In a ruling that fundamentally changes the landscape of biotechnology patent law in the United States, the Supreme Court unanimously held today that all genes are unpatentable subject matter.
In Association for Molecular Pathology v. Myriad Genetics, the court held that naturally occurring DNA is a product of nature and, even if isolated, is not patent eligible. The court noted, however, that synthetically created complementary DNA (cDNA) is patentable.
Genes are the foundation of biological organisms and provide the basis of hereditary traits. Each gene is encoded by DNA, and it is this DNA that creates proteins that modulate biological functions. The Myriad patents covered isolated BRCA1 and BRCA2 genes, and Myriad used the information from these genes to develop diagnostic tests to assess cancer risk. But the Supreme Court found that Myriad "did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA." It simply isolated that which is naturally occurring, and even though the information is useful, an isolated gene is not patentable per se.
According to the Supreme Court, however, cDNA is patentable subject matter. Since cDNA is created by scientists, thus not naturally occurring, it is an "invention" under 35 U.S.C. §101 of the patent laws.
The impact of the Supreme Court's decision on the biotechnology industry is considerable and far-reaching.