On September 11, 2015, Justice Gleason released her public Judgment and Reasons in a prohibition application involving Apotex and Canadian Patent No. 2,379,948 listed on the Patent Register against two of Eli Lilly’s tadalafil products, CIALIS AND ADCIRCA. The 948 Patent is generally directed to pharmaceutical formulation comprising free tadalafil particles of a specific size, a diluent, a lubricant, and specific hydrophillic binders and disintegrants.
This is not the first time that the 948 Patent had been subject to litigation under the PM(NOC) Regulations. As we previously wrote about here, Justice de Montigny dismissed Lilly’s prohibition application against Mylan, holding that Mylan’s allegations of non-infringement and obviousness were justified.
Abuse of Process – 6(5)(b)
Based on a similar allegations of non-infringement and obviousness as raised in the Mylan proceeding, Apotex, following the Court of Appeal’s decision in Novopharm Ramipril, sought to dismiss the prohibition application as an abuse of process under paragraph 6(5)(b) of the PM(NOC) Regulations. Lilly, on the other hand, sought to distinguish Novopharm Ramipril on the basis that its appeal of the Justice de Montigny’s decision was still pending. After noting that decision to dismiss an application was discretionary and that Lilly would be more severely prejudiced if Apotex’ motion was granted:
 In the event Lilly is successful in its appeal of Justice de Montigny’s decision in Mylan Tadalafil III, it would be impossible for this Court to set aside a dismissal of this application and re-examine the prohibition application before September 27, 2015. Therefore, if I grant Apotex’ dismissal request, Lilly will lose its opportunity to seek an order of prohibition in respect of the 948 Patent in the context of Apotex’ request for NOCs. However, if it wins its appeal, it probably would have been entitled to an order of prohibition in the instant case.
 While this may result in unnecessary litigation (in the event the appeal in Mylan Tadalafil III is dismissed), this is preferable to the unfairness that would result to Lilly if this dismissal request were granted. I therefore determine that Lilly’s pursuit of this prohibition application while its appeal in Mylan Tadalafil III is pending is not an abuse of process and that I accordingly will not summarily dismiss this application.
Non-infringement & Obviousness
On the merits, Justice Gleason held that Lilly’s evidence of infringement, which amounted to nothing more than bald speculation, was insufficient to discharge its burden to demonstrate that Apotex’ allegation of non-infringement was not justified.
On obviousness, Justice Gleason held that Apotex was not prevented from advancing an inventive concept that differed from that set out in its Notice of Allegation, since this is a matter of construction that need not be set out in the NOA. Adopting Justice de Montigny’s determination of the inventive concept from Mylan Tadalafil III, and after discounting the credibility of Lilly’s expert, Justice Gleason held that it was more or less self evident that reducing the particle size of tadalafil would result in the improved stability and dissolution.
A copy of Justice Gleason’s Judgment and Reasons may be found here.