On March 7 2018, the Federal Court of Canada (FC) held that Kennedy Trust’s Canadian Patent No 2,261,630 (630 Patent) is valid and infringed by Hospira’s (Hospira) biosimilar infliximab which is marketed as INFLECTRA (Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2018 FC 259).  The 630 Patent relates to the adjunctive use of methotrexate (MTX) and the anti-tumour necrosis factor-α [anti-TNF-α] antibody infliximab for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases. Infliximab (Janssen’s REMICADE) is only approved for the treatment of RA in Canada in combination with MTX.

The FC rejected a multitude of invalidity allegations raised by Hospira, including unpatentable subject matter, improper priority, novelty, obviousness, double patenting, insufficiency, overbreadth and utility/promise of the patent.  In particular, the FC found that experimental use exception applies to novelty and that utility is met if a “scintilla” of utility is demonstrated.

The FC also concluded that Hospira’s INFLECTRA infringed the asserted claims, finding that although the amino acid sequence of INFLECTRA has a single additional amino acid at the C‑terminal, this was known by the skilled person to have no impact on function.  The FC also rejected Hospira’s argument that the manufacture and sale of INFLECTRA was outside Canada particularly in reference to the Swiss-type claims.  The FC held that Hospira was still liable for infringement under the Saccharin doctrine.

In addition, the FC found that Hospira induced infringement by patient, concluding that Hospira’s product monograph amounted to instructions for infringement.

Summary By:  Junyi Chen

E-TIPS® ISSUE

2018 04 18

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