Circuit Rules Genes Can be Patented

By Robyn Hagan Cain on August 01, 2011 | Last updated on March 21, 2019

The Court of Appeals for the Federal District ruled on Friday that human genes can be patented.

The decision in the genome patent case, which could affect the long-term cost of genetic testing, came as a relief to the biotechnology industry and a shock to the American Civil Liberties Union and the Public Patent Foundation, which challenged the patents in the case.

The case, Association for Molecular Pathology v. Myriad Genetics, pitted the biotechnology industry against public interest groups on the issue of whether seven existing patents on two genes associated with increased breast and ovarian cancer risk -- BRCA1 and BRCA2 -- are valid, or whether the genes can't be patented because they are products of nature.

Appellant Myriad Genetics, the company that holds the patents, argued that isolating the BRCA1and 2 genes from a person results in a new material that has utility beyond the DNA that naturally occurs in the human body. According to Myriad, extracting the genome makes it patentable.

The ACLU and the PPF, claimed that Myriad's methods were well-known in science, and that isolating DNA from the body does not create something new. The Obama Administration, which sided with the plaintiffs in the litigation, filed an amicus brief with the Federal Circuit to argue that "the mere act of isolating something" that already exists in nature is insufficient support for patent protection.

Myriad sells tests that assess a woman's risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes; the cost for a full breast cancer risk test is more than $3,000. Some critics have claimed that BRCA1 and BRAC2 patents limit genetic testing and patient care due to monopolies and high costs, but Myriad's attorney argued in court that companies could still do whole-genome sequencing without violating the patent.

The court found that "the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different -- have a distinctive chemical identity and nature -- from molecules that exist in nature."

The case may not be over, reports The New York Times. The Supreme Court, which has already agreed to hear another case related to the patentability of diagnostics based on chemical changes in the human body, could review the Myriad decision as well.

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