By Audrey Millemann

The United States Supreme Court has dismissed a closely-watched patent infringement case, declining to narrow patentable subject matter. Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc., Case No. 04-607 (U.S. Supreme Court, June 22, 2006). The stage is set, however, for just that.

The patent in issue contained claims two new methods for determining the levels of an amino acid, homocysteine, as well as a broader claim (claim 13) for a method of detecting a deficiency of two vitamins based on elevated homocysteine levels. Claim 13 required “assaying a body fluid for an elevated level of total homocysteine” and “correlating an elevated level of total homocysteine … with a deficiency of cobalamin or folate.” Thus, a physician would infringe claim 13 if he or she determined the level homocysteine, by any test, regardless of whether the test was patented, and then noticed whether the level was elevated.

LabCorp licensed the patent from Metabolite, and paid royalties for seven years for each use of the specific test for homocysteine that was claimed in the patent. After that, other companies had developed alternative tests for homocysteine, and LabCorp then began to use their tests instead of Metabolite’s patented test. LabCorp stopped paying royalties, which triggered Metabolite’s lawsuit for patent infringement and breach of the license.

At trial, the jury returned a verdict of patent infringement of claim 13 against LabCorp and awarded $6.6 million in damages. The jury found that LabCorp had infringed Metabolite’s patent by inducing doctors to perform tests for homocysteine and use the results to determine whether a vitamin deficiency existed. LabCorp was held liable for every homocysteine test that a doctor reviewed or performed, regardless of whether it was covered by Metabolite’s patent.

LabCorp appealed to the Federal Circuit Court of Appeals. LabCorp argued that claim 13 was invalid as indefinite, lacking a written description, non-enabled, not novel, and obvious. According to LabCorp, the patent claim covered a scientific fact or principle – the link between high homocysteine levels and the deficiency in the vitamins cobalamin or folate – which was not invented by anyone. LabCorp contended that no one should be able to own a monopoly on a scientific principle.

The Court of Appeals affirmed the holding of infringement. LabCorp then appealed to the Supreme Court, who granted certiorari in October 2005. The question identified by the Court was whether a method patent was invalid on the grounds that it claimed a scientific principle or law of nature.

Since October 2005, numerous amicus briefs have been filed and the appeal has been the focus of extensive commentary. Many experts believed that the Court would take a careful look at patentable subject matter, including business methods. Although the LabCorp case did not involve a business method patent, it was expected that the Court would address business methods in connection with its decision on patentable subject matter.

That did not happen. On June 22, 2006, the Supreme Court dismissed the appeal, stating that the writ had been improvidently granted. The dismissal was based on the failure of LabCorp to specifically raise 35 U.S.C. section 101 as a defense.

Three justices on the Court, Breyer, Stevens, and Souter, however, wrote a lengthy dissent. The dissent argued that the case should not have been dismissed, as the question before the Court is significant to medical researchers, practicing physicians, and patients alike.

The dissent reiterated a fundamental concept of patent law: one cannot patent “laws of nature, natural phenomena, and abstract ideas,” citing Diamond v. Diehr, 450 U.S. 175, 185 (1981). The dissent explained that such patents are not allowed because they are very likely to inhibit, rather than encourage, basic research and the free exchange of knowledge.

The dissent noted that there is a fine line between patentable methods or processes and unpatentable phenomena of nature. “After all, many a patentable invention rests upon its inventor’s knowledge of natural phenomena; many ‘process’ patents seek to make abstract intellectual concepts workably concrete; and all conscious human action involve a mental process.” These justices concluded that claim 13, however, was not in that category. “There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomena’.” The inventors themselves had acknowledged that the correlation they discovered “is an observable aspect of biochemistry.”

The dissent disagreed with Metabolite’s contention that claim 13 is a patentable process because it is an application of a law of nature. They found that claim 13 did not require any specific test; rather, it required obtaining the results from any test and then thinking about them.

As the commentators had predicted, a discussion of patentable subject matter would lead to mention of business methods patents. In a statement that may indicate the future direction of the Court, the dissent stated: “Neither does the Federal Circuit’s decision in State Street Bank help respondents. That case does say that a process is patentable if it produces a ‘useful, concrete, tangible result.’ [Citation omitted.] But this Court has never made such a statement and, if taken literally, the statement would cover instances where this Court has held the contrary.” The Court emphasized that regardless of whether the claim produces a useful, concrete, or tangible result, it fails the requirement that it not constitute a natural phenomena. The claim is essentially a description of a natural law phrased as a process. Despite how it is phrased, the Court found that the process is still “no more than an instruction to read some numbers in light of medical knowledge.”

Audrey Millemann is a shareholder in Weintraub Genshlea Chediak Tobin & Tobin’s Intellectual Property and Disputes, Trials and Appeals sections. A business litigator and registered patent attorney, her practice focuses on intellectual property, unfair competition and antitrust matters. For more articles on IP law, please visit