View source for LabCorp v. Metabolite, Inc.

{{Use mdy dates|date=September 2023}}
{{Infobox SCOTUS case
  |Litigants=LabCorp of Am. Holdings v. Metabolite Labs., Inc.
  |ArgueDate=March 21
  |ArgueYear=2006
  |DecideDate=June 22
  |DecideYear=2006
  |FullName=Laboratory Corporation of America Holdings (d/b/a LabCorp) v. Metabolite Laboratories, Inc. et al.
  |USVol=548
  |USPage=124
  |ParallelCitations= 126 S. Ct. 2921; 165 [[L. Ed. 2d]] 399; 79 [[U.S.P.Q.2d]] ([[Bloomberg BNA|BNA]]) 1065
  |Docket=03-1120
  |OralArgument=http://www.oyez.org/cases/2005/04-607
  |OpinionAnnouncement=http://www.oyez.org/cases/2005/04-607
  |Prior=Judgment for plaintiff, judgment as a matter of law for defendant denied, ''Metabolite Labs, Inc. v. Lab. Corp. of Am. Holdings'', [https://www.courtlistener.com/docket/4775796/metabolite-labs-inc-v-laboratory-corp-amer/?page=2 No. 1:99-cv-00870] ([[United States District Court for the District of Colorado|D. Colo.]] 2002); 370 [[F.3d]] [https://www.leagle.com/decision/20041724370f3d135411586 1354] ([[Fed. Cir.]] 2004), ''[[Certiorari|cert]]. granted'', {{ussc|546|999|2005|el=no}}.
  |Subsequent=''Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc.'', 571 [[F. Supp. 2d]] [https://www.leagle.com/decision/20081770571dffsupp2d119911661 1199] ([[D. Colo.]] 2008) (partial relitigation); 599 F.3d [https://www.leagle.com/decision/infco20100311158 1277] (Fed. Cir. 2010) (denying jurisdiction and transferring appeal); 410 [[F. App'x]] 151 ([[10th Cir.]] 2011) (affirming summary judgment).
  |Holding= Writ of certiorari dismissed as [[Dismissed as improvidently granted|improvidently granted]].
  |PerCuriam=yes
  |Dissent=Breyer
  |JoinDissent=Souter, Stevens
  |LawsApplied=
}}
'''''LabCorp v. Metabolite, Inc.''''', 548 U.S. 124 (2006), is the first case since ''[[Diamond v. Chakrabarty]]''<ref>{{ussc|name=Diamond v. Chakrabarty|volume=447|page=303|pin=|year=1980}}.</ref> in which the [[Supreme Court of the United States|U.S. Supreme Court]] indicated a renewed interest in examining the limits of patentable subject matter for advances in life sciences. Although the Court initially agreed to hear the case, it was later dismissed in 2006 with three Justices dissenting.<ref>{{ussc|name=LabCorp v. Metabolite, Inc.|volume=548|page=124|pin=|year=2006}}.</ref> The defendant's petition to the Supreme Court raised an issue not addressed in opinions from the lower courts: the claim at issue was directed to patent ineligible subject matter and therefore invalid.

== Background ==
In 1999, Metabolite sued [[LabCorp]] for infringement of a patent covering a diagnostic test. The single claim at issue, claim 13, is reproduced in full below: 
"A method for detecting a deficiency of cobalamin or folate in warm-blooded 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."

Claim 13 is a diagnostic method for detecting deficiencies of vitamins [[Vitamin B6|B<sub>6</sub>]] and [[Vitamin B12|B<sub>12</sub>]] that relies on the correlation of that condition with elevated levels of [[homocysteine]]. The claim instructs medical providers to test homocysteine levels in a patient, without specifying any specific means of doing so, and make logical inferences based on the test results and aware of the discovered correlation between elevated levels and vitamin deficiencies.

A jury found the defendants liable for indirect infringement of claim 13 and breach of contract. The district court ordered LabCorp to pay $4.7 million in damages and permanently enjoined LabCorp from conducting future such tests at physicians' requests. The decision was upheld by the [[United States Court of Appeals for the Federal Circuit]], which further stated that doctors were 'directly infringing' Metabolite's patents each time such a test is ordered and interpreted.<ref>{{cite court |litigants=Metabolite Labs, Inc. v. Lab. Corp. of Am. Holdings |vol=370 |reporter=F.3d |opinion=1354 |pinpoint= |court=[[Fed. Cir.]] |date=2004 |url=https://www.leagle.com/decision/20041724370f3d135411586 |accessdate=2019-08-08 |quote=}}</ref> LabCorp argued that the correlation is a principle of nature, and therefore the patent should never have been granted.

== Dissent ==
The [[US Supreme Court]] dismissed the case, although [[Stephen Breyer|Justice Breyer]], [[John Paul Stevens|Justice Stevens]], and [[David Souter|Justice Souter]] dissented from this decision. Breyer's dissenting opinion cited numerous cases in which scientific and mathematical principles had been held to be patent ineligible, including ''[[O'Reilly v. Morse]]''<ref>{{ussc|name=O'Reilly v. Morse|56|62|1853|How.|15}}.</ref> and ''[[Gottschalk v. Benson]]''.<ref>{{ussc|name=Gottschalk v. Benson|volume=409|page=63|pin=|year=1972}}.</ref>

== Significance ==
Had the case been heard, and had Metabolite's patent been invalidated, the case would have had broad implications for biotechnology companies, which may have extended far beyond patentability of correlations of [[biomarker]]s to [[disease]] states. [[Lori Andrews]] outlined various concerns regarding how routine academic practices might become actionable under the results of the case.<ref>Andrews LB (2006) ''The patent office as thought police'', [[The Chronicle of Higher Education|CHE]] '''52'''(24), B20.</ref> Metabolite's brief to the court suggested that overturning the patent might lead to invalidation of all drug patents on the grounds that the inventors ''"merely discovered that certain chemicals interact with the human body in ways directed by chemistry."'' This statement is flawed, because it refers to process claims, while pharmaceutical are claimed as compositions-of-matter.

In ''[[Mayo Collaborative Services v. Prometheus Laboratories, Inc.|Mayo v. Prometheus]]'' in 2012 the Supreme Court unanimously held what the dissenting Justices argued for in this case.<ref>{{ussc|name=Mayo v. Prometheus|link=Mayo Collaborative Services v. Prometheus Laboratories, Inc.|volume=566|page=66|pin=|year=2012}}.</ref> That did not lead, however, to invalidation of all drug patents on the grounds that the inventors "merely discovered that certain chemicals interact with the human body in ways directed by chemistry." The only issue affected by Mayo v. Prometeus is the eligibility of method/process claims. Claims on articles of manufacture or compositions of matter are believed to be unaffected.

==See also==
*''[[Diamond v. Diehr]]''
*''[[Parker v. Flook]]''
*''[[Funk Brothers Seed Co. v. Kalo Inoculant Co.]]''
* [[Medical technologist]]
* [[Valid claim]]

==References==
{{Reflist}}

==External links==
* {{caselaw source
 | case = ''LabCorp v. Metabolite, Inc.'', {{ussc|548|124|2006|el=no}}
 | justia =https://supreme.justia.com/cases/federal/us/548/124/
 | oyez =https://www.oyez.org/cases/2005/04-607
 | other_source1 = Supreme Court (slip opinion) (archived)
 | other_url1 =https://web.archive.org/web/0/https://www.supremecourt.gov/opinions/05pdf/04-607.pdf
 }}
*{{US patent|4940658}}, the disputed patent
*Kinitsch E, et al. [http://www.sciencemag.org/cgi/content/summary/311/5763/946 What Good Is a Patent?]. ''Science''.'''311''':5763-946. {{doi|10.1126/science.311.5763.946}}

[[Category:2006 in United States case law]]
[[Category:United States biotechnology case law]]
[[Category:United States Supreme Court cases]]
[[Category:United States Supreme Court cases of the Roberts Court]]