Pass the Scalpel: “Surgical” Reply Report Responding to New Evidence Held Admissible

On the eve of trial, the Federal Court accepted filing of a reply report responding to new evidence but did not allow filing of a sur-reply report deemed confirmatory in nature. This decision further entrenches the principles governing admissibility of reply evidence recently examined in Teva paliperidone and highlights the evolving Hryniak-inspired “litigation culture change” in the Federal Court (see further details in our recent post here).

Bristol-Myers Squibb and Pfizer sued Apotex under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations for infringement of Canadian Patent No. 2,791,171. Apotex filed an initial expert report in support of its allegations that the patent is invalid for obviousness, overbreadth and insufficiency. In response to the BMS’ expert report addressing the same issues, Apotex moved for leave to serve and file a reply report on the basis that 16 new articles of prior art were raised and that the interpretation of the new art put forth could not have been anticipated.

The Court found that the 16 pieces of art raised in the BMS report constituted new evidence not previously brought to Apotex’s attention. In examining Apotex’s proposed reply report, the Court noted that it addressed only 6 of those 16 pieces of new art in a “surgical 21-page response”. The Court further commented that, given trial of the matter was scheduled to take place over only 9 days, “there is an obvious economy in having the Reply Report filed and entered as having been read, rather than take time to obtain those responses orally” through examination-in-chief of Apotex’s expert.

On the other hand, the Court noted that BMS’ proposed sur-reply report was not admissible “because it simply does not address anything new” and is “confirmatory in nature”, which runs contrary to recognized principles governing admissibility of reply evidence.

Apotex was granted leave to serve and file its proposed reply report and was awarded costs. BMS’ motion to serve and file its sur-reply report was denied.

The decision can be found here.