NEW YORK — A federal court has ruled that human genes can be patented, reversing a lower court's ruling that involved a test for breast cancer but which could have hurt research and profits for drug makers and agriculture companies.
Judge Alan Lourie's ruling says the genes can be patented because the isolated DNA has a “markedly different chemical structure” from DNA within the body.
The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.
“The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable,” Lourie wrote for a 2-to-1 majority. “It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect.”
The lawsuit concerned two patents held by Myriad Genetics Inc. of Salt Lake City. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
The American Civil Liberties Union argued that genes couldn't be patented and, in March 2010, a New York district court agreed.
“Today's ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project.
ACLU Attorney Sandra Park said the ACLU will consult with its clients to decide whether to appeal or seek another remedy. The plaintiffs include geneticists who said they were not able to continue their work because of Myriad's patents, along with breast cancer and women's health groups, patients, and groups of researchers, pathologists, and laboratory professionals.
Myriad was able to continue selling the BRACAnalysis test despite the previous ruling from Judge Robert Sweet of the U.S. District Court for the Southern District of New York.
Lourie ruled against Myriad on five claims, saying the company may not patent comparisons and analysis of DNA sequences. The company said it still holds 237 claims that are not affected by the decision.