Now is the time for you to review your patenting strategy for many diagnostics-related technologies.
Both the Prometheus and Myriad cases affect the legal concept of subject-matter eligibility, governed under U.S. law by 35 U.S.C. § 101. This initial test for patent eligibility has historically been very broad, because to obtain a patent, the claimed material must still meet the secondary hurdles of novelty and nonobviousness, as well as certain requirements intended to ensure that a patent applicant has sufficiently demonstrated possession of the invention and has disclosed enough to enable others to make and use the invention.
These recent decisions have generally narrowed the scope of the first screen for patent eligibility for many useful life sciences technologies. But they are not without clues for how to protect newer, more complex technologies.
Diagnostics based on the presence or absence of a single genomic subsequence will now require more for patent protection. But with respect to technologies relying on genetic markers, in fact these decisions may not have as severe an impact as they initially appear.
For instance, a company attempting to commercialize a method involving a single-gene reporter involving a claim to a cDNA for the normal human gene will be confronted by a novelty rejection, as most if not all human genes have already been cloned. Work in this area is best suited to developing kits implementing the test. The patentability of diagnostic kits continues to be uncontroversial.
Identifying and commercializing diagnostic sequence profiles is an even more promising area. Rather than focusing on the correlation between a single genetic marker (or reporter compound) and a patient’s condition, useful correlations between collections (or profiles) of genetic markers and a disease diagnosis, the risk of developing the disease, the predicted severity, or a preferred treatment can provide a path to patent eligibility.
One of the rationales used to reject the Prometheus claims was that every step of the method was routine and conventional, and it only served to inform doctors of the relevant correlation. But in the case of a diagnostic sequence profile, measurement of the profile can be fairly complex; there is value in identifying or developing the best mode of measurement, be it microarrays or newer technologies.
Additional complexity comes from the approach for determining whether a patient’s profile is associated with a normal or abnormal state—rather than a binary decision, the result is a more nuanced estimate that depends on the combined expression or mutational differences of reporters in the profile. These additional complexities can distinguish claims to these technologies from the unpatentable method in Prometheus.
Another path to patent eligibility may be inclusion of a “man-made” sample. For example, if a patent claim includes binding a DNA probe to a biological sample and such a sample with the bound probes would not otherwise exist in nature, the existence of a man-made sample may also impart patent eligibility.
While these recent decisions may at first glance cloud the landscape of patentability in biotech, in fact the outlook may not be so grim. All one may need to consider is a little creative patent drafting.