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Supreme Court Ruling Creates Uncertainty for Diagnostics Companies PDF Print E-mail
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Sunday, 25 March 2012 07:02

Rejection of Prometheus patents reverses lower court ruling.

The Supreme Court has invalidated patent protection for a blood test developed and sold by Prometheus Laboratories to help doctors select the optimal dose of a drug for certain gastrointestinal ailments, citing its reliance on unpatentable laws of nature.

Mayo Clinic bought and used diagnostic tests based on Prometheus’ patents until 2004, when it announced that it intended to sell and market its own, somewhat different, diagnostic test. Prometheus sued Mayo contending that Mayo’s test infringed its patents.

The Supreme Court ruling, which reverses a December 2010 decision by the Federal Circuit that had upheld Prometheus’ claims, is reigniting concern that companies selling biomarker-based diagnostics could face new challenges to the patentability of their tests and new competition if they’re unable to defend the claims on which their tests rely.

Laws of nature, physical phenomena, and abstract ideas are not patentable in the United States. Courts have long relied on what’s known as the machine-or-transformation test to determine whether something is patentable. That test looks at whether a specific machine was created to perform the process or if the process transforms something into a different state.

In this case, Mayo Collaborative Services v. Prometheus Laboratories, Inc., the court held that the processes claimed in Prometheus’ patent “are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.”

“Rewarding with patents those who discover laws of nature might encourage their discovery,” Justice Stephen Breyer wrote in the unanimous opinion. “But because those laws and principles are ‘the basic tools of scientific and technological work,’ there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”

The decision creates uncertainty for diagnostic method patent claims and for the personalized medicine industry, Morrison & Foerster attorneys noted in a client alert following the decision. “From the Supreme Court’s analysis of prior precedent, it appears the guiding principle from Mayo will be that an observed ‘correlation’ or ‘relationship’ is not itself patentable because it constitutes a “law of nature,” which is excluded from patent protection.”

Jim Greenwood, CEO of the trade group the Biotechnology Industry Organization, expressed disappointment in the ruling and concern about “unintended consequences” of the decision. “While the opinion’s lack of guidance may limit its practical impact,” he says, “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.”

By MICHAEL FITZHUGH

 
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