Judge Overturns Corporate Patent on Human DNA

Created: March 30, 2010 13:26 | Last updated: July 31, 2020 00:00

A federal judge on Monday struck down the patent, held jointly by the University of Utah and Myriad Genetics, over BCRA1 and BCRA2, two human genes in which mutations can cause breast and ovarian cancer. The case was filed in 2009 by the ACLU, which argued not just that the BCRA1 and BCRA2 gene patents were invalid, but that a 1979 Supreme Court decision upholding patents on engineered organisms did not apply to existing parts of the human genome and that such patents were unconstitutional. The judge agreed that the patents were invalid, but did not rule on the larger institutional question.

Myriad and the University of Utah argued that the technique used to find the specific genes made the genes they found patentable, but the judge didn’t buy it.

Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

Lawyer’s tricks, apparently, work on patent application examiners but not federal judges.

The ACLU notes that more than 2,000 human genes are currently under patent based on the legal idea, now overruled, that just discovering the existence of a gene means one can claim ownership over it.

Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other illnesses.

The Myriad and University of Utah patent over the BCRA1 and BCRA2 genes allowed Myriad to charge $3,000 for a screening exam to detect cancerous mutations to the genes, and forbade other organizations from developing alternative tests. Researchers interested in any type of research on the BCRA1 and BCRA2 genes — which are associated with a 500 percent higher risk of developing breast or ovarian cancer — had to get (and often pay for) the company’s permission to perform their research.

Companies that patent the building blocks of human life (and non-profit educational institutions that clearly make money from these arrangements) claim that the legal ruling, which may still be appealed, will stifle research: one researcher indicated that it will make it difficult for companies pursuing medicines targeted at individuals’ DNA from patenting individuals’ DNA profiles, as though that’s a bad idea. Of course, the Myriad test for the BCRA1 and BCRA2 gene will still be patented: They just can’t prevent competitors from patenting a different test that could find the same mutations any longer.