Working Example Not Required To Show Utility, Support And Enablement Of Innovative Biologic Claims

Case: The New York Blood Center Inc. No. 2,308,623 (Re) (Patent Appeal Board)

Nature of case: Appeal of Final Rejection – section 30(6) Patent Rules

Successful party: New York Blood Center Inc.

Date of decision: March 8, 2012

Summary

Canadian jurisprudence on the patentability/validity of monoclonal antibody claims is relatively scant. However, the Commissioner of Patents, via the decisions of the Patent Appeal Board ("Board"), has recently offered specific guidelines on the subject. The latest decision on monoclonal antibody claims was rendered on March 8, 2012¹. The Board determined that some claims to methods of making antibodies and hybridoma cells that produce monoclonal antibodies against the Duffy blood antigen (especially the Fy^a and Fy^b polymorphs) were found to be soundly predicted. No working examples of such methods were included in the application as filed. Further, claims directed to antibodies and hybridoma cells produced by the accepted