• Bifurcation of Infringement and Validity Issues in Section 8 Action
  • August 23, 2016 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • Apotex Inc. v. Alcon Canada Inc., 2016 FC 720
    Drug: Apo-Travoprost Z topical ophthalmic solution

    This is a motion for bifurcation in an action brought pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations"). Alcon was unsuccessful in proceedings brought pursuant to the Regulations relating to the '287 Patent and the '370 Patent. After Apotex came to market with its product, Alcon commenced an action alleging infringement of the '370 Patent and Apotex counterclaimed, alleging invalidity. Apotex commenced the within section 8 action. Alcon defended this section 8 action on the basis of, inter alia, infringement of the '370 Patent, the '287 Patent and the '172 Patent, which was not the subject of a proceeding pursuant the Regulations. The infringement action has proceeded quickly and trial dates for fall 2017 have been requested. The section 8 action has not proceeded quickly.

    Apotex brought this motion in the section 8 action, seeking to have Alcon's allegations of infringement, and its allegations of invalidity, of the '287 Patent and the '172 Patent determined before any of the other issues. The parties agreed that the findings in Alcon's infringement action relating to the '370 will be binding in the section 8 action. Alcon opposed bifurcation on the basis that Apotex was attempting to consolidate the infringement of the '287 Patent and the '172 Patent with the '370 Patent. Apotex responded that it was not seeking to consolidate. To address Alcon's other concern, Apotex offered to stipulate that its product would have been the same in the hypothetical world as in the real world.

    The Prothonotary considered the factors governing bifurcation and granted Apotex's motion. The Prothonotary noted that Alcon took the position that infringement would be a full defence to the section 8 claim or reduce Apotex's damages to zero, and thus found that there is a high likelihood that a finding of infringement would determine the second phase of the action or lead to settlement. The Prothonotary also noted that Alcon's infringement action is bifurcated. Costs were awarded in the cause and fixed in the amount of $3,750.