Eli Lilly sought an order of prohibition against Apotex until expiry of its patent for atomoxetine (the ‘735 patent). The ‘735 patent had previously been declared invalid by Mr. Justice Barnes in Novopharm v Eli Lilly in September 2010 for lack of utility (see the October edition of this newsletter). In these proceedings, Mr. Justice Barnes rejected all of Apotex’s allegations; including the lack of utility attack.
The Judge distinguished his two decisions on the basis that in Novopharm v Eli Lilly the parties addressed the utility arguments on the basis of considerable evidence pertaining to the merits of an earlier study. In this case, Apotex failed to address the study head on and instead attempted to have evidence in relation to the study excluded on evidentiary grounds. Furthermore, Apotex framed its arguments on allegations of lack of sound prediction whereas Eli Lilly said that a sound prediction analysis was unnecessary as the patentee had demonstrated utility. The Judge agreed with Eli Lilly.
In any event, because the ‘735 patent had been declared invalid in Novopharm v Eli Lilly, Apotex was granted a NOC for its generic product. The Judge thus dismissed Eli Lilly’s application for an order of prohibition on the ground of mootness and in doing so refused to declare that such a dismissal precluded Apotex from recovering damages pursuant to section 8 of the PMNOC Regulations.
The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2010/2010fc1065/2010fc1065.html