Outreach Sessions 2013

Montreal October 30, 2013Toronto, October 31, 2013

Patented Medicine Prices Review Board

Overview

Amendments to the Food and Drugs Regulations

Patent Pertains to a Medicine - FAQ

Best Practice: Filing• Filing “no sales”• Filing amended Form 2 data for one or more DINs• Preparing for on-line filing

CPI Initiative

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Amendments to the Food and Drug Regulations (FDR)

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Amendments to the FDR Schedule F of FDR to be replaced by a Prescription Drug List

Consequential amendments to the Patented Medicines Regulations to track the language used in the new FDR

All amendments to come into force on December 19, 2013

Impact on patentees reporting to the PMPRB: Check the Prescription Drug List to see if any of your patented drug

products are on it. If yes, send a Form 1 to the PMPRB if the product is not already under the PMPRB jurisdiction

Always use the most updated Form 1 on the PMPRB website

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Patent Pertains to a Medicine

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Definitions – Patent Act

79. (1) …”patentee” … means the person for the time being entitled to the benefit of the patent for that invention79. (2) … an invention pertains to a medicine if the invention is intended or capable of being used for medicine or for the preparation or production of medicine

ICN Pharmaceuticals, Inc. v. Canada (1996): There must be a rational connection or nexus between the invention described in the patent and the medicine.

Unnecessary to go beyond the face of the patent Nexus can be “the merest slender thread” No requirement that the invention described in the patent actually be used Board Staff has neither the experience nor the expertise to engage in the

task of patent construction

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Definitions – Compendium of Policies, Guidelines and Procedures

A.4.1.2 : any Canadian patent of invention that pertains to a medicine. This includes, but is not restricted or limited to: Patents for active ingredients; Patents for processes of manufacture; Patents for a particular delivery system or dosage form that are

integral to the delivery of the medicine; Patents for indications/uses; and Patents for formulations.

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Duration of a Patent (Patent Act section 45 and section 55.2)

http://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/introduction.html

If application filed on or after October 1, 1989Duration = 20 years after filing date

If application filed before October 1, 1989Duration = 17 years from date on which patent was issued

Laid open starts at the publication date

Example: Patent 2345678 Form 1Issued: 2007-11-13 Patent granted: 2007-11-13Filing date: 1999-09-23 Patent expired: 2019-09-23Publication date: 2000-04-06

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Patent Expiry – Process (through an example)

2012 2013 2014

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Board Staff sends a letter in Feb/March 2013, and reminder in Sept. 2013, asking patentee to confirm by November 30 that there are no further patents or patent applications pertaining to DINs 1, 2 and 3

Patent CA 234567 pertaining to DINs 1, 2 and 3 expires on Oct. 30, 2012

October 30 February/March September December

x

Board Staff sends Form 2 Block 4 and 5 templates (without DINs 1, 2 and 3). If patentee submits information for these DINs in subsequent filings, the submission is rejected and an error report is generated

XNo response from patentee or no further patents confirmed: DINS 1, 2 and 3 become inactive in PMPRB electronic system and are removed from templates early December

Patent lapse

Please let Board Staff know by e-mail or letter when a patent on a drug product lapses

Do not put a lapse date in Form 1 under expiry date

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FAQ - If a patented drug product is not listed on the HC Patent Register, is it under the PMPRB jurisdiction?

Patented drug products are under the PMPRB jurisdiction whether or not they are listed on the HC Patent Register

The two jurisdictions are independent: Health Canada (HC) derives its jurisdiction over the HC Patent Register

listing requirements from the subsection 55.2(4) of the Patent Act and section 4 of the Patented Medicines (NOC) Regulations

In contrast, the PMPRB derives its jurisdiction from sections 79 through 103 of the Patent Act

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FAQ - If a patented drug product is sold under SAP, does it fall under the PMPRB jurisdiction?

Yes, it does. See Supreme Court decision in Celgene Corp. v. Canada, January 20, 2011

[10] …Because its (PMPRB) mandate includes protecting Canadians from excessive prices that may be charged for patented medicines, it concluded that sales “in any market in Canada” include sales of medicine that are regulated by Canadian law, that will be delivered and used in Canada, and where the cost of medicine will be borne by Canadians. Since the SAP is a Canadian law, Celgene’s sales under this programme are included in this mandate.

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FAQ - If a patented drug product is sold under SAP, does it fall under the PMPRB jurisdiction?

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Does it have a NOC?

Is the product sold?

Should a Form 1 be submitted?

Should a Form 2 be submitted?

yes yes yes yes

no yes yes yes

yes no yes no

no no no no

Patented drug product

FAQ - What may happen if a patentee does not file Form 1 or Form 2 information as required or submits false information?

Compendium of Policies, Guidelines and Procedures Section A.8 Board Staff advises the patentee in writing that it is in failure to file

(FTF) and the patentee is given 7 days to send missing information

Failing this, Board Staff seeks a Board Order from the Chairperson requiring patentee to file information within a time specified in the Board Order

Failing this, the Board may refer the matter to the Attorney General of Canada to determine if summary conviction proceedings should be commenced under subsection 76.1(1) of the Act

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FAQ - What may happen if a patentee does not file Form 1 or Form 2 information as required or submits false information?

Patent Act76.1 (1) Every person who contravenes or fails to comply with section 80, 81, 82 or 88 or any order made thereunder is guilty of an offense punishable on summary conviction and liable

(a) in the case of an individual, to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding six months or to both; and(b) in the case of a corporation, to a fine not exceeding twenty-five thousand dollars.

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Best Practice: Filing

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An analysis is only as goodas the data on which it is based

Filing “no sales”

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Filing “no sales”

Patent Act

80. (1) A patentee of an invention pertaining to a medicine shall …. provide the Board with such information…

(b) the price at which the medicine is being or has been sold in any market in Canada and elsewhere

To be reported in a Form 2, a medicine must be sold

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Filing “no sales”

When none of a patentee’s drug products under the jurisdiction of the PMPRB are sold during a reporting period:

Send an e-mail to compliance@pmprb-cepmb.gc.ca to inform Board Staff that there were no sales during the reporting period

No sales = no Form 2 needed

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Filing “no sales”

When a drug product is not sold (no transactions) during a reporting period: Indicate in the e-mail accompanying the Form 2 filing, which DIN is

not reported for the period and provide an explanation, e.g., no sales, patent expired or lapsed

Delete the line(s) for this drug product in the Form 2 Block 4 and Block 5 templates for the reporting period

If the product is not sold, do not enter 0 in “number of packages sold” and “net revenues” columns as 0 is a value in the PMPRB electronic system. This is true at the DIN level, market level, province/country level, on Block 4 and Block 5.

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Form 2 Block 4 example: “no sales” in some markets and provinces

DIN 01234567 is sold solely to Wholesale in Québec and OntarioIncorrect way of reporting no sales in the Form 2 Block 4:

Impact on market-specific introductory prices

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Net Revenue AVG Price/Package

1234567 1MG/TAB S1 100.00 0.00 0.0000 1 31234567 1MG/TAB S1 100.00 0.00 0.0000 2 31234567 1MG/TAB S1 100.00 0.00 0.0000 3 31234567 1MG/TAB S1 100.00 0.00 0.0000 4 31234567 1MG/TAB S1 100.00 50.00 8,500.0000 5 31234567 1MG/TAB S1 100.00 60.00 10,200.0000 6 31234567 1MG/TAB S1 100.00 0.00 0.0000 7 31234567 1MG/TAB S1 100.00 0.00 0.0000 8 31234567 1MG/TAB S1 100.00 0.00 0.0000 9 31234567 1MG/TAB S1 100.00 0.00 0.0000 10 3

Province Class of Customer

INDICATE EITHERDrug identification Number (DIN) or

Assigned Number

Strength/Unit Dosage Form Package size Number of Packages Sold

Form 2 Block 4 example: “no sales” in some markets and provinces

DIN 01234567 is sold solely to Wholesale in Québec and Ontario

Correct way of reporting no sales in Form 2 Block 4:

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Net Revenue AVG Price/Package

1234567 1MG/TAB S1 100.00 50.00 8,500.0000 5 31234567 1MG/TAB S1 100.00 60.00 10,200.0000 6 3

Province Class of Customer

Drug identification

Number (DIN) or

Strength/Unit

Dosage Form

Package size

Number of Packages

Sold

INDICATE EITHER

Form 2 Block 5 example: “no sales” in some countries

abcdrug is sold solely to Wholesale in Canada (13), Germany (15), Sweden (18) and in the US (21) Incorrect way of reporting no sales in the Form 2 Block 5:

Impact on International Price Comparison tests

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abcdrug 1234567 1 MG/TAB S1 100 250.0000 13 3abcdrug 1234567 1 MG/TAB S1 100 80.0000 15 3abcdrug 1234567 1 MG/TAB S1 100 0.0000 15 2abcdrug 1234567 1 MG/TAB S1 100 700.0000 18 3abcdrug 1234567 1 MG/TAB S1 100 0.0000 18 2abcdrug 1234567 1 MG/TAB S1 100 0.0000 16 3abcdrug 1234567 1 MG/TAB S1 100 0.0000 17 3abcdrug 1234567 1 MG/TAB S1 100 0.0000 19 2abcdrug 1234567 1 MG/TAB S1 100 0.0000 20 3abcdrug 1234567 1 MG/TAB S1 100 480.0000 21 3abcdrug 1234567 1 MG/TAB S1 100 0.0000 21 2abcdrug 1234567 1 MG/TAB S1 100 120.0000 21 4-FSS

Country Customer Class

Generic name of medicine

DIN Strength/Unit Dosage Form

Package Size

Ex-Factory Price

Form 2 Block 5 example: “no sales” in some countries

abcdrug is sold solely to Wholesale in Canada (13), Germany (15), Sweden (18) and in the US (21)

Correct way of reporting no sales in the Form 2 Block 5:

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abcdrug 1234567 1 MG/TAB S1 100 250.0000 13 3abcdrug 1234567 1 MG/TAB S1 100 80.0000 15 3abcdrug 1234567 1 MG/TAB S1 100 700.0000 18 3abcdrug 1234567 1 MG/TAB S1 100 480.0000 21 3abcdrug 1234567 1 MG/TAB S1 100 120.0000 21 4-FSS

Customer Class

Generic name of medicine

DIN Strength/Unit Dosage Form

Package Size

Ex-Factory Price

Country

Form 2 Block 5 International Sources for 2013

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Country (code)

Formulary Hospital Pharmacy Wholesale Other

France (16) Vidal X X

Germany (15) Röte Liste X X

Italy (17) L’Informatore Farmaceutico X X

Sweden (18) TLV Website X X

Switzerland (19) BAG Website X

United Kingdom (20)

Monthly Index of Medical Specialties (MIMS)

X

United States (21) Thompson PDR- Red Book- Direct Price (DP)- Wholesale Acquisition Cost (WAC)Federal Supply Schedule

X X X(a)

X

X 4-FSS

(a) Report only one Wholesale price unless the DP and WAC prices are different(b) Check 2013 formulas used by Board Staff on PMPRB Website/Are you a Patentee?

Filing amended Form 2 data for one or more DINs

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Filing amended Form 2 data for one or more DINs

First complete Form 2 Block 2 and 3: In Block 2, specify which DIN(s) is(are) amended and for each DIN requiring amendments indicate whether you are amending

Block 4 data, Block 5 data or both. Sign Block 3

Form 2 Block 4 and/or Form 2 Block 5: Send the entire data for the DIN in the Block that you want to amend

(i.e. the lines that need to be changed and the lines that don’t), and only the DIN that needs to be amended (not all the DINs of your

company) in only the Block that needs to be changed (both if amendments needed in both)

Send completed Form 2 Block 2, 3, and Form 2 Block 4 and/or Form 2 Block 5 to: compliance@pmprb-cepmb.gc.ca

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Example: Filing amended Form 2 data for DIN 01234567

Original January-June 2013 filing of Company A reports sales of 4 DINs including DIN 01234567 sold in Ontario (W, H, P), in Quebec (W, H) and in Alberta (W, H, P)

In August 2013, Company A notes that the January-June filing should also have reported sales to Quebec Pharmacy (P) for the DIN 01234567

The amended filing will include: Form 2 Block 2 specifying that Block 4 is amended for DIN 01234567

for the January-June 2013 period Form 2 Block 4: only DIN 01234567 but entire data for that DIN, i.e.,

Ontario (W, H, P), Quebec (W, H, P) and Alberta (W, H, P)28

Example: Filing amended Form 2 for DIN 01234567

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Patented Medicine Privileged s.87

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

Cover Sheet : Block 1, 2, 3

Please Specify Original Filing

or x Amendment to Original Filing

BLOCK 1 : ORIGINAL FILING

REPORTING PERIOD

NAMES OF THE MEDICINE

Brand name of the medicine

Generic name of the medicine

DM

FORM 2

FROM

Complete Block 2 and 3

Period to which the information applies (only one reporting period per Form):

TO

M

Complete Block 1 and 3

DY Y

Example: Filing amended Form 2 Block 2 for DIN 01234567

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REPORTING PERIOD

BLOCK(s) and DIN(s) or ASSIGNED NUMBER(s)THAT ARE AMENDED

X

Y M D Y M D

Check Block(s) that is(are) amended :

Block 4

1234567

Period to which the information applies (only one reporting period per Form): 1 1

For each Block, list DIN(S) or Assigned Number(s) that is (are) amended.Write one DIN per cell.

FROMFROM

Block 5

2013

TO

6 302013

BLOCK 2 : AMENDMENT TO AN ORIGINAL FILING

Example: Filing amended Form 2 Block 3 for DIN 01234567

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John Smith

BC

*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.

in accordance with Section 7 of the Patented Medicines RegulationsI hereby certify that the information presented is true and correct.

Signature of duly authorized person for the reporting patentee

Name:

T itle:

Organization:

Date:

Tel. Number: Fax Number :

E-mail:

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

John.Smith@CompanyA.com

13/08/2013

(603) 123-4567 ( )

John Smith

BLOCK 3 : PATENTEE * AND CERTIFYING SIGNATURE

Patentee Name

Patentee Address

Pacific Rim Coast

Market Access Manager

Company A

John Smith

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Reporting Period: 131

4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1

Drug Identif ication Number (DIN) or Assigned Number Strength/Unit Dosage Form Package Size

Number of Packages Sold INDICATE EITHER (6) Province

Class of Customer

(2) (3) (3,4) (3,5) (5) Net Revenue AVG Price/Package (4) (4)

1234567 1G/TAB S1 100.00 10.00 140.0000 5 1

1234567 1G/TAB S1 100.00 30.00 420.0000 5 3

1234567 1G/TAB S1 100.00 18.00 252.0000 6 1

1234567 1G/TAB S1 100.00 25.00 350.0000 6 2

1234567 1G/TAB S1 100.00 40.00 560.0000 6 3

1234567 1G/TAB S1 100.00 7.00 98.0000 9 1

1234567 1G/TAB S1 100.00 10.00 140.0000 9 2

1234567 1G/TAB S1 100.00 15.00 210.0000 9 3

2345678 1MG/TAB S1 25.00 28.00 140.0000 5 2

2345678 1MG/TAB S1 25.00 33.00 165.0000 5 3

2345678 1MG/TAB S1 25.00 37.00 185.0000 6 2

2345678 1MG/TAB S1 25.00 41.00 205.0000 6 3

3456789 1MG/CAP S2 10.00 1.00 52.0000 6 1

3456789 1MG/CAP S2 10.00 3.00 156.0000 6 2

3456789 1MG/CAP S2 10.00 6.00 312.0000 6 3

4567890 1MG/CAP S2 100.00 4.00 2328.0000 4 3

4567890 1MG/CAP S2 100.00 7.00 4074.0000 5 3

4567890 1MG/CAP S2 100.00 11.00 6402.0000 6 3

4567890 1MG/CAP S2 100.00 9.00 5238.0000 10 3

Example: Original January-June 2013 Form 2 Block 4 of Company A

An original filing includes all transactions of all DINs

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Reporting Period: 131

4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1

Drug Identif ication Number (DIN) or Assigned Number Strength/Unit Dosage Form Package Size

Number of Packages Sold INDICATE EITHER (6) Province

Class of Customer

(2) (3) (3,4) (3,5) (5) Net Revenue AVG Price/Package (4) (4)

1234567 1G/TAB S1 100.00 10.00 140.0000 5 1

1234567 1G/TAB S1 100.00 15.00 210.0000 5 2

1234567 1G/TAB S1 100.00 30.00 420.0000 5 3

1234567 1G/TAB S1 100.00 18.00 252.0000 6 1

1234567 1G/TAB S1 100.00 25.00 350.0000 6 2

1234567 1G/TAB S1 100.00 40.00 560.0000 6 3

1234567 1G/TAB S1 100.00 7.00 98.0000 9 1

1234567 1G/TAB S1 100.00 10.00 140.0000 9 2

1234567 1G/TAB S1 100.00 15.00 210.0000 9 3

Example: Amended January-June 2013 Form 2 Block 4 for DIN 01234567

An amended filing includes only the amended DIN(s) but all transactions for that/those DIN(s) i.e. the lines that are changed and those that are not

Board Staff requires explanation and supporting evidence for the changes

Preparing for on-line filing

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Semi-Annual Regulatory Filing: Error Reports

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Reports Generated 2009 (1) 2009 (2) 2010 (1) 2010 (2) 2011(1) 2011(2) 2012(1) 2012(2) 2013(1)No error report 64.20% 67.47% 65.52% 68.97% 73.49% 80.00% 53.41% 46.51% 69.77%1 error report 29.63% 25.30% 29.88% 28.73% 25.30% 16.47% 32.95% 46.51% 27.91%2 error reports or more 6.17% 7.23% 4.60% 2.30% 1.21% 3.53% 13.64% 6.98% 2.32%

Checklist for filing a Form 2 successfully

3 separate files (not worksheets): Block 1,2,3 - Block 4 - Block 5 Files in Excel format Most recent Block 1,2,3 from PMPRB website is used Most recent Block 4 and 5 templates sent by PMPRB Staff are used Block 2 is blank in a semi-annual filing Block 2 includes drug names when reporting a first day sale Block 3 is signed in Excel– If not signed in Excel, send two Block

1,2,3 one not signed in Excel and one signed in PDF Block 4 and 5: DINs, strength/unit, dosage form and generic names

are reported as on the templates Block 4 and 5: Absolutely no combination - zero Revenues with

zero Number of Packages Sold - to indicate no sales. Please write it in e-mail accompanying sending of Form 2.

Completed Form 2 is sent to compliance@pmprb-cepmb.gc.ca

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Communication with Board Staff

Query to PMPRB Staff Guidelines: Ginette Tognet

Tel: (613) 954-8297 E-mail: ginette.tognet@pmprb-cepmb.gc.ca Scientific and new meds: Catherine Lombardo

Tel: (613) 952-7620 E-mail: catherine.lombardo@pmprb-cepmb.gc.ca

Filing Form 1 and 2: Beatrice MullingtonTel: (613) 952-2924 E-mail: beatrice.mullington@pmprb-

cepmb.gc.ca Investigation: Senior Regulatory Officer assigned to your Company Form 3: Lokanadha Cheruvu

Tel: (613) 954-9812 E-mail: lokanadha.cheruvu@pmprb-cepmb.gc.ca

All other questions: 1-877-861-2350 pmprb@pmprb-cepmb.gc.ca