The Supreme Court opinion on the Myriad Genetics case about the BRCA1 & BRCA2 patents is out. Great news for science and medicine. Opinion was 9-0, invalidating the patent Myriad used to exercise a monopoly over breast cancer diagnostic tests.http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf
Held: "A naturally occurring DNA segment is a product of nature andnot patent eligible merely because it has been isolated, but cDNA ispatent eligible because it is not naturally occurring."From the introductory summary --Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a “double helix.” Each “cross-bar” in that helix consists of two chemically joined nucleotides. Sequences of DNA nu- cleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are “exons,” and those that do not are “introns.” Sci- entists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nu- cleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically in- crease the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting muta- tions in these genes in a particular patient to assess the patient’s cancer risk. If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA. Petitioners filed suit, seeking a declaration that Myriad’s patents are invalid under 35 U. S. C. §101. As relevant here, the District Court granted summary judgment to petitioners, concluding that Myriad’s claims were invalid because they covered products of nature. The Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___, the Circuit found both isolated DNA and cDNA patent eligible.
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