## Facts

- Bristol-Myers Squibb marketed buspirone (BuSpar) and had an Orange Book-listed patent set to expire on November 21, 2000.
- Mylan Pharmaceuticals filed an ANDA seeking approval to market generic buspirone upon expiration of the listed patent.
- On November 21, 2000, Bristol obtained U.S. Patent No. 6,150,365 and submitted it to the FDA for Orange Book listing for BuSpar.
- The FDA listed the ’365 patent, which prevented final approval of Mylan’s ANDA unless Mylan addressed the newly listed patent through Hatch–Waxman certification procedures.
- Mylan sued federal officials and Bristol in the District of Columbia, seeking declaratory and injunctive relief requiring delisting of the ’365 patent and compelling the FDA to grant final ANDA approval.
- The district court granted a preliminary injunction ordering Bristol to take measures to delist the ’365 patent and directing the FDA to grant final approval of Mylan’s ANDA.
- Bristol appealed the preliminary injunction to the Federal Circuit.

## Issues

1. Whether federal patent law or the Hatch–Waxman Amendments create a private cause of action allowing an ANDA applicant to obtain declaratory or injunctive relief compelling a brand manufacturer to delist a patent from the FDA’s Orange Book.
2. Whether the district court could issue a preliminary injunction ordering delisting and final ANDA approval based on that asserted delisting claim.

## Decision

- The Federal Circuit reversed the preliminary injunction.
- The court held that neither the patent statutes nor the Hatch–Waxman Amendments provide (expressly or by implication) a private delisting cause of action against the patent holder.
- The Declaratory Judgment Act could not supply a remedy because it does not create substantive rights absent an underlying cause of action.
- Because Mylan lacked a legally cognizable claim to force delisting, it could not show likelihood of success on the merits, and the injunction was legally erroneous.

## Legal Principles

- A private party may not obtain declaratory or injunctive relief to compel Orange Book delisting unless a substantive federal cause of action authorizes that remedy.
- The Hatch–Waxman framework provides specific, enumerated mechanisms for resolving patent barriers to ANDA approval (including certifications and infringement litigation under 35 U.S.C. § 271(e)(2)); courts will not add an extra-statutory delisting remedy.
- The Declaratory Judgment Act is remedial only; it does not create independent jurisdiction or substantive rights.

## Conclusion

The Federal Circuit held that a generic manufacturer cannot sue a brand manufacturer under patent law or Hatch–Waxman to force Orange Book patent delisting, and it reversed a preliminary injunction that had ordered delisting and directed final approval of the generic ANDA.


Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001)