August 2013
Written Description Not Satisfied for Narrow Claims Where Disclosure Provides Only Generalized Guidance That May or May Not Lead to Useful Result
| Judges: Rader (dissenting), Schall (author), Bryson |
| [Appealed from W.D. Wis., Senior Judge Crabb] |
In Novozymes A/S v. DuPont Nutrition Biosciences APS, No. 12-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s JMOL that the claims of U.S. Patent No. 7,713,723 (“the ’723 patent”) are invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112.
Plaintiffs Novozymes A/S and Novozymes North America, Inc. (collectively “Novozymes”) and Defendants DuPont Nutrition Biosciences APS, Genencor International Wisconsin, Inc., Danisco US Inc., and Danisco USA Inc. (collectively “DuPont”) compete in the market of commercial enzyme preparation. The ’723 patent contains claims to particular modified alpha-amylase enzymes that exhibit improved function and stability under certain conditions, and claims priority from and has a nearly identical written description as a provisional application filed in 2000 (“the 2000 application”). Novozymes sued DuPont for infringement of the ’723 patent, and DuPont defended, inter alia, on the grounds of invalidity under the written description and enablement requirements. A jury found that the ’723 patent was not invalid and awarded infringement damages to Novozymes. The district court, however, granted DuPont’s JMOL motion that the claims of the ’723 patent are invalid for inadequate written description in the 2000 application. Novozymes appealed.
“[O]ne searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any ‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.” Slip op. at 24.
On appeal, the Federal Circuit held that no reasonable jury could find that the claims of the ’723 patent meet the written description requirement, and that the district court correctly entered JMOL invalidating the claims. The Court reasoned that “[i]n contrast to the claims—which narrowly recite specific
alpha-amylase variants that result from mutating a particular parent enzyme at a single amino acid position to yield distinctive functional properties—the supporting disclosure of the 2000 application provides only generalized guidance listing several variables that might, in some combination, lead to a useful result.” Slip op. at 18. The Court held that “[t]aking the claims as a whole rather than as the sum of their individual limitations, nothing in the 2000 application indicates that Novozymes then possessed what it now claims.” Id. The Court further concluded that the testimony of Novozymes’s experts did not overcome the fundamental deficiencies of the 2000 application’s written description.
The Court noted, as argued by Novozymes, that each of the individual claim limitations could be found in the specification and thus had “formal textual support” in the disclosure of the 2000 application, but that the combination of variables that constituted the later claimed subject matter was nowhere described. As stated by the Court, “one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any ‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.” Id. at 24. The Court noted that the bulk of the 2000 application focused on a different parent enzyme than that of the ’723 patent, that the amino acid position targeted in the ’723 patent was only one of thirty-three positions that could be altered, that the 2000 application only specifically described one substitution at that position, and that the parties agreed that such a substitution would fall outside the claims of the ’723 patent because it did not confer increased thermostability.
The Court rejected Novozymes’s argument that one of ordinary skill in the art directed to position 239 would have known how to test every possible variant at that position and thus would have found the claimed variants as a matter of course. The Court stated that the question before them was not whether one of ordinary skill in the art would have been enabled to take the final step of testing variants at the 239 position, but whether the 2000 application actually guided one skilled in the art to make a variant at 239 with the particular properties claimed some ten years later out of a slew of competing possibilities. As mentioned above, the Court found that there was nothing in the 2000 application that would have led one skilled in the art to the variants later claimed, and specifically held that one could not use knowledge of the later claimed subject matter as a guide to “pluck” from the specification the necessary claim limitations. Accordingly, the Court found that the 2000 application did not show possession of the claimed invention, stating that the application was “[a]t best, . . . a roadmap for producing candidate alpha-amylase variants and then determining which might exhibit enhanced thermostability.” Id. at 27. Because “[a] patent . . . ‘is not a reward for the search, but compensation for its successful conclusion,’ . . . the written description requirement forbids a patentee from ‘leaving it to the . . . industry to complete an unfinished invention.’” Id. (quoting Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353 (Fed. Cir. 2010) (en banc)).
The Court found Novozymes’s remaining arguments unpersuasive and concluded that the claims of the ’723 patent are invalid for failure to satisfy the written description requirement. The Court thus affirmed the district court’s JMOL on that basis.
Chief Judge Rader dissented, stating that “[the Court’s] written description rules urge reversing the district court’s post-verdict grant of judgment.” Rader Dissent at 2. In Judge Rader’s view, substantial evidence supported the jury’s determination that the claims were not invalid for failing to satisfy the written description requirement. In particular, Judge Rader noted that it was sufficient that the specification disclosed “well-known” tests for “determining activity and thermostability at the claimed conditions.” Id. at 3.
