The Federal Court has reaffirmed and reissued its original decision awarding section 8 damages to Teva following a redetermination that was ordered by the Federal Court of Appeal.
The original decision (2014 FC 248, our summary here) and judgment (2014 FC 634, our summary here) provided that Teva should be awarded section 8 damages for being kept out of the market for selling venlafaxine due to an unsuccessful application brought pursuant to the PM(NOC) Regulations.
On appeal, the Federal Court of Appeal ruled that inadmissible hearsay evidence was relied upon and remitted the decision back to the Federal Court (2016 FCA 161). The key issue for the redetermination was whether in the hypothetical world Ratiopharm (Teva) would have had and could have had access to sufficient quantities of venlafaxine at the relevant time.
On the redetermination, counsel to Wyeth (Pfizer) objected to additional evidence that was not previously objected to as hearsay evidence at trial or on appeal. The Court did not allow the objection, holding that the objection should have been made at first instance.
Therefore, after reviewing the evidence in the record, the Court affirmed that there was sufficient admissible evidence that showed on a balance of probabilities that Ratiopharm (Teva) would and could have entered and supplied the generic market at the start of the section 8 damages period. Since the damages originally awarded had already been paid by the Defendant, the Court only reaffirmed the original judgment and awarded costs.