GENEWATCH
 
RULING TO OVERTURN HUMAN GENE PATENTS IS A HUGE WIN FOR WOMEN’S HEALTH
By Karuna Jaggar
 

When it comes to our health, corporate interests and profits have been driving the agenda for a long time. There's no better example than breast cancer.

Over the last 30 years, companies have made billions of dollars off breast cancer by selling pink ribbon products with links to an increased risk of the disease; treatments that cost upwards of $100,000 a year extend life by a few weeks or months; early detection is wrongly sold as prevention; and breast cancer diagnoses continue to increase (most markedly in younger women) while lawmakers drag their feet on regulating toxic chemicals.

Until June 13, 2013, the commodification of breast cancer went all the way to our genes. But, I am proud to say, no longer.

In June the Supreme Court issued a historic ruling in favor of Breast Cancer Action and our co-plaintiffs in the landmark case Association of Molecular Pathology v. Myriad Genetics. The Court has rightly ruled that human DNA is a product of nature and is not patent eligible. With this sweeping ruling, the court has overturned one company's monopoly ownership of the human "breast cancer genes," creating an immediate and tangible benefit for women with a known or suspected inherited risk of breast cancer.

This change has been a long time coming. Ever since Myriad Genetics first patented the human BRCA 1&2 genes in the late-1990s, women and their doctors have been paying the price of one company's monopoly control of our genes. In 2009, when the ACLU filed suit against Myriad for patenting the very DNA in our bodies, Breast Cancer Action was the only breast cancer organization to join this landmark case as a plaintiff. We have been proud and honored to work over the years with all of our fellow plaintiffs and partners, including the Council for Responsible Genetics, to end the patenting of human genes.

This case matters. Many people shy away from phrases like "gene patents" but this seemingly abstract and esoteric case is truly life or death.

Through its patent, Myriad controlled both of the BRCA genes, and all possible variations and mutations, and all possible uses of those genes. No researcher or doctor could test for, study, or even look at the genes without permission from Myriad. And Myriad was extremely protective of its profitable patent, routinely blocking other researchers and clinicians from work which could benefit women living with and at risk of breast cancer. As a result, medical progress, scientific research and genetic testing have been blocked and limited by Myriad's patents. In the case of Myriad Genetics and the BRCA genes, we have seen a worst case scenario of what can happen when one corporation is allowed sole control over human DNA.

For approximately 15 years, Myriad's aggressive patent enforcement has meant that its BRACAnalysis test has been the only available test to determine whether someone has a genetic variant of the BRCA genes that increases their risk of breast and ovarian cancer. This monopoly means that Myriad was able to price the test at over $3,000, several times more than what other labs said they would charge. This high price has been prohibitively high for too many women who could not afford the test or whose insurance would not cover it. To deny access to genetic testing for BRCA mutations is to deny women potentially life-saving information.

Myriad's test is not only expensive, it is outmoded by today's standards. Myriad's monopoly meant there has been little to no incentive for the company to identify the significance of rare mutations of the BRCA genes - and other researchers have been blocked from studying these rare mutations. Women of color, including African Americans, Latinas and Asian Americans, disproportionately receive ambiguous test results. In essence, Myriad tells these women that they have a mutation on one or both of their BRCA genes, but Myriad doesn't know if this mutation is linked to an increased risk of cancer or not-putting these women in an impossible position. Meanwhile, no one could try to get better answers for them.

Furthermore, Myriad's patents made it impossible for women to get a second opinion. Thanks to Myriad's monopoly, women had no way to verify their genetic test results or get a second opinion about them. Most people expect access to a second opinion before any major medical decision, the absence of which has been especially impactful for women making decisions about increased cancer surveillance or even the removal of their healthy breasts and ovaries to reduce their risk of cancer.

The direct harms to women's health caused by Myriad's BRCA patents include not only the problems related to accessing meaningful genetic information, they extend to the control of scientific knowledge and medical progress. At a time when we desperately need new insights into cancer prevention, diagnosis and treatment, the human BRCA patents stopped vital scientific research and medical care connected to breast and ovarian cancer. One company has served for too long as a gatekeeper for all research into these genes and therefore set the research agenda - which was driven by corporate earnings from testing as well as future earnings based on all the bio-data they collected (and hoarded) from women's bodies.

For all these reasons, the Supreme Court's landmark decision to overturn Myriad Genetics' patents on the "breast cancer genes," BRCA1 and BRCA2, was a tremendous victory for women living with and at risk of breast cancer - and for all patients everywhere.

Women, and men, concerned about hereditary risk of breast and other cancers now have improved access to genetic testing. The very day of the Supreme Court's ruling at least 5 companies announced they would now offer BRCA testing at a fraction of the price of Myriad's BRACAnalysis test. Women who could not afford Myriad's test or whose insurance did not have a contract with Myriad, will now have lower-cost options.

For the first time, women who are considering their medical options will have access to second opinions. Myriad's test has never been peer-reviewed and the FDA does not regulate genetic tests. Second opinion testing is particularly important for women considering removing healthy organs to reduce the risk of cancer as well as for women who have received an ambiguous result from Myriad's test.

Furthermore, all labs, clinics, researchers and doctors now have access to the BRCA genes, opening the door to research and studies in new areas that may lead to clinical advances in diagnosis, risk reduction, and treatment. The door is now open to research and treatment for all hereditary diseases, without fear of patent infringement. This sweeping ruling ensures that the fundamental building blocks of life, our DNA, are available for scientific and medical inquiry and advance.

Some have questioned the impact of this case because the Supreme Court has ruled that cDNA may be patentable and because the case does not challenge the vast database of biospecimens accumulated by Myriad. While the specific impact remains to be seen in some ways and each represents an important area for monitoring and diligence, neither undermines the very significant benefit of this ruling for patients everywhere.

The Court found that cDNA is patent eligible, that is, it is a human creation, not a product of nature. However, the Court did not rule on whether it is patentable, that is, whether it meets the other requirements of the Patent Act. There has been much speculation that it will fail the obviousness test. And indeed the Court did not endorse patents on cDNA in general. This case does not address these issues, which will only be resolved going forward.

The impact of this ruling for patients is not diminished even if cDNA patents are upheld because laboratories can conduct genetic testing without using cDNA with next generation sequencing. For the first time since their discovery, Myriad no longer holds a monopoly on the BRCA genes and all naturally-occurring variations and mutations of these human genes.

The significance and impact of Myriad's business practice of hoarding of vast amounts of biodata accumulated over more than 15 years of monopoly testing also remains to be seen. Myriad maintains a proprietary database in which it treats genetic information as proprietary trade secrets rather than knowledge to be shared for the public good. The value of that database will diminish as publicly funded research identifies disease-associated and neutral mutations, and there are currently efforts to accelerate this. Additionally, it has been estimated that 98% of BRCA mutations are frame-sense and nonsense mutations, enabling genetic testers to provide accurate and useful information. While reassuring that the scope of the problem may not be as wide as feared by some, it remains true that the withholding of any potentially life-saving biological data is immoral and unjustifiable based on medical ethics.

We know that, in the realm of public health and medicine, and specifically the field of genetics, much remains to be seen and we still have work to do. This ruling demonstrates what we can accomplish working together in a diverse coalition to advance patient welfare and public health.

We have taken a tremendous step in putting patients before corporate profit when the Supreme Court made the right decision and ruled that human DNA is a product of nature and cannot be patented. This landmark ruling represents a major rollback of corporate control of our health and brings an essential diagnostic test into reach of more women. By freeing DNA, the building blocks of life, this far-reaching ruling opens the door to research and treatment for all hereditary diseases and firmly put patients before corporate profits.

 

Karuna Jaggar is Executive Director of Breast Cancer Action.


 
 
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