On October 5, 2006, the government of Canada passed substantive amendments to the Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations) and the data protection provisions of the Food and Drug Regulations (the FD Regulations).
According to the Regulatory Impact Analysis Statement (RIAS) issued by the government to explain the proposed amendments, the purpose of these amendments is to restore the balance between the rights of patent holding drug manufacturers (innovators) and the generic drug manufacturers (generics), in order to ensure a balance between the two policy goals of effectively protecting pharmaceutical inventions (in order to stimulate research and development) and keeping the cost of medicines down.
Although there are a number of changes to the PM(NOC) Regulations, two amendments were particularly significant: (i) a "frozen" patent register and (ii) refined patent listing requirements. In addition, one of the amendments to the FD Regulations (the Data Protection Amendments), which provides for a six-year no-filing period for generic manufacturers and a minimum of an eight-year period of market exclusivity to innovators, is of particular importance.
PM(NOC) Regulations Amendments
The PM(NOC) Regulations provide for a framework permitting pharmaceutical patents to be listed on Health Canada’s patent register. The Regulations link the Minister of Health’s ability to approve a generic drug to the patent status of the innovator’s product by requiring the generic to address the patents listed on the patent register before a notice of compliance (NOC) is issued by the Minister.
If a generic serves an innovator with a notice of allegations (NOA), alleging that each of the patents on the register are not infringed by the generic or are invalid, the innovator may bring an application to the Federal Court to prohibit the Minister from issuing an NOC to the generic. Once such an application has been made, an automatic twenty-four-month stay comes into in effect. This prevents the Minister from issuing the NOC to the generic until the issues of infringement and invalidity are addressed.
Frozen Patent Register
Prior to these amendments, if a patent was added to the patent register after the generic had filed an abbreviated new drug submission (ANDS) for an NOC, but before the NOC was issued, the generic had to amend the ANDS and serve a new NOA in order to address the newly added patent. This process—sometimes referred to as "evergreening"— effectively gave innovators the ability to invoke multiple twenty-four-month stays in order to extend the terms of their monopolies.
Under the amendments, the patent register is now "frozen" as of the date of filing of the generic’s ANDS. The generic no longer needs to address any patents listed on the register by the innovator subsequent to that date: only patents that are on the register at the time of its drug submission need to be adressed. For submissions filed prior to October 5, 2006, the patent register is considered frozen as of October 5, 2006.
The "freezing" of the patent register is considered by many to be a significant gain for the generics.
Refined Listing Requirements
The amendments also refine the listing requirements under s. 4 of the PM(NOC) Regulations. Under the new requirements, a patent can be listed on the patent register with a new drug submission (NDS) if it contains a claim for the medicinal ingredient itself, the formulation, the dosage form, or a claim for a use of the medicinal ingredient. Each of these claims must be approved claims.
The amendments also increase the scope of eligible subject matter for patents to be listed. Previously, courts have consistently held that "claim for the medicine itself" in s. 4 was insufficient to support the listing of dosage form patents. The amendments contain explicit language changing the allowable subject matter to include dosage form patents.
Prior to the amendments, a patent could be listed with almost any supplement to a new drug submission (SNDS), with the exception of an SNDS filed for an administrative change such as a name change. Under the new requirements, a patent that has been applied for prior to the filing of a SNDS may be submitted with the SNDS, provided the purpose of the SNDS is to obtain approval for a change in the use of the medicinal ingredient, formulation, or dosage form. In addition, the patent can only be listed if it claims the use of the medicinal ingredient, formulation, or dosage form for which approval is sought.
It has been argued, notwithstanding the expansion of subject matter to include dosage form patents, that the new listing requirements are far stricter than the previous regulations, and thus, a loss for the innovators.
The new patent listing eligibility requirements do not apply to patents listed before June 17, 2006.
Data Protection Amendments
The Data Protection Amendments are intended to clarify and effectively implement Canada's obligations under the North American Free Trade Agreement and the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement with respect to data protection. These obligations require that signatories provide protection against the unfair commercial use of undisclosed tests or other data submitted in order to obtain approval of pharmaceutical or agricultural chemical products that utilize new chemical entities. The intent of this protection is to allow the originator of the data to protect the investments made in the development of the product by allowing a period of market exclusivity.
Under the previous FD Regulations, data protection arises when the Minister examines and relies on an innovator's undisclosed data in order to grant a NOC to a generic. The previous data protection provisions were intended to guarantee the confidentiality and non-use of the innovator’s data for a period of five-years from the date of issuance of the NOC to the innovator. However, to receive an NOC in Canada, a generic need only demonstrate bioequivalence by comparing its generic product to the innovator's product. Therefore, in actual practice, the Minister typically does not examine the data contained in the innovator's submission in order to grant a NOC for a generic product. As a result, data protection did not arise where bioequivalence formed the basis of a generic submission (see Bayer v. Attorney General of Canada (1999), 87 C.P.R. (3d) 293 (Federal Court of Appeal)).
The FD Regulations have been amended to prohibit the granting of a NOC to a generic for eight years from the issuance of the innovator’s NOC. A six-month extension is added to this time if the innovator designed and conducted clinical trials for use of the drug in paediatric populations. In addition, within the eight-year period, the generic is not able to file a drug submission until six years after the date in which the NOC was issued to the innovator. The amendments also require the Minister to maintain a register of innovative drugs.
These amendments have been considered a significant win for innovators. Combined with another amendment to the PM(NOC) Regulations that prohibits a NOA from being filed until an ANDS has been submitted to the Minister, these amendments provide the innovator with a six-year period to get all relevant patents issued and listed on the register.
The Data Protection Amendments apply to drugs that have received an NOC on or after June 17, 2006. If a generic has already filed a submission for a generic version of a drug that would otherwise benefit from the new data-protection term, the filing date of the submission will be deemed to be six years from the day on which the first NOC was issued for the innovative drug.
The Canadian Generic Pharmaceutical Association has recently announced the launch of a suit in Federal Court, which requests that the Federal Court quash the provisions of the PM(NOC) Regulations which give innovator drug firms additional years of data protection.
Detailed information regarding several other amendments to the PM(NOC) Regulations and FD Regulations are available online at the websites below.
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