![]() News Story that Affects All Medical Laboratories The high court will likely hear arguments in March of next year and rule by the end of June, according to a story published by Bloomberg. According to the blawg, these observers had noted the fact that the Supreme Court quoted an amicus brief from two of the plaintiffs in the Myriad case in its Prometheus decision. “Many observers believe the Prometheus decision is a strong clue as to how the Supreme Court will rule on the Myriad case,” they wrote. (Prometheus) offers clues to how they might decide the Myriad case. The pathology “ blawgers” suggested that the Supreme’s ruling in Mayo Collaborative Services v. They claim denying patent protection could slow advances in personalized medicine. On the other hand, supporters of human gene patents, such a biotechnology firms, argue that rejecting gene patents will inhibit investment and innovation. Watson was a co-discoverer of the double helix structure of DNA. Watson, Ph.D., KBE, ForMemRS, in an amicus brief (friend of the court) that argued against gene patenting. “Life’s instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts,” declared James D. Even adjusting for inflation, noted this blogger, that is a 48% increase. The posting noted that, currently, the price for the Myriad BRCA tests is $3,340. “As reported in The Middletown Press, before the patents were awarded to Myriad, Yale offered BRCA1 and BRCA2 testing for $1,600,” the blogger observed. The result has been higher pricing for clinical laboratory tests that incorporate human genes covered by these patents. “Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person ,” the ACLU argued in its petition to the high court, according to the New York Times story.Īnother concern critics raise is that the gene patents give Myriad an unfair monopoly over BRCA testing, a writer observed in a posting at The Pathology Blawg. Opponents argue that patents on human genes stymie research, block clinical testing, and raise testing pricing. Opposing Sides Imply their Course Better Serves Patients The American Civil Liberties Union (ACLU) is representing the plaintiffs. Plaintiffs include the College of American Pathologists. In the spring of 2009, the Association for Molecular Pathology (AMP) and other plaintiffs sued Myriad Genetics, Inc. provider of tests for hereditary cancers involving the BRCA genes. Myriad obtained the patents on the two genes in 1996. (Cartoon by Chris Madden and published by .) Many pathologists and clinical laboratory administrators are following the progress of this case. The central legal question is whether isolated DNA is a product of nature and ineligible for patent protection. Last month, the Supreme Court agreed to hear the Association of Molecular Pathology vs. A central dispute for the federal appeals court was whether isolated genes are sufficiently different from ones in the body to allow them to be patented. In that decision, the lower court declared that Myriad’s “composition of matter” claims covering isolated DNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the United States Patent Act.ĭetermining When Human Genes Can Be PatentedĪs reported in the New York Times, the legal question for the justices is whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection. et al., a story published by The New York Times. ![]() The Supreme Court will review an earlier decision by a federal appeals court in The Association for Molecular Pathology, et al. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform. ![]() How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents? The case turns on whether human genes can be patented. ![]() The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand ![]()
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