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Federal Government enacts key changes to the PM(NOC) Regulations and to the data protection provisions of the Food and Drug Regulations

DATE

June 6, 2006

EXPERTISE

Intellectual Property

News Flash

The Government of Canada announced today that it has passed significant amendments to the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations. The new regulations and Regulatory Impact Analysis Statements will be published in the Canada Gazette, Part II on October 18, 2006. Unofficial electronic copies of the new regulations have been released by the government and are available online at Industry Canada.

Today's announcement marks the conclusion of an amending process that began with the release of a first round of draft regulations on December 11, 2004. After undergoing significant revisions, the draft regulations were re-published for comment on June 17, 2006. The new regulations were registered and brought into force on October 5, 2006.

Highlights of the New Law
The new amendments to the Patented Medicines (Notice of Compliance) Regulations:
  • Expand and modify the definitions in Sections 2 and 3;
  • Specify that only patents filed prior to the New Drug Submission (NDS), which contain either (1) a claim for the approved medicinal ingredient (chemical or biological); (2) a claim for the approved formulation containing that medicinal ingredient; (3) a claim for the approved dosage form containing that medicinal ingredient, or (4) a claim for the approved use of that 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 a Supplement to an NDS (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;
  • Introduce the concept of the "frozen register" by specifying that generic manufacturers need only address patents that are on the register at the time the abbreviated NDS (ANDS) is filed;
  • 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";
  • Repeal the Section 5(1.1) anti-avoidance provision;
  • Require generic manufacturers to retract a Notice of Allegation (NOA) where the submission or its supplement is withdrawn by the Minister of Health (the "Minister") 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 Drug Identification Numbers (DIN);
  • Specify that the court may, on the motion of a second person, dismiss the application in whole or in part (a) in respect of those patents that are not eligible for inclusion on the register; or (b) on the ground that it is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process in respect of one or more patents;
  • Exempt the Minister from liability for any delay under Section 8;
  • Remove the reference to "profits" for delayed market-entry from Section 8(4); and
  • Include certain transitional provisions:
    • Section 4 Transition - Patents submitted for listing on the register prior to the day of publication of the draft regulations (June 17, 2006) remain subject to the previous patent listing requirement;
    • Sections 5(1)(2) Transition - Generic submissions filed prior to the coming into force of the new regulations (October 5, 2006) will be subject to the new provisions and will be deemed to have been filed as of October 5, 2006; and
    • Section 8(4) Transition - Section 8 cases filed prior to the coming into force of the new regulations (October 5, 2006) are exempt from the new language of this provision.
The new amendments to the data protection provisions of the Food and Drug Regulations:
  • Implement a period of data protection of 8 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);
  • Implement an additional 6-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 NDS or SNDS any time within the first 5 years of the 8-year data protection period;
  • Create a register of innovative drugs which will specify the date upon which data protection and, where applicable, the pediatric extension, will terminate. (The period of data protection will automatically terminate if the innovative drug is withdrawn from the Canadian market);
  • Implement a 6-year no-filing rule which prohibits a generic manufacturer who makes a direct or indirect comparison with the innovative drug from filing an NDS, SNDS or ANDS for the first 6 years of the 8-year term. The Minister will not issue an NOC for a further 2 years (or 2 years and 6 months where a pediatric extension has been granted);
  • Exempt drug submissions made under the Jean Chrétien Pledge to Africa Act from the 6-year no-filing period. Despite this exemption, the Minister will not issue an NOC until the full term of data protection has expired.
  • Do not apply retroactively. Drugs issued an NOC before June 17, 2006 (the date the proposed regulations were published in Canada Gazette I) will not qualify for data protection under the new regime.

We would be pleased to discuss the new regulatory changes with you at your convenience.

About Ogilvy Renault

Ogilvy Renault LLP is a full-service law firm with more than 400 lawyers, patent and trade-mark agents. The firm has offices in Montréal, Ottawa, Québec, Toronto and London and serves a diverse client base that includes many Fortune 500 and FT 500 organizations.

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