Myriad's Patent of BRCA Gene is Contested by the ACLU in Court

Imagine you have been diagnosed with breast cancer and you desperately want to be tested for the BRCA gene to decide your next step. You already have had a double mastectomy but Myriad's BRCA1 or BRCA2 test will help you decide if you should have your ovaries removed. A positive result in Myriad's BRCA test indicates a 50% increased risk of ovarian cancer and an 87% likely hood of developing breast cancer. However, if you are like Lisbeth Ceriani, as reported in the NY times, you can't afford the test and there is no alternative one to take.

Myriad Genetics is the only company that is able to perform the BRCA test at a cost of $3,000. Not only are they the only lab that can test, but Myriad "owns" the patent to the BRCA gene itself so only they will ever be able do the test unless they allow other companies access to their research. Myriad has no plans to do that, they feel that they have spent the money, time and energy required to do the research in refining the DNA of this gene. Myriad believes that this entitles them to have sole control or should I say sole money making control in the diagnosis of these terrifying diseases. Breast cancer is the second most commonly diagnosed cancer in women and ovarian cancer affects over 20,000 women a year, but its physical symptoms are more difficult to diagnose.

The ACLU has taken on the U.S. Patent office and Myriad Genetics in court to contest the ownership of something that was unimaginable to own 15 years ago. How does a company have sole ownership of a gene? Myriad Genetics is not the only company that has obtained patents to genes and others could be named in the lawsuit. Patents have been placed on 20% of the human genome that have been discovered such as the one owned by FAMILION® for a long Q-T interval, that affects heart arrhythmias. However, to their credit the non-for-profit company that owns the patent to the Cerebral Palsy gene CFTR has made their research available to others to benefit the progression of research and development of treatments and cures.

If only Myriad can lay claim to a gene and prevent other companies from access, imagine the stalemates that have been created.

1. Future gene research is believed to need the compliances of several genes studied together to come up with progressive cures and treatments. How can that progress occur if only Myriad or any company lays claim to "their" gene and will not allow others access to collaborate.

2. No test is infallible. Dr. Nancy Schneiderman, on the Today show aptly pointed out that there is no second opinion option to make sure that the Myriad BRCA test is absolutely accurate. Does Myriad see that in the future someone can sue them if their test results were wrong and they suffer irreversible harm since their test could not be confirmed with another lab?

3. Without free market competition, Myriad can control and charge what ever they want for the BRCA test. The only other way other companies can compete would be to spend time figuring out alternative tests, which may not be as accurate and waste time and energy "reinventing the wheel" instead of coming up with a "new wheel" needed to move gene research forward.

We are entering a new age and territory in gene research and ownership of genetic property that will need firm guidelines to keep the momentum of cancer and disease cures progressing instead of being back logged in the courts like custody battles gone bad. The idea that a company can "own" a piece of life seems unfathomable. Didn't we give up "owning" pieces of people's lives when slavery was abolished? No one is trying to take away Myriad's ability to make money, but how much money is a company entitled to just for being first?

http://www.nytimes.com/2009/05/13/health/13patent.html?ref=health