Proposed amendments to overhaul the patent linkage regime and add certificates of supplementary protection were published today in the Canada Gazette, Part 1. Amendments to the Patented Medicines (Notice of Compliance) Regulations will replace the current summary procedures with full actions including rights of appeal. New Certificate of Supplementary Regulations are proposed to provide for up to two years of additional exclusivity based on the time to obtain a notice of compliance for a drug containing a new medicinal ingredient or combination of medicinal ingredients. A number of other proposed regulatory amendments relating to CETA were also published. There is a 15-day consultation period.
Patented Medicines (Notice of Compliance) Regulations
The Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 (link) overhauls the existing PM(NOC) Regulations. In addition to switching to full actions, the regulations add a number of procedural changes to permit the expeditious determinations within a 24 month hold period. Some highlights:
- actions will focus on infringement and validity, including by way of counterclaims for invalidity so appeals will not considered moot.
- declarations of infringement would stop issuance of the NOC until expiry of the patent. Injunctive relief may be granted if the NOC issues prior to a declaration of infringement being made.
- proceedings could address any claims of patents on the register, not just those claims directed to medicinal ingredients, formulations, dosage forms, and the use of the medicinal ingredients.
- there would be limits on joinder of other actions that may slow down the determination within the 24-months.
- if a proceeding is not brought by the first person or patent owner under the proposed regulations, the regulations would restrict from subsequent actions against the second person later.
- notices of allegation must address each claim of the listed patent and can include allegations the patent is ineligible for inclusion on the register. Requirements for alleging invalidity and non-infringement are included in the amendments. Certain documents and inventor information may be requested with the NOA. Confidentiality for the exchange of documents would be built into the regulations.
- Proposed rules for the procedural handling of actions are specified including:
- early case management;
- a duty to act diligently and reasonably cooperate;
- interlocutory appeals may only be made to the Federal Court of Appeal, and will require leave; and
- motions to dismiss proceedings.
- Details on when NOCs are issued under the patent linkage system and when NOCs will be held back. A first person and patent owner may renounce the 24-month hold period without prejudice to the right to sue or obtain relief from the court.
- Compensation for second persons who suffer losses due to being held off the market are specified in the proposed regulations.
- Standing would be provided to allow second persons to bring impeachment action prior to receiving an NOC and innovators could sue for patent infringement prior to a second person receiving an NOC.
The new regulations would not apply to any proceedings arising from NOAs served prior to the coming into force.
Certificate of Supplementary Protection Regulations
The proposed regulations (link) establish an additional period of protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent. According to the regulatory statement:
This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.
The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years