This article first appeared in the May/June 2005 issue of Update. Reprinted with the permission of the Food and Drug Law Institute (FDLI) © 2005.
The government of Canada recently published proposed amendments1 to the Patented Medicines (Notice of Compliance) Regulations2 and to the Food and Drug Regulations3 that will affect innovative drug companies. These regulations create the regulatory framework that, together with patent enforcement proceedings under Canada’s Patent Act,4 governs the protection of pharmaceutical patents. The proposed amendments seek to alter this regulatory framework as follows:
- restricting the application of the Patented Medicine (Notice of Compliance) Regulations, most notably by limiting an innovator’s ability to list and enforce patents on the patent register maintained by the Minister of Health; and
- enhancing protection for the data that an innovator is required to submit to the Minister of Health as part of its new drug submission, and extending the period of data protection from five to eight years (eight and a half years for pediatric studies).
Changes to the Patented Medicines (Notice of Compliance) Regulations
The Patented Medicines (Notice of Compliance) Regulations permit an innovator that files a new drug submission or supplementary new drug submission to submit certain patents for inclusion on the patent register. The patent register lists patents for medicinal products that have been approved by the Minister of Health for sale in Canada.
Listed patents are afforded certain protections. When a generic pharmaceutical company seeks marketing approval for its product by comparing it to an innovator’s reference product for which there is a listed patent, the generic manufacturer must either accept the fact that marketing approval of its product cannot be issued until the listed patent expires or serve the innovator with a notice of allegation. That notice must specify why the listed patent should not prevent the generic competitor from marketing its product before the expiry of the listed patent. The Patented Medicines (Notice of Compliance) Regulations permit the innovator 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 proposed amendments to the Patented Medicines (Notice of Compliance) Regulations will change the regime in three important ways.
First, the proposed amendments would restrict the type of patents that may be listed on the patent register. Currently, patents are eligible for inclusion on the patent register if they contain claims for the medicine contained in the product for which approval is sought; claims to formulations containing that medicine; and claims for indications involving the medicine. Moreover, under the current regime, a patent that relates to a formulation that is different from the approved product is still eligible for listing, as is a patent that claims an off-label indication.
Furthermore, the proposed amendments would restrict the type of patents listed on the patent register to those that include claims to the compound, formulation, or indication for which approval is sought—in other words, to patents that cover the approved product. For practical purposes, this amendment would have the most serious impact on patents that until now have been eligible for inclusion on the patent register in connection with supplementary new drug submissions. In addition, certain types of supplementary new drug submissions in respect of which patents can be listed have been excluded from the operation of the Patented Medicines (Notice of Compliance) Regulations. These excluded supplementary new drug submissions are those seeking approval for 1) brand name changes; 2) manufacturing site changes; 3) process changes; 4) quality control (specification) changes; 5) label changes; 6) dosage form changes; 7) safety profile changes; and 8) withdrawal period amendments. Basically, this leaves only supplementary new drug submissions that relate to new formulations or indications as being included.
Second, the proposed amendments would alter the existing requirement that a generic competitor must address all patents listed on the patent register, including newly added patents. Under the proposed amendments, a generic competitor would have to address a newly added patent only if it were added in relation to an innovator’s supplementary new drug submission, and then only if that submission were filed prior to the filing of a generic competitor’s request for marketing approval of its product.
Third, the proposed amendments would expand the type of allegation that a generic competitor may make in a notice of allegation. At present, a generic competitor typically will allege that its proposed product will not infringe the listed patent and/or that the listed patent is invalid. The proposed amendments would permit a generic competitor to make two additional allegations: 1) that the innovator has falsely certified a patent’s eligibility for inclusion on the patent register; and 2) that in the case of a patent listed against a supplementary new drug submission for a new use, the generic competitor is not seeking approval for the claimed use.
The proposed amendments contain both an anti-avoidance provision and a grandfathering provision. Under the anti-avoidance provision, an innovator that withdraws its original approved product to prevent generic competitors from using it as comparison will lose the protection of the Patented Medicines (Notice of Compliance) Regulations for all patents listed on the patent register for that approved medicine.
The grandfathering provision stipulates that patents on the patent register as of the date the amendments come into force will remain on the register and will be subject to the listing requirements as they existed prior to that date.
Enhanced Data Protection
The proposed amendments will render meaningful the protection for innovators under the data protection provisions of the Food and Drug Regulations and extend the period of data protection from five to eight years.
In Canada, generic competitors generally must demonstrate the bioequivalence of their product to an approved medicine before their product will be approved for sale by Health Canada. Generic competitors demonstrate this bioequivalence by comparing their product with the product of the innovator. Existing data protection provisions in the Food and Drug Regulations are intended to guarantee the confidentiality and non-use of an innovator’s data—and hence prevent a generic competitor from making the comparison—for a period of five years. The courts have interpreted the provisions so narrowly, however, as to be ineffective.
The proposed amendments would prohibit the granting of a notice of compliance to a party that directly or indirectly compares its drug to an innovator’s drug, if the comparison forms the basis on which the party seeks approval and if the medicinal ingredient in the party’s drug is identical to the medicinal ingredient in the innovator’s drug. This prohibition would last for a period of eight years from the first notice of compliance granted to the innovator for the drug in question. If the first notice of compliance to the innovator is based on studies that include pediatric studies, the period of prohibition is eight and a half years.
The deadline for filing submissions with the government of Canada on these proposed amendments was February 24, 2005. The government is assessing these submissions to determine whether to modify the proposed amendments and then promulgate them or whether to republish the proposed amendments if the changes that the government makes to them warrant republication.
2. S.O.R./1993-133. Available at http://laws.justice.gc.ca/en/p-4/sor-93-133/161377.html (last visited May 4, 2005).
3. C.R.C., c. 870. Available at http://laws.justice.gc.ca/en/f-27/c.r.c.-c.870/text.html (last visited May 2, 2005).
4. R.S.C. 1985, c. P-4. Available at http://laws.justice.gc.ca/en/p-4/91746.html (last visited May 4, 2005).
Mr. McCourt is a partner in the Intellectual Property Department in the Toronto office of Torys LLP.
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