Federal Court of Appeal Sets Aside STELARA® Decision

In Janssen Inc v AbbVie Corporation, 2014 FCA 242 (decision released October 28, 2014), the Federal Court of Appeal (FCA) set aside Justice Hughes’ decision (2014 FC 55) holding that the asserted claims from Abbvie’s Canadian Patent No 2,365,281 (281 Patent) were valid and infringed by Janssen’s psoriasis drug STELARA (ustekinumab) (previously reported in E-TIPS®). Prior to his decision on the merits, Justice Hughes had rejected a Janssen motion to amend the prior art references cited in Schedule A of its Defence and Counterclaim (2013 FC 1148). The FCA reversed Justice Hughes’ decision on this motion in 2014 FCA 242, finding that he had misapplied the test for pleading amendments, and in particular, that the interests of justice required him be in possession of all relevant prior art references. Because the amendment in question went to the heart of a key validity issue raised by Janssen (obviousness), the FCA set aside Justice Hughes’s finding of validity in 2014 FC 55, and also his finding of infringement, which was contingent on his finding of validity. The FCA declined to parse the issues and send back for re-hearing only those most directly affected by the amendment. Instead, a new trial was ordered on all issues before a new judge. In 2014 FCA 241, the FCA also set aside the injunction that had been granted by Justice Hughes in 2014 FC 489. Notably, in 2014 FC 863, Justice Brown held that Janssen was prima facie in contempt of Justice Hughes’ injunction order (previously reported in E-TIPS®). The setting aside of the injunction order may provide a defence to the prima facie contempt finding. For more commentary see: http://tinyurl.com/o43yw8z