Wyeth & Cordis Corp. v. Abbott Laboratories
720 F.3d 1380
| Fed. Cir. | 2013Background
- Patents involve use of rapamycin (sirolimus) to treat/prevent restenosis after arterial injury; sirolimus is the active species disclosed with a macrocyclic ring and substituent at C-37; claims cover use of an antirestenosis effective amount of rapamycin in mammals; the effective filing date is January 9, 1992; the specification discloses immunosuppressive/antirestenotic effects and in vitro/in vivo assays for activity; district court held claims not enabled for full scope and invalid for nonenablement; the district court’s construction of rapamycin framed the invention as a new use of sirolimus and related compounds; on appeal, the court reviews enablement de novo under Fed. Cir. standards; this court affirms nonenablement finding.
- Wyeth and Cordis sought judgment of nonenablement despite evidence of routine screening and structure-function considerations; the district court relied on the breadth of the claims and lack of guidance in the specification for structural modifications; the court accepted Wyeth’s assertion that many candidate compounds could meet the macrocyclic ring and weight/permeability constraints but would require extensive testing; the parties’ experts disagreed on the number of required compounds and the extent of routine experimentation; the court concluded substantial undue experimentation would be required to practice the full scope of the claims at filing date; the appellate court reviews enablement as a matter of law based on underlying facts and insists on no genuine factual dispute.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Enablement of full claim scope | Wyeth argues routine experimentation suffices; full scope covered by macrocyclic ring with differing substituents. | Wyeth’s position fails because guidance is limited to sirolimus properties and screening assays; tens of thousands of candidates require undue experimentation. | No; full scope requires undue experimentation; claims not enabled. |
| Scope and guidance for selecting substitutions | One skilled person could identify substitutions preserving activity via disclosed assays. | Spec discloses no guidance on structural substitutions; makes routine experimentation insufficient. | No; lack of structural guidance plus need to synthesize/screen many candidates shows nonenablement. |
Key Cases Cited
- MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377 (Fed. Cir. 2012) (enablement involves whether skilled artisans can practice the invention without undue experimentation)
- Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342 (Fed. Cir. 1998) (routine experimentation allowed but bounded by guidance in specification)
- Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330 (Fed. Cir. 2013) (examine whether required experimentation would be unreasonably long or excessive)
- Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004) (undue experimentation is a matter of degree in enablement analysis)
- ALZA Corp. v. Andrx Pharmaceuticals, LLC, 603 F.3d 935 (Fed. Cir. 2010) (starting point for research may still require iterative experimentation)