There are currently patents for 20% of the human genome. Almost half of known cancer genes have been patented (Scientific American).
The DNA Patent Database is available to the general public, and provides the full-text of patents at no cost.
A landmark case in the genome project was Amgen vs Genetics Institute in the 1980s. Amgen claimed the DNA sequence used to invent erythropoietin, used to form red blood cells. The case ruled in favor of Amgen, saying that the DNA sequence had to be included in the patent claim to secure intellectual property rights. The first gene patented was that of erythropoietin.
In 2000 the American College of Medical Genetics and the College of American Pathologists objected to genetic patents at the 2000 AMA Annual Meeting. They said that genes are naturally occurring, so they cannot be patentable. This is correct– naturally occurring substances are not patentable. However, the AMA said naturally occurring substances that are isolated from nature or manipulated may be patentable, which includes naked DNA.
Patent holders have the ability to prevent others from making or using their invention, but full disclosure of the invention is required to obtain a patent (AMA). The current term of a new patent is 20 years from the application filing date, and after 18 months of filing the application enters public domain.
The United States Patent and Trademark Office (PTO) issued guidelines in January 2001 for genetic patents. Patents for genes can be filed only if a specific and credible use was demonstrated. These guidelines have made it clear that genes can be patented. Although many people raised objections about genetic patenting, the PTO rejected the notion because “a gene may be removed from a person, then a clone of that gene may be made in a machine, which is then not a part of nature, but a product of the lab.” (AMA).
Since the 2001 guideline requiring that patents have “a specific and substantial utility”, there have been a substantial decline in the number of patents being sought (Scientific American).
Ethics and Concerns
The AMA Code of Medical Ethics has this to say about patenting human genes: “A patent grants the holder the right, for a limited amount of time, to prevent others from commercializing his or her inventions. At the same time, the patent system is designed to foster information sharing. Full disclosure of the invention—enabling another trained in the art to replicate it—is necessary to obtain a patent. Patenting is also through to encourage private investment into research.” As for the notion that genetic patents are an attempt to own human life, the AMA Code of Ethics says that DNA sequences are not the same as human life, and that much is to be gained in the form of new medical therapies.
A February 2010 panel of the U.S. Secretary’s Advisory Committee on Genetics, Health and Society wants patents on diagnostic genes to cease (New Scientist). The panel found that non-patented genetic tests (such as Huntington’s disease, cystic fibrosis, and colorectal cancer) were more available than patented tests (such as breast cancer, patent owned by Myriad). The committee said that doctors providing diagnostic gene tests shouldn’t face the threat of being sued by companies owning patents to those genes. The Biotechnology Industry Organization objects to this recommendation, saying that it will deter investors from funding new therapies.
Both Canada and Europe have rejected patents that the United States has accepted, including one of a gene causing cancer in a mouse (New Scientist). Canada said the mouse was a higher life form than a mere “composition of matter”, and Europe narrowly allowed the cancer mouse patent but excluded all other rodents.
The End of Patents?
A 2006 article published in the Scientific American says that patent holders of diagnostic genes “have inhibited both research and clinical medicine.” The Myriad company that owns the breast cancer genes BRCA1 and BRCA2 has “used its patents to stop major cancer centers from devising inexpensive ‘home-brew’ tests” for those genes. Europe successfully challenged some of Myriad’s patients. The test for breast cancer genes is now free in Europe except for Ashkenazi Jewish women, who must pay Myriad licensing fees since Myriad patents still cover mutations found in that population. Therefore, a physician in Europe must ask a woman if she is an Ashkenazi Jew by law before testing her genes for breast cancer.
A March 29, 2010 ruling in the U.S. District Court for the Southern District of New York found that genetic patents “violated long-standing precedents barring the patentability of natural phenomena, saying the DNA over which Myriad Genetics Inc. claimed a monopoly represented ‘the physical embodiment of laws of nature’.” (AMA) The specific genes in this case included those of hereditary breast and ovarian cancer. This ruling is believed to be the first of its kind. The case will probably be appealed, especially by those who say that the patent system is needed to attract investors to fund new research.
Opponents of genetic patents are claiming a major victory, saying that organized medicine will now have broader research and more accessible treatments. Bruce Korf, MD, PhD, president of the American College of Medical Genetics was a plaintiff in the case. He said, “Looking at genetic reports was like looking at a CIA document, where areas were blacked out because somebody owned them, and doctors couldn’t report the medical significance. Now we’re not going to be bumping into those areas claimed as property by someone else, and the innovation we are looking for could further more efficient ways of doing genetic testing.”
While most people involved believe that patents can be helpful for innovations, the patent in this case was overly broad, creating a monopoly “that hampered scientific discovery and medical care,” according to American Medical Association President J. James Rohack, MD.