Laboratory Corp. of America v. Metabolite Laboratories, et al. (06/22/2006)

Question presented: Whether a patent instructing a party to "correlate test results" can validly claim a monopoly over a basic scientific relationship used in medical treatment such that a doctor infringes the patent by looking at a test result and thinking about that relationship?

BY DANIEL WELCH, MEDILL NEWS SERVICE

It is well established in patent law that the laws of nature, including the body's biological processes, cannot be claimed or owned.

But a patent infringement lawsuit is testing the boundaries of that precedent, asking if a laboratory can patent the correlation between the level of an amino acid found in body tissues with the levels of vitamins in the body that make that amino acid.

Researchers at University Patents Inc. (UPI) in the early 1980s discovered a relationship between elevated levels of the amino acid homocysteine and the deficiency of two B vitamins, folate and cobalamin.

These vitamins help form homocysteine, and the researchers noted that unusually high homocysteine levels often signaled dangerously low levels of the important vitamins. Elevated homocysteine levels have been connected with a variety of health problems, including lupus, renal disease, arthritis and Alzheimer's disease.

As early as 1969, researchers discovered that elevated homocysteine levels could signal increased risk of heart disease.

In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids. In claim 13 of that patent, UPI sought to license the scientific connection between homocysteine levels and vitamin deficiency, describing a two-step process of testing for the amino acid, and then correlating the level with the B vitamin levels in the body.

Laboratory Corporation of America Holdings (LabCorp) obtained a sub-license for the patent from Metabolite Laboratories, Inc., which was licensed by UPI's successor. Beginning in 1992, LabCorp paid Metabolite a royalty every time it supplied a doctor with a homocysteine test. But after LabCorp began using another company's testing method in 1998, Metabolite sued LabCorp for patent infringement.

The jury in the November 2001 trial awarded Metabolite almost $5 million in damages after finding LabCorp liable for breach of contract and patent infringement. The trial judge assessed an additional $1 million in damages in finding the infringement intentional, and issued a permanent injunction barring LabCorp from using other tests.

LabCorp appealed to the Court of Appeals for the Federal Circuit, arguing that for the "correlation" step of the patent to have any meaning, a doctor must confirm the vitamin deficiency through physical diagnosis–simply thinking about the relationship should not violate the patent.

A panel of the appeals court rejected the argument, holding that an infringement "only requires association of homocysteine levels with vitamin deficiencies."

To Jonathan Franklin, who represents LabCorp, that decision amounts to regulating the thought processes of doctors who receive the test results and try to diagnose their patients' illnesses.

"The lower courts said that every doctor who orders a homocysteine test, for any reason, infringes the patent," Franklin said.

In Funk Bros. Seed Co. v. Kalo Inoculant Co., the U.S. Supreme Court ruled in 1948 that a previously unknown natural phenomenon cannot be patented, but an invention resulting from the discovery that has a "new and useful" application may be patentable.

To LabCorp, claim 13 has no new and useful application, and the patent is akin to discovering that high cholesterol may be linked to Alzheimer's disease, and claiming a monopoly on that connection–and in doing so collecting a royalty every time a doctor connects the two.

After LabCorp sought review from the U.S. Supreme Court, the Court asked the Solicitor General in February 2005 to file a brief expressing the government's opinion on whether the patent is invalid because "laws of nature, natural phenomena and abstract ideas" are not patentable.

The Solicitor General recommended the Court deny LabCorp's petition for a writ of certiorari, but argued that the natural phenomenon issue hadn't been sufficiently raised in the lower courts. The Solicitor General did not go so far as to conclude that the patent is valid on its merits alone.

On Oct. 31, 2005, the Court accepted review of the case limited to the question of whether a patent instructing a party to "correlate test results can validly claim a monopoly over a basic scientific relationship used in medical treatment" such that a doctor infringes the patent by looking at a test result and thinking about that relationship.

LabCorp argues claim 13 is too vague and offers no instructions as to how one should correlate the homocysteine levels with vitamin deficiency.

"If the Court allows the Federal Circuit opinion to stand, anyone could obtain a patent on any scientific correlation–that there is a link between fact A and fact B–merely by drafting a patent claiming no more than ‘test for fact A and correlate with fact B,'" Franklin argues in LabCorp's brief.

Glenn Beaton, who will represent Metabolite before the Court, counters that this example "grossly oversimplifies what the researchers did."

"The researchers came up with a new way of testing for homocysteine," Beaton said. "That example is an exaggeration because the correlation was not known previously."

Beaton noted in his response that the appeals court had no problems deciphering the correlation step, adding that even LabCorp's own employees testified they "understood the meaning of ‘correlating'" at trial.

In addition to the interpretation of the correlating step, the Court's decision is expected to clarify the issues surrounding patenting natural processes.

The Court may look to its 1981 opinion in Diamond v. Diehr for direction. In Diehr the Court ruled that, while a mathematical formula is not patentable, a process for curing rubber that used the formula could be patented because the process involved a transformation to a "different state or thing."

The Court may also rely on its 1978 decision in Parker v. Flook, in which it established that "the discovery of [a natural] phenomenon cannot support a patent unless there is some other inventive concept in its application."

The question before the Court, then, is whether the correlation requirement of claim 13 is sufficiently inventive, as in Flook, or whether the process results in a "different state" to allow the monopoly of a natural phenomenon, as it held in Diehr.

In November Chief Justice John Roberts recused himself from the case. Roberts did not provide a reason, but he previously worked at Franklin's law firm, Hogan & Hartson of Washington, D.C.

Noting that well-known and important medicine like drugs that treat AIDS were patented on the same correlation principle, Beaton says the precedent if Metabolite loses the case will lead to chaos in the scientific patent field.

"Thousands of correlation patents will be stripped, and there are huge investments in these patents," Beaton said.

LabCorp, on the other hand, argues the precedent that will be set if it loses could lead to a "crippling liability" for sharing medical information.

"Medical professionals and others must be able to discuss such facts…without fear of liability," Franklin said in the brief. "If the Federal Circuit's decision is not reversed, the ultimate losers will be thousands of doctors and millions of their patients."

On June 22, 2006, the Court dismissed the case, noting only that the writ granting review was improvidently granted. Three justices dissented to the dismissal, with Justice Stephen Breyer explaining in 14 pages the views of himself and Justices John Paul Stevens and David Souter.

Attorneys in this case:Attorneys for Petitioner:Jonathan Saul Franklin Jr.Hogan & Hartson, LLP(202) 637-5810555 13th StreetWashington, DC 20004Party name: Laboratory Corporation of America Holdings, dba LabCorp

Attorneys for Respondent:Glenn K. Beaton1801 California Street, Suite 4200(303) 298-5773Denver, CO 80202Party name: Metabolite Laboratories, Inc., et al.

Other:PAUL D. CLEMENTSolicitor General, Counsel of RecordPETER D. KEISLERAssistant Attorney GeneralTHOMAS G. HUNGARDeputy Solicitor GeneralDARYL JOSEFFERAssistant to the Solicitor GeneralANTHONY J. STEINMEYERJEFFREY CLAIR