Advocacy and Genetics: Who Owns Your Genes--and to What End?

On February 13, Michael Crichton published an op ed piece in the New York Times on gene patenting. Crichton’s piece argued that genes should not be patented:

Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly.

Crichton’s piece has been widely read, discussed and blogged about, including a thoughtful discussion of whether gene patenting is consistent with other patenting in scientific discovery or unique by Derek Lowe in the blog Corante.

The patenting of isolated genes as chemical entities is tricky. Yes, they are chemicals, and when they're isolated and purified like that they really are in a different state than found in nature. But their size is so far removed from many of the other things patented as substances that I can't help but wonder if a principle is being pushed too far. (The obvious other example here is the patenting of isolated proteins, which of course is also well established, for better or worse).

The patent law argument rests on a 1980 Supreme Court Decision in Diamond v. Chakrabarty, and is presented briefly along with a summary of arguments for and against gene patenting on the Human Genome Project Information web site.

Prior to 1980, life forms were considered a part of nature and were not patentable. Diamond v. Chakrabarty changed this with the 5 to 4 U.S. Supreme Court decision that genetically engineered (modified) bacteria were patentable because they did not occur naturally in nature. In this case, Chakrabarty had modified a bacteria to create an oil-dissolving bioengineered microbe.

In an unpublished letter to the New York Times (Feburary 14, 2007), Peter Arno,who teaches Health Economics in the Sarah Lawrence College Health Advocacy Program, and his colleague Michael Davis, wrote this response to Crichton’s piece.

Michael Crichton is right on target when he argues that gene patents inhibit medical innovation. However, this argument can be taken even further. In terms of new drug development, there is scant evidence that patents stimulate biomedical research or innovation. What they certainly do is protect the monopoly profits of multinational drug firms. Rather than stimulating creative drug development, patents promote the sale of high-priced drugs and massive expenditures on marketing pharmaceuticals for conditions prevalent in wealthy countries for which treatments already exist (better known as “me-too” drugs). What makes matters worse is that the Patent Office rejects an appallingly small number of applications. A good patent lawyer, it is said, can get a patent on a ham sandwich. When a patent system is so out of control, it is not surprising that innovation suffers.

[Note: A useful review of “the negative consequence of gene patents” can be found in Greenpeace’s report on The True Cost of Gene Patents: The Economic and Social Consequences of Patenting Genes and Living Organisms which summarizes these consequences as follows:

• considerable increase in the burden on patients and health insurance funds
• protracted litigation that may also severely impede research and development
• a blockade of research and development by whole bundles of patents to be observed for individual technical innovations
• hindrance to medical institutions, particularly in the field of diagnosis
• obstruction of current proteomics research by hastily granted and too extensive gene patents
• impediment of research and development, particularly in the field of infectious diseases
• unacceptable dependence of patients with hereditary diseases on individual companies
• danger to world food supply owing to the exorbitant cost and monopolization of seeds
• new systematic dependence of medium-sized plant breeders
• considerable financial risks and direct dependence of farmers
• stepping up of international concentration process in the seed industry
• new dependence of food industry on agrochemistry]

The issue of gene patenting has become central to the work of many patient advocacy organizations seeking to not only promote research related to particular genetic disorders, but to ensure that the voice of the patient—and the family—is part of the research planning process. These groups understand that in today’s research “marketplace,” the fact that very real people—often children—are the source of the tissue samples that enable researchers to find gene mutations, should mean that they are able to continue to play a role in the use of that research for testing or treatment. In another New York Times piece earlier this year (“Someone (other than you) may own your genes”), Denise Caruso, executive director of the Hybrid Vigor Institute, noted this concern and raised the example of families affected by the Canavan disease:

The degree of control that life patents grant their owners is of growing concern to scientists, human rights and patient advocates and ethicists. More than 20 percent of human genes have already been patented, and most of those patents are owned by corporations.

. . . . In the case of the Canavan disease patent, for example, a family afflicted by this rare genetic disorder initiated an effort to find the gene mutation responsible for the disease. They raised money, collected DNA samples and attracted researchers to the cause.

After a researcher found the gene in the late 1990s, he and his employer, Miami Children’s Hospital, patented it and began charging royalties on a genetic test to screen for the disease — despite the fact that they would never have found the gene without the efforts and the DNA samples of the afflicted.

Patient groups filed suit in 2000, contending misappropriation of trade secrets by using their children’s DNA without consent to obtain a patent. It took until 2003 for the parties to reach a confidential settlement; it allows certain laboratories to continue collecting royalties but lets institutions, doctors and scientists use the patented gene sequences without paying.

At the end of March, the two certificate programs at Sarah Lawrence, Applied Research Ethics and Public Health Genetics/Genomics, will come together to discuss with speakers and panelists ethical issues related to genetics and research. The Canavan Foundation situation and subsequent efforts by patient advocacy groups to control tissue banking and gene patenting, will be a focus of some of this discussion. Yet in the background now is advocacy of another sort: advocacy focused on pending Congressional legislation aimed at protecting the broad public interest. The “Genomic Research and Accessibility Act,” introduced by Representative Xavier Becerra, Democrat of California, and Rep. Dave Weldon, M.D. Republican of Florida, would “prohibit the patenting of human genetic material.”

Clearly discussion and dialogue between advocates in different arenas around these gene patenting issues is only beginning, but its importance is unquestionable.