June 13, 2013

Today the U.S. Supreme Court unanimously held in the Myriad Genetics case that human genes are not patent eligible subject matter, even when isolated from the human body.  In this part of its ruling, the High Court reversed the Court of Appeals for the Federal Circuit (CAFC).  However, the Supreme Court also affirmed the CAFC in part by agreeing that synthetically created composite DNA (cDNA) is patent eligible because it is not naturally occurring.

Myriad’s genetic screening patents are directed to two genes known as BRCA1 and BRCA2 that can indicate whether a woman has an increased risk of developing breast cancer or ovarian cancer.  In determining whether the discovery and use of these two genes constitutes patentable subject matter under Section 101 of the U.S. Patent Code, the Supreme Court has drawn a line between a naturally occurring product of nature (DNA), which it holds is un-patentable, and a composition of matter that is not naturally occurring (cDNA), which is patent eligible under Section 101.  The Court took no position on whether Myriad’s cDNA patent claims satisfied other sections of the Patent Code, such as Section 102 by being novel, or Section 103 by being nonobvious.

An amicus brief was filed by the United States advocating for the position taken today by the High Court.  Over the years the U.S. Patent and Trademark Office has issued patents for thousands of isolated genes, many of which can be used in other types of screening tests.  Many of these patents may be found invalid after today’s ruling.

While the Myriad decision will prevent the broadest aspects of genetic diagnostic testing (the isolated DNA itself) from being patented, other key aspects of these tests should remain patentable.  Today’s holding may well strike a suitable balance by allowing researchers to freely use the human genetic code to further advance medical care, while also providing companies the ability to protect their investments in specific applications of particular genes, such as with patent claims that cover specific diagnostic testing methods or alterations of the genetic code.  However, the decision by the Supreme Court last year in Mayo v. Prometheus (see MedTech Brief of March 20, 2012) introduces additional challenges in covering such diagnostic testing with method claims that may be deemed to preempt a law of nature. 

A copy of the Myriad Slip Opinion, written by Justice Thomas, may be found at: http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf