Digests

Bayer AG v. Apotex Inc.

T-877-02

2004 FC 177, Campbell J.

2/2/04

45 pp.

Since 1987, Bayer AG (Bayer) held Canadian patent for antibacterial medicine ciprofloxacin hydrochloride when made by processes claimed in patent or by obvious chemical equivalents--Ciprofloxacin hydrochloride sold in Canada under notice of compliance (NOC) granted by Minister under Food and Drug Regulations, s. C.08.004--Apotex filing several notices of allegation (NOA) claiming invalidity or non-infringement of patent--As preliminary matter, Bayer seeking order declaring Apotex's NOA invalid for non-compliance with Patented Medicines (Notice of Compliance) Regulations, s. 5 on basis Apotex failed to file submission for NOC with respect to its process for ciprofloxacin prior to serving non-infringement NOA on Bayer--(1) Apotex complying with timing requirements in s. 5(3)(c)(i)-- S. 5(3)(c)(i) requiring submission for NOC be filed with Minister before, or at same time as, non-infringement NOA served--Apotex originally filed abbreviated new drug submission (ANDS) for ciprofloxacin in 1993 and therefore this submission before Minister when NOA at issue served--On April 25, 2002 Apotex filed information with Minister with respect to "notifiable change" containing Apotex's process, which process subject of non-infringement NOA herein--To determine whether Apotex complied with timing requirements in s. 5(3)(c)(i) necessary to determine legal force, effect of "notifiable change" and then to determine whether modification of ANDS by way of notifiable change is "submission for a NOC" within s. 5--Bayer relying on Management of Drug Submissions Policy, Therapeutic Products Directorate (policy) to argue if notifiable change deficient upon filing, does not constitute submission for NOC until all appropriate documents filed, accepted for review by Minister--"Submission for a notice of compliance" not defined in Regulations, but definition of "notice of compliance" referring to Food and Drug Regulations, s. C.08.004--"Notifiable change" appearing neither in Food and Drug Regulations nor in NOC Regulations--Only mentioned in policy--Therefore merely notice-giving document required for administrative purposes--Has no force, effect in law-- Further support for Apotex's argument that definition of "submission for a NOC" within meaning of NOC Regulations, s. 5 not including notifiable change found in line of cases concluding expression "submission for a NOC" as used in ss. 4, 5 meaning only new drug submissions, ANDS and supplements to new drug submission or to ANDS--Notifiable change not "submission for a NOC" within meaning of s. 5 and cannot trigger s. 5(3)(c)(i)--Apotex's 1993 ANDS is "submission for a NOC" contemplated by NOC Regulations, s. 5, and fulfils requirement "submission for a NOC" be on file with Minister before, or at same time as, service of non-infringement NOA--(2) Applicants arguing Apotex failed to comply with NOC Regulations, s. 5(3)(c)(i) because NOA not "relating to" submission for NOC--Under s. 5(3)(c)(i), where second person (Apotex) filing submission for NOC, and alleging non-infringement, required to serve on first person (Bayer) NOA "relating to" submission for NOC filed with Minister--As Apotex's ANDS not containing current process which is subject of NOA herein, Bayer submitting ANDS not "related to" its NOA as ANDS not containing entire basis for non-infringement allegation--Gibson J. rejecting such argument in AB Hassle v. RhoxalPharma Inc. (2002), 21 C.P.R. (4th) 298 (F.C.T.D.)--Following reasoning of Gibson J., Apotex complied with NOC Regulations, s. 5--Thus Court has jurisdiction to render decision on merits--(3) As to non-infringement question, first objective in deciding whether patent infringed to construe claims of patent to determine what exactly lies within scope of monopoly granted by patent-- Second objective to consider whether impugned process falling within scope of claims--Court must distinguish essential from non-essential elements--While substitution or omission of essential element of patent invention will defeat allegation of infringement, substitution or omission of non-essential element of patent invention will not necessarily foreclose patentee's claim--Claims of patent to be read from perspective of person skilled in art to whom patent addressed --Here, person skilled in art someone with advanced knowledge in field of organic chemistry--Evidence on construction of patent reviewed--Apotex's construction of patent accepted as correct--However, in recognition of express wording of Patent Act, s. 39(1), as well as wording in patent itself, Court also added words "or an obvious chemical equivalent" to each of five essentials expressed--While Apotex's process comprises six steps, focus of inquiry on step 2 which Bayer submitted infringes claims 8(1) and 14(10) by being obvious chemical equivalent of Bayer's process-- Review of both parties' argument, evidence--Difference between chemicals used in Apotex's and Bayer's processes significant--Reasons for such finding detailed--Evidence establishing chemical reaction used in step 2 of Apotex process not obvious chemical equivalent of that used in Bayer process, i.e. claims 8(1) and 14(10) of patent--Bayer not demonstrating Apotex's allegation of non-infringement not justified--Food and Drug Regulations, C.R.C., c. 870, s. C.08.004 (as am. by SOR/95-411, s. 6)--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 4 (as am. by SOR/98-166, s. 3), 5(3)(c)(i) (as am. idem, s. 4)-- Patent Act, R.S.C., 1985, c. P-4, s. 39(1) (as am. by R.S.C., 1985 (1st Supp.), c. 33, s. 14).