What does Biotechnology mean?
Fast-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. 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. 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.Photo: Breakthrough Breast CancerImage of the BRCA gene (above). 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. 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.
The plaintiffs prevailed at first instance, when a New York judge held that DNA is un-patentable subject matter. 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).
By 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 interest the case provoked is unsurprising considering both the issues before the Court and trends within the pharmaceutical industry. 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 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 question before the Court was whether isolated human genes are patentable
The Supreme Court's nine justices took eight weeks to answer after hearing from both sides in the dispute. What they said was this: a naturally occurring DNA segment is a product of nature and, as such, cannot be patented. 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. "The lab technician unquestionably creates something new when cDNA is made, " they said. The impact on would-be gene patent holders was clear: within hours, the USPTO issued a memo to its examiners instructing them to reject product claims drawn solely to naturally occurring nucleic acids, or fragments of them, whether isolated or not.
The Court's opinion, drafted by Justice Thomas, ran to just 18 pages. Its brevity was interpreted by some as a sign of the open-and-shut nature of the case; by others as evidence of the Court's failure to get to grips with the difficult issues raised by the dispute. There were complaints that the case-specific ruling offered little guidance as to how the law should be applied in other biotech wrangles.
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