By Joe Allen, President, Allen and Associates
Recent Developments in Patentability: Prometheus and Myriad at the 2012 BIO International Convention was a very lively panel discussion on two cases that have set the life science industry on edge. The discussion presented an appropriate diversity of views as experts struggle with how broadly these cases should be interpreted.
Briefly, the unanimous decision by the Supreme Court overtuning a decision upholding the Prometheus patents by the Court of Appeals for the Federal Circuit raises more question than it answers. The panel reflected this uncertainty with Seth Waxman feeling that the case is narrowly applied to the facts of the Prometheus patents, while Neil Katyal held that the Court was sending a broad message reacting to overly broad patents being issued by the PTO and upheld by CAFC.
The impact on industry according to Kevin Marks is a cloud of uncertainty for a technology field requiring investments approaching pharma levels. He cited one instance where clinical trials alone for a diagnostic cost $70M.
Waxman underscored the chilling effect of Prometheus on the venture community which appeared stunned by the decision.
This uncertainty is heightened by the pending reconsideration of the Myriad patents by the CAFC ordered by the Supreme Court in light of Prometheus.
As many ‘gene’ patents originate in academia, industry may become reluctant to take further licenses when so much uncertainty continues to cloud the underlying patentability of the technology. While trade secrets present an alternative means of protection, they are not equivalent for building partnerships or attracting venture funding.
Finally, John Whalen mentioned the virtually unprecedented action by the Administration in overruling the judgement of the PTO in crafting it’s position in both cases. Their resulting briefs were virtually ignored by the Supreme Court in it’s decision making.
Briefs to the CAFC on Myriad were filed last week with agruments being presented on July 20. However, as reflected in the panel, it will be quite a while before we can fully understand the full implications of both decisions, and know whether Congress will be asked to step in to clarify a very murky situation that will certainly continue to hang over the industry.