Federal Circuit Finds No Written Description Support For Novozymes Amylase Patent

25 July 2013 PharmaPatents Blog

In Novozymes A/S v. DuPont Nutrition Biosciences APS, the Federal Circuit determined that the Novozymes amylase patent at issue did not satisfy the written description requirement of 35 USC § 112, because the disclosure did not demonstrate possession of the claimed subject matter as a whole. While the opinion states that the decision is consistent with other Federal Circuit case law (such as University of Rochester v. G.D. Searle & Co. (Fed. Cir. 2004)), I find the court’s analysis to reflect an EPO-type analysis. Indeed, the majority states that Novozymes needed to have actually reduced the claimed subject matter to practice in order to satisfy the written description requirement.  

The Patent At Issue

The patent at issue was Novozyme’s U.S. Patent 7,713,723, directed to “alpha-amylase mutants with altered properties.” In particular, the patent describes mutant enzymes with improved heat tolerance. Claim 1 recites:

1. An isolated variant of a parent alpha-amylase, wherein: (a) the variant has at least 90% sequence identity to SEQ ID NO: 6, (b) the variant comprises a substitution of serine at position 239 relative to the parent alpha-amylase, using the amino acid sequence of SEQ ID NO: 8 for determining position numbering, and (c) the variant has increased thermostability relative to the parent alpha-amylase, wherein thermostability is determined at pH 4.5, 90 °C and 5 ppm calcium and has alpha-amylase activity.

The patent issued from an application filed in December of 2009 with a priority claim through a series of continuation applications to U.S. Provisional Application Nos. 60/225,140, 60/233,986, 60/249,104 and 60/286,869, filed  Aug. 14, 2000, Sep. 20, 2000, Nov. 16, 2000, and Apr. 26, 2001, respectively. While the court framed the issue as whether the claims were supported by the Nov. 16, 2000 provisional application, it also noted that the disclosure of that application was “largely identical” to that of the ’723 patent. 

The Accused Product 

The accused product was DuPont’s alpha-amylase mutant based on an alpha-amylase produced by B. stearothermophilus (BSG), with a S239Q mutation. DuPont filed its own patent application on this mutant in November of 2008, and its patent was granted in June of 2009, before Novozymes filed the application that was granted as the ’723 patent. 

The District Court Proceedings

A jury upheld the patent and awarded Novozymes $18 million in damages, but the district court granted DuPont’s motion for judgment as a matter of law (JMOL) that the claims are invalid for failing to satisfy the written description requirement.

The Federal Circuit Decision

The decision of the court was written by Judge Schall and joined by Judge Bryson. Chief Judge Rader wrote a dissenting opinion.

The majority opinion notes the following about the specification:

  • the application disclosed seven potential parent enzymes
  • the application disclosed thirty-three separate amino acid positions along the alpha-amylase chain identified as promising mutation targets using rational protein design or random mutagenesis
  • the application indicated that one or more of those sites might be altered in any of the seven disclosed parent alpha-amylases by deletion, addition or substitution
  • the application indicated that the disclosed variants would exhibit improved stability at “high temperatures (i.e., 70-120°C.) and/or extreme pH (i.e., low or high pH, i.e., pH 4-6 or pH 8-11), in particular at free (i.e., unbound, therefore in solution) calcium concentrations below 60 ppm.” 
  • the application included two examples that do not involve claimed embodiments
  • the only mutation at position 239 disclosed in the application is S239W, which subsequently was determined not to increase thermostability.

The majority opinion states:

Given the number of parent enzymes (7), the number of target positions in each of those parent enzymes (33), and the number of possible mutations at each of those target positions (at least 40), the disclosure in the 2000 application spans a potentially wide range of alpha-amylase variants. … The 2000 application includes pages of … exemplary substitutions, presented alone and in double, triple, or larger combinations, but the application does not state that any one of the thirty-three disclosed mutations sites is preferred over any other and does not state whether single or combined mutations are preferred. 

The majority recognized that each of the claim limitations “can be found at points within the underlying 2000 application, but … Novozymes never presented them together in any particular embodiment and did not highlight the BSG parent or position 239 among the other disclosed options.”

The 2000 application … 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.

*****

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.

With regard to the subsequent failure of the S239W mutant, the majority noted:

[W]hile 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 majority then provides this guidance:

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 subclasses 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.” 

The court  therefore affirmed the district court’s grant of JMOL because the claims fail to satisfy the written description requirement.

Chief Judge Rader’s Dissent

Chief Judge Rader notes his continued dissatisfaction with “a separate written description requirement,” but focuses his dissent on the procedural posture of this case. In particular, Chief Judge Rader notes that “[t]he written description inquiry is a question of fact,” and believes that the jury verdict that upheld the patent was supported by substantial evidence.

Actual Reduction To Practice For Written Description?

The majority stopped short of requiring actual reduction to practice to satisfy the written description requirement, but it came uncomfortably close. While the majority asserts that Novozymes had not “identif[ied] subclasses of variants that could be expected to possess the claimed properties,” doesn’t the identification of seven reference enzymes, 33 amino acid positions to be modified, and specific suggested modifications indicate otherwise? Over all, the majority’s analysis reminds me of that encountered at the EPO, where the corresponding “basis” requirement of Article 123(2) EPC has been interpreted to require near ipsis verbis support for any claims.

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