CaseBayer Inc. and Bayer Intellectual Property GMBH v Pharmaceutical Partners of Canada Inc. and The Minister of Health, 2015 FC 388

DrugAVELOX® I.V. (moxifloxacin hydrochloride injection)

Nature of caseMotion to strike portions of an application pursuant to paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”)

Successful partiesPharmaceutical Partners of Canada Inc.  (“PPC”)

Date of decisionMarch 26, 2015

Summary

Prothonotary Lafrenière issued an order pursuant to section 6(5)(b) of the PM(NOC) Regulations striking all allegations relating to one of three patents asserted by Bayer Inc. and Bayer Intellectual Property GmbH (“Bayer”). The order was sought by PPC in the context of Bayer’s application under section 6 of the PM(NOC) Regulations to prevent the issuance of a Notice of Compliance for PPC’s moxifloxacin hydrochloride injectable product. The Court held that it was plain and obvious that evidence in the PPC draft Product Monograph could not support Bayer’s allegation that PPC was or would induce infringement of Canadian Patent No. 2,378,424 (the “‘424 Patent”).

Background

PPC sought a Notice of Compliance for its moxifloxacin hydrochloride intravenous solution for injection to be marketed under the name PPC-Moxifloxacin. PPC compared its PPC-Moxifloxacin to  AVELOX® I.V., Bayer’s moxifloxacin hydrochloride intravenous solution for injection product.

Bayer brought an application under section 6 of the PM(NOC) Regulations seeking a declaration that a letter from PPC was not a notice of allegation and detailed statement for the purposes of the PM(NOC) Regulationsand had no legal effect; or, in the alternative, seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to PPC for PPC-Moxifloxacin until the expiry of three of Bayer’s patents, including the ‘424 Patent – the only patent at issue in the motion.

The ‘424 Patent is entitled “Moxifloxacin Formulation Containing Common Salt” for a moxifloxacin formulation for parenteral administration, including a formulation for intravenous administration. All 49 claims of the ‘424 Patent require moxifloxacin and sodium chloride within specified concentrations.

PPC brought a motion pursuant to paragraph 6(5)(b) of the PM(NOC) Regulations for an order striking the portions of Bayer’s application related to the ‘424 Patent on the grounds that those portions were scandalous, frivolous and vexatious or otherwise an abuse of process since Bayer’s evidence could not support a conclusion of direct infringement or induced infringement of the ‘424 Patent by PPC.

The evidence on infringement

Bayer conceded there was no evidence of direct infringement by PPC. Rather, Bayer alleged that PPC would induce or procure others (specifically, health practitioners) to infringe the ‘424 Patent as a direct result of PPC’s representations in its Product Monograph. Bayer asserted that PPC’s Product Monograph directed infringement of the ‘424 Patent and that the sale of PPC-Moxifloxacin would result in the infringement of the ‘424 Patent.

No induced infringement

The test for inducing infringement is articulated by the Federal Court of Appeal in Weatherford Canada Ltd. v Corlac Inc.: (1) the act of infringement must have been completed by the direct infringer; (2) the completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and (3) the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement.1 The Court held that Bayer failed to establish the second prong of the inducement test –  that the alleged inducer influenced the direct infringer on the basis that nothing in PPC’s Product Monograph established that PPC was influencing others to infringe the ‘424 Patent.

Since PPC had not yet commenced marketing its product, there was no evidence, other than speculation, that PPC would be seeking to sell its product in combination with sodium chloride, as claimed in the ‘424 Patent, nor of any overt attempt by PPC to influence or encourage others to infringe the ‘424 Patent. The Court held that the general and generic references to sodium chloride in PPC’s Product Monograph did not amount to inducement. There was no suggestion in its Product Monograph that PPC-Moxifloxacin should be substituted for, or used in the same way as, Bayer’s AVELOX® I.V.

Therefore, the Court held it was plain and obvious that Bayer had no reasonable chance of success in demonstrating that PPC was or would be inducing infringement of the ‘424 Patent. The motion to strike the portions of the application relating to the ‘424 Patent was granted pursuant to paragraph 6(5)(b) of thePM(NOC) Regulations.

Link to decision:

2015 FC 388 may be found here.