Timing is everything: risks of delayed patent list submission in Canada

In EMD Serono v The Minister of Health and Apotex, the Federal Court of Canada determined that the relevant date for assessing whether a patent must be addressed by a “second person” who seeks to market a generic version of a patented drug is the date the patent is listed on the patent register by the Minister of Health (Minister), rather than the date the patent is submitted for listing by the “first person” (i.e. the innovative drug manufacturer).

What you need to know

• A “second person” who seeks to market a generic version of a patented drug must address patents listed on the Health Canada patent register (the Register), the Canadian equivalent of the U.S. “Orange Book” for pharmaceutical patents¹.
• In this decision, the Federal Court confirmed that a second person is not required to address a patent that was submitted to the Minister and not yet listed on the Register, nor a patent added to the Register on or after the date of filing of the second person’s drug submission².
• The Federal Court has reiterated that the Minister must exercise discretion in determining whether patents are eligible for listing on the Register prior to any patents being listed (i.e., listing is not “automatic” when a patent list is submitted to the Minister).
• Patents are listed on the Register when they are found to be eligible for listing by the Minister, and not on the date the patent lists are submitted to the Minister.
• The Court found that seven days for the Minister to review, assess listability and then list the patent on the Register did not constitute a delay.
• The applicants have appealed this decision to the Federal Court of Appeal.

Regulatory framework

The Patented Medicines (Notice of Compliance) Regulations (Regulations) state that the Minister shall maintain a register of patents and shall add any patent on a patent list or certificate of supplementary protection that meets the requirements for addition to the Register³. If patents are listed on the Register, the Regulations prohibit a second person from entering the market with the same medicine as one covered by a listed patent, except in accordance with the notice of compliance regime set out in the Regulations.

A second person must file a submission seeking a notice of compliance (Canada’s version of a “marketing authorization”) to market a generic version of a patented medicine. If the submission directly or indirectly compares the drug to, or references, another drug marketed in Canada under a notice of compliance issued to a first person in respect of which a patent list has been submitted, the second person must address each patent listed on the Register. The second person may address each patent by, for example, stating that the second person will not market the drug until the expiry of the listed patents or by including an allegation that the listed patents are invalid or not infringed⁴. The second person addresses the Register as of the date it files its submission, in essence, freezing in time the patents that must be addressed.

If the second person alleges that a listed patent is invalid or would not be infringed, it must serve a Notice of Allegation on the patent holder⁵. The patentee may then bring an action seeking a declaration that the generic product would infringe a listed patent⁶. The action prevents the Minister from issuing a notice of compliance for 24 months following the filing of the action⁷.

Administrative decision

EMD Serono, a division of EMD Inc., Canada and Merck Serono SA (collectively, Serono) was granted Canadian Patent No 3,087,419 (‘419 Patent), entitled “Cladribine Regimen for Treating Multiple Sclerosis”, on March 7, 2023. On March 16, 2023, nine days following the grant date, Serono submitted patent lists to the Minister for the ‘419 Patent against MAVENCLAD® (cladribine), a drug used to treat adult patients with relapsing-remitting multiple sclerosis⁸.

One week later, Serono was informed that the patent had been added to the Register as of March 23, 2023. However, Apotex Inc. (Apotex) had filed an abbreviated new drug submission for generic cladribine on March 22, 2023⁹. Serono asked the Minister to reconsider the listing date of March 23, 2023, arguing the proper date for listing should have been the date on which the patent lists were submitted, March 16, 2023.

The Minister found that Apotex needed only to address listed patents, not patents that have merely been submitted for listing, and patents are not eligible to be added to the Register until the Minister has determined the submitted patents meet the regulatory requirements for listing. The Minister maintained the listing date of March 23, 2023, meaning Apotex did not have to address the ‘419 Patent. Serono sought judicial review of the Minister’s decision¹⁰.

Judicial review decision

On judicial review, Serono framed the relevant provision of the Regulations as a race between a first person and a second person. The first person rushes to have their patents listed on the Register, whilst the second person rushes to file a regulatory submission. Serono argued it won the race against Apotex (submitting a patent list prior to Apotex’s notice of compliance filing), and the delay in adding the patent to the Register was attributable to the Minister¹¹.

Additionally, Serono argued the wording of section 5(1)—"in respect of which a patent list has been submitted”—supports the position that second persons must address patent lists that have been merely submitted by a first person. Serono argued that the language is consistent with section 3(2) of the Regulations, requiring the Minister to maintain a register of “patents that have been submitted for addition to the register”¹².

Justice O’Reilly did not find Serono’s arguments persuasive and dismissed Serono’s application for judicial review, agreeing with the Minister’s interpretation of the Regulations and finding the Minister’s decision was not unreasonable.

The Court found that whilst the Minister does not have discretion to delay adding patents to the Register, the Minister does exercise discretion in determining whether patents submitted for listing are indeed eligible to be added to the Register¹³.

According to the Court, following a reasonable approach to interpreting the Regulations read as a whole, the Register contains those patents the Minister has determined to be eligible for listing, not all patents submitted for listing. As such, patents are not added to the Register immediately upon submission. A second person must only address each patent that has been included on the Register and is not required to address patents that are added to the register after it has submitted its regulatory filings¹⁴.

Once a patent has been submitted for addition to the Register, the Minister must determine whether the regulatory requirements for listing have been met. The Minister determines whether a patent is eligible for listing by reviewing the patent to determine whether it claims a medicinal ingredient, formulation, dosage form or use set out in the first person’s regulatory submission. A first person must await a determination from the Minister before the patent is listed. The Court found support for this interpretation in a previous Federal Court decision, Eli Lilly Canada Inc v Canada (Attorney General), 2009 FC 474¹⁵.

Conclusion

The decision highlights the importance of prompt submission of patent lists to the Minister following the grant of a patent. In the circumstances of this case, Apotex avoided having to address the ‘419 Patent by filing its regulatory submission one day before the ‘419 Patent was listed on the Register. Whilst Serono alleged that seven days of the delay was attributable to the Minister for reviewing the patent and assessing eligibility for listing, Serono did not file their patent lists until nine days after the patent was granted.