-
S i n c eD e p u i s
1987
Web site: www.pmprb-cepmb.gc.caE-mail:
[email protected]
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:[email protected]
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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
1
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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)
2
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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;”
3
http://www.pmprb-cepmb.gc.ca/
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4
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: [email protected]
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:[email protected]
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:[email protected]:[email protected]
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( ) -
( ) -
5
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:
[email protected]
mailto:[email protected]
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Form-1 – Medicine Identification Sheet
6
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: [email protected]
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:[email protected]
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1 The Compendium of Pharmaceuticals and Specialties (CPS) is
published and copyrighted by the CanadianPharmaceutical
Association.
7
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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8
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
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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.
9
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.
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Form-2 – Identity and Prices of Medicines
10
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:
[email protected].
(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:[email protected]
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11
(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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12
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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13
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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14
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.
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Form-3 – Licensees, Revenues and Expenditures
15
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:
[email protected]
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:[email protected]
-
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.
16
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.
17
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.
18
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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
19
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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)).
20
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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.
21
-
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]
22
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Notification of Intent to Sell
23
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
24
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”.
-
25
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
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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.
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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
29
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
30
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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31
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:
[email protected]
http://www.pmprb-cepmb.gc.ca/CMFiles/Form_1_-_English38KAD-3192008-5877.xlsmailto:[email protected]
-
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: [email protected]
http://www.pmprb-cepmb.gc.ca/CMFiles/Form_2_Cover_Sheet_-_English38KGQ-3192008-8751.xlsmailto:[email protected]
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34
Pat
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Pri
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Pri
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