Certificate of Supplementary Protection Regulations
On September 21, 2017, the Comprehensive Economic and Trade Agreement (“CETA”) provisionally came into force in Canada. Among the elements introduced to better align the Canadian patent regime with the standards of Europe are the new Certificate of Supplementary Protection Regulations (“CSP Regulations”), in conjunction with significant amendments to the Patent Act.
Impetus behind the CSP Regulations
The reality of pharmaceutical patenting is that often the protection afforded by patents expires much too soon after a drug is approved for sale. Unlike a mechanical device or an industrial chemical, human and veterinary drugs are subject to lengthy approval processes by government regulatory bodies to ensure they are ready and safe for public use. The CSP Regulations thus provide a means to level the playing field and allow eligible drugs to benefit from supplemental protection, while also reconciling the Canadian and European patent systems. Certificates of Supplementary Protection (“CSP”) will be issued and administered by the Minister of Health (“the Minister”) for which rights holders with patents covering human and veterinary drugs may apply.
In addition to applying to the Minister for a CSP and paying the prescribed fee, the following general requirements must be met in order for a patented invention to receive supplementary protection:
- The patent must not be void and must meet any other prescribed requirements,
- The filing date of application for the patent application must have been on or after October 1, 1989,
- The patent pertains to a medicinal ingredient or combination of medicinal ingredients contained in a drug for which authorization for sale was issued on or after September 21, 2017,
- The authorization for sale has to be the first authorization for sale issued with respect to the medicinal ingredient or combination of medicinal ingredients,
- No other CSP has been issued with respect to the medicinal ingredient or combination of medicinal ingredients, and
- If an application for marketing approval, equivalent to an authorization for sale, has been submitted in a prescribed country with respect to the medicinal ingredient or combination of medicinal ingredients before the application for authorization for sale was filed with the Minister, the application for the authorization for sale was filed before the end of the prescribed period beginning on the day on which the first such application for marketing approval was submitted. [Patent Act, s. 106(1)]
Application Process and Fee
An application for a CSP is to be filed with the Minister before the end of the prescribed period (currently 120 days [CSP Regulations, s. 6(2)]) that begins on either the day on which the authorization for sale is issued in 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. [Patent Act, s. 106(3)] The fee currently payable on filing an application for a CSP is $9191 and increases annually at a rate of 2%. [CSP Regulations, s. 9(1)]
Term and Timing Requirements
A CSP will take effect on the expiry of the patent it is applied for, provided the patent remains valid until its expiry. [Patent Act, s. 116(2)] The term of a CSP is calculated as the difference between the filing date of the patent application and the date of issuance of the authorization for sale, subtracting five years, and then capping this result at two years. [Patent Act, s. 116(3)] The Minister may reduce the term of a CSP in response to unjustified delays in obtaining the authorization of the sale. [Patent Act, s. 116(4)].
The CSP regime favors timely introduction of new drugs into Canada. The prescribed period for filing an application for the authorization for sale (i.e. Notice of Compliance) is 24 months if the application for the CSP was filed before September 21, 2018, or 12 months in any other case. [Patent Act, s. 106(1)(f); CSP Regulations, s. 6(1)(b)]
During the term of an issued CSP, its holder and their legal representatives, have the same rights, privileges and liberties that are provided by the patent to which the CSP attaches, but only with respect to the making, constructing, using and selling of a drug containing the medicinal ingredient, or combination of medicinal ingredients, set out in the CSP, either by itself or in addition to any other medicinal ingredient. [Patent Act, s. 115(1)] However, it is both important and interesting to note that making, constructing, using or selling the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada will not be deemed infringement. [Patent Act, s. 115(2)]
An action for the infringement of a CSP can be brought in the same manner as an action for the infringement of a patent [Patent Act, s. 124]. Furthermore, an interested party can seek a declaration from the Federal Court that a CSP (or any claim in the patent set out in the certificate) is void or invalid [Patent Act, s. 125].
Variations of Medicinal Ingredients
In CSPs, a medicinal ingredient or a combination of medicinal ingredients authorized for human use, and a medicinal ingredient or combination of medicinal ingredients authorized for veterinary use, will be treated as different medicinal ingredients or different combinations of medicinal ingredients, and will fall under different registers. [Patent Act, s. 105(2)] Within the two separate sub-categories, prescribed variations of medicinal ingredients authorized for human use, and prescribed variations of medicinal ingredients authorized for veterinary use, will be treated as the same medicinal ingredient, respectively, where the prescribed variations are:
- variations within the molecular structure of a medicinal ingredient that cause it to become an ester, salt, complex, chelate, clathrate or any non-covalent derivative,
- variations that are enantiomers, or mixtures of enantiomers, of a medicinal ingredient,
- variations that are solvates or polymorphs of a medicinal ingredient,
- in vivo or in vitro post-translational modifications of a medicinal ingredient, and
- combinations of the variations set out in sections (a) to (d). [CSP Regulations, s. 2]
Furthermore, combinations of medicinal ingredients contained in drugs authorized for human use and combinations of medicinal ingredients contained in drugs authorized for veterinary use, which differ only with respect to variation in the ratio between those medicinal ingredients, are treated as the same combination of medicinal ingredients, respectively. [Patent Act, ss. 105(5), 105(6)]
Filing of the Application and Transferability
A CSP application may be filed by the patentee and recorded owner in the Patent Office or the authorized manufacturer to which the authorization for sale was issued. [CSP Regulations, ss. 6(3)(c), 8] Transfer of a CSP or an application for a CSP will only be possible via transfer of the patent or part of the patent to which the CSP or application is attached. [Patent Act, s. 118(1)] Just as a patent may be transferred in whole or in part, so too may a CSP or an application for a CSP. [Patent Act, ss. 118(2), 118(3)]
Suggested Best Practices
In order to fully benefit from the CSP Regime, Pharma Patentees should:
- Diligently pursue drug approvals in Canada to avoid a reduction in the CSP term,
- Stay up to date on patent maintenance fees,
- Review pending patent applications to include a CSP application (if possible),
- Review patents families for related compounds or combination (and if necessary, seek supplementary protection for the most appropriate family member),
- Exercise due diligence in reviews and opinions: consult the CSP Register in addition to the CIPO patent database (as CSPs do not appear on the latter)
A year into the introduction of the CSP regime, 24 applications were filed with the Minister; 23 for human use and 1 for veterinary use. Of the 24, 14 were issued, 3 were refused, and 7 are still pending.
A matter of great interest is the manner in which combinations of medicinal ingredients are defined as variations. Consider hypothetical Combinations A and B, both composed of medicinal ingredients X, Y and Z. In Combination A, X makes up 25%, Y makes up 50% and Z makes up 25%. In Combination B, X makes up 10%, Y makes up 30% and Z makes up 60%. If a CSP is attached to a patented drug for Combination A, but Combination B is discovered to be a new use of the same three medicinal ingredients, then it is possible, according to the Patent Act, that the CSP for Combination A would conflict with the patent granted for Combination B. In other words, the CSP for Combination A would already cover any ratio-related variations of the medicinal ingredients, under which Combination B would fall. Therefore, if Combination A is already approved under the CSP regime, an application for a CSP under Combination B would most likely be refused, whether Combination B belongs to the same entity that owns Combination A, or whether Combination A and Combination B belong to different entities. Despite all this, Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77 tells us that new uses for known compounds are eligible for patent protection, so it seems only time will tell how the courts will treat this potential overlap in legal rights.