Bayer AG et al. v. Apotex Inc. et al., 2003 FC 1199

• Judge: Gibson, J.
• Court: Federal Court (Canada)
• Case Date: October 17, 2003
• Jurisdiction: Canada (Federal)
• Citations: 2003 FC 1199;(2003), 240 F.T.R. 267 (FC)

Bayer AG v. Apotex Inc. (2003), 240 F.T.R. 267 (FC)

MLB headnote and full text

Temp. Cite: [2003] F.T.R. TBEd. NO.002

Bayer AG and Bayer Inc. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-2052-01; 2003 FC 1199)

Indexed As: Bayer AG et al. v. Apotex Inc. et al.

Federal Court

Gibson, J.

October 17, 2003.

Summary:

Bayer owned a patent which contained process and product by process claims for the compound ciprofloxacin, used in the treatment of hard to treat bacterial infections. Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in connection with ciprofloxacin hydrochloride tablets.

The Federal Court allowed the application.

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - Bayer owned a patent which contained process and product by process claims for the compound ciprofloxacin, used in the treatment of hard to treat bacterial infections - Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in connection with ciprofloxacin hydrochloride tablets - Apotex argued that Bayer's patent was invalid for obviousness - The Federal Court discussed the onus and burden of proof and held that while the legal burden rested with Bayer, the question to be answered was whether Apotex had proved, on a balance of probabilities, that Bayer's patent was invalid by reason of obviousness - See paragraphs 53 to 57.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - Bayer owned a patent which contained process and product by process claims for the compound ciprofloxacin, used in the treatment of hard to treat bacterial infections - Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in connection with ciprofloxacin hydrochloride tablets - Apotex argued that Bayer's patent was invalid for obviousness - The Federal Court rejected Apotex's argument and allowed the application - Bayer's patent made modest promises for ciprofloxacin - Since its introduction into the market, it had demonstrated "unexpected usefulness" - The introduction of the drug on the market solved a long-felt need and the drug was a commercial success - Prior art taught away from the purported invention - The court held that Bayer's patent was valid and that Bayer had refuted the allegations of obviousness - See paragraphs 74 to 92.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - Bayer owned a patent which contained process and product by process claims for the compound ciprofloxacin, used in the treatment of hard to treat bacterial infections - Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in connection with ciprofloxacin hydrochloride tablets - Apotex argued that Bayer's patent was invalid for obviousness - The Federal Court rejected Apotex's argument and allowed the application - The court held that "having found ciprofloxacin, the product-by-process substance, as produced by the MES [Malonic Ester Synthesis Process] ... to be a new and useful substance deserving of patent protection as not being obvious, ciprofloxacin, at the same time, supplies the utility necessary to elevate the MES process as applied to the materials used to produce ciprofloxacin to the status of an invention as well." - See paragraphs 94 to 97.

Patents of Invention - Topic 1591

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Time to determine obviousness (incl. date of invention) - Bayer owned a patent which contained process and product by process claims for the compound ciprofloxacin, used in the treatment of hard to treat bacterial infections - Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in connection with ciprofloxacin hydrochloride tablets - Bayer argued that the relevant date for the purposes of assessing the obviousness of the claim was the invention date, or alternatively the priority filing date - The Federal Court held that Bayer failed to prove the date of invention - The court assessed the obviousness of the patent according to the priority filing date - See paragraphs 60 to 66.

Cases Noticed:

Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 133 F.T.R. 184; 74 C.P.R.(3d) 307 (T.D.), refd to. [para. 6, footnote 2].

Hoffmann-La Roche v. Canada (Minister of National Health and Welfare) (1999), 86 C.P.R.(3d) 303 (F.C.T.D.), refd to. [para. 47, footnote 10].

AB Hassle et al. v. Apotex Inc. et al., [2003] F.T.R. Uned. 741 (T.D.), refd to. [para. 54, footnote 13].

GlaxoSmithKline Inc. et al. v. Canada (Minister of Health) et al. (2003), 237 F.T.R. 218 (F.C.), refd to. [para. 55, footnote 14].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2001), 208 F.T.R. 105; 14 C.P.R.(4th) 76 (T.D.), affd. (2002), 291 N.R. 168; 21 C.P.R.(4th) 129 (F.C.A.), refd to. [para. 57. footnote 15].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 225 F.T.R. 1; 22 C.P.R.(4th) 466 (T.D.), folld. [para. 58, footnote 16].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (2000), 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. (2002), 296 N.R. 130; 21 C.P.R.(4th) 499 (S.C.C.), refd to. [para. 61, footnote 17].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 142 F.T.R. 32; 78 C.P.R.(3d) 489 (T.D.), refd to. [para. 24, footnote 63, footnote 19].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 92 F.T.R. 253; 60 C.P.R.(3d) 328 (T.D.), refd to. [para. 65, footnote 20].

AB Hassle and Astra Pharma Inc. v. Canada (Minister of National Health and Welfare) (1997), 125 F.T.R. 57; 71 C.P.R.(3d) 129 (T.D.), refd to. [para. 65, footnote 20].

Wellcome Foundation Ltd. et al. v. Apotex Inc. (1991), 47 F.T.R. 81; 39 C.P.R.(3d) 289 (T.D.), varied (1995), 187 N.R. 284; 60 C.P.R.(3d) 135 (F.C.A.), refd to. [para. 74, footnote 30].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 78, footnote 34].

Société des Usines Chimiques Rhone-Poulenc v. Gilbert (Jules R.) Ltd., [1966] Ex. C.R. 59, refd to. [para. 84, footnote 39].

Faberwerke Hoechst AG v. Halocarbon (Ont.) Ltd. and Halocarbon Products Corp. (1979), 27 N.R. 582; 42 C.P.R.(2d) 145 (S.C.C.), refd to. [para. 89, footnote 41].

Société-Rhône Pollenc v. Gilbert (Jules R.) Ltd. (1968), 55 C.P.R. 207 (S.C.C.), refd to. [para. 94, footnote 42].

Counsel:

Neil Belmore and Ken Clark, for the applicants;

Harry Radomski and Rick Tuzl, for the respondent, Apotex Inc.;

No one appeared for the respondent, the Minister of Health.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Toronto, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

Morris Rosenberg, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, the Minister of Health.

This application was heard on September 2 to 8, 2003, at Toronto, Ontario, by Gibson, J., of the Federal Court, who delivered the following decision on October 17, 2003.