Canada: Working Example No Longer Required to Patent Monoclonal Antibodies

Confidential Reasons released June 4, 2010

Summary:

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 enabling.

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.

LINK TO DECISION:

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Footnote

^{1 (1995), 76 C.P.R. (3d) 206 (P.A.B.)}

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