Last week the ACLU and the Public Patent Foundation filed a lawsuit challenging the U.S. government's practice of granting patents on human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. In the last 20 or so years the U.S. Patent and Trademark Office (PTO) has issued patents on thousands of human genes — the segments of DNA that we all have in our cells — giving private corporations, individuals, and universities the exclusive rights to those genetic sequences and their usage.
The patents on the BRCA genes are particularly broad and offensive. The PTO has granted Myriad Genetics, a private biotechnology company based in Utah, patents on both the BRCA1 and BRCA2 genetic sequences, on any mutations along those genes, on any methods for locating mutations on the genes, without further specification on the type of methods, and on correlations between genetic mutations and susceptibility to breast and ovarian cancer.
The lawsuit charges, as critics of gene patents have argued for years, that gene patents stifle biomedical research and interfere with patients' access to genetic testing. The lawsuit argues that the patents on the BRCA genes are unconstitutional and invalid given the long-standing legal precedent that "products of nature" and "laws of nature" are not patentable. The suit also makes the novel argument that the practice of patenting genes, their correlations with disease, and the thought of comparing two genes violates the First Amendment and interferes with scientific freedom.
To be clear, the patent claims being challenged do in fact include claims on the genes themselves. For example, the text of Patent 5,747,282, Claim 1 reads:
What is claimed is:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
Translation: Claim 1 covers the BRCA1 genetic sequence, specifically the wild-type, or what is considered typical, sequence. Because the PTO grants patents on the genes themselves, it essentially gives patent holders a monopoly over the patented genes and all of the information contained within them. Anyone who uses a patented gene without permission of the patent holder is committing patent infringement and can be sued by the patent holder. Thus patent holders have the right to prevent other researchers from testing, studying or even looking at the genes. If the PTO simply granted patents on particular methods of examining and testing genes, then other scientists and laboratories could develop alternative methods, and research and testing could advance at a much faster pace. This lawsuit is not challenging any patent claims over specific genetic tests.
This suit is the first to challenge the patentability of human genes in the United States. The PTO has justified these patents by holding that "DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified." Yet, "isolated and purified" simply means that the gene has been excised from the natural chromosome; it otherwise has not been engineered or transformed.
Patent law has long held that products of nature and laws of nature are not patentable subject matter. Proponents of gene patents often cite Diamond v. Chakrabarty, a divided five to four U.S. Supreme Court decision issued in 1980. In that case, the court upheld patenting of a genetically modified bacterium that was genetically engineered to ingest oil for use in oil spill cleanups. However, Chakrabarty actually reaffirmed the principle advanced in this case: "The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter." While the identification of human genes and their associations with disease are important contributions to scientific progress, genes and their correlations nonetheless remain products and laws of nature.
More recently, the U.S. Supreme Court has signaled its disapproval of patents on medical correlations. In the 2006 LabCorp v. Metabolite, some of the current justices said that, had the case been heard by the court rather than dismissed as improvidently granted, they would have ruled that such correlation claims are invalid for being unpatentable.
Gene patents also raise constitutional questions. The Patent Clause in Article 1, Section 8 of the U.S. Constitution gives Congress the power to award patents "to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Human genes are not inventions, and awarding patents on them does not promote the progress of science. Instead, gene patents slow scientific advancement, because there is no way to invent around a gene — the gene is the basis for all subsequent research. Furthermore, gene patents implicate the First Amendment. By granting monopolies on the very thought that there is a relationship between specific genetic mutations and diseases, the government has restricted scientific freedom of inquiry.
The patents on the BRCA genes have serious implications because mutations along these genes are responsible for most cases of hereditary breast and ovarian cancers. Genetic tests can detect these mutations and tell women if they are at increased risk of cancer, which in turn informs their decisions about screening, prevention and treatment options. In addition, this case could have far-reaching effects beyond the BRCA genes because it challenges the fundamental notion of gene patenting. Twenty percent of human genes have been patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, and asthma.
To read the complaint, plaintiff statements, and much more about the case, visit www.aclu.org/brca.
— By Selene Kaye, Advocacy Coordinator, ACLU Women's Rights Project and Sandra Park, Staff Attorney, ACLU Women's Rights Project