Intellectual Property

More than 45 genetic sequences related to diabetes have been patented. For 20 years from the date of the filing of the patent application, the patent holder controls any use of “its” gene sequence and can prevent anyone else from using the genetic sequence in a diagnostic test or treatment. The patent holder can forbid anyone else from analyzing anyone’s insulin sequence and can charge as much as it wants for a genetic test, such as a test for predisposition to diabetes.

This ability to control all uses of a patented invention might make sense with a machine, such as a gene sequencer, but does it make sense for the gene sequence itself, which is not only a tangible item, but also information? With its ability to control all uses of a gene sequence, the holder of a gene patent can keep off the market a genetic test that would tell a patient that a medication would not work for him or her. The patent holder can prevent other researchers from undertaking promising research on that genetic disease. The patent holder can charge an excessive royalty for a genetic test and prevent doctors from diagnosing their patients. All of these abuses have already occurred with respect to gene sequences linked to other diseases.

Researchers at the Institute for Science, Law, and Technology at IIT are undertaking studies about the legal underpinnings of patents on genetic sequences related to diabetes and the potential impacts of those patents on diabetes research and the health care services provided to people with diabetes.