Association for Molecular Pathology v. Myriad Genetics, Inc.
Supreme Court Case involving: patents, DNA, medical industry
Background: A research firm that engages in genetic interpretation, Myriad Genetics, Inc., obtained patents on two “isolated” forms of genes. These genes, BRCA1 and BRCA2, are known to have mutations that suggest a higher risk of breast and ovarian cancer in women. In order to analyze these specific genes they must be isolated and fragmented.
In a 1980 decision, the Supreme Court had clarified that an inventor cannot get a patent if the idea is no more than an application of the laws of nature or natural phenomena. Essentially, naturally occurring phenomena are not patentable. Myriad’s patents claim exclusive control over the genes once they have been extracted from the body and isolated from human cells. These claims are under challenge by a lawsuit filed by various organizations of health professionals including doctors and researches as well as geneticists, genetic counselors, women’s health and breast cancer organizations, and even patients diagnosed with a hereditary version of breast or ovarian cancer. The challenge claims Myriad’s claims are overly broad and should not have been issued as the isolated genes are in no way altered from their characteristics when in the body.
Opinion Summary: The court unanimously ruled that biotech researchers must create something to get monopoly protection to study and apply the phenomenon. Myriad’s patent on isolating human genes was struck down, although a synthetic form of the genes that Myriad created could be eligible for a patent. In the Court’s opinion Justice Thomas explains, “In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
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Implications: The opinion delivered by the Court was very narrow but it clarifies that work being done with genetics is not patentable when it only applies to finding and isolating genes. Companies that create synthetic forms of genes may be eligible for patents as imitations do not exist in nature.