Pfizer Canada Inc. et al. v. Apotex Inc. et al., 2005 FC 1421

• Judge: Mosley, J.
• Court: Federal Court (Canada)
• Case Date: October 17, 2005
• Jurisdiction: Canada (Federal)
• Citations: 2005 FC 1421;(2005), 282 F.T.R. 8 (FC)

Pfizer Can. Inc. v. Apotex Inc. (2005), 282 F.T.R. 8 (FC)

MLB headnote and full text

Temp. Cite: [2005] F.T.R. TBEd. OC.059

Pfizer Canada Inc. and Pfizer Inc. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1937-03; 2005 FC 1421)

Indexed As: Pfizer Canada Inc. et al. v. Apotex Inc. et al.

Federal Court

Mosley, J.

October 17, 2005.

Summary:

Azithromycin was a medicine used to treat certain microbial infections. Pfizer marketed its azithromycin under the brand name "Zithromax". "Zithromax" was initially marked only in capsule dosage as tablets were not approved. The capsule form, however, presented dosage difficulties for patients because it had to be taken on an empty stomach. Pfizer scientists discovered that azithromycin in tablets, powders or suspensions coud be taken with food without losing approximately 50% of its bioavailability (i.e., absorption into the bloodstream). Pfizer obtained a patent for its discovery and began marketing "Zithromax" in tablet form. Apotex Inc., a generic drug manufacturer, issued a notice of allegation and sought a notice of compliance with respect to its apo-azithromycin tablets. Pfizer applied under s. 6 of the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing the notice of compliance.

The Federal Court dismissed the prohibition application where there was no bar to issuing the notice of compliance. The court held that the Pfizer patent was invalid for obviousness and because it claimed a mere discovery. The Apotex product would not infringe the patent. Accordingly, Pfizer did not discharge its burden to establish that the allegations of invalidity and infringement were not justified.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Apotex Inc., a generic drug manufacturer, issued a notice of allegation, alleging that its apo-azithromycin tablets would not infringe Pfizer's patent for azithromycin tablets or that Pfizer's patent was invalid and sought a notice of compliance - Pfizer sought an order prohibiting the Minister of Health from issuing the notice of compliance - The Federal Court reiterated that Apotex had no evidentiary burden to support the allegations in its notice of allegation and detailed statement - The legal burden in the proceedings was on Pfizer to prove, on a balance of probabilities, that the allegations in Apotex's notice were not justified - In establishing that the allegations of invalidity were not justified Pfizer was entitled to rely upon the statutory presumption of validity found in s. 43(2) of the Patent Act - Apotex had the evidentiary burden, on a balance of probabilities, to prove that the patent was invalid - If the allegations were not justified, the prohibition order would be granted - See paragraphs 11 to 13.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for - Azithromycin was a medicine used to treat certain microbial infections - Pfizer marketed its azithromycin under the brand name "Zithromax" - "Zithromax" was initially marked only in capsule dosage as tablets were not approved - The capsule form, however, presented dosage difficulties for patients because it had to be taken on an empty stomach - Pfizer scientists discovered that azithromycin in tablets, powders or suspensions could be taken with food without losing approximately 50% of its bioavailability (i.e., absorption into the bloodstream) - Pfizer obtained a patent for its discovery and began marketing "Zithromax" in tablet form - Apotex Inc., a generic drug manufacturer, issued a notice of allegation and sought a notice of compliance with respect to its apo-azithromycin tablets - Pfizer applied under s. 6 of the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing the notice of compliance - The Federal Court dismissed the prohibition application where there was no bar to issuing the notice of compliance - The court held that although the Pfizer patent was not invalid on the grounds of anticipation, ambiguity or insufficiency or overbreadth, it was invalid for obviousness and because it claimed a mere discovery (i.e., it had improper subject matter) - Since the patent was invalid, the Apotex tablets would not infringe the patent - See paragraphs 31 to 157.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Pfizer applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing the notice of compliance to Apotex respecting 250 mg. azithromycin tablets - Apotex argued that Pfizer's patent was improperly listed on the Patent Register because the listing was made outside the time requirements of the Regulations and was not relevant to the submissions with which it was listed - Pfizer argued that Apotex's concerns about the listing should have been raised by way of preliminary motion under s. 6(5) of the Regulations - The Federal Court held that it was open to Apotex to make its allegation as part of the prohibition (i.e., s. 6(1)) proceedings and Apotex was not required to have brought its motion under s. 6(5) in advance of the hearing of the 6(1) application - Further, the court was satisfied that Pfizer failed to establish on a balance of probabilities that the patent was properly listed on the patent register because it was out of time - See paragraphs 169 to 178.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1128.2

The specification and claims - The description - Ambiguity - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented (overbreadth) - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1533

Grounds of invalidity - Want of subject matter - Substances prepared by chemical processes and intended for food or medicine - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Test for obviousness - The Federal Court reiterated the test for obviousness: "... The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy." - The court stated that in determining whether a patent claim was obvious, the court had to avoid using the benefit of hindsight - The question to be asked was whether the solution taught by the patent would be "plain as day" to the skilled technician who was searching for something novel, without having to do experimentation or research - Suggestions or signposts in the prior art were not sufficient to make a patent invalid for obviousness - See paragraphs 102 and 103.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Particular patents - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - [See Food and Drug Control - Topic 1108.2 ].

Cases Noticed:

Gillette Safety Razor Co. v. Anglo-American Trading Co. (1913), 30 R.P.C. 465 (H.L.), refd to. [para. 9].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 2005 FCA 270, refd to. [para. 11].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2002), 298 N.R. 323; 22 C.P.R.(4th) 1; 2002 FCA 421, refd to. [para. 12].

Eli Lilly & Co. et al. v. Apotex Inc. et al. (1995), 91 F.T.R. 181; 60 C.P.R.(3d) 206 (T.D.), affd. (1996), 195 N.R. 378; 66 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 13].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 13].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2005] 2 F.C.R. 269; 328 N.R. 149; 2004 FCA 393, refd to. [para. 13].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 27].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 32].

Novartis Pharmaceuticals Canada Inc. et al. v. RhoxalPharma Inc. et al. (2005), 330 N.R. 303; 38 C.P.R.(4th) 193; 2005 FCA 11, refd to. [para. 33].

GlaxoSmithKline Inc. v. Canada (Attorney General) et al. (2005), 334 N.R. 324; 40 C.P.R.(4th) 93; 2005 FCA 197, refd to. [para. 41].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 49].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 63].

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; 2002 FCA 216, refd to. [para. 77].

GlaxoSmithKline Inc. et al. v. Apotex Inc. et al. (2003), 234 F.T.R. 251; 27 C.P.R.(4th) 114; 2003 FCT 687, refd to. [para. 78].

Baker Petrolite Corp. et al. v. Canwell Enviro-Industries Ltd. et al. (2002), 288 N.R. 201; 17 C.P.R.(4th) 478; 2002 FCA 158, refd to. [para. 80].

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. 91].

Hoffman-LaRoche Ltd. v. Apotex Inc. (1983), 41 O.R.(2d) 84; 71 C.P.R.(2d) 20 (H.C.), affd. (1984), 47 O.R.(2d) 287; 1 C.P.R.(3d) 507 (C.A.), refd to. [para. 91].

Eli Lilly & Co. et al. v. Nu-Pharm Inc. et al., [1997] 1 F.C. 3; 199 N.R. 185; 69 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 91].

Illinois Tool Works Inc. et al. v. Cobra Anchors Co. (2002), 221 F.T.R. 161; 2002 FCT 829, affd. in part (2003), 312 N.R. 184; 2003 FCA 358, refd to. [para. 101].

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

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), revd. in part [2001] 1 F.C. 495; 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 103].

Bayer Aktiengesellschaft et al. v. Apotex Inc. (1995), 60 C.P.R.(3d) 58 (Ont. Gen. Div.), varied (1998), 113 O.A.C. 1; 82 C.P.R.(3d) 526 (C.A.), leave to appeal denied (1999), 239 N.R. 200; 124 O.A.C. 199 (S.C.C.), refd to. [para. 103].

Farbwerke Hoechst Aktiengesellschaf v. Halocarbon (Ontario) Ltd. et al., [1979] 2 S.C.R. 929; 27 N.R. 582; 42 C.P.R.(2d) 145, refd to. [para. 103].

Diversified Products Corp. et al. v. Tye-Sil Corp. (1991), 125 N.R. 218; 35 C.P.R.(3d) 350 (F.C.A.), refd to. [para. 121].

R. v. Abbey, [1982] 2 S.C.R. 24; 43 N.R. 30, refd to. [para. 125].

Apotex Inc. v. Hoffmann-La Roche Ltd. (1989), 99 N.R. 198; 24 C.P.R.(3d) 289; 23 C.I.P.R. 1 (F.C.A.), refd to. [para. 133].

Farbwerke Hoechst AG v. Canada (Commissioner of Patents), [1966] Ex. C.R. 91; 50 C.P.R. 220, affd. [1966] S.C.R. 604; 50 C.P.R. 220, refd to. [para. 137].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553; 17 C.P.R.(2d) 97, refd to. [para. 139].

Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111; 8 C.P.R.(2d) 202, refd to. [para. 143].

Bristol-Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc., [1999] R.P.C. 253, refd to. [para. 146].

Istituto Gentili SpA v. Teva Pharmaceutical Industries Ltd., [2003] All E.R.(D) 62 (Nov.) (Aust. F.C.A.), refd to. [para. 147].

Arrow Pharmaceuticals Ltd. v. Merck & Co., [2004] F.C.A. 1282 (Aust.), refd to. [para. 147].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35; 2005 FC 755, refd to. [para. 148].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541, refd to. [para. 151].

Sharpe & Dohme Inc. v. Boots Pure Drug Co. (1928), 45 R.P.C. 153 (C.A.), refd to. [para. 152].

Riello Canada Inc. v. Lambert (1986), 3 F.T.R. 23; 9 C.P.R.(3d) 324; 8 C.I.P.R. 286 (T.D.), refd to. [para. 153].

Reynolds v. Herbert Smith & Co. (1902), 20 R.P.C. 123 (Ch. D.), refd to. [para. 153].

Novopharm Ltd. v. Canada (Minister of National Health and Welfare) et al. (1998), 149 F.T.R. 63; 78 C.P.R.(3d) 54 (T.D.), refd to. [para. 172].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2003), 233 F.T.R. 189; 26 C.P.R.(4th) 180 (T.D.), refd to. [para. 175].

Radil Bros. Fishing Co. v. Canada (Minister of Fisheries and Oceans) et al. (2003), 230 F.T.R. 228; 2003 FCT 79, refd to. [para. 176].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 177].

Authors and Works Noticed:

Toothaker and Welling, The Effect of Food on Drug Bioavailability (1980), p. 176 [para. 109].

Counsel:

Sheila Block, Andrew Shaughnessy and Andrew Bernstein, for the applicants;

Harry Radomski, Andrew Brodkin and Sorelle Simmons, for the respondents.

Solicitors of Record:

Torrys LLP, Toronto, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondents;

John H. Sims, Q.C., Deputy Attorney General of Canada, Toronto, Ontario, for the respondents.

This application was heard at Toronto, Ontario, on July 25 to 27, 2005, before Mosley, J., of the Federal Court, who delivered the following reasons for judgment at Ottawa, Ontario, on October 17, 2005.