The US Supreme Court has ruled unanimously that the patents held by Myriad Genetics Inc. for the BRCA1 and BRCA2 gene sequences are invalid, on the basis that they are a product of nature.
Justice Thomas wrote: “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes”.
This decision brings to an end many years of legal wrangling, and is expected to set an important precedent for many other gene patents, thousands of which relate in part to other gene sequences. As anticipated (see previous news), the decision relates to unmodified DNA merely isolated from human cells, but not to any form of laboratory synthesised or modified sequence, including complementary DNA (cDNA, sequences from which non-coding introns have been removed), nor methods for extraction or analysis
One interesting observation about the ruling made by Steven Salzburg is that it does contain some essential inaccuracies relating to basic molecular genetics – for example, defining exons as ‘the nucleotides that code for amino acids’ (as opposed to all the nucleotides left after the removal of introns by splicing, which includes the coding sequences but many others as well).
Whilst the earliest genetic research routinely patented gene sequences, as this landmark legal case has progressed most of those seeking to commercialise genetic research have been careful to patent much wider claims relating to modified. Indeed, whilst the decision effectively removed Myriad’s monopoly on BRCA1/2 testing in the US, and is likely to lead to increased competition and a drop in price for such tests, they still retain a large amount of valid intellectual property relating to BRCA testing.
Interestingly, the greatest impact of the ruling may be not on human gene patents – which since the publication of the complete human genome sequence in 2003 have held less value, this case aside - but on work involving microbial genes and their products, such as medically useful compounds.