Today, the Supreme Court ruled in the case of Association for Molecular Pathology v. Myriad Genetics Inc. The court voted unanimously to overturn Myriad’s patents on the naturally occurring DNA fragments containing the BRCA1 and BRCA2 genes, while in the same ruling upheld the patents on forms of the genes never found in nature.
The ASBMB applauds the Supreme Court for overturning the patents on the isolated BRCA1 and BRCA2 genes. On behalf of the court, Justice Clarence Thomas wrote, “Many of Myriad’s patent descriptions simply detail the ‘iterative process’ of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought… But extensive effort alone is insufficient to satisfy the demands of” patent eligibility. The sequences and structures of genes, whether in the context of the genome or in isolation, and sequences derived from genomic DNA, like messenger RNA and protein, are naturally occurring and should not be eligible for patenting.
However, the ASBMB is disappointed that the patents on complementary DNA, or cDNA, were upheld. Thomas wrote, “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible.” Obviousness is a test that the U.S. Patent and Trademark Office uses to determine if something is patent worthy, and obvious inventions are not patent eligible. ASBMB’s position is that the BRCA1 and BRCA2 cDNAs are obvious derivations of the mRNAs, do not represent novel inventions and should not be eligible for patent protection.
The patents on the cDNA versions of BRCA1 and BRCA2 make important scientific tools unavailable to researchers and may slow progress in developing new tools for diagnosing heritable breast cancer. However, striking down Myriad’s patents on genomic DNA is an important victory toward improving breast-cancer diagnostics. Stay tuned to the Policy Blotter as we closely monitor the developments in this continuing case.