Martek Biosciences v. Nutrinova and Lonza (Fed. Cir. 2009)
[Read part I of the discussion of Martek]
Sitting in as an expanded five-member panel, the Court of Appeals for the Federal Circuit has largely affirmed a jury verdict finding Martek's patents valid and infringed. The case involves issues of written description, enablement, sufficiency of infringement evidence, corroboration of prior inventorship arguments, and claim construction of the word "animal." The five members agreed as to all issues except for claim construction. On that claim construction issue, the majority opinion of Judges Newman, Gajarsa, and Moore held that a human is an animal. Judges Lourie and Rader argued in dissent that the patentee's use of animal suggested that it did not include humans.
Is a human an animal: The four patents in suit cover various aspects of making and using the omega-3 fatty acids. Nutrinova sells allegedly infringing products for human consumption. One of the patents claims a method for achieving high concentrations of the omega-3 acids in an "animal," and the parties contested whether an a human is an animal. The majority based its decision on the maxim that the patentee is free to be its own lexicographer. "When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls." In its specification, Martek appears to plainly define the term animal in the following sentence: "The term 'animal' means any organism belonging to the kingdom Animalia." It is undisputed that humans are classified within the kingdom Animalia – and thus, humans fit within the claims animal limitation. Q.E.D.
According to the court, once a patentee defines a term, extrinsic evidence of that term's meaning "is simply irrelevant." On remand, the district court will need to consider whether the patent is infringed under the broader definition.
The dissent does not disagree with the traditional maxim, but argues that the patent is not so clear in its definition:
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.
In particular, the dissent points to the fact that the claim in question is "a method of raising an animal" in a way that increases the "content of omega-3 highly unsaturated fatty acids in said animal" and that the field of the invention looks toward "food products derived from such animals." The specification and claims spell out a variety of animals that could be so-raised: poultry, swine, cattle, shrimp, shellfish, milk producers, and goats. However, the specification only refers to humans when it discusses the benefits of ingesting the milk and meat of those animals.
Written Description: The accused infringers argued that the patentee had added new matter to the claims of one of the patents during prosecution and that the claims are consequently invalid under the traditional written description requirement of 35 U.S.C. § 112. The Federal Circuit disagreed – finding that the jury had sufficient evidence to reject the written description argument. In particular, the '594 patent generally claims "a food product." Although that claim term had been added during prosecution, the Federal Circuit found that it was sufficiently supported by the original disclosure – noting again that "the earlier application need not describe the claimed subject matter in precisely the same terms as found in the claim." Tech Licensing (Fed. Cir. 2008). Rather, the test is "whether the disclosure of the application relied upon reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter."
Evidence of Infringement: The claims of the '281 patent recite a limitation that the claimed microorganisms designed to create the omega-3 fatty acids caused less vessel damage than another other cultural medium (which used more sodium chloride). Martek did not provide results of any physical analysis of the accused infringing product to ensure that it met this limitation. Rather, Martek's experts discussed the "literature" on the topic and a conceptual analysis of the known effects of a high chlorine concentration. On appeal, the Federal Circuit affirmed that the expert testimony was sufficient for a jury to find infringement – holding that there is no "general rule requiring one who alleges infringement of a claim containing functional limitations to perform actual tests or experiments on the accused product or method. Rather, a "patentee may prove infringement by any method of analysis that is probative of the fact of infringement." Forest Labs. 239 F.3d 1305 (Fed. Cir. 2001).
Evidence of Prior Inventorship: It is improper to say that 'prior inventorship' is a defense to patent infringement. However, an accused infringer can invalidate a patent under 35 U.S.C. § 102(g)(2) by showing clear and convincing evidence that it (1) conceived of the invention before the patentee and (2) either reduced the invention to practice or was diligent in reducing the invention to practice from a time beginning before the patentee's conception date; and (3) did not abandon, suppress, or conceal the invention. In this case, the defendants had filed a patent application on a similar invention prior to the patentee. However, that application had gone abandoned. The application properly serves as evidence of conception, but – because it was abandoned – does not serve as constructive reduction to practice. Here, the accused infringer's defense failed because it could not provide other corroborating evidence of reduction to practice or diligence.
Enablement: The claims of the '567 patent were found invalid on JMOL due to lack of enablement due to a genus-species issue. Claim 1 broadly discusses growing "euryhaline microorganisms" while the specification only discloses two examples of thraustochytrium and schizochytrium organisms. The defendants' experts testified that there were at least 10,000 different qualifying species and the district court agreed that two species were insufficient. On appeal, it appears that the patentee gave-up on its claim 1, but the Federal Circuit agreed that the other claims had been improperly invalidated because they included limitations to the specific examples proffered in the specification. Evidence presented indicated that the species of those dependent claims together encompassed "only 22 known species."