The US Court of Appeals for the Federal Circuit upheld a patent directed to certain fermentation methods used to produce fatty acids such as DHA and reversed the trial court’s interpretation of the term animal to exclude humans in claims directed to methods of increasing the concentration of microbial omega-3 fatty acids such as DHA in an animal. The Federal Circuit concluded that the term animal does include humans and remanded the patent to the trial court for further proceedings consistent with this interpretation.  See Martek Biosciences v. Nutrinova (08-1459, -1476).

dhaEarlier, Martek Biosciences sued Nutrinova Nutrition Specialties and Food Ingredients GmbH Inc for the infringement of a variety of patents related to the production of DHA, an important omega-3 fatty acid. In 2005, Lonza purchased the DHA-business from Nutrinova and Nutrinova and Lonza were held to have infringed certain claims of Martek Biosciences’ patents.

Lonza appealed claiming that the ’594 patent claims are invalid and that Lonza does not infringe the ’281 patent claims. Lonza also fought the district court’s exclusion of its prior inventorship evidence and the district court’s construction of the claim term “non-chloride sodium salt.” Meanwhile, Martek cross appealed the district court’s grant of Lonza’s motion for JMOL that the asserted claims of Martek’s U.S. Patent No. 6,451,567 are invalid and the district court’s construction of the claim term “animal” in Martek’s U.S. Patent No. 5,698,244.

Martek and Lonza make and sell products containing docosahexaenoic acid (DHA), an essential omega-3 fatty acid that plays an important role in the development of organs such as the heart, brain, and eyes, and is reported to have many additional health benefits. They obtain DHA by extracting lipids from fermented microalgae. The patents at issue relate to specified microorganisms that are useful for the commercial production of DHA because they produce high levels of DHA.

Three of the patents at issue are directed 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 or for use in pharmaceutical and industrial products. The ’244 patent is directed to methods for increasing the concentration of omega-3 HUFA in animals by feeding them microorganisms of the order Thraustochytriales, which includes the Thraustochytrium and Schizochytrium genera, or lipids extracted from such microorganisms.

All asserted claims of the ’244 patent are directed to methods for achieving high concentrations of omega-3 HUFA in an “animal.” The district court construed the claim term animal to mean “any member of the kingdom Animalia, except humans.” Based on the court’s construction, Martek stipulated that Lonza does not infringe the ’244 patent claims, because neither Lonza nor its customers use the claimed methods to provide omega-3 HUFA to non-human animals.

Martek pointed out that the patent’s stated definition of animal would include humans and the court agreed:

When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls. See Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed. Cir. 2005) (en banc) (“[T]he specification ‘acts as a dictionary when it expressly defines terms used in the claims . . . .’”

Here, Martek explicitly defined the term “animal” in the ’244 patent: “The term ‘animal’ means any organism belonging to the kingdom Animalia.” ’244 Patent col.5 ll.11–12. That definition controls. Thus, because it is 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.

Lonza tried to argue that when the ’244 patent specification is considered in its entirety, it clearly limits the claim term animal to non-human animals even while agreeing that humans are members of the kingdom Animalia.

The court reversed stating:

Although the patent contemplates that certain animals are “[p]referred animals from which to produce a food product,” that statement does not disavow human animals because it relates to preferred embodiments only; it does not state that all animals covered by the claims must produce a food product. As we have explained:

[P]articular embodiments appearing in the written description will not be used to limit claim language that has broader effect. And, even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004) (citations and internal quotation marks omitted). Here, the patentee has used no words or expressions that manifestly exclude coverage of humans, and thus, it would be improper to override the patentee’s express definition of “animal” to limit the scope of the claims. Moreover, the patentee’s use of modifying language to specify “[p]referred animals” as “economic food animal[s]” ultimately supports a broad construction of the unmodified term “animal” that includes non-food animals, such as humans.6 In summary, absent a clear intention to restrict the invention to particular members of the kingdom Animalia, we cannot limit the claims to the listed preferred embodiments. See id.

The court held that the ’244 patent does not otherwise contain language that can be fairly interpreted as a clear intention to disclaim coverage of humans. See id.; Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“Absent a clear disavowal or contrary definition in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language.”). For example, the fact that the claims refer to “raising” and “feeding” animals does not clearly disclaim humans.

Circuit Judge Lourie and Rader, dissenting, focused on statements in the patent that allegedly distinguish between humans and other animals:

This 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. Martek’s attempt at lexicography does not conform to the way in which it otherwise describes its invention.

It is fundamental that we must read a claim term in a manner that comports with the written description of the patent as a whole, see Markman v. Westview Instruments, Inc., 517 U.S. 370, 389 (1996), and not simply with a single sentence, even one purporting to be a definition, that is inconsistent with the remainder of the specification. We have stated many times that the specification of a patent is the “single best guide to the meaning of a disputed term,” and that the specification is to be viewed in its totality. …

Thus, rather than reading in isolation the single line in the specification that Martek argues provides a definition of “animal,” one should review the entire patent to determine the proper construction of the term. Having done so, it is clear that humans should be excluded from the construction of the term “animal” in the ’244 patent.

Starting with the claims, claim 1, which is the only independent claim in the ’244 patent, reads, “A method of raising an animal, comprising feeding said animal material” that contains omega-3 highly unsaturated fatty acids “in an amount effective to increase the content of omega-3 highly unsaturated fatty acids in said animal.” Martek argues that this language applies to humans, since children are “raised” in the sense that they are “reared.” But, as demonstrated by the discussion below, the specification is not directed to raising children; it is directed to raising non-human animals.

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    […] EPA/DHA to Support Heart and Brain Health1,2* COPPELL, Texas–(Business Wire)– Mannatech, … A Human By Any Other Name Is Still A Human (Even If It's An Animal)The '244 patent is directed to methods for increasing the concentration of omega-3 HUFA in […]