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Three years in the making, the now highly publicized American Civil Liberties Union lawsuit against Myriad Genetics is still hanging in the balance. On May 12, 2009, ACLU sued Myriad Genetics, a Salt Lake City-based company that holds patents for the genes BRCA1 and BRCA2, both of which affect risk for developing breast cancer and ovarian cancer. Representing individual scientists and physicians, genetic counselors, patients and scientific organizations, ACLU claimed these patents were invalid.

As discussed in Rebecca Skloot’s book “The Immortal Life of Henrietta Lacks,” monetary gain from biological materials has been occurring for decades. HeLa cell lines were developed from cancer cells taken from Henrietta Lacks. Skloot notes that HeLa cell products cost $100 to $10,000 for a single vial and there are more than 17,000 patents related to HeLa cells.

After BRCA1 and BRCA2 were patented, Myriad Genetics developed genetic tests for these genes. While the initial funding investment and scientific efforts to develop these tests have been acknowledged, the monopoly created by this ownership has resulted in major controversy.

The patenting system was established to foster creativity and innovation while protecting intellectual property. By protecting ideas, companies can secure investments for developing and bringing new products to market, without worrying about competition. Furthermore, patenting offers a way to reward innovators for their ideas, which therefore encourages creative endeavors. Patents have had a positive impact in creating some outstanding products, for example, in wireless technology. But when it comes to biological entities, the value of patents has been questioned, especially in the case of genes.

Since harmful changes in the BRCA1 and BRCA2 genes are strongly linked to heredity, a woman with multiple close relatives who have had breast cancer might choose to get a genetic test for these genes. In San Diego, she could go to one of several cancer institutes, including Moores Cancer Center at UC San Diego, San Diego Cancer Center or Scripps Clinic. Given a strong family history, a doctor might recommend a genetic test for BRCA1 and BRCA2. However, the doctor can only refer the patient to a provider that uses a genetic test developed by Myriad Genetics. Legally, this is the only test that can be used; no other company or institute can develop genetic tests for BRCA1 and BRCA2.

What does this mean for a patient who needs to get this test? Not only will she have to pay a high cost for the test, but might have to pay out-of-pocket depending on her insurance coverage. This decreases access to the test and might make it completely inaccessible if the patient’s funds are limited. Another serious concern is that there is no option for a second opinion about BRCA1 and BRCA2 genetic tests: all physicians have to rely on documentation provided by Myriad Genetics.

While these tests have gone through rigorous quality control, the benefit of having multiple groups develop tests allows comparison and selection of the best test, thereby improving testing quality. As ACLU argues, this monopoly is creating a barrier to innovation and causing more harm than good.

The debate about gene patenting has drawn international attention. An entire session was dedicated to discussions around the Myriad Genetics case at a joint meeting of the International Congress in Human Genetics and the American Society of Human Genetics, held in Montreal in October 2011. One of the presenters asked audience members, a majority of whom were researchers and clinicians, if gene patenting has affected their work. While it was not surprising that clinicians felt that gene patents have negatively affected their practice, researchers felt it did not affect their scientific projects.

However, this latter response will most likely change in the near future. Thanks to technological advances, genetic information is becoming increasingly accessible, to a point where the entire genome of a person can be sequenced. With gene patents in place, this will result in obvious complications since a researcher will have access to genetic information about patented genes. It is conceivable that a researcher would have to avoid looking at a gene for fear that doing so might result in patent infringement. However, there are some limited instances where a research exemption can be obtained to avoid infringing a patent.

For clinicians, genetic information is increasingly being used to help in diagnosis of a condition and also when prescribing medication. Gene patenting might prevent physicians and researchers from making scientific progress and could ultimately reduce the quality of care for patients.

The Myriad Genetics patents for BRCA1 and BRCA2 are set to expire in 2015. For this reason, it has been argued that there is no need to continue the debate since only a few years remain. However, due to the patents, Myriad Genetics has not shared any knowledge about specific gene changes with the scientific community. Once the patents expire, the company will be under no obligation to open up this information, therefore still slowing down development of new genetic tests for these genes.

Three years since the lawsuit was filed, court decisions have gone back and forth, first with a New York federal court making the patents invalid, only to be overturned a year later by the U.S. Court of Appeals for the Federal Circuit. Last year, the case finally reached the Supreme Court. However, less than a month ago, the Supreme Court sent the case back to the appeals court to re-evaluate their decision.

The Myriad Genetics case is only about two genes. However, whatever decision is made will set the standard for all other gene patents, which now add up to more than 20 percent of our genes.

Alka Malhotra, Ph.D is a genetic epidemiologist and writes as a member of the San Diego Center for Ethics in Science and Technology.

The Reuben H. Fleet Science Center and the San Diego Center for Ethics in Science and Technology will be hosting a free public forum on May 2 at 5:30 p.m. to further discuss the ethical issues surrounding human subject research. This is the last of a program series that will focus on the book “The Immortal Life of Henrietta Lacks.” Come join the conversation and share your perspective.

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