Myriad Genetics was founded in 1994 as a startup company out of the University of Utah, by scientists involved in the hunt for the BRCA genes. It was understood at the time that a test for these mutations would be a clinically important prognostic tool. In 1990, at a meeting of the American Society of Human Genetics, a team of scientists led by Mary-Claire King, from the University of California, Berkeley announced the localization through linkage analysis of a gene associated with increased risk for breast cancer ( BRCA1) to the long arm of chromosome 17. The global search for a genetic basis for breast and ovarian cancer began in earnest in 1988. "It is inconsistent to conclude that isolated DNA and naturally occurring DNA are not markedly different because their information content is the same, and at the same time find that cDNA is patent eligible despite having virtually identical information content to naturally occurring mRNA." Background A prominent US biotech patent lawyer commented on the SCOTUS decision: However, the SCOTUS agreed with the “friend of the court brief,” submitted by the USPTO, that cDNA should be patent eligible, because it does not exist in Nature but rather was “engineered by man. The Supreme Court held that merely isolating genes (even with introns removed) that are found in nature does not make them patentable. The Supreme Court granted certiorari and unanimously invalidated Myriad's claims to isolated genes. On remand, the Federal Circuit held that Prometheus did not affect the outcome of the case, so the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari. On appeal, the Supreme Court vacated and remanded the case for the Federal Circuit to reconsider the issues in light of Prometheus. The CAFC considered the valid gene claims as directed toward compositions-of-matter rather than toward information, like the District Court did. The Federal Circuit reversed the district court in part and affirmed in part, ruling that isolated DNA that does not exist alone in nature can be patented and that the drug screening claims were valid but that Myriad's diagnostic claims were unpatentable. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The majority opinion called patenting isolated or purified natural products a “lawyer’s trick” that circumvents the prohibitions on the direct patenting of products of nature. The District Court ruled that none of the challenged claims were patent eligible. Opponents argued that these patents would stifle innovation by preventing others from conducting cancer research, would limit options for cancer patients in seeking genetic testing, and that the patents are not valid because they relate to genetic information that is not inventive, but is rather produced by nature. Proponents of the validity of these patents argued that recognizing such patents would encourage investment in biotechnology and promote innovation in genetic research by not keeping technology shrouded in secrecy. The case was originally heard in Southern District Court of New York. Drug screening claims were not seriously questioned prior to this case. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Patent Office accepted patents on isolated DNA sequences as a composition of matter. 576 (2013), was a Supreme Court case that challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. § 101Īssociation for Molecular Pathology v. Article I, Section 8, Clause 8, 35 U.S.C. Thomas, joined by Roberts, Kennedy, Ginsburg, Breyer, Alito, Sotomayor, Kagan Scalia (in part) Naturally occurring DNA sequences, even when isolated from the body, cannot be patented, but artificially created DNA is patent eligible because it is not naturally occurring.Ĭhief Justice John Roberts Associate Justices Antonin Scalia On appeal, the Federal Circuit reversed the decision and found 2-1 in favor of Myriad, 653 F.3d 1329 (Fed. 2009), and found that patents were ineligible, 702 F. The District Court for the Southern District of New York denied the USPTO's motion to dismiss, 669 F.
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