Health Canada Releases Final Guidance Document on NOC Regulations

On December 13, 2007, the Therapeutics Products Directorate (TPD) of Health Canada released its final publication of the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Guidance). The Guidance outlines the roles and responsibilities of first persons (brand manufacturers), second persons (generic manufacturers) and the TPD's Offices of Patented Medicines and Liaison (OPML) under the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), some of which are highlighted below. Responsibilities of First Persons The Guidance reviews substantive requirements which must be met in order for a first person's patent to be listed on the Patent Register under section 4 of the NOC Regulations, including: (1) timing requirements; (2) patent list information requirements; (3) drug submissions eligible for filing a patent list; and (4) product specificity/relevance requirements. In particular, the Guidance sets out the following factors, based on the NOC Regulations and related jurisprudence, for determining the eligibility of a patent for listing under the product specificity /relevance requirements:

1. Patent List for New Drug Submissions
   1. The patent must contain "a claim for the medicinal ingredient". For example:
      • Patents claiming different polymorphs of the medicinal ingredient are eligible for listing.
      • Patents claiming a combination of medicinal ingredients are not eligible for listing with respect to a drug that contains only one of the claimed medicinal ingredients. However, a patent claiming a single medical ingredient as a compound can be listed with respect to a drug that contains the medicinal ingredient in combination with other medicinal ingredients.
      • A patent claiming an enantiomer is not eligible to be listed in respect of a medicinal ingredient that is a racemate.
   2. The patent must contain "a claim for the formulation that contains the medicinal ingredient". In order to ensure that a patent that is directed solely to a formulation with no claim for the drug is not eligible for listing, the formulation claimed in a patent must include the medicinal ingredient of the drug. In addition, that formulation must correspond to the formulation approved in the relevant drug submission.
   3. The patent must contain "a claim for the dosage form". The claimed dosage form must correspond to the dosage form identified on the NOC and approved in the relevant drug submission, and the patent must include a claim to the medicinal ingredient in the dosage form.
   4. The patent must contain "a claim for the use of the medicinal ingredient" and it must contain a claim for a use of the medicinal ingredient that has been approved through the issuance of an NOC. In order to determine whether the patent claims an approved use, reference will be made to the indication section of a product monograph of the drug.
   5. The "medicinal ingredient", "formulation", dosage form", or "use of the medicinal ingredient" has been approved in an NOC for the drug to be submission for which the patent is to be listed.
   6. The patent must have been granted and in good standing.
2. Patent List for New Drug SubmissionsA new patent may be submitted for listing against a supplement to a new drug submission (SNDS) only if the supplement is for: (1) a change in the formulation; (2) a change in the dosage form; or (3) a change in the use of the medicinal ingredient. The patent will only be eligible for listing if it has a claim for the change that is the subject of the SNDS.

Responsibilities of OPML to First Persons To verify that a patent is eligible for listing, the OPML will review both the patent and the related drug submission(s). In conducting this assessment, the OPML may, under subsection 3(8) of the NOC Regulations, request that the Canadian Intellectual Property Office make a recommendation on the subject matter of the patent and/or the eligibility of the patent for listing. If the OPML determines that a patent is not eligible, they will notify the first person and the first person will be provided with a chance to submit written representations in response. Responsibilities of Second Persons

1. Scope and Application of Section 5 of the NOC RegulationsWhen a second person files a submission (or a supplement to a submission), seeking an NOC for a drug based on a comparison to another drug that has been marketed in Canada and in which patents have been listed on the Patent Register, the second person must comply with the requirements under section 5 of the NOC Regulations and make certain allegations with respect to those patents. The Guidance clarifies that for drugs which have been previously issued an NOC to a second person, administrative submissions filed pursuant to TPD's policy "Change in Manufacturer's Name and/or Product Name" do not trigger the requirement to meet section 5. However, administrative submissions by cross-licensees for NOCs will trigger section 5 because the cross-licensees have not previously met the requirements under section 5.
2. "Freezing" the Patent RegisterUnder subsections 5(4)(a) and (b) of the NOC Regulations, the Patent Register is essentially "frozen" as of the date of filing of the second person's drug submission, and a second person is not required to address any patent listed on the Patent Register on or after that date. However, the "date of filing" refers to the date in which the submission or supplement is received by Health Canada, unless that submission or supplement is administratively incomplete or invalid. An incomplete or invalid submission or supplement will not trigger the freezing on the Patent Register. The "date of filing" for such a submission for the purpose of freezing the Patent Register is the date on which the deficiencies are corrected. Furthermore, if a second person cancels its submission or supplement and later re-files, or Health Canada issues a rejection letter, the original date of filing is lost for the purpose of freezing the Patent Register.
3. Certification of Date of FilingWhen a second person's submission or supplement is complete, Health Canada will issue a certification confirming the date of filing. Under paragraph 5(3)(c) of the NOC Regulations, the certification must be included in the material served on the first person when a second person serves a Notice of Allegation (NOA) and detailed statement setting out the legal and factual basis for the allegations.
4. Retraction of an NOASubsection 5(6) of the NOC Regulations requires a second person, who has served an NOA, to retract it and serve a notice of retraction on the first person within 90 days after either: (1) the date on which the Minister notifies the second person that the submission does not meet the requirements of the Food and Drug Regulations; (2) the date of the cancellation by the second person of the submission or supplement to which the allegation relates. If that NOA is the subject of prohibition proceedings under the NOC Regulations, the first person must apply for a discontinuance of the proceedings without delay.

In describing the policy objectives of this document, the TPD emphasizes that Canada's pharmaceutical patent policy objective is to "balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors". For a complete copy of the Guidance, visit: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3_e.html Article by: Nick Wong