High Court asks for government’s view on patentability of tests to determine vitamin deficiency.

LABORATORY CORP. OF AMERICA (LabCorp) V. METABOLITE LABORATORIES, ET AL. (on petition for cert at the Supreme Court 2005).

The Supreme Court moved a step closer to granting cert in the case by inviting the Acting Solicitor General to file a brief expressing the views of the United States 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).

In the opinion below, the CAFC (Rader, J.) affirmed the jury verdict of indirect infringement and breach of contract, and affirmed the district court’s award of over $8 million in damages to Metabolite (including damages for willfulness). The dissent (Schall, J.) argued that claim interpretation had been mishandled. Metabolite Laboratories, Inc. v. Laboratory Corp. of America Holdings, dba as LabCorp., 370 F.3d 1354 (Fed. Cir. 2004) (read my summary)

The question that the High Court is now considering does not appear to have even been addressed by the CAFC decision. The Court’s docket shows that the case has already been distributed for conference five times since January 1, 2005.

In its petition for a writ of certiorari, LabCorp presented three questions to the Court:

1. Whether liability can be imposed for willfully inducing patent infringement under 35 U.S.C. § 271(b) based solely on evidence that a party has disseminated a basic scientific fact to others.

2. Whether an express limitation in a patent claim can be ignored so as to allow the patent to cover the exact opposite of what was claimed.

3. Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to “correlat[e]” test 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 Court, however, appears to be interested only the extent that a basic scientific relationship used in medical treatment is patentable. LabCorp’s introduction provides a compelling story and sets the stage for the debate:

The holding of the Federal Circuit in this case is truly extraordinary. The court construed a patent to confer on respondents a legally-protected monopoly to bar any doctor in the Nation from even about a well-known scientific correlation. It then went even further, holding—in conflict with other Federal Circuit decisions—that petitioner LabCorp indirectly “induced” such infringement merely by publishing truthful information informing doctors of this basic scientific fact. And further compounding its errors, the Federal Circuit violated well-established tenets of patent law by expanding the patent beyond its express terms, and by upholding its validity.

Documents:

Thanks to Jonathan Franklin at Hogan & Hartson and Glenn Beaton at Gibson Dunn for copies of the briefs and to appellate attorney Howard Bashman at How Appealing for the heads-up on the case.