A U.S. Supreme Court ruling that says you can’t “own” DNA is a reason to celebrate for both consumers and innovative researchers. America’s highest court has ruled unanimously that “products of nature” cannot be patented. The ruling overturned a lower federal court decision to allow Myriad Genetics’ patent of two human genes—BRCA1 and BRCA2. This is going to have a positive effect on both cancer testing costs and genetic testing more generally.
As Mary-Claire King, the geneticist who discovered the BRCA1 gene, put it: “This is a fabulous result for patients, physicians, scientists, and common sense. When I was working on it from 1974 to 1994, it did not cross my mind that a legal case that would end up in the Supreme Court would be the consequence of my work and I’m so gratified that it was a unanimous decision.”
This ruling comes on the heels of massive press attention about BRCA1 and BRCA2 after actress Angelina Jolie went public in May about her double mastectomy. She chose that step because she had been tested and knew she possessed those gene mutations, which put her risk of developing breast cancer at greater than 80%.
About one in 500 to one in 1,000 individuals will carry a mutation or a gene change in one or another of these genes. If you have concerns about carrying the gene—such as cancer an your family history, you may wish to be tested. For Canadians, consumer access to BRCA testing has never been an issue as our health system has covered the cost for those who meet the criteria. (Myriad was charging $4,000 before the court ruling.) The patent decision means our health care system will now pay less for the tests. As taxpayers this translates to savings in the millions of dollars. (And for those who don’t meet the criteria for getting it done under the health plan, it’s now more affordable.)
As a pioneer (our clinic, Executive Health Centre, was the first to offer consumer genetic testing in North America) in genetic testing, I can attest that in the wake of the ruling pricing has already become more competitive. Companies including DNATraits and Ambry Genetics are now offering testing or analysis for thousands less than Myriad.
Most importantly, this ruling will have a ripple effect on all genetic testing. For example, with better access to genetic information, we can create more personalized treatment care, whether for customizing cancer chemotherapy or understanding if you need more fatty acids or vitamin D.
If you’re worried about Myriad, the company that just lost the right to patent DNA, don’t be. The company will be fine as it still controls the assay (the testing methodology) for BRCA gene testing and remains the global leader in this field of work. The U.S. Patent Office granted Myriad’s patent for the two genes and the assay in 1997 and more than 250,000 patients have used Myriad for BCRA1 and BCRA2 gene testing. Myriad (NASDAQ: MYGN) recorded sales in 2012 of close to US$550 million.
By claiming the actual gene, rather than just the test derived from the discovery of the BRCA genes, Myriad went too far with its attempted patent protection. That level of protection put the necessary balance between research and development, and commercialization and patient access, at risk. Its rather bold claim would have effectively prevented any laboratory from developing another, perhaps better and cheaper test, for the BRCA genes. These new entrants would need to get a licensing agreement from Myriad for anything they discovered related to the BRCA genes, which would effectively shut down future work by anyone other than Myriad in this area.
In this regard, the ruling also opens up opportunities for business.
In breaking Myriad’s monopoly on BRCA testing, the court decision paves the way for innovative newcomers to offer new and less expensive ways for testing BRCA. Free-market competition has now arrived in the field of genetic testing in the United States.
Will the ruling help buoy Canadian biotech firms? That remains to be seen. The Canadian Patent Office would have to reverse the Patent licenses it has granted to companies who have received them for what’s called single gene loci. Given the similarities between the Canadian Patent Act and its U.S. counterpart for the definition of ‘invention’, the Canadian Patent Office has for many years granted claims like Myriad’s to isolated gene sequences and continues to do so. To date, no Canadian court has questioned the patentability of isolated gene sequences.