In Gilead Sciences, Inc v JAMP Pharma Corporation, 2023 FC 1141, Associate Judge Crinson of the Federal Court granted a motion for an extension of time for inter partes testing brought by JAMP Pharma. The underlying two proceedings under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations concern patents relating to the drug tenofovir alafenamide (Canadian Patent Nos. 2,845,553 and 2,990,210).
JAMP sent Gilead a notice for inter partes testing (April Notice) by the deadline in the Scheduling Order. The April Notice provided for the “measurement to determine melting point” and for other testing.
The parties performed testing, including melting point measurement. The testing performed did not include differential scanning calorimetry (DSC). JAMP had been trying to arrange for melting temperature measurement using DSC equipment but did not communicate these attempts to Gilead.
JAMP then sent a further notice of inter partes testing (June Notice) proposing to conduct DSC ahead of the deadline to complete the inter partes testing. Gilead did not consent to the proposed testing.
JAMP brought a motion under Rule 8(1) of the Federal Courts Rules for an extension of time to serve its notice. Gilead characterized the motion differently. It argued that JAMP was seeking a second round of testing not contemplated in the Scheduling Order and, as a result, JAMP was seeking to vary the Scheduling Order, in which case Rule 399(2)(a), whereby an order may be set aside or varied, was applicable.
Associate Judge Crinson found that Rule 399(2)(a) had no application. He found it was not a motion for a second round of testing but for an extension of time to complete testing within the scope of the first notice of inter partes testing. The April Notice had referred to “measurement to determine melting point”, which may have been intended to include DSC testing of melting temperature. Claims 8 and 9 of the 553 Patent, which are in issue, both refer to DSC data.
The relevant factors when considering a request for an extension of time were identified by the Federal Court of Appeal in Canada (Attorney General) v Larkman, 2012 FCA 204:
- Did the moving party have a continuing intention to pursue the proceeding?
- Is there some potential merit to the application?
- Has the opposing party been prejudiced from the delay?
- Does the moving party have a reasonable explanation for the delay?
Associate Judge Crinson found that JAMP had a continuing intention to pursue the proceeding and that the determination of the melting point using DSC data was relevant to the issues in dispute. He found Gilead would be prejudiced from the delay because the testing would require reattendance by counsel and an expert, but that this prejudice may be compensated by costs. Finally, he found that JAMP’s explanation for the delay was weak and that “[a] lack of planning or organisation does not constitute a good explanation for the delay.”
Weighing the factors and the interests of justice, the Court held that the requested extension ought be allowed on the condition that JAMP pay the reasonable disbursements incurred by Gilead’s expert to reattend the testing. Associate Judge Crinson declined to order costs for the motion because it may have been unnecessary if not for the lack of communication from JAMP concerning its efforts to perform DSC testing.
A copy of the decision is available here.