The Manual of Patent Office Practice discusses
antibodies as a "special topic"; no other molecule is set
apart this way. The Commissioner's Decisions CD 1302 on monoclonal antibodies and the
recent CD 1398 on humanized antibodies, indicate that
the Canadian Intellectual Property Office (CIPO) is becoming more
amenable to treating antibody inventions according to the same
rules that apply to other molecules.
The applicants in CD 1302 and CD 1398 were represented by Smart &
When an application contains a claim for humanized antibody,
CIPO's practice has been to reject the claim for insufficient
disclosure unless a humanized antibody was actually made before the
filing date, or the CDR (Complementarity Determining Region)
sequences defining the antibody binding site have been disclosed in
the application. In a development favourable to applicants,
this practice is set to change with CD 1398 in re Chugai Seiyaku and Kabushiki
The application in CD 1398 is for a pharmaceutical preparation
comprising an anti-glypican 3 antibody for inhibiting abnormal
proliferation of hepatic and lung cancer cells. The
application disclosed two anti-glypican 3 mouse monoclonal
antibodies and showed in vitro that they displayed
activities relevant to cancer therapy. The application
disclosed known methods for making humanized antibodies but did not
disclose the CDR sequences, and there was no evidence that a
humanized antibody was made before the filing date.
The examiner allowed the independent claims which recite an
anti-glypican 3 antibody, but rejected the dependent claims that
specify a humanized anti-glypican 3 antibody. The
examiner's rejection rested largely on CD 1296 in Re Sloan-Kettering Institute
for Cancer Research which concluded that, based on the absence
of CDR sequence information and other factual considerations, the
specification in that case did not adequately describe or enable a
humanized antibody. CD 1398 reversed the examiner's
The Commissioner framed the issue thus:
Would the recited humanized
antibodies be correctly and fully described; and would the
specification enable the POSITA to practice the invention as
claimed without displaying inventive ingenuity or undertaking undue
experimentation in circumstances where there is no evidence
that a humanized antibody had been made and sequence information
regarding the variable regions of an anti-glypican-3 antibody is
not disclosed? [emphasis added]
On enablement, the Commissioner distinguished the present case
from CD 1296, stating that the evolution of common
general knowledge is an important factor and that CD 1296 cannot impose a rigid rule requiring
sequence information. The Commissioner noted that the
application at issue in CD 1296 was filed in 1990 while the subject
application was filed in 2002. In the intervening 12 years, common
general knowledge has evolved such that antibody humanization has
On written description, the Commissioner also distinguished the
present case from CD 1296, stating that the specification does
not need to disclose the CDRs if the humanized antibodies are
adequately described in other terms. The Commissioner referred
to CD 1302 in Re Immunex Corporation,
where it was decided that a monoclonal antibody is adequately
described by disclosure of the corresponding antigen because there
is a direct structural relationship and functional identity between
the antigen and the monoclonal antibody. The Commissioner
considered that the rationale in CD 1302 also applies to humanized antibodies
and, since the glypican 3 antigen is well characterized (in
contrast to the antigen in CD 1296), the humanized antibodies are
It is notable that until recently CIPO has required that a claim
for a monoclonal antibody be supported by actual demonstration that
such an antibody was made before the filing date. CIPO
changed its practice on monoclonal antibodies only in 2010 when the
Commissioner reconsidered the issue in CD 1302.
CD 1398 and CD 1302 signal a welcome change to CIPO's
practice towards giving antibody inventions equal treatment to
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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