The Federal Court of Appeal ("FCA") has ordered a
new trial in the STELARA litigation. As reported in the January 20, 2014 issue of IP Update —
Canada, earlier this year Justice Hughes of the Federal Court
concluded that Janssen Inc (Janssen)'s antibody drug
STELARA (ustekinumab) infringed
AbbVie's patent for the use of an antibody with certain
characteristics for the treatment of psoriasis, and that the patent
was valid (2014 FC 55). Following a second trial, Justice
Hughes granted AbbVie an injunction (2014 FC 489), reported in the June 2014 edition of Rx IP Update).
On October 28, 2014, the Federal Court of Appeal granted
Janssen's appeal of a pre-trial Order denying its request to
plead further prior art references, consequently set aside the
lower Court's decision declaring the subject patent to be valid
and infringed, and remitted the matter back to the trial court for
a hearing before a new judge (2014 FCA 242). The injunction was also set
aside (2014 FCA 241).
Janssen's appeal from the order dismissing its motion to
In allowing Janssen's appeal, thus permitting Janssen to
plead further prior art references, the FCA held that the Judge did
not give sufficient weight to all relevant considerations. In so
holding, the FCA acknowledged that the Judge relied on relevant
factors, such as timeliness, the extent to which amendments would
delay a trial and the extent to which a position taken by the party
seeking the amendment would require the other party to change its
position; however, it found the Judge failed to consider other
important factors including that the party seeking an amendment
must demonstrate that prejudice to the other party can be
compensated in costs and that allowing the amendment is in the
interests of justice. As the Judge failed to fully consider these
criteria, there was a legal error and the FCA considered the
matter de novo and arrived at a different conclusion.
Of particular importance to the FCA was that the Judge failed to
give proper weight to the interests of justice, indicating that
"it would have served the interests of justice that all the
relevant prior art be before the Judge to allow him to fully
address the issue of obviousness especially in a case where Janssen
was not on a fishing expedition for "the" piece of prior
art that would support its position" (indeed, the parties'
experts knew of the existence of one of the references and agreed
it formed part of the common general knowledge and it was alleged
that AbbVie's expert was an author of another reference). In
considering the criteria to be met, and finding that Janssen's
motion to amend should be allowed, the FCA cautioned that the
decision whether or not to grant an amendment is to be conducted on
the facts of each case.
To Continue the Trial or Start Fresh
Despite AbbVie's request that the matter be remitted only on
the issues of obviousness and overbreadth, the FCA held that the
matter should be retried on all issues because: (i) all issues were
decided by the Judge; (ii) the finding of infringement was
contingent on the finding of validity; (iii) issues of infringement
and validity were intertwined; and (iv) to do otherwise would
require the FCA to "transform itself into a court of first
instance" and "receive and assess the evidence, including
the fresh evidence, and draw conclusions on what findings may be
affected by the new documents." A new trial date has not yet
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
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Materials from a recent "refresher training" for examiners at the Canadian Intellectual Property Office (CIPO) highlight inconsistencies between CIPO's examination practices and Supreme Court precedent.
In this recently reported decision, the Court granted Apotex leave to deliver Fresh as Amended Responding Statement of Issues for the reference into AstraZeneca's damages or Apotex's profits, following the Court's decision that the ‘693 Patent is valid and infringed by Apotex.
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