Topics of Interest for Patentees

Regulations 2008

Amendments to Patented Medicines Regulations, 1994: new filing schedule, required electronic format, complaint driven process for vet and OTC drugs
May–June 2008 Outreach Session (PPTX)
slides 4 to 8


Patent Issues

Patent Pertain

Patent pertaining
October 2001, NEWSletter, Volume 5, Issue No. 4 (PDF)
pages 6 and 7

The scope of the PMPRB's jurisdiction: When does a patent pertain to a medicine?
July 2006, NEWSletter, Volume 10, Issue No. 3

Patent pertains to a medicine
October 2013 Outreach Session (PPTX)
slides 5 to 8

Patent Expiry

Patent expiry process
October 2013 Outreach Session (PPTX)
slide 9

PMPRB Jurisdiction

FAQ – If a patented drug product is not listed on the HC Patent Register, is it under the PMPRB jurisdiction?
October 2013 Outreach Session (PPTX)
slide 11

FAQ – If a patented drug product is sold under SAP, does it fall under the PMPRB jurisdiction?
October 2013 Outreach Session (PPTX)
slides 12 and 13

FAQ – What may happen if a patentee does not file Form 1 or Form 2 information as required or submits false information?
October 2013 Outreach Session (PPTX)
slides 14 and 15

Patent Pending

Patent pending policy
July 2002, NEWSletter, Volume 6, Issue No. 3 (PDF)
pages 9 and 10


HDAP

Drug products not normally reviewed by HDAP
October 2011, NEWSletter, Volume 15, Issue No. 4

Submissions by patentees on level of therapeutic improvement
January 2014, NEWSletter, Volume 18, Issue No. 1

HDAP schedule for following year
Every July issue of NEWSletter


Price Review

Introductory Price Tests and Other Tests

Introductory price tests including public price sources, how to calculate IMS price and top of TCC
October 2009 Outreach Session (PDF)
slides 6 to 14

International Therapeutic Class Comparison Test
April 2010, NEWSletter, Volume 14, Issue No. 2

Guidelines: Use of patented and non-patented products in price tests
October 2010, NEWSletter, Volume 14, Issue No. 4 (see The Guidelines – Update)

Guidelines: Existing drug products subsequently sold by another patentee
January 2011, NEWSletter, Volume 15, Issue No. 1

Post-interim MAPP
November 2012 Outreach Session (PPTX)
slides 11 to 26

Scientific review and introductory price tests
December 2012 Webinar, PMPRB 101 (PPTX)
slides 2 to 42

Let's talk numbers (Price review of existing medicines CPI-ajustment methodology)
December 2012 Webinar, PMPRB 101 (PPTX)
slides 3 to 14

Impact of Refunds, Rebates etc. on ATP

Calculation of the ATP in the event of special programs and incentives offered by patentees – Clarification of the board's Guidelines (re: samples)
April 2000, NEWSletter, Volume 4, Issue No. 2 (PDF)
page 5

Filing requirements – impact of refunds on ATP
October 2005, NEWSletter, Volume 9, Issue No. 4 (see Of Particular Interest to Patentees)

Market Review

Any market review
October 2009 Outreach Session (PDF)
slides 16 to 21

Clarification on the Guidelines on "any market" price reviews
April 2012, NEWSletter, Volume 16, Issue No. 2

Form 2 Block 5 including Verification of Foreign Prices

Implementation of the use of U.S. FSS prices in international price comparisons
January 2000, NEWSletter, Volume 4, Issue No. 1 (PDF)
pages 1 to 3

Block 5 foreign price verification
January 2011, NEWSletter, Volume 15, Issue No. 1

Back-out methodology
July 2011, NEWSletter, Volume 15, Issue No. 3

Backing-out formulas for foreign price verification
January 2012, NEWSletter, Volume 16, Issue No. 1

New Developments

New lagged CPI-adjustment methodology initiative – 2015 implementation
January 2014, NEWSletter, Volume 18, Issue No. 1


Filing Form 1 and Form 2

Filing requirements: reporting domestic sales in Canadian currency
January 2004, NEWSletter, Volume 8, Issue No. 1

Filing requirements – Impact of refunds on ATP
October 2005, NEWSletter, Volume 9, Issue No. 4 (see Of Particular Interest to Patentees)

Reporting ex-factory prices of medicines sold in countries listed in the Patented Medicines Regulations
April 2008, NEWSletter, Volume 12, Issue No. 2

Form 2 Block 4: how to report (options) and how to report corrections
March 2011 Outreach Session (PDF)
slides 15 to 31

Form 2 Block 5 including verification of foreign prices
February 2012 Outreach Session (PDF)
slides 14 to 34

Filing "no sales"
October 2013 Outreach Session (PPTX)
slides 18 to 24

Filing amended Form 2
October 2013 Outreach Session (PPTX)
slides 27 to 33

Top 10 – Checklist for filing a Form 2 successfully
October 2013 Outreach Session (PPTX)
slide 36

Table summarizing when to file a Form 1 and Form 2 depending on NOC and sales
October 2013 Outreach Session (PPTX)
slide 13

On-line Filing Tool
June 2014 Outreach Sessions (PPTX)


DIP Methodology

DIP Methodology – General information including application forms
April 2011 Webinar (PDF)
slides 1 to 15

DIP Methodology – Issues (IBP when drug product previously sold by another patentee; benefits at intro; calculation of IBP* when there is a decrease in list price; application of CPI-adjustment methodology after application of DIP) and solutions
June 2012 Webinar (PDF)
slides 1 to 23

DIP Methodology – Regular DIP
November 2012 Outreach Session (PPTX)
slides 29 to 31

DIP Methodology – Regular DIP
May 2013 Webinar (PPTX)
slides 1 to 34

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