You Can’t Have Your Non-infringing Alternative and Eat it Too

Hospira Healthcare Corporation v The Kennedy Trust for Rheumatology Research 2020 FCA 191 Gleason JA: Stratas, Laskin JJA aff’g 2019 FC 1252 & 2019 FC 1253 Phelan J

            2,261,630 / infliximab / INFLECTRA

In the liability phase of Hospira v Kennedy Trust 2018 FC 259 var’d 2020 FCA 30 Hospira and others were found to have infringed the 230 patent by making and selling INFLECTRA, an infliximab biosimilar of REMICADE [FC 16-17]. They also had a second drug, REMSIMA, also an infliximab biosimilar. During the liability phase Hospira took the position that REMSIMA was the same as INFLECTRA in material respects and the liability trial proceeded on that basis [2]. During the damages phase of the proceedings, Hospira sought to amend its Statement of Issues to assert that REMSIMA was a non-infringing alternative, which it claimed disentitled the patentee to damages [2]. Phelan J, in unreported decisions, held that the proposed amendments were abusive as being a radical departure from the position taken by Hospira in the liability phase, and undercut the basis upon which the proceeding had taken place [5]. The FCA has now affirmed. The FCA noted that “While there may well be cases where a party may set out an alternative for the first time as part of the ‘but for’ world in the damages phase of a patent infringement matter, this is not one of them” [5].