This month, the U.S. Supreme Court unanimously held that a naturally occurring, isolated segment of human DNA may not be patented because it is a product of nature. The Court also held, however, that complementary DNA (cDNA), which is synthetically created exons-only strands of nucleotides, may be patented because it is not naturally occurring.
The case focused on Myriad Genetics, Inc. (Myriad) and its discovery of the location and nucleotide sequence of two human genes, BRCA1 and BRCA2, that substantially increase the risk of breast and ovarian cancer if they are mutated. Myriad used its discovery to create a medical test for detecting mutations in BRCA1 and BRCA2. Its test is used to determine an individual patient’s breast or ovarian cancer risk.
Myriad obtained a number of patents related to its discovery. It claimed that these patents gave it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes and synthetically create BRCA cDNA, and it filed patent infringement suits against other companies that offered BRCA testing. For example, Dr. Harry Ostrer routinely sent his patients’ samples to GDL for testing until Myriad sent a letter to GDL informing it that its genetic testing infringed Myriad’s patents.
Several years later, Dr. Oster, medical patients, advocacy groups, and other doctors, filed the present lawsuit against Myriad in hopes that the Supreme Court would declare Myriad’s patents invalid.
In striking down the patent on the isolated BRCA1 and BRCA2 genes because it claimed a naturally occurring phenomenon, the Supreme Court noted that the patents exist to promote creation. According to the Supreme Court, Myriad “did not create anything.” Rather, the company “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of intervention.” Such a discovery is outside the bounds of patent protection.
Myriad’s cDNA patent is not subject to the same criticisms because the exons-only molecule is not naturally occurring. In order for cDNA to exist, the non-coding portions of the gene must be removed. As a result, the Supreme Court held that “cDNA is not a ‘product of nature’ and is patent eligible . . .” The Supreme Court limited this holding, clarifying that if a short strand of cDNA is indistinguishable from natural DNA, it cannot be patented either.
The Supreme Court left open the door that altering the order of naturally occurring nucleotides may be patentable.
After the Supreme Court announced its decision, several companies began offering BRCA tests and reduced rates compared to Myriad’s pricing. Analysts predict that the Supreme Court’s decision will open up the genetic testing field and allow for second opinions.