10 F.4th 1330
Fed. Cir.2021Background
- The ’190 patent claims a three-part CAR (CD3-zeta intracellular domain + CD28 costimulatory region defined by SEQ ID NO:6 + a binding element) encoded by a nucleic acid polymer; dependent claims limit the binding element to an scFv and, in some claims, to CD19-binding scFvs.
- The specification disclosed two example scFvs (SJ25C1 for CD19 and J591 for PSMA) but did not disclose their amino acid or nucleotide sequences or other identifying structural features.
- Kite’s product YESCARTA® uses a three-part CAR containing a CD19-binding scFv; Juno sued Kite for infringement of the ’190 patent, and a jury found the asserted claims valid and infringed, awarding substantial damages.
- Kite moved for JMOL, arguing lack of written description and enablement, invalidity of Juno’s certificate of correction, and other defenses; the district court denied JMOL and enhanced damages.
- On appeal, the Federal Circuit held that substantial evidence did not support the jury’s finding that the specification satisfied the written description requirement for the claimed functional genus of scFvs, and reversed (claims invalid); the court did not reach Kite’s other arguments.
Issues
| Issue | Juno's Argument | Kite's Argument | Held |
|---|---|---|---|
| Written description for functionally claimed scFv genus (claims 3,9) | Specification and two working scFv examples (plus field knowledge) sufficiently show possession of the genus | Specification lacks representative species or common structural features to identify which scFvs bind which targets; genus is vast and unpredictable | Reversed—no substantial evidence that written description supports the broad functional scFv claims; claims invalid |
| Written description for CD19‑specific scFvs (claims 5,11) | Known CD19 scFvs and SJ25C1 example show possession; expert testimony that several CD19 scFvs existed | Only one CD19 scFv disclosed in patent; only a few CD19 scFvs known in prior art; disclosure insufficient to show possession of all CD19-binding scFvs | Reversed—insufficient written description support for CD19‑specific genus claims |
| Enablement of asserted claims | (Juno) Patent enables making and using claimed CARs with scFvs | (Kite) Enablement challenged as insufficient for broad functional genus | Not reached—court invalidated claims on written description grounds, so enablement not decided on appeal |
| Certificate of correction / willfulness / damages | (Juno) Certificate valid; infringement willful; damages appropriate | (Kite) Certificate invalid; good faith/non‑willful; errors in damages evidence | Not reached on appeal (claims invalidated); factual findings below were in Juno’s favor but vacated as to patent validity |
Key Cases Cited
- Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) (written description requires disclosure showing inventor possessed claimed subject matter; genus-by-function requires representative species or common structural features)
- Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) (written description standard varies with existing knowledge and predictability; caution against overly rigid nucleotide‑sequence rules)
- Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (chemical genus/species disclosure requires precise structural definition when necessary)
- Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993) (written description may require structure/formula/name to distinguish claimed chemical subject matter)
- Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149 (Fed. Cir. 2019) (claims invalid where specification lists examples without explaining what makes them effective for the claimed function)
- AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014) (written description insufficient where claims broadly cover antibodies achieving a result but only one lead antibody species is described)
- Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011) (written description test applies equally to novel combinations and to auxiliary claim elements)