Ten “Must-Knows” About Proposed Amendments to Canada’s Pharmaceutical Patent Linkage Regulations

On July 15, 2017, the Canadian government published its proposed amendments (Proposed Regulations) to the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Regulations, similar to the Hatch-Waxman Act in the US, links regulatory approval (known as Notice of Compliance or NOC) of a “generic” drug, including biosimilars, to the protection of patent rights of an “innovator”. Pursuant to the obligation under the Canadian-European Union Comprehensive Economic and Trade Agreement (CETA) that all parties be afforded equivalent and effective rights of appeal, the Canadian government introduced the proposed amendments. These amendments, if implemented, will essentially revamp pharmaceutical patent litigation in Canada. There is a 15-day consultation period on the proposed amendments, ending on July 30, 2017. The finalized amendments may be in force as early as September 21, 2017, which is the start date of the provisional application of CETA and will apply to Notices of Allegation (NOAs) served on or after the coming-into-force date.

This article highlights ten “must-know” amendments from the Proposed Regulations, when compared with the current Regulations:

1. Replacement of summary applications under the Regulations with full actions;

2. Availability of remedies under the Patent Act to innovators;

3. Right of action regarding unlisted patents;

4. New allegation requirements: all claims of listed patents must be addressed;

5. New allegation of ineligibility of patent for listing, although not dispositive of actions if successful;

6. Early document disclosure requirements accompanying the NOA;

7. Early documentary production with the Statement of Claim;

8. Prohibition against innovators bringing a subsequent action;

9. Expansion of section 8 damages; and

10. Innovators can renounce 24-month statutory stay to avoid section 8 damages

    Lastly, the Canadian government published the Certificate of Supplementary Protection Regulations concurrently with the proposed amendments. The proposed amendments will apply to Certificates of Supplementary Protection (CSPs), also known as patent term restoration. Innovators may obtain up to a two-year additional patent term for drugs containing a new medicinal ingredient or a new combination of medicinal ingredients to as a result of delays in research and obtaining marketing authorization. Importantly, a CSP can apply to patents and generics that are already the subject of an action under the Regulations.

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    Summary By: Junyi Chen