Correspondence
Medical-Process Patents
N Engl J Med 2007; 356:753-754February 15, 2007
- Article
To the Editor:
Kesselheim and Mello (Nov. 9 issue)1 report on medical-process patents. There is a long-standing rule in the United States against patenting natural phenomena.2 The issue in the LabCorp case (Laboratory Corporation of America v. Metabolite Laboratories) was whether patent applicants can circumvent this prohibition and assert ownership over biologic correlations by characterizing them as stepwise processes. The disputed patent in the LabCorp case claimed inverse associations between homocysteine levels and cobalamin (vitamin B12) and folate levels.
However, the most important implications of the LabCorp case are for patents that claim analogous correlations between genetic variants and predisposition to disease, therapeutic drug response, and susceptibility to pharmacologic side effects. If the disputed claim in the LabCorp case is invalid, such patents may also be invalid. The Supreme Court first raised the question of whether the homocysteine–vitamin B12 patent claims an unpatentable natural phenomenon,3 but it appears to have been persuaded not to rule on this issue because LabCorp did not raise it in the lower courts.4,5 Molecular genetic testing is rapidly increasing in importance.6 Yet correlation patents are already restricting its availability, resulting in increased costs, diminished access, decreased innovation, and an inability to confirm results. The dissenting opinion of Justices Stephen Breyer, David Souter, and John Paul Stevens4 is cause for optimism that in a future case the Court will rule in the best interests of our patients.
6 ReferencesRoger D. Klein, M.D., J.D.
Yale University School of Medicine, New Haven, CT 06150
roger.klein@yale. edu 1
Kesselheim AS ,Mello MM . Medical-process patents -- monopolizing the delivery of health care. N Engl J Med 2006;355:2036-2041
Full Text | Web of Science | Medline2
Diamond v. Diehr, 450 U.S. 175 (1981).
3
Order, Laboratory Corp. of Am. v. Metabolite Labs, Inc., 543 U.S. 1185 (2005) (No. 04-607).
4
Laboratory Corp. of Am. v. Metabolite Labs, Inc., 126 S.Ct. 2921 (2006) (dismissed as improvidently granted).
5
Brief for the United States as Amicus Curiae on Petition for a Writ of Certiorari, Laboratory Corp. of Am. v. Metabolite Labs, Inc., 126 S.Ct. 2921 (2006) (No. 04-607).
6
Klein RD ,Kant JA . Opportunity knocks: the pathologist as laboratory genetics consultant. Arch Pathol Lab Med 2006;130:1603-1604
Web of Science | Medline
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