Can a gene be patented? An appeals court in Washington, D.C., is reconsidering… (National Human Genome Research…)
Appelate judges in Washington, D.C., heard arguments Friday in a case that has traveled from U.S. district court in New York to the federal appeals court to the Supreme Court and back again.
At issue: Can a company patent a gene?
In 2009, a group of researchers, patient advocates and others led by the American Civil Liberties Union sued the U.S. Patent and Trademark Office and Myriad Genetics Inc., a Salt Lake City-based company that makes a test that screens DNA for mutations in the BRCA1 and BRCA2 genes. Because Myriad holds patents related to the DNA in question, no other company can create a test for mutated BRCA genes, which are known to increase the chances for those who have it of developing breast, ovarian and other cancers.
The plaintiffs say the patent restriction limits women’s options because it discourages other researchers from developing competing tests for the genes. Because BRCA1 and BRCA2 occur in the DNA of all humans, they argue, the genes are a product of nature and not eligible for patent.
“Genes are not 'invented,' so they cannot be said to be owned by anyone,” said Daniel B. Ravicher, executive director the Public Patent Foundation, in a statement released Friday.
Myriad and the patent office, on the other hand, argue that the isolated DNA in the test kits does not exist in nature as such, and therefore should be eligible for patent after all.
The appeals court judges decided in favor of Myriad last year on a 2-1 vote. But in March 2012 the Supreme Court ordered the appeals court to reconsider the case in light of its ruling in Mayo vs. Prometheus. In that case, the Supreme Court ruled unanimously that a particular diagnostic test could not be patented because the patent attempted to cover a product that is found in nature. The issue was explored in a Los Angeles Times report in 2010.
One new twist in the Myriad case: James D. Watson, the controversial 84-year-old researcher known best for his role in discovering the structure of the DNA molecule, has filed an amicus brief supporting the ACLU's argument, Slate magazine reported. In the brief, Watson recalled rejecting the idea of patenting the structure of DNA all the way back in 1953, shortly after making his first presentation on the discovery. From Slate’s report:
"Watson argues, among other things, that 'we would not want one individual or company to monopolize the legal right to the beneficial information of a human gene — information that should be used for the betterment of the human race as a whole.' "
But on Friday, legal experts and early news reports seemed to suggest that the judges were unlikely to change their minds — Watson’s input notwithstanding. During 45 minutes of arguments, the judges reiterated many of the same arguments they made in 2011, the Wall Street Journal reported. Judge Alan Lourie, who wrote the opinion supporting Myriad’s claims, also stated Friday that it appeared that different legal issues were in play in the Mayo vs. Prometheus case.
A decision should land within a few months.