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Drugs and Health Products

Notice - Patented Medicines (Notice of Compliance) Regulations

September 19, 2017
Our reference number: 17-106004-740

This notice applies in respect of the Patented Medicines (Notice of Compliance) Regulations.

In light of the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017, Health Canada is in the process of updating the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”). In the interim, this Notice outlines updated information relating to Health Canada’s administration of the PM(NOC) Regulations as they read on or after September 21, 2017.

How to provide litigation information

As the Minister of Health will not be a party to actions for patent infringement under the amended PM(NOC) Regulations, litigation documents in such actions will no longer be served on the Minister. However, the Office of Patented Medicines and Liaison (“OPML”) within the Therapeutic Products Directorate (“TPD”) must have access to relevant information to determine whether there are any barriers under the PM(NOC) Regulations that would prohibit issuance of a notice of compliance (“NOC”) for a second person’s submission. As such, section 6.13 of the amended PM(NOC) Regulations requires a person who brings an action for infringement to provide the TPD with certain documents as soon as feasible. The TPD may also request any information or document required to assess whether NOC issuance is prohibited under section 7 of the PM(NOC) Regulations. If an action is brought, requests for verification of any portion of a submission served with a notice of allegation or produced in the litigation can be made under section 6.05 of the PM(NOC) Regulations.

All information related to litigation, including requests for verifications, must be submitted to the TPD electronically and no duplicate copy should be sent in paper format. Please provide the information by email to: opml_bmbl@hc-sc.gc.ca, or on an acceptable media format, using the requirements outlined below.

By email:

Litigation information should be provided via email unless it exceeds the size limit, in which case it should be provided on media.

  • The sender assumes the risk of transmitting confidential or sensitive information through email.
  • The maximum email size accepted by the corporate mail server is 20 megabytes, anything larger should be sent on media.
  • Documents contained in the email should not be password protected.
  • Please indicate PM(NOC) Regulations, the court file number and the stakeholder name in the subject line of the email.

On media:

The media formats acceptable when providing information are:

  • Compact Disc-Recordable (CD-R) conforming to the Joliet specification;
  • Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard;
  • Single and dual layer Recordable Digital Versatile Discs;
  • Universal Serial Bus (USB) 2.0 or 3.0 drive.

Contact ereview@hc-sc.gc.ca for other media formats that may be acceptable at the time of providing the information.

  • Media and files should not be password protected.
  • Files stored on the media should not be zipped.
  • All information should be provided on a single disc/drive.
  • Media should be scanned using current virus-scanning software and should be certified virus-free.
  • All media should be labelled. The label on the disc/drive should contain the following information:
    • PM(NOC) Regulations
    • Stakeholder name
    • Court file number
    •  “This media has been virus-scanned and we certify that it is virus free”
  • Subsequent to burning the CD/DVD or transferring data to a drive, stakeholders should ensure that all files can be opened and no files are corrupt.
  • Information provided on approved media formats should be sent to the below address, to the attention of the OPML:

    Office of Submissions and Intellectual Property (OSIP)
    Finance Building
    101 Tunney's Pasture Driveway
    Address Locator: 0201A1
    Ottawa, Ontario
    K1A 0K9

How to provide other information

As is currently required, other information related to the PM(NOC) Regulations should be submitted in either the electronic Common Technical Document (“eCTD”) format or the non-eCTD electronic-only format. In accordance with Health Canada’s Frequently Asked Questions - Regulatory Activities in eCTD Format, regulatory transactions accepted in the eCTD format include:

  • Written correspondence related to the PM(NOC) Regulations;
  • Notice of allegation packages (e.g. including proof of service of the notice of allegation on the first person and certification of the date of filing of the submission) under the PM(NOC) Regulations;
  • Form IVs, including updates, filed in accordance with the PM(NOC) Regulations;
  • Form Vs, including updates, filed in accordance with the PM(NOC) Regulations; and
  • Consent letters (under the PM(NOC) Regulations).

For eCTD submissions, the regulatory transactions listed above should be submitted via the Common Electronic Submissions Gateway, as indicated in the Frequently Asked Questions - Common Electronic Submissions Gateway. For non-eCTD submissions, the above-noted information should be sent on an acceptable media format as indicated in the Guidance Document: Preparation of Drug Regulatory Activities in the 'Non-eCTD Electronic-Only' Format.

Form V update

Please note that updates have been made to the Form V: Declaration re: Patent List (“Form V”), in accordance with subsection 5(2.1) of the PM(NOC) Regulations. On or after September 21, 2017, second persons are required to use the new version of the Form V. However, there is no need to re-submit a Form V that was filed before September 21, 2017.

Verification

Section 6.05 of the PM(NOC) Regulations provides that, on the request of any party to an action under the regulations, the Minister must verify that any portion of a submission or supplement that is required to be served with a notice of allegation, or that is produced as a result of an order, corresponds to the information in the submission or supplement. As noted above, the documents to be verified are now to be provided directly to the TPD. To facilitate the verification process, parties are encouraged to continue to provide good quality copies of documents that are indexed using the format found in the example below, with respect to their location within the original submission or supplement. This format is similar to that requested for verifications under subsection 6(7) of the pre-September 21, 2017 version of the PM(NOC) Regulations.

If the productions are not formatted in a format acceptable to the TPD, they may be rejected for verification. To this effect, productions should be formatted as follows:

Index: The documents should be indexed and tabbed. The index should denote the location of the documents from within the production. It is important to note that providing detailed descriptions and information in the index will assist the TPD in locating the documents and verifying the production efficiently.

Description of Item: If multiple versions of a document were filed in respect of the relevant submission, for example a product monograph, add the “date of preparation” to the description (see Tab 2 of the example below).

If multiple documents have similar titles, use a distinguishing name and/or highlight the difference(s) between the documents (see Tab 6 of the example below).

Location: If a document is located in a Master File, provide the Master File number and note whether the document can be found in the Unrestricted/Open or Restricted/Closed portion of the file (see Tabs 4 and 5 of the example below).

Pages within a tab: When only certain pages are provided for verification from a larger document, note the page numbers to be verified in the index and the complete number of pages of the document (see Tab 3 of the example below).

Tabs: Use a naming convention similar to “Tab 3 - [name of document]” when formatting the electronic production. If there are multiple documents contained in one tab, use one New Folder per tab (see Tab 7 of the example below).

Sample Index Example
Tab Sequence Section Description of Item Location
1 0002 3.2.S.1.2 Quality - Body of Data - Drug Substance - Stability - Stability Data - Supplier Commitment [Submission no.]
2 0005 1.3.1 Non-Annotated Product Monograph [date of preparation] [Submission no.]
3 0004 3.2.S.3 Characterization, pp. 416-423 of 739 [Submission no.]
4 0000 1.0.4 Master File [Master File No.] - Administrative Information and Prescribing Information - Quality Overall Summary Master File [Master File No.] - Open Portion or Closed Portion
5 The portions of [drug manufacturer name]’s Master File [Master File No.] that comprise the Productions are the following:
0001 3.2.S.1 General Information, pp. 6-7 of 739 Unrestricted Part or Restricted Part
6 0009 5.3.1.2 Comparative Bioavailability and Bioequivalence Study Reports: Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fed Conditions, Drug Concentration by Formulation [Submission no.]
Comparative Bioavailability and Bioequivalence  Study Reports: Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fasting Conditions, Drug Concentration by Formulation
7 0003 3.2.1.5 Drug Product - Specification(s) [drug name] - 10-mg-release-specifications [Submission no.]
Drug Product - Specification(s) [drug name] - 15-mg-release-specifications [Submission no.]
Drug Product - Specification(s) [drug name] - 20-mg-release-specifications [Submission no.]

Paper Version of the Patent Register

As of September 21, 2017, the TPD will no longer maintain a paper version of the Patent Register. The Patent Register continues to be available electronically for public inspection.

Addition of Certificates of Supplementary Protection to the Patent Register

Once issued, all Certificates of Supplementary Protection will be assessed by the TPD in accordance with subsection 4(3.1) of the PM(NOC) Regulations for eligibility to be added to the Patent Register without requiring a separate form or request from the first person. It is possible that a Certificate of Supplementary Protection will be added to the Patent Register before publication on the Register of Certificates of Supplementary Protection and Applications.

Questions related to this Notice should be directed to the Office of Patented Medicines and Liaison at: opml_bmbl@hc-sc.gc.ca