The Supreme Court ruled yesterday that companies could not patent human genes. This case focused on the BRCA 1 and 2 genes linked to breast cancer risk, but the U.S. Patent Office has issued patents on thousands of human genes, including genes associated with colon cancer, Alzheimer’s disease, and muscular dystrophy.
The unanimous decision was written by Justice Thomas:
Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
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As one the plaintiffs in the case, the ACLU was pretty happy:
We celebrate the Court’s ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalized medicine. … The ACLU and the Public Patent Foundation filed the case four years ago on behalf of twenty plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and women’s health advocacy groups, and patients. Few thought we had a chance against the decades-long Patent Office practice as well as the entrenched industry position. But litigation can be a strong tool in producing change, never more than when diverse communities come together.
The feeling was mutual among other people associated with the case, including Runi Limary, breast cancer survivor:
This is a monumental day for me and for everyone that has a known or suspected inherited risk of breast and ovarian cancer. This opens the door for researchers and access to testing which can potentially save lives. My test result showed that I have a variant of uncertain significance, so I do not know if I am BRCA positive or not.
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The Wall Street Journal’s take was that Myriad Genetics may have lost this battle but is winning the bigger war:
‘We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,’ said Peter D. Meldrum, president and CEO. ‘More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.’
Jim Greenwood, the President and CEO of the Biotechnology Industry Organization was not so sure:
The Supreme Court’s decision represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences. In addition, the Court’s decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions. The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences.
On the Stanford Medicine Scope blog, Jake Sherkow pointed out the unusual statement from Justice Scalia:
Bizarrely, Justice Scalia joined the Court’s opinion in its entirety except for its preliminary scientific discussion. In a separate concurrence, Justice Scalia wrote: ‘I am unable to affirm those details on my own knowledge or even my own belief.’
He also listed the questions that the decision did not answer:
What about other patents directed to “isolated and purified” natural products? Are cDNAs nonetheless obvious, and therefore unpatentable for that reason? And, considering the Court’s mention of retrovirii, how ‘unusual and rare’” must a ‘natural phenomena’ be to still be patent eligible if synthetically created? These are issues that the lower courts are likely to struggle with going forward, and issues that may, one day, be back in the hands of the Supreme Court.
[Image from the ACLU web site]
