Teva Pharm. United States, Inc. v. Sandoz, Inc.
135 S. Ct. 831
| SCOTUS | 2015Background
- Teva owns a patent claiming copolymer-1 (active ingredient of Copaxone) with a "molecular weight of about 5 to 9 kilodaltons." Teva sued Sandoz for infringement after Sandoz sought to market a generic.
- Sandoz argued the claim was indefinite under 35 U.S.C. § 112 because "molecular weight" could be measured in multiple scientifically distinct ways (peak/most prevalent, number-average, or weight-average), and the claim did not specify which method.
- The district court heard expert testimony, found a skilled artisan would understand the patent to refer to peak (most prevalent) molecular weight, and held the claim definite and valid.
- The Federal Circuit reviewed the district court’s claim construction (including subsidiary factual findings) de novo, reversed, and held the claim indefinite.
- The Supreme Court granted certiorari to decide the appropriate standard of appellate review for district-court subsidiary factual findings made during patent claim construction.
Issues
| Issue | Plaintiff's Argument (Teva) | Defendant's Argument (Sandoz) | Held |
|---|---|---|---|
| What standard should an appellate court apply when reviewing district-court subsidiary factual findings made during claim construction? | Deferential review: district-court factual findings (e.g., expert credibility about technical meaning) should be accepted unless clearly erroneous. | De novo review of the entire claim construction is appropriate because claim construction is principally a legal exercise about documents; applying two standards is difficult and risks inconsistency. | The Court held that appellate courts must review subsidiary factual findings for clear error under Fed. R. Civ. P. 52(a)(6), while reviewing the ultimate legal claim construction de novo. |
| Whether Markman created an exception to Rule 52(a)(6) such that all aspects of claim construction are reviewed de novo. | Markman did not create any exception to Rule 52(a)(6); it recognized "evidentiary underpinnings" that may require factual findings. | The Federal Circuit interpreted Markman to permit de novo review of subsidiary findings. | Markman treated ultimate claim construction as a legal question but acknowledged subsidiary factual issues; Rule 52(a)(6) still governs those subsidiary factual findings. |
| Did the Federal Circuit err in this case by failing to apply clear-error review to the district court’s factual finding about how a skilled artisan would read Figure 1? | The district court credited Teva’s expert explaining an expected chromatogram peak shift; that factual finding should have been accepted unless clearly erroneous. | The Federal Circuit discounted the district-court factual finding and reviewed de novo. | The Supreme Court held the Federal Circuit erred by not applying clear-error review to that subsidiary factual determination; vacated and remanded. |
| How should courts treat intrinsic vs extrinsic evidence in claim construction on appeal? | Intrinsic-only constructions are legal and reviewed de novo; when extrinsic evidence raises disputed subsidiary facts, those factual findings are reviewed for clear error. | (Overlaps) Argued uniformity favors de novo review even when extrinsic evidence is used. | Court reiterated: intrinsic evidence → legal question (de novo); extrinsic fact disputes → factual findings (clear error), then ultimate legal construction reviewed de novo. |
Key Cases Cited
- Markman v. Westview Instrs., 517 U.S. 370 (1996) (claim construction is for the court; acknowledged evidentiary underpinnings)
- Anderson v. Bessemer City, 470 U.S. 564 (1985) (appellate courts must not overturn district-court factual findings unless clearly erroneous)
- Pullman-Standard v. Swint, 456 U.S. 273 (1982) (Rule 52(a) has no categorical exceptions for types of factual findings)
- Cybor Corp. v. FAS Techs., 138 F.3d 1448 (Fed. Cir. 1998) (Federal Circuit precedent treating claim construction review as entirely de novo)
- Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809 (1986) (subsidiary factual determinations in patent cases are subject to clear-error review)
- Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605 (1950) (patent adjudication often depends on technical familiarity; trial courts are well positioned)
- Great Northern R. Co. v. Merchants Elevator Co., 259 U.S. 285 (1922) (construction of written instruments may involve subsidiary factual issues)
- Ornelas v. United States, 517 U.S. 690 (1996) (appellate review framework: legal conclusions de novo, factual findings for clear error)