The Federal Circuit has taken a tortured path (in common with the U.S. Patent and Trademark Office and the district courts) applying the patent eligibility decisions under Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp. v. CLS Bank Int’l. over the past few years. But some light can be perceived (albeit with some effort and hope) in the Court’s decision on March 8 in Exergen Corp. v. Kaz USA, Inc.
The patents at issue, U.S. Patent No. 6,292,685 and U.S. Patent No. 7,787,938, were directed to body temperature detection apparatus and methods for detecting body temperature, respectively. The claimed detectors calculate a person’s body temperature “by detecting the temperature of the forehead directly above the superficial temporal artery.” The device then calculates the body temperature by applying a “constant coefficient” to skin and ambient temperature readings. The temperature is detected by scanning the forehead to detect a peak reading that indicates the location of the temporal artery and hence provides the most reliable temperature reading. A jury found the patents to be infringed and not invalid and assessed damages (in a total amount in excess of $15 million). The District Court denied Kaz’s arguments that the claims were invalid under § 101 for failing to be directed to patent eligible subject matter.
The Federal Circuit affirmed the decision on the subject matter eligibility question, in a 2-1 decision authored by Judge Kimberly Moore. The majority accepted Defendant Kaz’s contention that the claimed invention is dependent on the “natural law” that body temperature can be measured from skin temperature at the forehead. But the Federal Circuit majority agreed with the District Court that claims recited “additional steps” that “transformed the underlying natural laws into inventive methods and useful devices that noninvasively and accurately detect human body temperature.” These steps, which included “(1) moving while laterally scanning; (2) obtaining a peak temperature reading; and (3) obtaining at least three readings per second were known in the prior art but that was not enough to defeat patent eligibility. According to the District Court “simply being known in the art did not suffice to establish that the subject matter was not eligible for patenting” because “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” The distinction persuasive to the Court was that these methods were used for a different purpose in the prior art, in this case detecting “hot spots” indicative of tumors, fractures, or other injuries (and in at least some testimony, used in horses not humans). In addition, the invention here newly provided a “calculated coefficient for translating measurements taken at the forehead into core body temperature readings” which was not routine, well understood or conventional in the prior art.
The opinion explains that, although the question of subject matter eligibility is one of law it is (or at least can be; the opinion is careful to state that it isn’t always) reliant on underlying facts, analogizing this question to other issues in patent law such as indefiniteness, enablement, and non-obviousness. To illustrate this point, the opinion goes on to say that “[s]omething is not well-understood, routine, and conventional merely because it is disclosed in a prior art reference.” The opinion states that this case is different from earlier applications of the Supreme Court’s subject matter eligibility law, based on the unconventionality of how the natural law was applied in the claimed invention (“the inventor determined for the first time the coefficient representing the relationship between temporal-arterial temperature and core body temperature and incorporated that discovery into an unconventional method of temperature measurement”).
The Court’s decision is contrary to much recent precedent, wherein discovery of a new phenomenon and using conventional means to detect it (when such detection is not possible in the prior art) has extended patent ineligibility further than the Court has indicated it needs to go. It is one thing to take conventional activity and prevent it from being subject to patent exclusivity without the elusive “something more” and quite another to preclude beneficial method claims to detect previously unknown phenomena unless a new method for detecting is also provided. As suggested in the case, perhaps the more relevant inquiry should be, why shouldn’t a claimed invention’s unconventionality, by itself, be sufficient to render the claim patent eligible? This would permit truly innovative inventions (such as those deemed patent ineligible in Ariosa v. Sequenom and other cases) to be properly patent eligible because conventional methods were applied in new and unconventional ways due to the appreciation (or in the case of innovations such as using novel biomarkers to predict disease risk, discovery) of relationships in nature. Such an appreciation of how innovation and invention arise in life sciences would go a long way toward reaching an equipoise that fosters innovation between what is properly patent eligible and what is properly not.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.