human genes

Last week, federal district court Judge Robert Sweet made history by issuing the first ruling ever that human genes can't be patented. The ruling was in a case brought by the ACLU and the Public Patent Foundation (PUBPAT) challenging patents granted by the U.S. Patent and Trademark Office (PTO) to Myriad Genetics on two human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. The lawsuit was filed on behalf of breast cancer and women's health groups, individual women, geneticists, and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. 

The ACLU believes gene patenting raises serious civil liberties concerns because the government is essentially giving patent-holders a monopoly over the patented genes and all of the information contained within them. Patent-holders have the right to prevent anyone else from testing, studying, or even examining the genes. Under patent law, if you or your doctor were to remove your genes from your cells in order to look at them, you potentially could be sued by the patent-holder for committing patent infringement. Thus, when Myriad obtained its patents, it was able to shut down other labs that were providing testing - not because those labs were using a particular kind of test developed and patented by Myriad, but because Myriad controlled the genes themselves. (For a discussion of the legal background and arguments we made in the case, see our earlier post.)

In his decision, Judge Sweet declared that all 15 patent claims that we challenged are invalid, because they cover products of nature and abstract ideas.

The judge ruled that Myriad's argument - that the "isolation" of the BRCA genes from the surrounding DNA and cellular material makes them into something distinct and patentable - is fundamentally flawed and nothing more than semantics: 

Many, however, including scientists in the field of molecular biology and genomics, have considered this practice a "lawyer's trick" that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.

His decision recognized that patents on genes - like patents on chemically-treated fruit, a combination of species of bacteria, and purified tungsten that have been rejected by the courts - are not authorized by the Patent Act. Myriad did not invent the biological information embodied by genes.

The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an "isolated" form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to "isolated DNA" containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.