Patented Medicine Prices Review Board
Outreach Sessions 2013
Montreal October 30, 2013
Toronto, October 31, 2013
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
2
Amendments to the Food and Drug
Regulations (FDR)
3
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
4
Patent Pertains to a Medicine
5
Definitions – Patent Act
79. (1) …”patentee” … means the person for the time being entitled to the
benefit of the patent for that invention
79. (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
6
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:





7
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.
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, 1989
Duration = 20 years after filing date
 If application filed before October 1, 1989
Duration = 17 years from date on which patent was issued
 Laid open starts at the publication date
Example: Patent 2345678
Issued: 2007-11-13
Filing date: 1999-09-23
Publication date: 2000-04-06
8
Form 1
Patent granted: 2007-11-13
Patent expired: 2019-09-23
Patent Expiry – Process (through an example)
2012
October 30
2013
February/March
2014
September
December
x
Patent CA 234567 pertaining to DINs 1, 2 and 3 expires on Oct. 30, 2012
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
X
No 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
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
9
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
10
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
11
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.
12
FAQ - If a patented drug product is sold under SAP, does
it fall under the PMPRB jurisdiction?
Patented drug product
13
Does it have
a NOC?
Is the product
sold?
Should a Form 1 be Should a Form 2 be
submitted?
submitted?
yes
yes
yes
yes
no
yes
yes
yes
yes
no
yes
no
no
no
no
no
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
14
FAQ - What may happen if a patentee does not file Form 1 or
Form 2 information as required or submits false information?
Patent Act
76.1 (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 twentyfive thousand dollars.
15
Best Practice: Filing
An analysis is only as good
as the data on which it is based
16
Filing “no sales”
17
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
18
Filing “no sales”
 When none of a patentee’s drug products under the jurisdiction
of the PMPRB are sold during a reporting period:
19

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
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.
20
Form 2 Block 4 example: “no sales” in some markets and
provinces
DIN 01234567 is sold solely to Wholesale in Québec and Ontario
Incorrect way of reporting no sales in the Form 2 Block 4:
Drug identification
Number (DIN) or
Assigned Number
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
Strength/Unit
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
1MG/TAB
Dosage Form
S1
S1
S1
S1
S1
S1
S1
S1
S1
S1
Package size
100.00
100.00
100.00
100.00
100.00
100.00
100.00
100.00
100.00
100.00
Number of
INDICATE EITHER
Province Class of
Packages Sold Net Revenue
AVG
Customer
Price/Package
0.00
0.0000
1
3
0.00
0.0000
2
3
0.00
0.0000
3
3
0.00
0.0000
4
3
50.00
8,500.0000
5
3
60.00 10,200.0000
6
3
0.00
0.0000
7
3
0.00
0.0000
8
3
0.00
0.0000
9
3
0.00
0.0000
10
3
Impact on market-specific introductory prices
21
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:
Drug
Strength/ Dosage
identification
Unit
Form
Number (DIN) or
1234567
1MG/TAB S1
1234567
1MG/TAB S1
22
Package
size
Number of
INDICATE EITHER
Province
Class of
Packages Net Revenue
AVG
Customer
Sold
Price/Package
100.00
50.00
8,500.0000
5
3
100.00
60.00
10,200.0000
6
3
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:
Generic name
of medicine
DIN
Strength/Unit
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1234567
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
1 MG/TAB
Dosage
Form
S1
S1
S1
S1
S1
S1
S1
S1
S1
S1
S1
S1
Package
Size
100
100
100
100
100
100
100
100
100
100
100
100
Ex-Factory Country
Price
250.0000
13
3
80.0000
15
3
0.0000
15
2
700.0000
18
3
0.0000
18
2
0.0000
16
3
0.0000
17
3
0.0000
19
2
0.0000
20
3
480.0000
21
3
0.0000
21
2
120.0000
21
4-FSS
Impact on International Price Comparison tests
23
Customer
Class
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:
Generic name
of medicine
abcdrug
abcdrug
abcdrug
abcdrug
abcdrug
24
DIN
Strength/Unit
1234567 1 MG/TAB
1234567 1 MG/TAB
1234567 1 MG/TAB
1234567 1 MG/TAB
1234567 1 MG/TAB
Dosage Package Ex-Factory
Customer
Country
Form
Size
Price
Class
S1
100 250.0000
13
3
S1
100 80.0000
15
3
S1
100 700.0000
18
3
S1
100 480.0000
21
3
S1
100 120.0000
21
4-FSS
Form 2 Block 5 International Sources for 2013
Country
(code)
Formulary
France (16)
Hospital
Pharmacy
Wholesale
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
United Kingdom
(20)
Monthly Index of Medical
Specialties (MIMS)
United States (21)
Thompson PDR- Red Book
- Direct Price (DP)
- Wholesale Acquisition
Cost (WAC)
Federal Supply Schedule
Other
X
X
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?
25
Filing amended Form 2 data for one
or more DINs
26
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
27
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
FORM 2
INFORMATION ON THE IDENTITY AND PRICES OF THE MEDICINE
Patented Medicine
Prices Review Board
Privileged s.87
Patent Act
Cover Sheet : Block 1, 2, 3
Please Specify
or
Original Filing
Complete Block 1 and 3
x Amendment to Original Filing
Complete Block 2 and 3
BLOCK 1 : ORIGINAL FILING
REPORTING PERIOD
Period to which the information
applies (only one reporting period per
Form):
NAMES OF THE MEDICINE
Brand name of the medicine
Generic name of the medicine
29
FROM
Y
TO
M
D
Y
M
D
Example: Filing amended Form 2 Block 2 for DIN 01234567
BLOCK 2 : AMENDMENT TO AN ORIGINAL FILING
REPORTING PERIOD
Period to which the information
applies (only one reporting period per
Form):
FROM
TO
Y
M
D
Y
M
D
2013
1
1
2013
6
30
BLOCK(s) and DIN(s) or ASSIGNED NUMBER(s)THAT ARE AMENDED
Check Block(s) that
is(are) amended :
For each Block, list DIN(S) or Assigned Number(s) that is (are) amended.
Write one DIN per cell.
1234567
Block 4
Block 5
30
X
Example: Filing amended Form 2 Block 3 for DIN 01234567
BLOCK 3 : PATENTEE * AND CERTIFYING SIGNATURE
Patentee Name
John Smith
Pacific Rim Coast
Patentee Address
BC
*Please see section 79(1) of the Patent Act for the definition of a "patentee". Note that a patentee is any person entitled
to 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 Regulations
I he re by ce rtify that the information pre se nte d is true and corre ct.
Signature of duly authorized person for the reporting patentee
Name:
T itle:
John Smith
John Smith
Market Access Manager
Organization: Company A
Date:
13/08/2013
T el. Number: (603) 123-4567
E-mail:
Fax Number : (
John.Smith@CompanyA.com
Please send completed Form 2 including the cover sheet, Block 4 and Block 5 to:
compliance@pmprb-cepmb.gc.ca
31
)
Example: Original January-June 2013 Form 2 Block 4 of Company A
Reporting Period:
131
4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA
Drug Identification Number
(DIN) or Assigned Number
Strength/Unit
Dosage Form
(2)
(3)
(3,4)
Number of
Package Size Packages Sold
(3,5)
(5)
1
INDICATE EITHER (6)
1234567 1G/TAB
S1
100.00
10.00
140.0000
5
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
AVG Price/Package
(4)
Class of
Customer
(4)
1
Net Revenue
An original filing includes all transactions of all DINs
32
Province
Example: Amended January-June 2013 Form 2 Block 4
for DIN 01234567
Reporting Period:
131
4 SALES OF THE MEDICINE BY THE REPORTING PATENTEE IN FINAL DOSAGE FORM IN CANADA 1
Drug Identification Number
(DIN) or Assigned Number
Strength/Unit
Dosage Form
(2)
(3)
(3,4)
Number of
Package Size Packages Sold
(3,5)
(5)
INDICATE EITHER (6)
Province
1234567 1G/TAB
S1
100.00
10.00
140.0000
5
(4)
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
Net Revenue
AVG Price/Package
(4)
Class of
Customer
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
33
Preparing for on-line filing
34
Semi-Annual Regulatory Filing: Error Reports
Reports Generated
No error report
1 error report
2 error reports or more
35
2009 (1)
64.20%
29.63%
6.17%
2009 (2)
67.47%
25.30%
7.23%
2010 (1)
65.52%
29.88%
4.60%
2010 (2)
68.97%
28.73%
2.30%
2011(1)
73.49%
25.30%
1.21%
2011(2)
80.00%
16.47%
3.53%
2012(1)
53.41%
32.95%
13.64%
2012(2)
46.51%
46.51%
6.98%
2013(1)
69.77%
27.91%
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
36
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 Mullington
Tel: (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
37
pmprb@pmprb-cepmb.gc.ca