Novozymes A/S v. DuPont Nutrition Biosciences APS
723 F.3d 1336
| Fed. Cir. | 2013Background
- Novozymes filed a 2000 provisional patent application disclosing seven Bacillus alpha‑amylase parent sequences, 33 candidate amino‑acid positions for mutation (including position 239), and a goal of improved thermostability/acid tolerance at low calcium; two working examples supported variants from random mutagenesis (16 positions), but no working BSG‑S239 thermostable variant was disclosed.
- Novozymes later filed continuation applications and in 2009 added claims directed to BSG variants substituted at S239 with increased thermostability; U.S. Patent No. 7,713,723 (the '723 patent) issued in 2010 and Novozymes sued DuPont for infringement.
- DuPont had independently developed a BSG S239Q thermostable variant and was accused; DuPont counterclaimed that the '723 claims were invalid under 35 U.S.C. § 112 (written description and enablement).
- A jury found the claims not invalid and awarded Novozymes >$18M for willful infringement, but the district court granted JMOL for DuPont, holding the claims invalid for lack of adequate written description in the 2000 application.
- The Federal Circuit affirmed: it held the 2000 application did not show possession of the narrowly claimed BSG‑S239 thermostable species and thus failed the § 112 written description requirement.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Written description (possession as of 2000 filing) | 2000 application expressly disclosed the BSG parent, position 239, and the claimed thermostability conditions; a skilled artisan would understand the specification to show possession of the claimed variants. | 2000 application only provided a generic roadmap/"laundry list" of parents, positions, and possible substitutions; it did not identify or verify any working BSG‑S239 thermostable species and thus did not show possession. | Affirmed: no reasonable jury could find written description satisfied; claims invalid under § 112 ¶1. |
| Enablement (whether claims were enabled by 2000 disclosure) | (Novozymes) Skilled artisans could make/test variants from the disclosure; enablement was met. | (DuPont) The disclosure left the inventive work to others; enablement was lacking for the claimed species. | Not reached as the court affirmed on written description (district court had dismissed enablement motion after invalidation). |
| Hindsight / expert testimony reliance | Novozymes: expert testimony supported that a skilled artisan would derive the claims from the 2000 disclosure; jury verdict should be upheld. | DuPont: testimony improperly relied on hindsight and post‑filed knowledge; the specification lacked "blaze marks" to the claimed species. | Court found expert testimony insufficient to overcome lack of contemporaneous possession; rejected hindsight‑based reconstructions. |
| Standard of review for JMOL on written description | Novozymes: jury resolved factual issue; JMOL inappropriate where substantial evidence supports verdict. | DuPont: JMOL proper because no legally sufficient evidentiary basis existed for the jury verdict. | Affirmed JMOL: applying Seventh Circuit standard, court concluded no reasonable jury could find for Novozymes on written description. |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) (written description is a separate§112 requirement; possession standard).
- Vas‑Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991) (specification must convey possession to skilled artisan).
- In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) (generic structural disclosure insufficient to support later‑claimed specific compound absent guidance/blaze marks).
- Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011) (genus disclosure failed to show possession of claimed subgenus species).
- Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011) (affirming invalidity where specification did not show possession of claimed species).
- Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004) (specification that only provides screening assays does not demonstrate possession of claimed compounds).
- Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000) (claim limitation not identified or emphasized in specification defeats written description).
- Snitzer v. Etzel, 465 F.2d 899 (C.C.P.A. 1972) (literal listing of a species among enumerated alternatives can support a species claim despite some inoperative members).
- Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989 (Fed. Cir. 2000) (when art is predictable, recited functional/physical properties can convey possession of concrete compositions).