F Hoffmann-La Roche
AG v Commissioner of Patents, 2013
This is an application for an order pursuant to s. 20 of
the Federal Courts Act and s. 53(2) of the Patent Act. It is not an action for
impeachment or infringement – there are no validity allegations. The
application concerns Canadian Patent No. 2,103,324. The remedy sought is either
a declaration amending page 2 of the disclosure or a declaration striking a
portion of the disclosure.
The validity of the patent has previously been challenged
and a prohibition order issued on consent. The difficulty that the Applicant
seeks to overcome is underlined below:
represented by the above mentioned general formula (I) have selectively
improved pharmacokinetic profiles in monkeys, viz., 4 to 7 times higher
maximum concentration (Cmax) of 5'-DFUR and 4 times larger higher area under
the curve (AUC) of 5'-DFUR in blood than the other compounds, and less intestinal
toxicity, and thus completed the present invention.
The Applicant is concerned that that phrase may overstate
the promised utility of all the claimed compounds based upon the use of ‘viz’.
If viz is interpreted to mean ‘namely, that is to say’ it would not be
accurate. From the Applicants perspective the use of ‘e.g.’ was preferable.
The respondents only argued that s. 53(2) of the Patent Act was not open to the
The Applicant argued that section 53(2) is to be used to
allow the Court to correct a patent that contains an involuntary error to
ensure the patent is held valid. Section 47 and 48 may have provided some
remedy to the patentee. Reissue (s.47) is only available within four years of
the date of the original issuance of the patent and so is not available. Additionally
the Applicant does not want to utilize disclaimer as it would potentially
deprive them of their invention.
The Applicant submits that, based upon s. 12 of the Interpretations Act, legislation must be deemed remedial and
the lack of remedy in the Patent Act makes
it possible to use s. 53(2) to deal with the mistake.[23-24]
Section 53 of the Patent
Act cannot be used to correct a patent that contains an involuntary error. The
subsections of s. 53 must be read in conjunction. When that is done it is clear
that where a patent would otherwise be declared void the s. 53(2) exception
will be of assistance.
The Applicant argues that s. 53(2) can be a standalone
remedy – the patent need not be at risk of being declared void to make the
argument. Read as a whole a patentee must fall under s. 53(1) first in order to
qualify for the application of s. 53(2). The error must relate back to s. 53(1)
or else s. 53(2) cannot apply.
No one is arguing before the court that the recognized
error actually qualifies to render a patent void. The basic requirement of s.
53(2) is therefore not met.
Alternately relief under s. 53(2) cannot easily be
applied in the circumstances. Amending a patent as sought by the Applicant is
not a remedy available under s. 53(2).
The Attorney General argued that if s. 53(2) were applied
in the way the Applicants seek then it would render s. 47 meaningless. The
Attorney General also pointed out that this application functioned essentially
as an ex parte application that could
defeat imminent litigation. It is for Parliament to confirm a remedy such as
this exists. It may be necessary for procedural safeguards to be put in place
to prevent this type of abuse.
Finally the Applicant had procedural issues. An
application was made under s. 20 since there were no infringement or
impeachment proceedings – or any proceedings at all. Section 53(2) only allows
a remedy where 53(1) is engaged. As such 53(2) cannot be used to launch an
independent application – it only fits s. 53(1).
The present case presents an interesting example of the
stress being created by the current frenetic application of the "promise doctrine". Here the applicant went to extraordinary
lengths to try and remedy a potential issue that in other periods of patent
jurisprudence might not have attracted so much attention.