LabCorp v. Metabolite, Inc
Encyclopedia
LabCorp v. Metabolite, Inc. is a court case related to the patentability of scientific principles which the U.S. Supreme Court
agreed to hear, and later dismissed, in 2006.
In 1999, Metabolite sued LabCorp
for infringement of a patent covering a diagnostic test. The claims of Metabolite's patent include the correlation between levels of homocysteine
and vitamins B6
and B12
. A jury ordered LabCorp to pay $4.7 million in damages and the decision was upheld by a federal court, which further stated that doctors were 'directly infringing' Metabolite's patents each time such a test is ordered and interpreted. LabCorp argued that the correlation is a principle of nature, and therefore the patent should never have been granted. The court dismissed the case, although Justice Breyer
, Justice Stevens
, and Justice Souter
dissented from this decision. Breyer's dissenting opinion cited numerous cases in which scientific principles had been held to be unpatentable.
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 biomarkers to disease
states. 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.”
----
Supreme Court of the United States
The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...
agreed to hear, and later dismissed, in 2006.
In 1999, Metabolite sued LabCorp
LabCorp
Laboratory Corporation of America Holdings , more commonly known as LabCorp, is an S&P 500 company headquartered in Burlington, North Carolina. It operates one of the largest clinical laboratory networks in the world, with a United States network of 36 primary laboratories. Before a merger with...
for infringement of a patent covering a diagnostic test. The claims of Metabolite's patent include the correlation between levels of homocysteine
Homocysteine
Homocysteine is a non-protein amino acid with the formula HSCH2CH2CHCO2H. It is a homologue of the amino acid cysteine, differing by an additional methylene group. It is biosynthesized from methionine by the removal of its terminal Cε methyl group...
and vitamins B6
Vitamin B6
Vitamin B6 is a water-soluble vitamin and is part of the vitamin B complex group. Several forms of the vitamin are known, but pyridoxal phosphate is the active form and is a cofactor in many reactions of amino acid metabolism, including transamination, deamination, and decarboxylation...
and B12
Vitamin B12
Vitamin B12, vitamin B12 or vitamin B-12, also called cobalamin, is a water-soluble vitamin with a key role in the normal functioning of the brain and nervous system, and for the formation of blood. It is one of the eight B vitamins...
. A jury ordered LabCorp to pay $4.7 million in damages and the decision was upheld by a federal court, which further stated that doctors were 'directly infringing' Metabolite's patents each time such a test is ordered and interpreted. LabCorp argued that the correlation is a principle of nature, and therefore the patent should never have been granted. The court dismissed the case, although Justice Breyer
Stephen Breyer
Stephen Gerald Breyer is an Associate Justice of the U.S. Supreme Court. Appointed by President Bill Clinton in 1994, and known for his pragmatic approach to constitutional law, Breyer is generally associated with the more liberal side of the Court....
, Justice Stevens
John Paul Stevens
John Paul Stevens served as an Associate Justice of the Supreme Court of the United States from December 19, 1975 until his retirement on June 29, 2010. At the time of his retirement, he was the oldest member of the Court and the third-longest serving justice in the Court's history...
, and Justice Souter
David Souter
David Hackett Souter is a former Associate Justice of the Supreme Court of the United States. He served from 1990 until his retirement on June 29, 2009. Appointed by President George H. W. Bush to fill the seat vacated by William J...
dissented from this decision. Breyer's dissenting opinion cited numerous cases in which scientific principles had been held to be unpatentable.
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 biomarkers to disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
states. 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.”
See also
- Diamond v. DiehrDiamond v. DiehrDiamond v. Diehr, , was a 1981 U.S. Supreme Court decision which held that the execution of a physical process, controlled by running a computer program was patentable...
- Diamond v. ChakrabartyDiamond v. ChakrabartyDiamond v. Chakrabarty, , was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.-Background:...
- Parker v. FlookParker v. FlookParker v. Flook, was a 1978 United States Supreme Court decision that ruled that an invention that departs from the prior art only in its use of a mathematical algorithm is patent-eligible only if the implementation is novel and unobvious. The algorithm itself must be considered as if it were part...
- O'Reilly v. Morse
- Funk Brothers Seed Co. v. Kalo Inoculant Co.Funk Brothers Seed Co. v. Kalo Inoculant Co.Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 is a United States Supreme Court decision in which the Court held that a facially trivial implementation of a natural principle or phenomenon of nature is not eligible for a patent....
- Medical technologistMedical technologistA Medical Laboratory Scientist is a healthcare professional who performs chemical, hematological, immunologic, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid , peritoneal fluid, pericardial fluid, and synovial...
- Valid claimValid claimIn Law, a valid claim is a "grievance that can be resolved by legal action." It is a claim that is not frivolous, nor is based on fraud. In some state court systems, a valid claim is called a Claim for relief or a Claim and delivery...
----