Although reading the CAFC opinion on Otsuka Pharmaceuticals Co., Ltd. v. Sandoz inc. et al. is painful for those of us who have strayed away from the chemical rings (it also points out why we call our colleagues with PhD’s in organic chemistry “Lords and Ladies of the Ring”), the opinion makes those of us who practice mostly outside of the chemical area jealous of the obviousness analysis for chemical composition. As stated in Takeda, the obviousness analysis for a claim for a chemical composition starts with the identification of a lead compound that would be the most promising to modify and, after identifying the lead compound, determines whether the prior art would have provided a reason or motivation to modify the lead compound in a manner that shows obviousness of the claimed chemical composition. Otsuka sheds more light on the identification of the lead compound, such as the fact that mere structural similarity between the chemical composition of the proposed lead compound and the claimed chemical composition is not enough.
Those of us who are somewhat outside of the chemical area look at this and grow green with envy. The Takeda approach has a strong similarity to the European problem-and-solution approach. In the European problem-and-solution approach to the examination of inventive step (a.k.a. obviousness), the first step is the determination of the “closest prior art.” In determining the closest prior art, the first consideration is a similar purpose or effect. In order to determine non-obviousness, the problem being solved by the claimed invention is identified and a determination is made as to whether it was obvious to provide the differences between the claimed invention and the closest prior art in order to solve the problem.
Comparing the two approaches, the Takeda approach and the “problem-and-solution approach,” the lead compound is similar to the closest prior art. In the problem-and-solution approach, the determination of whether it would have been obvious to provide the differences between the claimed invention and the closest prior art relies on the “could/would analysis” – whether the prior art would (“not simply could, but would”) have led one skilled in the art trying to solve the problem to provide the differences between the claimed invention and the closest prior art. The “could/would analysis” is very similar to the second requirement in Takeda – the determination of whether the prior art would have provided a reason or motivation to modify the lead compound.
Although we are not clamoring for a return to the TSM approach that led to the KSR decision, the problem- and-solution approach, within the expanded framework for motivation given in KSR, would provide a rational approach to obviousness determination which will make the life of the patent practitioners more bearable. However, only the courts and mainly the CAFC, can get us there. The BPAI (soon to change names) can not be expected to make this change since it would be tantamount to “cooperating with the enemy.” I would not expect that the voice of a single blogger would have any impact on moving the CAFC. So, as Tom Lehrer would say, “Hip hip hooray, let’s hear it for the problem-and-solution approach!” Please join me in this chant.