Digests

Ferring Inc. v. Canada (Attorney General)

T-1524-00, T-1830-00

2003 FCT 293, Simpson J.

11/3/03

19 pp.

Judicial review applications relating to dispute about whether patent list filed in timely manner--Ferring Inc. owner of 296 patent for antidiuretic drug--Filed supplemental new drug submission (SDNS) mentioning brand name "Minirin", but not "DDAVP", with patent list--Minister issued notice of compliance (NOC), listed patent on register without reference to brand names, but referring to drug identification number (DIN) for "Minirin"--Apotex filing abbreviated new drug submission (ANDS) for generic version of drug, referring to "DDAVP"--Minister issued NOC to Apotex without requiring Apotex to serve Notice of Allegation (NOA) on Ferring--Minister's representative later acknowledging "DDAVP", "Minirin" brand names for same drug--Thus NOC issued in error, but patent should not have been added to register--Patent de-listed--Whether respondent erred in deleting 296 patent from patent register and, if so, whether Minister should be ordered to reinstate 296 patent--Patented Medicines (Notice of Compliance) (PM(NOC)) Regulations, s. 4 definition of "notice of compliance", and Food and Drug (F & D) Regulations, s. C-008.004(1) indicating SNDS is submission for notice of compliance--Only certainty to which generic entitled that which flows from seeing patents listed on register, and that patents can be listed in circumstances in which timing cannot be foreseen eg. if patent applications predate filing of submissions for NOCs under PM(NOC) Regulations, patents will be submitted within 30 days of issuance and no way of forecasting when that will occur--Use of phrase "in respect of" in PM(NOC) Regulations, s. 4(1) meaning "in relation to" drug and including NOCs which deal with drug's brand name and all other matters listed in F & D Regulations, s. C.08.003(2)--Submission for NOC still required for all changes listed in C.08.003(2) despite enumerated changes--Changes in brand names and labels, as well as more substantive matters such as changes in drug's ingredients, uses and side effects all require NOC--If objective of PM(NOC) Regulations prevention of patent infringement, not anomalous for Parliament to say patent lists, once on patent register, can only be changed by addition of patents pending when lists submitted while at same time providing broad right to file initial patent lists with all submissions for NOCs--Patent lists can be submitted with all types of submissions for NOCs but, once submitted, only possible to change in exceptional circumstances described in PM(NOC) Regulations, s. 4(4)--Clear language indicating patent lists can only be filed in respect of new drug submissions (NDS) and not in respect of supplements required if Parliament intended to curtail innovator's rights under PM(NOC) Regulations--No such indications in PM(NOC) or F & D Regulations--F & D Regulations, s. C.08.003(1), (2)(b) indicate if brand name for new drug "significantly different" from information in drug's NDS, SNDS must be submitted to Minister and NOC must be issued for new brand name--Because brand name "Minirin" significantly different from brand name "DDAVP", Ferring obliged to submit SNDS --Clear from both PM(NOC) Regulations and from Guidelines entitled Health Canada, Therapeutic Products Programme, "Changes to Marketed New Drug Products", brand name changes require SNDS--Evidence disclosed Minister distinguished between submissions for NOCs requiring scientific evaluation and those that did not--No such distinction appears in either F & D Regulations or PM(NOC) Regulations and no basis for suggesting submissions which do not require scientific evaluation not submissions for NOC--Accordingly, because properly listed under PM(NOC), s. 4(1), (3) Minister erred in deleting 296 patent from register--Given conclusion 296 patent properly on register as of August 27, 1998, Apotex not entitled to NOC because issued without prior service of NOA on Ferring-- Application allowed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4 (as am. by SOR/98-166, s. 3)--Food and Drug Regulations, C.R.C., c. 870, ss. C-008.003 (as am. by SOR/95-411, s. 6), C-008.004 (as am. idem).