Time warp on the patent register: Amendments to EMD Serono’s MAVENCLAD judicial review
This is one of two motions relating to judicial reviews that considered when a first person’s patent is eligible for listing on the Patent Register. Bayer’s related motion is described here.
EMD Serono submitted patent lists for the 419 Patent with respect to MAVENCLAD to OSIP on March 16, 2023. The Minister issued his eligibility decision on March 23, 2023.
On March 22, 2023, Apotex filed a drug submission comparing its drug to MAVENCLAD. The Minister did not require Apotex to address the 419 Patent.
In this motion, EMD Serono 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 EMD Serono leave, allowing it to change the description of the communicated decision to “Final Decision” and add particulars of a determination by the Minister on March 21, 2023, rendering patent lists for the 419 Patent eligible for listing such that a second person would be required to address the 419 Patent under the Regulations. EMD Serono’s request had a reasonable prospect of success. In considering whether the proposed amendment would be consonant with the interests of justice, the Court found that the motion to amend was (1) brought in a timely manner, (2) would cause some delay in getting to the hearing, but that this delay could be addressed through case management; and (3) did not lead Apotex to follow a course of action that would be difficult or impossible to alter.
The Court held that the real question was when the Minister should have listed the 419 Patent on the Patent Register for MAVENCLAD, and it was more consonant with the interests of justice that the proposed amendments be permitted.
The Court also ordered the Minister to add Standard Operating Procedure and “Patent List Screening and Eligibility” documents to its Certified Tribunal Record. Although the Minister conceded that the Additional Documents should be added if the amendments are permitted, the Court held that the documents should be included if the application for judicial review was not amended. The Court found that the Additional Documents were relevant to the process conducted in deciding when to list the 419 Patent on the Register and should therefore be included in an amended certified tribunal record.
The Court declined to order the Minister to produce a witness for examination. There was no basis that the lack of a right to compel a witness to attend for examination was a “gap” and not an intentional choice in the context of an application. The Court noted that the absence of a provision in the Federal Court Rules does not mean there is a gap if it can be explained by the general scheme of those Rules. Since Applications are summary procedures that are aimed at facilitating expeditious proceedings, the Applicant’s motion to produce a witness who had not sworn an affidavit in the proceeding was denied.
A copy of the decision can be found here.
