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 Biotech
& Pharma: Divisional Practices and New Prosecution
Opportunities
Ariadni Athanassiadis
Evolving and increasingly more costly
patent practices in Patent Offices around the world are
challenging patentees with global filing aspirations to come
up with filing and prosecution strategies that allow them to
seek expeditious, cost effective and most importantly,
meaningful patent protection in jurisdictions of interest.
In the past and still today, one common
approach to address one’s Canadian patent aspirations was to
take claims allowed in the US or Europe and essentially place
these claims on file in a related Canadian application.
Canada’s deferred examination request system and the fact that
Canadian Examiners routinely consider aspects of related US
and European prosecution histories helped make this strategy
commonplace.
To default to this strategy however, in the
absence of considering how Canadian patent practice has
evolved relative to other jurisdictions and without
considering more broadly what it has to offer, may be
unnecessarily leading some applicants to limit their strategic
prosecution options.
Canada, as a member of the G8, is still one of
the most inexpensive jurisdictions for obtaining patents.
Business in Canada is also uniquely positioned to participate
in the most open movement of trade with the US. Fortunately,
Canadian patent laws also correspond closely with US patent
laws and therefore opportunities exist for consistent patent
protection to be obtained in both countries. Moreover, it may
be anticipated that with the operation of the Canadian based
International (PCT) Examination Authority and the continuation
of programs like the Patent Prosecution Highway, the review
work of Canadian Examiners will either by necessity, practice,
or reputation carry more and more weight with Examiners in
other jurisdictions considering related applications.
It is important, however, to keep in mind
differences between Canadian and US Patent Office practice.
Restriction practice is one notable aspect of Canadian Patent
Office practice that has evolved differently from the practice
of the US Patent and Trademark Office. Simply stated, in the
US applicants have come to expect it and in Canada applicants
do not.
In the US, this has had the consequence of
turning applicants’ attention more towards continuing
prosecution options as the path of least resistance in order
to expeditiously secure some initial scope of patent
protection, while still prosecuting for the full scope of
protection desired. By contrast, Canadian patent practice does
not provide for the filing of continuation applications and
terminal disclaimers which, in effect, allows applicants in
the US to obtain patents with claims that may not be
patentably distinct, so long as such patents remain commonly
owned.
Applicants in Canada only have the option of
filing a divisional application for a patentably distinct
invention described in an original application. The guiding
principle is that there can be only one invention claimed per
patent. The option to file a divisional application when more
than one invention may be described in the original
application may arise as a result of an Examiner’s restriction
(if more than one invention appears to be claimed), or may be
done voluntarily by an applicant.
This difference between Canadian and US
practice can give rise to a dilemma for applicants seeking to
align their Canadian and US claims. The dilemma is whether to:
(1) accept claiming less if it is not an option to devote more
resources and time to the prosecution of Canadian claims, (2)
try and claim all subject matter of interest based on one or
more US claim sets in a single Canadian application, or (3)
consider alternative prosecution strategies based on a
different claim structure than what may have been pursued in
the US.
This dilemma, however, might also be
appreciated as an opportunity for applicants to position their
claims, both within and outside of the Canadian legal
framework, in order to maximize the options for the future
exercise of rights as patentees.
For example, it is commonplace in the
biotechnological and pharmaceutical arts for applicants in
Canada and the US to have patent claims pending in a
genus/species relationship. In the US, depending on the
circumstances, one may first seek to expeditiously obtain
claims for a commercially “preferred” species (or sub-genus),
irrespective of whether it may in fact represent an unobvious
improvement over a genus. The option then remains to pursue
claims to the genus or other species in a continuation or
divisional application.
Under Canadian practice, similar circumstances
would instead lead one to consider either pursuing a complete
genus/species claim set in one Canadian application, or a
different claim structure in two or more applications, as may
be dictated by the inventive aspects embodied in one or more
species. In other words, claims to an unobvious species may be
allowable even when a genus encompassing that species has been
previously disclosed or filed for in an application.
When species claims are examined in an
application filed at a later date, or in an application filed
by a different applicant, examination generally proceeds with
more confidence that a faithful application of the tests for
novelty and obviousness will naturally not result in any
double patenting. In the context of a voluntary divisional
filing, however, the inquiry immediately takes on a heightened
anxiety to ensure that two patents are not granted for the
same invention to the same applicant, which may, or may not
translate into more conservative applications of the tests for
novelty and obviousness. Therefore, if a division in subject
matter is to be contemplated and be broken down along the
lines of a genus/species relationship, the species chosen for
a divisional application should be described in the
specification in such a way as to make it apparent to one
skilled in the art, that the species has some additional
inventive advantage not possessed as a whole by the genus
claimed in the original (parent) application.
Whether or not consistency in claim structure
in the US and Canada is of paramount importance, the
differences in Patent Office practice may be overcome by
opting to leverage the processes available for expedited
examination in Canada, particularly given the relatively
inexpensive costs of prosecuting patent applications in
Canada. Notably, upon the payment of a modest government fee,
applicants in Canada may request that the Commissioner advance
an application in the examination queue. There is no need as
part of this process to provide anything in the way of a brief
or search to assist the Examiner with the review of the
application. In addition, the Canadian Patent Office has
implemented a
Patent Prosecution Highway (PPH) Pilot Project
with the US which under defined conditions may allow
applicants to align their US and Canadian claims more readily
if claims have been found allowable in either jurisdiction.
Accordingly, genus/species claims found to be
allowable in Canada using procedures available for expedited
examination, can then be used to help achieve consistent claim
language in the US. Whether or not it is an objective to
maintain Canadian patent rights in the long run because of
regulatory considerations, the economics of such an approach
may well play out in favor of taking the time to prosecute
Canadian claims to allowance, if the overall costs with regard
to the prosecution of US and European claims are thereby
reduced.
For example, a search done by a Canadian
Examiner giving rise to an art objection that is successfully
overcome by the applicant with regard to a Canadian
application, may provide the threshold information necessary
to support a request for expedited examination in the US. If a
divisional strategy has also been successfully applied in
Canada, then the options for continued prosecution in the US
become more numerous and may even allow one to avoid having to
rely on terminal disclaimers as part of a US prosecution
strategy.
Finally, it is also important to keep in mind
that the more minimalist Canadian practice that exists with
regard to the division of subject matter may in fact be very
well aligned with the legal framework governing the exercise
of patent rights in Canada. Potential patentees are faced with
new strategic considerations today in view of: (1) the
continued oversight of the pricing of patented medicines by
the Patented Medicines Prices Review Board (PMPRB), (2) the
2006 regulatory amendments improving the availability of data
protection in Canada and (3) the 2006 regulatory amendments
impacting access to the injunctive-like relief available under
the Patented Medicines (Notice of Compliance) Regulations (PM(NOC)
Regulations) against potentially infringing generic
manufacturers.
In this greater context, some layering of
patent protection may be needed to leave all options open
while market assessments can be made of the impact of the
PMPRB on innovator drug sales. By not committing, however, to
the filing of numerous applications, innovators are less
likely to find themselves dealing with potential
inefficiencies under the new regulatory framework of the
PM(NOC) Regulations, and costs can be more effectively managed
until decisions on the long term course of patent rights in
Canada can be made for innovative drug products.
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