Merck & Co. et al. v. Apotex Inc., (1995) 180 N.R. 373 (FCA)

• Judge: Stone, MacGuigan and Robertson, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: April 19, 1995
• Jurisdiction: Canada (Federal)
• Citations: (1995), 180 N.R. 373 (FCA)

Merck & Co. v. Apotex Inc. (1995), 180 N.R. 373 (FCA)

MLB headnote and full text

Apotex Inc. (appellant/defendant) v. Merck & Co. Inc. and Merck Frosst Canada Inc. (respondents/plaintiffs)

(A-724-94)

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

Federal Court of Appeal

Stone, MacGuigan and

Robertson, JJ.A.

April 19, 1995.

Summary:

The plaintiffs sued the defendant for vari­ous relief for patent infringement of the compounds enalapril and enalapril maleate. The defendant submitted that it had a defence under s. 56 of the Patent Act because its product was manufactured from bulk product made in Canada prior to the grant of the plaintiffs' patent. The de­fendant also counter-claimed for declarations that the composition claims and the claims to the use of the compounds contained in the plaintiffs' patent were invalid.

The Federal Court of Canada, Trial Divi­sion, in a decision reported 88 F.T.R. 260, allowed the plaintiffs' action and dis­missed the counter-claim. The defendant appealed.

The Federal Court of Appeal allowed the appeal in part. The counter-claim appeal was dismissed.

Patents of Invention - Topic 1001

The specification and claims - General - The Federal Court of Appeal ruled that the date of significance respecting a patent applicant's ability to meet the specification requirements under s. 34 of the Patent Act was the date at the time the patent issued - See paragraphs 66 and 67.

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - The plaintiffs sued the defendant for patent infringement - The plaintiffs' patent for pharmaceuticals included the claimed invention of certain compounds - One compound, combined with an acceptable carrier into tablets or liquid, provided a composition dispensed as a prescription drug - The patent included claims for the compounds, the com­positions including the compounds and for their use - The defen­dant counter-claimed on the ground that the portions of the patent dealing with the composition claims and the claims for use as drugs were invalid - The defendant also submitted that those portions were invalid because they dealt with a medical treatment, not a discovery and because they were redundant - The Federal Court of Appeal dismissed the counter-claim - See paragraphs 51 to 74.

Patents of Invention - Topic 1533

Grounds of invalidity - Want of subject matter - Substances prepared by chemical processes and intended for medicine - [See Patents of Invention - Topic 1532 ].

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inven­tive ingenuity" - Chemical processes - [See Patents of Invention - Topic 1532 ].

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" - Chemical processes - The Federal Court of Appeal held that claims for compounds and claims for composi­tions of those compounds in or with a carrier could coexist, as valid claims, within the same patent - The Court of Appeal stated that "[a]t least after Shell Oil, it must be clear that the earlier cases do not stand for the proposition that a composition claim cannot survive with a compound claim, on the ground that it involves no inventive ingenuity. As long as there is no separate invention in the com­positions, there is no rule that claims to compounds and claims to compositions including them cannot be combined in a single patent" - See paragraphs 52 to 62

Patents of Invention - Topic 3001

Infringement of patent - Defences - Gen­eral - Implied licence - Merck obtained a patent on the compounds enalapril and enalapril maleate - The patent included the compound claim, composition claims and claims as to the use of the compounds as antihypertensives - Apotex produced tablets made from bulk enalapril purchased from a foreign customer of Delmar - Delmar had manufactured the bulk enal­april under a compulsory licence from Merck - Merck sued Apotex for infringe­ment - Apotex claimed, inter alia, an implied licence on the basis of Delmar's compulsory licence from Merck - Merck submitted that there was no implied licence because the compulsory licence was extinguished prior to Apotex's pur­chase from the foreign customer - The Federal Court of Appeal held that Apotex's use constituted an infringement - See paragraphs 48 to 50.

Patents of Invention - Topic 3010

Infringement of patent - Defences - Pur­chase prior to issue of patent - Merck obtained a patent on the compounds enal­april and enalapril maleate - The patent included the compound claim, composition claims and claims as to the use of the compounds as antihypertensives - Merck sued Apotex for infringement - Apotex claimed a defence under s. 56 of the Patent Act on the ground that its product was manufactured from bulk enalapril maleate made in Canada prior to the grant of Merck's patent - Merck submitted that s. 56 only applied to the use of the bulk product, not to the tablets manufactured from the bulk by the addition of a carrier - The Federal Court of Appeal held that Apotex's use did not infringe because it was protected by s. 56 of the Act - See paragraphs 16 to 40.

Patents of Invention - Topic 3010

Infringement of patent - Defences - Pur­chase prior to issue of patent - Merck obtained a patent on the compounds enal­april and enalapril maleate - The patent included the compound claim, composition claims and claims as to the use of the compounds as antihypertensives - Merck sued Apotex for infringement - Apotex claimed a defence under s. 56 of the Patent Act on the ground that its product was manufactured from bulk enalapril maleate made in Canada prior to the grant of Merck's patent - Merck submitted that s. 56 did not apply to three bulk purchases of impure product because the reprocessing by the vendor was not com­pleted until after Merck obtained its patent - The Federal Court of Appeal held that s. 56 did not protect the product made from the reprocessed com­pound - See para­graphs 41 to 47.

Cases Noticed:

Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc. (1993), 66 F.T.R. 36; 49 C.P.R.(3d) 161 (T.D.), affd. [1994] 1 F.C. 742; 162 N.R. 177 (F.C.A.), affd. [1994] 3 S.C.R. 1100; 176 N.R. 1, refd to. [para. 7].

Nekoosa Packaging Corp. et al. v. AMCA Inter­national Ltd. et al. (1994), 172 N.R. 387 (F.C.A.), refd to. [para. 10].

Lovell Manufacturing Co. v. Beatty Brothers Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.), refd to. [para. 13].

Computalog Ltd. v. Comtech Logging Ltd. (1992), 142 N.R. 216; 44 C.P.R.(3d) 77 (F.C.A.), refd to. [para. 13].

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1994), 54 C.P.R.(3d) 538 (F.C.T.D.), refd to. [para. 20].

Reeves Brothers Inc. v. Toronto Quilting & Embroidery Ltd. (1978), 43 C.P.R.(2d) 145 (F.C.T.D.), consd. [para. 20].

Libbey-Owens-Ford Glass Co. v. Ford Motor Co. of Canada Ltd. (1969), 57 C.P.R. 155 (Ex. Ct.), affd. [1970] S.C.R. 833; 62 C.P.R. 223, appld. [para. 21].

Diamond Shamrock Corp. v. Hooker Chemicals & Plastics Corp. (1982), 66 C.P.R.(2d) 145 (F.C.T.D.), consd. [para. 30].

Teledyne Industries Inc. and Teledyne Industries Canada Ltd. v. Lido Industrial Products Ltd. (1981), 39 N.R. 561; 57 C.P.R.(2d) 29 (F.C.A.), leave to appeal refused (1981), 59 C.P.R.(2d) 183 (S.C.C.), consd. [para. 33].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, consd. [para. 34].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541; 67 C.P.R.(2d) 1, reving. (1980), 36 N.R. 1; 54 C.P.R.(2d) 183 (F.C.A.), appld. [para. 52].

Rohm & Haas Co. v. Commissioner of Patents, [1959] Ex. C.R. 153; 30 C.P.R. 113 (Ex. Ct.), dist. [para. 52].

Commissioner of Patents v. Farbwerke Hoechst, [1964] S.C.R. 49; 41 C.P.R. 9, dist. [para. 52].

Gilbert (Jules R.) Ltd. v. Sandoz Patents Ltd. (1970), 64 C.P.R. 14 (Ex. Ct.), dist. [para. 52].

Sandoz Patents Ltd. v. Gilcross Ltd., [1974] S.C.R. 1336; 8 C.P.R.(2d) 210, dist. [para. 52].

Agripat S.A. v. Commissioner of Patents (1976), 52 C.P.R.(2d) 220 (Pat. App. Bd. and Pat. Commr.), affd. (1977), 52 C.P.R.(2d) 229 (F.C.A.), dist. [para. 52].

Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111; 8 C.P.R.(2d) 202, refd to. [para. 64].

Imperial Chemical Industries Ltd. v. Com­missioner of Patents, [1986] 3 F.C. 40; 67 N.R. 121; 9 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 64].

Statutes Noticed:

Patent Act Amendment Act, S.C. 1993, c. 2, sect. 12 [para. 48].

Patent Act, An Act to amend and to pro­vide for certain matters in relation there­to, R.S.C. 1985 (3rd Supp.), c. 33, sect. 14 [para. 59, footnote 4].

Patent Act, R.S.C. 1970, c. P-4, sect. 41 [para. 55]; sect. 41(1) [para. 59, footnote 4]; sect. 58 [para. 20].

Patent Act, R.S.C. 1985, c. P-4, sect. 10 [para. 15, footnote 2]; sect. 27(1) [para. 30, footnote 3]; sect. 28 [para. 15, footnote 2]; sect. 34 [para. 63]; sect. 39(1) [para. 59, footnote 4]; sect. 56 [para. 15].

Sale of Goods Act, R.S.O. 1990, c. S-1, sect. 19, rule 5 [para. 46].

Authors and Works Noticed:

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), pp. 46 to 47 [para. 59, footnote 4].

Counsel:

Harry B. Radomski, Malcolm S. John­ston, Q.C., and Richard Naiberg, for the appellant;

G. Alexander Macklin, Q.C., and Emman­uel Manolakis, for the respondent.

Solicitors of Record:

Goodman, Phillip & Vineberg, Toronto, Ontario, for the appellant;

Gowling, Strathy & Henderson, Ottawa, Ontario, for the respondent.

This appeal was heard on March 21 to 24, 1995, at Toronto, Ontario, before Stone, MacGuigan and Robertson, JJ.A., of the Federal Court of Appeal.

The decision of the Court of Appeal was delivered by MacGuigan, J.A., on April 19, 1995.