Janssen-Ortho Inc. et al. v. Apotex Inc. et al., (2008) 332 F.T.R. 1 (FC)

• Judge: Shore, J.
• Court: Federal Court (Canada)
• Case Date: June 17, 2008
• Jurisdiction: Canada (Federal)
• Citations: (2008), 332 F.T.R. 1 (FC);2008 FC 744

Janssen-Ortho Inc. v. Apotex Inc. (2008), 332 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. JN.026

Janssen-Ortho Inc. and Daiichi Sankyo Company, Limited (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1508-05; 2008 FC 744)

Indexed As: Janssen-Ortho Inc. et al. v. Apotex Inc. et al.

Federal Court

Shore, J.

June 17, 2008.

Summary:

Apotex Inc., a generic drug manufacturer, sought a notice of compliance (NOC) respecting the antimicrobial drug, known as levofloxacin, in the form of 250, 500 and 700 mg tablet strengths until the expiry of Canadian Patent No. 1,304,080 ('080 patent). Daiichi Sankyo Co. (patent owner) and Janssen-Ortho Inc. (licensee) (the applicants) sought an order prohibiting the Minister of Health from issuing the NOC. Apotex alleged that the '080 patent was invalid or that its tablets would not infringe the '080 patent. The applicants claimed that the issues raised by Apotex were substantially similar to the issues and evidence on obviousness and anticipation previously submitted to the court in earlier litigation involving the same patent.

The Federal Court held that the patent was valid and that Apotex's tablets would infringe the patent. The court therefore issued the prohibition order sought by the applicants. The court held, subsequent to its analysis of the infringement and validity issues, that it agreed with the applicants' abuse of process argument.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Apotex Inc., a generic drug manufacturer, sought a notice of compliance (NOC) respecting the antimicrobial drug, known as levofloxacin, in the form of 250, 500 and 700 mg tablet strengths until the expiry of Canadian Patent No. 1,304,080 ('080 patent) - Janssen-Ortho Inc. (licensee) and Daiichi Sankyo Co. (patent owner), the applicants, sought an order prohibiting the Minister of Health from issuing the NOC - Apotex alleged that the '080 patent was invalid or that their tablets would not infringe the '080 patent - The applicants claimed that the issues raised by Apotex were substantially similar to the issues and evidence on obviousness and anticipation previously submitted to the court in earlier litigation involving the same patent, but a different generic drug manufacturer (i.e., that this proceeding constituted an abuse of process) - The Federal Court stated that a second person challenging a patent that was previously upheld in a prohibition proceeding, under s. 6 of the NOC Regulations, had established that it had provided either "better evidence or a more appropriate legal argument" than existed in the previous case - Here, although the court considered all the issues raised by Apotex, it agreed with the applicants' abuse of process argument - The court granted the prohibition order - See paragraphs 40 to 48 and 205 to 251.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 705

Application for grant - Disclosure and examination (incl. duty of candour) - Daiichi Sankyo Co. owned Canadian patent 1,304,080 ('080) which disclosed the means to isolate the chemical compound levoflaxacin  (i.e., S(-)-ofloxacin) which was used as an antibiotic known as LEVAQUIN - Janssen-Ortho Inc. was a licensee - Apotex, a generic drug manufacturer, sought a notice of compliance - Apotex alleged that the '080 patent was void because Daiichi or its agents failed to comply with examination requests (disclosure requirements) contrary to Patent Rules 40(1)(a) and (c) and thereby breached their duty of candour to the Commissioner of Patents - The Federal Court found no breaches of the rules, except for an inadvertence in failing to respond to one requirement within the prescribed time, but which was responded to later - The court noted that there was no express duty of candour or mention of that word in the Patent Act or the Patent Rules - While a duty of candour and good faith existed during the prosecution of patent applications in the United States Patent Office, a similar duty did not exist in Canada - The facts alleged by Apotex in its notice of allegation were addressed by s. 30(1) of the Patent Act and Patent Rules 40(l)(a), 40(1)(c) and 45 - There was no basis in Canadian law for the separate allegation of breach of candour put forth by Apotex - The court opined that even if such a duty were to be implied, there was nothing in the prosecution of the '080 patent to suggest that Daiichi failed to act with candour or in good faith - See paragraphs 188 to 204.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Daiichi Sankyo Co. owned Canadian patent 1,304,080 ('080) which disclosed the means to isolate the chemical compound levofloxacin (i.e., S(-)-ofloxacin) which was used as an antibiotic known as LEVAQUIN - Janssen-Ortho Inc. was a licensee - Apotex, a generic drug manufacturer, sought a notice of compliance for its levofloxacin tablets, claiming that the active ingredient in its product was "levofloxacin hemihydrate" (a compound having two molecules of levofloxacin for each molecule of water) which it claimed to be a different chemical substance than that which was found in levofloxacin and was not covered by the '080 patent - The Federal Court held that the '080 patent included within its scope both anhydrous levofloxacin (having no water molecules) and levofloxacin hemihydrate (having two molecules of levofloxacin for each molecule of water) - Therefore, the Apotex tablets would infringe the '080 patent and Daiichi and Janssen were granted the prohibition order - See paragraphs 65 to 83.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - Daiichi Sankyo Co. owned Canadian patent 1,304,080 ('080) which disclosed the means to isolate the chemical compound levoflaxacin (i.e., S(-)-ofloxacin) which was used as an antibiotic known as LEVAQUIN - Janssen-Ortho Inc. was a licensee - Apotex, a generic drug manufacturer, sought a notice of compliance, claiming that the claims of the '080 patent were broader than the invention made and lacked sound prediction - The Federal Court rejected this argument, holding that Apotex misconstrued the promise of the '080 patent and the utility of the invention - See paragraphs 177 to 187.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals - [See Patents of Invention - Topic 1032 ].

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - Daiichi Sankyo Co. owned Canadian patent 1,304,080 ('080) which disclosed the means to isolate the chemical compound levoflaxacin (i.e., S(-)-ofloxacin) which was used as an antibiotic known as LEVAQUIN - Janssen-Ortho Inc. was a licensee - Apotex, a generic drug manufacturer, sought a notice of compliance, claiming that the '080 patent was invalid for obviousness - The Federal Court rejected this argument, holding that levofloxacin was inventive - The court granted the prohibition order - See paragraphs 105 to 176.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1584 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Daiichi Sankyo Co. owned Canadian patent 1,304,080 ('080) which disclosed the means to isolate the chemical compound levoflaxacin (i.e., S(-)-ofloxacin) which was used as an antibiotic known as LEVAQUIN - Janssen-Ortho Inc. was a licensee - Apotex, a generic drug manufacturer, sought a notice of compliance, claiming that the '080 patent was invalid for anticipation (i.e., by prior patent) - Daiichi and Janssen sought a prohibition order - The Federal Court rejected the anticipation argument and granted the prohibition order - See paragraphs 84 to 104.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1603 ].

Cases Noticed:

Farbwerke Hoechst Aktiengessellschaf v. Halocarbon (Ontario) Ltd. and Halocarbon Products Corp., [1979] 2 S.C.R. 929; 27 N.R. 582; 42 C.P.R.(2d) 145; 104 D.L.R.(3d) 51, refd to. [para. 2].

Canadian General Electric Co. v. Fada Radio Ltd., [1930] R.P.C. 69 (P.C.), refd to. [para. 2].

American Cyanamid Co. v. Berk Pharmaceuticals Ltd., [1976] R.P.C. 231 (Ch. D.), refd to. [para. 2].

Pfizer Canada Inc. v. Ratiopharm - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2007] 2 F.C.R. 137; 351 N.R. 189; 2006 FCA 214, reving. (2006), 288 F.T.R. 215; 2006 FC 220, refd to. [paras. 3, 171].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 4].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 4].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 4].

Pfizer Canada Inc. et al. v. Mayne Pharmacy (Canada) - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 4].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 5].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 5].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. et al. (2004), 264 F.T.R. 202; 2004 FC 1631, refd to. [para. 31].

Pfizer Canada Inc. et al. v. Apotex Inc. - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, reving. (2005), 279 F.T.R. 164; 2005 FC 1205, refd to. [para. 38].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 174; 364 N.R. 325; 2007 FCA 163, refd to. [para. 40].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 58 C.P.R.(4th) 214; 2007 FC 596, refd to. [para. 40].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 2008 FC 11, refd to. [para. 40].

King v. Uhlemann Optical Co., [1950] Ex. C.R. 142; 10 Fox Pat. C. 24, affd. [1952] 1 S.C.R. 143, refd to. [paras. 53, 88].

Ortho-McNeil Pharmaceutical v. Mylan Laboratories (2004), 348 F. Supp.2d 713 (N.D. W. Va.), refd to. [para. 62].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2004), 247 F.T.R. 21; 2004 FC 204, affd. [2005] 2 F.C.R. 269; 328 N.R. 149; 2004 FCA 393, refd to. [para. 63].

Pfizer Canada Inc. v. Pharmascience - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 326 F.T.R. 88; 2008 FC 500, refd to. [para. 78].

Gillette Safety Razor Co. v. Anglo-American Trading Co. (1913), 30 R.P.C. 465 (H.L.), refd to. [para. 80].

General Tire & Rubber v. Firestone Tyre and Rubber, [1972] R.P.C. 457 (C.A.), refd to. [para. 88].

Reeves Brothers Inc. v. Toronto Quilting & Embroidery Ltd., [1979] A.C.W.S. 79; 43 C.P.R.(2d) 145 (F.C.T.D.), refd to. [para. 88].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 88].

Novartis AG et al. v. Apotex Inc. et al. (2001), 212 F.T.R. 161; 2001 FCT 1129, refd to. [para. 88].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2001), 208 F.T.R. 105; 2001 FCT 770, affd. [2003] 1 F.C. 118; 291 N.R. 168; 2002 FCA 216, refd to. [para. 88].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 225 F.T.R. 1; 2002 FCT 1138, refd to. [para. 88].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 88].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, refd to. [para. 88].

Calgon Carbon Corp. v. North Bay (City) et al. (2006), 304 F.T.R. 1; 2006 FC 1373, refd to. [para. 88].

Abbott Laboratories v. Apotex Inc. - see Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 88].

Ranbaxy UK Ltd. v. Warner-Lambert Co., [2005] EWHC 2142 (Pat.), affd. [2006] EWCA Civ. 876 (C.A.), refd to. [para. 88].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, refd to. [para. 88].

Jamb Sets Ltd. v. Carlton, [1964] Ex. C.R. 377; 42 C.P.R. 65, affd. (1965), 46 C.P.R. 192 (S.C.C.), refd to. [para. 88].

Xerox of Canada Ltd. v. IBM Canada Ltd. (1977), 33 C.P.R.(2d) 24; 2 A.C.W.S. 387 (F.C.T.D.), refd to. [para. 88].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 315 F.T.R. 169; 2007 FC 753, refd to. [para. 89].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 60 C.P.R.(4th) 199; 2007 FC 688, refd to. [para. 89].

Bristol-Myers Squibb Co. v. Ben Venue Labs (2001), 246 F.3d 1368, refd to. [para. 89].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, affd. (2008), 375 N.R. 381; 2008 FCA 44, refd to. [paras. 90, 91].

Du Pont Nemours (E.I.) & Co. Application, Re, [1982] F.S.R. 303 (H.L.), refd to. [para. 90].

Pfizer Canada and Warner-Lambert Co. v. Ranbaxy Laboratories Ltd. - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 2008 FCA 108, refd to. [para. 94].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 2005 FC 390, affd. (2006), 358 N.R. 135; 282 D.L.R.(4th) 179; 2006 FCA 421, refd to. [para. 96].

Merrell Dow Pharmaceuticals Inc. et al. v. Norton (H.N.) & Co. et al., [1996] R.P.C. 76; 189 N.R. 364 (H.L.), refd to. [para. 98].

GlaxoSmithKline Inc. et al. v. Canada (Minister of Health) et al. (2003), 237 F.T.R. 218; 2003 FC 899, refd to. [para. 105].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), affd. [2001] 1 F.C. 495; 262 N.R. 137 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 105].

Windsurfing International Inc. v. Bic Sports Inc. (1985), 63 N.R. 218; 8 C.P.R.(3d) 241 (F.C.A.), refd to. [para. 105].

Wellcome Foundation Ltd. et al. v. Novopharm Ltd. (1998), 151 F.T.R. 47; 82 C.P.R.(3d) 129 (T.D.), affd. (2000), 253 N.R. 297; 7 C.P.R.(4th) 330 (F.C.A.), refd to. [para. 105].

Procter & Gamble Co. v. Beecham Canada Ltd. and Calgon Interamerican Corp. (1982), 40 N.R. 313; 61 C.P.R.(2d) 1 (F.C.A.), refd to. [para. 105].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 176 F.T.R. 142; 2 C.P.R.(4th) 368 (T.D.), refd to. [para. 105].

Sharp and Dohme v. Boots Pure Drug Co. (1928), 45 R.P.C. 153 (C.A.), refd to. [para. 105].

Leithiser and Timberland Ellicott Ltd. v. Pengo Hydra-Pull of Canada Ltd., [1974] 2 F.C. 954; 6 N.R. 301 (F.C.A.), refd to. [para. 105].

Apotex Inc. v. Hoffman La-Roche Ltd. (1987), 11 F.T.R. 161; 15 C.P.R.(3d) 217 (T.D.), affd. (1989), 99 N.R. 198; 24 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 105].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 43 C.P.R.(4th) 81; 2005 FC 1421, refd to. [para. 110].

Bristol-Myers Squibb Canada Co. et al. v. Novopharm Ltd. et al. (2005), 282 F.T.R. 255; 2005 FC 1458, refd to. [para. 110].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6; 2003 FC 1443, affd. (2004), 329 N.R. 374; 2004 FCA 413, refd to. [para. 111].

Bayer Aktiengesellschaft et al. v. Apotex Inc. (1995), 60 C.P.R.(3d) 58; 53 A.C.W.S.(3d) 163 (Gen. Div.), affd. (1998), 113 O.A.C. 1; 82 C.P.R.(3d) 526 (C.A.), refd to. [para. 111].

Illinois Tool Works Inc. et al. v. Cobra Anchors Co. (2002), 221 F.T.R. 161; 2002 FCT 829, refd to. [para. 113].

Illinois Tool Works Inc. v. Cobra Fixations Cie - see Illinois Tool Works Inc. et al. v. Cobra Anchors Co.

Procter & Gamble Co. v. Kimberly-Clark of Canada Ltd. (No. 4) (1991), 49 F.T.R. 31; 40 C.P.R.(3d) 1 (T.D.), refd to. [para. 113].

Forest Labs v. Ivax Pharms, 2006 U.S. Dist. LEXIS 47985 (D. Del.), refd to. [para. 121].

Merck & Co. et al. v. Apotex Inc., [1995] 2 F.C. 723; 180 N.R. 373 (F.C.A.), reving. in part (1994), 88 F.T.R. 260; 59 C.P.R.(3d) 133 (T.D.), refd to. [para. 143].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 2006 FC 524, refd to. [para. 143].

Bayer AG et al. v. Apotex Inc. et al. (2003), 240 F.T.R. 267; 2003 FC 1199, refd to. [para. 171].

Brady (W.H.) Co. v. Letraset Canada Ltd. (1985), 7 C.I.P.R. 1; 7 C.P.R.(3d) 82 (F.C.T.D.), refd to. [para. 177].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 265 D.L.R.(4th) 308; 2006 FCA 64, refd to. [para. 178].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al. (2007), 296 F.T.R. 254; 2007 FC 81, refd to. [para. 178].

Bourgault Industries Ltd. v. Flexi-Coil Ltd. (1999), 237 N.R. 74; 86 C.P.R.(3d) 221 (F.C.A.), affing. (1998), 141 F.T.R. 268; 80 C.P.R.(3d) 1; 78 A.C.W.S.(3d) 373 (T.D.), refd to. [para. 201].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 30(1) [para. 190].

Patent Act Regulations (Can.), Patent Rules, C.R.C. 1978, c. 1250, rule 40(1)(a) [para. 197]; rule 40(1)(c) [para. 193]; rule 45 [para. 191].

Patent Rules - see Patent Act Regulations (Can.).

Authors and Works Noticed:

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 90 [para. 110].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed.) (2005 Looseleaf), p. 128, § 7 [para. 110].

Counsel:

Neil Belmore and Lindsay Neidrauer, for the applicant, Janssen-Ortho Inc.;

Michael E. Charles, Andrew I. McIntosh and Joshua W. Spicer, for the applicant, Daiichi Sankyo Company Limited;

Andrew R. Brodkin, David E. Lederman and Belle Van, for the respondent, Apotex Inc.;

No-one appearing for the respondent, Minister of Health.

Solicitors of Record:

Gowling Lafleur Henderson, Toronto, Ontario, for the applicant, Janssen-Ortho Inc.;

Bereskin & Parr, Toronto, Ontario, for the applicant, Daiichi Sankyo Company Limited;

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

This case was heard in Toronto, Ontario, on May 12-16, 2008, by Shore, J., of the Federal Court, who delivered the following decision on June 17, 2008.