Appeal of Final Rejection - section 30(6) Patent
On June 4, 2010, the Patent Appeal Board ("Board")
determined that claims to a monoclonalantibody are enabled where
the antigen is a novel polypeptide which has been fully
characterized (for example by complete amino acid sequence). An
Applicant can now claim a monoclonal antibody that is
immunoreactive to the fully characterized novel polypeptide without
having made or deposited a specific embodiment. The Board permitted
the Applicant to make certain amendments which would overcome other
objections the Commissioner had and thus enable the patent
application to be allowed.
Prior to this decision, the Canadian Intellectual Property
Office ("CIPO") evaluated the patentability of monoclonal
antibodies based on the decision in Re Institut Pasteur
Application1 In applications disclosing a novel
antigen, CIPO's practice had been to permit a claim to an
antibody only if the specification included at least one working
example demonstrating the preparation of the monoclonal antibody.
In Institut Pasteur, the Commissioner held that in the
mid-1980s, the technique for producing monoclonal antibodies was
sufficiently uncertain that a mere reference in a patent
application to use of "traditional techniques" was not
In the present case, the Board concluded that the underlying
core technology of making monoclonal antibodies had matured to such
a point that by the late 1980's it was reasonable to say that a
person skilled in the art would generally not experience undue
burden in trying to make a monoclonal antibody immunoreactive with
a defined polypeptide. Accordingly, an exemplified antibody in the
description is no longer the minimal requirement to support a claim
to a monoclonal antibody. In coming to this conclusion, the Board
had regard to the practice in other jurisdictions in respect of the
patentability of monoclonal antibodies.
The Board determined that the application met the requirements
of enablement, sufficiency and utility. The Board held that because
the monoclonal antibodies of the application were enabled, it
necessarily followed that they would possess the ability to bind to
the immunizing antigen and therefore "the soundness of their
predicted utility is self-evident". The Board confirmed that
Canadian jurisprudence does not require an explicit mention of
utility in the description or claims and held that an expression of
utility in general terms is sufficient. The Board found that
post-filing evidence presenting results obtained without undue
experimentation or with methods known in the art can be taken as
indication that the specification was enabling.
In sum, this decision significantly changes CIPO's position
on the evaluation of the patentability of a claimed monoclonal
antibody in Canada. It eliminates the unique requirement that
evidence of production of a monoclonal antibody is necessary in the
description in order to claim the monoclonal antibody.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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