The patent claims for these genes relate to the isolated gene sequences and the methods used to determine whether a patient has these genes or mutations of these genes in their body.Ĭells in the human body have twenty-three pairs of chromosomes and each chromosome has numerous genes. The challenged patents cover the “isolated” human genes, BRCA1 and BRCA2 (collectively “ BRCA1/2”) and alterations of those genes. Whether Myriad’s claimed invention, the sequence of certain human genes in both isolated and purified forms, falls within the scope of inventions for which a patent may be granted.Īlthough the question before the Supreme Court is whether human genes are patentable, in fact, three different kinds of “genes” are in question. LIMITED TO QUESTION 1 PRESENTED BY THE PETITION. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action? Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc.Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs.This case therefore presents the following questions: Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ("isolating") the genes from the body. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public. How the Supreme Court decides this case will greatly impact the scope of patentable subject-matter.
The district court held that naturally-occurring genes were not patentable subject-matter, but the Federal Circuit court reversed. Conversely, the Association for Molecular Pathologists contends that Myriad only isolated, and did not modify, a gene already existing in nature and that this isolated gene performs a similar function as the gene in natural form. Myriad claims that the isolated and modified genes that they hold patents for never occur in nature, and subsequently are patentable subject-matter. § 101 however, the Supreme Court has consistently held that laws of nature, abstract ideas, and natural phenomenon cannot be patented. The Patent Act defines the scope of patentable subject-matter in 35 U.S.C.
Myriad claims patents on the isolated BRCA genes along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and "primers" used in diagnostics. Myriad Genetics first identified and isolated the BRCA1 and BRCA2 genes responsible for diagnosing an elevated risk of breast and ovarian cancer.
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