Sunday, July 5, 2009

Who owns your genes?

In May of this year, the American Civil Liberties Union (ACLU) filed a lawsuit against Myriad Genetics claiming that the company's patents on two breast cancer genes should be voided. Anyone working in the biotechnology industry should be aware of this pending case because it's outcome will have a huge impact on the future of biotechnology.

Myriad Genetics owns the patent rights to 2 genes known as BRCA1 and BRCA2. Mutations in these two genes have been strongly linked to developing breast and ovarian cancer. The link is so strong that some women testing positive for mutations in these genes have been having both breasts surgically removed (double mastectomy) and often their ovaries removed as a preventative measure to avoid the very likely chance of developing cancer. This medical scenario was even a story line on the popular Gray's Anatomy television show.

Myriad Genetics owns the only available and approved medical test for the BRCA mutations. The ACLU is leading the fight against Myriad Genetics. The lawsuit claims that Myriad Genetics' patents restrict research scientists at universities and other companies from studying and learning more about these genes. From a patient advocacy standpoint, the lawsuit claims that since the only BRCA tests available are developed and sold by Myriad Genetics, it prevents patients from obtaining a truly independent second opinion.

What's at stake is much more than whether or not Myriad Genetics can own a patent on the BRCA genes. The big issue, which the ACLU is going after, is whether anyone can own a patent on any gene or biological entity. It is estimated that about 20 percent of all the human genes now have some sort of patent rights placed upon them.

Biotechnology companies will claim that it is these patent rights that allow them the confidence and incentives to risk many millions, sometimes billions, of dollars needed to develop new drugs, treatments, and medical tests to improve patient safety and efficacy in treating our most challenging diseases. If these patents all become in danger of being voided and future patents on biological entities are prohibited, the public may be the biggest loser because biotechnology companies will no longer be willing to develop new or better treatments.

Let me know which side you are on. Whichever side you stand with in this battle, the outcome will have an important impact into not only the biotechnology industry, but the practice of medicine for you and those you love.

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