Patent Register - Frequently Asked Questions

1. When can a generic version of a drug come on the market?

The expiry date of patents or certificates of supplementary protection (CSP) included on the Patent Register is not always a good indication of when a generic version of a drug may receive its Notice of Compliance (NOC) and, thereby, enter the market. Generic drug manufacturers who file a submission that makes a comparison or reference to another drug marketed in Canada must address all patents and CSPs included on the Patent Register for that drug. The generic drug manufacturer may elect to await expiry of one, some, or all of the patents and/or CSPs included on the Patent Register in respect of the drug or may address the patents and/or CSPs in a Notice of Allegation (NOA) and serve that NOA on the first person. If the generic drug manufacturer addresses the patent(s) and/or CSPs in an NOA, then the first person has 45 days to commence an action for a declaration of infringement with the Federal Court regarding all or some of the patents and/or CSPs addressed in the NOA. The Court will decide if the making, constructing, using or selling of the generic drug manufacturer's drug would infringe the patents and/or CSPs. If the Court’s decision is in favour of the first person, the NOC will not issue for the generic drug until the expiry of the patent(s) and/or CSPs, depending on the Court's order. If more than one patent and/or CSP is the subject of the action, the court can render a different decision for each patent or CSP. The court's decision will determine whether or not the generic drug manufacturer must await the expiry of any of the patents and will affect the date on which the generic drug's NOC can issue. If no decision is rendered before the expiry of 24 months, the NOC can issue. The generic drug manufacturer must then decide whether or not to market its drug before the patent issues are resolved.

2. Who administers the Patent Register?

Pursuant to subsection 3(2) of the PM(NOC) Regulations, the Minister of Health is required to maintain a register of patents (Patent Register) that have been submitted for addition to the register and certificates of supplementary protection in which any of those patents are set out. The submission of a 'patent list' is not obligatory. Therefore, even if a drug has received marketing authorization in Canada, patents may not be listed on the Patent Register for that drug.

3. How do I apply for a patent and where can I find further information on patents?

The Canadian Intellectual Property Office (CIPO) is the agency responsible for the examination and granting of patents in Canada. The CIPO website also has a searchable database of Canadian patents.

4. Where can I find further information on CSP?

For more information on certificates of supplementary protection, please consult the Health Canada Guidance Document Certificate of Supplementary Protection Regulations.

5. When can I submit a patent list for inclusion on the Patent Register?

Subsections 4(5) and 4(6) of the Patented Medicines (Notice of Compliance) Regulations specify when a patent list may be submitted for addition to the Patent Register.

“ (5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates. ”

“ (6) A first person may, after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement, submit a patent list, including the information referred to in subsection (4) of the Patented Medicines (Notice of Compliance) Regulations, in relation to the submission or supplement. ”

6. When will a drug and/or CSP be added to the Patent Register?

The Patent Register lists patents in respect of drugs that have received marketing authorization from the Minister of Health. Subsection 3(7) of the Patented Medicines (Notice of Compliance) Regulations states:

“ No patent on a patent list or certificate of supplementary protection shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or certificate of supplementary protection relates. ”

7. Why do PDF files sometimes not display?

The scanning of Form IVs for conversion into the Portable Document Format (PDF) is an ongoing process. If you select the PDF version icon and receive an error message informing you that the page cannot be found, the Form IV for that record may not have been scanned. Please report any omissions to opml-bmbl@hc-sc.gc.ca.

8. Why are fields in a record sometimes empty?

The Form IV itself has changed over the years such that the information required on the older forms is not the same as that required on the current Form IV. Consequently, in the case of older Form IVs, it is common to have data missing in the web page display. To ensure that there has not been any error in retrieving the data from the database, please view the Form IV directly.

9. How up-to-date is the information retrieved?

The database from which the Patent Register search pages retrieve data is updated on a daily basis. The date of the last update is shown on the bottom of each page.

10. Are removed patents searchable?

Yes, removed patents are searchable as of January 1, 2010. Inquiries relating to patents that were removed prior to this date can be sent to opml-bmbl@hc-sc.gc.ca. The patents which were removed and were available for viewing previously on the Patent Register are listed below.

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