Apotex Inc. v. Pfizer Canada Inc., 2013 FC 493  Drug: AZITHROMYCIN

In this case, Apotex claimed damages pursuant to s. 8 of the NOC Regulations, and Pfizer alleged that Apotex should not be entitled to damages, due to the principles of ex turpi causa relating to its alleged infringement of the relevant patent. The period of liability and the quantum of damages will be determined in a separate proceeding. The Court held that Apotex had made out its claim for compensation.

The Court held that, under the principles of judicial comity, it was bound by the construction of the patent performed by the judge in the NOC Proceeding, as
it had not been shown any reason to depart from that construction.

The Court accepted that there is a close connection between s. 6 and s. 8 of the NOC Regulations, as to hold otherwise would “create a duplicate regulatory alternative to infringement and impeachment actions under the Patent Act, one completely disconnected from the rest of the scheme of the Regulations.” (para 20). Furthermore the allegations addressed in the s. 8 proceeding must relate to the proceeding brought pursuant to s. 6. Thus, entirely new allegations of infringement or invalidity are not relevant in a s. 8 proceeding. Now that the product is on the market and can be tested, evidence can be introduced to show actual infringement. However, as the NOA did not raise issues of invalidity, such issues cannot now be alleged in the context of the s. 8 proceeding.

The Court held that it is settled law that the principles of ex turpi causa do not prevent a s. 8 proceeding from being brought. However, they do apply to the relevant circumstances a court should consider pursuant to s. 8(5). In this case, the Court held that Pfizer had not provided evidence to show, on a balance of probabilities, that Apotex infringed the patent at issue; they had only shown the possibility that the tablets may have contained a small amount of infringing material. Thus, the Court did not rule out the possibility that Pfizer’s evidence could be relevant to the amount of compensation appropriate pursuant to s. 8(5).

In this case, the Court held that Apotex must meet two requirements: 1) it must show that Pfizer’s application pursuant to s. 6(1) was dismissed; and 2) it must show it suffered a loss during the period it was kept off the market. Apotex was held to have met those requirements. Thus, Apotex’ claim was allowed, with quantum to be determined.