Even before the Supreme Court ruled on Myriad Genetics yesterday, there was talk in the biotech industry that a decision against the company’s patents would spell bad news for innovation.
Trade group BIO is among those expressing concern post-ruling about how young biotechs who have built their business models on DNA patents will fare. Others have said there won’t be as much incentive for companies to be innovative in the genetics space – or for investors to back those companies – if they can’t patent these discoveries.
But the theme among analysts, lawyers and scholars seems to be that the decision, which calls naturally occurring genes not patentable, will drive down the cost of genetic tests for patients without being too disruptive to the companies making them.
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“The cDNA (protected under the ruling) contains all the coding portions of the DNA sequence – that’s really important from the business perspective,” said Craig A. Nard, a professor of law and director of the Center for Law, Technology & the Arts at Case Western Reserve University. “Moreover, the court was quick to point out that the opinion does not address new and non-obvious methods for using DNA sequences. It does not address the innovative applications of using DNA sequences or alterations in the nucleotide sequence. It seems the court was aware of the implications of painting with a broad brush.”
In fact, most companies these days have moved beyond even trying to patent natural DNA.
Mary Williams, executive director of the Association for Molecular Pathology, one of the plaintiffs in the Myriad case, told Medical Marketing & Media that the decision will open the door for investment in diagnostics. “If you have a test that relies on patented DNA, you’re held hostage to whatever technology the IP holder chooses to apply, but with access to genomic sequencing open to all, companies are free to develop and market their tests and that’s a huge win for patient care.”
In the short time since the ruling, Ambry Genetics and Quest Diagnostics have both announced plans to offer BCRA 1/2 tests, which they couldn’t do under Myriad’s IP monopoly. University of Washington geneticist Mary-Claire King told Bloomberg she fully expects that many firms will enter the breast cancer testing market.
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The decision may also be good news for companies that previously had not pursued certain tests because of fear of patent infringement lawsuits, Dr. Debu Tripathy, a professor of medicine at the University of Southern California’s Keck School of Medicine told CBSNews.com.
Nard summarized that there are still incentives in place for biotech companies working in genomics, even without the ability to patent natural DNA. “There remains a great deal of economic value to be had, given that cDNA is patentable as well as methods and applications,” he said. “It was a nicely crafted compromise.”
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