Following the Prometheus and Myriad decisions, the U.S. Court of Appeals for the Federal Circuit held that diagnostic claims that were directed to the use of biomarkers for screening the risk of Down’s syndrome were not patent-eligible.  PerkinElmer, Inc. v. Intema, Ltd., Case No. 11-1577 (Fed. Cir., Nov. 20, 2012) (O’Malley, J.) (non-precedential).

The claims at issue were directed to non-invasive prenatal screening to determine the risk of a fetus having Down’s syndrome, by measuring certain biomarkers during the first and the second trimester of pregnancy and then performing statistical analysis to determine the risk of Down’s syndrome.

The Federal Circuit held that the claims were not patent-eligible because they were drawn to an “abstract mental process” (analytical data manipulation to determine a disease risk) and to “a law of nature” (the relationship between screening biomarker levels and the risk of fetal Down’s syndrome).  Citing Prometheus and Myriad, the Court held that the claims included only “conventional steps, specified at a high level of generality,” which are insufficient because “anyone who want to use this mental step or natural law must follow the claimed process.”  Instead, for a process claim to cover a patentable application of a natural law, it must contain an “inventive concept” to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.

The Federal Circuit further noted that the claims failed the machine-or-transformation test, even though this test does not trump the “law of nature” exclusion.  Although the assaying step required the transformation of biological samples based on current technology, the Federal Circuit reasoned that the assaying could be performed without transforming the sample, should science develop a totally different method in the future.

To be patent-eligible, diagnostic claims need to include certain post-solution activities that move the claims from a “scientific principle” to a “specific application.”  For example, the Court compared this case to Diehr and noted that the claims in Diehr were patent-eligible “because of the way the additional steps of the process integrated the [ineligible] equations into the process as a whole” (i.e., the data manipulation caused the heated mold to open when the widgets were optimally cured).  Similarly, in Classen, patent-eligible claims required the further act of immunization in accordance with a lower-risk schedule.  In contrast, in this case there is no requirement that a doctor act on the calculated risk.

Practice Note:  The Supreme Court has granted certiorari in Myriad.  However, the Supreme Court limited to the scope of review to whether isolated DNA molecules are patent-eligible.  In the meantime, drafters of diagnostic or personalized medicine claims should consider adding specific steps that move the claims “from abstract scientific principle to specific application.”  Such steps also need to be unconventional or novel because “conventional and obvious extra-solution activity […] cannot save the claims.”