Steps are currently being taken by the United States congress to address the issue of patent eligible subject matter that has plagued the United States patent system in recent years.
How we got here?
There is no question that United States Supreme Court decisions such as Mayo Collaborative Services v Prometheus Laboratories Inc, 566 US 66 (2012) and Alice Corp. v. CLS Bank International, 573 US 208 (2014) have changed the Life Sciences patent landscape, particularly with regard to diagnostic inventions based on, for example, measuring various biological components (metabolites, genes, etc.) present in patient’s blood.
A leading example of the impact of these decisions is Ariosa Diagnostics, Inc. v. Sequenom Inc, 788 F3d 1371 (Fed Cir 2015) (“Ariosa”). The patent at issue in Ariosa, US Patent No 6,258,540, concerned detecting cell-free fetal DNA (“cffDNA”) in maternal plasma to identify fetal characteristics and abnormalities. This invention replaces invasive pre-natal techniques. However, the cffDNA was deemed a “natural phenomenon” and its detection an application of routine methods. Accordingly, the claims were found to be directed to non-patentable subject matter. Judge Linn concurred in the decision but emphasized that the invention at issue was “truly meritorious” and “ground breaking”, highlighting the illogical result that no patent protection could be awarded despite no one having ever used maternal plasma to detect cffDNA. As Judge Linn stated:
“But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute why this breakthrough invention should be deemed patent ineligible.”
Thus, research into diagnostic methods, which clearly have value to society, would no longer be rewarded with patent protection.
A small area of protection was clawed back by the Federal Circuit decision of Vanda Pharmaceuticals Inc v West-Ward Pharmaceuticals International Limited, 887 F3d 1117 (Fed Cir 2018). At issue in Vanda was US Patent No 8,586,610, which included claims directed to a method of treatment comprising a diagnostic step based on the genotype of a patient and a step of administering a pharmaceutical in view of the outcome of that diagnostic analysis. This claim format was enough to overcome the Mayo problem. Although the tenuousness of this decision is apparent from the dissenting opinion of Chief Judge Prost, who stated that “the end result of the claimed process is no more than the conclusion of a natural law … I see no distinction from Mayo”.
The USPTO embraced the Vanda decision, providing guidance to applicants to formulate patent eligible claims based on a Vanda-style claim. However, since the Vanda claim format includes a diagnostic step and an administration step, the commercial relevance of such claims is questionable since different parties are likely to perform each of the steps.
Now, it seems even Vanda claims may be in danger as the case could be granted certiorari by the Supreme Court as the Supreme Court has requested that the Solicitor General file a brief expressing the view of the United States.
If the Supreme Court should grant certiorari, it would seem to be a negative indication, as it has declined to do so in about 40 post Alice cases.
What is Congress Doing?
In the face of this legal uncertainty, several members of the United States Congress released draft legislation to address the patentable subject matter issue. The legislation seeks to base patent eligibility on the usefulness of the invention, which is defined to be “any invention or discovery that provides specific and practical utility in any field of technology through human intervention”. Significantly, the legislation would abrogate the Supreme Court cases applying the natural phenomena criteria to patent eligibility.
The draft legislation served as a starting point for three days of public hearings before the United States Senate Intellectual Property subcommittee, which drew together testimony from a former Chief Judge of the United States Federal Circuit, heads of biotechnology and pharmaceutical concerns, law professors, former directors of the USPTO, and groups such as the American Civil Liberties Union. Thus, parties on all sides of the patent debate were represented and heard.
The ranking members of the subcommittee released a statement capturing their thoughts on the hearing. Despite having heard from both sides, the statement appears to weigh more heavily in favour of establishing a system that grants protection to inventions such as diagnostics based on a naturally-occurring correlation. Significantly, the statement emphasized the misplaced concern surrounding the patenting of human genes and, rather, pointed to the protections afforded by other elements of patentability. The subcommittee members recognized the need to “incentivize research and development into the exciting prospects of individualized diagnostics and precision medicine” and to “ensure the protections that will enable our innovators to bring these products to market while safeguarding research into the next generation of medical advances”. Indeed, it should not go unappreciated that the statement refers to the Ariosa decision, which is characterized as the invalidation of claims to “a revolutionary prenatal test … that allowed doctors to avoid invasive procedures”, and quotes from Judge Linn’s concurring opinion.
Thus, the subcommittee appears to fully appreciate that maintaining the current law on patent eligibility is not an option. While we are only at the beginning of this processes, a return to rewarding inventive effort may be on the horizon. Stay tuned.