The US 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.
Since it was announced on June 13, we’ve heard questions about the impact of this case because the Supreme Court ruled that cDNA may be patentable and because the case does not challenge the vast database of biospecimens Myriad has accumulated. 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 cDNA Question
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 at the US Patent Trademark Office. 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 Impact of Myriad’s Biodata Hoarding
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 treat 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. 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.
Learn more about what this landmark Supreme Court decision means in our free webinar with a panel of experts on June 25th.