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Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 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. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Kappos and Mayo v. Prometheus. Drug screening claims were not seriously questioned prior to this case.

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  • Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 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. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Kappos and Mayo v. Prometheus. Drug screening claims were not seriously questioned prior to this case. The case was originally heard in Southern District Court of New York. 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. 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. The District Court ruled that none of the challenged claims were patent eligible. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. 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. On appeal, the Supreme Court vacated and remanded the case for the Federal Circuit to reconsider the issues in light of Prometheus. On remand, the Federal Circuit held that Prometheus did not affect the outcome of the case, so the American Civil Liberties Union and the filed a petition for certiorari. The Supreme Court granted certiorari and unanimously invalidated Myriad's claims to isolated genes. The Supreme Court held that merely isolating genes that are found in nature does not make them patentable. (en)
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  • Association for Molecular Pathology v. Myriad Genetics, Inc., (en)
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  • Douglas L. (en)
  • Jorge L. (en)
  • Laurie E. (en)
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  • Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. (en)
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dbp:holding
  • 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. (en)
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  • Roberts, Kennedy, Ginsburg, Breyer, Alito, Sotomayor, Kagan; Scalia (en)
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  • Duke L. & Tech. Rev. (en)
  • Fla. St. U. L. Rev. (en)
  • Utah L. Rev. (en)
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  • Rogers (en)
  • Abbott (en)
  • Contreras (en)
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  • U.S. Const. Article I, Section 8, Clause 8, 35 U.S.C. ยง 101 (en)
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  • Association for Molecular Pathology v. Myriad Genetics, Inc. (en)
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  • Thomas (en)
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  • After Prometheus, are Human Genes Patentable? (en)
  • Narratives of Gene Patenting (en)
  • Incentive for Innovation or Invitation to Inhumanity?: A Human Rights Analysis of Gene Patenting and the Case of Myriad Genetics (en)
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  • Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 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. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Kappos and Mayo v. Prometheus. Drug screening claims were not seriously questioned prior to this case. (en)
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  • Association for Molecular Pathology v. Myriad Genetics, Inc. (en)
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  • Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. (en)
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