One of the tenants of our patent regime is that an invention
must be “new” — it must not have
been previously disclosed to the
public. According to the Supreme
Court of Canada (SCC) in Apotex
Inc. v. Sanofi-Synthelabo Canada Inc., [2008] S.C.J. No. 63, a
patent claim will be anticipated
if: (a) the subject matter of the
claim was previously disclosed,
and (b) the disclosure would have
enabled a person skilled in the
art to practice the subject matter
disclosed therein.
As set out in Sanofi, the Canadian test for anticipation is premised on the approach recited in
Synthon BV v. SmithKline Beecham plc, [2005] UKHL 59. However, recent jurisprudence in the
U.K. appears to have shifted this
approach, resulting in a “
disclosure” requirement that is challenging to apply and may lead to
untenable results.
For pharmaceutical inventions,
even if a chemical compound has
been disclosed, a patentee may
nonetheless be able to procure patent protection by showing that the
compound has surprising and
unexpected properties that warrant a “selection” and a corresponding patent monopoly.
The invention in a selection
resides in the surprising and
unexpected properties of the
selected compounds. As stated by
the Federal Court of Appeal in
Eli Lilly Canada Inc. v.
Novopharm Ltd., [2010] F.C.J.
No. 951: “If a property, quality or
use in relation to one or more
&RYAN
EVANS
GEOFFREY
MOWATT
members of the genus is subse-
quently discovered, that discov-
ery may be an invention”.
Relying on I.G. Farbenindust-rie (1930), 47 R.P.C. 289 (Ch.D.),
the SCC formulated three criteria for a valid selection: (a) the
selection must secure a substantial advantage or avoid a disadvantage; (b) all of the selected
members possess the advantage;
and (c) the selection is in respect
of a character peculiar to the
selected compound(s).
In this context, the first stage of
an anticipation analysis is con-
cerned with disclosure of the
claimed invention — not disclosure
of the selected compound, per se.
As explained in Sanofi, “the person
skilled in the art is reading the
prior patent to understand
whether it discloses the special
advantages of the second inven-
tion… If …the special advantages
of the invention of the selection
patent are not disclosed, the genus
patent does not anticipate the
selection patent.”
In Dr. Reddy’s Laboratories v.
Eli Lilly, [2008] EWHC 2345
(Pat), Justice Floyd considered
whether olanzapine was “
disclosed” by a genus patent that generally described more than “ 10 billion billion” compounds. Although
part of a narrower subset of preferred compounds, olanzapine was
not individually identified.
Adopting the European Patent
Office’s (EPO) approach concerning items previously described by
a genus under the European Patent Convention, Justice Floyd
held that “a general formula with
multiple substituents chosen
from lists of some length will not
normally take away the novelty of
a subsequent claim to an individual compound.” Rather, a disclosure of the compound in “
individualised form” would be necessary
for anticipation.
Affirming Justice Floyd’s decision, Lord Justice Jacob equated
any potential disclosure of olanzapine within the original genus to
hiding a leaf in a forest — “It is, at
least faintly, ridiculous to say that
a particular leaf has been made
available to you by telling you that
it is in Sherwood Forest. Once
identified, you can of course see it.
But if not identified you know
only the generality: that Sherwood Forest has millions of
leaves.” However, Lord Justice
Jacob declined to go into what is
sufficient to amount to an “
individualised description” ([2009]
EWCA Civ 1362).
By focusing on the disclosure
of an individual compound, rather
than its advantages, the U.K.
courts appear to have adopted a
troublesome approach to the
issue. For instance, quantifying
how narrow the originating genus
must be to comprise an “
individualised description” on a case by
case basis becomes a subjective, if
not arbitrary, task.
Further, the jurisprudence in
both the U.K. and Canada has held
that a selection patent is no differ-
ent than any other patent. To rec-
oncile this view with the Dr. Red-
dy’s approach means that an
“individualised description” is a
necessary element of any anticipa-
tion analysis. Indeed, Justice Floyd
has recently suggested, albeit in
obiter, extending the same
approach to claims in which a
range of values are specified (for
example the amount of an excipi-
ent in a composition) in H. Lund-
beck v. Norpharma, [2011] EWHC
907 (Pat). In particular, Justice
Floyd opined that, absent clear
directions in a prior reference to
use a specific value within a range,
there would be no anticipating
disclosure even if the range over-
laps with that in a claim. The EPO
has taken a different approach to
this issue, considering whether the
skilled person “would find it diffi-
cult to carry out the prior art teach-
ing in the range of overlap.”
A key shortcoming in Dr. Red-
dy’s is exposed by restating the
anticipation question: “what
would infringe if later, anticipates
if earlier” (see Abbott Laboratories
v. Canada (Minister of Health),
[2006] F.C.J. No. 782). The con-
verse should also hold true. Thus,
using the Dr. Reddy’s approach, a
genus claim that is held not to dis-
close a specific compound within
its scope must also not be infringed
by the manufacture or use of that
compound. If this were so, count-
less genus claims would have little,
if any, value to patentees.
Geoffrey Mowatt and Ryan
Evans practice intellectual prop-
erty law and litigation at Dimock
Stratton LLP in Toronto.
Strong patent laws good for the future of medicine
Labelling not
Patent
Continued From Page 13
it by attacking the patent system
not only misses the point but
could have serious fallout in the
long term.
Patents are key to stimulating
research and development in
medicine; in return for disclosing
a valuable discovery to the public
early, an inventor receives a time-limited grant of exclusivity in the
form of a patent.
Looking back, a good example
of the path from discovery to hos-
pital bedside is provided by taxol,
a potent, naturally occurring
anti-cancer drug which previ-
ously had to be harvested from
the bark of the Pacific yew at
great ecological cost. From its
discovery, it took 26 years to
arrive at a system for producing
this compound in the lab and
scale production to meet demand
(reliance on dwindling supplies
of Pacific yew ended in 1993).
Without the incentive of a pat-
ent, what impetus will there be
for others to assume the risk of
similar research and develop-
ment costs?
Graeme Boocock is a Technical
Advisor at the Ottawa office of
Borden Ladner Gervais LLP. His
doctoral research was carried out
at the Hospital for Sick Children
in Toronto, where he was on the
team which discovered the gene
mutated in Shwachman-Dia-
mond syndrome.
mandatory in
Canada
Food
Continued From Page 13
around the labelling of GM food
because in North America genetic
modification plays a major role in
agricultural biotech and is generally accepted by the industry and
most consumers as a reality.
“The question has come up as
to whether Canadian regulators
will require mandatory labelling
of GM food products, but they
haven’t done so yet,” says de
Beer. “Whether that should happen depends, technically and
legally, on a science-based
assessment of risks. But social,
cultural, ethical and other considerations cannot be ignored in
appreciating consumers’ sensi-tivities and in developing overarching policies.” n
