Spectrum Pharmaceuticals, Inc. v. Sandoz Inc.
802 F.3d 1326
| Fed. Cir. | 2015Background
- Spectrum appeals district court rulings that claims 1–2 of the ’829 patent are invalid as obvious and that claims 5–9 are not infringed by Sandoz’s ANDA product.
- The ’829 patent covers pharmaceutical compositions of substantially pure levoleucovorin (6S) with minimal 6R impurity, at specified purity thresholds (≥92–95% 6S).
- The district court held that the prior art, including Cosulich and Rees, rendered the claimed invention obvious and that the anticipated purity limitations were not patentably distinct.
- Spectrum holds the FDA-approved Fusilev product; Sandoz submitted an ANDA seeking 175 mg or 250 mg single-use vials for methotrexate rescue use.
- Claims 5–9 add a quantitative limitation: a mixture with at least 92% (6S) and a generous dosage amount corresponding to 2000 mg per dose, which the district court construed as per-dose.
- The court found the prior art enabling for purification and rejected Spectrum’s nexus/secondary-indicia arguments; it also found no infringement under literal or doctrine-of-equivalents theory for claims 5–9.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are claims 1–2 invalid as obvious? | Spectrum asserts nonobviousness due to purification limitations and lack of anticipated results. | Sandoz contends motivation to purify from the 50/50 mixture and expected success render obviousness. | Claims 1–2 invalid as obvious. |
| Do claims 5–9 infringe under literal infringement? | Spectrum argues Sandoz’s product and aggregate quantities infringe the 2000 mg per two-dose limitation. | Sandoz argues the ANDA product does not meet per-dose quantity limits and prosecution history, estoppel applies. | No literal infringement by Sandoz’s product. |
| Does prosecution history estoppel bar the doctrine of equivalents for claims 5–9? | Spectrum asserts DOE remains available despite amendments. | Sandoz shows amendments and statements disclaiming coverage of lower quantities create estoppel. | Yes; prosecution history estoppel bars the doctrine of equivalents. |
Key Cases Cited
- KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (Supreme Court 2007) (motivation to combine is a factual question; common knowledge supports obviousness)
- Graham v. John Deere Co., 383 U.S. 1 (Supreme Court 1966) (basis for determining obviousness with the facts of prior art, scope, and skill)
- Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007) (purified compound obvious over known mixture when desirable property derives from one component)
- Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008) (purified isomer and prior art interplay; expectations of purification)
- Warner–Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (Supreme Court 1997) (doctrine of equivalents and prosecution history estoppel framework)
- Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (Supreme Court 2002) (prosecution history estoppel rule and rebuttal burden)
- Intervet Inc. v. Merial Ltd., 617 F.3d 1282 (Fed. Cir. 2010) (prosecution history estoppel as a question of law)