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The Canadian government has introduced proposed amendments to the Patented Medicines (Notice of Compliance) Regulations, and the Data Protection Provisions. The announcement was made June 17th, 2006. These proposed amendments pick up from previous proposals introduced in December 2004 which were roundly criticized by both the innovators and the generics. Click here to see our article on the December 2004 proposed amendments. The government went back to the drawing board in 2005 and after a change of government in January 2006 has just now published the most recent proposals.

Generally the proposed amendments differ from the prior proposal by giving the innovators an 8 year data exclusivity term with the inclusion of a 6 year no filing term during which a generic company cannot have Health Canada review its drug submission that references brand name data. The generics now get the "frozen" Register they sought so that they will not be subject to multiple NOC Proceedings when new patents are added to the Patent Register after a first NOC Proceeding has begun. In addition, the proposed amendments continue to include restrictions favouring the generics on eligible patents for listing with New Drug Submissions (NDS) and Supplementary New Drug Submissions (SNDS).

Eligible Patents for Listing

With an NDS: The patent must contain a claim for the medicinal ingredient, formulation, dosage form that contains the medicinal ingredient, or the use of the medicinal ingredient, and an NOC must have issued for such medicinal ingredient, formulation, etc. This narrows what may be listed with an NDS. No longer can a patent for a formulation of a medicine be listed where there is no NOC for that medicine i.e. where the formulation covered by the patent has not been approved to go on the market, and thus could not be on the market.

With an SNDS: Only certain SNDS's are eligible -those where there is a change in the formulation, dosage form or use of the medicinal ingredient. Previously less substantive and even "administrative" SNDS's were relied upon. Additionally, there are restrictions on the type of patents that can be listed with an SNDS. The patent must contain a claim for the changed formulation, dosage form or use and an NOC must have issued in respect of the SNDS.

These new provisions are proposed to apply for patents on a list submitted on or after June 17th, 2006. In addition, the usual timing requirements apply so that the patent list must be submitted with the NDS or SNDS as appropriate, or within 30 days after issuance of the patent if its filing date proceeds the filing date of the submission.

The Frozen Register

The generic will no longer have to address all patents on the Register prior to the issuance of the generic's NOC. Section 5(2) of the current Regulations is to be repealed. The generic only need address those patents on the Register prior to the filing of the generic's submission. The previous proposal from December 2004 gave the generics a partially frozen register - only patents subsequently added by SNDS would have been frozen out. Patents subsequently added to the Patent Register via the principal NDS 30 days after grant would still have had to be addressed. The generics lobbied for the full freeze.

The new provisions would apply to a generic which has filed its submission prior to the coming into force of the amendments, but the freeze date would be the coming into force date. However, if a generic is not subject to the new data protection provisions, the freeze would be 6 years from the date of the first NOC of the innovator.

Other Amendments to the PM(NOC) Regulations

These include:

a) Repeal of present Section 5(1.1), which was previously proposed in December 2004.

b) Generics must first file a New Drug Submission before they can deliver a Notice of Allegation.

c) Section 8 liability (the innovator's liability for keeping the generic off the market resulting from the automatic statutory stay) would be limited by deleting the reference to "profits" in Section 8(4). This provision has been used by the generics to claim the brand's profits from keeping the generic off the market pursuant to the statutory stay, rather than just the generic's loss. There has been no award of such profits to date. This would be applicable only to Section 8 actions commenced after the coming into force date.

Proposed Amendments to Data Protection

The proposed amendments would provide a guaranteed minimum period of exclusivity of 8 years (with an additional 6 months of data protection for pediatric drugs). This is what was proposed in 2004. In addition, there would be a six year no filing period for generic submissions. The 8 year term is viewed as a compromise between the terms of between 5 and 10 years used by various other countries (the U.S. at five years, most European countries about 10).

Data protection is to apply if a generic seeks an NOC for a new drug on the basis of any comparison between it and an "innovative drug". The latter is defined as a drug that contains a medicinal ingredient not previously approved in Canada, and that is not a variation of a previously approved drug such as a salt, ester, enantiomer, solvate or polymorph.

The new data protection provision would apply for drugs for which an NOC is issued on or after the coming into force of the amendments.

The full text of the proposed amendments to both the PM(NOC) Regulations and the Data Protection Provisions, as well as the Canadian government's Regulatory Impact Analysis Statements are set out at:

http://canadagazette.gc.ca/partI/2006/20060617/html/regle6-e.html; and
http://canadagazette.gc.ca/partI/2006/20060617/html/regle4-e.html

Consultation

There is a 30 day consultation period during which submissions may be made to the government on the proposals, which will expire on July 17th, 2006.

Prepared by Mike Charles, June 20, 2006.

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