Martek Biosciences Corp. v. Nutrinova, Inc. (Fed. Cir. Sept. 3, 2009)

In this case, the district court (District of Delaware) entered final judgment that the defendants infringed certain claims of two of plaintiff's patents and, based on the court's claim construction, plaintiff stipulated that the defendants did not infringe one of plaintiff's patents-in-suit. Both plaintiff and defendant appealed on various issues, including claim construction of two terms. The Federal Circuit, in an opinion by Judge Gajarsa, affirmed the claim claim construction of one term and reversed on the other, remanding back to the district court for further proceedings. Judge Lourie wrote an opinion dissenting in part, to which Judge Rader joined (this particular panel consisted of five judges).

The disputed claims in one of the patents relate to "heterotrophic organisms and a process for culturing them for the production of lipids with high concentrations of omega-3 highly unsaturated fatty acids (HUFA) suitable for human and animal consumption as food additives for use in pharmaceutical and industrial products." One essential omega-3 fatty acid is Docosahexaenoic acid ("DHA"), which is produced in limited quantities by the human body and plays an important role in the development of various organs. The disputed claims in the other patent relate to methods for increasing the concentration of omega-3 HUFA in animals by feeding them microorganisms of the order Thraustochytriales or lipids extracted from such microorganisms.

Two issues on appeal were the constructions of the claim terms "non-chloride sodium salt" and "animal." The district court construed the term "non-chloride sodium salt" to encompass sodium hydroxide (NaOH) and construed the term "animal" to exclude humans.

A. "Non-Chloride Sodium Salt"

Regarding this term, the Federal Circuit found the district court's claim construction "comports with the intrinsic and extrinsic evidence of record." Specifically, defendants primary argument was that the plaintiff disclaimed coverage of NaOH during prosecution, citing to "selected statements spanning two pages of the prosecution history." While the Federal Circuit found that "the selected statements arguably support [the defendants'] assertion, those statements are undercut considerably by additional statements recited in the same two pages of prosecution history relied upon by [the defendants]: (1) the applicant's explicit statement that NaOH is a non-chloride sodium salt, and (2) the applicants' statements distinguishing the prior art at issue from the claimed invention on alternative grounds unrelated to the way NaOH was used in the prior art reference." Citing to its prior precedent, the Court found that the plaintiff "committed no clear and unmistakable disavowal of claim scope" and affirmed the district court's claim construction.

B. "Animal"

The district court had construed this term to mean "any member of the kingdom Animalia, except humans." The Federal Circuit, citing Phillips, stated that "[w]hen a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls." In this case, the patentee explicitly provided in the specification that "[t]he term 'animal' means any organism belonging to the kingdom Animalia." The Court found that since it was "undisputed that humans are members of the kingdom Animalia, it was error for the district court to limit the claim term 'animal' to exclude humans."

Defendants argued that, when the specification is considered in its entirety, it clearly limits "animal" to non-human animals. In this regard, defendants appeared to raise three arguments. First, defendants pointed out that the specification discloses and enumerates a number of "economic food animals" (including cows, sheep, goats, bison, buffalo, antelope, deer, and camels) but the Federal Circuit responded by stating that this actually supports a broad definition of the unmodified term "animal" as found in the patent claims, and the applicable specification language did not contain "words or expressions that manifestly exclude coverage of humans." Second, the defendants argued the fact that the claims refer to "raising" and "feeding" animals, along with the fact that dependent claims are directed to certain types of animals such as cows, sheep, and goats, shows a disclaimer of coverage for humans. The Federal Circuit responded by stating that the terms "raising" and "feeding" can also apply to humans, and "the patent plainly contemplates that the invention is applicable to humans", citing to various passages from the specification. Finally, the defendants argued that the extrinsic evidence of record demonstrated that the ordinary meaning of "animal" is a non-human animal. However, the Federal Circuit found that since "the patentee explicitly defined 'animal,' [the defendants'] extrinsic evidence is simply irrelevant." The district court's construction of "animal" was therefore reversed.

In dissent, Judge Lourie opined that, while the term "animal" was defined "in a single line in the [] patent ... [t]his case illustrates the unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent." Judge Lourie found it was "clear that humans should be excluded from the construction of the term 'animal' ... [as] the specification is not directed to raising children; it is directed to raising non-human animals." First, the specification states that "[t]he present invention concerns a method for raising an animal ... and food products derived from such animals." Judge Lourie noted that using the words "the present invention" can limit the invention to what is described (citing Honeywell v. ITT) and "[f]ood products are not derived from humans." Judge Lourie also found the enumeration of "economic food animals" in the specification "strongly supports a conclusion that the term 'animal' encompasses only those animals raised for production of food and milk products, thereby not including humans." Finally, Judge Lourie pointed to various portions of the specification that he believed differentiated between humans and other non-human animals. He concluded "it is clear that one of ordinary skill in the art would conclude that, despite the purported definition in the specification, the term 'animal' in the claims cannot include humans."

This decision shows yet again that reasonable minds (in this case five Federal Circuit Judges) can still disagree over a particular claim construction of an arguably simple term ("animal"), even when the term appears to have been explicitly defined in the patent specification.

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