A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Wednesday, 26 July 2017

Canadian Government proposes Certificate of Supplementary Protection Regulation


Canada appears to be moving closer towards having system for patent term extension. On 15 July 2017, the Government of Canada published a proposed Certificate of Supplementary Protection Regulations in the Canada Gazette (here).  In addition, the Government is seeking comments on the proposed Regulation by 30 July 2017.

The background section of the Regulatory Impact Analysis Statement is reproduced here:

"In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply. As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.

The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years [i.e. CSP term = (Notice of Compliance date – Patent filing date) – five years, with a cap of two years].

The Act allows CSP applications to be submitted within a prescribed timeframe from (i) the authorization for sale of a drug, or (ii) the subsequent grant of an eligible patent that occurs after the authorization for sale of the drug. To be eligible, the application for authorization to sell a drug containing a medicinal ingredient or combination must be filed with the Minister before, or within a reasonable amount of time from, when the approval of a drug containing the same medicinal ingredient or combination was first sought in any comparable jurisdictions (the timely submission requirement). For a medicinal ingredient or combination to be eligible for a CSP, a drug containing it must not have been previously authorized for sale (as that phrase is defined) in Canada.

This regime is substantially defined in the amendments to the Act. The proposed Regulations specify the various timelines and requirements necessary for the purpose of the regime."

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