The human genome, a set of 20,000 different genes, is the basic roadmap for everything that makes us human. Should it be patented? Does this mean that some corporate entity owns a piece of our basic genetic make-up – can we be sued if we have a mutation? An interesting concept, but the reality of patent law and what corporations can and cannot patent is still being defined.
The human genome itself is public knowledge, the result of a 13-year long project that had contributors from the international community to complete the research. Everything has been mapped, even if we’re not sure what everything does yet. Of the 20,000 genes, 2,000 of them are the subject of over 40,000 patents. Most of these patents have to do with using the isolating the genes to manufacture other items or methods of detecting or diagnosing disease derived from the association between an isolated gene and that disease. However, there are actual patents for isolated genes themselves.
The benefit of patents is that it spurs investors to put money into research in the hopes it will produce a patentable outcome, allowing them to get a decent return on their investment. This spurs research into disease and testing and all sorts of beneficial things for mankind. You can’t have breakthroughs without research. You can’t have research without money. This type of thinking is what led to discovering and being able to artificially produce things like adrenaline and insulin. These clearly benefitted mankind and had a profitable end result for the companies that did the research and obtained the patents. So, everybody wins, right?
The dark side comes to fore when a company patents an isolated gene known to be associated with a disease and, by nature of that patent, prevents anyone from isolating that gene for testing. This is currently the subject of a lawsuit involving the company Myriad Genetics, the University Of Utah Research Foundation and the U.S. Patent Law Office. The lawsuit involves the BRCA1 and BRCA2 genes that have been linked to breast and ovarian cancer. Myriad Genetics has developed an expensive test that isolates the genes; they claim that by isolating the genes they, in effect, transform them and they become patentable. The patent also blocks any competitor from isolating the gene in any way, regardless of the final manipulation method of testing.
Several of the patents have been invalidated by Judge Sweet, a U.S. District Court Judge. The decision was appealed and the Department of Justice filed an amicus brief supporting part of the judge’s ruling, but arguing against other parts. While not a final ruling, the implications are bound to ripple through the biotechnology field. Multi-billion dollar corporations are built upon the soundness of gene patents granted in the past.
The ethical side of the genetic argument is being able to isolate a gene and freely test it for disease. The monetary side of the equation covers some investments made in the field of biotechnology that hinge on the value of patents. There will be some financial fallout from the patent melee, should some of the rulings be upheld. However, the isolated genes free of alteration or manipulation should not be patented; researchers shouldn’t be scared of violating a patent by researching a particular part of the human genome. The testing methodology and valid manipulation of the genetic material resulting in unique substances are reasonable areas for patent law to protect, and that rewards the ingenuity of humanity, not of nature.