JULY / AUGUST 2008
How biotech patentees can navigate KSR
Ewa M Davison and Gary M Myles provide strategies for establishing non-obviousness in the biotechnology and pharmaceutical arts in light of the Supreme Court’s rejection of a rigid TSM test
| One-minute read |
| In overcoming an obviousness challenge asserted during patent prosecution or litigation, the patentee of a biotechnology or pharmaceutical invention must stress the unpredictability of the art and/or the absence of a reasonable expectation of success. Consequently, although inventions in these unpredictable fields are more vulnerable to a finding of obviousness post-KSR, several factors lend themselves to a strong non-obviousness argument. While practitioners can no longer rely on the absence of an express teaching, suggestion or motivation in the prior art to overcome an obviousness challenge, the approaches outlined here provide a roadmap for navigating the post-KSR non-obviousness framework. |
The US Supreme Court in KSR International Co v Teleflex Inc raised the bar for establishing non-obviousness, arguably the most easily challenged patentability requirement in the United States. By rejecting the Federal Circuit's requirement that the prior art contain an express teaching, suggestion or motivation (the TSM test) to combine the claimed elements of the invention, the Supreme Court encouraged an analytical shift towards a framework focusing on the predictability of the art and reasonable expectation of success. This article explores how this shift may be used to the patentee's advantage in the fields of biotechnology and pharmaceuticals.
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