Takeda Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 751 (Barnes, J.)
July 30, 2015
Christopher Van Barr, Kiernan A. Murphy and William Boyer of Gowling Lafleur Henderson LLP for Takeda Canada Inc. and Takeda GMBH
J. Bradley White, Vincent M. de Grandpré and Geoffrey Langen of Osler, Hoskin & Harcourt LLP for Mylan Pharmaceuticals ULC and The Minister of Health
This was a proceeding pursuant to the Patented Medicines (Notice of Compliance) Regulations in which Takeda Canada Inc. and Takeda GMBH (collectively, "Takeda") sought an order to prohibit the Minister of Health from issuing a Notice of Compliance to Mylan for its generic version of Takeda's TECTA, containing the active ingredient pantoprazole magnesium.
At issue was Canadian Patent No. 2,341,031, the asserted claims of which essentially claimed pantoprazole magnesium dihydrate. Mylan alleged its proposed product would not infringe the 031 Patent on the basis that it would contain the hemipentahydrate of pantoprazole magnesium, and not the dihydrate. Mylan further alleged that the 031 Patent was invalid.
The Court held that Takeda failed to show Mylan's allegation of invalidity of the '031 Patent on the basis of anticipation was unjustified, and further held that Takeda failed to show the allegation of non-infringement was unjustified.
With respect to the question of anticipation, the issue was whether Example 10 of International Patent Application WO 97/41114 anticipated the claims of the 031 Patent. Since WO 114 did not inform the skilled reader the product of Example 10 was the dihydrate form of pantoprazole magnesium, there could be anticipation only if a skilled person following the example would inevitably or necessarily obtain pantoprazole magnesium dihydrate.
On this question, the Court accepted evidence of an experiment conducted by one of Mylan's experts which showed that Example 10 of WO 114 could produce pantoprazole magnesium dihydrate. The Court also considered that different choices of a skilled person in following Example 10 may have produced something other than a dihydrate. However, the only evidence in this regard, the theoretical concerns by Takeda's expert, was given little weight as the expert failed to conduct his own tests, and Takeda failed to cross-examine Mylan's expert on these theoretical concerns.
Regarding the issue of infringement, Takeda's expert opined that Mylan's product specification for water indicated Mylan's product was a dihydrate. The Court rejected this evidence as unsupported and refused to infer that Mylan's statements to the Minister were deceitful.
The Court further considered the assertion Mylan's product analyses confirmed that its product was a dihydrate. After reviewing the various data and the assessments thereof by the experts, the Court concluded that the evidence supported Mylan's allegation that its product was pantoprazole magnesium hemipentahydrate.
Finally, the Court rejected Takeda's contention that a negative inference against Mylan should be drawn because Mylan refused to produce samples and Mylan's disclosure of its process was insufficient to allow Takeda to replicate it. Under the circumstances of the case, sufficient information had been produced to allow for replication. In addition, Takeda's expert could have shown failure by attempting to replicate the process with the information available, but he had not done this.
By: Cheryl Cheung