No matter how much folks may differ on the implications of the Myriad case, everyone I spoke with or emailed agreed that the U.S. Supreme Court’s unanimous (9-0) ruling means no company can patent human genes isolated from the bloodstream. They also agree that the decision reaffirmed Myriad Genetics’ (NASDAQ: MYGN) right to patent a genetic test, but it also paves the way for competition in this and other aspects of personalized medicine, an area of biotechnology still learning to find its feet. But the bigger question the ruling raises is what the longterm implications will be for companies that develop products like vaccines that may be affected by the precedent set today.
Even Myriad’s stock performance was mixed. Initially it soared from $33.92 to a high of $38.27 falling back down to $32. So here are a variety of opinions from an analyst to scientists to legal minds.
Charlie Miller, equity analyst with Morningstar
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In an emailed comment Miller said: “There will be significant pricing pressure on BRAC Analysis in the future but not necessarily correlated with today’s ruling – more just as a function of technological advancements in the field (next-gen sequencing in particular).”
In his analyst note he said: “With fierce competition on the horizon and a possible paradigm shift in routine clinical practice, we remain cautious about Myriad’s ability to keep ahead of the field and withstand severe margin and pricing pressure. Simultaneously, we think it is too early to tell whether the company’s portfolio of emerging tests – including its new myRisk Hereditary Cancer Panel, designed to address this market evolution to multi-gene analysis – will effectively diversify its revenue base. If Myriad is unable to adapt, we believe forthcoming technologies may ultimately render its products obsolete.
Daniel MacArthur heads the MacArthur Lab at Massachusetts General Hospital and the Broad Institute to extract information from human DNA sequence data.
“These findings, while mixed, are generally good news for the future of genomic medicine. Myriad Genetics will continue to operate effectively in the breast cancer testing market, but this ruling opens the way for competitors to move into this important area of testing, which should bring prices down for women seeking BRCA testing. Most importantly, the court’s finding means there will be less uncertainty about the regulatory barriers to disease testing based on whole genome sequencing.”
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Dr. Hakon Hakonarson, director of Children’s Hospital of Philadelphia’s Center for Applied Genomics
“These patents [on the BRCA genes] were outrageous and I think the landscape will change drastically… A lot of institutions could not afford to do research because of the patent contingency. Many more people will be helped by [the Supreme Court ruling].”
Mary Anthony Merchant, partner and patent attorney in life sciences at Ballard Spahr
“For a long time there have been questions about who owns what [in the body.] Just look at the debate over Henrietta Lacks. I think this is along the lines of questions being asked now that we would not give ownership to something that belongs to everybody… What’s the point of having a patent on a gene? You can control who does what research.” She added that it raises questions about how broadly the ruling will be applied to biotechnology inventions that come from plants and bacteria. Merchant mused that in light of the the government initiative to map the human brain, it will be interesting to see what potential patent debates arise from whatever findings the scientists on the project make.
Matthew Kreeger of Morrison & Foerster
“There are not many inventions like Myriad’s [diagnostic] so the immediate impact of the ruling will be small. But the decision sets a precedent that could be applied to many other areas like vaccines, diagnostics and therapeutics. The question is how much? So many companies use reagents that isolated from nature. For If the example, a lot of vaccines contain a portion of bacteria – the original virus… After the dust settles, the decision may have an impact on commercialization down the road. ”
[Photo of Supreme Court from Flickr]
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