The Supreme Court’s unanimous decision to ban patents on human genes isn’t likely to be popular among companies that have staked their business around a gene-dependent patent, but it’s not entirely bad news for medical device maker and diagnostics companies.
"It’s good and bad," Jennifer Camacho, partner at the law firm Greenberg Traurig, said in an interview with MassDevice.com today. "On the balance, for medical device makers it’s probably good news. The reason I say that is because what the Supreme Court has done is shut the door on patent of human genes, effectively raising the bar for inventions in genetic technologies."
The ruling definitively invalidated Myriad’s claims, but it also rendered moot all other claims on human DNA by making them effectively indefensible in court. That means companies, universities and researchers are free to conduct research in areas that were closed to them.
The high-profile Myriad Genetics case hinged on a primary question: Does human genetic material, once it has been isolated by means of intentional intervention, represent a patentable material, a so-called "human-made invention," or is it inherently a "product of nature"?
Myriad maintained that its manipulation and identification of the BRCA1 and BRCA2 genes, which suggest a heightened risk of breast or ovarian cancer, had made the genes themselves an patentable invention. The Justices today ruled 9-0 that Myriad’s patents were invalid, setting a landmark precedent for research & development in genetics and diagnostics.
The decisions closes some doors for industry, but it opens others, Camacho told us. For medical device companies that have relied on patents that are "to the gene" or dependent upon the DNA itself to demonstrate novelty and patentability, the patent portfolio is likely to suffer.
"However, on the flip side all the other companies’ protection based on the gene itself is also at risk, which means that that opens the door to potentially use more information for screening, but putting on their diagnostic tools, for personalized medicine, those sorts of things," Camacho said.
Ultimately the Supreme Court ruling strips back just 1 part of patent protection for gene-based inventions, she added. Patent claims that rely solely on the gene in question, like Myriad’s BRCA1 and BRCA2 patents, are basically out the window, but many companies’ patents also claim novelty for methods of identification and use of the gene in a particular assay or in producing a recombinant protein.
"We’ve lost 1 layer here, intended in part to open up the field for additional invention and research and work that would be the subject of patent protection," she said. "There is meaningful paten protection still out there and available for genetic inventions."