PROMETHEUS
unanimous court: “Te upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform un patentable natural correlations into patentable applications of those regularities.”
Breyer further underlines that: “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a draſting effort designed to monopolize the law of nature itself.”
Burning issue
Tere have been mixed reactions to the court’s decision, both on the subject of how wide its impact is likely to be and on whether the court was correct to decide as it did.
“We are surprised and disappointed by the Court's decision,” says Hans Sauer, deputy general counsel for IP at the Biotechnology Industry Organization. “While we are still analyzing the opinion, we are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement. While the opinion’s lack of guidance may limit its practical impact, we are troubled that the court’s opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.”
Prometheus itself is similarly disappointed, claiming the decision will “encourage imitation, not innovation”. But, it adds, “we are committed to providing valuable research, diagnostic services and products to the medical community for the better care of their patients and we will endeavour to do so within the framework that the court has laid out.”
On the other side of the argument, Mayo welcomes the decision, saying it has pursued the case “in the best interests of our patients”, and that the decision “concerns the value of delivering high quality patient care in a timely manner and at an affordable cost”.
“IF THE PROMETHEUS PATENTS HAD REMAINED IN FORCE, PHYSICIANS WOULD HAVE ENCOUNTERED A VAST THICKET OF EXCLUSIVE RIGHTS THAT WOULD PREVENT THEM FROM CONSIDERING ALL RELEVANT SCIENTIFIC INFORMATION WHEN REVIEWING DIAGNOSTIC TEST RESULTS.”
Te American Medical Association, which represents the interests of practising doctors, agreed with Mayo. Chair of the AMA board Robert Wah says the court had “prevented irreparable harm to patient care” with its decision, claiming that the patents “gave Prometheus Laboratories exclusive rights over the body’s natural responses to illness and medical treatment”.
He adds: “If the Prometheus patents had remained in force, physicians would have encountered a vast thicket of exclusive rights that would prevent them from considering all relevant scientific information when reviewing diagnostic test results.”
Damp squib
Of course, as with most decisions of this nature, those gleefully celebrating its implications and those bemoaning them are matched by many observers who think that the decision may not have much of an impact at all.
18 World Intellectual Property Review March/April 2012
James Haley, partner at Ropes & Gray LLP in New York, observes that the decision “is very fact-specific and may not have very wide application”. But, he adds, “Its effect may be that the courts and the patent office will interpret the decision too broadly and reject many types of method claims.”
As ever, it seems, much will come down to interpretation. It is possible to read the Supreme Court’s decision as implying a very broad definition of what constitutes ‘natural’. Were courts to follow such an interpretation, there could be wide-ranging effects, not least for personalised medicine. And some have complained that the Supreme Court paid too much attention to novelty and obviousness in its decision, which should have focused solely on patent eligibility.
Edward Reines, of Weil Gotshal & Manges LLP in Silicon Valley, calls the ruling “disappointing”, but takes solace in the fact that the court “did not set forth a clear rule that would mandate a wholesale change in the law”. He suggests that those applying for patents in this area “should include real-world steps unique to the invention in patent claims”, in order to avoid potential problems.
Friendly fire
One of the more intriguing things reinforced by the Supreme Court’s decision is a growing perception of a split with the Federal Circuit on what constitutes patent eligibility. “At the 10,000ſt level [the decision] demonstrates a disagreement with the Federal Circuit,” says Haley. “Many had assumed aſter Bilski that if you pass the machine or transformation test you would be patentable,” he adds. “Te Supreme Court agrees that machine or transformation test is useful, but thinks that even if you pass it, that doesn't mean you’re patentable.”
While it’s always difficult to assess the impact of a case until it has been implemented by the patent office and the lower courts, the apparent gulf between the two highest patent court in the US promises to pose challenges to practitioners in the future, even as it also holds out the promise of even more contentious work in this area.
What seems certain is that this case points to a more general problem in the future: as medical advances continue, the line between ‘nature’ and ‘an invention’ is likely to become even finer. And without a definitive rule on where that line is, companies will have do their best to work with what they do know about the Supreme Court’s attitudes. n
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