Patent term extensions for patented medicines
Effective September 21, 2017, patentees in the pharmaceutical sector are able to effectively extend the term of protection for certain patented medicines under the new Certificate of Supplementary Protection (CSP) regime. CSPs are designed to provide extended protection for eligible human and veterinary drug patents, in recognition of the time spent in research and obtaining marketing approval.
The new regime was introduced in view of Canada’s obligations under the Comprehensive Economic and Trade Agreement (“CETA”) between Canada and the European Union, and is administered by Health Canada.
Highlights of the CSP regime
- A CSP provides up to two years of additional patent protection for an approved drug containing the medicinal ingredient or combination of medicinal ingredients set out in the CSP in respect of a patent directed to the medicinal ingredient or combination in the prescribed manner.
- The additional protection begins on the expiration of twenty years from the Canadian filing date of the patent, provided the patent was valid at end of the twenty-year term.
- The effect of the CSP is to effectively continue the exclusive rights of the patent in respect of drugs containing the medicinal ingredient or combination, with the exception that third parties are permitted to make, construct, use, or sell the medicinal ingredient or combination for the purpose of export from Canada.
- A CSP will only be available in respect of drugs for having a “first authorization of sale” (i.e., a Notice of Compliance or NOC) which issued on or after September 21, 2017.
- The CSP regime emphasizes the timely introduction of new drugs into Canada. An application for a NOC in Canada must be filed within 12 months of an equivalent foreign submission in the EU, USA, Australia, Switzerland, or Japan.
Best practices in the CSP regime
- As the Minister of Health has the discretion to reduce the CSP term, patent owners need to be diligent in avoiding delays in filing and pursuing drug approval in Canada.
- Not all patents are CSP eligible. Pending patent applications should be reviewed to include, where possible, CSP eligible claims, namely, claims to the medicinal ingredient or combination (including product-by-process claims) and any use of the medicinal ingredient or combination. Pure process claims, formulation claims and dosage claims are not eligible for supplementary protection.
- Only one CSP is available for a given medicinal ingredient or combination. Medicinal ingredients which only differ from each other with respect to a prescribed variation are considered the “same” medicinal ingredient. Patent families for related compounds or combinations should be reviewed to ensure that supplementary protection is sought for the most appropriate family member (the patent having the broadest claims, the patent having the latest expiry date, etc.).
- A CSP application must be filed within 120 days of (a) the NOC issuance date for patents granted on or before the issuance date or (b) the patent grant date for patents granted after the NOC issuance date.
- To be eligible for a CSP, the patent must be in force as of the end of its maximum term, twenty years after the application filing date. Patentees should be aware that amendments to the Patent Act and Patent Rules expected to come into force in 2019 are expected to reduce the generous one-year late fee payment period, and to cause retroactive expiry of a patent if its maintenance fee is not paid.
Eligibility requirements for obtaining a CSP
The requirements for obtaining a certificate are set out in section 106 of the Patent Act and section 6 of the Certificate of Supplementary Protection Regulations:
(a) only available for valid patents. Unsurprisingly, a CSP will only be issued for a patent that has not been invalidated or held to be void.
(b) only available for patents issued on applications filed on or after October 1, 1989. A CSP is only available for patents based on so-called “new Act” applications, which are filed on or after October 1, 1989 and are entitled to a maximum term of twenty years after the Canadian filing date.
(c) only available for a “first authorization for sale”. A CSP is only available in respect of a “first authorization for sale” of a drug in Canada. To be eligible for a CSP, the medicinal ingredient or combination cannot have been the sole medicinal ingredient or the combination of all the medicinal ingredients in a drug previously authorized for sale in Canada. The first authorization for sale must be a NOC issued in accordance with section C.08.004 or C.08.004.01 of the Food and Drug Regulations.
(d) authorization for sale must have issued on or after September 21, 2017. To be eligible for a CSP, the first authorization for sale (i.e., NOC) must have been issued on or after September 21, 2017, the date these provisions came into force. Marketed drugs which previously received an authorization for sale prior to the September 21, 2017 implementation date are not eligible for a CSP.
(e) patent must “pertain” to the medicinal ingredient or combination of medicinal ingredients. A CSP-eligible patent need not protect the approved medicinal ingredient or combination of medical ingredients, but must “pertain” to the medicinal ingredient or combination contained in the drug authorized for sale.
To avoid relatively minor variations in medicinal ingredients or combinations being used to circumvent the scope of protection granted by an issued CSP, for the purpose of determining whether a CSP application correctly relates to the first NOC and is otherwise timely, medicinal ingredients are considered the same if they only differ from each other with respect to a prescribed variation, namely:
- a variation in any appendage within the molecular structure of a medicinal ingredient that causes it to be an ester, salt, complex, chelate, clathrate or any non-covalent derivative;
- a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient;
- a variation that is a solvate or polymorph of a medicinal ingredient;
- an in vivo or in vitro post-translational modification of a medicinal ingredient; and
- any combination of the above variations.
To “pertain” to the same medicinal ingredient or combination of medicinal ingredients, the patent must include at least one claim that is directed to:
- the same medicinal ingredient or combination (i.e. product claim);
- any use of the same medicinal ingredient or combination (i.e. use claim); or
- the same medicinal ingredient or combination produced by a defined process (i.e. product-by-process claim).
As noted in the Regulatory Impact Analysis Statement (RIAS) accompanying the Certificate of Supplementary Protection Regulations, patents having only pure process claims (e.g. methods of manufacture) or formulation claims containing the medicinal ingredient or combination (e.g. compositions, dosage forms) are not considered eligible for a CSP. Such claims are considered outside the CETA requirements for the protection of the medicinal ingredient or combination of medicinal ingredients.
(f) only one CSP is available for the same medical ingredient or combination of medical ingredients. Only one CSP will be granted for a given medicinal ingredient or combination. As noted above, medicinal ingredients that only differ from each other by way of a prescribed variation are considered the same medicinal ingredient.
Where there are multiple CSP applications in respect of different patents for the same authorization for sale, the certificate will be issued for the patent having the earliest grant date. Should two or more CSP applications pertain to patents having the same grant date, the applicants will be provided written notice and given the opportunity to timely seek (within 90 days of the date set out in the written notice) a declaration by the Federal Court that the other applicant’s CSP application is not compliant with section 106 of the Patent Act. As part of the conflict resolution process, applicants have the option to withdraw one or more of their applications.
(g) application for authorization of sale must be timely filed. To incentivize the early introduction of innovative drugs into the Canadian market, the Patent Act requires the timely filing of an application for the authorization for sale following the equivalent submission for foreign marketing approval for the same medicinal ingredient or combination in a prescribed country. This requirement applies to equivalent submissions previously made in the European Union (and any member country of the European Union), the United States of America, Australia, Switzerland and Japan.
To be eligible for a CSP, an application for the authorization for sale must be filed within 12 months of the earlier foreign application for marketing approval. When the CSP regime came into force, a transitional provision extended the prescribed period to 24 months if the CSP application was made filed no later than September 21, 2018.
Scope of supplementary protection and term
The issuance of a CSP provides extended protection for the certificate holder and their legal representatives to exclusively make, construct, use and sell any drug that contains the medicinal ingredient, or combination of medicinal ingredients, as set out in the certificate. However, practising the claimed invention for the purpose of export from Canada is not considered infringement of a CSP.
A CSP takes effect upon the expiry of the original term (i.e. 20 years from the patent filing date) of the patent that is the subject of the CSP. The term of protection provided by a CSP is the lesser of:
- the period between the date on which the authorization for sale (i.e., NOC) issued and the patent filing date, minus five years; and
- two years.
The term of the CSP may be reduced in response to “unjustified” delays, attributable to the patentee’s failure to act in obtaining the authorization of sale set out in the certificate, in a timely manner. The reduction of term is only applicable where the patentee is also the person who obtained the authorization for sale.
An action for infringement of a CSP may be brought in the same manner as for an action for the infringement of a patent. A CSP or any claim in the patent set out in the certificate, be declared void or valid by the Federal Court by way of an impeachment proceeding, which may be brought by any interested party.
Obtaining supplementary protection
(a) Who can file a CSP application. A CSP application may be filed by the patentee. Alternatively, “a person recorded in the Patent Office as the owner of the patent” may authorize a manufacturer to file a CSP application on their behalf if the relevant authorization for sale was issued to that manufacturer.
The Patent Office has indicated that “a person recorded in the Patent Office as the owner of the patent” is intended to include the person identified in the declaration of legal representative or entitlement filed in the patent application, who becomes the patentee named on issuance, even if no assignment has been recorded. However, if there is a subsequent change in ownership from the person identified in the declaration, it will be necessary to record an assignment or another appropriate conveyance document to update the recorded ownership in the Patent Office.
(b) When to file a CSP application. A CSP application must be filed before the end of the prescribed period of 120 days, which begins on:
- the day on which the authorization for sale is issued, if the patent is granted on or before that day; or
- the day on which the patent is granted, if the patent is granted after the day on which the authorization for sale is issued.
Applicants need to be cognizant of the timing requirements for obtaining their Notice of Compliance (in particular, relative to an earlier equivalent submission in a prescribed country and relative to the implementation date of the CSP legislation). The timing considerations for filing a CSP application are summarized in the flowchart below.
(c) How to file a CSP Application. The applicant must submit to the Minister of Health within the prescribed period, a CSP application containing:
- the applicant’s name and contact information in Canada, including their complete address;
- particulars of the patent for the which the certificate is being sought, including the patent number, filing date, grant date, patent term expiry date;
- particulars of the authorization of sale, including the number of the authorization of sale (e.g. Drug Identification Number), the medicinal ingredient or combination of medicinal ingredients;
- an attestation that the applicant is the patentee and recorded patent owner in the Patent Office or an authorized manufacturer;
- an attestation that the applicant has either not sought marketing approval for the same medicinal ingredient or combination in the prescribed countries or, if the applicant has previously sought foreign marketing approval, that an authorization for sale was been filed within the prescribed time period;
- if foreign marketing approval was previously sought in a prescribed country, the date of the first application for marketing approval and the country in which the application was made must be identified; and
- a description of the payment method for the prescribed fee.
The applicant is required to provide any additional information that the Minister considers necessary. Each application is limited to one patent for which supplementary protection is sought. With the exception of errors in the identified patent number (which must be corrected by the Minister prior to the expiry of the relevant application period), the applicant may request the correction of any obvious errors in the application prior to the issuance of the certificate.
The application must be submitted with the prescribed fee, which is currently $9,192CAD (the fee increases annually by 2% April 1), to be payable to the Receiver General for Canada in Canadian dollars.
(d) Issuance of the CSP. Assuming the submitted CSP application and submitted fee are compliant with the requirements set out in section 106 of the Patent Act, the Minister will issue the certificate once the following additional conditions have been met:
- the applicable period for filing the application has ended;
- there are no other pending applications for the same authorization for sale and which have priority over or the same priority, as the application; and
- any court proceedings for a declaration of non-compliance of the application or another application for the same authorization for sale and having the same priority have been finally disposed of.
The issued certificate is presumed to be valid in the absence of evidence to the contrary.
Any obvious errors in the issued certificate may be corrected by the Minister based on the available information as certificate issuance date, with the exception of errors concerning how the medicinal ingredient or combination is set out in the certificate (in which case the Minister may consider subsequently available information).
The CSP (or an application for an CSP) can be transferred, in whole or part, by accordingly transferring the entirety or part of the patent set out in the certificate (or the application).