Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.
789 F.3d 1335
| Fed. Cir. | 2015Background
- Teva sued ANDA filers (Sandoz et al.) for infringing patents covering Copaxone; the appeal focuses on claim 1 of U.S. Patent No. 5,800,808 (the '808 patent) which requires copolymer-1 having a "molecular weight of about 5 to 9 kilodaltons."
- The disputed term "molecular weight" is ambiguous among three polymer measures: peak average (Mp), number average (Mn), and weight average (Mw); the specification and claim do not expressly identify which measure applies.
- The district court credited expert testimony that the patent’s Size Exclusion Chromatography (SEC) Example 1 and Figure 1 imply Mp and that Mp can be read directly from the chromatogram, while Mw/Mn require additional calculations; it also discounted a prosecution statement implying Mw as scientifically erroneous but accepted another prosecution statement identifying Mp.
- The Federal Circuit initially reversed the district court as to Group I claims (including claim 1), holding them indefinite, but the Supreme Court vacated and remanded, instructing that subsidiary factual findings be reviewed for clear error (Teva) and clarified the indefiniteness standard requiring "reasonable certainty" (Nautilus).
- On remand, applying Teva and Nautilus, the Federal Circuit: (1) accepted the district court’s factual findings about SEC and chromatogram conversion (not clearly erroneous), (2) held that legal interpretation of intrinsic evidence remains for the court, and (3) concluded the claim is invalid for indefiniteness because the patent and prosecution history do not inform with reasonable certainty which molecular-weight measure is claimed.
Issues
| Issue | Teva's Argument | Sandoz's Argument | Held |
|---|---|---|---|
| Whether "molecular weight" in claim 1 is definite | District court findings + SEC example show Mp is the intended measure; experts support Mp inference | Claim language and specification do not specify Mp/Mw/Mn; prosecution history shows conflicting definitions so ambiguity remains | Indefinite: intrinsic record and prosecution history fail to inform with reasonable certainty which measure applies (claim invalid) |
| Standard of review for subsidiary facts in claim construction | Appellate court should review all claim construction de novo | Subsidiary factual findings (e.g., expert disputes about SEC interpretation) are reviewed for clear error | Supreme Court’s Teva controls: ultimate construction is legal (de novo), subsidiary factual findings reviewed for clear error; applied on remand |
| Role of prosecution history from related continuations | Prosecution statements were erroneous or irrelevant and district court factual findings resolving them should be dispositive | Statements in related patents’ prosecution histories (one identifying Mw to overcome rejection; another identifying Mp) are legally significant and can inform claim meaning | Prosecution statements are legally significant; an applicant’s explicit statement to overcome a rejection can define claim meaning; conflicting prosecution statements here create indefiniteness |
| Effect of Nautilus indefiniteness standard | District court’s prior analysis under older standard still supports definiteness | Nautilus requires "reasonable certainty" and is stricter; must re-evaluate definiteness under that standard | Nautilus applied: claims must inform with reasonable certainty; here they do not, so claim invalid |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (U.S. 2015) (subsidiary factual findings in claim construction reviewed for clear error; ultimate construction is legal)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (U.S. 2014) (patent claims indefinite unless they inform skilled artisans of scope with reasonable certainty)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (construction uses intrinsic evidence as primary guide)
- Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc) (held claim construction de novo; later limited by Teva)
- Springs Window Fashions LP v. Novo Indus., L.P., 323 F.3d 989 (Fed. Cir. 2003) (patentee is held to statements made during prosecution)