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27 November 2019
On 10 October 2019 Justice O'Reilly of the Federal Court issued two decisions relating to Pharmascience's claim for Section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its pregabalin product (Pfizer's Lyrica).
In Pharmascience v Pfizer (2019 FC 1271) O'Reilly found that Pfizer's defence of ex turpi causa was not a legally viable defence to Pharmascience's claim for Section 8 damages and granted Pharmascience's motion for summary trial on this issue.
Pfizer had asserted an ex turpi causa defence – namely, that Pharmascience's Section 8 damages should be reduced or eliminated, as it would have infringed a valid patent. O'Reilly held that, as Pfizer did not bring an infringement action against Pharmascience in the real world, in the 'but-for' world Pharmascience would not have been prevented from marketing and selling its product and would have suffered losses as a result.
Pfizer has appealed (A-405-19).
In Pharmascience v Pfizer (2019 FC 1272) O'Reilly overturned the prothonotary's order, which had denied Pfizer leave to amend its pleading relating to Pharmascience's capacity to obtain sufficient quantities of the active pharmaceutical ingredient and therefore its ability to supply PMS-pregabalin.
The prothonotary denied the motion on the basis that Pfizer had failed to discharge its burden on this issue in a case involving another generic manufacturer, Teva, and that allowing the amendments would therefore be an abuse of process. However, O'Reilly found that the prothonotary had erred in concluding that the proposed amendments would result in the litigation of issues already decided. O'Reilly also found that the witnesses and parties were different, and that the proposed amendments related to a factual issue particular to the action between Pfizer and Pharmascience.
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