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. (“Janssen”)
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 parties.1
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 injunction order.
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 infringed.
The matter was remitted to the Federal Court for a new trial before another judge.
Link to decision