Canada Gazette, Part I, Volume 155, Number 17: Regulations Amending the Patented Medicines (Notice of Compliance) Regulations

April 24, 2021

Statutory authority
Patent Act

Sponsoring department
Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The Patented Medicines (Notice of Compliance) Regulations (the Regulations) create a patent linkage regime, which ties regulatory approval of subsequent entry drugs (typically generic or biosimilar drugs) under the Food and Drugs Act and the Food and Drug Regulations (FDR) to the patent status of the equivalent innovative product that the subsequent entry manufacturer seeks to copy. Proposed amendments to the FDR intended to improve access to generic medicines could upset the balance between effective patent enforcement over new and innovative drugs and the timely market entry of their lower-priced generic competitors that lies at the heart of the Government's pharmaceutical patent policy. To preserve that balance, an amendment to the Regulations is required to ensure that the scope of protection under the Regulations corresponds to the type of activities contemplated under the proposed amendments to the FDR.

Background

Subsection 55.2(1) of the Patent Act helps facilitate timely access to generic medicines by providing that “[i]t is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.” Under this “early-working” exception, a generics manufacturer can make and use its own version of a patented drug to generate information needed for regulatory approval without fear of infringement. The Regulations help ensure the exception is not abused by generics drugs applicants by providing legal means, prior to approval of the subsequent entry drug, to address possible patent infringement. They do so by linking Health Canada's ability to approve a generic drug to the patent status of the drug that the generic seeks to copy.

To benefit from protection under the Regulations, a person who files or who has filed a new drug submission or a supplement to a new drug submission (i.e. a “first person” under subsection 2(1) of the Regulations) must submit a patent list in relation to the submission or supplement for addition to Health Canada's patent register. Only those patents that meet the timing, subject matter and relevance requirements set out in section 4 of the Regulations can be added to the patent register. Currently, patents with claims only relating to different chemical forms, including different salt forms, footnote 1 of the medicinal ingredient in the approved drug are ineligible for listing on the patent register. The ineligibility of claims related to different salt forms of the medicinal ingredient in the approved drug is no longer appropriate in light of proposed amendments to the FDR.

On March 30, 2019, the Regulations Amending the Food and Drug Regulations (Improving Access to Generics) were prepublished in the Canada Gazette, Part I (the proposed FDR amendments). footnote 2 Among other things, the proposed FDR amendments are intended to clarify the regulatory requirements under the abbreviated new drug submission (ANDS) pathway for generic drug products that contain different forms (e.g. different salt forms) of the medicinal ingredient in comparison to the Canadian reference product or “CRP” (i.e. the previously approved drug product to which the generic product is being compared). footnote 3 Should the different salt form for which approval is sought be patented, the generics manufacturer could benefit from the early working exception in developing its ANDS. However, the innovator manufacturer would not be able to benefit from the corresponding protection offered under the Regulations, as the relevant patent could not be added to the patent register because claims related to a different chemical form of the medicinal ingredient are currently ineligible. This imbalance is contrary to the intended operation of the linkage regime.

Objective

The proposed amendments would seek to restore the balance at the heart of the linkage regime by making patents with claims related to a different salt form of an approved medicinal ingredient eligible for inclusion on the patent register, and to provide a first person with a period of time to submit or resubmit a patent containing such a claim for inclusion on the patent register. These amendments are not intended to have any further effect on the Regulations.

Description

The proposed amendments would expand the definition of “claim for the medicinal ingredient” in section 2 of the Regulations to include “a claim for a variation of the medicinal ingredient that, when compared to the medicinal ingredient, is identical, excluding those appended portions, if any, that cause either the variation or the medicinal ingredient to be a salt, hydrate, or solvate.” This would permit patents containing a claim related to a different salt form of an approved medicinal ingredient to be eligible for listing on the patent register. As drafted, this definition, which is informed by the definition of “therapeutically active component” in the proposed FDR amendments, covers (i) a claim for a salt form that is different from the approved medicinal ingredient (where the approved medicinal ingredient is a different salt form or is a base form) and (ii) a claim for the base form of the medicinal ingredient (where the approved medicinal ingredient is a salt form). Other different chemical forms of the medicinal ingredient continue to fall outside the scope of the definition.

The specific mention of hydrates and solvates in the amended definition does not mean that claims related to a hydrated or solvated variation of the medicinal ingredient were previously ineligible for inclusion on the patent register. Hydrates and solvates already fell within the scope of the definition as “different polymorphs of the medicinal ingredient,” and a patent with a claim to a different hydrate or solvate was already eligible for addition to the patent register. Their specific mention in the new definition only makes this fact more explicit. As before, the proposed amendment to the definition of “claim for the medicinal ingredient” in section 2 would further inform the interpretation of the eligibility requirements in section 4 of the Regulations.

Subsection 4(5) of the Regulations requires that a patent list be submitted at the time the first person files the new drug submission or the supplement to a new drug submission to which the patent list relates. Subsection 4(6) of the Regulations creates a limited exception to the rule in subsection 4(5), permitting a first person to submit a patent list within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement. To ensure that the time limits in subsections 4(5) and 4(6) do not prevent the submission of a patent list containing a patent with claims related to a different salt form of the medicinal ingredient, it is necessary to provide a period of time during which a first person may submit or resubmit such a patent list. Therefore, the proposed amendments include a transitional provision that permits a first person to submit or resubmit, within 30 days after the day on which the amendments come into force, a patent on a patent list that meets the eligibility criteria prescribed in the transitional provision. The 30-day period would provide first persons with sufficient time to make a submission without creating prolonged uncertainty for subsequent entry manufacturers looking for clarity, in advance of filing their submission, on what patents they will be required to address under the Regulations. Patents that were otherwise ineligible for listing under the Regulations may not be submitted or resubmitted under the transitional provision.

One-for-one rule

The one-for-one rule does not apply to this proposal, as it does not impose any administrative burden on business.

Small business lens

The small business lens does not apply to this proposal, as it does not impose any costs on business, including small business.

Consultation

Following publication of the proposed FDR amendments in the Canada Gazette, Part I, stakeholders provided comments on the impact of that proposal on the Regulations and the linkage regime more broadly. Stakeholders from the innovative pharmaceutical industry stated that amendments must be made to the Regulations to account for the increased variability in potentially infringing products eligible for the ANDS pathway under the proposed amendments to the FDR. These stakeholders further submitted that without amendments to the Regulations, the proposed amendments to the FDR would allow a generics manufacturer to file an ANDS for an alternative form of the medicinal ingredient while patents that claim that different form would be ineligible for listing on the patent register. The stakeholders asserted that this would violate the intention of the Regulations to prevent patent infringement. These comments were taken into account in developing the proposed amendments.

Rationale

The Government's pharmaceutical patent policy carefully balances effective patent enforcement over new and innovative drugs with the timely market entry of their lower-priced, generic competitors. Canada's patent linkage regime, embodied in the Regulations, establishes this balance by tying regulatory approval of subsequent entry drugs to the patent status of the equivalent innovative product.

Proposed amendments to the FDR intended to increase access to generic medicines by clarifying regulatory requirements under the abbreviated new drug submission pathway for generic drug products that contain different salt forms of the medicinal ingredient in comparison to the CRP could upset this balance unless the Regulations are amended to permit patents with claims related to these different salt forms to be listed on the patent register and benefit from attendant protections. Amending the Regulations to make patents with claims related to a different salt form of an approved medicinal ingredient eligible for inclusion on the patent register would ensure that regulatory approval requirements for the ANDS pathway remain linked to the status of patents protecting the forms of the medicinal ingredient potentially eligible for that pathway.

These proposed amendments would preserve the balance at the heart of the patent linkage regime by ensuring that the increased access to generic medicines under the FDR amendments is counterpoised by corresponding protections under the Regulations. More specifically, these amendments would ensure that first persons are able to benefit from protections offered under the Regulations in circumstances where a second person takes benefit of the proposed FDR amendments by seeking approval of a generic drug that has a different salt form than its CRP. These proposed amendments are consistent with the pre-existing policy balance and are not intended to favour either innovative drug manufacturers or subsequent entry drug manufacturers.

The proposed amendments would also provide a reasonable period of time during which such patents could be submitted for listing, providing both the innovative and generic sides of the industry with timely insight into any additional patents that will need to be addressed in bringing a new subsequent entry drug to market.

Implementation, compliance and enforcement, and service standards

The proposed amendments would come into force on the day on which the proposed FDR amendments are registered, but if the proposed amendments are registered after that day, they would come into force on the day of registration. The intent is for the proposed amendments to come into force first in order to provide time for a first person to submit or resubmit patent lists for eligible patents prior to the coming into force of the proposed FDR amendments.

Given that the proposed amendments would only amend the definition of “claim for the medicinal ingredient” and add a limited transitional provision, they would not impose any new or modified compliance or administrative requirements on targeted stakeholders. Developing an enforcement strategy or service standards are not necessary. There would be no change in the manner in which the Regulations are enforced.

Contact

Jennifer Miller
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
Email: ic.mfpbconsultations.consultations.dgpcm.ic@canada.ca
Telephone: 343‑291‑3700

PROPOSED REGULATORY TEXT

Notice is given that the Administrator in Council, pursuant to section 55.2 footnote a of the Patent Act footnote b, proposes to make the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.

Interested persons may make representations concerning the proposed Regulations within 30 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 Erin Campbell, Director, Patent Policy Directorate, Marketplace Framework Policy Branch, Strategy and Innovation Policy Sector, Innovation, Science and Economic Development Canada, CD Howe Building, 235 Queen St., Ottawa, Ontario K1A 0H5 (email: erin.campbell2@canada.ca).

Ottawa, April 15, 2021

Julie Adair
Assistant Clerk of the Privy Council

Regulations Amending the Patented Medicines (Notice of Compliance) Regulations

Amendment

1 The definition claim for the medicinal ingredient in subsection 2(1) of the Patented Medicines (Notice of Compliance) Regulations footnote 4 is replaced by the following:

claim for the medicinal ingredient
includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient and a claim for a variation of the medicinal ingredient that, when compared to the medicinal ingredient, is identical, excluding those appended portions, if any, that cause either the variation or the medicinal ingredient to be a salt, hydrate or solvate, but does not include other chemical forms of the medicinal ingredient; (revendication de l'ingrédient médicinal)

Transitional Provision

2 Despite subsections 4(5) and (6) of the Patented Medicines (Notice of Compliance) Regulations, a first person may submit or resubmit to the Minister a patent on a patent list for addition to the register of patents within 30 days after the day on which these Regulations come into force if the following conditions are met:

Coming into Force

3 These Regulations come into force on the day on which the Regulations Amending the Food and Drug Regulations (Improving Access to Generics) are registered, but if these Regulations are registered after that day, they come into force on the day on which they are registered.