Lawsuit fighting right to patent human genes stirs debate

May 18, 2009

The right to patent human genes has long been a subject of intense debate. Critics contend that this practice infringes on human privacy and stifles scientific progress. The ACLU has finally got a case it can sink its legal teeth into: a woman who tested positive for gene predisposing her to ovarian cancer was denied access to a second opinion because of current patent law.

Is it unconstitutional to patent human genes? According to the ACLU it is, at least BRCA1/2 genes that are predictive indicators for developing breast and ovarian cancers. At the heart of the debate is a woman (reported in the New York Times) who tested positive for a BRCA mutation that predisposes her to ovarian cancer. Before having a prophylactic  oophorectomy, she wanted a second opinion from another testing site, but her request was denied by Myriad Genetics, the biotech company that holds the patents on BRCA genes. In short, test with them, or don't test at all.

Enter the ACLU. This is the case they've been waiting for in this long-overdue debate over privacy and medical access. This case also is one of many that will ultimately ensue as our knowledge of human genetics continues to expand into heretofore uncharted waters.

Myriad Genetics charges about $3,000 for its BRACAnalysis test that predicts a woman's predisposition to developing breast or ovarian cancer. Myriad has come under fire in the past for what many in the community felt were misleading direct-to-consumer advertising methods. Advocates and doctors site a cautionary note: genetic testing is still in relative infancy and they worry that unless patient information is handled by well-trained, sensitive professionals, it could cause more harm than good.

This current controversy over intellectual property rights started nearly 20 years ago when in 1994 Myriad filed its first BRCA patents. The ACLU argues that the patents give Myriad the sole rights to perform diagnostic tests on BRCA genes and prevent researchers from studying the genes without first getting permission from Myriad. Along with the previously mentioned woman, the lawsuit also included two University of Pennsylvania researchers who received cease-and-desist orders from Myriad concerning their lab work with BRCA genes.

Lawyers for Myriad argue that genes have successfully been patented in many countries, such as Canada, Japan, Australia, and throughout Europe. Patent law requires that the invention being patented not necessarily be original in the sense that the thing owes its existence solely to the inventor...the inventor need only show that the thing did not exist in the exact way the inventor described (that is, that it is placed in a different context), that the inventor exercised a degree of creativity, and that the invention as described is useful.

While it might seem to some that Myriad lawyers are using patent law to split hairs over a very sensitive issue, the human gene might not be an invention in ordinary parlance, it does seem to fall under the accepted principles of patent law as currently written.

But more than legal wrangling, what is truly at stake in this and other cases dealing with intellectual property rights are the overarching societal rights of scientific advances and the sanctity of medical privacy. And although a lot of genes have received patents, the ACLU chose BRCA1/2 genes because of the extremely sensitive and dramatic consequences they have in women's health.

Myriad's case report and the response by the ACLU are both posted on their respective websites.

This is not a zero-sum game. How we view intellectual freedom, property rights, and medical privacy, among other issues, is at stake. This blog will follow the story as it develops...