Time warp on the Patent Register: Amendments to Bayer’s aflibercept judicial review

In two judicial reviews considering when a first person’s patent is determined to be eligible for the Patent Register, and when a second person must address that patent under the Patented Medicines (Notice of Compliance Regulations), the Federal Court granted leave to both Bayer Inc. and EMD Serono to amend their pleadings and ordered the Minster of Health to produce an amended Certified Tribunal Record. The Court declined to order the Minister to produce a witness for examination.

This blog post discusses Bayer’s proceeding involving Amgen Canada Inc. and the drug aflibercept. See here for our thoughts on EMD Serono’s proceeding involving Apotex Inc. and cladribine.

Bayer submitted a Form IV to the Office of Patented Medicines and Liaison on August 22, 2023, requesting that Canada Patent 2,970,315 be added to the Patent Register with respect to EYLEA (aflibercept). The Minister (through OMPL) issued his eligibility decision on August 30, 2023.

On August 24, 2023, Amgen filed a New Drug Submission as a second person under the Regulations, and the Minister certified this NDS on August 31, 2023. The OMPL did not require Amgen to address the 315 Patent.

In this motion, Bayer sought leave to amend its Notice of Application, an order compelling the Minister to produce an amended Certified Tribunal Record, and an order compelling the Minister to produce an individual for examination.

The Court granted Bayer leave, allowing it to change the description of the August 30, 2023 event from the “Eligibility Decision” to the “Communicated Eligibility Decision” and to allege that the exact date when 315 Patent’s eligibility was determined is unknown. Bayer’s request was timely because it became aware of documents motivating the amendments within two business days of proposing them. The Court also found that any delay caused by the amendment could be addressed through case management. And, Amgen had not followed a course of action that would be impossible to alter, as it had only served a Notice of Appearance.

The Court held that the real question in controversy was the appropriate date for the Minister to list the 315 Patent on the Patent Register for EYLEA, and it was more consonant with the interests of justice in this case that the proposed amendments be permitted.

The Court also ordered the Minister to add four documents to its CTR: two operating procedures, an annotated version of the 315 Patent, and a completed screening and eligibility sheet. Although the Minister conceded that the documents should be included if Bayer’s amendments were granted, the Court found in any event that the Additional Documents were relevant to the screening process that led to the decision regarding the 315 Patent, which was the subject matter of the judicial review.

The Court declined order the Minister to produce a witness for examination, finding there was no “gap” under Rule 4 of the Federal Courts Rules that would enable the applicant to compel a witness to be cross-examined where they had not sworn an affidavit. The Court held an application for judicial review is intended to be a summary and expeditious proceeding, and applicants are not entitled to conduct discovery of the materials.

A copy of the decision can be found here.