Apotex Inc. v. Takeda Canada Inc., 2013 FC 1237

This decision provides answers to certain issues that would allow the parties to calculate the loss under section 8 of thePM(NOC) Regulations that arose from an earlier decision of the Federal Court. In that earlier decision, Apotex’s allegations of non-infringement for the product pantoprazole were found to be justified.

The issues left to be resolved in this proceeding included: 1) the burden of proof; 2) the number and identity of generic market entrants; 3) market share; 4) price; 5) inventory adjustment; 6) double ramp-up; 7) rebates; 8) interest; and 9) discretion to reduce the award based on Apotex’s misconduct.

This was a highly fact-based exercise, but the Court did decide to not deduct the “ramp up” period at the start of the relevant period because a “ramp up” was experienced by Apotex in the real world. In distinguishing precedent, the Court considered that adding it in a second time was seen as doubling the ramp up to the detriment of the generic company.

Prejudgment interest was calculated from the quarter proceeding the date the Apotex sent their statement of claim, calculated from the patent hold date.

Takeda had argued that the award should be reduced by Apotex’s alleged breach of undertaking. In the NOA, Apotex had stated that “[e]ach of the claims of the ’748 Patent includes as an essential element a Helicobacter-inhibiting anti-microbial agent. Our sodium pantoprazole tablets shall not contain said agent, as that term is construed in accordance with the claims of the ’748 Patent, nor shall our tablets be marketed or promoted to doctors, pharmacists or others to be used in combination with a Helicobacter-inhibiting anti-microbial agent or as part of a medicament package comprising said agent. As such, our tablets shall not infringe any of the claims of the ’748 patent.”

The Court declined to find that the allegation within Apotex’s NOA rose to the level of an undertaking to be relied upon by the Court. Therefore, the fact that Apotex took no steps to prevent the marketing and promoting of their product for the treatment of Helicobacter pylori was of no consequence.