Publication

The Government of Canada will publish in the Saturday, June 17, 2006 Canada Gazette the attached draft regulations amending the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations. The draft regulations and Regulatory Impact Analysis Statements are available online at:

http://canadagazette.gc.ca/partI/2006/20060617/html/regle4-e.html (Data Protection)

http://canadagazette.gc.ca/partI/2006/20060617/html/regle6-e.html PM(NOC) Regulations

HIGHLIGHTS

The proposed amendments to the Food and Drug Regulations will:

• Implement a period of data protection of eight years from the issuance of the first notice of compliance (NOC) for an "innovative drug" (a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph); and
• Implement an additional six -month period of data protection for data relating to pediatric studies.  Clinical trial data relating to the use of the drug in pediatric populations may be submitted in the New Drug Submission (NDS) or a Supplement to an NDS (SNDS) any time within the first five years of the eight-year data protection period.
• Create a register of innovative drugs which will specify the date upon which data protection and, where applicable, pediatric extension, will terminate.  (The period of data protection will automatically terminate if the innovative drug is withdrawn from the Canadian market).
• Prohibit a generic manufacturer who makes a direct or indirect comparison with the innovative drug from filing an NDS, SNDS or Abbreviated NDS (ANDS) for the first six years of the eight-year term.  The Minister will not issue an NOC for a further two years (or two and one-half years where a pediatric extension has been granted).

The proposed amendments to the Patented Medicines (Notice of Compliance) Regulations will:

• Expand and modify the definitions in sections 2 and 3;
• Specify that only patents filed prior to the NDS, which contain either (1) a claim for the approved medicinal ingredient; (2) a claim for the approved formulation or dosage form containing the medicinal ingredient, or (3) a claim for an approved use of the medicinal ingredient, may be added to the register in relation to the original form of the drug;
• Permit the listing of "dosage form" patents on the register if they contain a claim to the specific dosage form and medicinal ingredient in the NDS;
• Confirm the right to list new patents on the basis of an SNDS for a new indication, a change in formulation, or a change in dosage form, if the patent contains a claim to the formulation, dosage form or use in the submission;
• Specify that generic manufacturers need only address patents that are on the register when the ANDS is filed;
• Repeal section 5(1.1);
• Expand section 5 by allowing a generic manufacturer to allege that: "no claim for the medicinal ingredient, no claim for the formulation or dosage form and no claim for the use of the medicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the submission is filed";
• Require generic manufacturers to retract an NOA where the submission or its supplement is withdrawn by the Minister of Health for non-compliance or cancelled by the manufacturer;
• Require the Minister to delete any patents on the Register in respect of drugs that no longer have active DINs;
• Exempt the Minister from liability for any delay under Section 8;
• Remove the reference to "profits" from Section 8(4); and
• Include certain transitional provisions.

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