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Where There Is No Clear Disavowal of Claim Scope, a Patentee’s Express Defi nition of a Claim Term Controls

08-1459
September 03, 2009

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Last Month at the Federal Circuit - October 2009

Judges: Newman, Lourie (dissenting-in-part), Rader (dissenting-in-part, joining Lourie), Gajarsa (author), Moore

[Appealed from: D. Del., Chief Judge Sleet]

In Martek Biosciences Corp. v. Nutrinova, Inc., Nos. 08-1459, -1476 (Fed. Cir. Sept. 3, 2009), the Federal Circuit affi rmed the district court’s denial of JMOL that the claims of Martek Biosciences Corp.’s (“Martek”) U.S. Patent No. 5,340,594 (“the ’594 patent”) were invalid and that Nutrinova, Inc., Nutrinova Nutrition Specialties and Food Ingredients GmbH, and Lonza, Ltd. (collectively “Lonza”) did not infringe claims of U.S. Patent No. 6,410,281 (“the ’281 patent”). The Court also found that the district court did not abuse its discretion in excluding Lonza’s prior inventorship evidence, and that the district court correctly construed the term “non-chloride sodium salt.” Finally, the Federal Circuit reversed the district court’s grant of JMOL that the asserted claims of Martek’s U.S. Patent No. 6,451,567 (“the ’567 patent”) were invalid and reversed the district court’s construction of the term “animal” in Martek’s U.S. Patent No. 5,698,244 (“the ’244 patent”).

Martek and Lonza make and sell products containing docosahexaenoic acid (“DHA”), an essential omega-3 fatty acid involved in organ development. Because the human body produces limited quantities of DHA, it is desirable to provide supplemental DHA.

Martek asserted that Lonza infringed claims of the ’594, ’281, ’567, and ’244 patents, which relate to specified microorganisms that are useful for the commercial production of DHA. Lonza argued that the asserted claims were invalid under 35 U.S.C. §§ 102, 103, and 112. The district court construed the contested claim terms and, based on the construction, Martek stipulated that Lonza did not infringe the asserted claims of the ’244 patent, but preserved its right to appeal the court’s construction of “animal.” A jury then found the remaining asserted claims infringed and not invalid, and further found that Lonza’s infringement of the
’281 patent claims was willful. The district court granted Lonza’s motion for JMOL that the ’567 patent claims were invalid for lack of enablement, and Martek’s motion for a permanent injunction. Both parties appealed.

On appeal, Lonza argued that the ’594 patent claims were invalid as anticipated by WO 89/00606 and that the jury erred in fi nding that the application was not prior art against the ’594 patent. Lonza argued that substantial evidence did not support the jury’s fi nding that the ’594 patent claims were entitled to the priority date of an abandoned application fi led in 1988 (“the 1988 application”). Specifically, Lonza argued that two claim limitations, namely, “mixed culture” and “food product,” were not described in the 1988 application.

The Federal Circuit found that Martek’s expert explained how a person of ordinary skill in the art would recognize that at least one passage in the 1988 application disclosed the process of extracting lipids from a mixed culture of fermenting microorganisms. Accordingly, the Court held that the text of the 1988 application, in light of Martek’s expert’s testimony, provided substantial evidence to support the fi nding that the application met the written description requirement for the “mixed culture” limitation.

Noting that a patent claim is not necessarily invalid for lack of written description just because it is broader than the specific examples disclosed, the Court rejected Lonza’s argument that the jury could not reasonably rely on the expert’s interpretation of the 1988 application because the application did not contain any working examples that consolidated cells from different strains. Further, the Court disagreed with Lonza’s argument that the 1988 application taught away from growing the two strains together. The Court found no evidence to suggest that the two strains could not be grown together. Therefore, the Court found substantial evidence to support the jury’s fi nding that the 1988 application adequately described the “mixed culture” limitation of the claims.

Moreover, the Court found that the text of the 1988 application, in light of Martek’s expert’s testimony, provided substantial evidentiary support for the jury’s finding that the 1988 application adequately described the claimed food product comprising extracted lipids and food material. Accordingly, the Court held that substantial evidence supports the jury’s finding that the ’594 patent claims are entitled to the priority date of the 1988 application and that the district court did not err in denying Lonza’s JMOL motion.

Regarding the infringement of the ’281 patent claims, the district court construed the claims to require that “the culture medium causes less chemical wearing of the vessel in which the microorganisms are grown as compared to the level of chemical wearing away to a vessel caused by a culture medium comprising sodium chloride as the primary source of sodium.” Slip op. at 12 (citation omitted). Lonza argued that Martek failed to prove infringement because it failed to conduct comparative testing to demonstrate that Lonza’s culture medium caused “less chemical wear” than a culture medium containing sodium chloride as the primary source of sodium. The Court found that, based on Martek’s experts’ testimony, the jury could have reasonably concluded that Lonza’s culture medium caused less chemical wear than a culture medium containing sodium chloride as the primary source of sodium.

Additionally, Lonza appealed the exclusion of evidence that allegedly showed prior inventorship of the claimed invention. Lonza offered the alleged prior inventor’s abandoned patent application and evidence that the examples originally disclosed in the abandoned application were later reproduced, generating the results described in the application. The Court found that the abandoned application failed to establish that the alleged prior inventor reduced the invention to practice, even in view of additional evidence that the Court noted was merely “a post hoc replication of experiments cited in the abandoned application, which does not qualify as evidence from a time prior to or contemporaneous with the alleged prior invention.” Id. at 19. Because the evidence failed to establish corroboration of the alleged prior inventor’s testimony, the Court held that the district court did not abuse its discretion in excluding Lonza’s evidence of prior inventorship.

Finally, Lonza argued that the district court misconstrued the ’281 patent claim term “non-chloride sodium salt” by allowing that term to include sodium hydroxide. The Court affi rmed the district court’s construction, finding that the intrinsic and extrinsic evidence supported the construction. Specifically, the prosecution history explicitly stated that sodium hydroxide is a non-chloride sodium salt, and that two treatises taught that sodium hydroxide can be considered a non-chloride sodium salt. The Court further noted that Lonza cited no evidence that sodium hydroxide cannot be considered a non-chloride sodium salt. Moreover, the Court held that Martek committed no clear and unmistakable disavowal of claim scope in light of the prosecution history as a whole.

Turning to Martek’s appeal, Martek argued that the district court erred in granting JMOL that all asserted claims of the ’567 patent were invalid for lack of enablement. The Federal Circuit held that the district court erred in granting JMOL with respect to the asserted dependent claims because it failed to consider the additional limitations of the dependent claims. Specifically, although the independent claim covered “perhaps 10,000” organisms and the ‘567 patent disclosed only one such example, the Court found that Lonza failed to present any evidence—much less clear and convincing evidence—that one of ordinary skill in the art must perform undue experimentation to practice the asserted dependent claims. But because the embodiments covered by dependent claims 4 and 5 comprised only twenty-two possibilities, the Court found that the evidence supported the jury’s implicit finding that one need not perform undue experimentation to practice these claims. Thus, the Court reversed the district court’s grant of JMOL as to claims 4 and 5 of the ’567 patent.

Martek also appealed the construction of the term “animal” found in the asserted claims of the ’244 patent. In view of the district court’s construction, which excluded humans, Martek stipulated that Lonza did not infringe the ’244 patent claims. On appeal, the Federal Circuit held that because Martek explicitly defined “animal” in the specification to include humans, that definition controls. The Court also found that Martek had not clearly disavowed itself of humans, even though it had included only nonhuman animals in its preferred embodiments. And the Court found no disavowal in view of isolated statements in the prosecution—that the dissent alleged distinguished between humans and other animals—because the Court failed to fi nd evidence of a clear disclaimer of “humans” from “animal.” Further, the Court noted that, because the patentee explicitly defined “animal,” Lonza’s extrinsic evidence was simply irrelevant.

Judge Lourie, with whom Judge Rader joined, dissented-in-part with respect to the majority’s holding that the term “animal” in the claims of the ’244 patent includes humans. The dissent acknowledged that the specification defines “animal” to include humans in a single sentence, but reasoned that “[t]his case illustrates the unusual situation in which a purported defi nition of a claim term in the written description is totally negated by the remainder of the text of the patent.” Lourie Dissent at 2. The dissent noted that the specification and claims distinguished between animals and humans in several places. Because the Court is bound to read the claim term in a manner that is consistent with the specification as a whole, the dissent stated that it was clear that one of ordinary skill in the art would conclude that, despite the purported definition in the specification, the term “animal” cannot include humans.

Summary authored by John W. Cox, Ph.D., Esq.