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Supreme Court Limits Patentability of Human Gene Sequences
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Supreme Court Limits Patentability of Human Gene Sequences

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  • 1. PattonBoggs.com Intellectual Property Client Alert 1JUNE 13, 2013This Alert provides only generalinformation and should not berelied upon as legal advice. ThisAlert may be considered attorneyadvertising under court and barrules in certain jurisdictions.For more information, contact yourPatton Boggs LLP attorney or theauthors listed below.SCOTT CHAMBERS, PH.D.schambers@pattonboggs.comKEVIN BELLkbell@pattonboggs.comRICHARD OPARILroparil@pattonboggs.comMATTHEW LASKOSKImlaskoski@pattonboggs.comABU DHABIANCHORAGEDALLASDENVERDOHADUBAINEW JERSEYNEW YORKRIYADHWASHINGTON DCINTELLECTUAL PROPERTY CLIENT ALERTSUPREME COURT LIMITS PATENTABILITY OFHUMAN GENE SEQUENCESThe Supreme Court today issued a decision in Association for Molecular Pathology v.Myriad Genetics, which reduced the ability to patent human gene sequences.In a departure from established Federal Circuit law, the Supreme Court determinedthat isolated gene sequences found in nature are natural phenomena and not patenteligible. Myriad’s patents covered gene sequences removed from a cell, referenced byMyriad as isolated DNA. The gene sequences are identical to those found in the bodyexcept that they are isolated from the remainder of the strand of DNA. The SupremeCourt found that these isolated gene sequences are a “product of nature and notpatent eligible merely because it has been isolated.” The Court found that “Myriaddid not create or alter either the genetic information encoded in the [isolated] genes orthe genetic structure of the DNA.” In particular, Justice Thomas, writing for theCourt stated “[t]he claims are not expressed in terms of chemical composition, nor dothey rely on the chemical changes resulting from the isolation of a particular DNAsection. Instead, they focus on the genetic information encoded in the [isolated]genes.”The Supreme Court did, however, specifically hold that complementary DNA(“cDNA”) was patentable because it is not found in nature and something new iscreated when portions of the DNA are removed to make the end product.The Court was explicit in noting that this decision did not cover “method claims,patents on new applications of knowledge about the [isolated] genes, or thepatentability of DNA in which the order of the naturally occurring nucleotides hasbeen altered.”Patent owners with issued patents related to gene sequences and patent applicationswith currently pending or unfiled applications should carefully review their portfoliosto determine how this decision will affect the value and enforceability of theirapplications, and determine if there are strategies to create value around this decision.A copy of the decision may be found here.