Late Report of Patent Grant leads to Irretrievable Loss of Drug Patent Register Listing Rights

Merck Canada Inc. v Canada (Health), 2021 FC 345

The grant of a patent containing a claim that relates to a medicine or use of the medicine approved by Health Canada triggers a 30-day deadline from the date of payment of the final fee to list the patent on the Patent Register maintained by the Therapeutic Products Directorate. A careful review of the timing of the grant after payment of the Final Fee (i.e., Issue Fee) in this case and the Canadian Intellectual Property Office’s service standards offers valuable lessons.

In this decision, the Federal Court (the “FC”) dismissed an application for judicial review brought by Merck Canada Inc. (“Merck”) over the refusal by the Minister of Health (the “Minister”) to add Canadian Patent No. 2,830,806 (the “‘806 Patent”) to the Patent Register pursuant to section 4(6) of the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”).

BACKGROUND

Merck markets KEYTRUDA®, a biologic drug for the treatment of certain advanced-stage cancers. The ‘806 Patent was issued on May 12, 2020, and contains claims that are directed to a formulation of the drug KEYTRUDA®.

The issuance of the ‘806 Patent was not reported by the Canadian patent agent retained by Merck’s American parent company (“Merck USA”) until June 15, 2020, more than a month after the patent had issued. Merck USA had however independently learned of the issuance on June 12, 2020 and immediately instructed Merck to take the necessary next steps. Patent lists were submitted the same day, but after the close of business, and were therefore deemed to have been filed on Monday, June 15, 2020.

On June 19, 2020, the Minister informed Merck of the preliminary determination that the patent lists relating to the ‘806 Patent were ineligible for being submitted outside of the 30-day window stipulated in section 4(6) of the PM(NOC) Regulations. Merck replied with written representations and affidavit evidence.

The Minister later confirmed on November 6, 2020 that the patent lists relating to the ‘806 Patent were ineligible for inclusion on the Patent Register holding, among other elements, that the Time Limits and Other Periods Act (COVID-19) (the “Time Limits Act”) does not extend the deadline within which first persons may submit patent lists in accordance with s 4(6) of the PM(NOC) Regulations; and that the 30-day deadline in section 4(6) of the PM(NOC) Regulations is not discretionary.

ANALYSIS

Merck argued that the Minister’s refusal would deprive the patent holder of substantial protections available under the PM(NOC) Regulations. Additionally, Merck said it would suffer prejudice because a subsequent entrant would be able to file a drug submission after the expiry of the six-year “no file” period for KEYTRUDA®, on May 19, 2021.

The issues, in this case, were a) was the Minister’s determination reasonable that the Time Limits Act cannot be applied here and as a result cannot suspend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations? And b) was the Minister’s determination reasonable that she had no discretion to extend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations?

The FC determined that the Minister’s decision would be subject to review against the standard of reasonableness, meaning the FC would only intervene if “there are sufficiently serious shortcomings in the decision such that it cannot be said to exhibit the requisite degree of justification, intelligibility and transparency.”

With regard to the reasonableness of the Minister’s determination, that the Time Limits Act did not cause suspending of the 30-day time period specified in section 4(6) of the PM(NOC) Regulations, the FC found that the Time Limits Act applied in only three circumstances: limitation or prescription periods for commencing a proceeding before a court; time limits for doing something in a proceeding before a court; and time limits where a party makes an application for leave of a court, either to commence a court proceeding or to do something in relation to a court proceeding. Merck asserted that section 4(6) of the PM(NOC) Regulations functions as a “gateway” to the summary litigation provisions that begin at section 6(1), and therefore Merck argued that the 30-day period specified in section 4(6) of the PM(NOC) Regulations is a “limitation period within a limitation period.” The FC concluded that the listing of a patent on the Patent Register pursuant to section 4(6) of the PM(NOC) Regulations is too remote from the commencement of a court proceeding under section 6(1) to constitute a “limitation period within a limitation period” for the purpose of section 6(1) of the Time Limits Act.

With regard to the Minister’s determination that she had no discretion to extend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations being reasonable, Merck relied on a previous FC decision to argue that the Minister may add a “late” patent list to the Patent Register. The FC was not convinced of this argument though, maintaining that it is well established that the timelines prescribed by the PM(NOC) Regulations are exact. The FC further added that the 2017 amendments to the PM(NOC) Regulations also did not confer any new discretionary powers to the Minister.

The FC concluded that the Minister’s decision was justified, intelligible and transparent, and therefore reasonable. No costs were awarded by agreement of the parties.

COMMENTARY

A patent will only issue in Canada following payment of the Final Fee. The Client Service Standards at CIPO for grant of a patent after payment of the Final Fee is stated as being within 12 weeks (Client Service Standards - Canadian Intellectual Property Office).

The Final Fee for the ‘806 application was paid on March 20, 2020. The ‘806 patent granted 53 days later (about 7½ weeks) well before the 12 weeks service standard. A brief review of recently issued patents in Canada indicates that the quick grant of the ‘806 patent was not an anomaly and that patents are regularly granting within 6 to 8 weeks of payment of the Final Fee.

A key takeaway from this case is that once the Final Fee is paid for applications that are eligible for listing on the Patent Register, the CIPO database should be monitored closely for grant of the patent. To help with that, CIPO now also lists “Forecast Issue Date” on the Administrative Status page for each patent application and further sends a notification by email that the patent has granted. Please note that this is also applicable when filing a divisional application after payment of the Final Fee.

For more information please contact:

Claire Palmer, Ph.D., Senior Patent Agent
T: 613.801.0450
E: cpalmer@mbm.com

Osman Ismaili, Patent Agent & Lawyer
T: 613.801.1054
E: oismaili@mbm.com

This article is general information only and is not to be taken as legal or professional advice. This article does not create a solicitor-client relationship between you and MBM Intellectual Property Law LLP. If you would like more information about intellectual property, please feel free to reach out to MBM for a free consultation.