Apotex v. Pfizer 2013 FC 493

Drug: azithromycin

Apotex claimed damages from Pfizer pursuant to s. 8 of the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations). The hearing that resulted in this decision was solely to determine whether Apotex had a valid claim to damages. The Judge held that they did.

The Court held that it was bound by the previous construction of the patent, unless there were strong reasons to depart from that construction. The Court held that there were none. The Court also held that s. 8 did not create a free-standing right of action separate from the proceeding brought pursuant to s. 6 of the NOC Regulations. The second person is not permitted to, in effect, serve a second NOA on the first person by way of the s. 8 proceeding. Entirely new allegations of invalidity or non-infringement are not permitted. Thus, as the original NOA did not allege invalidity of the patent, Apotex’ invalidity claims were not heard by the Court.

However, Pfizer was entitled to test Apotex’ product now that it is on the market, and the Court heard evidence on that issue. The Court held that this evidence only amounted to the possibility that Apotex’ tablets may have contained a small amount of infringing material before the expiry of the patent. This was not enough to support a conclusion of infringement on a balance of probabilities. Thus, the Court allowed Apotex’ claim for s. 8 damages. The assessment will be conducted at a later date.