Earlier this month, the American Civil Liberties Union joined the Association for Molecular Pathology, the American College of Medical Genetics, the Boston Women's Health Book Collective, and numerous other plaintiffs--including individual breast cancer patients--in filing a lawsuit against Myriad Genetics, the U.S. Patent Office, and the directors of the University of Utah Research Foundation. Myriad Genetics has patents in the U.S. for the BRCA1 and BRCA2 genes, the presence of which has been linked to an increased risk of breast or ovarian cancer. The suit alleges that such gene patenting is unconstitutional, in large part because "ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical laboratory tests that benefit patients in the emerging era of personalized and predictive medicine," and such patents restrict the use of the genes.
The ACLU suit points out that
Because of the patents, defendant Myriad has the right to prevent clinicians form independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder. [...] Many women at risk cannot even be tested because they are uninsured and/or cannot afford the test offered by Myriad.
The suit gives several examples of ways that some of the plaintiffs have been put in jeopardy by the patent. Particularly upsetting to me was this anecdote:
Plaintiff Lisbeth Ceriani is a 43-year-old single mother who was diagnosed with cancer in both breasts in May 2008. Ms. Ceriani is insured through MassHealth, a Medicaid insurance program for low-income people. Her oncologist and genetic counselor recommended that she obtain BRCA1 and BRCA2 genetic testing, because she may need to consider further surgery in order to reduce her risk of ovarian cancer. They submitted a blood sample to Myriad on her behalf. However, she was notified that Myriad would not process the sample. Even though her insurance has informed her that it would cover the BRCA genetic test, Myriad will not accept the MassHealth coverage. Ms. Ceriani is unable to pay the full cost out-of-pocket and, to date, has not been tested. Without the genetic test results, she cannot determine the best medical course for herself.
What the hey?
Women bloggers have latched onto the story like metastases to lymph nodes.
In her article "Enough with Patenting the Breast Cancer Gene," Rebecca Skloot (of the blog Culture Dish) writes of the literal cost of patenting to scientists and patients.
In a survey done a few years ago, 53 percent of laboratories had stopped offering or developing a genetic test because of patent enforcement, and 67 percent felt patents interfered with medical research. It costs $25,000 for an academic institution to license the gene for researching a common blood disorder, hereditary haemochromatosis, and up to $250,000 to license the same gene for commercial testing. At that rate, it would cost anywhere from $46.4 million (for academic institutions) to $464 million (for commercial labs) to test a person for all currently-known genetic diseases.
Click through to Skloot's article to learn more about the history of patenting genes--and why it's possible to patent genes at all in the first place.
Over at the Huffington Post, Joanna Rudnick, who has tested positive for the BRCA1 mutation, shares a video interview with Dr. Mark Skolnick, the founder and chief scientific officer of Myriad. Rudnick writes that "the lab was beautiful and state of the art, but Skolnick's answers surrounding the ethics and detrimental consequences of gene patenting were unsatisfying, leaving more questions than answers and leading to where we are now with the ACLU challenge."
Stephanie Anderson, writing on an intellectual property blog, explains the key issues in the case:
What seems to be the main issue is not that patents should be unavailable whenever genetic sequences are at issue, but that the USPTO’s policies and understanding of biotechnology and science has not kept up with the pace of the industry itself. I coincidentally worked in a genetics laboratory for several years some time after seeing the documentary about BRCA1 and 2. Like my initial very strong pro-patent beliefs when I was involved in research, part of the problem with many patents is their overly broad nature. As the root of more and more diseases is being attributed to mutations within our genetic code, gene patents run the risk of limiting research if a disease is known to be caused by a genetic mutation. If gene patents are defined too broadly, patent holders theoretically could prevent research on proteins produced in the body associated with a disease because the proteins were encoded by genes. As has been stated by bioethics experts, patents are a privilege, not a right. Unless the USPTO steps in and clearly identifies what exactly is being patented so to limit patent protection appropriately, research will undoubtedly be stifled to some extent.
Will the lawsuit succeed? Arthur Caplan, director of the Center of Bioethics at the University of Pennsylvania, thinks Myriad will prevail. He explains why the law may in this case be on the side of the patent holder and not the patients--even though it doesn't necessarily make ethical sense:
The notion that patents interfere with free speech by restricting research communication presumes that the constitution recognizes research as a form of free speech and that Myriad has done anything to block researchers from speaking and those are pretty iffy presumptions.
Tossing out the Myriad patents would indeed imperil thousands of other patents, and courts tend not to want to cause that much turmoil.
That forecast offered, those bringing the lawsuit have an important point. Patent offices and courts in the U.S. and other countries have been granting patents on genes without thinking hard enough about the social and health implications of doing so. If companies sit on their patents and restrict licensing, gouge consumers, or fail to develop their patents by improving their tests or therapies then government should step in and yank the patent.
Patents are not given for any reason other than to encourage innovation which advances the public good. They are a privilege — not a right.
What are your thoughts?