sometimes referred to as 'evergreening.' Ultimately, the case was remanded for further proceedings, allowing Andrx the opportunity to amend its claims under the APA.

Legal Issues Addressed

Administrative Procedure Act (APA) Review of FDA Actions

Application: The Federal Circuit considered whether Andrx could assert a claim under the APA based on the FDA's handling of the '463 patent listing, though this was not adequately pleaded.

Reasoning: Under the Administrative Procedure Act (APA), individuals adversely affected by agency actions are entitled to judicial review, provided the action is a final agency action and no other adequate remedy exists.

Interpretation of Hatch-Waxman Amendments

Application: The case examines the balance between promoting new drug development and facilitating market entry of generic drugs under the Hatch-Waxman Amendments, specifically regarding the approval process of ANDAs.

Reasoning: The case involves the interpretation of the Hatch-Waxman Amendments, which balance the promotion of new drug development with the facilitation of generic drug entry into the market.

Patent Listing in the FDA's Orange Book

Application: The court addressed the implications of listing patents in the Orange Book, which can delay generic drug approvals and affect patent infringement litigation timelines.

Reasoning: Listing a patent in the Orange Book can significantly hinder generic competition by providing the patentee or NDA holder with near automatic injunctive relief for even minor infringement claims.

Statutory Stay under 21 U.S.C. § 355(j)(5)(B)(iii)

Application: Biovail's conduct regarding the '463 patent's listing and formulation changes led the district court to decide to shorten the thirty-month stay period, a decision later vacated by the Federal Circuit.

Reasoning: Biovail contends that the district court incorrectly interpreted section 355(j)(5)(B)(iii) by shortening the thirty-month stay period.