The case of Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research (2018 FC 259) concerned Canadian Patent 2,261,630 (“the 630 Patent”) which details the adjunctive use of infliximab, an anti-TNF-α antibody, in combination with MTX for the treatment of rheumatoid arthritis in patients who do not respond fully to MTX alone. The Canadian Federal Court upheld the validity of the 630 Patent and granted Kennedy’s counterclaim that Hospira’s subsequent entry biosimilar INFLECTRA infringed the 630 Patent.

Hospira argued, in the words of Phelan J, an astonishing number and veritable panoply of patent law issues, including anticipation, obviousness, sufficiency, utility, and overbreadth. The common general knowledge of the person of skill in the art (POSITA) was one of the hotly contested issues in this litigation. Based on the evidence it was determined that the common general knowledge at the claim date of August 1, 1996 pointed away from what was claimed in the 630 Patent.

Significantly, regarding an attack on the sufficiency and utility of the 630 Patent, the Court rejected ─ consistent with other recent Federal Court decisions ─ attempts to import the discarded “promise” doctrine into the analysis of insufficiency and overbreadth. The Court held that, since the Supreme Court of Canada discarded the doctrine earlier, it would be inconsistent to allow it resurface under another principle without clear language to do so. Moreover, the Court held that the POSITA working with a “mind willing to understand” would be able to practise the invention as of February 1998, the publication date of the 630 patent, using only those instructions contained in the description.

In the end, the Court affirmed the validity of the 630 Patent and, despite manufacture outside of Canada, Hospira was liable for infringement under the Saccharin doctrine. The Court also accepted the product monograph as persuasive and uncontested evidence that INFLECTRA was to be used for the performance of adjunctive therapy (as defined by the 630 Patent) with MTX, which, corroborated by other evidence, established inducement of infringement. The Court concluded incisively: Hospira knew that infringement will occur. It is not possible or acceptable that Hospira “turn a blind eye” to what it set in motion. Further, if it did not know – it ought to have known. In both cases, Hospira is liable. Hospira may appeal as of right.