BakerHostetler Patent Watch: Novozymes A/S v. DuPont Nutrition Biosciences APS

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"[T]he written description requirement prohibits a patentee from 'leaving it to the. . . industry to complete an unfinished invention.'"

On July 22, 2013, in Novozymes A/S v. DuPont Nutrition Biosciences APS, the U.S. Court of Appeals for the Federal Circuit (Rader, Schall,* Bryson) affirmed the district court's judgment as a matter of law that U.S. Patent No. 7,713,723, which related to recombinant alpha-amylases, were invalid under 35 U.S.C. § 112 for failure to satisfy the written description requirement. The Federal Circuit stated:

The written description requirement is set forth in the first paragraph of 35 U.S.C. § 112. . . . To satisfy the written description requirement, "the applicant must 'convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,' and demonstrate that by disclosure in the specification of the patent." Accordingly, claims added during prosecution must find support sufficient to satisfy § 112 in the written description of the original priority application. Assessing "possession as shown in the disclosure" requires "an objective inquiry into the four corners of the specification." Ultimately, "the specification must describe an invention understandable to [a] skilled artisan and show that the inventor actually invented the invention claimed." A "mere wish or plan" for obtaining the claimed invention does not satisfy the written description requirement. The written description inquiry presents an issue of fact. . . .

In view of the record before us, including the disclosure of the 2000 application, we hold that no reasonable jury could find that the claims of the '723 patent meet the written description requirement of § 112, ¶ 1, and that the district court therefore correctly entered judgment as a matter of law invalidating those claims. In 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. Taking 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. Finally, the testimony of Novozymes's experts does not overcome the fundamental deficiencies of the 2000 application's written description.

[T]o satisfy § 112, a patent's written description "must 'clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.'" A "mere wish or plan" to obtain the claimed inven¬tion is not sufficient. We have often applied those fundamental concepts to hold claims invalid in cases where a patent's written description disclosed certain subject matter in terms of abroad genus but its claims specified a particular sub¬genus or species contained therein. . . . On the other hand, in some cases, broad or generic disclosures can adequately describe particular constituent species. [T]he question before us is whether the 2000 application demonstrates to one of ordinary skill in the art that, by the application's filing date, Novozymes had invented the particular alpha-amylase variants that Novozymes claimed almost a decade later in the '723 patent. We conclude that it does not.

[C]laim 1 of the '723 patent recites an alpha-amylase variant that (1) has at least 90% sequence identity to BSG alpha-amylase, (2) includes an amino acid substitution at serine 239, and (3) has increased thermostability at pH 4.5, 90°C, and 5 ppm calcium. Novozymes is correct that each of those individual limitations is expressly stated in the disclosure of the 2000 application. . . . The 2000 application, however, contains no disclosure of any variant that actually satisfies the claims, nor is there anything to suggest that Novozymes actually possessed such a variant at the time of filing. First, the bulk of the specification focuses on using BLA (Termamyl™)alpha-amylase, rather than BSG alpha-amylase, as the parent enzyme. [W]hile the bulk of the disclosure concerns substitutions, the only specifically described substitution at position 239 is S239W,which the parties agree does not confer increased thermostability in alpha-amylase enzymes and thus would fall outside of the claims. . . .

While the 2000 application provides formal textual support for each individual limitation recited in the claims of the '723 patent, it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim -- as we must -- as an integrated whole rather than as a collection of independent limitations, 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. "Working backward from a knowledge of [the claims], that is by hindsight," Novozymes seeks to derive written description support from an amalgam of disclosures plucked selectively from the 2000 application. [V]iewing the matter from the proper vantage point "of one with no foreknowledge of the specific compound," we agree with the district court that the particular variants claimed in the '723 patent lack meaningful support in the written description of the 2000 application.

Furthermore, while the disclosure of an inoperative embodiment like the S239W substitution is not necessarily invalidating, the 2000 application lacks any indication that Novozymes had invented any thermostable alpha-amylase variants substituted at amino acid position 239 by the time of filing, much less one specifically produced from a BSG parent. The specification does provide examples showing that Novozymes had tested and verified at least some thermostable variants for the sixteen amino acid positions identi¬fied by random mutagenesis, but nothing in the 2000 application demonstrates that it had verified whether any of the remaining seventeen positions predicted by rational protein design (including position 239) actually yielded a thermostable variant. In fact, the 2000 application's limited disclosure compels the opposite conclusion -- if Novozymes had possessed a working variant substituted at position 239, it surely would have disclosed that substitution instead of, or at least along with, the non¬functional S239W substitution in the several pages of the 2000 application devoted to listing exemplary substitutions.

[O]ne of ordinary skill in the art reading the2000 application would have understood that Novozymes had only predicted that at least some mutations at position 239 would yield variants with increased thermostability, not that it possessed or had definitively identified any mutations that would do so. The parties' experts agreed that one could not know which, if any, individual substitutions at any of the seventeen sites selected by rational protein design would yield increased thermostability without actually making and testing the variants. In fact, DuPont's later empirical work showed that only six of the nineteen possible substitutions at position 239actually conferred increased thermostability. Novozymes nonetheless maintains 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. That argument misses the point, however. The question before us is not whether one of ordinary skill in the art presented with the 2000 application would have been enabled to take those final steps, but whether the 2000 application "discloses the [variants] to him, specifically, as something appellants actually invented."

In this case, to actually possess the variant enzymes claimed in the '723 patent would have required Novozymes to confirm its predictions by actually making and testing individual variants or at least identifying sub¬classes of variants that could be expected to possess the claimed properties, which it did not do before filing the 2000 application. At best, the 2000 application describes a roadmap for producing candidate alpha-amylase variants and then determining which might exhibit enhanced thermostability. A patent, however, "is not a reward for the search, but compensation for its successful conclusion." For that reason, the written description requirement prohibits a patentee from "leaving it to the . . . industry to complete an unfinished invention." . . . In sum, we agree with the district court that no reasonable jury could conclude that the 2000 application provides adequate written description to support the later-filed claims of the '723 patent.

Topics:  Biotechnology, Patent Litigation, Patents, Pharmaceutical, Prescription Drugs, USPTO

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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