With recent court rulings in the US against Prometheus Laboratories and Myriad Genetics, rules issued by the Patent and Trademark Office say that for an invention to be patentable it has to be "significantly different" from natural products. These new USPTO guidelines, which are open for public comment through the end of the month, are causing angst among some biotech, Nature News' Erika Check-Hayden writes.
"The patent office has decided that because the decisions in these cases built on previous rulings that involved a wide range of natural phenomena and products, the policy should apply to all claims reciting or involving such laws of nature," she says. "But critics say that many existing medicines would not have qualified for protection under this standard — and that deserving patents are now being rejected."
Kevin Noonan, a patent lawyer at the Chicago firm McDonnell Boehnen Hulbert & Berghoff, tells her that no patents means no drugs. Additionally, Sherry Knowles, the former chief patent counsel at GlaxoSmithKline, says that about half of the drugs approved in the US between 1981 and 2010 would be rejected under these guidelines as they contain some natural product element.
While Check-Hayden notes that USPTO doesn't have to change its guidelines based on the public comments it receives, spokesperson Patrick Ross tells her it likely will.