Patentee’s Guide to Reporting – Updated July 2015

This publication replaces the Patentee’s Guide to Reporting issued in March 2008.

Notification of Intention to Sell a Patented Medicine pursuant to the Patent Act

Form 1, 2 and 3 pursuant to the Patented Medicines Regulations

Table of Contents

1. Introduction
2. Notification of Intention to Sell
3. Form 1 – Medicine Identification Sheet
4. Form 2 – Identity and Prices of the Medicine
5. Form 3 – Licensees, Revenues and Expenditures
6. Failure to File
7. Glossary
8. Appendix A – Notification of Intention to Sell
9. Appendix B – Reporting Forms
10. Appendix C – List of Codes
11. Patentee’s Guide to Reporting – February 2012

Introduction

1. Background and Authority
2. Purpose, Scope and Limitations of the Guide
3. Interpretation
4. Confidentiality of Reported Information
5. Electronic Filing
6. Where to Get Help: Address, Telephone, Facsimile, E-mail address
7. Electronic/Mailing List

Background and Authority

The 1987 amendments to the Patent Act( Act) established the Patented Medicine Prices Review Board (PMPRB). The Patented Medicines Regulations (Regulations), as provided for by the Act, establish the data reporting requirements to which this Guide is addressed.

This Guide has been prepared under the authority of the PMPRB, which is responsible for ensuring compliance with the Patent Act and the Regulations.

Purpose, Scope and Limitations of the Guide

This Guide is a reference document to help patentees complete a Notification of Intention to Sell a Patented Medicine and Forms 1, 2 and 3. The Guide explains each element of information to be reported, and how and when the information is to be submitted to the PMPRB.

This Guide is intended as a reference tool, not an exhaustive interpretation of the reporting requirements of the Regulations. The instructions and definitions contained in this Guide are intended to assist patentees; they have no legal force and should be read in conjunction with the legislation. In the event of a discrepancy between this Guide and the Act and/or the Regulations, the Act and the Regulations shall, in all cases, prevail.

This Guide may be revised from time to time to reflect changes in reporting requirements and to further clarify current requirements.

Interpretation

For the purposes of this Guide, please note the following:

Person
For reporting purposes the word “person” means an individual, a corporation, or any other legal entity such as a partnership, trust, or other form of business enterprise.

Singular/Plural
All references in the singular case shall include the plural, and references to the plural shall include the singular.

Patentee
Section 79(1) of the Act provides the definition of the word “patentee”:

In other words the word “patentee” is used to mean not only the patent holder/owner, but also any person otherwise entitled to the benefit of the patent or to exercise any rights in relation to that patent (other than by compulsory license). The patent(s) may be for (among other things) the active ingredient(s), processes of manufacture, a particular delivery system or dosage form that is integral to the delivery of the medicine, indications or uses, or formulations of the medicine. The patent(s) need not be used in producing the drug product in order to be found to pertain.

Former Patentee
A former patentee is a person who is no longer entitled to the benefit of a patent pertaining to a medicine.

Confidentiality of Reported Information

Section 87 of the Act states that information provided to the PMPRB by means of these reporting forms is privileged, and will not (except when permitted by that section) be disclosed to any party not legally entitled to such information.

Electronic Filing

The information to be submitted to the PMPRB must be provided using the electronic forms (including layout and file type) that are downloadable from the PMPRB Web site.

Completed forms must be sent to the PMPRB’s e-mail address that is available on the PMPRB website: compliance@pmprb-cepmb.gc.ca

Where to Get Help

Please direct questions regarding completion of the reporting forms to the PMPRB by mail, telephone, fax or e-mail:

Address:
Patented Medicine Prices Review Board
Box L40
Standard Life Centre
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario
K1P 1C1

Telephone:

Forms 1 & 2
613-288-9628

Form 3
613-288-9642
Tanya Potashnik
Director, Policy and Economic Analysis

Facsimile:
613-288-9643

E-mail address:
PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca
Communications may be in either official language.

Electronic Mailing List

If you would like to be added to the PMPRB’s eBulletin, please register by accessing the subscriptions page.

Notification of Intention to Sell

Under subsection 82(1) of the Patent Act, a patentee is required to notify the PMPRB, as soon as practicable, of its intention to sell a patented drug product in Canada, and the date on which the patentee intends to offer the drug product for sale. A Notification of Intention to Sell a Patented Medicine is available in Appendix A.

Form 1 – Medicine Identification Sheet

1. General Information
2. Block 1 - Names and Use(s) of the Medicine
3. Block 2 - Reporting Patentee
4. Block 3 - Notice of Compliance (NOC)
5. Block 4 - Drug Identification Number (DIN)
6. Block 5 - Date of First Sale
7. Block 6 - Product Monograph
8. Block 7 - Patent Numbers of Reporting Patentee’s Inventions Pertaining to the Medicine
9. Block 8 - Certifying Signature

General Information

Purpose Form 1 (see Appendix B) is used by patentees to report information on a patented drug product for which a Notice of Compliance (NOC) has been issued, or which is being first offered for sale in Canada. The PMPRB uses the reported information to identify patentees and patented drug products that are subject to the reporting requirements of the Regulations. Form 1 must be sent to the PMPRB prior to Form 2 and must be maintained up to date at all times.

Definitions of key terms used in these forms are included in the Glossary.

The information to be submitted to the PMPRB must be provided using the electronic forms (including layout and file type) that are downloadable from the PMPRB website under Are you a patentee?/Frequently Requested Items/Forms.

A separate electronic Form 1 must be submitted for each Drug Identification Number (DIN) of the patented drug product within seven days of it being issued an NOC or being first offered for sale in Canada, whichever comes first. For those patented drug products which have not been assigned a DIN, a separate Form 1 must be submitted for each strength of an individual, final dosage form.

The electronic copy of Form 1 must be in Excel format. If a patentee does not wish to send the requested electronic signature in Excel, it should send two electronic Form 1s, one in Excel without the electronic signature and one in portable document format (PDF) with the electronic signature. An electronic copy of the product monograph (Word or PDF), or information similar to that contained in a product monograph when an NOC has not been issued, must be submitted with the Form 1.

Completed forms must be sent to the e-mail address that is specified on the PMPRB website: compliance@pmprb-cepmb.gc.ca

Who should provide information?
Patentees or former patentees.

Which drug products should be reported in Form 1?
All patented drug products (human prescription, OTC and veterinary) must be reported.

Patented drug products sold under the Special Access Programme (SAP), a Clinical Trial Application or as an Investigational New Drug and for which no NOC has been issued, should be reported on a Form 1 within seven days of being first offered for sale.

Changes/Additions/Deletions
Patentees and former patentees are required to update the previously completed electronic Form 1 to report to the PMPRB any changes, additions and deletions to information previously submitted for a drug product. This includes any change to the identity (i.e., name and/or address) of the patentee or former patentee. Please check the box at the top of the Form 1 indicating that it constitutes an amendment and complete all the required sections. There is no need to submit a product monograph with an amended Form 1 unless there has been a change to the product monograph. The amended Form 1 shall be signed and dated when the amendment is submitted to the PMPRB. It is not appropriate to maintain the original signature and filing date when amending the Form 1.

Due Dates
Form 1 shall be submitted to the PMPRB not later than:

i. The earliest of:

• Seven (7) days after the date the first NOC is issued
• Seven (7) days after the date the medicine is first offered for sale in Canada

ii. 30 days after any changes, additions or deletions are made to the information originally submitted to the PMPRB on a Form 1.

Filing Information
In the appropriate box at the top of the Form 1, specify whether it is an original filing or an amendment.

If it is an original filing, please complete all blocks as described below.

If it is an amendment to an original filing, please complete all blocks as described below and specify which block(s) is (are) amended in the space designated for it at the end of the line. For example, if the product has a new patent, please write: 7

Block 1 - Names and Use(s) of the Medicine

State the Brand Name and Generic Name of the drug product to be identified by this form. For example:

Brand Name... ...Diastat
Generic Name... ...diazepam

Therapeutic Use of the Medicine
State the therapeutic class as provided by Health Canada in the NOC or if an NOC has not been issued, the anticipated therapeutic use(s) of the drug product. For example, the therapeutic use of Diastat would be Benzodiazepine Anticonvulsivant as listed in the NOC under therapeutic class. The Compendium of Pharmaceuticals and Specialties (CPS)1 provides acceptable therapeutic use descriptions in bold italic at the beginning of each product monograph.

Human Prescription/Human Over-the-Counter/Veterinary
Indicate in the boxes provided whether the drug product is:

• Human Prescription i.e. prescribed for human use and is a controlled substance as defined in the Controlled Drugs and Substances Act or contains a substance listed or described in Schedules C or D to the Food and Drugs Act or Schedule F to the Food and Drug Regulations;
• Human Over-the-Counter i.e. provided overthe-counter for human use and is not a controlled substance as defined in the Controlled Drugs and Substances Act or does not contain a substance listed or described in Schedules C or D to the Food and Drugs Act or Schedule F to the Food and Drug Regulations;
• Veterinary i.e. intended for veterinary use. Veterinary drug products include feed additives (e.g., antibiotics, vitamins) which have been classified as drug products.

If the drug product is intended for both human and veterinary uses, complete a separate Form 1 for each use.

Block 2 - Patentee

State the name and address of the patentee or former patentee.

Unless indicated otherwise, questions regarding completeness, accuracy, etc, will be directed to the individual signing the form at the address recorded here.

Status of Reporting Patentee
In the boxes provided, check off the description that best describes the status of the patentee or former patentee completing this form.

• The patent holder is the person (“person” is defined in the Interpretation section) that owns the patent.
• A person entitled to the benefits of a patent or to exercise any rights in relation to a patent is a person who has a license or other agreement, whether express or implied, with the patent holder/owner to exercise one or more rights under the patent. This category excludes a person who has a compulsory license, as previously defined under section 39(4) of the Act amended in 1993.

Please note that a patentee may be the patent holder of one patent and the person entitled to the benefits of a second patent on the same DIN. In this case, both boxes of Block 2 should be checked.

Block 3 - Notice of Compliance (NOC)

Patentee’s First NOC
Indicate the date on which the first NOC was issued to the patentee or former patentee for the drug product named in Block 1 (i.e. first NOC for this DIN).

Special Access Programme or Clinical Trial Application or Investigational New Drug
If no NOC has been issued, use the provided boxes to indicate whether the drug product named in Block 1 is being sold under the SAP, a Clinical Trial Application or as an Investigational New Drug (see definitions in Glossary).

Block 4 - Drug Identification Number (DIN)

Drug Identification Number (DIN)
Enter the DIN that applies to the drug product identified in Block 1. Enter only the DIN that identifies a form of the drug product which the patentee or former patentee is selling, has sold or intends to sell in Canada.

If the drug product has no DIN, leave this space blank. Following receipt of Form 1, the PMPRB will provide an assigned number to any patented drug product that does not have a DIN. The patentee will be asked to use this Assigned Number when completing Form 2 during the subsequent reporting periods until an NOC is issued.

Dosage Form
Enter the dosage form that corresponds to the DIN entered in the first column. Write out the dosage form in full – do not use codes.

Examples of dosage forms include: tablets, capsules, vials, injectable ampoules, oral ampoules, liquid, solution, suspensions, drops, lotions, creams, sprays, aerosols, suppositories.

Following receipt of a Form 1 for a new drug product, Board Staff assigns a code to the dosage form for the purpose of recording the new DIN into the PMPRB electronic system. The code of each DIN is found on the Form 2 Block 4 and Block 5 templates that Board Staff sends to the patentee after receiving a Form 1 for a new drug product and prior to the filing deadline for the semi-annual regulatory filings.

Appendix C provides the list of dosage form codes that are used for the purpose of recording each DIN in the PMPRB electronic system. Please note that these dosage forms and codes are not used for the scientific and introductory price review.

Strength/Unit
For the DIN in the first column, indicate the corresponding strength of the drug product. Strength is defined as the amount of active ingredient, expressed in milligrams (mg), micrograms (ìg or mcg) or as appropriate per unit of medicine.

The unit of medicine is expressed in units of the dosage form such as tablets, milliliters, vials, etc. Be sure to state the units being used. For example:

Do not use percentages; use the style shown above. For example, instead of reporting an oral liquid with 1% of active ingredient, report 0.01 mg/mL.

For drug products with more than one active ingredient, report as above, but with the amounts of active ingredients linked by a “+” sign. For example:

Please note that the strength/unit reported by the patentee in the Form 1 is usually the strength/unit registered in the NOC. Please note that the PMPRB may amend the description of the strength/unit (for example from 1 mg/vial to 1 mg/ml) for the purpose of conducting a price review. This amended strength/unit description would be recorded in the PMPRB electronic system and on the Form 2, Block 4 and Block 5 templates provided to the patentee.

Block 5 - Date of First Sale

Indicate the year, month and day when the drug product identified in Block 1 is first sold in Canada, whether it is following issuance of an NOC, under the SAP, a Clinical Trial Application or as an Investigational New Drug.

Block 6 - Product Monograph

Patentees must provide an electronic copy (Word or PDF) of the product monograph along with the Form 1, or if an NOC has not been issued, information similar to that contained in a product monograph.

Block 7 - Patent Numbers of Reporting Patentee’s Inventions Pertaining to the Medicine

Patent Number
State the patent numbers for all the Canadian patents that pertain to the drug product named in Block 1.

List those patents owned by the patentee or former patentee, assigned to the patentee or former patentee, or in respect of which the patentee or former patentee is or was entitled to the benefit or to exercise any rights (other than through a compulsory license).

Date Granted
For each patent listed in the first column, enter the date (year/month/ day) the patent was granted on the corresponding line in the middle column.

Expiry Date
For each patent number listed in the first column, enter the corresponding expiry date on the corresponding line in the third column. For patent applications filed on or after October 1, 1989, the patent period is a maximum of 20 years from the date of filing of the patent application in Canada. For patent applications filed before October 1, 1989, the patent period is a maximum of 17 years from the date the patent was granted.

Block 8 - Certifying Signature

This form should be signed by an authorized individual for the patentee or former patentee.

Signature

The individual signing should have the authority to bind the patentee/former patentee and be knowledgeable about information reported on the form. Below the signature, type the name of the person, his or her title and the name of the organization which the person represents. An electronic reproduction of the manual signature of the authorized person is required by the Board and should be copied and pasted in the box reserved to that effect. A Form 1 must be submitted in Excel format. A patentee who does not wish to submit its electronic signature on a Form 1 in Excel format must send two Form 1s, an Excel copy with no signature and a PDF copy with the signature.

Telephone, Facsimile Numbers and E-mail Address

Provide telephone and facsimile numbers as well as the e-mail address for the signatory.

Date Signed

State the date (year/month/day) the form was signed.

1 The Compendium of Pharmaceuticals and Specialties (CPS) is published and copyrighted by the Canadian Pharmaceutical Association.

Form 2 – Identity and Prices of the Medicine

1. General Information
2. Block 1 - Original Filing
3. Block 2 - Amendment to an original filing
4. Block 3 - Patentee Certifying Signature
5. Block 4 - Sales of the Medicine by the Patentee in Final Dosage Form in Canada
6. Block 5 - Publicly Available Ex-Factory Prices for Canada and Other Countries

General Information

Purpose

Form 2 (see Appendix B) is a multi-page reporting form on which the reporting patentee provides information on the prices of patented drug products.

• For Human Prescription drug products, submit a Form 2 semi-annually for each patented drug product, according to the reporting periods and due dates described below.
• For Human Over-the-Counter and Veterinary drug products, submit a Form 2 only if the PMPRB sends a request in response to a complaint respecting the price of the medicine. It is the patentee’s responsibility to maintain up-to-date Form 2 information from the date of first sale in the event of such a request.

Definitions of key terms used in these forms are included in the Glossary.

Who should provide information?
Patentees and former patentees.

How to Complete a Form 2?

A Form 2 includes three sections that must be submitted electronically as three separate files:

The cover sheet (i.e. Block 1, 2, 3 and electronic signature) must be sent in Excel format. If a patentee does not wish to send the requested electronic signature in Excel, it should send two electronic Form 2 Block 1, 2, 3s , one in Excel without the electronic signature and one in portable document format (PDF) with the electronic signature. The cover sheet can be downloaded from the PMPRB website

Block 4 Sales of the Medicine by the Reporting Patentee in Final Dosage Form in Canada must be sent in Excel format

Block 5 Publicly Available Ex-Factory Prices for Canada and Other Countries must be sent in Excel format.

Following receipt of a Form 1 for a new product and prior to the filing deadline for the semi-annual regulatory filings, Board Staff sends Form 2 Block 4 and Block 5 templates to each patentee. Please use these templates and ensure that each field of each row is filled as specified below.

Completed forms must be sent to the e-mail address that is specified on the PMPRB website: compliance@pmprb-cepmb.gc.ca

Reporting Periods and Due Dates

(A) Semi-Annual Filing

Report Form 2 information semi-annually. Reporting periods and due dates will be as follows:

* If a due date falls on a weekend or statutory holiday in Ontario the due date shall be the next business day.

(B) Day of First Sale

When a drug product is first offered for sale in Canada by, or on behalf of, the patentee, the following reporting requirements apply:

a) A Form 2 must be filed with the PMPRB no later than thirty (30) days after the day on which the medicine is first sold in Canada.

b) The information provided in the Form 2 must cover the first day of sale in Canada of the new drug product.

EXAMPLE:
If a new Human Prescription drug product is first offered for sale on March 15, 2011, a completed Form 2 would be due on April 14, 2011. The Form 2 report would report the price and sales of the drug product for March 15, 2011. The next Form 2 would be due on July 30 and would cover the period March 15 to June 30 (it is recognized that some information will be reported twice).

(C) Human Over-the-Counter (OTC) and Veterinary Drug Products

A Form 2 for Human OTC and Veterinary drug products must be submitted to report sales data from the date of first sale until March 6, 2008. After March 6, 2008 sales data of veterinary and OTC patented drug products must be reported only when the PMPRB sends a request to the patentee in response to a complaint. The information must be provided within 30 days after the date on which the PMPRB sends a request and semi-annually for two (2) years following the request, within 30 days after each six-month period. The PMPRB may request this information up to three years after the patent’s expiry. It is the patentee’s responsibility to maintain up-to-date Form 2 information from the date of first sale in the event of a request for this information from the PMPRB in response to a complaint.

Form 2 Block 4 and/or Block 5 Data Corrections

Patentees wishing to submit data corrections to Form 2 Block 4 and/or Block 5 will be required to provide evidence supporting their proposed revision. Even if the changes affect only one row of data previously submitted for one DIN, the data for the entire DIN must be resubmitted. An amended Form 2 Block 1, 2, 3 should be completed, signed and dated when the data corrections are submitted to the PMPRB. It is not appropriate to maintain the original signature and filing date when amending the Form 2. The patentee will be notified whether the proposed revisions are accepted.

Filing Information
Cover Sheet : Block 1, 2 and 3

In the appropriate box at the top of the cover sheet, specify whether it is an original filing or an amendment. If it is an original filing, please complete Block 1 and 3 described below. If it is an amendment to an original filing, please complete Block 2 and 3 as described below.

Block 1 - Original Filing

Reporting Period

Enter the beginning and ending dates of the period to which the information applies. There should be only one semi-annual reporting period per Form 2. If you wish to submit for more than one reporting period, please complete one Form 2 per semi-annual reporting period. Use the dropdown menu to select the year, month and day. For example:

From: 2012/01/01
(year/month/day)

To: 2012/06/30
(year/month/day)

Names of the Medicine

Brand Name and Generic Name of the Medicine
This section must be completed when reporting the first day of sales. It should be left blank when completing semi-annual reports for multiple drug products.

Block 2 - Amendment to an original filing

Reporting period

Enter the beginning and ending dates of the period to which the amended information applies. There should be only one semi-annual reporting period per Form 2. Use the dropdown menu to select the year, month and day.

Block(s) and DIN(s) or assigned number(s) that are amended

In the first column, please check which Block(s) is (are) amended: Block 4 or Block 5 or both.
For each Block, list the DIN(s) or assigned number(s) that are amended.

For example, to amend DIN 01234567 in Block 4 and 5, you would complete this section as follows:

Block 3 - Patentee and Certifying Signature

State the patentee or former patentee’s name and address; in other words, the name and address of the company or individual completing this form.

Certifying Signature
This form should be signed by an authorized individual for the patentee or former patentee. The individual signing should have the authority to bind the patentee/former patentee and be knowledgeable about information reported on the form. Below the signature, type the name of the person, his or her title and the name of the organization which the person represents. An electronic reproduction of the manual signature of the authorized person is required by the Board and should be copied and pasted in the box reserved to that effect. A Form 2 Block 1, 2, 3 and certifying signature must be submitted in Excel format. If a patentee does not wish to send the requested electronic signature in Excel, it should send two electronic Form 2 Block 1, 2, 3s , one in Excel without the electronic signature and one in PDF with the electronic signature.

Date Signed
State the date (year/month/day) the form was signed.

Telephone, Facsimile Numbers and Email Address
Provide telephone and facsimile numbers as well as the email address of the signatory.

Block 4 - Sales of the Medicine by the Patentee in Final Dosage Form in Canada

Introduction
Each time a Form 1 reporting a new patented drug product is sent by a patentee to the PMPRB, Board Staff prepares updated Form 2 Block 4 and Block 5 templates including the new patented drug product. These updated Form 2 Block 4 and Block 5 templates are sent to the patentee for future filing reference.

Use these templates to complete Form 2 Block 4 and Block 5, to report data for the first day of sales or for the semi-annual report.

The detailed information requested in Block 4 relates to quantity and revenues of Canadian sales of the drug product, in final dosage form, named in Block 2. Each field of the row where a DIN is reported should be fully completed to include DIN, brand name, strength/unit, dosage form, package size, number of packages sold, total number of units sold, net revenue or average price/package, provinces/territories, and class of customer. Add as many rows as needed by using the “Insert Row” function on the top menu item in Excel or by placing the cursor on the row below which a new row must be added and using the right click/insert function of the mouse. Rows can be deleted either by using the menu item at the top of the screen or by using the right click/delete function of the mouse.

The Block 4 template already includes the following information for every patented drug product under the PMPRB’s jurisdiction for a specific patentee:

Drug Identification Number (DIN) or Number Assigned by the PMPRB

• Strength/Unit as coded in the PMPRB electronic system on the basis of the information submitted by the patentee in the Form 1 for the drug product. Please note that the unit refers to the unit of price review which may or may not be the same as the unit reported in the NOC and on Form 1.
• Dosage Form2 as coded in the PMPRB electronic system on the basis of the information submitted by the patentee in the Form 1 for the drug product.
• Package Sizes that are proposed based on CPS information. Since package sizes vary over time, a patentee can add new package sizes or delete obsolete package sizes that are on the templates. A package size should be a numeric value representing the number of “units” in the package (please refer to the unit reported under strength/unit on the template).

The fields where the number of packages sold, net revenue or average price per package, province/territory and customer class are reported must be completed by the patentee. A patentee may choose to report the sales, promotions, rebates, free goods etc. on separate rows. Please refer to the Outreach session of April 2011 for examples and additional explanations. Please make sure that each line of information is fully completed and includes DIN or Assigned Number, Strength/Unit, Dosage Form, Package Size, Number of Packages Sold, Net Revenues or Average Price/Package and Class of Customer.

Number of Packages Sold
Indicate for each DIN or Assigned Number the total number of packages sold including quantities distributed for promotions, rebates, free goods, etc. (see Subsections 4(4) and 4(5) of the Regulations) during the reporting period. The date of sale is considered to be the date the product was shipped, not the date payment was received. Returns (i.e., product returned to the patentee/former patentee for which a refund was provided) are to be included with the data of the reporting period in which the patentee or former patentee received the return. Only Canadian sales of the drug product in final dosage form are to be reported.

Net Revenue or Average Price per Package
Record the Net Revenue whenever possible, otherwise provide the Average Price per Package that corresponds to the number of packages sold. Report in dollars and cents – do not round up to the nearest dollar.

Net revenue consists of actual sales revenue using the accrual accounting method (excluding federal/harmonized sales tax) for the drug product sold (i.e., shipped) during the reporting period less amounts disbursed for rebates, refunds, or other such type of reduction during the same period (see Subsections 4(4) and 4(5) of the Regulations).

The average price per package is defined as net revenue (excluding federal/harmonized sales tax) divided by the total number of packages sold (or distributed as part of a promotion, rebate, etc.).

Province/Territory and Class of Customer
Use codes provided in Appendix C to complete these fields or use the dropdown menu available in the Form 2 Block 4 template (place your cursor in the cell where you want to enter the code in the Province/Territory column or in the Class of Customer column and double click to access the dropdown menu).

Please note that a breakdown of sales by province must be provided in Block 4. Code 13 should be used only when it is not known in which province the sales have occurred.

Block 5 - Publicly available Ex-Factory Prices for Canada and Other Countries

Information in Block 5 covers publicly available ex-factory prices in Canada and in the seven countries listed in the Regulations (France, Germany, Italy, Sweden, Switzerland, United Kingdom and United States), for all final dosage forms of the medicine identified in Block 2.

Use the Form 2 Block 5 template specific to your organization that is sent by Board Staff following receipt of Form 1 or prior to the filing deadline for the semi-annual regulatory filing. The Form 2 Block 5 template already includes the following information for every patented drug product under the PMPRB’s jurisdiction for a specific patentee:

• Generic name of the medicine as recorded in the PMPRB electronic system based on the information submitted in Form 1 and the Product Monograph
• Drug Identification Number (DIN) or Assigned Number
• Strength/unit as in Block 4
• Dosage Form2 as in Block 4
• Package Size: Please note that a patentee can add new package sizes or delete obsolete package sizes that are on the templates.

Each field of the row where a DIN or Assigned Number is reported should be fully completed to include the generic name of the medicine, DIN, strength/unit, dosage form, package size, ex-factory price, country or province, and class of customer. Use the codes listed in Appendix C. Add as many rows as needed by using the “Insert Row” function in the menu item in Excel or by placing the cursor on the row below which a new row must be added and using the right click/insert function of the mouse. Rows can be deleted either by using the menu item at the top of the screen or by using the right click/delete function of the mouse.

Ex-factory Price
Enter the publicly available ex-factory price per package at which the drug product was sold during the reporting period indicated in Block-1. State the public ex-factory price in the currency of the country in which it was sold.

If there is more than one ex-factory price for a particular country/province and class of customer for a reporting period, use the most recent price for the reporting period.

The public ex-factory price is the price at which a drug product is first sold to wholesalers, hospitals, pharmacies, or others. This price excludes sales taxes and wholesale mark-ups if the wholesale function is not being carried out by the patentee or has not been carried out by the former patentee.

Important: The patentee or former patentee must supply public foreign ex-factory price data for all patented drug products that the patentee/former patentee sells or has sold in Canada. This is necessary even if the patentee/former patentee itself does not sell/has not sold the product in any of the seven foreign countries. The information that is reported must pertain to the same patented drug product. It is not permitted to simply include prices relating to the same active ingredient. Patentees and former patentees who are unsure of, or have difficulty acquiring, foreign ex-factory price data should contact Board Staff for advice.

A Block 5 including the publicly available ex-factory price(s) for Canada must be submitted even if the product is sold in none of the seven countries listed in the Regulations.

Use a separate line to report each combination of “strength/dosage form/package size”, “country/ province” and “class of customer” that applies. Board Staff may request a patentee to provide supportive documentation of its ex-factory price, on a case-by-case basis.

Country or Province, and Class of Customer
Use codes provided in Appendix C to complete these fields or use the dropdown menu available in the Block 5 template (Place your cursor in the cell where you want to enter the code in the Country/Province column or in the Class of Customer column and double click to access the dropdown menu). If the publicly available ex-factory price is the same in every Canadian province where the product is sold, use the province code “13” to signify all of Canada instead of listing each province separately.

When reporting the price of the US Federal Supply Schedule (FSS), patentees must enter code 21 in the Country column and code 4-FSS in the Class of Customer column.

Please refer to the PMPRB document “Backing out Formulas for Foreign Price Verification” for the methodology used by Board Staff to verify publicly available ex-factory prices.

2 Appendix C provides a complete list of dosage forms. It is not intended to be used for the purpose of identifying comparable dosage forms. The Compendium of Policies, Guidelines and Procedures, Schedule 2, identifies comparable dosage forms.

Form-3 – Licensees, Revenues and Expenditures

1. General Information
2. Research and Development
3. Block 1 - Year to which Information Applies
4. Block 2 - Identification of the Patentee
5. Block 3 - Licensee(s) Others
6. Block 4 - Revenues
7. Block 5 - Research and Development Pertaining to Medicines
8. Block 6 - Total Capital Expenditures
9. Block 7 - Type of Research and Development – Medicine for Human Use
10. Block 8 - Type of Research and Development – Medicine for Veterinary Use
11. Block 9 - Source of Funds for R&D
12. Block 10 - Information for R&D in Each Province
13. Block 11 - Certifying Signature

General Information

Purpose
Section 88 of the Patent Act requires a patentee of an invention pertaining to a medicine to provide to the PMPRB information on research and development relating to medicine. Form 3 is designed to collect information on: the patentee; the names and addresses of all licensees; gross revenue (net of taxes) from sales of both patented and non-patented medicines in Canada; and expenditures in Canada for scientific research and experimental development (SR&ED) pertaining to all medicines for human and veterinary use.

Who must report?

All patentees that filed a Form 2 during the calendar year must report gross revenues (net of taxes) and SR&ED expenditures on Form 3. Foreign residency of the patentee does not remove the responsibility to complete a Form 3. Foreign persons should report their gross revenues (net of taxes) from sales in Canada and expenditures on SR&ED in Canada as if they were Canadian taxpayers.

Reporting Period and Due Dates

Report Form 3 information annually; the due date is as follows:

* If a due date falls on a weekend the due date shall be the next business day.

The information to be submitted to the PMPRB must be provided using the electronic forms (including layout and file type) that are downloadable from the PMPRB website, under Are you a Patentee?/Frequently Requested Items/Forms.

Completed forms must be sent to the PMPRB’s e-mail address that is specified on the PMPRB website: compliance@pmprb-cepmb.gc.ca

Research and Development

Criteria of Eligibility
Research and development (R&D) expenditures reported on Form-3 must meet the criteria for claiming an investment tax credit in respect of scientific research and experimental development as set out in subsections 37(1) and 127(9) of the Income Tax Act and section 2902 of the Income Tax Regulations as they read on December 1, 1987. The term “Research and Development” as it appears on the reporting forms should be interpreted as meaning Scientific Research and Experimental Development (SR&ED).

It does not matter if the patentee actually files an income tax return for the reporting year in question, or if any of the research and development tax credits are actually claimed. Individuals and corporations who are not Canadian taxpayers should complete Form-3 as if they were Canadian taxpayers.

Revenue Canada publishes guidelines to claiming an investment tax credit for SR&ED expenditures. Whenever possible, the guidelines outlined in these materials should be used to report SR&ED expenditures on Form-3. Refer to the following documents as they read on December 1, 1987:5

Subsections 37(1) and 127(9) of the Income Tax Act

Sections 2900 and 2902 of the Income Tax Regulations

Revenue Canada Form T661

Interpretation Bulletin No. IT-151R3

Information Circular No. 86-4R2.

Definition – Scientific Research and Experimental Development
Scientific Research and Experimental Development may be defined as a “systematic investigation or search carried out in the field of science or technology by means of experiment or analysis”. Technology refers to the systematic study of the application of scientific knowledge to industrial processes or product development.6

There are three main categories:

Basic research
Work undertaken to advance scientific knowledge without a specific practical application in view;

Applied research
Work undertaken to advance scientific knowledge with a specific practical application in view; and

Development
Use of results of basic or applied research to create new materials, devices, products or processes, or to improve existing ones.

Activities such as engineering or design, operations research, mathematical analysis or computer programming, and psychological research are eligible only if such activities directly support basic or applied research, or eligible development activities. Examples of activities that cannot be included as SR&ED include:

• market research or sales promotion;
• quality control or routine testing of materials, devices or products;
• research in the social sciences or humanities;
• prospecting, exploring or drilling for, or producing, minerals, petroleum or natural gas;
• commercial production of a new or improved material, device or product, or the commercial use of a new or improved process;
• style changes; or
• routine data collection.7

Expenditures – Scientific Research and Experimental Development
Note that only expenditures made in Canada on SR&ED carried on in Canada are allowed; to qualify as SR&ED expenditures on Form-3, the expenditures must conform to criteria for claiming the investment tax credit for scientific research and experimental development as set out in subsections 37(1) and 127(9) of the Income Tax Act and section 2902 of the Income Tax Regulations as they read on December 1, 1987.

Amounts that would normally qualify for a deduction (but not an investment tax credit) under subsection 37(2) as it read on December 1, 1987 (Research outside Canada) should not be included on Form-3. Foreign travel expenditures, including the salaries and benefits of a Canadian employee undertaking foreign travel, and any other expenditure that relates to SR&ED carried on outside Canada are all deemed to be “Research outside Canada”. Therefore these are not to be included with SR&ED expenditures on Form-3. This is the case even if the expenditures were made in Canada, for example to a Canadian sub-contractor. Patentees who are uncertain as to whether to include certain expenditures as SR&ED expenditures on Form-3 should call Board Staff for advice.

Block 1 - Year to which Information Applies

Enter the calendar year to which the information applies.

Block 2 - Identification of the Reporting Patentee

State the name and address of the patentee; in other words, the name and address of the person completing this form.

Block 3 - Licensee(s)/Other(s)

Provide the names and addresses of all licensees with whom the patentee has a license (including compulsory license) or other agreement that entitles that person to exercise any rights in relation to a patent.

Block 4 - Revenues

Total Gross Revenues of the Reporting Patentee from all Sales of Medicines in Canada
Report the total gross revenues (net of taxes) from all sales of medicines8 that have been assigned a Drug Identification Number (DIN) under the Food and Drug Regulations or which have been approved for sale to qualified investigators or through Health Canada’s Special Access Programme in accordance with those Regulations. This includes both patented and non-patented medicines, whether sold by prescription or “over the counter” and whether for human or veterinary use.

Gross revenues from the sales of medicines should be reported on an accrual basis, i.e., in the year the product was shipped or left the plant gate.

Total Gross Revenues Received from all Licensees/Others in Canada
Report the total revenues (net of taxes) received (including royalties and license fees) from all licensees/others listed in Block 3, from the sale in Canada of medicines for human and veterinary use. This includes both patented and non-patented medicines, whether sold by prescription or “over the counter”.

Revenues from licensees/others, in the form of license fees or royalties may be reported on an accrual basis (i.e., the year in which the medicines were shipped) or on a cash basis (i.e., the year the royalties were actually paid) but reporting should be consistent from year to year.

Block 5 - Research and Development Pertaining to Medicines

Non-Capital Expenditures Incurred by the Patentee
Non-capital expenditures do not include general administrative expenses or factory overhead expenses that would have been incurred even if SR&ED had not been carried out. Expenses must all, or substantially all, be linked to SR&ED. All, or substantially all, means at least 90% of the time. For example, if a patentee rents a photocopy machine that will be used approximately 50% of the time for SR&ED; no portion of the rental payments is considered to be an expenditure that is directly attributable to SR&ED. The following cannot be included as non-capital expenditures in Block-5 under any circumstances:

• capital expenditures or depreciation expenses (see Block-6)
• entertainment expenses
• advertising or selling expenses
• convention expenses
• legal or accounting expenses
• membership dues or fees
• fines or penalties
• expenditures made to acquire rights in, or arising out of, research and development (e.g., patent or registration fees)

Allowable non-capital expenditures should be broken out into the following categories:

A. Wages and salaries
Only include wages and salaries (and other related costs such as benefits) paid to employees who:

• are actually doing research work
• are directly supervising research work, or
• are directly supporting research work.

These expenditures must:

• include employee benefits and
• exclude bonuses or other remuneration based on the profits of the company.

B. Direct material
All costs are to be the net laid-down price after deducting trade discounts, etc.

C. Contractors and sub-contractors
This category only covers contractors hired to carry out SR&ED on the patentee’s behalf. The expression “on the patentee’s behalf” distinguishes contractors from other expenditure categories such as payments to universities and granting councils.

D. Other direct costs
Include only the incremental general administrative and/or factory overhead costs incurred solely as a result of carrying on SR&ED activities.

E. Payments to designated institutions
Under this category, report payments to an approved university, college, research institute or other similar institution, to be used by that institution for SR&ED related to the patentee’s class of business. Amounts paid to carry out SR&ED on the patentee’s behalf should not be included here, but under section C pertaining to contractors and sub-contractors.

F. Payments to granting councils
Under this category, report payments to each granting council for eligible SR&ED activities. A granting council is an approved organization that pays an association, institution or corporation to do SR&ED related to the patentee’s class of business. Approved granting councils include:

• Natural Sciences and Engineering Research Council
• Canadian Institutes for Health Research (formerly the Medical Research Council)

G. Payments to other organizations
Include payments to other organizations for SR&ED related to the patentee’s class of business and not included under “E” (designated institutions) or “F” (granting councils) above.

Block 6 - Total Capital Expenditures

Buildings – Annual Depreciation
Patentees should report annual depreciation of buildings used for SR&ED in Canada. The annual depreciation should be calculated at the rate of 4% of the qualifying capital cost per year over a maximum of twenty-five years. Depreciation is applied beginning with the year in which the building was purchased or acquired.

If a building was built or purchased to be used partly for SR&ED and partly for other purposes, and a specific area within the building is allocated solely for SR&ED use, a reasonable portion of the building’s original cost can be used to calculate annual depreciation. Calculate the applicable portion of the building’s cost by applying the proportion of SR&ED floor-space, to total floorspace to the total original cost of the building.

For example, a 1000 square metre building originally costing $400,000 has a 250 square metre wing allocated entirely for SR&ED activities. Since 25% (250 of 1000) of the total floor-space is devoted to SR&ED, calculate annual depreciation based on $100,000 (25% of $400,000). Annual depreciation would be 4% of $100,000 = $4,000.

If a building was originally used for purposes other than SR&ED, but is converted for SR&ED use, the cost of the conversion may be depreciated as above. However, do not include any part of the building’s original cost in the reported annual depreciation.

To calculate the total annual depreciation of all buildings (and eligible conversion costs) dedicated to SR&ED, the annual depreciation of each should be calculated separately, and then totalled.

Total Capital Expenditures in the Year (buildings)
This line refers to capital expenditures made on buildings. Report total capital expenditures made during the reporting year on buildings in Canada to be used for SR&ED. Do not include capital expenditures made on land.

If a building was built or purchased to be used partly for SR&ED and partly for other purposes, and a specific area within the building is allocated solely for SR&ED, a reasonable portion of the building’s total cost can qualify as a capital expenditure on SR&ED. If part or all of an existing building is converted for SR&ED, the conversion costs may qualify as a capital expenditure on SR&ED. However, no part of the building’s original cost or of its un-depreciated capital cost is eligible.

Equipment (capital expenditures)
Capital expenditures on equipment must be made in Canada. When an asset is purchased from a supplier outside Canada and is imported and used for SR&ED in Canada, the expenditure is considered to be made in Canada. Normal accrual accounting principles will apply to capital expenditures for SR&ED.

Expenditures on equipment partly used for SR&ED and partly used for other purposes may be included only if it can be demonstrated that all, or substantially all of the equipment’s use is for SR&ED. “All, or substantially all” means the equipment is used at least 90% of the time throughout its expected useful life for SR&ED.

Block 7 - Type of Research and Development – Medicine for Human Use

List expenditures (non-capital only) on SR&ED in Canada for medicines for human use according to “type of research” and “who carried out the research”. The following definitions may help in interpreting the meaning of the categories “type of research” and “who carried out the research”. These definitions also apply to Block 8.

Type of R&D

Basic Research

Basic – chemical
Systematic investigation undertaken to advance knowledge in chemistry by means of experimentation or analysis, without any practical application in view.

Basic – biological
Systematic investigation undertaken to advance knowledge in biology by means of experimentation or analysis, without any practical application in view.

Applied Research
Manufacturing processes
Experimental development of new or improved manufacturing processes in support of basic or applied research.

Note: Preclinical and Clinical Trials
Generally, preclinical trials involve animal testing while clinical trials involve human subjects. However, preclinical and clinical trials often overlap. Some drug evaluations may not follow the phases of evaluation described here. Patentees should strive to report according to the phases defined below.

Preclinical Trials I

• Acute toxicity – single administration to two or more animal species
• Detailed pharmacological studies (main effect, side effects, duration of effect, etc.)
• Specifications or analysis of active substance
• Stability of active substance
• Specifications of inactive substances

Preclinical Trials II

• Pharmacokinetics
• Chronic toxicity (two animal species)
• Reproduction toxicological studies
• Mutagenicity and carcinogenicity studies
• Synthesis of active substance on technical scale
• Development of final dosage form(s)
• Analytical evaluation of final dosage form(s)
• Stability of final dosage form(s)
• Production of clinical samples
• Sub-chronic (sub-acute) toxicity (other animal species)
• Supplementary animal pharmacology
• Carcinogenicity trials
• Supplementary animal pharmacology

Clinical Trials Phase I

• Tolerance in healthy volunteers
• Pharmacokinetics in humans

Clinical Trials Phase II

• First controlled trials on safety and efficacy in patients
• Chronic toxicity

Clinical Trials Phase III

• Therapeutic large scale trial at several trial centres for final establishment of therapeutic and safety profiles
• Proof of efficacy and safety in long term administration
• Demonstration of therapeutic advantages, if any
• Clarification of any interactions with concomitant medication
• Chronic toxicity (if required)

Other Qualifying R&D
This includes eligible research and development expenditures that cannot be classified into any of the preceding categories of “type of research and development.”

Other qualifying research includes drug regulation submissions, bioavailability studies and Phase IV clinical trials.

Categories Describing Who Carried Out Research
Patentee
If you are no longer a patentee but were a patentee during part or all of the year Form 3 covers, you are still required to submit Form 3 information in respect of that calendar year.

Other companies
Include corporations, resident in Canada, undertaking research on behalf of the patentee, or research in the same class of business as the patentee. Corporations carrying out the research do not have to be at arm’s-length from the patentee.

Universities
Include universities, colleges and other institutions, such as research institutes, approved under the Income Tax Act.

Hospitals
A facility licensed, approved or designated as such by a federal, provincial or territorial government.

Note: Hospital vs. University
There may be some uncertainty as to whether to classify, as hospital or university, research carried out in a teaching hospital or when scientists doing the work are affiliated with both a hospital and a university. If it can be ascertained where the monies for the research are being handled/managed (i.e., through the university or through the hospital), then these amounts should be assigned to reflect this. When payment is made directly to a scientist or other researcher with dual affiliations, the amounts should be included under the category that best describes the setting where the research took place.

Others
This category is reserved for expenditures that do not logically fit into any of the other categories.

Block 8 - Type of Research and Development – Medicine for Veterinary Use

Expenditures (non-capital only) on SR&ED in Canada, pertaining to medicines for veterinary use, are to be listed according to “type of research” and “who carried out the research”. The definitions in Block 7 above may help you interpret the categories of “type of research” and “who carried out the research”.

Block 9 - Source of Funds for R&D

Detail sources of funds for non-capital expenditures and capital equipment expenditures according to the categories described below. The total source of funds reported in this block is to correspond to the total of non-capital expenditures and capital equipment expenditures (Block 5 and Block 6 (Equipment)).

Internal Funds
Refers to the internal corporate funds of the reporting patentee. It does not include monies from parent or subsidiary companies if these companies are distinct corporate entities in their own right. Monies from parent or subsidiary companies should be included under “not arm’s-length”.

Arm’s-Length Person
An “arm’s-length person” is an individual, corporation or other legal entity that is not related to the reporting patentee. If in doubt, refer to the Income Tax Act for a definition of “arm’s-length”. Examples of “not arm’s-length” relationships are given in the following section.

Not Arm’s-Length Person
A “not arm’s-length person” is an individual, corporation or other legal entity that is related to the reporting patentee. There are many types of “not arm’s length” relationships. It is beyond the scope of this document to list them all. However, some examples of “not arm’s-length” relationships of corporations follow.

Corporations are related (i.e., not at arm’s-length) to each other if:

• one is controlled by the other
• one corporation is a member of a related group that controls the other
• they are controlled by the same person or persons (“person” can mean an individual or a corporation)

The above list is a small sample only. Reporting patentees should consult the Income Tax Act if there is doubt as to whether a relationship is, or is not, at arm’s-length.

Federal Government
This category includes all monies received during the year from departments and agencies of the federal government of Canada. These monies include, among other things, all assistance paid during the year to a patentee under the terms of an Appropriation Act for SR&ED expenditures. Such assistance includes, among other things, any grant, subsidy, reimbursement or forgivable loan (including a contingently repayable loan) received by the patentee. The amount reported is to be net of amounts repaid to the federal government during the year.

Provincial Government
Include all monies received from provincial or territorial government departments or agencies.

Other
Include all monies received by the patentee from sources that do not logically fall into any of the above categories.

Block 10 - Information for R&D in Each Province/Territory

Provide a provincial/territorial distribution of SR&ED expen ditures (non-capital only), by each of the “who carried out the research” categories. Definitions of the “who carried out the research” categories are in the definitions for Block 7. The total expen ditures reported in Block 10 should correspond to total non-capital expenditures (Block 5).

Block 11 - Certifying Signature

This block is for the signature of the patentee (or authorized company representative). The individual signing should have authority to bind the company and be knowledgeable about the information reported on the form.

Reconciling Expenditures and Sources of Funds
To verify the accuracy of information reported on Form 3, ensure that the “expenditures” and “source of funds” figures can be properly reconciled.

The sum of all non-capital expenditures (Block 5) should be equal to the sum of Block 7 and Block 8, as well as to the total of the expenditures provided in the provincial/territorial breakdown in Block 10. The sum of non-capital (Block 5) and capital equipment expenditures (Block 6 equipment only) should equal the total source of funds (Block 9).

5 These documents are available by contacting the Director, Board Secretariat and Communications.

6 Revenue Canada Taxation, Information Circular No 86-4R2, Scientific Research and Experimental Development, August 29, 1988 – para. 2.3.

7 Ibid., para 2.5.

8 Consult Glossary for definition of “medicine as” it applies to Form 3.

Failure to File

When a patentee or a former patentee fails to file the Form 2 or the Form 3 by the required date, the president of the company in failure-to-file is advised in writing that the information required to be filed has not been received by the PMPRB. The company is given seven (7) days from the date of the letter to comply. In the event that the patentee does not file within the further period, Board Staff will seek an order from the Board on an ex parte basis pursuant to section 81 of the Patent Actrequiring that the patentee or former patentee file the specified information within the time specified in the Board Order.

Glossary

Note to Reader: This glossary is included for the convenience of the reader. It does not have the force of law and is not binding on the PMPRB. For more detailed information and definitions please refer to the Act, the Regulations and the Compendium of Policies, Guidelines and Procedures, or contact the PMPRB.

Accrual accounting: Under the “accrual” accounting method, revenues should be reported in the year in which they are earned, regardless of when payment is received. Expenditures should be reported in the year in which they were incurred, whether or not they were paid in that period. With the exception of “Revenues from licensees” on Form-3, all revenues and expenditures must be reported using normal accrual accounting methods.

Active Ingredient: Any component in a drug product – whether produced biologically, chemically or otherwise - that has medicinal properties, meaning that it is applied or administered in vivo in humans or in animals to aid in the diagnosis, treatment, mitigation, or prevention of disease, symptoms, disorders, abnormal physical states, or to modify organic functions of humans or animals, however formulated and administered.

Assigned Number: Number attributed by Board Staff for reporting purposes to a patented drug product that has no DIN. This number will be assigned once the completed Form 1 for the patented drug product with no DIN has been filed and should be used on Form 2 for all subsequent reporting periods.

Average price per package: Average price per package is defined as net revenues divided by the total number of packages sold (including those distributed for free). Net revenues consist of actual sales revenues (excluding sales tax) less any amounts disbursed for benefits or promotions such as rebates, refunds, or gifts.

Cash Accounting: Under the cash accounting method revenues are reported in the year in which they are actually received. Only “Revenues from Licensees” on Form 3 may be reported using the cash method; all other revenues and all expenditures must be reported using normal accrual accounting methods.

Drug Identification Number (DIN): computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada.

A DIN uniquely identifies the following product characteristics:

• Manufacturer;
• Product name;
• Active ingredient(s);
• Strength(s) of active ingredients(s);
• Pharmaceutical form; and
• Route of administration.

Drug Product: A particular presentation of a medicine characterized by its pharmaceutical dosage form and the strength of the active ingredient(s).

Ex-factory price: The price established for the first arm’s length sale of the product into the distribution chain, whether to wholesalers, hospitals, pharmacies and others. This price always excludes sales taxes and wholesale mark-ups when the wholesale function is not carried out by the patentee. With respect to the reporting of publicly available ex-factory prices in Form 2 Block 5, the ex-factory price can be the price that is agreed on between the patentee or former patentee and the regulatory body of the country in which it is sold by the patentee.

Former patentee: A former patentee is a person who is no longer entitled to the benefit of the patent pertaining to a medicine. For example, a patentee may become a former patentee as a result of patent expiration, patent lapse, or termination of contractual agreements with the patent owner/holder. The filing should only cover the periods during which the drug product was patented.

Generic Product: A pharmaceutical product that is bioequivalent to a brand-name drug product sold in Canada, or that is a licensed version of the same brand name drug product sold in Canada. A generic product may nonetheless have patents that pertain to it.

Hospital: A health care institution licensed, approved or designated as a hospital by a provincial or territorial government or is owned or operated by the Government of Canada to provide continuing medical care and supporting diagnostic and therapeutic services.

Indication: An indication is a specific condition, manifested by the presence of disease or medical signs or symptoms that the medicine addresses, prevents and treats, as approved by Health Canada.

Investigational New Drug (IND): A drug for human or veterinary use that is being investigated with approval from Health Canada.

In vivo: In relation to a medicine, the application or administering of such medicine into or upon the living body of human beings or animals.

License: A contractual agreement, whether express or implied, between a patent holder and a licensee under which the latter is permitted to exercise some or all of the otherwise exclusive patent rights of the patentee, generally for monetary consideration (e.g., royalties in the form of a share of the licensee’s sales).

License, Compulsory: A license granted by the Commissioner of Patents that permits the licensee to import, make, use or sell a patented invention pertaining to a medicine. The compulsory licensee pays license fees or royalties to the patent holder for use of the patented invention.

With the exception of those compulsory licenses issued prior to December 20, 1991, which continue to be in effect, the 1993 amendments to the Patent Act repealed the compulsory licensing regime effective December 20, 1991. Accordingly all compulsory licenses issued after December 20, 1991 cease to have effect.

Medicine: Any substance or mixture of substances made by any means, whether produced biologically, chemically, or otherwise, that is applied or administered in vivo in humans or in animals to aid in the diagnosis, treatment, mitigation or prevention of disease, symptoms, disorders, abnormal physical states, or modifying organic functions in humans and or animals, however administered.

For greater certainty, this definition includes vaccines, topical preparations, anaesthetics and diagnostic products used in vivo, regardless of delivery mechanism (e.g., transdermally, capsule form, injectable, inhaler, etc.). This definition excludes medical devices, in vitro diagnostic products and disinfectants that are not used in vivo.

Net Revenues: Net revenues consist of actual sales revenues (excluding federal/harmonized sales tax) for medicine sold (i.e., shipped) during the reporting period less amounts disbursed for benefits or promotions such as rebates, refunds, or gifts.

Notice of Compliance (NOC): A notice in respect of a medicine issued by the Health Products and Food Branch of Health Canada under section C.08.004 of the Food and Drug Regulations. The issuance of an NOC indicates that a drug product meets the required Health Canada standards for use in humans or animals and that the product is approved for sale in Canada.

Patent: In Canada, an instrument issued by the Commissioner of Patents that gives the patent owner, in exchange for public disclosure of the invention, the right to exclude others from making, using, selling, importing or distributing the invention in Canada for a limited period of time. This term of exclusivity extends from the day the patent is granted to a maximum of 20 years after the day on which the patent application was filed (subject to the payment of maintenance fees). However, if the patent application was filed before October 1, 1989, the patent is valid for a period of 17 years from the date of grant.

Patent Holder: A person that owns a patent.

Patent Lapse: A patent lapses upon failure to pay the annual maintenance fee within the time provided by the Patent Rules. The Rules allow for a one-year grace period in the event that the payment deadline is missed. If adequate payment is not made prior to the expiration of that grace period, the patent lapses and cannot be revived.

Patent Pending Period: A patent is pending in Canada from the day on which the patent application is filed with the Canadian Intellectual Property Office until the day on which either the patent is granted or the patent application is abandoned. When a medicine subject to a pending patent is being sold in any market in Canada, the PMPRB will, when the patent is issued, review the price as of the date of first sale or the date on which the patent application was laid open, whichever comes later.

Patented Medicines Regulations: A federal regulatory instrument promulgated under the authority of the Patent Act. The Regulations specify the information patentees must report to the Board relating to the identity of the medicine, price and sales of the medicine, revenues and research and development expenditures as well as the timing of the filing.

Patentee: For purposes of subsection 79 to 103 of the Patent Act, “the person for the time being entitled to the benefit of the patent for that invention (pertaining to a medicine) and includes, where any other person is entitled to exercise any rights in relation to that patent other than under a license continued by subsection 11(1) of the Patent Act Amendment Act, 1992, that other person in respect of those rights;”

Pharmacy or Drugstore: An establishment licensed by a provincial licensing body to dispense or sell drugs, pharmaceuticals, patented medicines and drug sundries to patients.

Research and Development (R&D): Basic or applied research for the purpose of creating new, or improving existing materials, devices, products or processes (e.g., manufacturing processes).

Research and Development – Applied Research: Work that advances scientific knowledge with a specific practical application in view such as creating new or improved products or processes through manufacturing processes or through preclinical or clinical studies.

Research and Development – Basic Research: Work that advances scientific knowledge without a specific application in view.

Research and Development – Clinical Research: The assessment of the effect of a new medicine on humans. It typically consists of three successive phases, beginning with limited testing for safety in healthy humans then proceeding to further safety and efficacy studies in patients suffering from the target disease.

Research and Development – Preclinical Research: Tests on animals to evaluate the pharmacological and toxicological effects of medicines.

Research and Development Expenditures: For the purposes of the Patented Medicines Regulations, in particular sections 5 and 6, research and development includes activities for which expenditures would have qualified for the investment tax credit for scientific research and experimental development under the Income Tax Act as it read on December 1, 1987.

Sale: A “sale” is the transfer of property rights from one person to another for money, money’s worth, or other consideration. On Form 2, information is requested on the revenues from sales of patented medicines only, while on Form 3, information is requested on revenues from the sales of all medicines.

Special Access Programme (SAP): The SAP provides access to drugs which have not received a Notice of Compliance from Health Canada to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

Wholesaler: With respect to medicines, a person primarily engaged in buying merchandise for resale to retailers, generally pharmacies and/or hospitals.

Appendix A - Notification of Intention to Sell

Appendix B - Reporting Forms

Reporting Forms

Form 1: Medicine Identification Sheet (XLS)

Form 2: Information on the Identity of Prices of the Medicine

• Blocks 1, 2, 3, and Signature (XLS)
• Block 4: Sales of the medicine by the reporting patentee in final dosage form in Canada (XLS)
• Block 5: Publicly available ex-factory prices for Canada and other countries (XLS)

Form 3: Revenues and Research and Development Expenditures Provided Pursuant to subsection 88(1) of the Patent Act (XLS)

NOTIFICATION OF INTENT TO SELL – pursuant to Subsection 82(1) of the
Patent Act (as published in the Compendium of Guidelines, Polices and Procedures) (XLS)

Appendix C – List of Codes

Class of Customer Codes

1 - Hospital
2 - Drugstore or Pharmacy
3 - Wholesaler
4 - Other (see note below for US-FSS)

Note To enter the US-FSS data for a drug product in Block 5 of Form 2, use code 21 in the column “Country or Province” and 4-FSS in the column Class of Customer.

Patentee’s Guide to Reporting – February 2012

Updates to the Patentee’s Guide to Reporting

The revised Patentee’s Guide to Reporting was posted in February 2012. Any further additions, amendments and/or clarifications are promptly communicated to the patentees through the What’s New page of the website.