The Patented Medicines (Notice of Compliance) Regulations, Patent List and Certificates of Supplementary Protection
The Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”) provide a special procedure to attempt to prevent patent infringement commonly known as “patent linkage”. The PM(NOC) Regulations can potentially block infringing products before market entry by prohibiting Health Canada from issuing marketing authorization.
Canada has also implemented a limited form of patent term extension for new drugs protected by an eligible patent. A Certificate of Supplemental Protection (“CSP”) provides up to 2 years of additional protection in certain circumstances where there has been a delay in regulatory approval.
You may need to act immediately to determine whether a particular patent can be used to take advantage of patent linkage and/or patent term extension in Canada.
Patent Linkage under the PM(NOC) Regulations
The government marketing authorization to sell a drug in Canada is called a Notice of Compliance (“NOC”). The PM(NOC) Regulations are triggered when a competitor files a drug submission that refers to a patented drug for which an innovator company has submitted a patent list to Health Canada. As a precondition to receiving its NOC, the competitor may be required to demonstrate that: i) it would not infringe the patent or CSP, ii) that the patent or CSP is invalid or void, or iii) that it has a license for the patent or CSP.
How to Obtain the Benefit of the Regulations – the Patent List?
In order to benefit from the PM(NOC) Regulations, the patent owner (or licensee etc.) must ensure that its patent is on a patent list submitted to Health Canada. As discussed below, eligibility for listing on the register is subject to strict timing, subject matter and relevance requirements. A patent or CSP that is eligible for listing must be directly relevant to the patent owner’s NOC. In particular, patents submitted for listing on a patent list must contain at least one claim for: 1) the approved medicinal ingredient (i.e. a product or product by process claim); 2) the approved formulation that contains the medicinal ingredient; 3) the approved dosage form and medicinal ingredient; or 4) the approved use. A CSP is eligible for listing on the patent list if: 1) the patent set out in the CSP is included on the register in respect of a NDS or SNDS; and 2) the NDS or SNDS relates to a drug with respect to which the CSP grants protection.
An innovator that files a submission (i.e. a new drug submission (“NDS”) or a supplement to a new drug submission (“SNDS”) may submit a patent list to Health Canada for inclusion on the register. With respect to an SNDS, a patent list may be submitted in respect of patents that claim: 1) an approved change in the formulation; 2) an approved change in the dosage form; and 3) an approved change in use of the medicinal ingredient (i.e. new use or indication).
When to File a Patent List?
A patent may be listed under the PM(NOC) Regulations if its filing date precedes the date of the corresponding drug submission. The patent list must be submitted with the submission for an NOC, unless the patent issues after the date of filing of the submission. In the latter case, the patent list may be submitted within 30 days after the patent is issued, provided that the issued patent is based on an application that has a filing date that occurred prior to the date of filing of the submission. Additions to a patent list cannot otherwise be made except in limited circumstances. A person who submits a patent list must keep it up to date.
Contents of a Patent List
A patent list submitted in respect of a drug must include:
(a) identification of the NDS or SNDS to which the patent list relates;
(b) the medicinal ingredient, brand name, dosage form, strength, route of administration, and use set out in the NDS or SNDS;
(c) the Canadian patent number, filing, issuance and expiry dates;
(d) for each patent on the list, a statement that the person who filed the submission is: 1) the owner of the patent; 2) a person who has an exclusive license to the patent or to a CSP in which the patent is set out; or 3) a person who has obtained consent from the patent owner to include it on the list;
(e) Canadian address for service of NOAs; and
(f) certification that the information submitted is accurate and eligible for listing. A patent list form is available from Bereskin & Parr LLP or Health Canada.
Procedure to Prevent Infringement
Submission of a patent list by a first person (i.e. innovator) in respect of a drug does not prevent a second person (e.g. generic company) from attempting to obtain market authorization to sell the same or similar drug. A second person may still file a submission for an NOC. The following is a summary of the mechanism available to a second person to proceed under the PM(NOC) Regulations.
If a second person files a submission with Health Canada that directly or indirectly compares with, or makes reference to, another drug marketed in Canada (i.e. patented or innovator drug) for which an NOC has issued to another person (a “first person”) and for which a patent list has been submitted, in that submission the second person shall, with respect to each patent on the register in respect of the other drug and each CSP in which the patent is set out and is included on the register in respect of the other drug, state:
(1) that they have the patent owner’s consent to make, construct, use or sell the drug that is the subject of the NOC;
(2) that they accept that an NOC will not issue until the patent or CSP on the patent list expires; or
(3) allege that:
(i) the first person who filed the submission to which the patent list relates is not the owner, the exclusive licensee or a person with consent to list; or
(ii) the patent or CSP has expired, is invalid, is ineligible for listing on the Register or is not infringed.
The second person is required to serve the first person with its statement in a Notice of Allegation (“NOA”) relating to the submission. The NOA must include: 1) a description of the medicinal ingredient, dosage form, strength, route of administration and use of the drug in respect of which the submission has been filed; and 2) a detailed statement of the legal and factual basis for the allegation.
Right of Action
After receiving an NOA from a second person, a first person may, within 45 days, commence an action for a declaration that the making, constructing, using or selling of the second person’s drug would infringe any patent or CSP that is the subject of the NOA.
Commencing an action under the PM(NOC) Regulations will prevent the Minister of Health from issuing an NOC to the second person until the action is discontinued or dismissed, or a period of 24 months has expired, whichever comes first.
Failure to commence an action within 45 days on a listed patent in an NOA will preclude a subsequent infringement action on that patent, unless there was no reasonable basis to bring the action within 45 days.
At any time after receiving an NOA from a second person, a first person may bring an action for infringement of any patent not listed on the Register, provided infringement could result if the second person’s NOC is granted.
Patent Term Extension under the CSP Regulations
The CSP Regulations provide for a limited form of patent term extension for new pharmaceutical products protected by an eligible patent. A CSP provides a maximum of 24 months of additional protection after the expiry of a patent for a drug containing a new medicinal ingredient or combination thereof.
Patent term extension under the CSP Regulations is not automatic; a patentee must file an application within strict time limits and pay a filing fee in order to obtain a CSP.
Only one CSP may be granted for a given medicinal ingredient or combination of medicinal ingredients; if there are multiple conflicting CSP applications the Patent Act provides a scheme to determine priority and, if necessary, initiate conflict proceedings between CSP applicants. If a patentee has multiple patents that otherwise qualify under the CSP Regulations, the patentee will need to select a single patent for a CSP application.
The term of a CSP is calculated by subtracting 5 years from the period beginning on the filing date of the application for the patent and ending on the day on which the authorization for sale set out in the certificate is issued. In all cases the maximum term of a CSP is two years.
Patents Eligible for a CSP
Protection under the CSP Regulations is available for patents directed towards medicines intended for human use as well as veterinary medicines. A patentee may apply for a CSP for a patented invention provided that all of the following conditions are met:
(a) the patent is valid and in force;
(b) the filing date of the application for the patent is on or after October 1st, 1989;
(c) the patent contains at least one product claim, product by-process claim or use claim for the medicinal ingredient or for all the medicinal ingredients contained in a drug for which an authorization for sale (NOC) issued on or after September 21st, 2017;
(d) the authorization for sale (NOC) is the first authorization for sale that has been issued with respect to the medicinal ingredient or combination of medicinal ingredients;
(e) no other CSP has been issued with respect to the medicinal ingredient or combination of medicinal ingredients; and
(f) if an application for marketing approval was submitted with respect to the medicinal ingredient or combination of medicinal ingredients in the European Union (EU), any country that is a member of the EU, the United States, Australia, Switzerland, Japan or the United Kingdom, an application for an authorization for sale (NOC) must be filed in Canada before the end of the 12 month period that begins on the day on which the first such application for marketing approval was submitted, or 24 months if the application for the CSP was filed no later than September 21st, 2018.
When to File an Application for a CSP
An application for a CSP must be filed before the end of the 120 day period beginning on the day on which the NOC is issued (if the patent is granted on or before that day) or the day the patent is granted (if the patent is granted after the NOC).
As noted above, the CSP Regulations also require that in order to obtain the benefit of a CSP, an NOC must be filed within a specific time limit (12 months or 24 months) if an application for marketing has been filed in the EU, any country that is a member of the EU, the United States, Australia, Switzerland, Japan or the United Kingdom.
Scope of Protection of a CSP
A CSP does not necessarily provide patent term extension for all claims in an eligible patent but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the NOC, by itself or in addition to any other medicinal ingredient.
It is not an infringement of a CSP for any person to make, construct, use or sell the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.
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The above represents a general overview of the PM(NOC) and CSP Regulations. It is not legal advice.
For more information, please contact your patent agent or call Bereskin & Parr LLP at (416) 364-7311.