On October 5, 2006, amendments to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) and the Food and Drug Regulations (commonly referred to as the "Data Protection Regulations") came into force. The PM(NOC) Regulations create the regulatory framework that applies to pharmaceutical patents to be listed on Health Canada’s Patent Register. The Data Protection Regulations create the regulatory framework that applies to protect data in regulatory submissions. The amendments are the culmination of significant stakeholder consultation and two earlier versions of the regulations. The key amendments are discussed below.
PM(NOC) Regulations
The PM(NOC) Regulations permit a manufacturer of an innovative drug to submit certain patents for inclusion on the Patent Register in connection with the filing of a New Drug Submission or a Supplement to a New Drug Submission. The Patent Register lists patents that relate to innovative drugs that have been approved for sale by the Minister of Health.
Listed patents have certain protections. When marketing approval is sought for a generic drug through comparison to an innovative product for which there is a listed patent, the generic drug manufacturer must either accept that the marketing approval cannot be issued until expiry of the listed patent or serve the manufacturer of the innovative product with a "notice of allegation". The notice must specify why the listed patent should not prevent the generic drug from coming to market as soon as marketing approval is obtained. The PM(NOC) Regulations permit the manufacturer of the innovative drug to commence legal proceedings in response to the notice of allegation. The proceedings trigger an automatic stay of marketing approval for the generic product for up to 24 months.
The amendments to the PM(NOC) Regulations change the regime in several important ways. They restrict the types of patents that may be listed on the Patent Register. A patent is eligible for listing against a New Drug Submission if it contains claims to the medicinal ingredient, formulation, dosage form or indication for which drug regulatory approval is sought. A "claim to a medicinal ingredient" includes a claim for different polymorphs, but no such recognition is given for claims to other forms of a medicinal ingredient (e.g., salts, esters, enantiomers or solvates). A patent is eligible for listing against a Supplement to a New Drug Submission only if it contains claims to the formulation, dosage form or indication for which drug regulatory approval is sought. A claim for the formulation is defined as a claim for a substance that is a mixture of medicinal and non-medicinal ingredients in a drug and that is administered to a patient in a particular dosage form; a claim for the dosage form is defined as a claim for a delivery system for administering a medicinal ingredient in a drug or a formulation of a drug that includes within its scope that medicinal ingredient or formulation. According to the Regulatory Impact Analysis Statement (RIAS), the requirement for a specific patent claim is meant to ensure that a patent directed solely to a device, such as an intravenous stand or syringe, is not eligible for listing as a patent directed to a dosage form. The RIAS states that dosage forms include controlled-release tablets and capsules, implants and transdermal patches.
The new patent listing eligibility requirements do not apply to patent lists submitted before June 17, 2006.
The amendments also restrict the types of drug regulatory submissions that will support a patent listing. Specifically excluded from a Supplement to a New Drug Submission for which patents can be listed are (i) brand name changes, (ii) manufacturing site changes, (iii) process changes, (iv) quality control (specification) changes, (v) label changes, (vi) safety profile changes, and (vii) withdrawal period amendments. Supplements to New Drug Submissions for dosage form, formulation or indication changes will support a patent listing.
The amendments also limit the requirements for a generic drug manufacturer to address patents listed on the Patent Register. A generic drug manufacturer must issue a notice of allegation for only those patents on the Patent Register as of the date of filing its submission. In most cases, generic drug manufacturers that have already filed a submission benefit from these limitations through a transitional rule that deems the filing date of the submission to be the date that the amendments come into force (i.e., October 5, 2006). If the generic drug manufacturer’s submission for approval was filed less than six years from the date when a Notice of Compliance was issued for the innovative drug, the generic drug manufacturer will be required to address patents added to the Patent Register during the six-year period dating from the issuance of the first Notice of Compliance.
The amendments also expand the type of allegation that a generic drug manufacturer may make in a notice of allegation. In addition to allegations that the proposed product will not infringe the listed patent and/or that the listed patent is invalid, it may be alleged that (i) the manufacturer of the innovative drug has falsely certified a patent’s eligibility for inclusion on the Patent Register, and (ii) the generic drug manufacturer is not seeking approval for the claimed use. A generic drug manufacturer cannot avoid serving a notice of allegation by maintaining that its drug regulatory submission does not seek approval for a patented use. However, according to the RIAS, this is meant to ensure that, in assessing infringement of a use patent, the court’s inquiry is to be limited to a consideration of whether acts of infringement will occur by or at the behest of the generic drug manufacturer (i.e., the court may not consider whether activities by physicians or pharmacists may result in infringement). The amendments require a notice of allegation whether the approval for a generic drug is sought through an Abbreviated New Drug Submission or otherwise. According to the RIAS, this is meant to ensure that the PM(NOC) Regulations apply to "hybrid" or "paper" New Drug Submissions when approval is sought on the basis of a direct or an indirect comparison or reference to an innovative drug. A generic drug manufacturer is required to retract a notice of allegation if the submission for drug approval is cancelled. Moreover, the Minister of Health is required to delete from the Patent Register patents relating to drugs whose Drug Identification Numbers have been cancelled (other than by reason of a change in manufacturer). As the reason for the cancellation is not always apparent, the Minister’s duty is subject to a 90-day grace period. Finally, except for proceedings commenced before October 5, 2006, courts are not permitted to award profits to compensate a generic drug manufacturer for delay in obtaining a Notice of Compliance as a result of proceedings brought under the PM(NOC) Regulations.
Data Protection Regulations
In Canada, a generic drug is generally approved for sale following a demonstration that the generic product is bioequivalent to an approved drug. Bioequivalence typically involves a comparison between the generic drug and the original, innovative product. The previous data protection provisions in the Food and Drug Regulations were intended to guarantee the confidentiality and non-use of the data relating to the innovative drug and prevent a generic drug manufacturer from obtaining drug approval for a period of five years from the date that the innovative drug obtained a Notice of Compliance. However, the provisions were so narrowly interpreted by the courts as to be virtually ineffective.
The amendments to the Data Protection Regulations enhance the protections for data relating to an innovative drug by prohibiting the granting of a Notice of Compliance to a manufacturer that seeks approval of a product on the basis of "a direct or indirect comparison to an innovative drug". According to the RIAS, this is meant to include submissions for approval of generic drugs made through either an Abbreviated New Drug Submission or a New Drug Submission. The period of data protection is eight years from the date that the innovative drug obtained a Notice of Compliance. Pediatric data are eligible for an additional six-month period of protection if submitted with the New Drug Submission or with a Supplement to a New Drug Submission filed within five years after the issuance of the first Notice of Compliance. There is also a six-year no-filing period (within the eight-year term of protection) during which a generic drug manufacturer is not permitted to file a submission for drug approval. The data protections cease to apply if the innovative drug is no longer being marketed in Canada.
The "innovative drugs" that qualify for the data protection provisions are drugs that (i) contain a medicinal ingredient that has not previously been approved in a drug; and (ii) are not variations of a previously approved medicinal ingredient, such as a salt, an ester, an enantiomer, a solvate or a polymorph. According to the RIAS, minor variations of the medicinal ingredient are not entitled to separate terms of data protection; nor are additional terms of data protection available for drugs that contain combinations of medicinal ingredients that have already been approved. The RIAS states that other variations, such as metabolites, may qualify for the protections provided that marketing approval is sought on the basis of new and significant clinical data, rather than previously submitted data.
According to the transitional provision, data in submissions for which Notices of Compliance were issued before June 17, 2006 do not have the benefit of the enhanced data protections.
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