In judging the Prometheus patents invalid, the Supreme Court may have shown its hand on the upcoming Myriad Genetics case.
In a unanimous decision on Tuesday, the Supreme Court stripped two Prometheus patents on the grounds that the company didn’t go far enough beyond merely identifying a natural law. Natural laws – a product of the natural phenomenon doctrine in patent law, are the province of everyone in the US, ever since Justice Rehnquist wrote in 1981 that “laws of nature, natural phenomena, and abstract ideas” aren’t patentable.
But to what extent must a biopharma organization show an application of a natural law, to support a claim? In Mayo Collaborative Services v. Prometheus Laboratories, the latter held two patents describing a method for optimal dosing of thiopurine for autoimmune disorders. To wit: if metabolite levels are too high with patients using thiopurine drugs, toxicities are likely to occur; if they’re too low, the drugs lose efficacy in the patient. Prometheus markets a blood test to measure metabolite levels, and the Mayo Clinic, acknowledging the relationship to thiopurine dosage and efficacy, created it’s own blood test to be used by physicians. Prometheus (acquired by Nestle last May) sued, claiming the Mayo Clinic violated its patents, and despite winning a Federal Circuit decision, the Supreme Court begged to differ.
With the Myriad Genetics case on the Supreme Court’s horizon, some attorneys following both cases are predicting another reversal. In the Prometheus decision, the court directly cites an amicus brief from two organizations – the American College of Medical Genetics, and the Association for Molecular Pathology – in defense of its judgment; both organizations are also named plaintiffs in the Myriad case. The amicus brief quoted in the Prometheus decision argues that if “claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”
This is precisely the argument being made against Myriad, which holds patents on two genes known as BRCA1 and BRCA2; mutations in those two genes are associated with increased risk of breast and ovarian cancer, and Myriad sequences the genes to reveal the mutations. In light of the Prometheus decision, “there is a good chance the Supreme Court will remand the pending Myriad Genetics case to the Federal Circuit, to have it reconsider its opinion,” says Craig Smith, a partner at Lando & Anastasi. The Federal Circuit court ruling on Myriad upheld patent claims on isolated DNA, defined by patent law as composition of matter claims, but the diagnostic claims made by Myriad – first debunked by United States District Court Judge Robert Sweet – were similarly refuted by the Federal Circuit. Judge Sweet also stripped the BRCA1 and BRCA2 gene patents, but the Federal Circuit court reinstated those patents.
Many companies have gene patents; Myriad is hardly the first to receive composition of matter patents on genes. However, the argument that patents stifle, or erect barriers to medical research, seems to be gaining traction with the Supreme Court. “I’m not buying the argument that the court threw in there as a policy palliative…it seems to me that the court is saying the [Prometheus] claims go to far, and any benefits from patent protection are outweighed by the chilling effect on future innovation,” via medical research, says James Mullen, partner at Morrison & Foerster. How strongly this argument is made will have a least some bearing on the Myriad outcome, although gene patents are more or less entrenched as precedent.
What does this mean for industry? Unfortunately, the Promethius case offers little in the form of new guidance. If a claim is so broad as to state a law of nature, with the added suggestion that it be applied, it won’t be considered patentable, but “everyone knew that ahead of time,” says Mullen. “I think the decision creates more uncertainty,” because “the Court didn’t give any signposts as to what level of post-solution activity is necessary to go beyond the order to ‘go out and apply this law,’ which isn’t a patentable claim…there was no detail as to what application – by doing a, b, or c – by opening the mold for your rubber plant, at a particular temperature point, like the Court did with Diamond v Diehr.”
D’vorah Graeser, CEO at Graeser Associates International, says the Prometheus decision, and the upcoming Myriad case, may cast a “pall over the entire diagnostic industry.” Without specific guidance, “Where do you draw the line?” wonders Graeser. “Is it having an antibody involved, or some kind of machinery? From the Prometheus decision, it’s impossible to tell.”