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Supreme Court Strikes Down Prometheus Patents

NEW YORK (GenomeWeb News) – The US Supreme Court today invalidated two patents held by Prometheus Laboratories in a widely watched case for those involved in the personalized medicine field.

In a unanimous decision, the court called the patents in dispute, US Patent Nos. 6,355,623 and 6,680,302 unpatentable because they merely describe the laws of nature and "add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity."

The patents cover methods of determining proper dosing of thiopurine drugs for autoimmune diseases by correlating dosage levels of the drugs with the levels of certain metabolites in a patient's blood.

In making its decision, the Supreme Court said it considered claims covered by the two patents held by Prometheus that involves three steps: the administration of the drug to a patient by a doctor; instructions to the doctor to measure the resulting metabolite levels in the patient's blood; and the description of metabolite concentrations, which can indicate whether a drug may have harmful side effects, or conversely may be too low to be effective, and informing the doctor that the dosage may need to be changed.

The relationship between the levels of certain metabolites in blood and the effectiveness of a thiopurine drug dosage are laws of nature and are not patentable, the Supreme Court said. Whether the '623 and '302 patents are enforceable thus boiled down to whether 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," the Supreme Court said.

In writing the opinion for the court, Justice Stephen Breyer said, "The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.

"We believe that the answer to this question is no," he said.

He added that the three additional steps described in the patent claims advises doctors about natural laws and to take steps that were already routine, conventional, and previously being performed.

The claims of the two patents "when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities," Breyer said.

Prometheus sued Mayo Collaborative Services in 2004 after Mayo announced it would begin selling its own tests, which were similar to Prometheus' tests.

Prometheus holds the licenses to the patents and had granted Mayo a license to use the intellectual property. Mayo had been using Prometheus' test for several years prior to saying it would sell its own tests.

In 2008, a federal district court said that Mayo had, in fact, infringed on at least one claim of the patents, but ruled in favor of Mayo because the patents claimed natural laws or phenomena and as such are not patentable.

Prometheus appealed the decision to the US Court of Appeals for the Federal Circuit, which reversed the district court's decision after finding the patents to be patent eligible because they meet the "machine or transformation test," a standard based on whether a technology is tied to a particular apparatus or if it transforms an article to a different state.

The Supreme Court remanded the case back to the appellate court, after the Supreme Court upheld a lower court's decision that certain business method patents are invalid but rejected a determination that such patents must be tied to a machine or undergo a transformation in order to be patentable.

The appellate court upheld its earlier decision.

In presenting its argument to the Supreme Court in December, Mayo said that Prometheus' patents seek to monopolize blood testing for thiopurine metabolites, with the effect of preventing doctors from providing a full range of information about metabolite levels and health for any range of immune diseases.

Mayo's lawyer Stephen Shapiro added that Prometheus' patents' "broad preemption of a physical phenomenon … prevents others like Mayo Clinic from offering a better metabolite test with more accurate numbers. And this is a huge practical problem for patients."

Prometheus countered at the December hearing that its patents are not regurgitations of natural phenomena and its claims are preemptive only in the narrow sense that all inventions are. A ruling for Mayo, it added, could confuse existing views of patent law and hinder innovation.

"And there certainly is no reason," Prometheus continued, "at the dawn of the 21st century, for this court to adopt special rules that would render personalized medicine inventions, or other processes designed to produce useful information, uniquely unpatentable, under 35 U.S.C. Section 101," which claims that "whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore."

Today, Prometheus said that it disappointed in the Supreme Court's decision.

"Without the availability of patent protection, future healthcare will suffer as companies may opt out of new research and development," it said in a statement. "This decision will, in our view, encourage imitation, not innovation."

The case has been followed closely by the biotech industry, especially for clues about how the Supreme Court might rule if it decides to take on the Association of Molecular Pathology et al v US Patent and Trademark Office case. In that case, Myriad Genetics is trying to protect its patents related to BRCA1 and BRCA2 and methods of analysis for detecting breast cancer.

The US District Court for the Southern District of New York ruled against Myriad, but the US Court of Appeals for the Federal Circuit later overruled most of the district court's decision.

In a research note today, Peter Lawson of Mizuho Securities said that while the Supreme Court's decision against Prometheus "adds pressure and risk to Myriad's BRCA patents … Prometheus' patents are not directly comparable to Myriad's gene patents."

He issued a Buy recommendation for Myriad's stock as the Prometheus decision dragged down Myriad's share price. In mid-afternoon trading on the Nasdaq, Myriad shares were down 5 percent to $24.30.

Jon Wood of investment bank Jefferies said in a research note that in light of today's decision, it is likely that the Supreme Court will remand the Myriad case back to the Federal Circuit Court for another review and a decision to be made in the second half of 2013 or first half of 2014.

He added that he believes that isolated DNA and cDNA will remain patent-eligible materials as the US Court of Appeals for the Federal Circuit had determined in the Myriad case.

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