Boston Scientific Corp. v. Johnson & Johnson
647 F.3d 1353
| Fed. Cir. | 2011Background
- Patents-in-suit cover drug-eluting stents using rapamycin or macrocyclic lactone analogs; the 1997 patents and the '662 patent are at issue.
- Cordis added the phrase macrocyclic lactone analog to claims after Guidant's everolimus-coated stent approval; Cypher stent is central to alleged infringement.
- District court granted summary judgment invalidating the 1997 patents for nonenablement and lack of written description, and invalidating the '662 patent for lack of written description.
- The court construed 'rapamycin or a macrocyclic lactone analog thereof' to require sirolimus or a structurally similar macrocyclic lactone; no examples of macrocyclic lactone analogs were disclosed.
- On appeal, court held no reasonable juror could find adequate written description for the asserted analogs; enablement issues raised separately by some judges.
- Overall, the Federal Circuit affirmed the district court's invalidity rulings for the asserted claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Written description sufficiency for 1997 patents | Appellants contend the genus is described by knowledge in art and function-structure correlations. | BSC argues the specification lacks sufficient species or blaze marks; cannot describe broad genus. | No adequate written description for genus; affirmed. |
| Written description sufficiency for '662 patent | Appellants argue broader disclosure supports sub-genus macrocyclic triene analogs. | BSC asserts lack of disclosed analogs or blaze marks for the sub-genus. | No adequate written description for macrocyclic triene analogs; affirmed. |
| Enablement of asserted claims | Appellants rely on enablement theories under Wands factors to support depth of disclosure. | District court proper application showing undue experimentation for practicing analogs. | Enablement lacks; majority treats as part of reasoning; concurrence later emphasizes enablement further. |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir. 2010) (written description requires possession of claimed subject matter)
- Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed.Cir. 2008) (genus claims and predictability considerations in written description)
- Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed.Cir. 2003) (functional description and enablement considerations)
- In re Herschler, 591 F.2d 693 (CCPA 1979) (early guidance on genus descriptiveness)
- Falko-Gunter Falkner v. Inglis, 448 F.3d 1366 (Fed.Cir. 2006) (well-known art can support written description, but not when contradicted by specification)
- Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir. 1997) (genus description requires precise definition to distinguish from others)
- Capron v. Eshhar, 418 F.3d 1349 (Fed.Cir. 2005) (factors for evaluating written description with evolving art)