Gene Patents - Rewarding Innovation or Inhibiting Research?


In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit against Myriad Genetics and the University of Utah Research Foundation. The lawsuit challenged patents granted to Myriad on two genes related to breast and ovarian cancer. U.S. District Court Judge Robert Sweet in New York invalidated the seven patents in his March 29, 2010 ruling.
Myriad and its founder, Mark Skolnick, were granted patents on the BRCA1 and BRCA2 genes. Mutations of these genes have been linked to breast and ovarian cancer. With the patents, Myriad had exclusive rights to perform diagnostic testing on the genes, the power to prohibit outside research, and the discretion to decide the cost for the preventative tests.
ACLU, joined by individual patients and medical organizations, charged in the lawsuit that the patents restrict scientific research and patients’ access to medical care. The union of plaintiffs also asserts that genes are products of nature and, therefore, are not subject to patents. Judge Sweet agreed, ruling the patents were “improperly granted.”
As reported by John Schwartz of the New York Times, Myriad and companies like it that hold patents on approximately 20% of human genes argue that the patent system rewards the considerable investment required for research by providing a temporary monopoly. In response to being a product of nature, Myriad contests that isolating the DNA makes it patentable.
The ACLU believes that a patent should not be granted until a company or individual develops a test or drug based on a gene, not when the gene has been isolated.
The decision is likely to be appealed. Watch for updates in the future.
Comment: The dictionary definition of a patent is “a grant made by a government that confers upon the creator of an invention the sole right to make, use, and sell that invention for a set period of time.” In other words, patents are intended to protect ideas or knowledge, not things created by nature. Last time I checked, genes were not inventions.

“Cancer Patients Challenge the Patenting of a Gene,” by John Schwartz, The NY Times, published 05/12/09
“Judge Invalidates Human Gene Patent,” by John Schwartz and Andrew Pollack, The New York Times, published 03/29/10
“Is It Fair to Patent Genes? ACLU Takes on Biotech Over Issue,” by Elizabeth Weise, USA Today, published 04/13/10
“ACLU Sues Over Patents on Breast Cancer Genes,”
“Patents On Breast Cancer Genes Ruled Invalid In ACLU/PubPat Case,”, published 03/29/10


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