Identification of the factors that result in obviousness rulings for biotech patents: an updated analysis of the US Federal Circuit decisions after KSR.

To demonstrate the influence of the US Supreme Court's KSR case, our analysis has shown that the ratio of obvious ruling increased from 0.42 to 0.62 after this case, whereas the ratio of non-obvious ruling decreased from 0.47 to 0.28. Therefore, without the rigid application of a "teaching, suggestion or motivation" test, the trends of obvious and non-obvious CAFC rulings significantly increased and decreased, respectively.   Based on this analysis, biotech inventors should contemplate the factors that have resulted in ruling of obviousness, which include claims that are too broad, the lack of secondary considerations, the reasonable expectation of success, and the reason or motivation to create a structure based on structural similarity. The presence of these factors most likely would result in the rejection of the claim during patent prosecution or the invalidation of the claim in patent litigation. Two immunotherapy and vaccine cases have applied these factors to overcome the obvious rejections.