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Federal Court dismisses motion for a fifth generic to be added to rivaroxaban trial of common issues under PMNOC Regulations

Authored byKatie Lee

The Federal Court had previously allowed a concurrent trial on common invalidity issues in actions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) against four generic manufacturers: Apotex, Teva, Taro and Sandoz (see article here under procedural decisions). The trial relates to rivaroxaban (Bayer’s XARELTO) and is currently scheduled to begin September 2020.  Bayer brought an action against a fifth generic manufacturer, Dr. Reddy’s.  On November 12, 2019, Prothonotary Tabib dismissed Dr. Reddy’s motion seeking an order directing that the invalidity issues it raised be heard together with the trial against the first four generic manufacturers: Bayer v Dr. Reddy’s, 2019 FC 1408.

Prothonotary Tabib held that the circumstances were different from the previous motions. The Court stated that the addition of another party will add to the complexity and unwieldiness, and that the current schedule and trial days would not be able to accommodate contribution by another party. Further, the Dr. Reddy’s action was started six months after the first generic action, and it would be reasonable to hold a full trial in the spring of 2021 on the issues in the Dr. Reddy’s action without unduly taxing the Court and Bayer. While jointly hearing the issues for Dr. Reddy’s would avoid duplication, this would imperil the Court’s ability to hear and determine the first two actions within the 24-month period mandated by the PMNOC Regulations.

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