Generic Not Yet in Market, Evidence of Inducement is Speculative

  • March 26, 2015

Bayer Inc., et al v. Pharmaceutical Partners of Canada Inc., et al, 2015 FC 388, (Roger R. Lafrenière Prothonotary)

March 26, 2015

Peter Wilcox and Frederic Lussier for Bayer Inc. and Bayer Intellectual Property GmbH
Tim Gilbert and Nathaniel Lipkus for Pharmaceutical Partners of Canada Inc.

This is a motion to strike portions of an application pursuant to the PM(NOC) Regulations.

The underlying proceeding is an application by Bayer seeking a declaration that a letter from PPC is not a notice of allegation and has no legal effect. In the alternative, Bayer seeks an order prohibiting the Minister of Health from issuing a notice of compliance to PPC for its proposed moxifloxacin hydrochloride product for injection until the expiration of three of Bayer’s patents, including the 424 Patent.

PPC moved for an order striking portions of Bayer’s application on the grounds that the application is scandalous, frivolous and vexatious or is otherwise an abuse of process. PPC maintains that Bayer’s evidence simply cannot support a conclusion of direct infringement or inducing infringement by PPC.

PPC did not file any evidence in support of its motion. It relies solely on the affidavit evidence served by Bayer in the main proceeding relating to the infringement or induced infringement of the 424 Patent.

Bayer’s counsel agreed during the hearing of the motion that the evidence of induced infringement by PPC boils down to the following evidence:

Based on the content of the PPC Product Monograph, if the PPC Product was to be marketed in Canada, as a pharmacist I would advise physicians that the PPC Product can be prescribed, used and administered in the same way as Avelox® I.V. It is therefore my opinion that, as instructed by the PPC Product Monographs, physicians would prescribe and use the PPC Product in the same was as Avelox® I.V., including co-administering the PPC Product with a normal saline solution in circumstances where the treating physician determines it to be advisable.

Bayer submits that the evidence is clear that PPC’s Product Monograph directs infringement of the 424 Patent and that the sale of PPC-Moxifloxacin will result in the infringement of the 424 Patent.

The Court found that the second branch of the test for induced infringement was not satisfied, namely: 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.

Here, obviously PPC’s product was not in the marketplace, and the evidence presented on inducement was characterized by the Court as being nothing more than “conjecture and speculation.” However, the Court stated that “If PPC does in fact induce or procure another person to infringe the 424 Patent, Bayer will have recourse in an action for infringement.

The Court found that PPC has established that it was plain and obvious that Bayer had no reasonable chance of success in showing that PPC is or will be inducing infringement of the 424 Patent, and therefore, the prohibition application as it relates to the 424 Patent will inevitably fail. As such it is “vexatious” within the meaning of s. 6(5) of the PM(NOC) Regulations.

By: Peter W. Choe, Gowling Lafleur Henderson LLP