Sanofi-Aventis v. Apotex Inc.
659 F.3d 1171
Fed. Cir.2011Background
- This is a Hatch-Waxman dispute over clopidogrel bisulfate (Plavix).
- Apotex sought ANDA approval prior to expiration of the '265 patent and asserted invalidity; Sanofi sued under 35 U.S.C. §271(e)(2).
- Settlement agreements (March 2006 and May 2006) defined Sanofi's actual damages as 50% of Apotex net sales and barred increased damages under 35 U.S.C. §284.
- The May 2006 agreement included a separate provision for inventory reimbursements with interest, but was silent on prejudgment interest related to infringement damages.
- The district court awarded prejudgment interest and held Apotex jointly and severally liable for damages; Apotex challenged both the interest award and the liability finding.
- On appeal, the court reversed the prejudgment-interest award as contrary to the May 2006 agreement, affirmed joint and several liability, and affirmed the denial of a motion to add patent-misuse/breach-of-contract claims for reasons related to timing and scope.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether prejudgment interest can be awarded in addition to the May 2006 damages. | Apotex argues the agreement caps damages at 50% with no room for interest. | Sanofi contends interest is recoverable under §284 and not precluded by the contract. | Prejudgment interest barred; contract read as full compensatory damages. |
| Whether prejudgment interest should be calculated at the prime rate. | Not explicitly discussed; focus is on contract scope. | Interest rate not dispositive to the contract interpretation. | Not reached; issue avoided by ruling on 14(ii) interpretation. |
| Whether Apotex Inc. is jointly and severally liable for Sanofi's damages. | Apotex contends narrow liability to Apotex Corp. or per-entity. | The agreement defined Apotex to include all related entities; liability is joint and several. | Affirmed joint-and-separate liability for Sanofi's damages. |
| Whether the district court properly denied leave to amend to add patent misuse and breach-of-contract claims. | Apotex sought to add misuse and breach claims. | Affirmed district court’s denial as within discretion; amendments would delay resolution. |
Key Cases Cited
- Gen. Motors Corp. v. Devex Corp., 461 U.S. 648 (Sup. Ct. 1983) (prejudgment interest ordinarily awarded to make patent owner whole)
- Transmatic, Inc. v. Gulton Indus., 180 F.3d 1343 (Fed. Cir. 1999) (prejudgment interest as compensatory, not punitive)
- Oiness v. Walgreen Co., 88 F.3d 1025 (Fed. Cir. 1996) (prejudgment interest as compensatory remedy in patent cases)
- Beatrice Foods Co. v. New England Printing & Lithographing Co., 923 F.2d 1576 (Fed. Cir. 1991) (prejudgment interest on actual damages only; not on punitive damages)
- Bank of New York v. Amoco Oil Co., 35 F.3d 643 (2d Cir. 1994) (ambiguity in settlement agreements regarding prejudgment interest; trench on damages interpretation)