Can big multinational corporations buy and own rights to what I do with my nose, my liver, my heart, my little right toe? Possibly, because they can buy or license patent rights for many of my genes. That is the way it has been for a number of years now. I have always thought that having someone else hold rights to my natural body parts is completely absurd. I should be able to do anything with my genes that I want. But what do I know about such matters? I am not a lawyer.
Finally, patentability of genes is being challenged in the courts. According to a Feb 2 news highlight in Gen “Today, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) will deliver oral arguments asking the court to rule that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The groups charge that the patents stifle diagnostic testing and research that could lead to cures and that they limit women’s options regarding their medical care. — The lawsuit Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al. was originally filed on May 12, 2009, in the U.S. District Court for the Southern District of New York on behalf of breast cancer and women’s health groups, individual women, and scientific associations representing approximately 150,000 researchers, pathologists, and laboratory professionals. — The lawsuit was filed against the PTO as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes BRCA1 and BRCA2. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are “products of nature” and therefore can’t be patented.”
“The plaintiffs include Breast Cancer Action, The American College of Medical Genetics, the Association for Molecular Pathology, the College of American Pathologists, the American Society for Clinical Pathology, individual researchers, patient advocacy groups, genetic counselors, and individual women(ref).”
So, how did genes get to be patentable in the first case, and what are the main issues involved? For genes to be patentable, they have to be viewed as inventions. And they have been so-viewed because attorneys have successfully argued that it has taken inventions to identify them. Basically, “the US Patent and Trademark Office (USPTO) and the European Patent Office (EPO) have treated isolated and purified nucleotide sequences as if they were the same as man-made chemicals(ref).” The decision to allow genes to be patented has engendered much controversy and endless opinion papers. See this list for some of them.
The economic argument for gene patentability is of course that it provides economic incentive for discovery and invention. The biotech and pharma companies and universities that hold the gene patents will want to hold onto them. Increasingly, however, voices are questioning the wisdom of gene patentability and whether it gets in the way of scientific progress, public health and patient care.
A recent position paper starts out: “Concerns about human gene patents go beyond moral disquiet about creating a commodity from a part of the human body and also beyond legal questions about whether genes are unpatentable products of nature. New concerns are being raised about harm to public health and to research. In response to these concerns, various policy options, such as litigation, legislation, patent pools and compulsory licensing, are being explored to ensure that gene patents do not impede the practice of medicine and scientific progress. Although gene patents have been granted worldwide for several years, the wisdom of this action is now being questioned. Lawsuits, proposed legislation, international protests and even patent-office proposals have recently been initiated to eliminate, undermine or otherwise challenge the scope of patents on human genes. The challenges come from various interested parties — people from whom patented genes have been isolated, researchers who wish to undertake genetic epidemiological studies or to develop gene therapies, clinicians and health-care providers who cannot afford expensive licensing fees for genetic tests and policymakers who want to ensure that the patent system actually meets its goal by encouraging invention. Evidence is mounting that gene patents are inhibiting important biomedical research, interfering with patient care and provoking criticisms from international trading partners.”
My guess is that the case may take 5-10 years to work its way through the courts and may well end up in front of the Supreme Court. And who knows how they will choose to look at the situation. In terms of property rights or interstate commerce? Meanwhile we will have to live with gene patentability. I realize that in working out on the treadmill or taking supplements that either activate or inhibit certain of my genes, I am probably violating somebody or the other’s patent. So are you. Bah!