When one thinks of patents, one generally thinks of mechanical contraptions, the products of a creative genius, such as Thomas Edison. Rarely does one think of human genes. Alas, since 1982 the United States Patent and Trademark Office has granted patents on human genes. As of 2005 nearly 20 percent of our circa 23,000 genes had been patented. Sixty-three percent of those patented genes are owned by private companies. "How can one patent my genes?" is a query I often hear when I offer lectures on the subject. Even university scientists have interrupted me to explain that natural products are not patentable. Other incredulous statements and queries quickly ensue. "Genes are not inventions, but discoveries." "How can another person or entity 'own' my genes?" "Can I patent my own genes before someone else does?" Eventually, the conversation turns to issues of impact. "How does this affect scientific and medical research?" "Does gene patenting encourage innovative research?" "Does it influence the 'objectivity' of science, which [it is claimed] is free from commercial interest?" "Does it foster collaboration or thwart it by means of secrecy?" These questions are crucial ones. As for the answers: in many cases, the proverbial jury is still out.
In one sense the patenting of genes is the next step in the continued commodification of biological entities. Throughout the twentieth century, purified hormones, vitamins, steroids, antibiotics, and asexually reproduced new varieties of plants (other than tuber-propagated plants) have all been patented. In other respects, gene patenting is actually something very different. First, since one cannot patent around a gene, as one can for example with a chemical, the patent holder can potentially stymie downstream research on diagnostics and therapeutics. Second, recent studies by bioethicists have demonstrated that those working in laboratories interested in patenting genes tend to be much more secretive about their research until after the patent is granted. In addition, a number of laboratories have ceased performed clinical genetic tests as a result of a patent of license. Hence, despite the historical purpose of patents -- to render public the knowledge about what the invention is, how it is made, and what its best use is and to promote further research, gene patents can actually enhance secrecy and impede further research.
The problems with gene patenting took center stage with the ACLU's lawsuit against Myriad Genetics, The Association for Molecular Pathology, et al. vs. Myriad Genetics, et al. This Utah-based company owns the patents on two genes, BRCA 1 and 2, which code for tumor-suppressing proteins. Mutations in these genes can result in the proteins' inability to interact with cancer cells, thereby increasing the chance of developing breast cancer. Myriad Genetics also own the patents on all possible mutations of those two genes and on the test for the mutations. Myriad does not permit any biomedical researchers to perform full sequencing testing on those genes. Indeed, the company has sent cease-and-desist letters a number of U.S. laboratories to prevent scientists from offering BRCA testing. It is impossible to get an outside verification of the results. The test can be rather expensive, over $3,000. Many American women cannot afford such a fee, and their insurance might not cover it.
In March 2010 Judge Robert W. Sweet of the federal court of the Southern District of New York ruled that the gene patents were invalid, as they were products of nature. Historically the U.S. Supreme Court has argued that products of nature are not patentable, as they are not a result of human invention. Myriad Genetics appealed Sweet's ruling to the U.S. Court of Appeals for the Federal Circuit (CAFC), which overturned the decision in August of 2011 by a vote of 2 to 1. The ACLU appealed this reversal to the U.S. Supreme Court, which remanded the case back to the CAFC in March of 2012. This past August, the CAFC upheld its original decision: Myriad Genetics' patents on BRCA 1 and 2 are still valid.
The decision is an interesting one. It seems that the lower courts and the U.S. Patent and Trademark Office are ceding too much ground to biotech companies with a view to spark the biotech sector. Sequencing companies in particular argued early on that patents were the only way for them to secure capital, as they had no marketable products. Gene patents would convince potential investors that there would be some future payoff. Curious decisions on gene patenting made in the 1980s and 90s resulted. Just how much such moves will affect the commons and public healthcare remain to be seen.