The U.S. Supreme Court has agreed to review a case relating to subject matter issues under 35 U.S.C. §101 for a patent that allegedly claims “laws of nature, natural phenomena, and abstract ideas” in Laboratory Corp. of America v. Metabolite Laboratories, U.S., No. 04-607, 10/31/05. Review was granted only with respect to question 3 in the petition:

Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to “correlat[e]” results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.

The United States District Court trial jury found that Laboratory Corporation (LabCorp) indirectly infringed Metabolite Laboratories, Inc.’s (Metabolite’s) U.S. Patent No. 4,940,658 (the ’658 patent). The jury also found that LabCorp partially breached its contract with Metabolite.

The ’658 patent claims methods for detecting cobalamin or folate deficiency. Cobalamin and folate are both B vitamins, commonly known as B12 and folic acid, respectively. A deficiency in these vitamins can cause serious illnesses in humans, including vascular disease, cognitive dysfunction, birth defects and cancer. If detected early enough, however, vitamin supplements readily treat the deficiency.

Because these B vitamins assist in metabolizing the amino acid homocysteine, scientists directly assayed homocysteine to screen for cobalamin and folate deficiency. These direct homocysteine assays were unreliable. Then researchers at University Patents Inc. (UPI) discovered a relationship between elevated levels of total homocysteine and a deficiency in either cobalamin or folate. The total homocysteine test, however, could not alone identify which vitamin was deficient. Total homocysteine includes free and protein-complexed homocysteine and also includes homocysteine derivatives homocystine and homocysteine-cysteine.

Originally, doctors could not conveniently treat both deficiencies because while folate was available in tablet form, cobalamin could only be administered by injection. After cobalamin became available in tablet form, however, doctors could simply order a total homocysteine test and, without identifying the deficient vitamin, treat elevated levels of total homocysteine with a tablet containing both cobalamin and folate. The UPI inventors also developed a test to identify the deficient vitamin using methylmalonic acid (the panel test method). The ’658 patent claims both the total homocysteine test and the total homocysteine-methylmalonic acid test. Claim 13 claims the total homocysteine test:

13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

On appeal, LabCorp argued that claim 13’s correlating step should be construed as establishing that an elevated level of homocysteine is caused by a “shortage of cobalamin which causes a hematologic or neuropsychiatric abnormality,” or a “deficiency of folate which causes a hematologic abnormality.” LabCorp interprets the specification to clearly define a “deficiency of cobalamin” as the presence of a clinical or hematologic syndrome or both that responds to cyano-cobalamin treatment, and to acknowledge that some clinical or hematologic syndrome or neuropsychiatric abnormality must be present. Thus, LabCorp contends that the correlation step of claim 13 should be construed to require a showing of a separate hematologic or neuropsychiatric symptom to confirm the “correlation.”

The claim states that the method must correlate “an elevated level of total homocysteine . . . with a deficiency of cobalamin or folate.” This language does not require a further association between the level of total homocysteine and either a hematologic or neuropyschiatric abnormality or both. The claim only requires association of homocysteine levels with vitamin deficiencies. It requires no further correlation to confirm the relationship to vitamin deficiencies. The claim simply says nothing about a confirmatory step or a further correlation beyond the stated relationship.

On appeal to the CAFC, LabCorp argued that claim 13 is invalid on grounds of indefiniteness, lack of written description and enablement, anticipation, and obviousness. Likewise, LabCorp contends that claim 18, directed to the panel test, is also invalid on grounds of indefiniteness, and lack of written description and enablement.

First, LabCorp contends that the “correlating” step in claim 13 is indefinite. 35 U.S.C. § 112, second paragraph, provides: “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” The CAFC affirmed the trial court’s denial of JMOL.

In its petition, Laboratory Corp. argued that the standard of intent to induce applied by the Federal Circuit is so low that a defendant becomes an inducer by merely delivering to doctors factual information about the correlation of elevated homocysteine levels and vitamin deficiency. According to the brief, a truthful statement of medical fact alone cannot under any circumstances constitute a specific intent to infringe a patent. It added that scientific facts and laws of nature are outside the scope of patentable inventions, citing Diamond v. Diehr, 450 U.S. 175 (1981).

The Supreme Court invited the government to brief on the following question:

Respondent’s patent claims a method for detecting a form of vitamin B deficiency, which focuses upon a correlation in the human body between elevated levels of certain amino acids and deficient levels of vitamin B. The method consists of the following: First, measure the level of the relevant amino acids using any device, whether the device is, or is not, patented; second, notice whether the amino acid level is elevated and, if so, conclude that a vitamin B deficiency exists. Is the patent invalid because one cannot patent “laws of nature, natural phenomena, and abstract ideas”? Diamond v. Diehr, 450 U.S. 175, 185 (1981).

The PTO contends that the record in this case is not sufficiently developed to answer particular fact questions to make the Section 101 determination under Parker v. Flook, 437 U.S. 584 (1978), and Diamond v. Diehr, 450 U.S. 175 (1981). Those questions are whether the claimed invention transforms matter and whether it prevents all practical applications of the natural phenomenon. According to the PTO, the courts below did not construe the claim term “assay,” which can suggest a variety of ways in which a product is transformed and made no finding as to the practical applications of the natural phenomenon preempted by the claim.

The government’s brief conceded that the claim in question involves a natural relationship but states that this is only the beginning of the Section 101 analysis. A claim involving a natural phenomenon must transform an article to a different state. Parker v. Flook, 437 U.S. 584 (1978). Moreover, the claim as a whole must contain some inventive aspect other than the natural phenomenon itself, and must not prevent all practical applications of the natural phenomenon. On the other hand, Diehr stated that patentable subject matter includes everything under the sun made by man, and that the novelty of an invention is of no relevance in determining whether the subject matter of the claim is within Section 101.

See the Federal Circuit decision here.

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