6(5)(b) motion successful where Applicant’s evidence incapable of establishing infringement
On March 26, 2015, Prothonotary Lafrenière granted Pharmaceutical Partners of Canada’s motion to dismiss Bayer’s prohibition application in respect of Canadian Patent 2,378,424. The 424 Patent is listed on the Patent Register against Bayer’s moxifloxacin product for injection, AVELOX IV.
The 424 Patent is generally directed to an aqueous formulation of moxifloxacin and sodium chloride. While the excipients in PPC-moxifloxacin are redacted from the public decision, the parties agreed that PPC would not directly infringe the 424 Patent. Bayer, however, relied on a passage from PPC’s proposed product monograph indicating that that PPC-Moxifloxacin is compatible with six intravenous solutions, including sodium chloride for injection, to argue that the PPC’s proposed product monograph would induce infringement.
PPC brought a motion under 6(5)(b) of the Regulations seeking to dismiss the application in relation to the 424 Patent on the basis that it Bayer’s evidence, taken at its best, cannot support a conclusion of direct or induced infringement by PPC.
Prothonotary Lafrenière, applying the three-part test set out in by the Court of Appeal in Weatherford v. Corlac, concluded there was no reasonable chance that Bayer could show that PPC influenced the act of infringement:
In my view, Bayer has no reasonable chance of success on the second prong of the inducement test set out in Weatherford based on the evidence before the Court. Integral to the issue of inducement is the requirement that the alleged inducer influence the direct infringer. There is nothing in PPC’s Product Monograph that is capable of establishing that PPC will infringe the 424 patent by inducing infringement by others.
Prothonotary Lafrenière further held that generic references to sodium chloride in PPC’s proposed product monograph do not amount to an inducement:
Merely stating that PPC-Moxifloxacin is safe for dilution with one of six intravaneous solutions, including sodium chloride, or that it can be used in sequence with solutions containing sodium chloride, without more, is not sufficient to conclude that PPC is knowingly inducing healthcare practitioners to coadminister PPC-Moxifloxacin with sodium chloride.
Prothonotary Lafrenière accordingly dismissed the prohibition application in respect of the 424 Patent.
A copy of Prothonotary Lafrenière’s Reasons for Order and Order may be found here.
Bayer’s appeal of Prothonotary Lafrenière’s Order is scheduled to be heard on May 5, 2015.