The recent decision of the Federal Court of Appeal (FCA) in Hopsira Healthcare Corporation v. The Kennedy Trust for Rheumatology Research, 2020 FCA 30, offers helpful guidance from the Court in a number of key areas of patent law. In particular, the decision offers useful commentary on foundational patent validity issues of anticipation, obviousness and methods of medical treatment. The decision also confirms the scope of the Saccharine doctrine relating to domestic infringement for acts taken abroad.
Particularly with respect to anticipation and obviousness, the decision of the FCA appears to continue the trend, most notably arising from the Supreme Court in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, to focus on the primacy of the claims of the patent. The essential elements of each of the claims in issue are the primary focus of the inquiry, not the “special advantages” imported under the rubric of “inventive concept” or otherwise.
The decision related to four appeals from the trial decision of Justice Phelan in a patent impeachment and infringement suit. At first instance, the patent in suit, Canadian Patent No. 2,261,630 (630 patent) was found to be valid and infringed. On appeal, Justice Locke, writing for the FCA, allowed one of the appeals (the appeal on the merits) and remitted the matter to the trial judge on the issues of anticipation and obviousness.
The 630 patent related to the “adjunctive use of methotrexate (MTX) and the anti-tumor necrosis factor-α (anti-TNF-α) antibody ‘infliximab’ for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases”. The essential elements of claim 1 of the 630 patent were found to be as follows, a finding was not challenged on appeal:
- use of TNFα inhibiting monoclonal antibody (or Fab fragment thereof) for making a medicine;
- for performing adjunctive therapy with MTX;
- on a patient with active RA whose disease is incompletely controlled despite already receiving MTX;
- to reduce or eliminate the signs and symptoms of RA;
- where the TFNα-inhibiting monoclonal antibody (or Fab fragment) (a) binds to an epitope on human TNFα, and (b) inhibits binding of human TNFα to human TNFα cell surface receptors
The appellant took issue with numerous findings of the trial judge, including relating to claims construction, infringement, whether the 630 patent claims a method of medical treatment, anticipation, obviousness, double patenting and insufficiency of disclosure.