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IP Court Case Summary:2013(Gyo-Ke) 10311:

<Invention>

The title of the invention at issue is “Animal Model for Human Disease”. Claim-1 is “A non-human animal model for human neoplastic disease, said animal having neoplastic tissue obtained from a human organ implanted into the corresponding organ of said animal, and having sufficient immunodeficiency to allow said implanted neoplastic tissue to grow and metastasize.”

<Citations>

Citation-1 indicated the animal having the permeation of the tumor. Citation-3 and citation-4 indicated sub-cultured tumor tissue mass which caused metastasis of the tumor.

<Comparison>

The animal in Citation-1 showed only the permeation of the tumor whereas claimed invention is a model animal to the metastasis.

<JPO Board of Appeal>

JPO board of appeal approved the inventive step because of the following reasons;

There was not the common general technical knowledge that metastasis always happens in case of permeation.

Moreover, claimed invention used a tumor tissue mass itself which was gathered from a human organ. On the other hand, citation-3 and citation-4 used sub-cultured tumor tissue mass though these citations indicated metastasis of the tumor.

<IP High Court>

IP High Court finally reversed JPO board of appeal’s decision, and denied the inventive step of the claimed invention at issue. The reasons are as follows;

– In case that a tumor permeation is observed, permeation further spreads gradually, and the possibility of metastasis becomes high. At the time of the priority date of this patent at issue, generally, the knowledge as above was known as the common general technical knowledge on the aggravation of cancer process.

– Citation-3 and citation-4 are under “the homotopic transplantation” which is the same as citation-1. Therefore, it is predictable that the possibility of metastasis from the spread of permeation is high in citation-1.

(*) “The homotopic transplantation” means the transplant of a tumor tissue from the organ of humans into the corresponding organ of the immune deficiency model animal.

<Comments>

Metastasis and permeation of the tumors are different phenomena, but IP high court decided that the invention related to the metastasis is predictable from the invention related to the permeation based on the common general technical knowledge.

Therefore, the common general technical knowledge should be considered carefully in this technical field also in future.

http://www.ip.courts.go.jp/app/files/hanrei_jp/876/084876_hanrei.pdf