ARCHIVED — Vol. 149, No. 18 — May 2, 2015

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Regulations Amending the Patented Medicines (Notice of Compliance) Regulations

Statutory authority

Patent Act

Sponsoring department

Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Two recent decisions of the Federal Court and Federal Court of Appeal have reinterpreted the requirements of section 4 of the Patented Medicines (Notice of Compliance) Regulations [the PM(NOC) Regulations] regarding the eligibility for listing on the patent register of patents claiming one or more medicinal ingredients in a manner that conflicts with the intent of the Governor in Council in making the Regulations. Long-standing practices of Health Canada in administering the eligibility requirements of the PM(NOC) Regulations have therefore been called into question, with the result that numerous drugs are at risk of losing patent protection under the Regulations. The purpose of these amendments is to provide rules for the interpretation of the eligibility requirements for listing patents on the patent register in respect of combination drugs in a manner that is consistent with the purpose of the PM(NOC) Regulations and the authority under which they are made.

Background

The Government’s pharmaceutical patent policy seeks to balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower-priced generic competitors. Under the early working exception in section 55.2 of the Patent Act, which allows a person to make, use or sell patented inventions for uses reasonably related to the development and submission of information required by a law regulating marketing any product, a generic drug manufacturer is permitted to conduct the studies needed to develop a generic version of a drug and to file a notice of compliance (NOC) drug submission (a submission) under the Food and Drug Regulations while relevant patents are still in force. As a balance to the early working exception, the PM(NOC) Regulations are intended to provide effective patent protection by ensuring that a notice of compliance is not issued to the generic manufacturer until expiry of all relevant patents or such earlier time as the court or innovator is satisfied with the allegation by the generic manufacturer that no valid patent relating to the drug would be infringed. The linkage to relevant patents is assured through the maintenance of a patent register by the Minister of Health as required by subsection 3(2) and in accordance with the criteria in section 4 of the PM(NOC) Regulations. If the brand name drug manufacturer initiates proceedings to protect its patent listed on the patent register, it is automatically granted a 24-month stay prohibiting the generic manufacturer from being granted regulatory approval. The generic manufacturer may only be granted regulatory approval after the 24-month stay expires or once the PM(NOC) Regulations prohibition proceedings commenced by the brand are resolved in favour of the generic manufacturer, whichever is earlier.

Since the creation of the PM(NOC) Regulations, Health Canada’s practice has been to list patents containing a claim for the medicinal ingredient on the patent register in respect of any approved drug that includes that medicinal ingredient. However, in Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada (Gilead), (see footnote 1) the Federal Court of Appeal interpreted the word “the” in the words “. . . and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission” in paragraph 4(2)(a) of the PM(NOC) Regulations as precluding a patent that claims only two of three medicinal ingredients in the approved drug from listing on the patent register. In Viiv et al v. Teva et al (Viiv), (see footnote 2) the Federal Court, relying on the Federal Court of Appeal’s Reasons for Judgment in Gilead, held that for a patent to be eligible for addition to the register under paragraph 4(2)(a), it must specifically claim all of the medicinal ingredients in the approved drug containing more than one medicinal ingredient. This decision is currently being appealed. The principle set out by these decisions would require that in order to be eligible for listing on the patent register under paragraph 4(2)(a), a patent must contain a claim for all the medicinal ingredients that are contained in the approved drug. As a result, Health Canada has been required to refuse for listing on the register some patents in reference to drugs with multiple medicinal ingredients, as well as to reconsider the listing of some patents already on the register in reference to such combination drugs.

The interpretation by the Federal Court is inconsistent with the policy intent of the PM(NOC) Regulations of allowing the listing of patents that claim one or more, but not all, of the medicinal ingredients contained in an approved combination drug. The policy intent of the PM(NOC) Regulations is reflective of the realities of the drug development process whereby after a medicinal ingredient is patented and a drug with that medicinal ingredient is developed, an innovator may seek to combine the patented medicinal ingredient with other known medicinal ingredients to create new, innovative, and efficacious combination drugs without forgoing the benefit of the protections afforded under the PM(NOC) Regulations.

Objectives

The proposed amendments would restore the intent of the original and amended PM(NOC) Regulations, and clarify ambiguities regarding the listing requirements as they relate to patents containing a claim for the medicinal ingredient and combination drugs. The amendments also confirm the eligibility requirements as they relate to patents containing a claim for the formulation, while clarifying the requirements with respect to non-medicinal ingredients specified in the claim. The amendments also seek to clarify the eligibility requirements in respect of patents containing a claim for the use of the medicinal ingredient, alone or in combination with other medicinal ingredients, in order to ensure a consistent approach to eligibility under section 4 of the PM(NOC) Regulations.

Description

The desired outcome of the proposed regulatory amendments is limited to amending the PM(NOC) Regulations to capture the original policy intent of the listing requirements and to ensure that patents that were rendered ineligible for listing following the Gilead and Viiv decisions are eligible for listing.

The amendments clarify the eligibility rules for adding to the register a patent containing a claim for a medicinal ingredient, a claim for the formulation that contains the medicinal ingredient, and a claim for the use of the medicinal ingredient in relation to a new drug submission.

Specifically, in accordance with the proposed addition of paragraph 4(2.1)(a) of the amended PM(NOC) Regulations, a patent that contains a claim for one or more medicinal ingredients is eligible for addition to the register with respect to a new drug approved through the issuance of a NOC in respect of the submission that includes that medicinal ingredient (or those medicinal ingredients), alone or in combination with other medicinal ingredients.

A refined definition of “claim for the formulation” is proposed, along with language to clarify that such a claim need not specify the non-medicinal ingredients in the formulation. The amendments are not intended to modify the existing requirement that an eligible claim for the formulation under paragraph 4(2)(b) must contain all the medicinal ingredients in the approved drug.

Furthermore, the amendments clarify that a patent that contains a claim for the formulation is eligible for addition to the patent register if the submission includes the non-medicinal ingredients specified in the claim, whether or not the submission contains additional non-medicinal ingredients. Accordingly, a patent that contains a formulation claim that specifies only the medicinal ingredients is eligible to be listed in respect of a drug containing those medicinal ingredients, regardless of the non-medicinal ingredients in the drug. Conversely, a patent that contains a formulation claim that specifies the non-medicinal ingredients will only be eligible for listing against a drug that contains those non-medicinal ingredients.

Amendments are also proposed with respect to patents containing a claim for the use of the medicinal ingredient, aligning the policy intent behind the listing eligibility rule for patents claiming a use of the medicinal ingredient with the rule that applies to patents containing a claim for the medicinal ingredient. Accordingly, a patent that contains a claim for the use of the medicinal ingredient is eligible to be added to the register if the submission includes the use claimed in the patent. The submission in respect of which the patent is sought to be listed may include additional medicinal ingredients, or additional uses of the medicinal ingredient. In addition, the drug submission may require the use of the medicinal ingredient in combination with another drug.

The proposed amendments provide for the drug manufacturer whose request to add a patent to the register has been denied on the basis of the Federal Court’s interpretation of subsection 4(2) in Viiv or whose patent was removed from the register on the same basis to apply under section 3.2, within 30 days following the making of these Regulations to have the patent added to the register. However, the frozen register rule in subsection 5(4) will apply, so a second person filing a submission for an NOC under subsection 5(1) or (2) will not be required to address a patent added to the register in accordance with section 3.2 after the filing date of the second person’s submission for an NOC.

In any legal proceeding commenced under section 6 of the PM(NOC) Regulations for an order of prohibition or any motion brought under paragraph 6(5)(a) following the prepublication of these regulatory amendments in the Canada Gazette, Part I, the Court will be required to apply the PM(NOC) Regulations as amended if the matter is still ongoing at the time that the Regulations come into force.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal, as it would not impose any administrative burden on business.

Small business lens

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

Consultation

Officials from Industry Canada and Health Canada have communicated the intent to amend the PM(NOC) Regulations to both associations representing brand and generic manufacturers, and have been in contact with the brand name pharmaceutical manufacturers chiefly affected by changes that would result from the interpretation adopted in the Gilead and Viiv decisions. Prepublication in the Canada Gazette, Part I, will be followed by a 30-day period during which interested members of the public may submit written representations on the proposed amendments.

Rationale

The stated purpose of the PM(NOC) Regulations is to balance the interests of patent holders with those of generic drug manufacturers by allowing the effective enforcement of patents over new and innovative drugs while allowing the timely entry of their lower-priced generic competitors into the market. Listing patents on the register is perhaps the most important step to allow brand manufacturers to protect their patented drugs, and it also provides generic manufacturers with a comprehensive database of all relevant patents that must be expired before a generic version of a drug can be introduced into the market. The Regulations grant a 24-month stay preventing the Minister of Health from issuing an NOC to allow the marketing of a generic drug until the patents associated with the reference innovative drug have been addressed, either by awaiting patent expiry or being successfully challenged in the Federal Court. Delisting a large number of patents pursuant to the rationale set out by the Federal Court in the Gilead and Viiv decisions would compromise the ability of brand manufacturers to seek protection under the PM(NOC) Regulations for their innovative combination drugs, undermine the balanced interests of brand-name and generic drug producers, and harm consumers, who could be prevented from accessing combination drug products if companies opt to wait until single ingredient drug patents expire before introducing combination drugs to the Canadian market.

Implementation, enforcement and service standards

The proposed amendment does not impose any new requirements; it seeks to reaffirm Health Canada’s long-standing practice in respect of listing compound patents against combination drugs on the patent register.

Contact

Interested persons may make representations with respect to 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

Denis Martel
Director
Patent Policy
Marketplace Framework Policy Branch
Industry Canada
235 Queen Street, East Tower, 10th Floor
Ottawa, Ontario
K1A 0H5
Email: denis.martel@ic.gc.ca
Telephone: 343-291-2686
Fax: 613-952-1980

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 55.2(4) (see footnote a) of the Patent Act (see 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 Paul Halucha, Senior Director General, Marketplace Framework Policy Branch, Industry Canada, 235 Queen Street, Ottawa, Ontario K1A 0H5 (fax: 613-948-6393; email: Paul.Halucha@ic.gc.ca).

Ottawa, April 23, 2015

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS

AMENDMENTS

1. The heading before section 2 of the French version of the Patented Medicines (Notice of Compliance) Regulations (see footnote 3) is replaced by the following:

DÉFINITIONS ET INTERPRÉTATION

2. (1) The definition “claim for the formulation” in section 2 of the Regulations is replaced by the following:

“claim for the formulation” means a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained in a drug and that is administered to a patient in a particular dosage form; (revendication de la formulation)

(2) Section 2 of the Regulations is renumbered as subsection 2(1) and is amended by adding the following:

(2) For the purposes of the definition “claim for the formulation” in subsection (1), the claim for the formulation need not specify the non-medicinal ingredients contained in the drug.

3. The Regulations are amended by adding the following after section 3.1:

3.2 (1) If the Minister deleted a patent from the register in the period beginning October 18, 2014 and ending on the day on which this section comes into force on the basis of the decision in ViiV Healthcare ULC v. Teva Canada Limited, 2014 FC 893, rendered by the Federal Court of Canada on September 18, 2014, the first person who submitted the patent list in relation to that patent may, within 30 days after the day on which this section comes into force, resubmit to the Minister the patent list in relation to the submission or supplement for addition to the register.

(2) If the Minister refused to add a patent to the register in the period beginning October 18, 2014 and ending on the day on which this section comes into force on the basis of that Federal Court of Canada decision, the first person who submitted the patent list may, within 30 days after the day on which this section comes into force, resubmit to the Minister the patent list in relation to the submission or supplement for addition to the register.

4. (1) Paragraph 4(2)(a) of the French version of the Regulations is replaced by the following:

  • a) une revendication de l’ingrédient médicinal, l’ingrédient médicinal ayant été approuvé par la délivrance d’un avis de conformité à l’égard de la présentation;

(2) Section 4 of the Regulations is amended by adding the following after subsection (2):

(2.1) The following rules apply when determining the eligibility of a patent to be added to the register under subsection (2):

  • (a) for the purposes of paragraph (2)(a), a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients;
  • (b) for the purposes of paragraph (2)(b), a patent that contains a claim for the formulation is eligible if the submission includes the non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains any additional non-medicinal ingredients; and
  • (c) for the purposes of paragraph (2)(d), a patent that contains a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if
    • (i) the submission includes additional medicinal ingredients,
    • (ii) the submission includes other additional uses of the medicinal ingredient, or
    • (iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.

TRANSITIONAL PROVISION

5. The court shall consider any ongoing application made under subsection 6(1) or any ongoing motion made under paragraph 6(5)(a) of the Patented Medicines (Notice of Compliance) Regulations that are initiated during the period that begins on the day on which this section is published in the Canada Gazette, Part I, and ends on the day on which this section comes into force, having regard to sections 2 and 4 of the Patented Medicines (Notice of Compliance) Regulations, as amended on the coming into force of this section.

COMING INTO FORCE

6. These Regulations come into force on the day on which they are registered.

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