TOPICS

Overview:

This case concerns a case seeking to overturn an appeal decision that dismissed a request for a patent invalidation trial.

The court dismissed the plaintiff’s claim.

▶Summary of Judgment and Link to Full Text (in Japanese)

Main Issue:

Whether the differences between the invention at issue in the appeal decision and invention taught in the cited document (the invention of Plaintiff’s Exhibit 3) could have been easily conceived of by a person skilled in the art.

Summary:

Finding of similarities and differences between the invention at issue and the invention of Plaintiff’s Exhibit 3

In identifying the points of similarity and difference between the so-called “use invention” of the present invention and the cited invention, it is necessary to examine whether the cited invention can be recognized as a use invention, and similarity as use inventions cannot be extracted, this should be clarified as a difference.

Furthermore, particularly in the field of pharmaceuticals, unlike technical fields such as machinery, it is often difficult to predict the action or effect from the structure (i.e., a chemical substance specified by a chemical formula). Typically, it is only after a time- and cost-intensive process—such as conducting animal experiments or clinical trials to clarify efficacy for the target disease, or performing experiments that demonstrate that a specific mechanism of action possessed by the chemical substance is closely related to efficacy for the target disease, thereby verifying feasibility—that a use invention is completed. In light of this, for a cited invention to be recognized as a use invention, it must be disclosed with supporting data sufficient to allow the skilled person to trust that the substance (drug) is useful for the intended use, such that the person skilled in the art can understand and recognize its feasibility for the intended use. If this is not the case, a pharmaceutical use invention, which has been completed through the above process and is actually feasible, could easily have its novelty or inventive step denied by a cited invention for which feasibility is difficult to acknowledge, which would be an unjust result.

…

Accordingly, it should be concluded that it cannot be recognized that the skilled person would understand or recognize that the drug of the invention of Plaintiff’s Exhibit 3 can be used (is feasible) “for reducing the duration of off-time in patients with advanced-stage Parkinson’s disease”.

…

Therefore, upon re-examining the points of similarity and difference between the present invention and the invention of Plaintiff’s Exhibit 3, they should properly be identified as follows.

Points of similarity: [omitted]

Difference 1: The present invention is a “pharmaceutical agent” as a use invention “administered to a patient for the purpose of reducing off-time in wearing-off phenomena and/or on-off fluctuations in L-dopa therapy”, whereas the invention of Plaintiff’s Exhibit 3 cannot be recognized as such a use invention.

Difference 2: (omitted)

Concerning Difference 1

…even without considering the results of further experimental research on theophylline or adenosine A2A receptor antagonists, it cannot be said that Plaintiff’s Exhibit (a)3 provides motivation for the skilled person to apply the use of the pharmaceutical agent of the invention of Plaintiff’s Exhibit 3 to the use of the pharmaceutical agent of the present invention.

Comments:

The court did not adopt the plaintiff’s argument, which was predicated on the assertion that “the skilled person could recognize the use of the pharmaceutical agent of the invention of Plaintiff’s Exhibit 3 as the use of the pharmaceutical agent of the present invention”.

Kazuyuki YOSHIZUMI