Regardless of your beliefs, it was probably not any medical researcher or scientist. Recently, however, PXE International received the patent for a gene associated with pseudoxanthoma elasticum (PXE). PXE is a rare inherited disease which affects connective tissue, resulting in changes in the skin, eyes, cardiovascular system, and gastrointestinal system.

Sharon Terry, the executive director of PXE International, was quoted on Betterhumans.com stating, “we are stewards of this gene, we are responsible for using it to develop diagnostics and therapeutics that are accessible and affordable.” The ultimate goal of PXE International is to develop an FDA approved diagnostic kit for PXE.

So, does this make Sharon Terry one of the gene’s “inventors”? Can genes, which are naturally occurring sequences, be considered inventions at all?

The purpose of patenting genes, of course, is so that companies may charge for the use of their patented genes in the development and use of diagnostic tests, treatments, and therapies.

Is this ethical? If it is ethical, is it a very good idea?

On one hand, it presents companies with an incentive to discover genes related to certain diseases, as well as an incentive to develop diagnostic tests and the like. Many consider patent rights to be the greatest reward for innovation and discovery.

On the other hand, gene patenting greatly reduces the accessibility of genetic tests, treatments, and therapeutics. It also limits concurrent research on the same disease. Further, non-profit agencies and other companies without adequate funding may not be able to pay for the license to use the genes in their research, on top of all of the other costs associated with medical research.

The Australian Law Reform Commission has come up with 2 possible solutions to this dilemma. First, it advises governments and health departments to “challenge dubious patents or questionable licensing practices.” This may require the courts to be involved from time to time. Perhaps a higher showing of usefulness of the genetic “invention” would reduce overbroad claims and dubious patents.

Second, the Commission suggested that scientists and researchers should be immune from prosecution for infringement. This would greatly reduce the problem of inhibition of medical research, but what, then, would be the point of patenting the gene at all? Would the companies and organizations who fund the researchers also be immune?

Clearly, this is an ethical and legal dilemma which will only grow more complex. What do you think should be done to protect medical researchers and “inventors” of genetic material at the same time? Is this even possible?

Kelsey L. Buntyn