The invention relates to a pharmaceutical composition containing a publicly known active ingredient named “antagonist of interleukin-23 (IL-23)”. Said active ingredient is the same as that contained in a cited invention.
Although therapeutic use is not clearly described in the claims, the purpose of the invention is to treat psoriasis by processing T-cells. Said purpose is also the same as that of the cited invention.
Even if an active ingredient and therapeutic use of an invention are the same as those of a cited invention, the invention may be determined to have novelty and inventive step if the invention is, for example, an invention which limits usage, dosage, and administration method.
However, in the case where an active ingredient and therapeutic use of the invention are the same as those of the cited invention, it is unusual that the court determines, after recognizing a newly discovered mechanism of action as matters specifying the invention, the invention to have novelty and inventive step because the matters specifying the invention are different from the matters specifying the cited invention.
More specifically, unless effects are described in claims of the invention and identified as the matters specifying the invention, in other words, unless a structure which produces the claimed effects as well as a structure which does not produce the claimed effect are described in the claims, the claimed effects cannot be acknowledged as a difference between the invention and the cited invention, and thus the invention cannot be found to have novelty and inventive step based on the claimed effects (if effects for an invention which are always produced by a specific structure are claimed, such claimed effects cannot be recognized to be matters specifying the invention). Therefore, novelty and inventive step cannot be determined to exist based on the mere discovery of a new (publicly unknown) mechanism of action inherent in a specific product because the merely discovered mechanism of action cannot be considered to be a matter specifying the invention.
In this case, the invention and the cited invention have the same purpose which is to treat psoriasis by processing T-cells. The cited invention disclosed the mechanism of action of “processing T-cells using IL-12″ (or prohibiting stimulation of T-cell by inducing Th1), while on the other hand, the invention of the new (publicly unknown) mechanism of action of “prohibiting the production of interleukin-17 (IL-17) by T-cells” was discovered.
Simply describing the mechanism of action of “prohibiting the production of interleukin-17(IL-17) by T-cells” in the claims results in merely claiming an effect which is always produced by an “IL-23 antagonist”, and the simply described mechanism of action cannot be considered to be the matter specifying the invention. In this case, the mechanism of action of the invention however was considered to be the matter specifying the invention because it was described as “intended use”. More specifically, even if both the invention and the cited invention relate to a treatment for psoriasis by processing T-cells, patients to whom the pharmaceutical composition is to be administered for the treatment can be selected based on the invention’s mechanism of action of “prohibiting the production of interleukin-17 (IL-17) by T-cells” and the cited invention’s mechanism of action of processing T-cells using IL-12 (or prohibiting stimulation of T-cell by inducing Th1); in other words, “use of the composition of the Present Invention 1 as medicine can be said to be a selective use for the treatment of patients who have shown elevated levels of IL-17”. Therefore, the newly discovered mechanism of action of the invention is recognized as the matter specifying the invention.
Therefore, it is not correct to understand that this is a case in which the court simply identified the newly discovered mechanism of action of the invention and found the invention to have novelty and inventive step. Rather, it should be understood that this is a case in which the court found the invention to be a “use invention” because the newly discovered mechanism of action makes it possible to differentiate patients who are to be medicated from those who are not to be medicated, and thus “intended use” of the invention is different from that of the cited invention. Conversely, when a new mechanism of action of a publicly known substance is discovered, novelty is determined to exist in an invention if the newly discovered mechanism of action of the invention is recognized as a matter specifying the invention by distinguishing a situation in which the newly discovered mechanism of action is shown and identifying the invention as a “use invention” to be utilized for such a situation, and further, an inventive step is determined to exist in the invention if the newly discovered mechanism of action could not easily be arrived at by a person skilled in the art. In that sense, this case is considered to have an important implication for a “use invention” as well as an “invention claiming effects”.
Writer: Hideki TAKAISHI
Supervising editor: Kazuhiko YOSHIDA
Contact information for inquiries: h_takaishi@nakapat.gr.jp
Hideki TAKAISHI (The person in charge of this Article)
Attorney at Law & Patent Attorney
Nakamura & Partners
Room No. 616, Shin-Tokyo Building,
3-3-1 Marunouchi, Chiyoda-ku
Tokyo 100-8355, JAPAN