It is perhaps unexpected that the United States — the oft-lampooned home of patents on peanut-butter-and-jelly sandwiches and ways to swing a swing — is emerging as one of the most hostile towards patents on naturally occurring genes.
Last week, Australia had the opportunity to join the United States in taking a dim view on such licensing of nature. But a federal court there instead upheld a patent claim on the cancer-associated gene BRCA1. In doing so, the country remains with Canada, Japan and several countries in the European Union, all of which, unlike the United States, recognize such patents.
The patent on BRCA1 has become a touchstone in the debate over ‘gene patents’, a broad term that can cover a wide swath of patent claims on DNA sequences. Certain mutations in BRCA1increase the risk of, in particular, breast and ovarian cancers. And Myriad Genetics, a genetic-testing company in Salt Lake City, Utah, has aggressively defended its patents, which cover the abnormal BRCA1 sequence and tests to identify it.
In the United States, debate on gene patenting has been tied to clear public-health concerns. Myriad’s monopoly bred worry that women would have only a single option for BRCA1 testing, with no possibility of receiving a second, confirmatory test elsewhere. So when advocates challenged US patents on BRCA1 and the closely related gene, BRCA2, the case provoked a passionate response from the public. The patents were defeated in a landmark decision last year that changed decades of legal practice in the field (see Nature 498, 281–282; 2013).
Australia is in a different situation. The BRCA patents have not been enforced there, either by Myriad or by the company that has licensed them in Australia: Genetic Technologies of Melbourne. Despite the fervent involvement in the case of patient advocates, including cancer survivors, the spectre of gene patents in Australia remains more theoretical.
Still, the case, and the attention it has received, shines new light on how such patents will affect the future of medical diagnostics, particularly as genetic tests expand to cover large numbers of genes, and even the full genome.