Vol. 151, No. 28 — July 15, 2017

Certificate of Supplementary Protection Regulations

Statutory authority

Patent Act

Sponsoring department

Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The proposed Certificate of Supplementary Protection Regulations (the proposed Regulations) are required, in conjunction with amendments to the Patent Act in the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, to establish an additional period of protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent. The legislative and regulatory changes are required to meet Canada’s commitment under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).

Background

In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply. As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.

The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years [i.e. CSP term = (Notice of Compliance date – Patent filing date) – five years, with a cap of two years].

The Act allows CSP applications to be submitted within a prescribed timeframe from (i) the authorization for sale of a drug, or (ii) the subsequent grant of an eligible patent that occurs after the authorization for sale of the drug. To be eligible, the application for authorization to sell a drug containing a medicinal ingredient or combination must be filed with the Minister before, or within a reasonable amount of time from, when the approval of a drug containing the same medicinal ingredient or combination was first sought in any comparable jurisdictions (the timely submission requirement). For a medicinal ingredient or combination to be eligible for a CSP, a drug containing it must not have been previously authorized for sale (as that phrase is defined) in Canada.

This regime is substantially defined in the amendments to the Act. The proposed Regulations specify the various timelines and requirements necessary for the purpose of the regime.

Objectives

The proposed Regulations accompany the Act amendments which establish the CSP regime. This regime implements Canada’s commitment in CETA by providing for an additional period of patent-like protection for drugs containing new medicinal ingredients and new combinations of medicinal ingredients.

The proposed Regulations provide for various timelines, requirements and procedures needed to carry out the CSP regime defined in sections 104–134 of the Act.

Description

The following describes the various specific elements of the CSP regime prescribed in the proposed Regulations.

(a) Same medicinal ingredients

In order to ensure that relatively minor variations in medicinal ingredients or combinations of medicinal ingredients cannot be used to circumvent the scope of protection granted by an issued CSP, or the eligibility requirements relating to the first authorization or timely submission, the proposed Regulations prescribe the variations in medicinal ingredients that would lead to the medicinal ingredients being considered the same.

Subject to subsection 105(2) of the Act regarding human and veterinary uses, if medicinal ingredients only differ from one another with respect to one or more of the following prescribed variations in any appendage within the molecular structure: an ester, salt, complex, chelate, clathrate or non-covalent derivative, then the medicinal ingredients are considered to be the same. The word “appendage” in the context of medicinal ingredients is intended to refer to a portion of the molecule that is connected or joined to a larger or more important part. It is meant to signify the non-principal part of the molecule which is not principally responsible for the mechanism of action of the medicinal ingredient. Also, if the medicinal ingredients only differ from one another with respect to a variation that is an enantiomer, mixture of enantiomers, solvate or polymorph, they are treated as the same medicinal ingredients. Medicinal ingredients that only differ from one another due to post-translational modifications which are done within a living cell (in vivo) or outside of it (in vitro) [e.g. PEGylation] are also treated as the same. Lastly, any differences that arise solely due to combining any of the prescribed variations would also render the medicinal ingredients to be the same.

It should be noted that two combinations, where the individual medicinal ingredients in one combination are prescribed variations of those in the other combination, are considered to be the same combination [e.g. Combo 1 (A+B) is the same as Combo 2 (A’+B’) wherein A’ and A are prescribed variations of one another, and B’ and B are also prescribed variations of one another]. It should also be noted that where differences between two combinations lie only in the proportion of two or more medicinal ingredients that are to be treated as the same, the Act provides that the two combinations are considered to be the same combination of medicinal ingredients. For example, combination 1, containing 0.5 g of medicinal ingredient A and 0.5 g of medicinal ingredient B, would be considered the same combination as combination 2, containing 0.4 g of medicinal ingredient A and 0.6 g of medicinal ingredient B (i.e. changing the medicinal ingredient dose/strength in a combination does not make it a new medicinal ingredient or combination).

(b) Authorizations for sale

To be eligible, the medicinal ingredient or combination cannot have been the sole medicinal ingredient or the combination of all medicinal ingredients in a drug previously authorized for regular sale in Canada (e.g. by way of a Notice of Compliance, Drug Identification Number, Natural Health Product Number). Limited purpose authorizations and interim orders permitting drug sales do not prohibit a medicinal ingredient or combination of medicinal ingredients contained therein from eligibility for a CSP, if a drug containing that medicinal ingredient or combination is subsequently approved by way of a Notice of Compliance (NOC).

The Act also defines that in order for a medicinal ingredient or a combination of medicinal ingredients to be eligible for a CSP it must be the medicinal ingredient or combination of all medicinal ingredients in a drug which is authorized for sale in Canada. The proposed Regulations prescribe the current authorization for sale which renders the medicinal ingredient eligible for a CSP as the NOC (section 4).

(c) Patent eligibility

The proposed Regulations prescribe that a patent must be in force, which is a condition that applies at the time of filing a CSP application and at the time of the issuance of a CSP by the Minister. Further, in order to apply for a CSP, the patent specified in the application must have at least 2 years remaining of its 20-year term in order to provide sufficient time for the completion of potential conflict proceedings, and administrative action by the Minister.

To be eligible for a CSP, the patent claims must pertain, in the case of a drug containing one medicinal ingredient, to the one medicinal ingredient, or, in the case of a drug containing two or more medicinal ingredients, to the combination of all medicinal ingredients.

With the intention that the eligibility of a patent for a CSP will mirror the scope of protection of the resulting CSP, an eligible patent need not protect the approved medicinal ingredient but must pertain to the same medicinal ingredient [see (a) above] as contained in the drug for which the authorization for sale specified on the CSP application was issued. To pertain to the same medicinal ingredient, the patent must include at least one claim that is directed at

  • the same medicinal ingredient;
  • any use of the same medicinal ingredient; or
  • the same medicinal ingredient as produced by a defined process (product-by-process).

Where the authorization is for a drug that contains a combination of medicinal ingredients, the eligible patent need not protect the approved combination of medicinal ingredients but it must pertain to the same combination of the same medicinal ingredients. To pertain to the same combination of the same medicinal ingredients, the patent must include at least one claim directed at

  • the same combination of the same medicinal ingredients;
  • any use of the same combination of the same medicinal ingredients; and
  • the same combination of the same medicinal ingredients as produced by a defined process (product-by-process).

A patent which protects more than one medicinal ingredient or more than one combination of medicinal ingredients, subject to the rules on variations and combinations, would be eligible to support a CSP application in respect of each of those medicinal ingredients or combinations, as the case may be. However, pure process claims do not protect the product and therefore do not render a patent eligible for a CSP.

Also, claims that are directed to a formulation containing the medicinal ingredient, including compositions, preparations or similar claim types, do not make a patent eligible for a CSP. A claim to a formulation does not protect the medicinal ingredient or combination of medicinal ingredients per se. A claim to a formulation may be directed, for example, to the improvement of the stability of medicinal ingredients. This is consistent with CETA, which only requires the protection of the medicinal ingredient or combination of medicinal ingredients when claimed “as such.”

(d) Timely submission

To incentivize the early introduction of innovative drugs into the Canadian market, filing of a Canadian application for authorization for sale for a drug containing the same medicinal ingredient as that contained in a drug for which an equivalent submission for a marketing approval was previously filed in any of the countries prescribed in paragraph 6(1)(a) of the proposed Regulations must be done within a reasonable period (timely submission requirement). The proposed Regulations prescribe the period and the relevant countries.

In order to provide companies an opportunity to adjust their international filings and factor the timely submission requirement, the proposed Regulations include a transitional period in which the prescribed period for timely submission is lengthened.

The filing date of the application for authorization for sale will be determined in accordance with Health Canada guidance that describes those elements of an application for authorization for sale that the Minister takes into account in determining when an application is administratively complete.

(e) Filing and fee

CETA requires that the right to apply for a CSP rests with the holder of the patent. The proposed Regulations allow the patent owner recorded in the Canadian Intellectual Property Office (Patent Office) to authorize the manufacturer to whom the Minister has issued a NOC to submit (and withdraw) the application for a CSP on the patent owner’s behalf. However, in accordance with the Act, the patent owner remains the beneficiary of the rights granted by a CSP upon its issuance.

The proposed Regulations also set the fee for filing a CSP application at $9,011 in the first year, to be increased annually by 2%, and rounded up to the nearest dollar.

(f) Conflicting CSP applications

The Act requires that only one CSP will be granted for a given medicinal ingredient or combination. The Act outlines what happens in situations where conflicting applications are submitted that set out the same authorization for sale and have the same priority. As part of resolving conflicts, the Act also allows the applicants to have one or more of their applications withdrawn.

The proposed Regulations prescribe the various time periods that must be respected when considering conflicting applications. Also, the proposed Regulations prescribe that the date of withdrawal of an application is the date a notice of withdrawal is received by the Minister.

(g) Register

The proposed Regulations prescribe a CSP register containing information about CSP applications and issuances to help members of the public in determining the existence and length of protections of certain medicinal ingredients. This registry is intended as a measure to further ensure transparency and efficiency in the regime.

(h) Amendments/Corrections

The validity of a CSP or an application for one should not be jeopardized by clerical errors. Therefore, the proposed Regulations allow for the corrections of obvious errors.

(i) Coming into force

The proposed Regulations come into force on the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force but, if they are registered after that day, they come into force on the day on which they are registered.

“One-for-One” Rule

Given that the CSP regime is being established and largely defined by the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, which is amending the Patent Act, the proposed Regulations will not independently increase or decrease the administrative burden on businesses. Limited additional burden on the pharmaceutical industry may result from obligations under CETA, which are non-discretionary and cause the proposed Regulations to fall under a “One-for-One” Rule carve-out (i.e. regulations that implement non-discretionary obligations).

Small business lens

The small business lens does not apply to this proposal, as there are insignificant costs on small business.

Consultation

Consultations with stakeholders were done on the CSP regime outlined in the Act and the proposed Regulations as well as the application fee. Both generic and innovative industry members were involved in the consultations conducted over the past two and a half years. These consultations included input from the various stakeholders which was fully considered by the government.

Prepublication in Part I of the Canada Gazette will be followed by a 15-day comment period in order to facilitate broader engagement on the proposed regulatory measures.

Rationale

The Canadian CSP regime is created with the aim of meeting obligations under Article 20.27 of CETA, which requires parties to provide an additional period of protection for patent-protected pharmaceutical products, while continuing to balance the interests of stakeholders and the public within the Patent Act. In determining if requirements should be defined by regulations and not the Act, the main consideration was that regulations can be more responsive to changes. Definitions and meanings that refer to other legislation and regulations (i.e. the Food and Drug Regulations) were inserted in the proposed Regulations, given that it would be easier to amend the relevant reference in case of a change in said related instruments. Elements (timelines, etc.) that are dependent on procedures currently in place at either Health Canada or other regulatory agencies were also defined in the proposed Regulations, given that they might need to be readily changed if or when these procedures are altered. Also, elements of a technical, industrial, scientific or litigious nature, which will evolve according to advancements in the field and will therefore need to be easily amended accordingly, were placed in the proposed Regulations.

Contact

Mark Schaan
Director General
Marketplace Framework Policy Branch, Strategy and Innovation Policy Sector
Innovation, Science and Economic Development Canada
235 Queen Street, East Tower, 10th Floor
Ottawa, Ontario
K1A 0H5
Telephone: 343-291-3700
Fax: 613-952-1980
Email: mark.schaan@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to paragraphs 12(1)(g) (see footnote a), (h) (see footnote b) and (k) (see footnote c) and subsection 134(1) (see footnote d) of the Patent Act (see footnote e), proposes to make the annexed Certificate of Supplementary Protection Regulations.

Interested persons may make representations concerning the proposed Regulations within 15 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mark Schaan, Director-General, Marketplace Framework Policy Branch, Strategy and Innovation Policy Sector, Innovation, Science and Economic Development Canada, 235 Queen Street, East Tower, 10th Floor, Ottawa, Ontario K1A 0H5 (tel.: 343-291-3700; fax: 613-952-1980; email: mark.schaan@canada.ca).

Ottawa, July 13, 2017

Jurica Čapkun
Assistant Clerk of the Privy Council

Certificate of Supplementary Protection Regulations

Definition of Act

1 (1) In these Regulations, Act means the Patent Act.

Definition of authorization for sale

(2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject-matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations, an exemption permitting the sale of a drug under subsection C.10.002(1) of those Regulations, an authorization under section C.05.006, C.05.008 or C.08.010 of those Regulations or section 67 or 71 of the Natural Health Products Regulations.

Variations

2 For the purposes of subsections 105(3) and (4) of the Act, the prescribed variations are

  • (a) 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;
  • (b) a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient;
  • (c) a variation that is a solvate or polymorph of a medicinal ingredient;
  • (d) an in vivo or in vitro post-translational modification of a medicinal ingredient; and
  • (e) any combination of the variations set out in paragraphs (a) to (d).

Eligible patents — requirement

3 (1) For the purpose of paragraph 106(1)(a) of the Act, the prescribed requirement is that the patent must be in force.

Eligible patents — manners of pertinence to medicinal ingredients

(2) For the purpose of paragraph 106(1)(c) of the Act, the prescribed manners in which a patent may pertain to a medicinal ingredient or combination of medicinal ingredients are the following:

  • (a) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued;
  • (b) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; and
  • (c) the patent contains a claim for a use of the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued.

Authorization for sale

4 For the purpose of paragraph 106(1)(c) of the Act, the prescribed kind of authorization for sale is a notice of compliance issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations.

Consultation with Patent Office

5 The Minister may consult with the officers or employees of the Patent Office about any matter relating to a patent that is set out in a certificate of supplementary protection or in an application for a certificate of supplementary protection.

Countries and period

6 (1) For the purpose of paragraph 106(1)(f) of the Act,

  • (a) the prescribed countries are
    • (i) the European Union and any country that is a member of the European Union,
    • (ii) the United States of America,
    • (iii) Australia,
    • (iv) Switzerland, and
    • (v) Japan; and
  • (b) the prescribed period for filing the application for the authorization for sale is
    • (i) 18 months, if the application for a certificate of supplementary protection was filed no later than the first anniversary of the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force, and
    • (ii) 12 months, in any other case.

Period — filing application for certificate

(2) For the purpose of subsection 106(3) of the Act, the prescribed period for filing the application for a certificate of supplementary protection is 120 days.

Period — exception

(3) For the purpose of subsection 106(4) of the Act, the prescribed period preceding the expiry of the term of the patent under section 44 of the Act, without taking into account section 46 of the Act, is two years.

Content of application

(4) An application for a certificate of supplementary protection must contain

  • (a) the applicant’s name and contact information in Canada, including their complete address;
  • (b) the filing date of the application for the patent, the date on which the patent was granted and the date on which the term of the patent will expire;
  • (c) the applicant’s attestation, as the case may be, that the applicant is the patentee and is recorded as an owner of the patent in the Patent Office or that they are the manufacturer who is authorized under section 8 to file the application;
  • (d) the applicant’s attestation that
    • (i) when the application was filed for the authorization for sale referred to in paragraph 106(1)(c) of the Act, no application for a marketing approval, equivalent to an authorization for sale, with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, set out in the application for the certificate of supplementary protection had been submitted in a country prescribed by paragraph (1)(a), or
    • (ii) if one or more of those applications for a marketing approval had been submitted in one or more of those countries, the application for the authorization for sale referred to in paragraph 106(1)(c) of the Act was filed before the end of the prescribed period referred to in paragraph (1)(b) that begins on the day of submission of the first of those marketing approval applications; and
  • (e) a description of the method of payment used to pay the fee prescribed under subsection 9(1).

Filing date

7 The filing date of an application for a certificate of supplementary protection is the date on which the information required by paragraphs 106(5)(a) and (b) of the Act and the content required by subsection 6(4) of these Regulations are received by the Minister.

Application by manufacturer

8 A person recorded in the Patent Office as the owner of a patent may authorize a manufacturer to file on their behalf an application for a certificate of supplementary protection that sets out the patent if the authorization for sale in relation to which the certificate of supplementary protection is sought was issued to that manufacturer.

Fee — application for certificate

9 (1) The fee payable on filing an application for a certificate of supplementary protection is $9,011. Beginning on April 1, 2018, the fee increases annually by an amount equal to 2% of the fee payable in the previous year, rounded up to the nearest dollar.

Manner of payment

(2) The fee must be paid in Canadian currency to the account of the Receiver General for Canada.

Period — commencement of proceeding

10 For the purpose of subsection 110(2) of the Act, the prescribed period for commencing a proceeding referred to in that subsection is 90 days.

Period — expiry of pending applications

11 For the purpose of subsection 111(1) of the Act, the prescribed period for the expiry of pending applications for a certificate of supplementary protection is 90 days. However, if any proceedings have been commenced under section 110 of the Act and two or more applications are pending at the end of the 90-day period, the prescribed period for the expiry of all of the pending applications is 30 days after the day on which the last of those proceedings has been finally disposed of.

Withdrawal of application

12 An application for a certificate of supplementary protection is withdrawn on the day on which the Minister receives a notice of withdrawal from the applicant.

Register

13 The Minister must maintain an electronic register of applications for certificates of supplementary protection and certificates of supplementary protection that contains the following information:

  • (a) in the case of an application, the number of the patent as recorded in the Patent Office, the date on which the term of the patent expires, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the application, along with an indication of whether the authorization for sale relates to human use or veterinary use; and
  • (b) in the case of a certificate of supplementary protection, the number of the patent as recorded in the Patent Office, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the certificate of supplementary protection, the number of the certificate of supplementary protection, the day on which its term begins and on which its term ends, along with an indication of whether it relates to human use or veterinary use.

Period — new patent notice

14 For the purpose of subsection 122(1) of the Act, the prescribed period that begins on the day on which a new patent is issued under section 47 of the Act is 30 days.

Correction of errors — application

15 (1) On the request of an applicant for a certificate of supplementary protection or with their consent, the Minister may, before the certificate of supplementary protection is issued, amend the application to correct any obvious error, including an obvious omission. However, after the expiry of the period prescribed by section 10, the Minister must not correct an error in the patent number that is set out in the application.

Correction of errors — certificate

(2) The Minister may correct any obvious error, including an obvious omission, in a certificate of supplementary protection, on the basis of information that the Minister had, or could have obtained, on the day of its issuance. However, the Minister may also correct such an error that concerns how a medicinal ingredient, or a combination of medicinal ingredients, is set out on the basis of information that the Minister obtains after that day.

Effect of correction

(3) A corrected application or certificate of supplementary protection has the same effect as if it were originally filed or issued in its corrected form.

Coming into force

16 These Regulations come into force on the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, chapter 6 of the Statutes of Canada, 2017, comes into force but, if they are registered after that day, they come into force on the day on which they are registered.

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