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 Poetic
License a Big "No No" in Patent Drafting: Changes to Canadian
Disclosure Obligations, Utility and Inequitable Conduct
Dr. Claire Palmer
In the recently released Federal Court decision
Ratiopharm Inc. v. Pfizer Limited
(2009 FC 711),
Justice J. Hughes has developed significant new law regarding
disclosure obligations, utility and inequitable conduct that,
if affirmed, may have far reaching implications for how
patent descriptions and claims are drafted in Canada.
In
this decision,
Canadian Patent No. 1,321,393 directed to the Besylate
Salt of Amlodipine was found to be invalid for: (i)
obviousness, (ii) being an invalid selection patent, (iii) a
lack of utility, (iv) a failure to describe the invention “as
contemplated by the inventor,” as required by Section 34(1) at
the relevant
time and (v) for misleading statements and
omitting relevant information from the specification in
violation of Section 53(2) of the Patent Act. This
brief summary is limited to a discussion of the last two
grounds of invalidity.
Section 34(1) reads:
An applicant shall in the specification of his invention
(a) correctly and fully
describe the invention and its operation or use as
contemplated by the inventor;
(b) set out clearly
the various steps in a process, or the method of constructing,
making, compounding or using a machine, manufacture or
composition of matter, in such full, clear, concise and exact
terms as to enable any person skilled in the art or science to
which it appertains, or with which it is most closely
connected, to make, construct, compound or use it;
[emphasis added]
Previously,
the Courts have limited its analysis of “sufficiency” to
“whether the patent itself describes sufficient information so
as to enable a person skilled in the art to put it into
practice” and have not assessed whether the patent
specification is an accurate reflection of the invention as
contemplated by the inventor. In previous cases, a lack of
evidence has required the Courts to “assume that the words in
the specification of a patent at issue coincided with what the
inventors contemplated”. The evidence presented in this case,
including the underlying data, various memorandums and witness
testimony of the inventors, provided Justice Hughes the unique
opportunity to compare the invention as contemplated by the
inventors with what the ‘393 Patent says. Justice Hughes
noted that
“where we have much evidence from the inventors themselves,
their colleagues and contemporaneous documents, the Court
cannot assume that the patent specification is an accurate
reflection of the understanding of the inventors.”
In making his findings of invalidity Justice Hughes was
heavily influenced by evidence presented detailing
discrepancies between the invention as contemplated by the
inventor and that contemplated by the patent agent/trainee who
drafted the ‘393 Patent and substantive “errors and omissions”
with respect to experimental results. Evidence was presented that Dr.
Wells, a named inventor on the ‘393 Patent had very limited
involvement with the preparation of the patent. Essentially,
Dr. Wells’ involvement in the patent process was limited to
the preparation of a memorandum reflective of a “majority
decision” “with technical details to allow them to convert
it into a patent with ease.”
This “Patent Memorandum” was
“directed to both the besylate salt and the tosylate salt, and
also says that the mesylate merits patent protection” and
formed the basis of the patent application. Although the
initial “Patent Memorandum” described the two salts, the
patent “was drafted directed to the besylate salt alone.”
Justice Hughes noted “many serious errors, omissions,
insertions from elsewhere and departures in the ‘393 Patent in
comparison with what the inventors contemplated.” Justice
Hughes particularly noted that “[w]ords such as
“unexpectedly”, “unique” and “outstandingly suitable” used in
describing the besylate do not come from Dr. Wells or Mr.
Davison, the two named inventors or anyone else in the
scientific area of Pfizer.” Justice Hughes concluded that
these words “could only have come from the Pfizer patent
department after some person, an executive or a patent agent,
had decided to apply for a patent directed to besylate alone.”
Although Canada does not have an explicit statutory provision
direct to issues of fraud, Justice Hughes notes that Section
53 of the Patent Act “comes close”.
Section 53 of the Patent Act, corresponding to “New
Act” Section 53, says in part:
53. (1) A patent is void if any material allegation in the
petition of the applicant in respect of the patent is untrue,
or if the specification and drawings contain more or less than
is necessary for obtaining the end for which they purport to
be made, and the omission or addition is wilfully made for the
purpose of misleading.
(2) Where it appears to a court that the omission or addition
referred to in subsection (1) was an involuntary error and it
is proved that the patentee is entitled to the remainder of
his patent, the court shall render a judgment in accordance
with the facts, and shall determine the costs, and the patent
shall be held valid for that part of the invention described
to which the patentee is so found to be entitled.
Justice Hughes noted that the misstatements “served to enhance
the alleged uniqueness and outstanding characteristics of the
besylate salt, which characteristics were not true. These
misstatements and the selection of words such as unique,
outstanding and particularly suitable were the work of patent
draftsmanship not of the inventors. Referring to his earlier
decision of G.D. Searle & Co. Novopharm Ltd., 2007 FC 81,
[2008], Justice Hughes further noted “that proper disclosure
is essential and that intent to mislead can be inferred”.
Although this decision is currently under appeal, this case
highlights the importance of inventor involvement in all
aspects of the patent process. To ensure that the patent is an
accurate reflection of the invention as contemplated by the
inventor, the inventors should be actively encouraged to
participate in the drafting process
by reviewing the specification prior to filing.
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