Federal Court Grants Motion for Bifurcating Determination of Start of Liability Period under s. 8 of the PM(NOC) Regulations

Federal Court Grants Motion for Bifurcating Determination of Start of Liability Period under s. 8 of the PM(NOC) Regulations

Apotex Inc v  Pfizer Canada Inc, 2014 FC 159

In this proceeding Apotex claims damages pursuant to s. 8 of the PM(NOC) Regulations, while Pfizer counterclaims against Apotex for patent infringement.  The drug in issue is Atorvastatin, sold under the brand name Lipitor. [2]

In calculating these damages, a critical factor is the period of time Apotex’s Atorvastatin would have been in the market, but for Pfizer’s actions. Typically the start date for this period cannot be before the Minister of Health approves the generic drug. In this case, there were two such approval dates: an earlier date relating to a “patent hold” letter for amorphous Atorvastatin, and a later certification date for Atorvastatin PGS. [3]-[4]

Pfizer argued that the later start date applies since Apotex has never brought its amorphous Atorvastatin to market. Apotex, on the other hand, argued that it would have brought the amorphous Atorvastatin into market at the earlier start date if it had been able to do so then. [5]

Pfizer brought this motion for bifurcation to determine the issue of start date first and separately from other issues in the proceeding.

Motion is granted.

Pfizer sought bifurcation on the grounds that it would simplify litigation of the remaining issues by determining the relevant time period for calculating s. 8 damages. [25]-[26] Apotex, for its part, opposed bifurcation on the grounds inter alia that no significant time or expense would be saved by bifurcation since the start date was not a threshold issue and further litigation on the remaining issues would be necessary regardless of the outcome of the start date determination. [28], [30]

The Court confirmed that bifurcation is not limited to liability/damages, and held that “[i]t is open to the Court to bifurcate any issue which will result in the saving of time, cost and judicial resources.” [46]

The Court also held that for an issue to be eligible for bifurcation, it need not be a threshold issue determinative of the proceedings. The Court stated:

…the bifurcation of an issue need not inexorably lead to the resolution of the litigation in its entirety, it is sufficient that if, on a balance of probabilities, the determination of an issue will lead to a shorter trial, a more focused discovery, contained production and less expert evidence. [47]

Finally, the Court also stated that whether bifurcation will lead to a saving of cost and time must be given “some extra weight” in determining whether to bifurcate. [54] The Court found that there would be such savings in this case. [56]