The Federal Court recently dismissed a motion to amend pleadings in a patent dispute between Janssen Inc. and Pharmascience Inc. Associate Judge Trent Horne's decision provides insight on when amendments to pleadings will be refused.
Background
The case involves two patents for pharmaceutical products containing macitentan. Canadian patent 2,659,770 covers macitentan's use combined with a PDE-5 inhibitor, while Canadian patent 2,621,273 covers a pharmaceutical composition with macitentan and other ingredients. PMS sought to amend its statement of defence to add a Gillette defence for both patents, claiming its product matched what was already disclosed in the prior art document WO 02/053557.
The Court's Analysis
For the 770 Patent, Associate Judge Horne found that allowing the amendments would create an "internally inconsistent pleading." PMS had previously asserted it would only engage in monotherapy (using macitentan alone), not combination therapy. Yet its proposed Gillette defence claimed the prior art taught combination therapy.
The Court noted: "PMS cannot simultaneously say that it will only make and sell a product for monotherapy, and also raise a defence for combination therapy." This inconsistency represented what the Court called a "radical departure" from PMS's previous position.
Further complicating matters, the 770 Patent had previously been litigated in Janssen Inc v Sandoz Canada Inc, where Justice Pallotta had concluded that macitentan in combination with a PDE-5 inhibitor "is not claimed" in the prior art document WO 557.
A Door Left Open
For the 273 Patent, Judge Horne found no similar inconsistency issues as it is a formulation patent where the existing defence is that the PMS product will not contain all essential elements. PMS could potentially argue both that its formulation is not disclosed in the 273 Patent and is disclosed in WO 557. However, the proposed amendments addressed both patents collectively without setting out "discrete material facts as they relate to each patent."
The dismissal for the 273 Patent was "without prejudice to PMS sending to the plaintiffs a proposed amended statement of defence that is consistent with these reasons."
The Court's Decision
While the motion was dismissed, Associate Judge Horne recognized that "success was partially divided." The Court awarded costs to Janssen, fixed at $2,000.00, "payable in any event of the cause."
The full decision is available here.
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