Monoclonal Antibodies – Now Patentable In Canada Without A Working Example

Monoclonal antibodies (mAbs) are big business with a market that continues to experience significant growth as new therapeutic mAbs are created and indications for therapeutic mAbs expand. With biosimilars also entering the market, adequate patent protection for mAbs is of critical importance to our clients.

Prior to this recent decision of the Canadian Patent Appeal Board,¹ the Canadian Patent Office refused to allow patents for mAbs against a novel antigen, unless the application included a working example with evidence of actual production of a mAb. This position of the Canadian Patent Office has been a challenge for our clients, as Canada was out of line with other major jurisdictions, such as the U.S. and Europe.