Following the Fed. Cir. holding that the claims in Intema’s patent (U.S. Pat. No. 6,573,103) on an improved method for determining the risk of a Down’s syndrome pregnancy were patent-ineligible as directed to a law of nature and a mental step, Intema petitioned the Supreme Court to grant cert. on May 16, 2013 (2013 U.S. S. Ct. Briefs LEXIS 2395). Intema urged the Court to consider that the Intema panel holding that Mayo (“Prometheus”) compelled the ruling, was a “miscarriage of justice” and would “eviscerate” claims to diagnostic and screening tests and personalized medicine.
The heart of Intema’s thorough analysis of Mayo, and about every other major decision involving patentable subject matter in the life sciences area, is its argument that the Fed. Cir. has imposed a “rigid rule” (a popular term to get the S. Ct. interested in reviewing a Fed. Cir. decision) that (a) data gathering steps, even if they include novel and non-obvious combinations of known steps, may not be considered all or even part of the “inventive concept” required by Mayo, that ensures that the patent is significantly more that the natural law itself, and (b) that a claimed method that provides test results (Intema studiously avoids the term “diagnosis” for some reason) that determine a (potential) course of action must include a final step that involves physical activity (as opposed to mental activity, such as arriving at a diagnosis).
Regarding rigid rule (a), you may recall that the Intema claims called for data gathering – via measuring biomarkers and/or doing ultrasound scans – during both the first and second trimesters of pregnancy. An algorithm is then applied to determine the risk of a Down’s syndrome pregnancy. A women can be provided the results of the first test, and choose to take some action, or the results from the first test can be carried over and combined with the second trimester results before a diagnosis is made, e.g. before the odds are calculated. Intema presented extensive evidence that this testing method was superior to the prior art methods, had been licensed multiple times and had become the art-recognized standard. Back to rule (a): Intema noted that its data gathering steps were novel and not just “well-understood, routine, [or] conventional activity previously engaged in by researchers in the field”, such as simply measuring the metabolite levels of the administered drug in Mayo. Intema argued that “[t]he Federal Circuit erred in its application of Mayo because of the rigid rule it imposed effectively barring consideration of data gathering steps as being ‘enough’ to limit the reach of a law of nature to its specific application.”
Put another way by Intema, “the Federal Circuit erred by characterizing the claimed ‘measurement’ steps as ‘merely tell[ing] the users to measure the screening markers through whatever known method they wish,’ using known markers effective at each trimester…” Intema argued that [w]hile the associations between individual markers in a single trimester and the risk of Down’s syndrome may be a law of nature and the claims contemplate the measuring of known markers, the claimed combination includes more than just the law of nature and known constituents….The claimed combination is more than ‘enough’ to ‘allow the processes they describe to qualify as patent-eligible processes that apply the natural laws.’” In other words, Intema believes that it has identified the elusive “inventive concept” or “enough” that was absent in Prometheus’ claims.
Leaving no stone unturned, Intema spent some time discussing the similarity of its claims to a model claim reciting the use of two diagnostic assays in the final step that was provided by the PTO in its 2012 Interim Procedure for determining the patent-eligibility of process claims involving laws of nature post-Mayo. However, Intema should recall the “weight” that the Myriad Court gave to PTO practices and procedures.
Regarding rule (b), Intema attacked the Fed. Cir.’s “complaint” that the claims require “[n]o action beyond the comparison’ of the ‘determining step’ and that ‘there is no requirement that a doctor act on the calculated risk’” as establishing a new rigid rule requiring claims implicating a law of nature to end in a physical step. The Brief spends relatively little space on analyzing this rule, except to argue that the “newly crafted rigid rules” will lead to “the wider effect that most diagnostic, screening and personal medicine patents (other than those involving a man-made cell, a new drug or new ways of using an existing drug) will be rendered unpatentable.” Apart from the analysis of Mayo and Myriad, there is a cogent discussion of Classen, Grams and Abele that will reward review.
Intema also presented the interesting argument that the Fed. Cir. had erred in not considering the District court’s Markman claim construction which found that the claim element “assaying a sample” requires “a device and reagents”, is carried out outside the body, and so is necessarily transformative, in that it changes the chemical composition of the sample. Intema argued that the entirety of the claims reciting this element must be considered transformative, and thus bring into play the machine or transformation test. This test in turn, increases the weight that should be given to the data-gathering steps in resolving the patent eligibility test.
Even if this petition fails to attract the interest of the Court in clarifying the requirements of Mayo and Myriad, attorney Lawrence Rosenthal and his colleagues at Stroock & Strook & Lavin LLP have written an intriguing law review article on Intema and the evils it may well unleash upon the world of life sciences patenting.