Addressing the Policy Issues
While the Supreme Court did not offer any new guidance on the application of § 101, discussions in both the Kennedy and Stevens opinions raise policy issues that biotech companies should take under consideration.
Justice Kennedy, in a portion of his opinion that does not form part of the majority opinion, recognized that the machine or transformation test may not be well-suited for “determining the patentability of inventions in the Information Age.” Kennedy noted that the test “would create uncertainty as to the patentability of . . . advanced diagnostic medicine techniques,” citing the amicus brief of BIO.
Kennedy emphasized “the larger object of securing patents for valuable inventions without transgressing the public domain,” and warned that “the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles.”
Justice Stevens raised a different balancing issue in his concurring opinion, which was joined by Justices Ginsburg, Breyer, and Sotomayor. Stevens considered the “dynamics of cost, risk, and reward,” and noted that “scholars generally agree that when innovation is expensive, risky, and easily copied, inventors are less likely to undertake the guaranteed costs of innovation in order to obtain the mere possibility of an invention that others can copy.”
Stevens reasoned that “whether a patent monopoly is necessary to motivate the innovation” is a subject matter-specific inquiry, and suggests that deciding whether a process can be patented under § 101 likewise requires a subject matter-specific inquiry into whether granting a patent “would, on balance, facilitate or impede . . . progress.”
Biotech companies may not be concerned about these policy issues, assuming that the high costs and high risks of innovation in the complex fields of biotechnology will always weigh in favor of patent protection. However, the BRCA1 breast cancer case brought by the ACLU against Myriad Genetics’ gene patents has many arguing that patent protection is not needed to promote genetic research.
The ACLU and others believe that government entities will undertake the research necessary to identify genetic markers and develop related diagnostic methods, and argue that patents hinder, not help, innovation in these fields. Those on the other side say that these arguments underestimate the complexities and costs of the research required to identify and validate genetic markers, and translate that research from laboratory bench to patient bedside.
The district court determined that Myriad’s patents are invalid under § 101 because they claim “products of nature” and “abstract mental processes”. Myriad appealed to the Federal Circuit, which may consider this case together with Prometheus.
The remand of Prometheus and the appeal in Myriad give biotech companies an opportunity to have their voices heard on these issues, through individual and group amicus briefs to the Federal Circuit. In the meantime, those seeking patents in this field probably will be advised to pursue claims that pass the machine or transformation test and include concrete language to minimize the risk of being found to be an abstract idea or natural phenomenon.