I Own Your Genes: The Issue of Patents in Biotechnology
By Ipsita Agarwal '13
What exactly qualifies as intellectual property? An original, abstract idea, a fresh thought, a re-discovered fact, a modified theory, a body of knowledge — all of the above or none? Where is the line between what is a product of nature and what is a result of human creation?

The debates over intellectual property rights have never been fiercer or murkier than in biotechnology, where the scramble to patent sequences of the human genome has been the gold rush of the genomic age. Over the last few decades and in the face of much controversy, the U.S. Patent and Trademark Office has issued about 35,000 patents involving gene sequences. These gene patents include isolated or purified DNA sequences covering over 20 percent of the human genome, RNA sequences, vectors, nucleic acid-based vaccines and various uses of gene sequences, such as using correlations between diseases and mutations as a diagnostic tool.

Perhaps the most controversial decisions by the USPTO in recent years have been the patents on the BRCA1 and BRCA2 genes, two important genes that potentially carry mutations found to be associated with a high risk of familial breast and ovarian cancer in women. Identifying the mutations is essential for diagnosis. Myriad Genetics Inc., in collaboration with the University of Utah, was the first to sequence these genes and was granted patent protection on the isolated DNA sequence and on a screening method. They held exclusive rights to a number of mutations in the gene. Because of its patents, Myriad could prevent anyone else from testing, studying or even looking at these genes. Furthermore, because full sequence testing by anyone but Myriad would be a clear instance of patent infringement, the company could get away with charging exorbitant rates close to $3000 for a single test. Women who could not afford this price and whose insurance companies would not cover the test would have no access to BRCA testing. To add to Myriad’s market power, no research could be conducted on those two gene sequences without the permission of the company, rendering the development of alternative diagnostic techniques impossible.

In a bold step to clear some of the long standing ethical tangles in this debate, the Federal Department of Justice on Friday came out strongly in support of a decision against patents on genes, arguing that they are products of nature and hence “free to all men and reserved exclusively to none.” While isolated and chemically modified DNA is still patentable, the judge ruled that merely isolating a DNA sequence does not change its nature and the fact that it is present, with a slight sequence variation, in every human genome makes the idea of anyone “owning” a gene absurd.

While this decision is expected to have a far-reaching impact in health care, and will come as a blessing to the thousands of women worldwide waiting to be screened for breast cancer, it also alters the balance of power in the biotechnology industry. With the lucrative revenues collected through gene patents curbed, the private sector is likely to rethink its research priorities. So, while it is a good idea to take it away, in the cases of Myriad and others who abuse their market power, it is also possible that this line of research may suffer because of reduced incentives to come up with better techniques faster to survive in a market economy. This brings us to the fundamental question of why patents are handed out in the first place. Patents are meant to create incentives and to compensate for the huge risk differentials involved in the biotechnology industry. While the ability to patent gene sequences, which would give a person or group control of a gene that is common to all humans, may seem like a recipe for disaster, it is not the patent itself which seems to be the real problem. The reason that Myriad has come under so much fire and other companies have not is because of the company’s atrocious licensing policy. Awarding a patent as a reward and an acknowledgement of the discoverer’s effort is acceptable, but when that patent starts to hinder the very purpose of its existence — incentivizing research to improve human health — it becomes counter-productive. Myriad has helped us realize the worst-case scenario that could arise as a result of patenting something as fundamental to our bodies as genes. One hopes that other patent-claim owners reconsider their licensing policies, especially when potential diagnostic tools are in the balance, to avoid similar or worse conflicts in the future.

Issue 08, Submitted 2010-11-03 02:48:50