![]() "The lab technician unquestionably creates something new when cDNA is made," they said. In contrast, so-called complementary DNA - an artificial product designed to mirror the coding parts of genes - is eligible for patent protection because it is not naturally occurring. ![]() What they said was this: a naturally occurring DNA segment is a product of nature and, as such, cannot be patented. The Supreme Court's nine justices took eight weeks to answer after hearing from both sides in the dispute. The question before the Court was whether isolated human genes are patentable The Court was asked to rule just as personalized medicine, offered via tests such as Myriad's BRACAnalysis, heralds a breakthrough in the delivery of healthcare but also as healthcare budgets come under greater financial pressure than ever. The dispute raises emotive issues relating to the ownership and control of genetic material just as pharmaceutical companies are desperate to obtain patent rights over medical innovations as the flow of blockbuster drugs dries up. The interest the case provoked is unsurprising considering both the issues before the Court and trends within the pharmaceutical industry. A quirk of timing saw the Federal Circuit for the Court of Appeals consider the dispute twice: once before and once after the Supreme Court ruled in another highly-anticipated biotech case - Prometheus v Mayo - that Prometheus's diagnostic method patents were invalid (See US courts grapple with patent-eligible subject matter).īy the time the Myriad case wound its way up to the Supreme Court, it had attracted almost 50 amicus briefs, from associations of IP lawyers and biotech researchers to venture capitalists and concerned citizens. The plaintiffs prevailed at first instance, when a New York judge held that DNA is un-patentable subject matter. In a unanimous decision, the nine presiding justices ruled that naturally isolated DNA is not patentable but that synthetic DNA, such as cDNA, is patentable. In the case involving Association for Molecular Pathology v Myriad Genetics the US Supreme Court addressed the issue of whether isolated human genes are patentable. Photo: Breakthrough Breast Cancer Image of the BRCA gene (above). Although thousands of genes are patented in the US, PUBPAT attorney Dan Ravicher says the groups targeted Myriad because of the company's reluctance to license its patents to competitors. The plaintiffs, who included the Public Patent Foundation (PUBPAT), the American Civil Liberties Union (ACLU) and Breast Cancer Action, challenged claims in seven of Myriad's BRCA patents. The effect of the decision was to make it harder for developers of genetic tests to obtain patent protection.įast-forward to 2009 and the company found itself (along with the Trustees of the University of Utah) sued by a group of human rights campaigners and patients' rights activists. In March 2012, the Supreme Court ruled that Prometheus' patent claims related to ways of optimizing doses of certain drugs used to treat specific conditions were invalid because they relate to a natural phenomenon. Prometheus Laboratories, Inc v Mayo Collaborative Services The EPO ultimately upheld the patent in 2004 but ruled that it should relate to transgenic mice only, rather than all rodents. Eight years later it granted a patent to the Harvard University researchers involved, a move opposed by an array of political parties, religious groups and environmental activists. In 1984, the European Patent Office (EPO) received its first application for a patent of an animal: the genetically modified Harvard Oncomouse. " The decision was a close-run thing, however: four justices dissented, a portent of litigation to come. nature, free to all men and reserved exclusively to none'. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter … Such discoveries are ‘manifestations of. The Court set an important precedent in the area of patentability by ruling: "The laws of nature, physical phenomena, and abstract ideas have been held not patentable. In 1980, the Supreme Court of the United States ruled that a micro-organism that had been genetically modified for use in cleaning oil spills was patentable on the grounds that it did not constitute a "product of nature ". ![]() ![]() Judges and patent office officials on both sides of the Atlantic have decided a series of high-profile gene-related disputes.
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