Digests

GlaxoSmithKline Inc. v. Apotex Inc.

T-876-02

2003 FC 1055, Russell J.

10/9/03

39 pp.

Application pursuant to Patented Medicines (Notice of Compliance) Regulations, s. 6(5) (Regulations) by which respondent Apotex Inc. (Apotex) seeking order dismissing application made under Regulations, s. 6(1) by GlaxoSmithKline Inc. and Smithkline Beecham P.L.C. (GSK) --GSK application under s. 6(1) for order prohibiting Minister of Health (Minister) from issuing Notice of Compliance (NOC) to Apotex for paroxetine hydrochloride anhydrate tablets with 10, 20 and 30 mg strengths--S. 6(1) application commenced by notice of allegation (NOA) dated June 6, 2002--Apotex taking position GSK's s. 6(1) application should be dismissed because Canadian Letters Patent Nos. 2168829 (829 patent), 2210023 (023 patent) and 2211522 (522 patent) (collectively, "Patents") improperly listed on register maintained by Minister pursuant to Regulations (Register)--GSK marketing paroxetine hydrochloride anhydrate tablets with 10, 20 and 30 mg dosage strengths--GSK's original NOC for paroxetine hydrochloride anhydrate tablets issued on May 4, 1993, as result of abbreviated new drug submission (ANDS) submitted on June 11, 1990--Application for all three of patents filed on February 5, 1996, several years after GSK received original NOC for paroxetine hydrochloride anhydrate tablets--829 Patent issued on December 16, 1997, 023 Patent issued on February 9, 1999 and 522 Patent issued on December 7, 1999--GSK submitted Patents for inclusion on Register in connection with number of supplementary New Drug Submissions (NDS)--829 Patent and 023 Patent first added to Register on October 18, 1999--522 Patent added to register on January 10, 2000--Of the several grounds advanced by Apotex to show Patents not properly listed on Register, most significant involving consideration of crucial timing issues--Timing issues bring into play whole scheme of Regulations and detailed consideration of provisions of ss. 4, 6--In accordance with scheme of Regulations, and in light of drastic consequences to second persons, important strict conditions outlined in s. 4 for addition of patents to Register be respected, and patents should not be added to Register outside these strict timelines--These stipulations designed to ensure generic manufacturers not impeded unfairly from accessing market--Since amendments to Regulations which introduced s. 4(6), timing requirements of Regulations to be strictly observed, and patentees may not subvert those timing requirements and add patents to existing list by filing subsequent NDS and including patent list with that submission--Rather, once patent list exists in respect of drug product, patents may only be added to list in respect of drug product if patent applied for before original NDS filed, and issued thereafter--Word "submissions" for purposes of ss. 4, 5 expressly including supplemental submission--In case at bar, expression "submissions for Notice of Compliance", as used in ss. 4, 5 means new drug submission, abbreviated new drug submission and supplement to new drug submission or to abbreviated new drug submission as clearly established in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.)--Timing issues raised by Apotex in present case squarely before McGillis J. in Apotex Inc.--Meticulous and extensive analysis of McGillis J. in Apotex Inc. applicable in case at bar--Word "submission" as appearing throughout ss. 4, 5 means "submission for Notice of Compliance" and includes "new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission" --In case at bar, Court not convinced under any relevant standard supplemental submissions not properly on register, at least in so far as timing issues raised by Apotex concerned--Hence, dismissal order cannot be granted on this ground--Apotex arguing Patents not eligible for inclusion on Register because of their subject-matter--S. 4(2) providing that, in order to be eligible for inclusion on Register, patent must, among other things, contain claim for "the medicine itself" or use of medicine in respect of which it is listed --GSK's NOC lists only "paroxetine hydrochloride" as medicine included in GSK's tablets, although form of paroxetine hydrochloride sold by GSK is hemihydrate form--Clear from GSK's product monograph for "Paxil" brand paroxetine hydrochloride tablets that both hemihydrate and anhydrate forms of paroxetine hydrochloride can be used as medicine in tablets--Furthermore, GSK has received NOA from Apotex indicating Apotex has filed ANDS comparing its tablets of paroxetine hydrochloride to GSK's tablets of paroxetine hydrochloride--Pursuant to Food and Drug Regulations, s. C.08.002.1, when generic drug manufacturer such as Apotex files ANDS it must compare drug product that it intends to market to already approved Candian reference product--In case at bar, Apotex obviously chose GSK's tablets of medicine paroxetine hydrochloride--In so doing, Apotex relying on Health Canada's approval of GSK's product for approval of its own product--Indeed, Apotex essentially must show only its tablet bioequivalent to GSK's tablets--In addition, s. C.08.002.1 requires Apotex's product be pharmaceutical equivalent of Canadian reference product-- In s. C.08.001.1, "pharmaceutical equivalent" defined to mean new drug that, in comparison with another drug, contains identical amounts of identical medicinal ingredients, and comparable dosage forms, but does not necessarily contain same non-medicinal ingredients--Since non-medicinal ingredients need not be identical, generic free to seek approval of different tablet formulation containing different non-medicinal ingredients from Canadian reference product-- GSK asks Court to conclude, on basis Apotex comparing anhydrate product to GSK's product, Apotex not free to assert anhydrate forms of paroxetine hydrochloride and paroxetine hydrochloride hemihydrate different substances and therefore different medicines--On basis of GSK's reasoning on this point, Court cannot conclude under any relevant standard Patents should be excluded from Register because of their subject-matter, and GSK s. 6(1) application dismissed under s. 6(5)--Apotex advances further argument Patents not relevant to medicine or submission in respect of which listed and so not eligible for inclusion on Register--Federal Court of Appeal recently affirmed patent that does not relate to commercial formulation of drug can be listed on Register with respect to that drug (Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140 (C.A.))--Furthermore, Court of Appeal affirmed in Eli Lilly that any other interpretation would defeat objective of Regulations--In Eli Lilly, Court of Appeal held that "relevance" limited to requirement for certification of relevance as to dosage form, strength and route of administration--Patents in issue relevant to submission in respect of which Patent Lists relating to these Patents filed--Court not convinced by Apotex's argument Patents not relevant to medicine or submission in respect of which they are listed to extent required under any relevant standard to warrant dismissal under Regulations, s. 6(5)--Apotex finally seeking to invoke Regulations, s. 6(5)(b) to dismiss GSK's s. 6(1) application on grounds that it is frivolous, vexatious and abuse of process--Regulations, s. 5(1) providing generic manufacturer only required to serve NOA where it makes comparison to drug product marketed in Canada pursuant to NOC--Standard for dismissal under s. 6(5)(b) restrictive, "plain and obvious test" which Apotex failed to meet on this ground--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 4 (as am. by SOR/98-166, s. 3), 5 (as am. idem, s. 4; 99-379, s. 2), 6 (as am. by SOR/98-166, s. 4; 99-379, s. 3)--Food and Drug Regulations, C.R.C., c. 870, s. C.08.001.1 (as enacted by SOR/95-441, s. 3), C.08.002.1 (as enacted idem, s. 5).