GLOBAL CHALLENGES

Can a Company Claim Rights to Your Genes?

Michael Steinhart | Date: 04-08-10 | Comments

A recent court decision challenges a corporation�s right to patent specific genes and genetic tests. How will this affect the future of medical research?

The successful mapping of the human genome is a very recent phenomenon, and the implications of the knowledge and the attendant medical discoveries are only starting to unfold.

Myriad Genetic Laboratories fields ads like this, touting its breast and ovarian cancer testing techniques.

That hasn�t stopped many pharmaceutical and bioresearch companies from applying for, and receiving, broad patents on the genes and genetic therapies they�ve discovered. In fact, experts say that 20 percent of the human genome is "owned" by commercial interests and protected by patents.

This all started back in 1980, when the Supreme Court ruled that ruled that "organisms" made from human DNA were patentable if they were "man-made"�produced by human intervention. This was interpreted, over time, to mean that genes of organisms could be patented, granting the holder exclusive ownership of that gene. Millions of genetic patents have been granted since.

According to a DailyTech blog entry on the subject, companies that own these patents can block other companies or labs from developing tests for these genes or developing medical treatments.

Whether this is good business or dangerous subversion of natural science (and quashing of potential lifesaving research) is a matter of debate. And the debate has been raging in court, with a lawsuit brought by the Association for Molecular Pathology and the ACLU against Myriad Genetics, which owns the rights to genetic mutations associated with breast cancer risk and the techniques to test for these genes in humans.

Until now, Myriad was the sole provider of these tests. With the recent ruling against Myriad in the Southern District Court of New York, that may change.

On March 29, Judge Robert W. Sweet ruled that the genes under Myriad�s patents aren�t man-made at all, but occur naturally in humans. Therefore, they�re not patentable. He also ruled that the tests to see whether breast cancer genes are present in a patient are mental processes, not specific intellectual property.

Says AMP President Dr. Karen Mann, "DNA patents have delayed, limited or even shut down clinical testing and scientific research, and in the case of the [breast cancer] genes, Myriad's lab is the only place in the country that performs full sequencing of the genes for diagnostic purposes. Patients can't get a second opinion before they make major, irreversible health decisions. The summary judgment � is a significant step forward to eliminating future DNA patents and calls into question the appropriateness of those already in existence. This ruling will most definitely advance the development of personalized, molecular medicine and the practice of molecular pathology."

It�s unclear whether this ruling will have an immediate effect on the availability of breast and ovarian cancer tests, as it�s still subject to appeal and it may be overturned or challenged in other courts as well. We, however, concur with the AMP and think this ruling is a move in the right direction�resulting in a more common-sense approach to medical research and the rights of companies to develop tests and treatments that will benefit everyone.

Do you think genes should be patentable? On the pro side, we don�t want to discourage companies from investing in research. On the con side, how can any company put a registered patent on a component of the human body? Sound off here!