Friday, April 20, 2012

Can Genes be Patented?

After several years of court battles and reversals of previous court decisions, there’s still no final decision on whether or not a human gene variant can be patented (see "Patenting Human Genes - An Update.") A company called Myriad Genetics believes that it holds a valid patent on the two gene variants known to confer a high risk of breast cancer, called BRCA1 and BRCA2. The company makes over 80% of its total revenue (over $350 million a year) from its BRACAnalysisR test for the presence of the gene.

To bring you up to date since my last post on this issue, two lower courts ruled that the patent was invalid. Then in 2011 the U.S. Court of Appeals for the Federal Circuit reversed the decision of the lower courts, ruling that the Myriad Genetics patents on the BRCA1 and BRCA2 genes were valid. But that was not the end of it. Last month the U.S. Supreme court issued a statement that it would “vacate”, or dismiss the Court of Appeals’ decision. In effect, the Supreme Court kicked the case back to the Court of Appeals “for further consideration”. It’s a gentle way of asking the lower court to reconsider their decision, without the Supreme Court itself having to issue a ruling.

In a previous decision in an unrelated case, the Supreme Court made it clear that structures or processes governed by “the laws of nature” cannot be patented. By kicking the Myriad Genetics case back down to the Court of Appeals, the Supreme Court seems to be asking the Court of Appeals to consider carefully whether the sequence of a gene is governed by the laws of nature, and hence not patent-eligible.

As long as the issue remains undecided, Myriad Genetics continues to have exclusive control over the BRCA gene test and will continue to profit from it. Given the way the Supreme Court seems to be leaning on this issue, it may be in Myriad Genetic’s best interest to drag the court battle out as long as possible. We can expect the company to defend its putative patent vigorously once the Court of Appeals takes up the case again.

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