The Canadian Patent Register is the first line of defense for innovators against premature market entry by generic drug manufacturers in respect of competing (and potentially infringing) generic products. Regulatory approval for market entry of a generic product will not be granted until all relevant patents on the Canadian Patent Register have been addressed, typically in court proceedings initiated under the Patented Medicines (Notice of Compliance) Regulations.
Before a drug can be lawfully marketed in Canada, regulatory approval in the form of a “Notice of Compliance” must be obtained from Health Canada. When a new drug submission is filed with Health Canada, innovators may submit their relevant patents for listing on the Canadian Patent Register, which is akin to the “Orange Book” in the United States. Since generic competitors are required to address all relevant patents on the Canadian Patent Register, innovators should know the eligibility and timing requirements that must be met in order to properly have their patents listed on the Canadian Patent Register.
An eligible patent is submitted for listing by filing a Form IV Patent List, available on the Health Canada website. A Patent List must be submitted at the time of filing the new drug submission (or certain supplements to the submission) except in the case of a patent that issues from an application that was pending at the time that the drug submission was filed. In these cases, the resulting patent can be submitted on a Patent List within 30 days from issuance of the patent. To be eligible for listing, a patent must have a filing date “in Canada” that is earlier than the date of the drug submission (an earlier foreign priority date is not sufficient).
It should be noted that the eligibility criteria for patent listing was amended in 2006. To the benefit of innovators, subject matter eligibility criteria were broadened allowing for the listing of patents claiming new medicinal ingredients, dosage forms, formulations or uses. However, relevancy requirements were tightened and now strictly require that at least one claim in the patent cover the “approved” commercial product or use for which the Notice of Compliance was actually granted.
The above should be kept in mind since the Federal Courts have now made it clear that the Minister of Health may remove or refuse to add any patent that does not precisely claim the approved product or use. For instance, a broad claim directed to the use of a medicine as an “anti-ulcer agent” was found to be insufficient to support the listing of a patent in connection with a Notice of Compliance granted for treatment of a subtype of ulcer that was not expressly set out in the claims. In other words, the patent claims must be very closely tied to the Notice of Compliance to be eligible for listing.
In view of the above, patent claims should be drafted or amended to ensure that the issued patent contains at least one claim explicitly covering the commercial product or use for which approval has been sought or granted in Canada under a Notice of Compliance.