Perhaps no other area of innovation is more critical to protect than pharmaceuticals and medical technology. But a piece today in Forbes discusses how a trend in Canadian courts may be threatening drug innovation by invalidating therapies and medicines already in use by patients on a wide scale.
Eli Lilly CEO John Lechleiter writes:
“Canadian courts have arbitrarily created – and retroactively applied – a standard for what is ‘useful’ under Canadian law. Applying the ‘Promise of the Patent Doctrine,’ the courts have set a standard found in no other developed country, and one that is more or less impossible for an innovative pharmaceutical company to consistently meet.”
He explains:
“When filing a patent application, an inventor must provide information describing the new invention. The internationally accepted standard for patent protection is that the invention must be novel, not obvious, and ‘useful or capable of industrial application.’
Over the past decade, Canadian judges have departed from this standard and have begun assessing utility of a patent by referencing a so-called ‘promise.’ To gain a patent, the inventor must ‘soundly predict’ how that invention will be used, and all the information packaged into the original application can be seen to imply a ‘promise’ of that invention. According to the reasoning of the judges, if the specific promise of the patent is not fulfilled, the patent is not useful.”
He concludes:
"This legal Rubik’s Cube makes successful acquisition and maintenance of a patent on an innovative new medicine in Canada essentially impossible.
Canada’s patent decisions not only fly in the face of long-established international standards, they’re highly subjective and completely unpredictable. It is impossible to know what specific 'promise' will be implied from an application, and how much data will be needed to support it. The standard seems to be that there is no standard."
To read the full article, please visit Forbes.com.