Patentees in the antibody arts in Canada have long been dogged
by policy-based objections to claims that seek protection that is
broader than the example antibodies in their applications. Some of
these objections were recently reviewed by the author in a paper "Antibody Examination Practice at the Canadian
Patent Office: Immune to Change?" (Canadian Intellectual
Property Review (2014), 29(2): 225-258). In a landmark decision,
the Federal Court of Canada has upheld broad "use" claims
including functionally defined antibodies.
Many patentees will know that even conservative sequence
modifications in complementary determining regions (CDRs) are
objected to because, in the view of the Canadian Intellectual
Property Office (CIPO), undue experimental burden would be required
to make candidate mutants and determine which ones maintain
function. To sustain these objections, patent examiners point to
decisions of the Commissioner of Patents dealing with applications
from the late 1980s to early 1990s.
In a decision marking the first time that antibody technology
has been extensively scrutinized by a Canadian court, the Federal
Court of Canada upheld claims covering uses of a human anti-IL12
antibody for treating psoriasis in its recent decision in AbbVie Corporation v. Janssen Inc., 2014 FC
AbbVie, the patent owner, had unexpectedly discovered that
psoriasis resolved in a patient who inadvertently received a human
anti-IL12 antibody, termed J695 (briakinumab), made using phage
display technology. The "use" claims asserted by Abbvie
were not, however, limited by specific epitope, antibody sequence,
or method of production, though the claims did specify minimum
affinity and potency values.
Janssen makes and markets a human anti-IL12 antibody for
treating psoriasis under the name STELARA" (ustekinumab). This
antibody was not developed by phage display, but rather in mice
having a reconstituted human immune system. In fact, the
STELARA" product shares only incidental sequence identity with
J695 (about 50%), and also binds to a completely different epitope
The patent claims were counter-attacked by Janssen on the
grounds of obviousness, over-broad or "covetous"
claiming, and ambiguity. The Court upheld the claims, finding them
to be both valid and infringed by Janssen.
In his analysis of obviousness, the trial judge provided a
helpful and lengthy list of technologies from expert testimony that
he accepted as forming the state of the art as of March 1999. These
include methods of CDR modification and mutagenesis, CDR grafting,
antibody fragmentation, and activity testing, as well methods of
making human antibodies by either phage display or
immune-reconstituted mice. These are many of the very technologies
currently alleged to be non-routine by patent examiners in
applications filed well after the year 2000.
The inventive concept of the claims in issue was found to be
that psoriasis may be treated by the use of human antibodies that
bind to human IL-12, which antibodies have a stickiness of at least
the claimed amount and a potency of at least the claimed amount.
Before this discovery there was only hope that binding IL-12 would
treat disease, but this was an example where a patient had
successfully been treated. The Court noted the distinction between
the approaches to obviousness, where an invention that is
"worth a try" may not be "more or less
self-evident". In this case, the invention was not
self-evident having regard to the prior art, and thus it was not
obvious. The Court also found that the claims were not unduly
The attack on ambiguity focused on claim features pertaining to
minimum affinity and potency variables. Patent applicants may
recognize that such features often fall afoul of CIPO examining
practice, with examiners alleging that such features are
objectionable for "encompassing antibodies with spectacularly
high affinities". The trial judge found nothing ambiguous
about these limitations, stating that they simply conveyed minimum
standards. The trial judge indicated that the question of whether
an antibody with vastly higher affinity or potency would be
considered a patentable improvement was one best left for another
A decision like Abbvie v. Janssen has been long awaited in the
field of biologics. Although the Court cautioned that the validity
of the claims must be assessed on a case-by-case basis, the
decision should nonetheless embolden patentees to argue against any
objection to a pending application in which an examiner states that
any departure from a specific set of CDR sequences would result in
a lack of utility, or that putting a claimed invention into
practice would require impermissible inventive work. If claims have
previously been deleted from an application to expedite
prosecution, applicants should consider reintroducing these.
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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