Superior and Unexpected Results

Analysis This case presents an example where superior and unexpected results associated with a molecule (one enantiomer) conveyed patentability to the enantiomer over its previously disclosed (prior art) racemate. The case also introduces another mechanism through which patents can be defeated by demonstrating that the claimed subject matter is obvious. 

A basic, or prima facie, case of obviousness, which would otherwise defeat patentability, may in turn be defeated by one or more "secondary considerations [18]." One of the most commonly employed secondary considerations is a "superior and unexpected result [18]." At trial, Apotex... 

Thus, Sanofi had two superior and unexpected results that (1) the dextrorotatory enantiomer separated from racemate PCR 4099 contained substantially all of the antiplatelet activity and (2) was essentially devoid of the neurotoxicity associated with PCR 4099. 

In summary, Sanofi presented two superior and unexpected results, in the form of a highly significant combination of properties [associated with one enantiomer], as part of a point-by-point rebuttal of Apotex s arguments in its prima facie obviousness case. By doing so, Sanofi retained patent protection for Plavix. Superior and unexpected results can thus overcome a basic case of obviousness and confer patentability, even in the close case of an enantiomer compared to a racemate. 

A listing of all superior and unexpected results and their associated molecules should be provided as part of each invention disclosure to the patent department. 

MAKE SURE SUPERIOR AND UNEXPECTED RESULTS ARE BOTH SUPERIOR AND UNEXPECTED... 

Thus, in response to Pfizer s asserted superior and unexpected results, the court, at various places, reasoned a particular result (e.g., solubility, chemical stability, ease of manufacturability) was not superior, not unexpected, or both not superior and not unexpected. This analysis, combined with the court s dismissal of Pfizer s other arguments for nonobviousness, resulted in invalidation of Claims 1-3 of the 303 patent. 

Suggested Best Practices for Chemists "Teaching away" from, like a "superior and unexpected result," is another secondary consideration that can be used to defeat a primafacie case of obviousness [37]. 

This discussion raises two key questions. First, what type of unexpected or superior results are necessary to overcome an obviousness rejection in chemical cases Second, what part of the claimed invention must demonstrate unexpected results and what part of the art are the unexpected results determined in comparison to To answer these two questions, we ll break the inquiry down into the following four aspects ... 

The applicant can still submit comparative data demonstrating unexpected activity or superior results associated with compounds of formula I and the examiner will reconsider the rejection in light of all of the evidence of record. 

Until now, our primary organizing principle has been understanding a prima facie case of obviousness, the TSM test, and rebutting the prima facie case with unexpected or superior results. To enhance our understanding further, we will see how this obviousness framework has been implemented in regard to different types of chemical subject matter. By presenting the remaining material in this fashion, we can expand on the analytical concepts we have already introduced as well as provide additional specific examples of how that those concepts have been interpreted and applied in the chemical arts. 

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