Abbvie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.
759 F.3d 1285
| Fed. Cir. | 2014Background
- AbbVie owns the '128 and '485 patents directed to fully human IL-12 antibodies; Centocor alleges Stelara infringing.
- Interference proceedings at the PTO awarded priority to AbbVie and held no obviousness issues; Centocor pursued § 146 review in district court.
- Infringement action: a jury found asserted claims invalid for written description, enablement, and obviousness; district court denied JMOL and a new trial.
- District court excluded PTO file-history evidence at trial, but allowed limited testimony about PTO consideration of written description.
- AbbVie moved for summary judgment on collateral estoppel; district court held Centocor was not collaterally estopped because the interference was pending under § 146.
- The appeal consolidates the § 146 interference, the infringement action, and the interference action; the court affirms overall invalidity and the lack of collateral estoppel.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Collateral estoppel in light of § 146 pending? | AbbVie: Board judgment final; estoppel applies. | Centocor: interference pending; Board judgment not final. | Centocor not collaterally estopped; Board lacked finality due to § 146 proceedings. |
| Written description sufficiency for genus of antibodies? | AbbVie argues representative species disclose full genus; Stelara is within genus. | Centocor: disclosure limited to Joe-9 family; not representative of Stelara. | Substantial evidence supports lack of adequate written description; claims invalid. |
| Remand to new trial based on evidentiary/jury-instruction issues? | AbbVie: evidentiary rulings and instructions prejudiced verdicts. | Centocor: district court did not err; no prejudice. | No reversible error; district court did not abuse discretion; no new trial required. |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir. 2010) (written description separate from enablement; genus description require representative species)
- Microsoft Corp. v. i4i Ltd.,, 131 S. Ct. 2238 (Sup. Ct. 2011) (clear and convincing standard; material information before PTO affects burden)
- Regents of Univ. of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir. 1997) (genus description requires adequate disclosure; description of one does not describe whole genus)
- Eli Lilly & Co. v. Fiers, 119 F.3d 1568 (Fed.Cir. 1997) (genus description and representative species requirement (cite for discussion in Ariad context))
- Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed.Cir. 1991) (written description test and possession by disclosure framework)
- Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed.Cir. 2002) (structure-function and written description in enabling claims)