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''Association for Molecular Pathology v. Myriad Genetics,'' 〔(USSC 12-398 )〕 was a case challenging the validity of gene patents in the United States, specifically challenging 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 ''In re Bilski'' and ''Mayo v. Prometheus'' cases. Drug screening claims were not seriously questioned prior to this case. The case was originally heard in Southern District Court of New York, which ruled that all the challenged claims were not patent eligible. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature ''can'' be patented and that the drug screening claims were valid, and confirmed in part, finding the diagnostic claims unpatentable. The plaintiffs appealed to the Supreme Court, which granted certiorari and remanded the case to the Federal Circuit. The Federal Circuit did not change its opinion, so on September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision. On November 30, 2012, the Supreme Court agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling. On June 13, 2013, in a unanimous decision, the Supreme Court invalidated Myriad's claims to isolated genes. The Court held that merely isolating genes that are found in nature does not make them patentable. Proponents of the validity of these patents argued that they encourage investment in biotechnology and promote innovation in genetic research by not keeping technology shrouded in secrecy. Opponents argued that these patents stifle innovation by preventing others from conducting cancer research, limit options for cancer patients in seeking genetic testing, and are not valid because they claim genetic information that is not inventive, but is rather produced by nature. == Background == The global search for a genetic basis for breast and ovarian cancer began in earnest in 1988. In 1990, at an American Society of Human Genetics Meeting, a team of scientists led by Mary-Claire King, from 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. It was understood at the time that a test for these mutations would be a clinically important prognostic tool. Myriad Genetics was founded in 1994 as a startup company out of University of Utah, by scientists involved in the hunt for the BRCA genes. In August 1994, Mark Skolnick, a founder of Myriad and scientist at University of Utah, and researchers at Myriad, along with colleagues at the University of Utah, the National Institutes of Health (NIH), and McGill University published the sequence of BRCA1, which they had isolated. In that same year, the first BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS), and Myriad.〔(US5747282 )〕 Over the next year, Myriad, in collaboration with University of Utah, isolated and sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by the University of Utah and other institutions in 1995.〔(US5837492 )〕 In 1996, Myriad launched their BRACAnalysis product, which detects certain mutations in the BRCA1 and BRCA2 genes that put women at high risk for breast cancer and ovarian cancer.〔(【引用サイトリンク】title=Myriad Marketed Products )〕 Myriad's business model has been to exclusively offer diagnostic testing services for the BRCA genes. It was on the basis of the premium price that the patents would allow Myriad to set during the 20 year life of the patents, that investors put money into Myriad.〔 These were the funds that allowed Myriad to rapidly sequence the BRCA2 gene and finalize a robust diagnostic test. The business model meant that Myriad would need to enforce its patents against competitors, which included diagnostic labs at universities, which function very much like for-profit businesses in addition to educating pathologists-in-training.〔''Association for Molecular Pathology v. U.S. Patent and Trademark Office'', No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010). (District Court Decision. ) Retrieved October 10, 2012.〕 The patents expire, starting in 2014. In 2012, Myriad—just a startup in 1994—employed about 1200 people, had revenue of around $500 million, and was a publicly traded company.〔(Myriad Investor Page—see "Myriad at a glance" ) accessed October 2012.〕 About 2000 isolated human genes had been patented in the United States before this case started. Gene patents have generated a great deal of controversy, especially when their owners or licensees have aggressively enforced them to create exclusivity. Clinical pathologists have been especially concerned with gene patents, as their medical practice of offering clinical diagnostic services is subject to patent law, unlike the practices of other doctors which are exempt from patent law.〔(USC § 287(c) ) Quote: "This subsection (exemptions of patent infringement for doctors) does not apply to the activities of any person...who is engaged in ...the provision of ... clinical laboratory services".〕 For example, in 1998, University of Pennsylvania's Genetic Diagnostic Laboratory received cease and desist letters on the basis of patent infringement from Myriad, which requested clinical pathologists to stop testing patient samples for BRCA.〔 Because of these kinds of legal threats to its members' medical practices, the Association for Molecular Pathology has actively lobbied against the existence of, and exclusive licensing of, gene patents and was the lead plaintiff in this litigation.〔 Association for Molecular Pathology Press Release, February 16, 2012. (AMP Testifies at USPTO: AMP presented testimony to the U.S. Patent and Trademark Office requesting moratorium on human gene patenting. )〕〔 Mary Steele Williams, Executive Director, Association for Molecular Pathology., February 16, 2012. (Association for Molecular Pathology Testimony to the USPTO )〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Ass'n for Molecular Pathology v. Myriad Genetics, Inc.」の詳細全文を読む スポンサード リンク
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