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
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.
We advise that the Canadian Patent Office has now changed its
position. For the first time, the Board has decided that a working
example is not required to support claims to a monoclonal antibody.
The Board instead determined that, while the actual physical
possession of a hybridoma producing a monoclonal antibody is a
consideration that should not be overlooked, in cases where the
antigen is novel, not overly complex and fully characterised in the
specification, claims to a monoclonal antibody immunoreactive with
the antigen are allowable without the applicant having actually
made or deposited a specific example of the antibody or
This is an important decision for our clients who patent in this
area, and puts Canada in line with the U.S. and Europe. Clients
have continued to file Canadian patent applications with claims
directed to monoclonal antibodies, with hopes that the law might
change during the pendency of their applications. Now it has. On
behalf of our clients, Osler will be taking steps for all pending
applications to advance these claims based on this recent decision.
We also encourage any applicants avoiding Canada as a jurisdiction
within which to pursue patent protection for this subject matter,
to proactively file and prosecute claims for monoclonal antibodies
1. (2011) 89 C.P.R. (4th) 34.
Stephanie White is a Registered Patent Agent
with the Canadian Patent Office and with the United States Patent
and Trademark Office.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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