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By Tony Dutra
A 2009 continuation patent application claim lacks adequate written description in a 2000-filed specification despite its description of all claim limitations, the U.S. Court of Appeals for the Federal Circuit ruled July 22 in a 2-1 decision (Novozymes A/S v. DuPont Nutrition Biosciences APS, Fed. Cir., No. 12-1433, 7/22/13).
The court affirmed a district court's judgment as a matter of law that Novozymes A/S was not in “possession” of the invention--required under the Federal Circuit's 2010 holding en banc in Ariad--of a specific alpha-amylase variant for use in corn ethanol production, when the specification identified numerous options for each limitation.
In dissent, Chief Judge Randall R. Rader said that substantial evidence supported the jury's opposite finding. His view of the state of the art of the technology--what it would take a person of skill in the art to get from the numerous options to the single enzyme--differed significantly from that of the majority.
As a consequence of research it began in 2006, DuPont Nutrition Biosciences APS received a patent (U.S. Patent No. 7,541,026) in 2009 on a thermostable alpha-amylase product. It used the bacteria B. stearothermophilus (BSG) as a parent, substituting glutamine for serine at position 239.
Novozymes immediately filed an application that ultimately issued as a patent (U.S. Patent No. 7,713,723) that read on the DuPont product. It was a continuation of a patent application filed in 2000. That specification identified seven possible alpha-amylase parent enzymes and 33 target positions for amino acid manipulation--deletion of the amino acid at that position or insertion or substitution of any of 19 other amino acids, either alone or in combination--likely to result in specific beneficial properties including thermostability.
BSG was one of the seven parent enzymes listed in the 2000 specification, but Novozymes identified its preference for starting with B. licheniformis (BLA), the parent enzyme of a product it marketed under the brand name Termamyl. And though the 2000 specification identified position 239 as one of the 33 targets for manipulation, the specification did not identify an example of a variant having the desired properties with a substitution at position 239.
As soon as the '723 patent was issued, Novozymes sued DuPont for patent infringement in the U.S. District Court for the Western District of Wisconsin.
A jury awarded $18 million in damages after finding no invalidity and willful infringement. However, Senior Judge Barbara B. Crabb granted DuPont's motion for JMOL of invalidity under 35 U.S.C. §112, ¶1, for lack of adequate written description in the 2000 application. Novozymes appealed.
Judge Alvin A. Schall first identified the en banc court's jurisprudence on the written description requirement pursuant to Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F.3d 1336, 94 U.S.P.Q.2d 1161 (Fed. Cir. 2010) (en banc). He said, quoting from the opinion, “Assessing 'possession as shown in the disclosure' requires 'an objective inquiry into the four corners of the specification.”
The majority said that Novozymes's 2000 application fails that inquiry because it “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.”
However, the bulk of the majority's analysis was in comparing the instant case to six precedents, going back to 1967, where the court held claims invalid or valid “where a patent's written description disclosed certain subject matter in terms of a broad genus but its claims specified a particular subgenus or species contained therein.”
Novozymes relied, for example, on Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 54 U.S.P.Q.2d 1227 (Fed. Cir. 2000), but the court said that case featured a “recognized level of standardization and predictability in mixing various petroleum stock to achieve particular properties in the result gas products.”
In the instant case, though, the court said, “one of ordinary skill in the art reading the 2000 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 court thus likened the case to Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 U.S.P.Q.2d 1886 (Fed. Cir. 2004), “where the patent specification failed to disclose any compounds that could be used in the claimed methods.”
Novozymes could have shown possession of the DuPont-centered variants if it had “confirm[ed] 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,” the majority said.
The court thus affirmed the district court's JMOL.
In dissent, Rader first took a swipe at the decision in Ariad--he filed a dissent in that case as well--saying that “the vague notion of 'possession' that it embodies[ ] still troubles me.”
However, his primary concern was that “substantial evidence supports the jury's verdict, which deserves significant deference.”
In particular, Rader cited the testimony of Novozymes's experts that the possible combinations of parent enzymes, target positions, and manipulation options were far more limited--given the expertise of the person of skill in the art at the time--than the majority presented.
“Making and testing all nineteen amino acid substitutions at one position was routine and would only take one week,” Rader said in noting one example. “In other words, a team of ten scientists could test all thirty-three positions with relative ease.” And he criticized the majority for failing to credit the inventors for reducing the possible 500 positions of the parent enzymes that could have been manipulated down to 33.
After an eight-day trial with expert testimony presented by skilled protein engineers, the jury's determination deserved deference, he said.
David Keith Tellekson of Fenwick & West, Seattle, represented Novozymes. Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner, Reston, Va., represented DuPont.
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