PMNOC Regulations – An Overview
The Patented Medicines (Notice of Compliance) Regulations, or PMNOC Regulations as they are often known, link the approval of subsequent-entry drugs (e.g., generic, biosimilar) to patents pertaining to the brand-name reference product. The Regulations are conceptually similar to patent linkage regimes in other jurisdictions, e.g., the US Hatch-Waxman Act, but with several important distinctions.
The PMNOC Regulations have five main components:
The Patent Register is a public list of eligible patents and certificates of supplementary protection (CSP) relating to marketed brand-name drugs. Patents are eligible for listing on the patent register if they meet substantive and temporal requirements. A patent must contain at least one claim to the medicinal ingredient, the use of the medicinal ingredient, or a dosage form or formulation of the medicinal ingredient, as defined in the Regulations. Issued patents must be submitted for listing on the patent register when the corresponding new drug submission or supplement is filed. Patents issuing from applications that were pending when the brand-name drug submission was filed may be added to the patent register within thirty days of issuance. These requirements are enforced strictly, by Health Canada.
Subsequent-entry drug submission. The PMNOC Regulations were designed to ensure that the making, constructing, use and sale of subsequent-entry products (generic, biosimilar) does not infringe patents and certificates of supplementary protection (CSP) that are listed on the patent register. The Regulations aim to achieve this goal by requiring that if a subsequent-entry manufacturer seeks approval to sell a product in Canada based on a direct or indirect comparison to a brand-name product – and if a patent or CSP has been listed on the patent register in respect of the brand name product – then the subsequent-entry manufacturer must do one of the following things before it can obtain marketing approval:
If a subsequent-entry manufacturer asserts that a patent or CSP is invalid, would not be infringed, or is not eligible for PMNOC protection, then it must serve a notice of allegation on the brand-name manufacturer (NOC holder) explaining the legal and factual basis for its assertions. The subsequent-entry manufacturer is not required to make an allegation in respect of a patent or CSP that is added to the patent register after its drug submission is filed.
Right of Action. A brand-name manufacturer has two options when it receives a notice of allegation: (1) start an action in the Federal Court against the subsequent-entry manufacturer for a declaration that the making, constructing, using or selling of the subsequent-entry product would infringe the patent or CSP that is the subject of the allegation; or (2) do not start an action and allow Health Canada to approve the subsequent-entry product once it meets the usual requirements under federal law (e.g., safety, efficacy and quality).
If an action is commenced, then the Minister of Health is authomatically prevented from approving the subsequent-entry product for 24 months. This period may be shortened or extended by the Court. Non-listed patents may also be asserted in an infringement action, but are not subject to the 24-month stay.
The subsequent-entry manufacturer may assert any available defenses to infringement (e.g., non-infringement, invalidity) and may also file a counterclaim for a declaration of invalidity.
PMNOC actions are governed by the usual rules of civil procedure (i.e., pleadings, discovery, expert reports, trial, judgment), with certain caveats under the Regulations and Federal Court practice directions. Cases are managed by the Court to ensure that trials in respect of listed patents are heard and decided within twenty-four months. Trial decisions can be appealed to the Federal Court of Appeal without leave. The losing party bears its own fees and disbursements, as well as a portion of the successful party’s costs.
Notice of Compliance. If the Court decides that at least one valid claim of a listed patent or CSP would be infringed by the manufacture, use or sale of the subsequent-entry product, then the Minister of Health may not approve the subsequent-entry product until after the relevant patent or CSP expires. However, if the Court determines that there will be no infringement of a listed patent or CSP, or if the 24-month period expires before a trial decision is rendered, or if a declaration of infringement is set aside on appeal, or if the brand-name manufacturer discontinues the infringement action during the 24-month period, then the subsequent-entry product can be approved once it meets the usual regulatory requirements under federal law (e.g., safety, efficacy and quality).
Damages. If a PMNOC action in respect of a listed patent is dismissed or discontinued, or if a declaration of infringement is reversed on appeal, then the subsequent-entry manufacturer may sue the brand-name manufacturer and patentee, jointly and severally, for any loss suffered due to to the delayed approval of the subsequent-entry product. The Court must consider all matters that it considers relevant to the assessment of the amount or the apportionment of compensation, including any conduct of the parties that contributed to delay the disposition of the action. No cause of action may be filed against the Crown.