On June 4, 2014 Justice Roger Hughes of the Federal Court released his public reasons for dismissing Bayer’s prohibition application against Apotex in respect of its generic YAZ tablets on the basis that Apotex’s non-infringement allegation was justified. His confidential judgment was issued on May 7, 2014 and Apotex received its NOC the very next day. The term of Bayer’s patent was not set to expire until August 31, 2020. For the full written decision see: Bayer Inc. et al. v. Apotex Inc. et al. 2014 FC 436.
Although not determinative, this decision addresses the somewhat contentious issue of whether the eligibility of a patent for listing on the patent register can be raised at the hearing of a prohibition application. In his reasons, Justice Hughes expresses the view that the PM(NOC) Regulations are “arcane enough”, stating that it “is time to put the matter to rest.” He found that eligibility can be raised at the hearing; however, Justice Hughes went further when explaining his reasons for doing so.
With reference to subsections 5(1) and (2) of the PM(NOC) Regulations, Justice Hughes found that there is nothing to preclude a generic manufacturer from raising “other relevant allegations”, such as eligibility. In doing so, Justice Hughes expressly distinguished so-called “mandatory allegations”, contained in subsections 5(1) and (2), from “other allegations”. The court appears to have expressly permitted the later, without providing guidance as to what constitutes non-mandatory relevant allegations that are capable of adjudication at the hearing of a prohibition application.
Justice Hughes also recognized a dichotomy when it comes to the burden. In his reasons, Justice Hughes differentiates between so-called “mandatory allegations” and “those raised outside subsections 5(1) and (2)” in so far as the burden is concerned. Accordingly, it would appear that the generic manufacturer bears the burden of establishing that the later type of allegations are justified, while the innovator bears the burden of establishing that the former type are not justified.
Given this, it is unclear whether other non-mandatory allegations will be seen in future PM(NOC) cases. It will be interesting to see if this reasoning is followed, especially given that eligibility was not determinative in this case.