Pharma In Brief - Ontario Superior Court Of Justice Dismisses Motion For Summary Judgment In Lansoprazole Section 8 Damages Action

Case: Abbott Laboratories Ltd v Apotex Inc, 2017 ONSC 1348 (Court File No. CV-09-391938)

Drug: PREVACID® (lansoprazole)

Nature of case: In general: Motion for summary judgment in an action for damages pursuant to Section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)

Successful party: Apotex Inc.

Date of decision: February 27, 2017

Summary

Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. (collectively, the Defendants) sought summary judgment of Apotex Inc.'s action for damages pursuant to section 8 of the Regulations. Apotex's action follows prohibition proceedings in the Federal Court decided in Apotex's favour in respect of its drug Apo-lansoprazole.

The central issue was whether Apotex could, would, and should have received a notice of compliance (NOC) in the hypothetical section 8 world, on April 17, 2007, its patent hold date. The Ontario Superior Court of Justice (ONSC) dismissed the motion for summary judgment finding that the Defendants had no standing to raise issues relating to Health Canada's generic product approval process. The ONSC further found that an NOC would have properly issued to Apotex on its patent hold date.

Background

The Defendants own patent rights relating to lansoprazole, a proton-pump inhibitor for the treatment of gastro-esophageal reflux disease, ulcers, and related conditions. Apotex Inc. seeks damages pursuant to section 8 of the Regulations following prohibition proceedings decided in Apotex's favour in respect of its drug Apo-lansoprazole.

Apotex received a patent hold letter from Health Canada confirming that, in the absence of the Regulations, Apotex would have received an NOC on April 17, 2007. However, on December 4, 2007, Health Canada changed its position on the basis that the bioequivalence study Apotex conducted did not conform to requirements set out in Health Canada's guidance documents. In early 2009, Health Canada issued a notice of non-compliance - withdrawal (NON-W) on this basis.

Apotex requested reconsideration of Health Canada's decision. After convening a review by an expert panel and conducting a further review on its own, Health Canada reverted to its original position and issued an NOC to Apotex in June 2009.

The Defendants alleged that in light of Apotex's non-compliance with the guidance document, the patent hold letter should never have been issued with the result that Apotex...