Monoclonal Antibodies Now Patentable in Canada Without Working Example


In a recently published decision, the Canadian Patent Appeal Board endorsed the principle established in other jurisdictions that in cases where an antigen is a novel polypeptide and has been fully characterized, a pioneering applicant can claim monoclonal antibodies that are immunoreactive with the polypeptide without the applicant actually having made or deposited a specific embodiment of such antibody. Prior to that decision, the Canadian Intellectual Property Office (CIPO) followed and relied upon a previous decision where claims to a monoclonal antibody were not enabled when the application failed to set out a detailed protocol or when the specification did not provide evidence of enablement in the form of the actual preparation of a monoclonal antibody.

This decision is a significant change in CIPO's previous rigid position on the patenting of monoclonal antibodies. Applicants will welcome the fact that actual physical preparation of monoclonal antibodies is no more a strict requirement for patentability and that the criteria of sufficiency of description of monoclonal antibodies in Canada is being aligned with that of other countries. It remains to be seen how this decision will impact examination of other types of antibodies, such as chimeric or humanized antibodies.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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