On July 15, 2017, the Canadian government published (link) its proposed amendments to the NOC Regulations. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. There will be a 15-day comment period, after which, the amendments will be published in final form. The finalized amendments are expected to be in force around late September 2017. These revamped NOC Regulations will apply to Notices of Allegation (“NOAs”) served on or after the date the revamped NOC Regulations come into force.
Overall, the revamped NOC Regulations make amendments that were sought after by both sides of the Canadian pharmaceutical industry. For innovators the NOC Regulations provide appeal rights, allow for the early adjudication of additional patent claims and patents not eligble for listing on the Patent Register prior to generic launch, and give effect to patent term restoration. For generics the NOC Regulations limit or prevent follow-on litigation, expand potential section 8 damages and grant expanded standing to sue for impeachment. These and other changes are described in more detail below.
- Actions not Applications: NOC cases will be converted from summary proceedings to actions that determine the validity and infringement of asserted patents. This change will necessitate documentary and oral discovery as well as live witness testimony at trial. NOAs are still required to address all patents listed on the Patent Register. The timelines for commencing a proceeding (45 days) and for the statutory stay (24 months) remain unchanged. The action is limited to a request for a declaration of infringement in respect of any asserted patent. Any patent owner must be made a party to the action, and a counterclaim for a declaration of invalidity may be made in response.
- Early disclosure: New early disclosure requirements apply to both second persons (the “Generic”) and first persons (the “Innovator”). A Generic’s NOA must now be accompanied by electronic documents, in English or French, cited in the invalidity allegations, as well as any portions of the regulatory dossier relevant to the infringement of any patent listed on the Patent Register. Notably, this latter requirement persists even where the Generic has made no allegation of non-infringement. Conversely, if a sufficiently specific request has been made by a Generic and provided with its NOA, the Innovator is subject to fairly onerous disclosure requirements. Contact information for inventors may have to be provided, as well as laboratory notebooks, research reports or other documents in electronic format, in English or French, that may be relevant to determine whether a particular property, advantage, or use asserted to be part of the invention was established as of the filing date of the application for the patent. Such a request must be forwarded to the owner of each patent within 5 days and the Generic must be promptly notified of this being done, or notified that the Innovator is the patent owner. If the Innovator commences an NOC case, these materials must be served on the Generic along with the statement of claim (i.e., within 45 days of receiving the NOA). If they are not yet available, a document explaining the steps that have been and are being taken to locate the information, or setting out the reasons for not providing them, must be served instead. Parties may now impose confidentiality requirements to protect these documents, where appropriate. The Court, on request by a party or on its own initiative, may amend such requirements.
- All claims of listed patents can be litigated: Although patent listing requirements remain unchanged, all claims of a listed patent can now be litigated instead of just those claims for the medicinal ingredient, the formulation, the dosage form, or the use of the medicinal ingredient. If it is determined that a patent is not properly listed, the NOC case will no longer be dismissed, but the 24-month stay will not be effective insofar as that patent is concerned.
- No repeat patent infringement claims: If a listed patent is the subject of an NOA, and there is a reasonable basis within the 45-day window to sue, then the only action that can be brought in respect of that patent is an NOC case. In such circumstances, the Innovator cannot allow the NOA to pass and sue for infringement at a later date; or, arguably, to defend s. 8 damages claims based on the infringement of addressed patents. Whether the Innovator had a “reasonable basis” to commence an action will be dependent on the quality of the Generic’s disclosure provided to the Innovator during the 45-day timeframe.
- Court process for timely resolution: The Court has broad powers to manage NOC cases. Any appeal of an interlocutory order must now be brought directly to the Federal Court of Appeal, instead of the Federal Court, and leave is required. The Court is also empowered to shorten or lengthen the 24-month stay and impose costs sanctions if a party fails to act diligently or reasonably cooperate in the action.
- More remedies available: The Court is now permitted to order any remedy available under the Patent Act in an NOC case, including damages and injunctions. For example, an injunction could be ordered to prevent ongoing sales of a generic drug in a situation where an NOC was granted before the NOC case was finally determined.
- Burden of proof shifted: Any person alleging that a patent is invalid in an NOC case will now bear the burden of proof.
- Appeals no longer mooted by NOC grant: Appeals of losses by Innovators in NOC cases will no longer be rendered moot by the grant of a Generic NOC by Health Canada.
- Section 8 damages expanded but avoidable: While the right to claim s. 8 damages remain, the NOC Regulations no longer specify an end date to the calculation. This may allow Generics to claim expanded future losses, including claims relating to “double ramp-up” and future market share erosion. While the commencement of an NOC case still triggers an automatic 24-month stay preventing NOC grant, the 24-month stay can be renounced when the action is brought in order to avoid potential liability for s. 8 damages while still preserving the right to sue and obtain any remedy from the Court permitted by the Patent Act.
- New separate rights of action: A person who files a copycat drug submission that has reasonable grounds to believe they might be alleged to infringe a patent, now has the right to bring an impeachment action. Furthermore, a person who receives an NOA may now commence a separate patent infringement action in respect of any patents that are not the subject of the NOA without risk of the lawsuit being dismissed as premature. This allows for early litigation over non-listed patents, and dual litigation that can proceed along two tracks. For example, a patentee might bring one fast-tracked lawsuit involving listed patents (that is intended to be completed within 24-months of commencement), along with a separate lawsuit involving non-listed patents, that may or may not be prosecuted as quickly. Such actions must remain separate and cannot be joined while the 24-month stay is extant.
- Certificates of Supplementary Protection (“CSP”): The Federal Government released the Certificate of Supplementary Protection Regulations concomitantly with the revamped NOC Regulations. The revamped NOC Regulations include CSP protection, often referred to as “patent term restoration”. Innovators may obtain up to two years of additional patent term as a result of delays in the time spent in research and obtaining marketing authorization. Importantly, a CSP can apply to patents and Generics that are already the subject of an action pursuant to the revamped NOC Regulations.