On July 14, 2017, long-awaited amendments to Canada’s patent linkage provisions (the Patented Medicines (Notice of Compliance) Regulations (“Regulations”)) relating to generic and biosimilar market approval were published. The amendments seek to implement changes agreed to under the Canadian-European, Comprehensive Economic and Trade Agreement (CETA) and address criticisms of the former patent linkage regime. Significantly, the amendments propose to change the litigation framework for proceedings under the Regulations from a summary process to a full trial-based procedure, with binding effect on the parties involved, and an equal right of appeal to innovators. Several substantive and procedural changes are proposed by the amendments. Some of the key proposed changes are set out below:
- Procedure: Proceedings under the Regulations will now be in the form of actions, commencing with a statement of claim for infringement and culminating in a trial. The trial will include viva voce evidence and may include a counterclaim seeking to invalidate the patents involved.
- Parties: The Minister will no longer be a party to the proceeding, but will still be served with relevant documents. Proceedings may be brought by a first person or an owner of a patent listed on the Patent Register who receives a Notice of Allegation (“NOA”).
- Timing: The innovator/patent owner must commence any infringement action on a listed patent within 45 days of receipt of the NOA after which, the innovator/patent owner may be estopped from asserting the listed patent. An innovator/patent owner may no longer bring an infringement proceeding on a listed patent at any time during the life of the patent unless the innovator/patent owner can show that there was no reasonable basis for bringing an action under the Regulations when the NOA was served.
- Scope of Proceeding: Although a patent must include a claim to the medicinal ingredient, formulation, dosage form, or use of the medicinal ingredient, to be listed on the Patent Register, proceedings may be brought in respect of any claim of a listed patent. A generic/biosimilar must address all claims of a listed patent in their submission and allegations.
- Documentary Production: Proceedings will involve a full discovery process and will also include early production of certain documents and information. Where an allegation of invalidity is made, the generic/biosimilar will have the right to request (and to be provided with) the contact information of the inventors at the outset of the dispute, as well as to request any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage or use, which is asserted by the generic/biosimilar to be part of the invention, was established as of the filing date of the patent. Similarly, the innovator/patent owner will be entitled to receive production of the generic/biosimilar’s submission documents relevant to the issue of infringement at the time of receiving the NOA, even if an allegation of non-infringement is not made.
- Effect of Proceeding: Findings on infringement and/or validity will be final determinations and may extend beyond the regulatory dispute between the parties. Where the generic/biosimilar counterclaims for impeachment of the asserted patent and the patent at issue is found to be invalid, such finding will be both final and applicable to other generics/biosimilars.
- NOC Issuance: NOC issuance is still barred for up to 24 months once an action is started, but this bar can be renounced by the parties to the action. Further, where a patent is declared to be ineligible for listing on the Patent Register during the course of the proceeding, the proceeding will still continue with respect to that patent, but the 24 month bar on NOC issuance in respect of that patent will no longer apply.
- Remedies: All remedies in respect of infringement of a patent are available, including a declaration of infringement barring issuance of an NOC until the patent expires. If an NOC issues prior to final determination of the issues in dispute, the innovator/patent owner may also claim injunctive relief where infringement is found. Where infringement is not found, a generic/biosimilar remains entitled to claim Section 8 damages, unless the innovator/patent owner renounced applicability of the 24-month stay period. Section 8 damages will no longer be limited to a specific end date.
- Appeals: The innovator/patent owner will have the right to appeal if unsuccessful at first instance.
Along with the amendments to the Regulations, additional regulations were introduced providing for the right of patent owners to apply for a Certificate of Supplementary Protection (“CSP”) for patents relating to drugs containing new medicinal ingredients or new combinations of medicinal ingredients. The amendments to the Regulations also apply to all relevant listed CSPs.
A fifteen-day consultation period has been provided with respect to the proposed amendments to the Regulations. The transitional provisions provide that the amended Regulations will come into force on the day that Section 59 of CETA comes into force, which is expected to be September 21, 2017, and would be applicable to any NOA served after that date.