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Working Example Not Required To Show Utility, Support and Enablement of Innovative Biologic Claims by Demian Barbas
Norton Rose Canada LLP - Montreal Office
Marie-Hélène Rochon
Norton Rose Canada LLP - Montreal Office
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August 2, 2012
Previously published on July 2012
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, 2012. 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 Fya and Fyb 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 method were also found to be sufficiently supported and enabled. The Board also suggested to include amendments to narrow the scope of some method claims to mirror more closely the experimental evidence (and the sound line of reasoning derived therefrom) presented in the application as filed.
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