The Supreme Court Got It Right Today, Unanimously Ruling That Human Genes Cannot Be Patented.

by John Roberts on June 13, 2013

The Supreme Court unanimously ruled today, June 13, 2013, that human genes cannot be patented.

  • Isolating genes not enough; but synthetic genes probably still patentable.

“Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material,” said Justice Clarence Thomas for the 9-0 court decision. “Myriad did not create anything,” said Thomas. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The justices took the position offered by the Obama administration — DNA itself is not patentable but so-called “cDNA” can be. Complementary DNA is artificially synthesized from the genetic template, and engineered to produce gene clones. Use of this protein-isolating procedure, known as “tagging,” is especially important in mapping and cataloguing the vast human genome. Thomas said, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.”

According to CNN (http://www.cnn.com/2013/06/13/politics/scotus-genes/index.html?hpt=hp_t2), the American Civil Liberties Union said the decision represents a major shift in patent law and overturns established policy.

“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, senior staff attorney with the ACLU Women’s Rights Project. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.” Dr. Harry Ostrer, director of genetic and genomic testing at Montefiore Medical Center in New York, said the decision will not undermine the genetically engineered drug industry and expects the costs of tests to fall. “I’m thrilled. We can offer BRCA 1 and 2 testing to low-income women without concerns about how it will be paid for,” he said.

The case is Association for Molecular Pathology v. Myriad Genetics (12-398).

John Roberts

812-418-3663

www.indianapatentlawyer.com

12-398_8njq.pdf

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