Apotex Inc. v Abbott Laboratories, Limited, 2017 ONSC 1348 Drug: lansoprazole
In this case, Abbott and Takeda brought a summary judgment motion as against Apotex, to dismiss the s. 8 proceeding in its entirety. As a preliminary matter, the Court held that the issues raised in the Applicant's factum were not enumerated in their Notice of Motion. The motion was restricted to the elements in the questions as originally posed: "(i) that Apotex' submission did not comply with the FDA or FDA Regulations when it was filed, and it was not compliant as of April 2007; and (ii) in the absence of the NOC Regulations, the FDA and FDA Regulations did not permit an Apo-lansoprazole NOC to be issued in April 2007. Therefore, no NOC could or would have issued to Apotex at that time in the absence of the NOC Regulations." (para 48)
The Court enumerated the law that applied to summary judgment motions in Ontario. It then considered the evidence. In this case, Apotex had received a Patent Hold letter. It then received correspondence revoking that letter and indicating that Apotex' Apo-lansoprazole product was no longer considered approvable. Additional bioequivalence studies, using different diet conditions, were needed. When those were submitted, bioequivalence was not demonstrated. The matter was referred to the Scientific Committee on Bioavailability and Bioequivalence, which recommended against approval. Health Canada issued a NON-W. Apotex used Health Canada's Reconsideration Process, which resulted in a finding that Apo-lansoprazole was cleared for sale. After the expert panel's recommendations, Health Canada spent another month reviewing the product and recommending descriptive changes to the usage circular and descriptions of the product. An NOC was then issued. The Court emphasized that this was the exact same product that had received the original Patent Hold letter.
The evidence before the Court was that an NOC would have issued at the first Patent Hold letter, but for the NOC Regulations. Furthermore, Health Canada's subsequent actions in relation to the request for further studies, would not have resulted in the revocation of that NOC. The Court made a finding that the issuance of the Patent Hold letter "definitively establishes that a NOC for the generic product not only could have, but would have been issued on April 17 or 18, 2007" but for the litigation under the NOC Regulations. The Court also stated that it was not persuaded that Apo-lansoprazole was not legally approvable as of that time. The Court held that the Applicant's position on the summary judgment motion was without factual or legal foundation or merit.
The Court also considered the Applicants' arguments that the FCA's decision in Apotex v. Canada (Health), 2012 FCA 322 [Omeprazole FCA] should apply in this situation. However, the Court distinguished the statements by the FCA as arising in a different contextual circumstance. The question of whether a generic is entitled to s. 8 damages is entirely separate from whether the Minister's decisions arising out of the drug approvals process may be challenged. A patentee does not have standing to impugn decisions made under the FDA Regulations. The Court further distinguished Omeprazole FCA on its facts.
Thus, the Court dismissed the motion for summary judgment. The Court further held that its findings were applicable on the merits. The Court held that the facts of the case plainly establish that Apotex has a s. 8 claim, and the question is about quantum. In addition, the Court held that due to its findings with respect to Omeprazole FCA, the Applicants will not be permitted to revisit avenues relating to the conduct of Health Canada. The Court appointed himself trial judge and narrowed the questions for trial.