The Supreme Court has just ruled in the case of Association of Molecular Pathology v USPTO, unanimously agreeing that natural DNA is not patentable. Pocket Full of Liberty covered this important issue recently.
The case involved Myriad Genetic’s monopoly on diagnostic testing for BRCA1 and BRCA2 mutations that are associated with breast and ovarian cancers. The ruling against Myriad means that the company does not have the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes.
This case has been closely watched by scientists in academia and industry. It should be noted that the judges were careful to use the wording “natural DNA” versus “synthetic DNA”, the latter of which they agreed still remains patentable.
Justice Thomas delivered the opinion of the court, with all judges joining, and Justice Scalia concurring in part in the opinion but concurring with the judgment:
cDNA is not a “product of nature”, so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally-ocurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.
Some scientists – including myself – may disagree with this last part regarding cDNA, but, overall, the decision is important for the continuation of relatively unfettered biomedical research and, more importantly, increased availability of diagnostic tests to at-risk individuals. The ruling does not prevent Myriad from patenting new tests to diagnose BRCA1/2 mutations or other diseases – it just prohibits sole ownership of DNA sequence.
How is the science world taking the news? The verdict was announced at a scientific meeting that I am attending in Chicago. The room of 200+ researchers broke into cheers and applause.