Merck & Co. et al. v. Apotex Inc. et al., 2005 FC 755

• Judge: Mosley, J.
• Court: Federal Court (Canada)
• Case Date: April 11, 2005
• Jurisdiction: Canada (Federal)
• Citations: 2005 FC 755;(2005), 274 F.T.R. 113 (FC)

Merck & Co. v. Apotex Inc. (2005), 274 F.T.R. 113 (FC)

MLB headnote and full text

Temp. Cite: [2005] F.T.R. TBEd. JN.030

Merck & Co. Inc. and Merck Frosst Canada & Co. (applicants) v. Apotex Inc. and the Minister of Health (respondents)

(T-884-03; 2005 FC 755)

Indexed As: Merck & Co. et al. v. Apotex Inc. et al.

Federal Court

Mosley, J.

May 26, 2005.

Summary:

Merck & Co. applied, pursuant to s. 6 of the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate.

The Federal Court dismissed the application.

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - Merck & Co. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate - Merck's patent claimed for alendronate in a once weekly administration of 70 mg tablets - Apotex argued that Merck's patent was invalid because its subject matter was a method of medical treatment - The Federal Court rejected the argument - Merck's patent was for a vendible product having a real economic value as demonstrated by its immediate success in the market and was, therefore, not for an unpatentable method of treatment - See paragraphs 133 to 138.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - Merck & Co. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate - Merck's patent claimed for alendronate in a once weekly administration of 70 mg tablets - Apotex argued that based on prior art, the claims made by Merck in its patent were obvious - The Federal Court held that the patent was invalid - The court held that given the prior art references (several articles in different medical journals), it was well known to persons skilled in the art that larger doses of alendronate could be safely administered - Accordingly, in light of the state of the art and common general knowledge, an ordinary person skilled in the pertinent art or science searching for something novel, without serious thought, research or experiment, would have come "directly and without difficulty to the solution taught by the patent" - See paragraphs 70 to 113.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - Merck & Co. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate - Merck's patent claimed for alendronate in a once weekly administration of 70 mg tablets - Apotex argued that Merck's patent was invalid for anticipation because the invention claim was not novel in view of prior publication, namely several articles in Lunar News publications - The Federal Court rejected the argument - The Lunar News publications, both individually and as a group constituted "a signpost or signposts", however "they did not plant a flag at the precise destination" - None of the articles squarely addressed the question of the safety of higher doses of alendronate, although that could be inferred from their text and footnoted references - The articles indicated that they were positing hypotheses and that these ideas required further testing - The author was not a medical doctor, so he was not in a position to test these hypotheses - He gave evidence after the fact in this proceeding that he knew of medical doctors who had followed his hypothesis by putting such dosing regimes into effect; however, this was not disclosed by the articles themselves - See paragraphs 114 to 120.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Merck & Co. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate - Merck's patent claimed for alendronate in a once weekly administration of 70 mg tablets - Apotex argued that Merck's patent was invalid because of inutility - Apotex argued that it was clear from the specifications in the patent that the claims covered dosage ranges that did not solve the problem of gastrointestinal effects (adverse side effect of alendronate) - Moreover, the testing was conducted on dogs rather than humans - The Federal Court held that the patent was invalid - The desired result of increased safety while maintaining efficacy could not be inferred from the flawed factual basis provided by Merck - There was neither an actual demonstration nor a sound line of reasoning articulated as to the utility of the claimed invention from the data - See paragraphs 121 to 127.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Merck & Co. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until the expiry of its Canadian patent relating to its osteoporosis drug, alendronate monosodium trihydrate - Merck's patent claimed for alendronate in a once weekly administration of 70 mg tablets - Apotex argued that Merck's patent was invalid on the ground of insufficiency - Apotex argued that the breadth of the claims in the patent were not supported by the disclosure in the patent - It argued that the scope of the claims was far broader than the claimed invention of a higher dose once weekly for safe administration to humans - The Federal Court rejected the argument - The scope of the claims in the patent did go beyond the purported invention, however the specification was not insufficient or ambiguous - A person skilled in the art reading the claims and disclosure would understand how the claimed pharmaceutical formulation would be made - See paragraphs 128 to 132.

Cases Noticed:

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 3].

Merck & Co. v. Teva Pharmaceuticals USA Inc. (2005), 395 F.3d 1364 (U.S. App.), reving. (2003), 288 F.Supp. 2d 601 (U.S. Dist. Del.), refd to. [para. 23].

Teva Pharamceutical Industries Ltd. et al. v. Istituto Gentili SpA et al., [2003] All E.R. 153 (Aust. H.C.), affd. [2003] All E.R. 62 (Aust. F.C.A.), refd to. [para. 23].

Arrow Pharmaceuticals Ltd. v. Merck & Co., [2004] F.C.A. No. 1282 (Aust. F.C.A.), refd to. [para. 23].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 261 F.T.R. 243; 2005 FC 9, refd to. [para. 26].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1025; 263 N.R. 150, refd to. [para. 26].

Eli Lilly and 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. 33].

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. 33].

Eli Lilly and Co. et al. v. Nu-Pharm Inc. et al. (1996), 199 N.R. 185; 69 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 34].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2004), 328 N.R. 149; 2004 FCA 393, refd to. [para. 35].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241; 89 C.C.C.(3d) 402; 114 D.L.R.(4th) 419; 29 C.R.(4th) 243, refd to. [para. 43].

R. v. Marquard (D.), [1993] 4 S.C.R. 223; 159 N.R. 81; 66 O.A.C. 161; 85 C.C.C.(3d) 193, refd to. [para. 46].

R. v. Béland and Phillips, [1987] 2 S.C.R. 398; 79 N.R. 263; 9 Q.A.C. 293; 36 C.C.C.(3d) 481; 60 C.R.(3d) 1, refd to. [para. 46].

Browne v. Dunn (1893), 6 R. 67 (H.L.), refd to. [para. 50].

R. v. Khan, [1990] 2 S.C.R. 531; 113 N.R. 53; 41 O.A.C. 353; 59 C.C.C.(3d) 92; 79 C.R.(3d) 1, refd to. [para. 54].

Dye v. Morehouse (1999), 45 C.P.C. (4th) 329 (B.C.S.C.), refd to. [para. 54].

E.S. v. D.M. (1996), 143 Nfld. & P.E.I.R. 192; 448 A.P.R. 192 (Nfld. U.F.C.), refd to. [para. 54].

Merck & Co. v. Apotex Inc. [1998] 3 F.C. 400; 146 F.T.R. 148; 79 C.P.R. (3d) 501 (T.D.), refd to. [para. 60].

Suchon v. Minister of National Revenue (2002), 291 N.R. 250 (F.C.A.), refd to. [para. 61].

Whitehouse v. Jordan, [1981] 1 All E.R. 267 (H.L.), refd to. [para. 64].

Windsurfing International Inc. v. Bic Sports Inc. (1985), 63 N.R. 218; 8 C.P.R.(3d) 241 (F.C.A.), consd. [para. 65].

Windsurfing International Inc. v. Trilantic CwT - see Windsurfing International Inc. v. Bic Sports Inc.

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), affd. (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. 70].

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. 70].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 71].

Diversified Products Corp. and Brown Fitzpatrick Lloyd Patent Ltd. v. Tye-Sil Corp. (1991), 125 N.R. 218; 35 C.P.R.(3d) 350 (F.C.A.), refd to. [para. 72].

Baker Petrolite Corp. et al. v. Canwell Enviro-Industries Ltd. et al. (2001), 288 N.R. 201; 17 C.P.R.(4th) 478 (F.C.A.), refd to. [para. 115].

Rosedale Associated Manufacturers Ltd. v. Carlton Tyre Saving Co., [1960] R.P.C. 59 (C.A.), refd to. [para. 115].

R. v. Uhlemann Optical Co. (1949), 11 C.P.R. 26 (Ex. Ct.), affd. (1951), 15 C.P.R. 99 (S.C.C.), refd to. [para. 116].

Mahurkar v. Vas-Cath of Canada Ltd. and Gambro Canada Ltd. (1988), 16 F.T.R. 48; 18 C.P.R.(3d) 417 (T.D.), affd. (1990), 105 N.R. 138; 32 C.P.R.(3d) 409 (F.C.A.), refd to. [para. 117].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6 (F.C.), refd to. [para. 129].

Mobil Oil Corp. et al. v. Hercules Canada Inc. (1995), 188 N.R. 382; 63 C.P.R.(3d) 473 (F.C.A.), refd to. [para. 129].

Baldwin International Radio Co. of Canada v. Western Electric Co. et al., [1934] S.C.R. 94, refd to. [para. 131].

Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111; 8 C.P.R.(2d) 202, refd to. [para. 134].

Apotex Inc. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495; 262 N.R. 137 (F.C.A.), refd to. [para. 136].

Merck & Co. et al. v. Apotex Inc. (1994), 88 F.T.R. 260; 59 C.P.R.(3d) 133 (T.D.), refd to. [para. 136].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 136].

Bristol-Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc., [2001] R.P.C. 1 (C.A.), refd to. [para. 137].

Authors and Works Noticed:

Black et al., Lancet (December 7, 1996), generally [para. 95].

De Groen et al., New England Journal of Medicine (October 3, 1996), generally [para. 93].

Harris et al., Journal of Clinical Endocrinology and Metabolism (1993), generally [para. 96].

Khan, S.A., Bone (March 1997), generally [para. 85].

Liberman et al., Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis, New England Journal of Medicine (November 30, 1995), p. 1438 [para. 91].

Lunar News, April edition (1996), generally [paras. 100, 101].

Lunar News, July edition (1996), generally [para. 100].

Lunar News, April edition (1997), generally [para. 100].

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (1992), pp. 536, 537 [para. 47].

Counsel:

Patrick Kierens and Andy Radhakant, for the applicants (representing Merck & Co. Inc.);

Harry Radomski, Andrew Brodkin and Shorelle Simmons, for the respondents (representing Apotex Inc.).

Solicitors of Record:

Ogilvy Renault LLP, Toronto, Ontario, for the applicants (representing Merck & Co. Inc.);

Goodmans LLP, Toronto, Ontario, for the respondents (representing Apotex Inc.).

This application was heard on April 11, 2005, at Toronto, Ontario, before Mosley, J., of the Federal Court, who delivered the following decision on May 26, 2005.