Pfizer Ireland Pharmaceuticals v Apotex Inc. [2014 FCA 13]
Background
This is an appeal of the summary judgment decision of Justice Zinn where he declared a patent invalid and not infringed by Apotex on the basis of the Teva decision (2012 SCC 60).
Canadian Patent 2,163,446 was previously litigated in the Teva decision where it was determined originally that the patent was invalid against the world in a NOC proceeding. This position was later reversed.
The only claims at issue in the present application are claims 5,6 and 7. Claims 2 to 5 are dependent on Claim 1. Claim 7 is the single compound sildenafil.
Teva succeeded in their claim because Pfizer had failed to adequately disclose the invention. Prior to the Teva decision Consolboard was the leading case on the issue. The approach in Consolboard has been adopted in numerous other Supreme Court cases including Monsanto Canada Inc., Whirlpool Corp., and Pioneer Hi-Bred.
Analysis
The Appeal was dismissed. The original judgment declared the patent entirely void which was surprising since the appeal originated as an application for prohibition under the NOC Regulations. These proceedings cannot result in a final determination of validity or infringement. The Supreme Court recognized this and amended their judgment accordingly.
Apotex’s current claim alleges insufficient disclosure. The day after the issuance of the initial judgment in Teva Apotex filed a motion seeking summary judgment. The motion was granted. An opposing motion must establish that there are genuine issues for trial. Pfizer was required to lead evidence that was capable of showing that sufficiency of disclosure could not be fairly determined without trial.
Pfizer attempted to do so but was unsuccessful. Justice Zinn concluded that the Teva decision bound him to reach a single conclusion.
On appellate review the question is whether the Judge erred in law or misapplied the test for summary judgment.
To overcome the Apotex motion Pfizer should have provided evidence that addressed how a skilled reader would construe the specification and why that construction could cast doubt on the correctness of the construction in Teva.
Pfizer pointed to testing related to claim 6 and its efficacy. The patent only disclosed that there was an especially preferred group and that studies had confirmed that one of the compounds was effective at treating erectile dysfunction. Nothing is disclosed indicating which compound.
Finally Pfizer argued that due to the nature of a summary judgment motion it did not have sufficient time to gather and prepare evidence. In response the Court states that Pfizer has been involved in numerous proceedings regarding this patent, most notably the Supreme Court decision dealing with precisely the same issue. The same issues were tried several times in other proceedings. Pfizer had ample opportunity to prepare.
Consequently the Court unanimously dismissed the Appeal.
Comments
On appeal the Court is clear about how Pfizer’s evidence on a motion for summary judgment was deficient. The Court indicates that Pfizer should have provided evidence regarding how the skilled reader would construe the specification. The Supreme Court judgment in Teva issued on November 9, 2012. Justice Zinn delivered his summary judgment decision on November 20, 2012. Pfizer argued that the Supreme Court of Canada exceeded its jurisdiction when it declared the ‘446 patent void(see paragraph 10 in 2012 FC 1339). Where the issue in this appeal lies is that the NOC process allows for multiple parallel challenges on the basis that each generic must obtain a Notice of Compliance. Each challenge is only valid between the parties. This is reflected in the availability of subsequent infringement actions. The dismissal of the appeal in this case is similar to the approach to judicial comity recently adopted by Justice Hughes for which he was subsequently rebuked. While stare decisis is always a relevant consideration when dealing with the Supreme Court, their decision is no more relevant in the context of a Notice of Compliance Application than in any other circumstance. Pfizer should have been provided an opportunity to lead new evidence and address deficiencies in their case just as they can in any other NOC process. Providing Pfizer with (at maximum) eleven days to prepare an adequate response to Apotex’s allegations does not seem consistent with fairness in the NOC context.
This decision may more accurately reflect Canada’s obligations under the forthcoming Comprehensive Economic and Trade Agreement to eliminate the duplicative process of NOC applications.