WASHINGTON (Legal Newsline) - The U.S. Supreme Court says a company's processes, which help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high, is not patent eligible.
When ingested, the body metabolizes the drugs, producing metabolites in the bloodstream. The court issued its ruling Tuesday.
Because patients metabolize these drugs differently, doctors have found it difficult to determine whether a patient's dose is too high, risking harmful side effects, or too low, and likely ineffective.
Petitioners Mayo Collaborative Services and Mayo Clinic Rochester had bought and used diagnostic tests based on Prometheus Laboratories Inc.'s patents.
But in 2004 Mayo 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.
A district court found that the test infringed the patents but granted summary judgment to Mayo, saying the processes claimed by the patents effectively claim natural laws or natural phenomena and are, therefore, not patentable.
The U.S. Court of Appeals for the Federal Circuit reversed, finding the processes to be patent eligible under its so-called "machine or transformation test."
The U.S. Supreme Court reversed the Federal Circuit's ruling.
Justice Stephen Breyer, who authored the Court's 12-page opinion, pointed to Section 101 of the Patent Act and its definition of "patentable subject matter." It states:
"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 therefor, subject to the conditions and requirements of this title."
The provision, Breyer noted, contains an important implicit exception: "Laws of nature, natural phenomena and abstract ideas" are not patentable.
"The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon or apply laws of nature, natural phenomena, or abstract ideas," the justice wrote.
However, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it," Breyer said.
In this case, the Court had to determine whether the claimed processes transformed unpatentable natural laws into patent eligible applications of those laws.
"We conclude that they have not done so and that therefore the processes are not patentable," Breyer wrote.
"In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries."
The American Medical Association, along with other medical groups, supported Mayo in the case.
Robert M. Wah, who chairs the AMA's Board of Trustees and is a reproductive endocrinologist and obstetrician-gynecologist, said the nation's high court "prevented irreparable harm" to patient care with its unanimous decision.
"This is a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research," he said in a statement Tuesday.
Medical innovations that provide insight into natural human biology must remain "freely accessible and widely disseminated," Wah said.
"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," he said.
From Legal Newsline: Reach Jessica Karmasek by email at firstname.lastname@example.org.