Qinghao Fu

Personalized medicine, an enhanced form of preventative and therapeutic care for the individual patient, is being promoted in the Obama health-care reform. It relies on analyzing genetic information to determine a person’s susceptibility to diseases and responsiveness to drug treatments, and it allows early detection of a disease.

With the continuing advancement of technology, we should expect genetic tests to become a routine practice in personalized medicine. However, there is a potential obstacle on the road to personalized medicine, namely, the practice of gene patenting.

Genetic analyses such as the Plavix test for heart disease and BRCA test for breast cancer are no longer new. You can even get your genetic profile without a prescription. Walgreens is working on plans to sell genetic test kits whose results will be analyzed by Pathway Genomics to assess a person’s risk of developing certain cancers, cardiovascular disease, diabetes and other ailments. Even though this product has not yet been approved by the FDA, there is little doubt that people will be able to benefit from understanding their risk and therefore switching to a healthier lifestyle.

With the continuing advancement of technology, we should expect genetic tests to become a routine practice in personalized medicine. However, there is a potential obstacle on the road to personalized medicine, namely, the practice of gene patenting.

A gene patent applies to a specific gene and the process of obtaining or using it. The early 1990s saw a sudden rush to patent genes, as many of them were discovered through the Human Genome Project. At the time, no one knew how to turn those patents into commercial use. With the popularity of genetic testing today, we see potential problems. Namely, patents can slow the progress of scientific discovery and limit access to genetic tests by the general population. For example, the BRCA gene test is critical in the treatment of breast cancer. Before patents on BRCA genes were awarded to a company called Myriad, there were some institutions offering such a test for several hundred dollars. After Myriad got exclusive rights to those patents in the United States, the charge for these tests has risen to $3,000 or more. In Europe the same test costs only half that amount because the patents are shared by Myriad and several other entities.

In March 2010 a New York court invalidated some of Myriad’s patents on BRCA genes. This was not only a victory for patient advocacy groups and medical professionals, but also a landmark event in gene patenting. It calls into question existing patents on another 2,000 genes.

One argument that has been made for gene patenting is that it provides an incentive for scientists and the private sector and without it progress in science and technology would slow down. But this argument is misleading. First, most discoveries are made in the academic world where scientists do not operate with the goal of making a fortune. The first discoverer of BRCA1 gene, Dr. Mary Claire King, did not conduct her research in response to financial incentives, but because of her interest and passion for science. We seldom see scientists driving expensive sports cars and living in luxury. A second argument for patenting is that in order to make genetic tests widely accessible, financial incentives are required to get more people involved in the research. In reality, the patents on BRCA are so broad that their existence has actually limited work on this gene.

Another problem with gene patents is that the advancement of technology has outpaced patent procedures, which are often at least decades old. Hundreds of years ago, if you discovered a land that nobody knew, you could claim it as your own, a practice that now sounds ridiculous. But when it comes to patents, we are stuck with the same procedures we used long ago. In an age when it is relatively easy and inexpensive to identify a new gene, this has major unanticipated implications. The human genome still contains a vast amount of information to be discovered such as gene mutation, modification and so forth, and we cannot afford to have an outdated system slow us down.

We all know of some absurd patents that have been approved, such as one for a spaceship that was never built. But when the patent in question can have a significant impact on the society, it needs to be taken seriously and scrutinized to prevent a few people from gaming the system at the expense of many others. In his decision regarding the BRCA patents,
U.S. District Court Judge Robert W. Sweet condemned the application, arguing that it was “a lawyer’s trick that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.” Science has progressed very far, but regulatory institutions have not kept up.

The Myriad group has vowed to appeal Judge Sweet’s decision, and other industry groups may join in to defend their interest. We need to make sure that the regulation regarding gene patents is given special focus and kept up-to-date in order to guard the public interest. This would remove a major obstacle as we proceed down the road toward personalized medicine.