S i n c eD e p u i s

1987

Web site: www.pmprb-cepmb.gc.caE-mail: pmprb@pmprb-cepmb.gc.ca

Patented Medicine Prices Review Board

NOVEMBER 2008 UPDATE

Patentee’s Guide to Reporting

Form 1, 2 and 3 pursuant to the Patented MedicinesRegulations

Patented Medicine Prices Review Board

Box L40Standard Life Centre333 Laurier Avenue WestSuite 1400Ottawa, OntarioK1P 1C1

Toll free number: 1 877 861-2350

Telephone: (613) 952-7360

Facsimile: (613) 952-7626

TTY: (613) 957-4373

http://www.pmprb-cepmb.gc.camailto:pmprb@pmprb-cepmb.gc.ca

Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Background and Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Purpose, Scope and Limitations of the Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Layout of the Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Interpretations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Confidentiality of Reported Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Electronic Filing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Where to Get Help: Address, Telephone, Facsimile, E-mail address. . . . . . . . . . . . . . . . . . . . . . . . . . 4

Electronic/Mailing List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Electronic/Mailing List Amendment Form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Form-1 – Medicine Identification Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Block-1 Names and Use(s) of the Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Block-2 Reporting Patentee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Block-3 Notice of Compliance (NOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Block-4 Drug Identification Number (DIN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Block-5 Date of First Sale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Block-6 Product Monograph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Block-7 Patent Numbers of Reporting Patentee’s Inventions Pertaining to the Medicine . . . . . . . . . 9

Block-8 Certifying Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Form-2 – Identity and Prices of the Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Block-1 Reporting Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Block-2 Names of the Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Block-3 Reporting Patentee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Block-4 Sales of the Medicine by the Patentee in Final Dosage Form in Canada . . . . . . . . . . . . . 11

Block-5 Publicly Available Ex-Factory Prices for Canada and Other Countries . . . . . . . . . . . . . . . 13

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Form-3 – Licensees, Revenues and Expenditures . . . . . . . . . . . . . . . . . . . . . . . . 15General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Research and Development. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Block-1 Year to which Information Applies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Block-2 Identification of the Reporting Patentee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Block-3 Licensee(s) Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Block-4 Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Block-5 Research and Development Pertaining to Medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Block-6 Total Capital Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Block-7 Type of Research and Development – Medicine for Human Use. . . . . . . . . . . . . . . . . . . . 19

Block-8 Type of Research and Development – Medicine for Veterinary Use . . . . . . . . . . . . . . . . . 20

Block-9 Source of Funds for R&D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Block-10 Information for R&D in Each Province . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Block-11 Certifying Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Notification of Intent to Sell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Appendix A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29List of Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Appendix B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Reporting Forms

FORM-1 Medicine Identification Sheet

FORM-2 Information on the Identity and Prices of the Medicine

Sales of the Medicine by the Reporting Patentee in Final Dosage Form in Canada

Publicly Available Ex-Factory Prices for Canada and Other Countries

FORM-3 Revenues and Research and Development Expenditures Provided Pursuant toSubsection 88(1) of the Patent Act

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

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Introduction

Background and Authority The 1987 amendments to the Patent Actestablished the Patented Medicine Prices ReviewBoard (hereafter referred to as the PMPRB). The Patented Medicines Regulations (hereafterreferred to as the Regulations), as provided for by the Patent Act, establish the data reportingrequirements to which this Guide is addressed.

This reporting Guide has been prepared under theauthority of the PMPRB, which is responsible forensuring compliance with the Patent Act and theRegulations.

Purpose, Scope andLimitations of the GuideThis Guide is a reference document to helppatentees complete Forms 1, 2 and 3. The Guideexplains each element of information to bereported, how and when the information is to besubmitted to the PMPRB.

This Guide is intended as a reference tool, not an exhaustive interpretation of the reportingrequirements of the Regulations. The instructionsand definitions are intended to assist patentees;they have no legal force and for the formaldefinitions, reference to the legislation must bemade. While every attempt has been made toexplain the three reporting forms, it may benecessary to consult directly with PMPRB staff for further guidance regarding complex situationsor particular cases.

In the event of a discrepancy between this Guideand the Regulations, the Regulations shall, in allcases, prevail. Further, the PMPRB has the rightto apply such definitions as it considers necessaryto administer the Patent Act and achieve itspurpose and intent in accordance with the law.

This Guide will be revised from time to time toreflect changes in reporting requirements, and tofurther clarify current requirements.

Layout of the GuideThe Guide consists of five sections: this introduction,three sections relating to the reporting forms, anda glossary. The appendices include the blankreporting forms and the list of codes to be used tocomplete Form-1 and Form-2.

The reporting forms included in this Guide are forinformation only. Patentees are required todownload the Forms from the PMPRB Web sitehttp://www.pmprb-cepmb.gc.ca/ for purposes oftheir regulatory filing requirements.

InterpretationsFor the purposes of this Guide, please note thefollowing:

PersonFor reporting purposes the word “person” meansan individual, a company or corporation, or anyother legal entity such as a partnership, trust, jointventure or other form of business enterprise

Singular/PluralAll references in the singular case shall includethe plural, and references to the plural shallinclude the singular.

PatenteeSection 79(1) of the Patent Act provides thedefinition of the word “patentee”:

“in respect of an invention pertaining to amedicine, means the person for the time beingentitled to the benefit of the patent for thatinvention and includes, where any otherperson is entitled to exercise any rights inrelation to that patent other than under alicense continued by subsection 11(1) of thePatent Act Amendment Act, 1992, that otherperson in respect of those rights;”

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In other words the word “patentee” is used tomean not only the patent holder, but also anyperson acting for the patent holder as a seller orotherwise entitled to the benefits of the patent(other than by compulsory license). Patent rightsmay include manufacturing, distributing, marketingand selling the medicine. The interpretation of“patentee” will depend on the situation; it willgenerally be the corporate entity that sells themedicine into the distribution chain.

The definition of “patentee” applies whether or notthe patentee resides in Canada, as long as thepatented medicine is sold in Canada.

Former Patentee A patentee is referred to as a former patenteeonce the relevant patents for a particular drugproduct expire. The Regulations require that aForm-1 and Form-2 be filed, for drug products notpreviously filed, and only for the periods underwhich the drug products were patented. TheBoard may request this information within threeyears of the patent’s expiry.

Reporting PatenteeThe “reporting patentee” completing Form-1 andForm-2 is either the patentee or the formerpatentee.

Confidentiality of ReportedInformationSection 87 of the Patent Act states thatinformation gathered by means of these reportingforms is privileged, and will not (except whenpermitted by that section) be communicated,disclosed or made available to any party notlegally entitled to such information.

Electronic FilingThe information to be submitted to the PMPRBmust be provided using the electronic forms(including layout and file type) that aredownloadable from the PMPRB Web site.

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

Where to Get HelpPlease direct questions regarding completion ofthe reporting forms to the PMPRB by mail,telephone, fax or e-mail:

Address:Patented Medicine Prices Review BoardBox L40Standard Life Center333 Laurier Avenue WestSuite 1400Ottawa, OntarioK1P 1C1

Telephone:613) 952-7360Sylvie DupontSecretary of the Board

Facsimile:(613) 952-7626

E-mail address:pmprb@pmprb-cepmb.gc.ca

Communications may be in either official language.

Electronic/Mailing ListIf you would like to be added to the PMPRB’smailing list and/or electronic mailing list pleasecomplete the following sheet and either mail, faxor e-mail the relevant information.

mailto:compliance@pmprb-cepmb.gc.camailto:pmprb@pmprb-cepmb.gc.ca

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( ) -

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Electronic/Mailing List Amendment FormPlease make the following change to your mailing list:

Addition [ ]Deletion [ ]Revision [ ]

Name: __________________________________________________________

Company/Organization: __________________________________________________________

__________________________________________________________

__________________________________________________________

Title: __________________________________________________________

__________________________________________________________

Address: __________________________________________________________

__________________________________________________________

__________________________________________________________

Postal Code: __________________________________________________________

Telephone: ________________________________

Facsimile: ________________________________

E-mail address: __________________________________________________________

Please send this completed form to:

Patentee’s Guide to ReportingPatented Medicine Prices Review BoardBox L40Standard Life Centre333 Laurier Avenue WestSuite 1400Ottawa, OntarioK1P 1C1

Tel: (613) 952-7360Fax: (613) 952-7626E-mail: pmprb@pmprb-cepmb.gc.ca

mailto:pmprb@pmprb-cepmb.gc.ca

Form-1 – Medicine Identification Sheet

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General InformationPurposeForm 1 (see Appendix B) is to be used by patenteesto report information on patented drug products forwhich a Notice of Compliance (NOC) has beenissued, or which are being offered for sale inCanada. The PMPRB uses the reported informationto identify patentees and patented drug productsthat are subject to the reporting requirements of theRegulations.

Definitions of key terms used in these forms areincluded in the Glossary (see page 24).

The information to be submitted to the PMPRBmust be provided using the electronic forms(including layout and file type) that are downloadable from the PMPRB Web site underLegislation, Regulations and Guidelines /Patentee’s Guide to Reporting.

Submit a separate electronic Form-1 for eachDrug Identification Number (DIN) of the patenteddrug product within seven days of it being issuedan NOC or being offered for sale in Canada,whichever comes first. An electronic copy of theproduct monograph (Word or pdf) or informationsimilar to that contained in a product monographwhen an NOC has not been issued, must beappended to Form-1.

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

Who should provide information?The patentee completing Form-1 is the “reportingpatentee” who is either the patentee or formerpatentee.

Which drug products should be reported?Once a patentee is issued an NOC for a drugproduct that has one or more related patents inforce, the patentee has seven days to submit aForm-1. The patent(s) may be for (among otherthings) formulation of the medicine, processesinvolved in making the drug product, dosageforms, preparation of dosage forms, or deliverysystems of the drug product. The patent(s) may ormay not be used in producing the drug product.

Patented drug products provided under theSpecial Access Programme or Clinical TrialApplication or Investigational New Drug of HealthCanada, that are being sold and for which noNOC has been issued, should also be reported ona Form-1 within seven days of first being offeredfor sale.

Changes/Additions/DeletionsUpdate the electronic Form-1 to report to thePMPRB any changes, additions and deletions toinformation previously submitted for a drugproduct. This includes any change to the identity(i.e., name and/or address) of the reportingpatentee.

Indicate in the check box at the top of the formthat this update amends the earlier submission.

Due DatesForm-1 should be submitted to the PMPRB notlater than:

i. 7 days after the Notice of Compliance isissued or

7 days after a patented drug product has beenoffered for sale in Canada, whichever comesfirst; and

ii. 30 days after any changes, additions ordeletions are made to the information originallysubmitted to the PMPRB on a Form-1.

mailto:compliance@pmprb-cepmb.gc.ca

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

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Filing InformationIn the appropriate box at the top of the form,specify whether it is an original filing or anamendment. Any amendment(s) must beexplained in a letter or e-mail.

Block-1Names and Use(s) of the MedicineState the Brand Name and Generic Name of the drug product to be identified by this form.For example:

Brand Name... ...ValiumTMGeneric Name... ...diazepam

Therapeutic Use of the MedicineState the therapeutic use(s) (not the indications)of the medicine as approved by Health Canada.The Compendium of Pharmaceuticals andSpecialties (CPS)1 provides acceptable therapeuticuse descriptions in bold italic at the beginning ofeach product monograph. For example, thetherapeutic uses of ValiumTM are listed as:

AnxiolyticSedativeMuscle Relaxant

Human Prescription/Human Over-the-Counter/VeterinaryIndicate in the boxes provided whether the drugproduct is:

• Human Prescription i.e. prescribed for humanuse and is a controlled substance as definedin the Controlled Drugs and Substances Act orcontains a substance listed or described inSchedules C or D to the Food and Drugs Actor Schedule F to the Food and DrugRegulations;

• Human Over-the-Counter i.e. provided overthe-counter for human use and is not acontrolled substance as defined in theControlled Drugs and Substances Act or doesnot contain a substance listed or described inSchedules C or D to the Food and Drugs Actor Schedule F to the Food and DrugRegulations;

• Veterinary i.e. intended for veterinary use.Veterinary drug products include feed additives(e.g., antibiotics, vitamins) which have beenclassified as drug products.

If the drug product is intended for both human andveterinary uses, complete a separate Form-1 foreach.

Block-2Reporting Patentee State the name and address of the reportingpatentee.

Unless indicated otherwise, questions regardingcompleteness, accuracy, etc, will be directed tothe individual signing the form at the addressrecorded here.

Status of Reporting PatenteeIn the boxes provided, check off the descriptionthat best describes the status of the reportingpatentee completing this form.

The patent holder is the person (“person” isdefined in the Interpretations section at page 3)that owns the patent.

A person entitled to the benefits of a patent orto exercise any rights in relation to a patent isa person who has a license or an agreementwith the patent holder to exercise certain rightsof the patent. This category excludes a personwho has a compulsory license, as previouslydefined under section 39(4) of the Patent Actamended in 1993.

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Block-3Notice of Compliance (NOC)Patentee’s First NOC Indicate the date on which the first NOC wasissued to the reporting patentee for the drugproduct named in Block-1.

Special Access Programme orClinical Trial Application orInvestigational New DrugIf no NOC has been issued, use the provided boxesto indicate whether the drug product named inBlock-1 is being provided under the Special AccessProgramme (SAP) or Clinical Trial Application or theInvestigational New Drug Program.

Block-4Drug Identification Number(DIN)Drug Identification Number (DIN) Enter the DIN that applies to the drug productidentified in Block-1. Enter only the DIN thatidentifies a form of the drug product to which thereporting patentee has rights to sell, distribute, etc.

If the drug product has no DIN, leave this spaceblank. Following receipt of Form-1, the PMPRBwill assign a number to all patented drug productsthat have no DIN. The patentee will be asked touse this Assigned Number when completingForm-2 during the subsequent reporting periods.

Dosage Form Enter the dosage form that corresponds to theDIN entered in the first column. Write out thedosage 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

For a complete list of dosage forms, please referto Appendix A.

Appendix A provides the list of dosage forms and isnot intended to be used for the purpose of identifyingcomparable dosage forms. The Compendium ofGuidelines, Policies and Procedures, Schedule 7,identifies comparable dosage forms.

Strength/UnitFor the DIN in the first column, indicate thecorresponding strength of the drug product. Strengthis defined as the amount of active ingredient,expressed in milligrams (mg), micrograms (µg ormcg) or as appropriate per unit of medicine.

The unit of medicine is expressed in units of thedosage 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 drug products with more than one activeingredient, report as above, but with the amountsof active ingredients linked by a “+” sign. For example:

Dosage Form Strength/Unit

Tablet 10 mg/tab

Oral Liquid 10 mg/ml

Injectable 10 mg/vial

Cream 10 mg/gm

Inhaler 10 µg/dose

Dosage Form Strength/Unit

Tablet 10 mg of active ingredientA + 20 mg of activeingredient B/tab

Oral Liquid 10 mg of active ingredientA + 40 mg of activeingredient B/ml

2 For patent applications filed before October 1, 1989, the life of the Canadian patent is 17 years from the date thepatent was granted. For patent applications filed on or after October 1, 1989, the life of the Canadian patent is 20years from the date of the filing of the application of the patent in Canada.

3 Corporate officer should be interpreted in the broad sense as meaning any corporate official or employeeauthorized to sign on behalf of the corporation.

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Block-5Date of First SaleIndicate the year, month, day when the drugproduct identified in Block-1 is first sold inCanada, whether it is following issuance of anNOC, under SAP, a Clinical Trial Application or as an Investigational New Drug.

Block-6Product MonographPatentees must provide an electronic copy of theproduct monograph along with the Form-1, or if anNOC has not been issued, information similar tothat contained in a product monograph.

Block-7Patent Numbers of ReportingPatentee’s InventionsPatent NumberState the patent numbers for Canadian patentsthat pertain to the drug product named in Block-1.Patents can be related to (among other things) thechemical formulation of the medicine, processesinvolved in making the drug product, dosageforms, preparation of dosage forms, or deliverysystems for the drug product.

List those patents owned by the reporting patentee,assigned to the reporting patentee, or for which thereporting patentee is entitled to the benefits of apatent or to exercise any rights in relation to apatent (other than a compulsory license).

Date GrantedFor each patent listed in the first column, enter thedate (year/month/ day) the patent was granted onthe corresponding line in the middle column.

Expiry DateFor each patent number listed in the first column,enter the corresponding expiry date on thecorresponding line in the third column. Patentsgranted under the revised section 44 of the PatentAct expire twenty (20) years from the date of thefiling of the application of the patent in Canada.2

Block-8Certifying Signature This form should be signed by the reportingpatentee (if an individual) or corporate officer3(if a corporation).

SignatureThe individual signing should have the authority torepresent the patentee, and be knowledgeableabout information reported on the form. Below thesignature, type the name of the person, title andorganization. An electronic reproduction of themanual signature of the authorized person isrequired by the Board and should be copied andpasted in the box reserved to that effect.

Telephone, Facsimile Numbers and E-mail AddressProvide telephone and facsimile numbers as wellas the e-mail address for the signatory.

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

Form-2 – Identity and Prices of Medicines

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General InformationPurpose

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

• For Human Prescription drug products (see p. 7for definition), submit Form-2 semi annually foreach patented drug product, according to thereporting periods and due dates described onpage 10.

• For Human Over-the-Counter and Veterinarydrug products (see p. 7 for definition), submitForm-2 only if the Board sends a request inresponse to a complaint respecting the price ofthe medicine.

Definitions of key terms used in these forms areincluded in the Glossary (see page 24).

Who should provide information?The patentee completing Form-2 is the “reportingpatentee” who is either the patentee or formerpatentee.

Which drug products should be reported?Complete a Form-2 for each drug product sold inCanada for which at least one patent related tothe medicine pertains. Patent(s) may be for(among other things) formulation of the medicine,processes involved in making the drug product,dosage forms, preparation of dosage forms, ordelivery systems for the drug product. Thepatent(s) may or may not be used in theproduction of the drug product.

Drug products may be sold pursuant to an NOC,under the Special Access Programme, underClinical Trial Application or as an InvestigationalNew Drug.

How to Complete the Forms?For Block-4 and Block-5, please use the formatprovided by the PMPRB and ensure that eachfield of each row is filled as specified. Please referto pages 11 to 14 for additional information onBlock-4 and Block-5.

Reporting Periods and Due DatesThe information to be submitted to the PMPRBmust be provided using the electronic forms(including layout and file type) that are downloadable from the PMPRB Web site underLegislation, Regulations and Guidelines /Patentee’s Guide to Reporting.

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

(A) Semi-Annual FilingReport Form-2 information semi-annually.Reporting periods and due dates will be asfollows:

(B) Day of First Sale When a drug product is first offered for sale inCanada by, or on behalf of, the patentee, thefollowing reporting requirements apply:

a) A completed Form-2 must be filed with thePMPRB no later than thirty (30) days after theday on which the medicine is first sold inCanada.

b) The information provided in the completedForm-2 must cover the first day of sale inCanada of the new drug product.

Reporting Period Due Date*

1 January 1 to June 30 July 30

2 July 1 to December 31 January 30

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

mailto:compliance@pmprb-cepmb.gc.ca

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(C) Human Over-the-Counter andVeterinary Drug Products

Form-2 for Human Over-the-Counter and Veterinarydrug products must be provided within 30 daysafter the date on which the Board sends a requestand semi-annually for two (2) years following therequest, within 30 days after each six-monthperiod.

EXAMPLE:

If a new drug product (Human Prescription) is firstoffered for sale on March 15, 2007, a completedForm-2 would be due on April 14, 2007. TheForm-2 report would report the price and sales ofthe drug product for March 15, 2007. The nextForm-2 would be due on July 30 and would coverthe period March 15 to June 30 (it is recognizedthat some information will be reported twice).

Filing InformationIn the appropriate box at the top of the form,specify whether it is an original filing or anamendment. Any amendment(s) must beexplained in a letter or e-mail.

Block-1Reporting PeriodEnter the beginning and ending dates of theperiod to which the information applies. For example:

From: 2007/01/01(year/month/day)

To: 2007/06/30 (year/month/day)

Block-2Names of the MedicineBrand Name and Generic Name of the MedicineBlock 2 must be completed when reporting firstday of sales or amendments affecting only onedrug product. It should be left blank when filingsemi-annual reports for multiple drug products.

Brand Name... ...ValiumTMGeneric Name... ...diazepam

Block-3Reporting Patentee State the reporting patentee’s name and address;in other words, the name and address of thecompany or individual completing this form.

Certifying SignatureThe individual signing should have the authority to represent the reporting patentee, and beknowledgeable about information reported on theform. Type or print the name of the person signingbelow the signature. The electronic reproduction ofthe manual signature of the authorized person isrequired and should be copied and pasted in thebox reserved to that effect.

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

Telephone, Facsimile Numbers and Email AddressProvide telephone and facsimile numbers as wellas the email address of the signatory.

Block-4Sales of the Medicine by theReporting Patentee in FinalDosage Form in CanadaIntroduction The detailed information requested in Block-4relates to quantity and revenues of Canadiansales, in final dosage form, of the drug productnamed in Block-2. Each field of the row where aDIN is reported should be fully completed toinclude DIN, brand name, strength/unit, dosageform, package size, number of packages sold,

Reporting Period Due Date

1 March 15 April 14

2 March 15 to June 30 July 30

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total number of units sold, net revenue or averageprice/package, provinces/territories, and class ofcustomer. Use the codes listed in the Appendix A.Use a separate line to report each strength,dosage form and package size. Add as many rowsas needed by using the “Insert Row” on the topmenu item in Excel or by placing the cursor on therow below which a new row must be added andusing the right click/insert function of the mouse.Rows can be deleted similarly either by using themenu item at the top of the screen or by using theright click/delete function of the mouse.

Drug Identification Number (DIN) orNumber Assigned by the PMPRBEnter the DIN that applies to the drug productidentified in Block-2. If the drug product has noDIN, use the Assigned Number that the PMPRBprovided following receipt of Form-1.

Strength/UnitIndicate the strength of the drug product. Strength isdefined as the amount of active ingredient, expressedin milligrams (mg), micrograms (ìg or mcg) or asappropriate per unit of medicine. The unit of medicineis expressed in units of the dosage form such astablets, milliliters, vials, etc. Be sure to indicate theunits being used. For example:

Avoid using percentages.

Drug products with more than one activeingredient should be reported as above, but withthe amounts of active ingredients linked by a “+”sign. For example:

Dosage FormUsing the codes that appear in Appendix A4,enter in the appropriate column the dosage formcode that corresponds to the strength and DINinformation entered in the first two columns of therow. For example:

• The dosage form code of a tablet is S1 • The dosage form code of an oral solution is L1 • The dosage form code of a topical cream is T2.

Package SizeIn the appropriate space, enter the number of“units” per package. Enter only a numeric value for package size. For example:

Number of Packages SoldIndicate for each DIN or Assigned Number thetotal number of packages sold including quantitiesdistributed for promotions, rebates, free goods,etc. (see Subsections 4(4) and 4(5) of thePatented Medicines Regulations) during thereporting period. The date of sale is considered tobe the date the product was shipped, not the datepayment was received. Returns (i.e., productreturned to the reporting patentee for which arefund was provided) are to be included with thedata of the reporting period in which reportingpatentee received the return. Report onlyCanadian sales of the drug product in finaldosage form.

Net Revenue or Average Price perPackage Record the Net Revenue whenever possible,otherwise provide the Average Price perPackage that corresponds to the number ofpackages sold. Report in dollars and cents –donot round up to the nearest dollar.

DIN Strength/Unit Dosage Form

12345678 10 mg/tab S1

24681012 10 mg/ml L1

11223344 10 mg/gm T2

Strength/Unit Dosage Form

10 mg of active ingredient A + 20mg S1of active ingredient B/tab

10 mg of active ingredient A + 40 mg L1of active ingredient B/ml

DIN Strength/ Dosage PackageUnit Form Size

1234567 10 mg/tab S1 200

2468101 10 mg/ml L1 100

1122334 10 mg/gm T2 12

4 Appendix A, on page 29, provides a complete list of dosage forms. It is not intended to be used for the purpose ofidentifying comparable dosage forms. The Compendium of Guidelines, Policies and Procedures, Schedule 7,identifies comparable dosage forms.

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Net revenue consists of actual sales revenueusing the accrual accounting method (excludingfederal sales tax) for the drug product sold (i.e.,shipped) during the reporting period less amountsdisbursed for rebates, refunds, or other such typeof reduction during the same period (seeSubsections 4(4) and 4(5) of the PatentedMedicines Regulations).

The average price per package is defined as netrevenue (excluding federal sales tax) divided bythe total number of packages sold (or distributedas part of a promotion, rebate, etc.).

Province/Territory and Class of Customer Use codes provided in Appendix A to completethese fields (see page 30) or use dropdown menuavailable in Form 2 Block 4 template (Place yourcursor in the cell where you want to enter thecode in Province/Territory column or in Class ofCustomer column and double click to accessdropdown menu).

Please note that a breakdown of sales byprovince must be provided in Block 4. Code 13can be used only when it is not known in whichprovince the sales have occurred.

Block-5 Publicly available Ex-FactoryPrices for Canada and OtherCountriesInformation in Block-5 covers publicly available ex-factory prices in Canada and in the sevencountries listed in the Patented MedicinesRegulations (France, Germany, Italy, Sweden,Switzerland, United Kingdom and United States),for all final dosage forms of the medicine namedin Block-2.

Each field of the row where a DIN or AssignedNumber is reported should be fully completed toinclude the generic name of the medicine, DIN,strength/unit, dosage form, package size, ex-factory price, country or province, and class ofcustomer. Use the codes listed in Appendix A, onpage 29 and 30. Add as many rows as needed byusing the “Insert Row” in the menu item in Excelor by placing the cursor on the row below which anew row must be added and using the rightclick/insert function of the mouse. Rows can be

deleted similarly either by using the menu item atthe top of the screen or by using the rightclick/delete function of the mouse.

Important: The Canadian reporting patenteemust supply public foreign ex-factory pricedata for all patented drug products that theCanadian patentee sells in Canada. This isnecessary even if the Canadian patentee itselfdoes not sell the product in any of the sevenforeign countries. Reporting patentees who areunsure of, or have difficulty acquiring, foreign ex-factory price data should contact PMPRB stafffor advice.

Use a separate line to report each combination of“strength/dosage form/package size”, “country/province” and “class of customer” that applies. Ifthere is only one ex-factory price for all of Canada(i.e., if the ex-factory price is the same in eachCanadian province) use the province code “13” tosignify all of Canada instead of listing eachprovince separately.

Generic Name of Drug ProductIn the first column, provide the generic name of the drug product as identified in Block-2 of Form-2.

Drug Identification Number or Assigned NumberIn the second column, enter the DIN that appliesto the drug product identified in Block-2 of Form-2.If the drug product has no DIN, use the AssignedNumber that the PMPRB provided followingreceipt of Form-1.

Strength/Unit, Dosage Form,Package Size

Report in the same manner as in Block-4 of Form-2. There is detailed explanation of how torecord strength, dosage form and package size in the instructions for Block-4 of Form-2 on pages 11 to 14 of this Guide.

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Ex-factory PriceEnter the publicly available ex-factory price perpackage at which the drug product was soldduring the reporting period indicated in Block-1.State the public ex-factory price in the currency ofthe country in which it was sold.

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

The public ex-factory price is the price at which adrug product is first sold to wholesalers, hospitals,pharmacies, or others. This price excludes salestaxes and wholesale mark-ups if the wholesalefunction is not carried out by the reportingpatentee.

Country or Province, and Class of CustomerUse codes provided in Appendix A to completethese field (see page 30) or use dropdown menuavailable in Block 5 template (Place your cursor inthe cell where you want to enter the code inCountry/Province column or in Class of Customercolumn and double click to access dropdown menu).

When the publicly available ex-factory price is thesame across Canada, use code 13 to report theCanadian price in Block 5.

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

Form-3 – Licensees, Revenues and Expenditures

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General InformationPurposeSection 88 of the Patent Act requires a patentee of an invention pertaining to a medicine (bothpatented and non-patented) sold in Canada toprovide to the Patented Medicine Prices ReviewBoard (hereafter referred to as the Board)information on scientific research and experimentaldevelopment (SR&ED). Form-3 is designed tocollect information on: the reporting patentee; thenames and addresses of all licensees; grossrevenue (net of taxes) from sales in Canada; andexpenditures in Canada for SR&ED pertaining toall medicines for human and veterinary use.

Who must report?All reporting patentees of medicines sold in Canadathat filed a Form-2 during the calendar year mustreport gross revenues (net of taxes) and SR&EDexpenditures on Form-3. Foreign residency of thereporting patentee does not remove theresponsibility to report on Form-3. Foreign personsshould report their gross revenues (net of taxes)from sales in Canada and expenditures on SR&EDin Canada as if they were Canadian taxpayers.

Reporting Period and Due DatesReport Form-3 information annually; the due dateis as follows:

The information to be submitted to the PMPRBmust be provided using the electronic forms(including layout and file type) that aredownloadable from the PMPRB Web site, underRegulatory.

Completed forms must be sent to the Board’s e-mail address: compliance@pmprb-cepmb.gc.ca

Research and DevelopmentCriteria of EligibilityResearch and development (R&D) expendituresreported on Form-3 must meet the criteria forclaiming an investment tax credit in respect ofscientific research and experimental developmentas set out in subsections 37(1) and 127(9) of theIncome Tax Act and section 2902 of the IncomeTax Regulations as they read on December 1,1987. The term “Research and Development” as itappears on the reporting forms should beinterpreted as meaning Scientific Research andExperimental Development (SR&ED).

It does not matter if the patentee actually files anincome tax return for the reporting year inquestion, or if any of the research anddevelopment tax credits are actually claimed.Individuals and corporations who are notCanadian taxpayers should complete Form-3 as ifthey were Canadian taxpayers.

Revenue Canada publishes guidelines to claimingan investment tax credit for SR&ED expenditures.Whenever possible, the guidelines outlined inthese materials should be used to report SR&EDexpenditures on Form-3. Refer to the followingdocuments as they read on December 1, 1987:5

Subsections 37(1) and 127(9) of the IncomeTax Act

Sections 2900 and 2902 of the Income TaxRegulations

Revenue Canada Form T661

Interpretation Bulletin No. IT-151R3

Information Circular No. 86-4R2.

Reporting Period Due Date*

January 1 to December 31 March 1

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

5 These documents are available by contacting the Secretary of the Board or the Compliance Officers.

mailto:compliance@pmprb-cepmb.gc.ca

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.

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Definition – Scientific Research andExperimental DevelopmentScientific Research and Experimental Developmentmay be defined as a “systematic investigation orsearch carried out in the field of science ortechnology by means of experiment or analysis”.Technology refers to the systematic study of theapplication of scientific knowledge to industrialprocesses or product development.6

There are three main categories:

Basic researchWork undertaken to advance scientific knowledgewithout a specific practical application in view;

Applied researchWork undertaken to advance scientific knowledgewith a specific practical application in view; and

DevelopmentUse of results of basic or applied research to createnew materials, devices, products or processes, or toimprove existing ones.

Activities such as engineering or design, operationsresearch, mathematical analysis or computerprogramming, and psychological research areeligible only if such activities directly support basicor applied research, or eligible developmentactivities. Examples of activities that cannot beincluded 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 commercialuse of a new or improved process;

• style changes; or • routine data collection.7

Expenditures – Scientific Researchand Experimental DevelopmentNote that only expenditures made in Canada onSR&ED carried on in Canada are allowed; toqualify as SR&ED expenditures on Form-3, theexpenditures must conform to criteria for claimingthe investment tax credit for scientific researchand experimental development as set out insubsections 37(1) and 127(9) of the Income TaxAct and section 2902 of the Income TaxRegulations as they read on December 1, 1987.

Amounts that would normally qualify for a deduction(but not an investment tax credit) under subsection37(2) as it read on December 1, 1987 (Researchoutside Canada) should not be included on Form-3.Foreign travel expenditures, including the salariesand benefits of a Canadian employee undertakingforeign travel, and any other expenditure that relatesto SR&ED carried on outside Canada are alldeemed to be “Research outside Canada”.Therefore these are not to be included with SR&EDexpenditures on Form-3. This is the case even if theexpenditures were made in Canada, for example toa Canadian sub-contractor. Patentees who areuncertain as to whether to include certainexpenditures as SR&ED expenditures on Form-3should call Board Staff for advice.

Block-1Year to which InformationAppliesEnter the calendar year to which the informationapplies.

Block-2Identification of theReporting Patentee State the name and address of the reportingpatentee; in other words, the name and address ofthe company completing this form.

A reporting patentee is either a current patentee ora former patentee (see pages 3 and 4 underInterpretations for further information).

8 Consult Glossary, on page 26, for definition of “medicine as” it applies to Form-3.

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Block-3Licensee(s)/Other(s)Provide the names and addresses of all licenseeswith whom the reporting patentee has a license(including compulsory license) or other agreementthat entitles that person to exercise any rights inrelation to a patent and which person sells apatented medicine in Canada.

Block-4RevenuesTotal Gross Revenues of theReporting Patentee from all Sales of Medicines in Canada Report the total gross revenues (net of taxes) fromall sales of medicines8 sold in Canada for humanand veterinary use, that have a Drug IdentificationNumber (DIN) under the Food and Drug Regulationsor which have been approved for sale to qualifiedinvestigators or through Health Canada’s SpecialAccess Program under those Regulations. Thisincludes 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 shouldbe reported on an accrual basis, i.e., in the year theproduct was shipped or left the plant gate.

Total Gross Revenues Received fromall Licensees/Others in Canada Report the total revenues (net of taxes) received(including royalties and license fees) from alllicensees/others listed in Block 3, from the sale inCanada of medicines for human and veterinary use.

Revenues from licensees/others, in the form oflicense fees or royalties may be reported on anaccrual basis (i.e., the year in which the medicineswere shipped) or on a cash basis (i.e., the yearthe royalties were actually paid) but reportingshould be consistent from year to year.

Block-5 Research and DevelopmentPertaining to MedicinesNon-Capital Expenditures Incurredby the PatenteeNon-capital expenditures do not include generaladministrative expenses or factory overheadexpenses that would have been incurred even ifSR&ED had not been carried out. Expenses mustall, or substantially all, be linked to SR&ED. All, orsubstantially all, means at least 90% of the time.For example, if a reporting patentee rents aphotocopy machine that will be used approximately50% of the time for SR&ED; no portion of the rentalpayments is considered to be an expenditure that isdirectly attributable to SR&ED. The followingcannot be included as non-capital expendituresin 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 bebroken out into the following categories:

A. Wages and salariesOnly include wages and salaries (and other relatedcosts 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 materialAll costs are to be the net laid-down price afterdeducting trade discounts, etc.

C. Contractors and sub-contractorsThis category only covers contractors hired to carryout SR&ED on the reporting patentee’s behalf. Theexpression “on the reporting patentee’s behalf”distinguishes contractors from other expenditurecategories such as payments to universities andgranting councils.

D. Other direct costsInclude only the incremental general administrativeand/or factory overhead costs incurred solely as aresult of carrying on SR&ED activities.

E. Payments to designatedinstitutions

Under this category, report payments to anapproved university, college, research institute orother similar institution, to be used by thatinstitution for SR&ED related to the reportingpatentee’s class of business. Amounts paid to carryout SR&ED on the reporting patentee’s behalfshould not be included here, but under section Cpertaining to contractors and sub-contractors.

F. Payments to granting councilsUnder this category, report payments to eachgranting council for eligible SR&ED activities. Agranting council is an approved organization thatpays an association, institution or corporation todo SR&ED related to the reporting patentee’sclass of business. Approved granting councilsinclude:

• Natural Sciences and Engineering ResearchCouncil

• Canadian Institutes for Health Research(formerly the Medical Research Council)

G. Payments to other organizationsInclude payments to other organizations for SR&EDrelated to the reporting patentee’s class of businessand not included under “E” (designated institutions)or “F” (granting councils) above.

Block-6Total Capital ExpendituresBuildings – Annual DepreciationPatentees should report annual depreciation ofbuildings used for SR&ED in Canada. The annualdepreciation should be calculated at the rate of4% of the qualifying capital cost per year over amaximum of twenty-five years. Depreciation isapplied beginning with the year in which thebuilding was purchased or acquired.

If a building was built or purchased to be usedpartly for SR&ED and partly for other purposes,and a specific area within the building isallocated solely for SR&ED use, a reasonableportion of the building’s original cost can be usedto calculate annual depreciation. Calculate theapplicable portion of the building’s cost byapplying the proportion of SR&ED floor-space, tototal floors space to the total original cost of thebuilding.

For example, a 1000 square meter buildingoriginally costing $400,000 has a 250 squaremeter wing allocated entirely for SR&EDactivities. Since 25% (250 of 1000) of thetotal floor-space is devoted to SR&ED,calculate annual depreciation based on$100,000 (25% of $400,000). Annualdepreciation would be 4% of $100,000 =$4,000.

If a building was originally used for purposes otherthan SR&ED, but is converted for SR&ED use, thecost of the conversion may be depreciated asabove. However, do not include any part of thebuilding’s original cost in the reported annualdepreciation.

To calculate the total annual depreciation of allbuildings (and eligible conversion costs) dedicatedto SR&ED, the annual depreciation of each shouldbe calculated separately, and then totalled.

Total Capital Expenditures in theYear (buildings)This line refers to capital expenditures made onbuildings. Report total capital expenditures madeduring the reporting year on buildings in Canadato be used for SR&ED. Do not include capitalexpenditures made on land.

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If a building was built or purchased to be usedpartly for SR&ED and partly for other purposes,and a specific area within the building isallocated solely for SR&ED, a reasonable portionof the building’s total cost can qualify as a capitalexpenditure on SR&ED. If part or all of an existingbuilding is converted for SR&ED, the conversioncosts may qualify as a capital expenditure onSR&ED. However, no part of the building’s originalcost or of its un-depreciated capital cost is eligible.

Equipment (capital expenditures)Capital expenditures on equipment must be madein Canada. When an asset is purchased from asupplier outside Canada and is imported andused for SR&ED in Canada, the expenditure isconsidered to be made in Canada. Normal accrualaccounting principles will apply to capitalexpenditures for SR&ED.

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

Block-7Type of Research andDevelopment – Medicine forHuman UseList expenditures (non-capital only) on SR&ED inCanada for medicines for human use according to “type of research” and “who carried out theresearch”. The following definitions may help ininterpreting the meaning of the categories “type ofresearch” and “who carried out the research”.These definitions also apply to Block-8.

Type of R&D

Basic ResearchBasic – chemicalSystematic investigation undertaken to advanceknowledge in chemistry by means ofexperimentation or analysis, without any practical application in view.

Basic – biologicalSystematic investigation undertaken to advanceknowledge in biology by means ofexperimentation or analysis, without any practical application in view.

Applied ResearchManufacturing processesExperimental development of new or improvedmanufacturing processes in support of basic orapplied research.

Note: Preclinical and Clinical TrialsGenerally, preclinical trials involve animal testingwhile clinical trials involve human subjects.However, preclinical and clinical trials oftenoverlap. Some drug evaluations may not follow thephases of evaluation described here. Reportingpatentees should strive to report according to thephases 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

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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 therapeuticand safety profiles

• Proof of efficacy and safety in long termadministration

• Demonstration of therapeutic advantages, if any

• Clarification of any interactions withconcomitant medication

• Chronic toxicity (if required)

Other Qualifying R&DThis includes eligible research and developmentexpenditures that cannot be classified into any ofthe preceding categories of “type of research anddevelopment.”

Other qualifying research includes drug regulationsubmissions, bioavailability studies and Phase IVclinical trials.

Categories Describing Who CarriedOut ResearchReporting PatenteeReporting patentee is either a current patentee ora former patentee (see definitions on pages 3 and4 under Interpretations). If you are no longer apatentee but were a patentee during part or all ofthe year Form-3 covers, you are required to reportas a former patentee.

Other companiesInclude corporations, resident in Canada,undertaking research on behalf of the reportingpatentee, or research in the same class ofbusiness as the reporting patentee. Corporationscarrying out the research do not have to be atarm’s-length from the reporting patentee.

UniversitiesInclude universities, colleges and otherinstitutions, such as research institutes, approvedunder the Income Tax Act.

HospitalsA facility licensed, approved or designated assuch by a federal, provincial or territorialgovernment.

Note: Hospital vs. UniversityThere may be some uncertainty as to whether toclassify, as hospital or university, research carriedout in a teaching hospital or when scientists doingthe work are affiliated with both a hospital and auniversity. If it can be ascertained where themonies for the research are beinghandled/managed (i.e., through the university orthrough the hospital), then these amounts shouldbe assigned to reflect this. When payment is madedirectly to a scientist or other researcher with dualaffiliations, the amounts should be included underthe category that best describes the setting wherethe research took place.

OthersThis category is reserved for expenditures that donot logically fit into any of the other categories.

Block-8Type of Research andDevelopment – Medicine forVeterinary UseExpenditures (non-capital only) on SR&ED inCanada, pertaining to medicines for veterinaryuse, are to be listed according to “type ofresearch” and “who carried out the research”. Thedefinitions in Block-7 above may help you interpretthe categories of “type of research” and “whocarried out the research”.

Block-9Source of Funds for R&DDetail sources of funds for non-capital expendituresand capital equipment expenditures according tothe categories described below. The total source offunds reported in this block is to correspond to thetotal of non-capital expenditures and capitalequipment expenditures (Block-5 and Block-6(Equipment)).

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Internal FundsRefers to the internal corporate funds of thereporting patentee. It does not include moniesfrom parent or subsidiary companies if thesecompanies are distinct corporate entities in theirown right. Monies from parent or subsidiarycompanies should be included under “not arm’s-length”.

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

Not Arm’s-Length PersonA “not arm’s-length person” is an individual,corporation or other legal entity that is related tothe reporting patentee. There are many types of“not arm’s length” relationships. It is beyond thescope of this document to list them all. However,some examples of “not arm’s-length” relationshipsof 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 acorporation)

The above list is a small sample only. Reportingpatentees should consult the Income Tax Act ifthere is doubt as to whether a relationship is, or isnot, at arm’s-length.

Federal GovernmentThis category includes all monies received duringthe year from departments and agencies of thefederal government of Canada. These moniesinclude, among other things, all assistance paidduring the year to a patentee under the terms ofan Appropriation Act for SR&ED expenditures.Such assistance includes, among other things,any grant, subsidy, reimbursement or forgivableloan (including a contingently repayable loan)received by the reporting patentee. The amountreported is to be net of amounts repaid to thefederal government during the year.

Provincial GovernmentInclude all monies received from provincial orterritorial government departments or agencies.

OtherInclude all monies received by the patentee fromsources that do not logically fall into any of theabove categories.

Block-10Information for R&D in Each Province/TerritoryProvide a provincial/territorial distribution ofSR&ED expenditures (non-capital only), by eachof the “who carried out the research” categories.Definitions of the “who carried out the research”categories are in the definitions for Block-7. Thetotal expenditures reported in Block-10 shouldcorrespond to total non-capital expenditures(Block-5).

Block-11Certifying SignatureThis block is for the signature of the reportingpatentee (or authorized corporate official). Theindividual signing should be knowledgeable aboutthe information reported on the form.

Reconciling Expenditures andSources of FundsTo verify the accuracy of information reported onForm-3, ensure that the “expenditures” and “sourceof 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 providedin the provincial/territorial breakdown in Block-10.The sum of non-capital (Block-5) and capitalequipment expenditures (Block-6 equipment only)should equal the total source of funds (Block-9).For summary table, see page 22.

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In summary:[Block-5] = [Block-7] + [Block-8]

[Block-5] = [Block-10]

[Block-9] = [Block-5] + [Block-6 (equipment only)]

Columns reconciliation:Patentee [Block-7] + [Block-8] = Patentee [Block-10]

Other companies [Block-7] + [Block-8] = Other companies [Block-10]

Universities [Block-7] + [Block-8] = Universities [Block-10]

Hospitals [Block-7] + [Block-8] = Hospitals [Block-10]

Others [Block-7] + [Block-8] = Others [Block-10]

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Notification of Intent to Sell

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The 1993 amendments to the Patent Act require patentees to notify the PMPRB, as soon as this is possible,of an intention to sell a patented drug product in a new market in Canada, and the date on which thepatentee intends to offer the drug product for sale. The form for providing the required information can befound in the Compendium of Guidelines, Policies and Procedures, Schedule 6, page 38, as well as at theback of this Guide on page 32.

Glossary

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Note to Reader: This glossary is included for theconvenience of the reader. For more detailedinformation and definitions please refer to thePatent Act, the Patented Medicines Regulationsand the Compendium of Guidelines, Policies andProcedures, or contact the PMPRB.

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

Active Ingredient: Chemical responsible for theclaimed pharmacologic effect of a drug product.

Arm’s-length person: An “arm’s-length person”is an individual, corporation or other legal entity(see also: definition of “Person”) that is notrelated to the reporting patentee. If in doubt,patentees should refer to the Income Tax Actfor a definition of “arm’s length”. Generally,“arm’s-length” persons (individuals orcorporations) are persons that have no corporateor other direct connections with each other, andthus act each in their own self-interest. Examplesof “not arm’s-length” relationships are given inthe definition of “not arm’s length” on page 21.

Persons normally operating at “arm’s length”may have a “not arm’s-length” relationship for aparticular contract. However, if outside thiscontract there is not special duty, obligation orrelationship to each other, then the two personsmay be considered to be at “arm’s length”.

Assignee: An assignee is a person (individual orcorporation or other legal entity) that enjoyssome or all of a patentee’s rights with respectto a patented medicine. Such rights mayinclude manufacturing, distributing or selling apatented medicine. The assigned rights mayhave time and geographic limitations. Theassigned rights are generally the outcome of acontractual agreement between the patenteeand the assignee. Compulsory licensees arenot considered to be assignees.

Assigned Number: Number attributed by thePMPRB for reporting purposes to a patenteddrug product that has no DIN. This number willbe assigned once the completed Form-1 forthe patented drug product with no DIN hasbeen filed and should be used on Form-2 forall subsequent reporting periods.

Average price per package: Average price perpackage is defined as net revenues divided bythe total number of packages sold (ordistributed as part of promotion, rebate, etc.)when net revenues consist of actual salesrevenues (excluding sales tax) less anyamounts disbursed for benefits or promotionssuch as rebates, refunds, or gifts.

Cash Accounting: Under the cash accountingmethod revenues are reported in the year inwhich they are actually received. Only “Revenuesfrom Licensees” on Form-3 may be reportedusing the cash method; all other revenues andall expenditures must be reported usingnormal accrual accounting methods.

Clinical Trial Stages: Generally, preclinical trialsinvolve animal testing while clinical trialsinvolve human subjects. However, there isoften overlap of the clinical and preclinicaltrials. Some drug evaluations may not havefollowed the phases of evaluation described inthese definitions. Reporting parties should striveto report according to the phases defined underthe headings “clinical trials” and “preclinical trials”.

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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

centers for final establishment of therapeuticand safety profiles

• Proof of efficacy and safety in long termadministration

• Demonstration of therapeutic advantages, if any

• Clarification of any interactions withconcomitant medication

• Chronic toxicity (if required)

Corporate officer: For reporting purposes,corporate officer is interpreted in the broadsense as meaning a corporate official oremployee authorized to sign on behalf of thecorporation. Corporate officials signing thereporting forms on behalf of their corporationshould be knowledgeable about the contentsof the forms.

Drug Identification Number (DIN): A registrationnumber that the Health Products and FoodBranch of Health Canada assigns to eachprescription and non-prescription drug productmarketed under the Food and DrugRegulations. The DIN is assigned usinginformation in the following areas:manufacturer of the product; activeingredient(s); strength of active ingredient(s);pharmaceutical dosage form; brand/tradename; and route of administration.

Drug Product: A particular presentation of amedicine characterized by its pharmaceuticaldosage form and the strength of the activeingredient(s).

Efficacy: The ability of a medicine to produce thepurported effect as determined by scientificmethods.

Special Access Programme (SAP): The SAPprovides access to non-marketed drugs forpractitioners treating patients with serious orlife-threatening conditions when conventionaltherapies have failed, are unsuitable, orunavailable. The SAP authorizes a manufacturerto sell a drug that cannot otherwise be sold ordistributed in Canada.

Ethical (medicine): Generally, the term “ethical”is used in the pharmaceutical industry todescribe products that require a prescriptionand are not usually advertised to the public. By contrast, the term “proprietary” is used todescribe products for which no prescription isrequired and which may be promoted directlyto the public.

Ex-factory price: The price established for thefirst sale (during the reporting period) of theproduct “at arm’s length” to distributors,wholesalers, hospitals, pharmacies, etc. Thisprice always excludes sales taxes, andwholesale mark-ups when the wholesalefunction is not carried out by the patentee. Theex-factory price is generally the “list price” formedicines. The ex-factory price can also bethe price that is agreed on between thepatentee and the regulatory body of thecountry in which it is sold by the patentee.

Format (of medicine): Also referred to as the“presentation”. The format of a medicine is the particular combination of active ingredientstrength, dosage form and package size (i.e., units of medicine per package).

Former patentee: A patentee is referred to as aformer patentee once the relevant patents for aparticular drug product expire. The Regulationsrequire filing of information for drug productsnot previously filed. The filing should only coverthe periods during which the drug product waspatented. The Board can request thisinformation within three years of the patent’sexpiry, if it has reason to do so.

Generic Product: A pharmaceutical product thatis a copy (i.e., the same active ingredient,strength and dosage form) of a brand-namedrug product.

Hospital: A health care institution licensed,approved or designated as a hospital by aprovincial or territorial government or is ownedor operated by the Government of Canada toprovide continuing medical care and supportingdiagnostic and therapeutic services.

Indication: An indication is a specific condition,manifested by the presence of disease ormedical signs or symptoms that the medicinetreats or cures, as approved by the HealthProtection Branch of Health Canada.

Investigational New Drug (IND): A drug that has been approved for clinical evaluation (i.e.,testing on humans) but that is not yet approvedfor sale for the indication under study.

In vitro: In relation to a medicine or patentedmedicine, the use or application of suchmedicine or patented medicine in a laboratoryor other environment that is not associatedwith its direct application to, or use for, humansor animals.

In vivo: In relation to a medicine or a patentedmedicine, the application or administering ofsuch medicine or patented medicine, as thecase may be, into or upon the living body ofhumans or animals.

Licence, Compulsory: A license granted by theCommissioner of Patents that permits thelicensee to import, make, use or sell apatented invention pertaining to a medicine.The compulsory licensee pays license fees orroyalties to the patent holder for use of thepatented invention.

With the exception of those compulsory licensesissued prior to December 20, 1991, whichcontinue to be in effect, the 1993 amendmentsto the Patent Act repealed the compulsorylicensing regime effective December 20, 1991.Accordingly all compulsory licenses issued afterDecember 20, 1991 cease to have effect.

Licence, Voluntary: A contractual agreementbetween a patent holder and a licensee underwhich the latter is permitted to exploit certainof the otherwise exclusive patent rights of the patentee, usually for some consideration(i.e., royalties in the form of a share of thelicensee’s sales).

Manufacturing: All operations involved in theproduction of a medicine, including processing,compounding, formulating, filling, packaging,and labeling.

Medicine: Any substance or mixture of substancesmade by any means, whether producedbiologically, chemically, or otherwise, that isapplied or administered in vivo in humans or inanimals to aid in the diagnosis, treatment,mitigation or prevention of disease, symptoms,disorders, abnormal physical states, or modifyingorganic functions in humans and or animals,however administered.

For greater certainty, this definition includesvaccines, topical preparations, anaestheticsand diagnostic products used in vivo, regardlessof delivery mechanism (e.g., transdermally,capsule form, injectable, inhaler, etc.). Thisdefinition excludes medical devices, in vitrodiagnostic products and disinfectants that arenot used in vivo.

Net Revenues: Net revenues consist of actualsales revenues (excluding sales tax) formedicine sold (i.e., shipped) during thereporting period less amounts disbursed forbenefits or promotions such as rebates,refunds, or gifts.

Not arm’s-length person: A “not arm’s-lengthperson” is an individual, corporation or other legalentity that is related to the patentee. For example,a foreign owned corporation and its Canadiansubsidiary do not have an arm’s-lengthrelationship with each other. However, there aremany types of “not arm’s-length” relationships. Itis beyond the scope of this document to list themall. However, some examples of ways in whichcorporations may have relationships that are notat arm’s-length are:

26

• if one corporation is controlled by the other • if one corporation is a member of a related

group that controls the other • if they are controlled by the same person or

persons (“person” can mean individual orcorporation)

The above list is a small sample only. If thereis any doubt as to whether a relationship is, oris not, at arm’s-length, patentees shouldconsult the Income Tax Act.

Notice of Compliance (NOC): A notice in respectof a medicine issued by the Health Productsand Food Branch of Health Canada undersection C.08.004 of the Food and DrugRegulations. The issuance of an NOC indicatesthat a drug product meets the required HealthCanada standards for use in humans oranimals and that the product is approved forsale in Canada.

Patent: An instrument issued by theCommissioner of Patents in the form of letterspatent for an invention that provides its holderwith a monopoly limited in time, for the claimsmade within the patent. A patent gives thepatentee the exclusive right to make, sell orotherwise exploit the invention for the term ofthe patent.

Patented Medicines Regulations: A federalregulatory instrument promulgated under theauthority of the Patent Act. The Regulationsspecify the information patentees must reportto the Board relating to the medicine, price andsales of the medicine, revenues and researchand development expenditures as well as thetiming of the filing.

Patentee: For purposes of subsection 79 to 103of the Act, “the person for the time beingentitled to the benefit of the patent for thatinvention (pertaining to a medicine) andincludes, where any other person is entitled toexercise any rights in relation to that patentother than under a license continued bysubsection 11(1) of the Patent Act AmendmentAct, 1992, that other person in respect ofthose rights;”

Pharmacokinetics: The rate of drug action,particularly with respect to absorption,distribution, metabolism and excretion of thedrug and its metabolites.

Pharmacy or Drugstore: An establishmentlicensed by a provincial licensing body todispense or sell drugs, pharmaceuticals,patented medicines and drug sundries topatients.

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

Proprietary Drug: The term “proprietary” is usedto describe products for which no prescriptionis required and which may be promoteddirectly to the public.

Quality control: All measures designed to ensurethe output of uniform batches of drugs thatconform to established specifications of identity,strength, purity, and other characteristics.

27

28

Research and Development (R&D): Basic orapplied research for the purpose of creatingnew, or improving existing materials, devices,products or processes (e.g., manufacturingprocesses).

Research and Development – Applied Research:Work that advances scientific knowledge witha specific practical application in view such ascreating new or improved products or processesthrough manufacturing processes or throughpreclinical or clinical studies.

Research and Development – Basic Research:Work that advances scientific knowledgewithout a specific application in view.

Research and Development – Clinical Research:The assessment of the effect of a new medicineon humans. It typically consists of threesuccessive phases, beginning with limitedtesting for safety in healthy humans thenproceeding to further safety and efficacy studiesin patients suffering from the target disease.

Research and Development – PreclinicalResearch: Tests on animals to evaluate thepharmacological and toxicological effects ofmedicines.

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

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

More specifically, the sales to be reported arefor any product for which a DIN has beenissued under the Food and Drug Regulationsor which has been approved for sale to qualifiedinvestigators under the said regulations; AND

that is used in the diagnosis, treatment,mitigation or prevention of disease, disorder,abnormal physical state or the symptomsthereof, or in the modification of organicfunctions in human or animal; AND

the sale of which is promoted by any means tophysicians, dentists, veterinarians, hospitals,drug retailers or wholesalers or manufacturersof ethical pharmaceutical products.

Wholesaler: An person (individual, corporation orother legal entity) primarily engaged in buyingmerchandise for resale to retailers; toindustrial, commercial, institutional, farm orprofessional business users; to otherwholesalers or in acting as an agent or brokerin buying merchandise for, or sellingmerchandise to, such persons or companiesfor a commission.

Appendix A – List of Codes

Topical (T)

T1 AerosolT2 CreamT3 GelT4 LiquidT5 OintmentT6 PasteT7 PowderT8 ShampooT9 SprayT10 PatchesT11 DisksT12 Dressings

T99 Other

Oral Liquid (L)

L1 SolutionL2 Powder for solutionL3 Powder for suspensionL4 SuspensionL5 DropsL6 Modified release liquid

L99 Other

Otic (E)/Ophthalmic (Y)

E1/Y1 LiquidE2/Y2 Powder for solutionE3/Y3 DropsE4/Y4 SuspensionE5/Y5 OintmentE6/Y6 GelE7/Y7 Modified release oculardevices

E99/Y99 Other

Nasal (N)/Pulmonary (P)

N1/P1 DropsN2/P2 AerosolN3/P3 SprayN4/P4 SolutionN5/P5 PowderN6/P6 GasN7/P7 Metered dosepreparations

N99/P99 Other

Vaginal (V)

V1 SuppositoryV2 CreamV3 TabletV4 DoucheV5 FoamV6 ConeV7 OvuleV8 GelV9 TamponV10 SpongeV11 Insert

V99 Other

Rectal (R)

R1 SuppositoryR2 CreamR3 OintmentR4 EnemaR5 SuspensionR6 Foam

R99 Other

Oral Solid (S)

S1 TabletS2 CapsuleS3 Modified release tabletsS4 Modified release capsulesS5 Effervescent powderS6 Effervescent tabletsS7 Effervescent granulesS8 CapletS9 Modified release caplets

S99 Other

Parenteral (J)

J1 SolutionJ2 Powder for solutionJ3 Suspensions or EmulsionsJ4 Modified release injectionsJ5 Implant

J99 Other

Dental – Sublingual Buccal (M)

M1 Mouth washM2 SolutionM3 SuspensionM4 Powder for suspensionM5 LozengeM6 GelM7 GumM8 Modified release buccaltabletsM9 Sprays – SublingualM10 Sprays – buccalM11 Sublingual tabletsM12 Tooth pasteM13 Tooth powder

M99 Other

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Comparable Dosage Form Codes (to be used in Form 1Block 4, and in Form 2 Block 4 and 5)

Province/Territory Codes

1 NL2 PE3 NS4 NB5 QC6 ON7 MB8 SK9 AB10 BC11 NT12 YT13 CANADA (when province / territory

is not known)14 NU

Class of customer Codes

1 Hospital2 Drugstore or Pharmacy3 Wholesaler4 Other

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Form 2 Block 4

Country or Province Codes

13 CANADA (when public price is the same inALL provinces/ territories) otherwise usesame codes as in Block 4 for each province/territory

15 GERMANY16 FRANCE17 ITALY18 SWEDEN19 SWITZERLAND20 UNITED KINGDOM21 UNITED STATES

Class of customer Codes

1 Hospital2 Drugstore or Pharmacy3 Wholesaler4 Other 4-FSS The price of a drug product on the US

Federal Supply Schedule should becoded as follows: use code 21 in thecolumn Country or Province and “4-FSS”in the column Class of Customer

Form 2 Block 5

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Appendix B – Reporting Forms

Patented Medicine Privileged s.87

Prices Review Board Patent Act

Use one form per DIN

Please Specify Original Filing or Amendment to Original Filing

1 NAME(S) AND USE(S) OF THE MEDICINE

Brand Name:

Generic Name:

Therapeutic use(s) of the medicine

approved by Health Canada:

Human Prescription

OR

Human Over-the-Counter

OR

Veterinary

2 REPORTING PATENTEE Patentee Name

Patentee Address

Identity if the reporting

patentee is: the patent holder person entitled to the benefits of a patent or to exercise any rights in relation to a patent

3 NOTICE OF COMPLIANCE (N.O.C.)

emmargorP sseccA laicepSfi kcehC

Y M D applicable or

Clinical Trial Application or Investigational New Drug

4 DRUG IDENTIFICATION NUMBER (DIN)

Drug Identification Number tinU/htgnertSmroF egasoD

MEDICINE IDENTIFICATION SHEETFORM 1

(The medicine is for human use and contains 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 orin Schedule F to the Food and Drug Regulations)

(The medicine is for human use and does not contain a controlled substance as defined in the ControlledDrugs and Substances Act or does not contain a substance listed or described in Schedules C or D to the Food and Drugs Act or in Schedule F to the Food and Drug Regulations)

First N.O.C.

HPARGONOM TCUDORP 6ELAS TSRIF FO ETAD 5

OR

Y M D

(Copy Included)(Copy Included)

Product Monograph Information similar to that contained in a Product Monograph

Date of 1st Sale

Patented Medicine Privileged s.87

Prices Review Board Patent Act

7 PATENT NUMBER OF REPORTING PATENTEE'S INVENTIONS PERTAINING TO THE MEDICINE

8 CERTIFIED BY: (in accordance with Section 7 of the Patented Medicines Regulations)

I hereby certify that the information presented is true and correct.

Signature of duly authorized person for the reporting patentee.

Name:

Title:

Organization:

Date:

: rebmuN xaF:rebmuN .leT

E-mail:

Patent Number Date Granted Expiration Date

FORM 1MEDICINE IDENTIFICATION SHEET

Y M Y M D# D

) () (

32

FORM-1 Medicine Identification Sheet (XLS)

Please send completed Form 1 to: compliance@pmprb-cepmb.gc.ca

http://www.pmprb-cepmb.gc.ca/CMFiles/Form_1_-_English38KAD-3192008-5877.xlsmailto:compliance@pmprb-cepmb.gc.ca

Patented Medicine Privileged s.87

Prices Review Board INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE Patent Act

Please Specify Original Filing or Amendment to Original Filing

1 REPORTING PERIOD

Y M D Y M D

2 NAMES OF THE MEDICINE

Brand name of the medicine

Generic name of the medicine

3 REPORTING PATENTEE*

Patentee Name

Patentee Address

*Please see section 79(1) of the Patent Act for the definition of a "patentee". Note that a patentee is any person entitledto the benefits of a patent or to exercise any rights in relation to a patent. This includes patent holders, licensees or others.

CERTIFIED BY: (in accordance with Section 7 of the Patented Medicines Regulations)

I hereby certify that the information presented is true and correct.

Signature of duly authorized person for the reporting patentee

Name:

Title:

Organization:

Date:

Tel. Number: Fax Number :

E-mail:

) () (

FORM 2

OTMORFPeriod to which the information applies:

33

FORM-2 Information on the Identity and Prices of the Medicine (XLS)

Please send completed Form 2 including the cover sheet, Block 4 and Block 5 to: compliance@pmprb-cepmb.gc.ca

http://www.pmprb-cepmb.gc.ca/CMFiles/Form_2_Cover_Sheet_-_English38KGQ-3192008-8751.xlsmailto:compliance@pmprb-cepmb.gc.ca

34

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