Vol. 149, No. 13 — July 1, 2015
SOR/2015-169 June 19, 2015
Regulations Amending the Patented Medicines (Notice of Compliance) Regulations
P.C. 2015-861 June 18, 2015
His Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to subsection 55.2(4) (see footnote a) of the Patent Act (see footnote b), makes the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.
REGULATIONS AMENDING THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS
1. The heading before section 2 of the French version of the Patented Medicines (Notice of Compliance) Regulations (see footnote 1) 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.
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 May 2, 2015 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.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Two recent decisions of the Federal Court and the 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 patents claiming one or more medicinal ingredients in a manner that conflicts with the intent of the Governor in Council in making the Regulations. As a result, numerous drugs are at risk of losing patent protection under the PM(NOC) Regulations. The purpose of these amendments is to restore the policy intent of the PM(NOC) Regulations by providing 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. They do not modify the underpinnings of the product specificity principle introduced in 2006 to prevent evergreening practices.
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 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, it has been the policy intent 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 2) 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 3) 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 was recently affirmed by the Federal Court of Appeal. (see footnote 4) 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 medicinal ingredients to create new, innovative, and efficacious combination drugs without forgoing the benefit of the protections afforded under the PM(NOC) Regulations.
These 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.
The desired outcome of the 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 the medicinal ingredient, a claim for the formulation and a claim for the use of the medicinal ingredient in relation to a new drug submission.
Specifically, in accordance with the addition of paragraph 4(2.1)(a) of the amended PM(NOC) Regulations, a patent that contains a claim for the medicinal ingredient 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, alone or in combination with other medicinal ingredients.
A refined definition of “claim for the formulation” is provided, 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 made 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 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. It is intended that the Regulations, as amended, will apply to the remaining patents on the patent register, even if they were not considered under ViiV. 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.
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.
Officials from Industry Canada and Health Canada 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. Publication in the Canada Gazette, Part I, was followed by a 30-day period during which interested members of the public submitted written representations on the proposed amendments. Comments were received and included submissions from both segments of the industry as well as other interested parties. A summary of the comments are as follows:
- Gilead Sciences, Inc. expressed support for the proposed Regulations, highlighting that the approach adopted will “obviate in most cases listing challenges caused by the court cases cited in the RIAS.”
- Canada’s Research-Based Pharmaceutical Companies (Rx&D), the industry group representing brand-name pharmaceutical companies expressed support for the Government’s “quick action to proactively restore the status quo” regarding the listing of patents claiming medicinal ingredients contained in fixed-dose combination drugs. They contend, however, that the “frozen register” rule should not apply; they suggest that paragraph 4(2.1)(a) be amended to specify that it applies to claims for one or more medicinal ingredient; they also submit that the amendments should be expanded to allow patents that contain “a claim for a class of drug” to be added to the register; they seek new amendments to ensure that the eligibility rules also apply in respect of supplemental new drug submissions; finally, they have called for the transitional provisions to apply to all PM(NOC) proceedings pending at the coming into force of the proposed amendments.
- Industry groups, including the Canadian Chamber of Commerce and BIOTECanada, applauded Industry Canada’s recognition of the issue and its prompt response. They considered that the amendments provide further clarification as to what was intended for listing on the patent register, but suggest that the frozen register rule should not apply.
- A number of submissions, especially from patient groups and healthcare practitioners involved in HIV/AIDS research and treatment, highlighted in their submissions the importance of fixed-dose combination drugs in improving “patient adherence to treatment which, in turn reduces the risk of hospitalization at every stage of disease progression” and “is critical to the success of anti-retroviral therapy.” Patent protection is, they contend, key to promoting innovation and leads to the development of new drugs that benefit Canadian patients. They support this government initiative which will ensure that patients and the overall Canadian society benefit from the treatment and cost-savings advantages of fixed-dose combination therapies.
- A concerned citizen wrote to urge the Government to consider amendments in the context of potential barriers to affordable medication and current health needs of Canadians from all socioeconomic backgrounds, and not only from the perspective of drug development.
- The Canadian Generic Pharmaceutical Association expressed a number of concerns with the proposed amendments, advising Industry Canada not to proceed with these amendments. They contend that the proposed changes go beyond the issues addressed in the Gilead and ViiV cases cited above by making changes to eligibility rules for the listing of “claims for the formulation” and “claims for the use of the medicinal ingredient;” they are concerned that subsection 2(2) and paragraph 4(2.1)(b) could remove the requirement for product specificity and potentially allow more patents to be listed on the register. In addition, they argue that paragraphs 4(2.1)(a) and (c) could render listable on the register patents for new medicinal ingredients or uses thereof, in combination with older, unpatentable medicinal ingredients; they argue against the approach adopted in the transitional provisions and the ability for holders of patents delisted or refused for listing on the register on the basis of the Gilead and ViiV decisions to seek relisting; finally, they raise other issues of interest to their membership they would like to see addressed in amendments to the PM(NOC) Regulations.
Response: The objective of these amendments is to restore the policy intent of the original and amended PM(NOC) Regulations and provide listing eligibility rules to be applied by the Minister and courts on a going-forward basis. The amendments address specifically the issues arising from the decisions in Gilead and ViiV cases regarding the listing eligibility of patents for claims to medicinal ingredients and introduce consistent eligibility rules for the listing of “claims for the formulations” and “claims for the use.” Other matters relating to the application of the PM(NOC) Regulations may deserve further examination, but are beyond the scope of the amendments made at this time. These amendments and the new rules and definitions they introduce should be read in conjunction with the rest of the PM(NOC) Regulations: the PM(NOC) Regulations address the timing and issuance of a Notice of Compliance with respect to eligible patents listed on the patent register. Where a generic manufacturer or other interested party contests the validity of a patent, they may bring a challenge for the impeachment of the relevant patent.
With respect to the eligibility of a claim for more than one medicinal ingredient in an eligible claim under paragraph 4(2)(a), the term “the” medicinal ingredient has been, in accordance with the Interpretation Act, understood to include both the singular and the plural, which is intended to apply to the eligibility rule in paragraph 4(2.1)(a) of the Regulations as amended.
With respect to a patent containing a claim for the formulation, the amendments provide that 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. Even though non-medicinal ingredients may not be specified, the use of terms such as “composition” in the claims implies a mixture of both medicinal and non-medicinal ingredients. 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, nor to modify the required degree of specificity with respect to a class of medicinal ingredients.
With respect to supplemental new drug submissions made under subsection 4(3) of the Regulations, a court may interpret the particular eligibility criteria under subjection 4(3) in a manner consistent with the rules in subsection 4(2.1). However, in keeping with well settled jurisprudence in respect of this subsection, the amendments are not intended to modify the existing requirement that an eligible claim must include the very change approved in the supplemental new drug submission.
Finally, the transitional provisions were drafted to prevent applications seeking to benefit from the old rules after the amendments were published in the Canada Gazette, Part I. The transitional provision clarifies when the amendments ought to apply to ongoing proceedings under section 6. The amendments and the Regulatory Impact Analysis Statement, as modified following the consultation period, would be considered by courts after the coming into effect of these amendments. A balanced approach was otherwise achieved by providing, on the one hand, an opportunity for patents that were denied listing on these grounds to be reconsidered eligible for listing while maintaining on the other hand the “frozen register rule,” so that in keeping with the current requirement, submissions made pursuant to subsections 5(1) and 5(2) of the Regulations would not be required to address patents subsequently added to the patent register.
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 a 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
These amendments do not impose any new requirements; they seek to reaffirm the original policy intent of the PM(NOC) Regulations in respect of listing compound patents against combination drugs on the patent register.
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