Supreme Court Prometheus decision on diagnostic method patent claims turns 101 on its head
- Erring on the side of caution, the Supreme Court turns 35 U.S.C. 101 on its head in Prometheus; opening the door for courts to decide questions of fact in diagnostic method patent claims
On March 20, 2012, in the much anticipated diagnostic method patent claims case of Mayo v. Prometheus, the Supreme Court struck down diagnostic method claims as unpatentable subject matter under 35 U.S.C. 101. The claims recited a “correlation” between metabolite levels and likely harm or ineffectiveness of thiopurine drugs to treat autoimmune diseases. The claims also required an (1) an “administering” step—administering a drug to a subject; (2) a “determining” step—determining the level of 6-thioguanine in the subject ; and (3) a “wherein” step—describing the need to increase or decrease the amount of the drug based upon the level of the 6-thioguanine concentrations in the blood.
That the Court found the “correlation” step to be a law of nature is not surprising. On the other hand, the Court’s analysis involving the remaining steps of the diagnostic method patent claims, which applied this law of nature, is not only surprising but may arguably have turned the law of 35 U.S. C. 101 subject matter patentability on its head. The Court held that the remaining recited elements of “determining,” and “administrating,” and the “wherein” recitation are “well known in the art” and so added nothing to the claims for purposes of subject matter patentability. Slip. Op. 11 Thus, the Court held that the claims preempt the law of nature “correlation” and so are unpatentable subject matter. Id.
It is hornbook patent law that questions of fact are questions for the jury to decide. By deciding Prometheus on the basis that the recited elements that are applying the “correlation” are “well known in the art,” the Court in effect has introduced a question of fact into the 35 U.S. C. 101 analysis. In addition, the Court has left it to the courts to decide this question of fact; thereby empowering the courts to decide questions which are typically the province of the jury to decide. On both counts, the Court’s precedent in Prometheus flies in the face of hornbook patent law on 35 U.S.C. 101, which is historically decided as a question of law.
The Prometheus decision may have been a knee-jerk reaction by the Court to the perceived wrong of upholding diagnostic method patent claims that are “well known in the art,” and the analysis by the Court may have been the best way the Court could think of to strike down those claims and right that wrong. Yet the 35 U.S.C. 101 question of the subject matter patentability of the claims arguably could have been limited to an analysis focusing on whether the claims recite any man made application of — in this case, of a law a nature — under the sun that is not an insignificant extra-solution activity; even if the man-made application is “well known in the art.”
Those Prometheus claims could arguably have been invalidated in a later proceeding by the lower court with the jury deciding whether the claims are “well known,” that is, anticipated or obvious, under 35 U.S. C. 102, 103. For now though, Prometheus stands as the law of the land on questions to be decided under 35 U.S. C. 101 involving claims reciting a law of nature, and arguably claims reciting a natural phenomenon or an abstract idea by extension. Until overruled by the Court or Congressional legislation, the take-away from Prometheus for practitioners is that at least one recitation that is not an extra-solution activity that is crafted into a claim must apply a recited law of nature in a way that that the recited application is not “well known in the art.”
We continue to believe that the “physical” or “virtual” links test provides a viable solution to the Court’s continuing struggle in dealing with subject matter questions that are close to the boundary line that defines what is subject matter patentable. If a law of nature, a fundamental principle, or an abstract idea (the three judicially created exceptions to subject matter patentability) is recited in the claims, the “physical” or “virtual” links test on the claim as a whole will help ensure that these recitations are significant and are being “applied” through man-made “physical or virtual links” or “manipulations” of something physical or tangible to move the application beyond a preemption. Absent the “physical” or “virtual” links, the claims preempt the law of nature, the fundamental principle, or the abstract idea. For more on this approach to claim drafting go to Physical and Virtual Links.
Nonetheless, with the unintended consequences of the Court’s Prometheus decision, we also recommend our clients and colleagues to pay close attention to the significant recitations in the claims that apply the law of nature, the fundamental principle, and the abstract idea. Each practitioner crafting claims should play the role of a trier of fact in deciding whether these recitations are “well known in the art.”
Hopefully, going forward, the law on 35 U.S.C. 101 will evolve in a way that will one day return the subject matter patentability question to a question of law; leaving questions of facts to the jury to decide under 35, U.S.C. 102 and 103, where the Court’s analysis in Prometheus arguably more properly belongs.
The Juhasz Burge PC Firm can help you to better understand the effect of Prometheus on your patents. Your patents may be your most important asset. For more information regarding this cases and advice on how these decisions may affect your patents, and to help protect your patents, contact Juhasz Burge PC, the firm committed to Guiding Your Patent Beyond The Horizon (sm).