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 Form 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 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  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, Celgenes 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 patentees drug products under the jurisdiction of the PMPRB are sold during a reporting period: 19 Send an e-mail to [email protected] 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 Qubec 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 Qubec 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
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
4-FSS Form 2 Block 5 International Sources for 2013 Country (code) Formulary France (16) Hospital Pharmacy Wholesale Vidal X X Germany (15) Rte Liste X X Italy (17) LInformatore 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 dont), 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: [email protected] 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
Pate nte d Me dicine Price s Re vie w Board Privile ge d 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 pat entee 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 : ( [email protected] Please send completed Form 2 including the cover sheet, Block 4 and Block 5 to: [email protected] 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 1 Drug Identification Number (DIN) or Assigned Number Strength/Unit Dosage Form (2) (3) (3,4) Number of Package Size Packages Sold (3,5)
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
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 [email protected]
36 Communication with Board Staff Query to PMPRB Staff Guidelines: Ginette Tognet Tel: (613) 954-8297 E-mail: [email protected] Scientific and new meds: Catherine Lombardo Tel: (613) 952-7620 E-mail: [email protected] Filing Form 1 and 2: Beatrice Mullington Tel: (613) 952-2924 E-mail: [email protected] Investigation: Senior Regulatory Officer assigned to your Company Form 3: Lokanadha Cheruvu Tel: (613) 954-9812 E-mail: [email protected] All other questions: 1-877-861-2350 37 [email protected]
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