1. Outreach Sessions 2013 Montreal October 30, 2013 Toronto, October 31, 2013 Patented Medicine Prices Review Board

2. 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

3. Amendments to the Food and Drug Regulations (FDR) 3

4. 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

5. Patent Pertains to a Medicine 5

6. 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

7. 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. 7

8. 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 2345678Form 1 Issued: 2007-11-13 Patent granted: 2007-11-13 Filing date: 1999-09-23 Patent expired: 2019-09-23 Publication date: 2000-04-06 8

9. Patent Expiry – Process (through an example) 20122013 2014 9 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 30February/MarchSeptemberDecember 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 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

10. 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

11. 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

12. 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

13. FAQ - If a patented drug product is sold under SAP, does it fall under the PMPRB jurisdiction? 13 Does it have a NOC? Is the product sold? Should a Form 1 be submitted? Should a Form 2 be submitted? yes noyes noyesno Patented drug product

14. 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

15. 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 twenty- five thousand dollars. 15

16. Best Practice: Filing 16 An analysis is only as good as the data on which it is based

17. Filing “no sales” 17

18. 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

19. 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 periodompliance@pmprb-cepmb.gc.ca  No sales = no Form 2 needed 19

20. 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

21. 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: Impact on market-specific introductory prices 21

22. 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: 22

23. 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 23

24. 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: 24

25. Form 2 Block 5 International Sources for 2013 25 Country (code) FormularyHospitalPharmacyWholesaleOther France (16)VidalXX Germany (15)Röte ListeXX Italy (17)L’Informatore FarmaceuticoXX Sweden (18)TLV WebsiteXX Switzerland (19)BAG WebsiteX 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 XX 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?

26. Filing amended Form 2 data for one or more DINs 26

27. 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.cacompliance@pmprb-cepmb.gc.ca 27

28. 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

29. Example: Filing amended Form 2 for DIN 01234567 29

30. Example: Filing amended Form 2 Block 2 for DIN 01234567 30

31. Example: Filing amended Form 2 Block 3 for DIN 01234567 31

32. 32 Example: Original January-June 2013 Form 2 Block 4 of Company A An original filing includes all transactions of all DINs

33. 33 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

34. Preparing for on-line filing 34

35. Semi-Annual Regulatory Filing: Error Reports 35

36. 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.cacompliance@pmprb-cepmb.gc.ca 36

37. 37 Communication with Board Staff  Query to PMPRB Staff  Guidelines: Ginette Tognet Tel: (613) 954-8297E-mail: ginette.tognet@pmprb-cepmb.gc.ca  Scientific and new meds: Catherine Lombardo Tel: (613) 952-7620E-mail: catherine.lombardo@pmprb-cepmb.gc.ca  Filing Form 1 and 2: Beatrice Mullington Tel: (613) 952-2924E-mail: beatrice.mullington@pmprb-cepmb.gc.ca  Investigation: Senior Regulatory Officer assigned to your Company  Form 3: Lokanadha Cheruvu Tel: (613) 954-9812E-mail: lokanadha.cheruvu@pmprb-cepmb.gc.ca  All other questions: 1-877-861-2350 pmprb@pmprb-cepmb.gc.ca