Association For Molecular Pathology V. Myriad Genetics, Inc.

Association for Molecular Pathology v. Myriad Genetics, Inc. is a landmark case in the field of genetics and patent law. The case was decided by the United States Supreme Court on June 13, 2013. The court ruled that a naturally occurring DNA sequence cannot be patented simply because it has been isolated from the rest of the human genome. However, cDNA, which is not naturally occurring, can be patented.

Background

The case began when Myriad Genetics, a Utah-based biotechnology company, was granted several patents related to the BRCA1 and BRCA2 genes. These genes are associated with an increased risk of breast cancer and ovarian cancer. Myriad's patents gave them the exclusive right to perform diagnostic tests on these genes.

The Association for Molecular Pathology, along with several other medical organizations and patients, filed a lawsuit against Myriad Genetics. They argued that the patents were invalid because they covered a product of nature.

Court's Decision

The Supreme Court, in a unanimous decision, held that naturally occurring DNA sequences, even when isolated from the rest of the human genome, are not patentable subject matter. The court reasoned that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes, they merely uncovered the precise location and sequence of them.

However, the court also held that cDNA, which is not naturally occurring, is patentable. cDNA is DNA that has been altered in a lab to remove non-coding regions. The court reasoned that because the creation of cDNA involves a significant amount of human ingenuity and intervention, it is not a product of nature and is therefore patentable.

Impact

The decision in Association for Molecular Pathology v. Myriad Genetics has had a significant impact on the field of genetics and patent law. It has led to an increase in competition in the genetic testing market, as other companies can now offer testing for the BRCA1 and BRCA2 genes. It has also raised questions about the patentability of other naturally occurring substances. Template:USCaseLaw-stub

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