Case: Janssen Inc. v. AbbVie Corporation,
AbbVie Deutschland GMBH & Co. KG and AbbVie Biotechnology
Ltd. (A-95-14, A-270-14 and A-380-14)
Drug: Ustekinumab (STELARA®)
Nature of case: Janssen appeals : (i) a
motion to amend Defence and Counterclaim on prior art (A-380-14);
(ii) finding of patent validity and infringement (A-95-14); and
(iii) injunction order (A-270-14)
Successful party: Janssen Inc.
Date of decision: October 28, 2014
The Federal Court of Appeal allowed Janssen's appeals of
three decisions of Mr. Justice Hughes that resulted in an
injunction order against Janssen following a finding that
AbbVie's patent, Canadian Patent no. 2,365,281
("281 Patent") entitled "Human
Antibodies that Bind Human IL-12 and Methods for Producing",
was valid and infringed. The Federal Court of Appeal's reversal
was founded on the trial judge's failure to allow Janssen to
amend its Defence and Counterclaim with respect to prior art
references. As a result, the entire matter is now remitted back to
the Federal Court for a new trial before another judge.
Justice Hughes issued a decision on January 17, 2014 that the
281 Patent is valid and that Janssen had infringed the 281 Patent
through the manufacture and sale of STELARA® (see
Pharma In Brief dated January 2014). On May 29, 2014, Justice
Hughes issued a post-trial injunction order against Janssen in
respect of STELARA® (see
Pharma In Brief dated June 2014). This injunction has also been
the subject of contempt proceedings between the
Janssen commenced three related appeals of Justice Hughes'
decisions in that proceeding. In A-380-14, Janssen appealed Justice
Hughes' dismissal of its motion to amend Schedule A to its
Defence and Counterclaim (i.e., the list of prior art references) a
few months prior to the hearing. In A-95-14, Janssen appealed
Justice Hughes' decision that the 281 Patent is valid. In
A-270-14, Janssen appealed Justice Hughes' post-trial
Janssen should have been allowed to amend its pleading
Justice Trudel, writing for the Federal Court of Appeal, held
that Justice Hughes had misapplied the test and failed to give
proper consideration to the relevant factors when he refused
Janssen's motion to amend its pleading to remove and add other
prior art references. The interests of justice required that
Justice Hughes be in possession of all the relevant prior art when
he considered whether the 281 Patent was obvious at the claim date.
Any delay flowing from the amendment could be compensated by costs
to AbbVie and was outweighed by the interests of justice.
The Court of Appeal allowed Janssen's proposed pleading
amendment, and set aside Justice Hughes' decision that the 281
Patent is valid. The Court of Appeal also set aside Justice
Hughes' finding of infringement since it necessarily relates to
patent validity, and the post-trial injunction order since it
requires that the 281 Patent is first found to be valid and
The matter was remitted to the Federal Court for a new trial
before another judge.
1. AbbVie Corporation, AbbVie Deutschland GMBH &
Co. KG and AbbVie Biotechnology Ltd. V. Janssen Inc. 2014 FC
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