The Supreme Court has held that isolated segments of DNA are not patentable. The decision, Association for Molecular Pathology v. Myriad Genetics, Inc., is in line with the Court’s previous holdings that a naturally occurring substance cannot be patented, even if it is useful or innovative. Myriad attempted to patent a segment of DNA, as well as a synthetic substance made from the isolated DNA known as “composite DNA,” or cDNA. These were used in diagnostic testing to identify patients with significantly increased breast and ovarian cancer risk. Myriad attempted to enforce their patents on the isolated DNA and manufactured cDNA when other medical centers began offering diagnostic testing using the isolated DNA.
The Court declared that Myriad’s patent for the isolated DNA strand was invalid since the patent was essentially a description of how Myriad discovered and isolated the strand of DNA. While complex, this fell into the “law of nature exception,” as a substance must have “markedly different characteristics from any found in nature” to be patentable. Laws of nature and natural phenomena are not patentable, regardless of the cost of their discovery. Even though Myriad was the first to isolate the strand of DNA, they did create or alter a naturally occurring substance while doing so. However, the Court upheld the validity of the cDNA patent, since Myriad created a substance that does not occur naturally in nature.
By affirming the validity of the cDNA patent, the decision allows Myriad to continue to benefit from its initial discovery. However, the lack of patent protection for the isolated DNA itself means that Myriad’s competitors can develop their own tests to compete. This may fulfill the Court’s stated goal in patent cases of incentivizing companies like Myriad to innovate while not impeding research and scientific progress by other companies. The full text of the opinion can be found here: https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf