ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)

[Title of the patent] “ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)”

[Key issue] Inventive step, support requirement and enablement requirement (Article 29, paragraph (2); Article 36, paragraph (4), item (i); and Article 36, paragraph (6), item (i) of the Patent Act)

Regarding the support requirement issue, Court stated in the decision “A person ordinarily skilled in the art who read the description could recognize that various neutralizing antibodies competing with the reference antibody included in the scope of the claims of the Corrected Invention 1 (Claim 1) other than neutralizing antibodies competing with the reference antibody in the description might be obtained by repetitively implementing the production and selection of immunized mouse in accordance with a procedure and a schedule of immunization program in the description, the hybridoma generation in which a selected immunized mouse is used, and a screening and an epitope binning assay for identifying an antibody that strongly blocks a binding interaction between PCSK9 and LDLR in the description from the start.  Therefore, it is recognized that Corrected Invention 1 (Claim 1) conforms to the support requirement.” and maintained the patent.