By Sandra S. Park, Staff Attorney, ACLU Women's Rights Project
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.
Judge Sweet also concluded that all of the so-called "method" claims that were challenged are unpatentable because they cover abstract ideas - the simple mental process of comparing the sequence of one person's BRCA1 gene with the normal BRCA1 genetic sequence. Myriad's claims are not limited to any particular method of comparing sequences and are not tied to the use of a particular machine. They are so broad as to prohibit anyone from taking two genetic sequences and comparing them, side-by-side, letter-by-letter.
Because Judge Sweet found that all of the challenged patent claims are invalid, he chose to dismiss without prejudice the claims brought against the PTO because it was unnecessary to decide the constitutional questions. He noted that:
[A] decision by the Federal Circuit or the Supreme Court affirming the holding set forth above would apply to both the issued patents as well as patent holders and applicants, as well as the USPTO....the USPTO would conform its examination policies to avoid issuing patents directed to isolated DNA or the comparison or analysis of DNA sequences.
The ruling is a significant step forward for women's health and scientific freedom. If this decision is upheld, it will mean that clinicians and researchers across the country - thousands of whom have the ability to conduct BRCA testing - will no longer be prohibited from providing genetic test results to women.
Myriad has announced that it will appeal the decision. But Judge Sweet's ruling is only the latest pronouncement rejecting gene patents.
Francis Collins, the Director of the National Institutes of Health, wrote in his recent book, called "The Language of Life: DNA and the Revolution in Personalized Medicine":
The information contained in our shared instruction book is so fundamental, and requires so much further research to understand its utility, that patenting it at the earliest stage is like putting up a whole lot of unnecessary toll booths on the road to discovery.
And in February, an advisory committee to the Secretary of Health and Human Services issued a report concluding that gene patents are not needed to incentivize the development of genetic testing. It recommended that the law be amended so that gene patents do not stand in the way of research and women's access to their own genetic information.