Should human genes be patentable?

Are human genes patentable? If so why? If they can be patented, what effect is this likely to have on the availability of, to those who need them, genetic tests for conditions such as breast cancer? If genes cannot be patented, what effect is this likely to have on the biomedicine industry? A recent article in the New York Review of Books sets out the issues - with respect to a forthcoming case in the United States - with admirable clarity.

But first to things closer to home.

Australia’s Federal Court recently dismissed a challenge – from Cancer Voices Australia - to patents held by Myriad Genetics Inc over isolated DNA or RNA sequences. This was the first time an Australian court had considered the matter. The court held in favour of Myriad Genetic’s claim to hold a patent relating to the BRCA1 gene, the presence of which gene predisposes a woman to breast cancer and ovarian cancer. The patent grants Myriad Genetics the right to exclude others from using this gene in medical research or health care.

In the next few months, the US Supreme Court will hear a similar case, this time involving Myriad Genetics Inc’s patents over two cancer-predisposing genes: BRCA1 and BRCA2.[3] In 2009, a lawsuit was filed in the Federal District Court of New York State to overturn the patents Myriad had on BRCA1 and BRCA2, patents which entitled Myriad to exclude others from using these genes in breast cancer research, diagnostics and treatment for the life of the patent (now twenty years).

The plaintiffs were not the usual parties in patent suits: competitors. They included the American Civil Liberties Union and the Public Patent Foundation as well as medical geneticists, pathologists, researchers, genetic counsellors, advocates for women’s health and several woman with breast cancer: all were opposed to Myriad’s patents allowing it to exercise monopolistic control over a biological substance as essential to medical research and health care as the DNA implicated in cancer.

Interestingly, in American law, opponents of a public policy cannot ordinarily pursue their objections n the Federal Courts unless the policy causes an injury that gives them ‘standing’ to sue. The plaintiffs argued that they had suffered harms from Myriad’s enforcement of its BRCA patents: because of the ‘gravity’ of the issue for health and for science the judge granted them standing.

The matters in the forthcoming American case were first raised in 1990 when a geneticist at Berkeley announced that her laboratory had discovered that BRCA1 was located somewhere on chromosome number 17. In 1994 (after a race amongst several geneticists) its exact location was found, and in 1995 the exact location of BRCA2 was found (on chromosome 13). Myriad promptly applied for patents on both the isolated RNA that makes up the BRCA1 and BRCA2 genes and also on a set of diagnostic tests to detect their presence.

Read more at Mercator.net.