Hostname: page-component-76fb5796d-5g6vh Total loading time: 0 Render date: 2024-04-27T22:05:16.410Z Has data issue: false hasContentIssue false
  • English
  • Français

LabCorp v. Metabolite Laboratories: The Supreme Court Listens, but Declines to Speak

Published online by Cambridge University Press:  01 January 2021

Roger D. Klein  and
Maurice J. Mahoney
Get access Rights & Permissions [Opens in a new window]

Extract

Molecular genetic testing has increasingly been incorporated into clinical medicine, and this trend is likely to accelerate in the future. The introduction of genetic testing into medical practice is beginning to collide head on with patents that claim ownership of correlations between human genetic variants and predisposition to disease, response to therapeutic drugs, and susceptibility to pharmacologic side effects. Patent holders or licensees of genes, genetic variants, and their genotype-phenotype correlations are already using the threat of litigation to monopolize genetic tests for important well-known syndromes like Duchenne Muscular Dystrophy and inherited breast and ovarian cancer, in addition to a host of less commonly discussed conditions.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 1 , Spring 2008 , pp. 141 - 149
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Klein, R. D. Kant, J. A. Editorial, , “Opportunity Knocks: The Pathologist as Laboratory Genetics Consultant,” Archives of Pathology and Laboratory Medicine 130, no. 11 (2006): 1603–1604.Google Scholar
See, e.g., Leonard, D. G. B., “Medical Practice and Gene Patents: A Personal Perspective,” Academic Medicine 77, no. 12, pt. 2 (2002): 1388–1391; Cho, M. K. Illangasekare, S. Weaver, M. A. Leonard, D. G. B. Merz, J. F., “Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services,” Journal of Molecular Diagnostics 5, no. 1 (2003): 3–8; Klein, R. D. Letter, , “Medical-Process Patents,” New England Journal of Medicine 356, no. 19 (2007): 753–754.CrossRefGoogle Scholar
Laboratory Corp. of America v. Metabolite Labs., Inc., Order Granting Certiorari, 126 S.Ct. 543 (2005).Google Scholar
See, e.g., Rice v. Sioux City Memorial Park Cemetary, Inc., 349 U.S. 70, 70–81 (1955).Google Scholar
Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.Google Scholar
35 U.S.C. §§ 101–103 (2004).Google Scholar
35 U.S.C. § 101 (2004).Google Scholar
Diamond v. Diehr, 450 U.S. 175, 185 (1981).Google Scholar
Allen, R. H. Stabler, S. P. Lindenbaum, J., “Assay for sulfhydryl amino acids and methods for detecting and distinguishing cobalamin and folic acid deficiency,” U.S. Patent 4,940,658, filed November 20, 1986, and issued July 10, 1990.Google Scholar
Brief for Petitioner on Writ of Certiorari at 5, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.Google Scholar
Weissbach, H. Taylor, R., “Role of vitamin B12 in Methionine Synthesis,” Federation Proceedings 25, no. 6 (1966): 1649–1656; Barker, H. A., “Biochemical Functions of Corrinoid Compounds,” Biochemical Journal 105, no. 1 (1967): 1–15.Google Scholar
Carmel, R. Green, R. Rosenblatt, D. S. Watkins, D., “Update on Cobalamin, Folate, and Homocysteine,” Hematology (2003): 62–81; Schneede, J. Ueland, P. M., “Novel and Established Markers of Cobalamin Deficiency: Complementary or Exclusive Diagnostic Strategies,” Seminars in Vascular Medicine 5, no. 2 (2006): 140–155.CrossRefGoogle Scholar
See supra note 10, at 7.Google Scholar
Id., at 7–9.Google Scholar
Id., at 10.Google Scholar
Metabolite Labs. v. Laboratory Corp. of America, No. 99-Z-870 (D. Colo. November 21, 2001).Google Scholar
Metabolite Labs. v. Laboratory Corp. of America, 370 F. 3d 1354, 1365 (2004).Google Scholar
Id., at 1364.Google Scholar
See, Kesselheim, A. S. Mello, M. M., “Medical-Process Patents – Monopolizing the Delivery of Health Care,” New England Journal of Medicine 355, no. 19 (2006): 2036–41.Google Scholar
See LabCorp, supra note 16.Google Scholar
See LabCorp, supra note 17, at 1372.Google Scholar
Order, February 28, 2005, Laboratory Corp. of America v. Metabolite Labs., Inc., 125 S.Ct. 1413 (2005) (citing Diamond v. Diehr, 450 U.S. 175 [1981]).Google Scholar
Brief for the United States as Amicus Curiae on Petition for a Writ of Certiorari at 5–7, 15–19, supra note 5.Google Scholar
Conley, J. M. Makowski, R., “Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechology Patents,” Journal of the Patent and Trademark Office Society 85, no. 5 (2003): 301–398, at 303–304.Google Scholar
Diamond v. Chakrabarty, 447 U.S. 303 (1980).Google Scholar
Diamond v. Diehr, 450 U.S. 175 (1980).Google Scholar
See Chakrabarty, supra note 25, at 309.Google Scholar
Kuehmsted v. Farbenfabriken, 179 F. 701 (7th Cir. 1910), cert. denied, 220 U.S. 622 (1911).Google Scholar
Parke-Davis & Co. v. H. K. Mulford & Co., 189 F. 95 (S.D.N.Y. 1911), aff’d, 196 F. 496 (2d Cir. 1912).Google Scholar
Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958).Google Scholar
In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970) (PGE, PGF).Google Scholar
See e.g., Amgen v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206 (Fed Cir 1991) (“A gene is a chemical compound, albeit a complex one…”).Google Scholar
See Diehr, , supra note 26.Google Scholar
Gottschalk v. Benson, 409 U.S. 63 (1972).Google Scholar
Parker v. Flook, 437 U.S. 584 (1978).Google Scholar
Arrhythmia Research Tech. v. Corazonix Corp., 958 F.2d 1053 (Fed. Cir. 1992) (EKG system that utilizes programmed computer to analyze electrocardiographic signals is statutory subject matter); In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994) (en banc) (digital processing circuitry programmed to generate antialiased oscilloscope tracing is statutory subject matter); State St. Bank & Trust v. Signature Fin. Group, 149 F.3d 1368 (Fed. Cir. 1998) (data processing system used to administer investment fund is statutory subject matter); ATT Corp. v Excel Commc’ns Inc., 172 F.3d 1352 (Fed. Cir. 1999) (computerized system for recording and billing long distance telephone calls that has ability to recognize called party's long distance carrier is statutory subject matter).Google Scholar
See Diehr, , supra note 8, at 187.Google Scholar
State Street Bank & Trust Co. v. Signature Financial Group, 149 F.3d 1368.Google Scholar
See Diehr, , supra note 8, at 189–191.Google Scholar
Id.Google Scholar
See State Street, supra note 38, at 1375. The omitted footnote reads, “Of course, the subject matter must fall into at least one category of statutory subject matter.”42. See Diehr, , supra note 8, at 184.Google Scholar
Id.Google Scholar
Laboratory Corp. of Am. v. Metabolite Labs., Inc., 126 S.Ct. 2921, 2927 (2006), dismissed as improvidently granted (Justice Breyer dissenting) (“But this case is not at the boundary. It does not require us to consider the precise scope of the ‘natural phenomenon’ doctrine or any other difficult issue. In my view claim 13 is invalid no matter how narrowly one reasonably interprets that doctrine.”)Google Scholar
Stabler, S. P. Marcell, P. D. Podell, E. R. Allen, R. H., “Quantitation of Total Homocysteine, Total Cysteine, and Methionine in Normal Serum and Urine Using Capillary Gas Chromatography-Mass Spectrometry,” Analytical Biochemistry 162, no. 1 (1987): 185–196.CrossRefGoogle Scholar
See LabCorp, , supra note 44, at 2927 (Justice Breyer dissenting).Google Scholar
Id., at 2928.Google Scholar
Bogart, M., “Method for assessing placental dysfunction,” U.S. Patent No. 4,874,693, filed October 10, 1986, and issued October 17, 1989.Google Scholar
Barzo, G., “Lawsuit Heats Up over Patent on Common Prenatal Test,” American Medical News, January 12, 1998, at 1.Google Scholar
Brief for Respondents on Writ of Certiorari at 43–46, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted; Brief for the United States as Amicus Curiae on Petition for a Writ of Certiorari at 14, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.Google Scholar
See generally, Duffy, J. F., “The Festo Decision and the Return of the Supreme Court to the Bar of Patents,” Supreme Court Review (2002): 273–342, particularly at 285 (“Because patent law is a fairly technical system of property rights, the Court has always behaved conservatively in the area, accepted doctrinal changes only incrementally, and looked to specialized actors in the patent system to take the lead in developing the law.”)CrossRefGoogle Scholar
Klein, R. D., “Gene Patents and Genetic Testing in the United States,” Nature Biotechnology 25, no. 9 (2007): 989–990.Google Scholar
See Leonard, , supra, note 2; Cho, et al., supra, note 2.Google Scholar
Shattuck-Eidens, D. M. Simard, J. Durocher, F. Mitsuuru, E. Nakamura, Y., “Linked breast and ovarian cancer susceptibility gene,” U.S. Patent No. 5,709,999, filed June 7, 1995, and issued January 20, 1998.Google Scholar
See Klein, , supra note 52.Google Scholar
See Leonard, , supra note 2.Google Scholar
Murphy, G. M. Schatzberg, A. F., “Method to determine the risk for side effects of an SSRI treatment in a person,” U.S. Patent No. 7,083,921, filed August 29, 2002, and issued August 1, 2006.Google Scholar
Kary B. Mullis won the 1993 Nobel Prize in Chemistry for his invention of the polymerase chain reaction (PCR).Google Scholar
Athena Diagnostics Web site, available at <http://www.athenadiagnostics.com/content/about/> (last visited September 21, 2007).+(last+visited+September+21,+2007).>Google Scholar
Athena Diagnostics, “List of Patents,” available at <http://www.athenadiagnostics.com/content/about/patents> (last visited September 21, 2007); the company also has patent rights to a number of immunologically related gene patents having less direct relationships with diseases.+(last+visited+September+21,+2007);+the+company+also+has+patent+rights+to+a+number+of+immunologically+related+gene+patents+having+less+direct+relationships+with+diseases.>Google Scholar
See generally, Davies, K. White, M., Breakthrough: The Race to Find the Breast Cancer Gene (New York: John Wiley & Sons, Inc., 1996).Google Scholar
ThermoFisher Scientific, Fisher Scientific Expands Presence in Molecular Diagnostics; Company to Acquire Athena Diagnostics from Behrman Capital and Purchase 9 Percent of Nanogen, News Release, March 16, 2006, available at <http://ir.thermofisher.com/phoenix.zhtml?c=89145&p=irol-newsArticle&ID=914979> (last visited September 21, 2007).+(last+visited+September+21,+2007).>Google Scholar
Myriad Genetics, “Genetic Testing for Hereditary Cancer,” available at <http:/www.myriad.com/products/cancerrisk.php> (last visited September 21, 2007).+(last+visited+September+21,+2007).>Google Scholar
Myriad Genetics, Myriad Genetics Reports Financial Results for Fiscal 2006, News Release, August 22, 2006, available at <http://www.myriad.com/news/release/898035> (last visited September 21, 2007).+(last+visited+September+21,+2007).>Google Scholar
Pollack, A., “Rivals Laying Siege to Amgen's Near Monopoly in Anemia Drugs,” New York Times, December 23, 2005, at C1, Late Edition.Google Scholar
Klein, R. D. Editorial, , “The Pain Protective Haplotype: Introducing the Modern Genetic Test,” Clinical Chemistry 53, no. 6 (2007): 1007–1009.CrossRefGoogle Scholar
Transcript of Oral Argument at 40, Laboratory Corp. of America v. Metabolite Labs., Inc., 126 S.Ct. 2921 (2006), dismissed as improvidently granted.Google Scholar