A Major Reversal:
No Patents on Genes

Gene patents have been issued for decades. The Patent and Trademark Office has granted thousands of patents on genes from various organisms, including about 20 percent of human genes. This has enabled the biotechnology industry to drive remarkable advances in medicine.

In late October, the Department of Justice declared that human and other genes should not be eligible for patents because they are part of nature.

The road to reversal began when a lawsuit was filed challenging patents covering the BRCA1 and BRCA2 genes and patent-holder Myriad Genetics' screenings that determine predisposition to breast and ovarian cancers. A district court judge in Manhattan ruled the patents invalid because genes carry important information, whether in the body or isolated from it, that can't be patented. His ruling prompted the government to reconsider its policy.

A subsequent friend-of-the-court brief stated: "The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."

Such a reversal and adamant position could endanger the progress being made in diagnostic testing and in development of highly effective new drugs designed to work in conjunction with the patient's genetic makeup.

I often write about how this progress is already helping patients. BRCA2 screening provided early diagnosis to a cancer victim's children so they could avoid chemotherapy and invasive treatment. In clinical trials, patient-tailored cancer vaccines have brought remission in difficult cases. Extracted genes, and the potential they hold for improving people's lives, are not at all like the limited possibilities of extracted cotton fibers and coal. 

The government's stand on patenting genes is not merely a matter of principle. It's a matter of life and death for current and future patients who depend upon the medical advances made possible through the development and delivery of gene therapies.

Appeals to the government's new stance are in progress. Let's hope they lead to a second reversal and further steps forward for biomedical science and the patients who benefit from it.

— Tom DeSanto

Source: New York Timeds. October 29, 2010. Image: Google Images