Prospective patentees in the antibody arts in Canada have long
faced objections to claims that cover antibodies different from
those exemplified in their applications. This typically includes
non-exemplified antibodies defined in term of percent identity to a
reference sequence, and those having conservative sequence
modifications based thereon. Patent examiners at the Canadian
Intellectual Property Office (CIPO) usually allege that undue
experimental burden would befall a skilled person wishing to make
candidate mutants and determine which ones are functional. To
sustain such objections, examiners usually point to decisions of
the Commissioner of Patents dealing with antibody 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 55.
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 recovery, modification, mutagenesis, and
grafting, as well as activity testing and methods of making human
antibodies by either phage display or using immune-reconstituted
mice. These are many of the technologies that have, to date, been
deemed "non-routine" by patent examiners in applications
filed well after 1999.
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 an affinity 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 now under appeal, the decision
should nonetheless encourage applicants to argue against antibody
claim objections in which an examiner states that 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.
Previously published in LifeSigns - Life Sciences Legal
Trends in Canada
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).