Gene Patenting Decision: One Perspective

Gene Patenting Decision: One Perspective 150 150 IEEE Journal of Translational Engineering in Health and Medicine (JTEHM)

Today’s blog is by Associate Editor and health care attorney Jonathan Ishee. He puts SCOTUS’s decision on gene patenting into perspective for our community.
On June 13, 2013 the Supreme Court handed down its unanimous decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court held “that genes and the information they encode are not patent eligible… simply because they have been isolated from the surrounding genetic material.”
This case surrounds Myriad Genetics’ discovery of the precise location and sequence of what are known as the BRCA1 and BRCA2 genes. That information in turn enabled Myriad to develop medical tests useful for detecting mutations in patients’ genes, and therefore determine likelihood for certain cancers. Myriad obtained patents directed to “an isolated DNA coding” for those genes. Other Myriad patent claims were directed to “complementary DNA,” called “cDNA,” which omits portions of the genetic sequence within the naturally occurring DNA.  In its decision, the court held “[i]t is undisputed that Myriad did not create or alter the genetic information” encoded in the naturally occurring genes. Determining the location and order of the nucleotides merely discovered what existed in nature. “[S]eparating that gene from its surrounding genetic material is not an act of invention,” to hold otherwise “would be at odds with the very point of patents, which exist to promote creation.”
The decision is being viewed by many as something of a victory for both sides. Myriad lost its patent claims related to isolated DNA, but maintained its patent coverage on the non-naturally occurring cDNA and its claims directed to methods of using genetic sequences to aid in the diagnosis and treatment of diseases. It remains to be seen what impact this may have on a company’s interest in expending the kind of investment of time and money to make the discovery in the first place.