In Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., Supreme Court No. 04607 (June 22, 2006), the Supreme Court dismissed the petition for certiorari filed by Lab Corp as improvidently granted. The issue briefed and argued by the parties and over 20 amici (including the U.S. government) was "[w]hether a method patent ... 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 debate was keyed to the tension between the broad scope of patentable subject matter defined in 35 U.S.C. §101 ("any new and useful process, machine, manufacture, or composition of matter") and the prohibition from patent protection of 'laws of nature, natural phenomena, and abstract ideas.' Diamond v. Diehr, 450 U.S. 175, 185 (1981).
The per curiam dismissal was accompanied by the dissenting opinion of Justice Breyer, joined by Justices Stevens and Souter, who disagreed that the §101 issue was not ripe for decision by the Court. Although Lab Corp failed to raise §101 in the lower courts and the benefit of a Federal Circuit opinion were acknowledged as reasons for dismissal, the dissenting Justices considered the completeness of the briefing, the lack of prejudice to the parties, and the important public interest to outweigh the "technical procedural" reasons for dismissing the appeal.
Justice Breyer opined that in his view, asserted Claim 13 was invalid because it recited nothing more a process that instructed the user to "(1) obtain test results and (2) think about them." Regardless of how narrowly the "natural phenomenon" doctrine was construed, "respondents simply described the natural law at issue in the abstract language of a 'process,'" but could not avoid the fact that "the process is no more than an instruction to read some numbers in light of medical knowledge." (Dissent pp. 13-14). He acknowledged that any natural phenomenon could be described in stepwise fashion using process language (e.g., 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly) but that does not make the subject matter patentable as a result.
The dissent was unpersuaded by respondent's reliance on State Street Bank in which the Federal Circuit stated that a process is patentable if it produces a "useful, concrete, and tangible result." According to the Justice Breyer, "this Court has never made such a statement and, if taken literally, the statement would cover instances where this Court has held the contrary." (Dissent at 13, citing O'Reilly v. Morse, 15 How. 62 (1854); Parker v. Flook, 437 U. S. 584, 585 (1978)).
It remains to be seen where the next step takes the parties. Yet it is clear that the §101 debate raised impacts technologies well beyond those found in the medical industry, and is far from over with the dismissal of Lab Corp.
Please visit http://media.aplf.org/rm/20060623-public/lab-corp.pdf for a copy of the case for your reference.
To discuss these topics further, please feel free to contact the author, Michael R. Dzwonczyk (firstname.lastname@example.org), at Sughrue Mion, PLLC in Washington DC, USA.
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