The US Supreme Court issued, on 13 June, their long-awaited decision in the Association of Molecular Pathology v. Myriad Genetics case. The issue at hand was whether or not Myriad’s patent claims to the isolated BRCA1 and BRCA2 genes (genes strongly associated with risk of breast cancer) related to patentable subject-matter – essentially, whether a genetic sequence or gene isolated from the genome is patentable merely by virtue of being isolated.
The Supreme Court held, in a unanimous decision, that “a naturally-occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. The gene sequences are naturally-occurring and are therefore a “product of nature” and unpatentable – this was not altered by the fact that the sequence had been chemically isolated from the rest of the genome.
On the other hand, the Supreme Court stated that claims to complementary DNA (cDNA), encoding the BRCA1 or BRCA2 protein would be patentable. cDNA contains all the protein sequence information encoded in the natural gene, but is not itself naturally-occurring; rather, it is produced using laboratory techniques. The Supreme Court therefore concluded that cDNA would be patent eligible.
The Supreme Court reasoned that mere discovery of the location and sequence of the BRCA1 and BRCA2 genes by Myriad did not mean that, when isolated, those genes were new “compositions of matter”. Myriad may have “found an important and useful gene” by extensive, laborious and even groundbreaking discovery, but “separating [the gene] from its surrounding genetic material is not an act of invention” – Myriad had not “create[d] anything” but were rather claiming a product of nature.
In contrast, cDNA was held not to be a product of nature. The court reasoned that cDNA contains all the protein-coding elements of the natural gene (“exons”) but lacks the non-protein coding “introns” that are also present in the natural gene. The cDNA therefore contains all the information of the naturally-occurring gene “but it is distinct from the DNA from which it was derived”. As a result, cDNA is held not to be a “product of nature” and is therefore able to be patented.
It remains to be seen how the Myriad decision will be applied, although it is clear that the previous practice of claiming “isolated” genes in the United States is gone. The Court note that no opinion is given on patents to methods, for example diagnostics, using naturally-occurring gene sequences. It may be that the patentability of such claims would be unaffected by this decision; however, such claims would still be subject to the recent decision of the Supreme Court in Mayo v Prometheus. Similarly, it remains unclear how broadly the “naturally-occurring” test will be applied; in particular, whether higher-order entities such as proteins and isolated cell populations will be subject to the same requirements, or whether claims to such entities will require more structural language. It will also be interesting to see how other jurisdictions react to the decision. Currently, isolated genes are in principle patent eligible before the European Patent Office.