NEW YORK, NY: Playing Monopoly with Your Genes: Not All Fun and Games. (10/20/09)

Here's an (un)fun fact: Did you know you can patent a gene? A gene- something found in nature, not invented by humans- you can patent that. Now, you may be scratching your head saying, "But gee, I thought patents were only for things like inventions." Well, the United States agrees with you- and recognizes this distinction between inventions and naturally occurring parts of nature. For example- you cannot patent oxygen. Can't do it. However- for almost two decades, the US Patent and Trademark Office (PTO) has allowed patents on human genes, something I did not know before going to an ACLU viewing and panel discussion of the film "In the Family."

How can this be bad? It's just a patent. Well, let's break it down in terms of two common killers: breast and ovarian cancers. In 1990, Mary-Claire King of University of Washington discovered the gene mutations BRCA1 and BRCA2. Everyone has these genes, they're on the 17th chromosome. However, individuals with mutations on these genes have- pay attention- an almost 90% risk of developing breast cancer, and 60% risk of developing ovarian cancer.

Dr. King discovered these mutations, but where they existed in genetic sequencing remained unknown. A competition began between research labs, with Myriad Genetics in Utah discovering where in the sequence this gene falls. Lax biotech procedures in the PTO resulted in a patent. Myriad has been one of the first pharmaceutical companies to actually enforce a patent on a gene.

Pharmaceutical companies differ from scientists in this respect. Scientists often discover and publish, not patent. Or, if patented, leave the patent open so that other scientists are free to research the gene, develop treatments, and just plain look at the gene. Royalty checks are negligible.

Under Myriad's patent, nobody but Myriad is allowed to research, develop or look at the gene without paying a substantial patent fee. Doctors receive cease and desist orders if they are discovered, because Myriad owns the rights to the gene. In short, as soon as the blood is drawn out of your body- you forfeit your rights to your BRCA1 and BRCA2 genes. What's more- this is the case with 20% of your body's genes. 1/5th of your body is copyrighted by someone else- not the process of isolating them, not any treatment, the actual gene.

Per PTO protocol, the patent clerk who approved this complicated patent had, like all other patent requests, 18 hours to review this submission. 18 hours to wrangle hundreds of pages representing years of genetic research is awarded the same amount of review as the "ShamWow." The turnaround time is so quick because the PTO operates on the money made from patent submissions and renewals.

Here's where this comes down to you and me.

At the time of this discovery in 1994, to be fully tested for this gene mutation was $1,600. However, with the prospects and promises of future science, the cost was justified by saying it would go down once we had better technology. Fifteen years of technological advance later, the laboratory cost to perform this test is $400-$600, yet the commercial cost to patients is up to $3,800 (633% higher than operational cost). To put this in perspective, to map the entire human genome costs $4,000; the test through Myriad is only on two genes: BRCA1 and BRCA2.

Not everyone needs to be tested. Those of us who should be tested have high incidences of breast and ovarian cancers in our families, as this gene is hereditary. Groups most often genetically predisposed to this mutation include Ashkenazi Jews. Yet women without these indicators which point to this mutation are still being tested for this, at a profit to Myriad.

Myriad Genetics (with their myriad dollars) has undertaken a PR campaign. Ads are targeted towards upper middle class women- encouraging them to get the test without seeking advice from a genetic counselor and without further information on risk. Most women do not have this gene mutation- and this test is costly and irrelevant for those with no risk factors. The campaign, in targeting women in a certain wealth bracket, also neglects an upfront number for the cost- which is often paid by the patient as many insurance plans do not cover the test.

The monopoly on genetics (and insurance company apathy) has made tests costly. Most women at risk remain untested for BRCA1 and BRCA2 mutations. As a result, there is too little research to provide definitive answers for those who are tested within certain groups: including African American, Hispanic, and Asian American women- there's just not a big enough pool of tested women within these groups to draw conclusions in the gene test. Results are often inconclusive. This commercial, socio-economical, and elitist take on healthcare curtails the possibility of preventative measures like bilateral mastectomies, bilateral profilactic mastectomies, and telling your daughter, "hey- you may have this too."

The ACLU has filed a lawsuit against the holder of the patent, Myriad Genetics, as well as the US Patent and Trademark Office. The presence of these patents is a violation of the most fundamental of civil rights. Part of your body is patented by someone else and you do not have a right to it. At the ACLU panel tonight, someone asked if you can just sue a part of the government. To this, a lawyer on the suit said "Well, the ACLU sues the government all the time so...yes."

So what do we do? Write to your congress-people. Tell everyone you know. Tell your mom, your sister, your friend. Tell your brother. Men carry this gene too, can develop breast cancer- and what's more- can still pass this mutation on to their kids. We all stand to gain by the patent being revoked. This will make important medical treatment available to everyone who needs it.

"To realize full promise of the research, raw fundamental data on the human genome including the human DNA sequence and its variations, should be made freely available to scientists everywhere...We must ensure that the profits of human genome research are measured not in dollars but in the betterment of human life."

- March 14, 2000 joint statement by President Bill Clinton and Prime Minister Tony Blair, in honor of the Human Genome Project.

"In the Family" will stream free online through 10/30/09- please visit http://www.pbs.org/pov/inthefamily. Watch it. For more information on the ACLU lawsuit please visit www.aclu.org/brca. Images courtesy of www.wikipedia.org.