Wellcome Foundation Ltd. et al. v. Apotex Inc., (1995) 187 N.R. 284 (FCA)

• Judge: Hugessen, Strayer and Décary, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: February 01, 1995
• Jurisdiction: Canada (Federal)
• Citations: (1995), 187 N.R. 284 (FCA)

Wellcome Foundation Ltd. v. Apotex (1995), 187 N.R. 284 (FCA)

MLB headnote and full text

Apotex Inc. (appellant/defendant) v. The Wellcome Foundation Limited and Burroughs Wellcome Inc. (respondents/plaintiffs)

(A-214-92)

Indexed As: Wellcome Foundation Ltd. et al. v. Apotex Inc.

Federal Court of Appeal

Hugessen, Strayer and Décary, JJ.A.

February 1, 1995.

Summary:

The plaintiffs were the owner and licen­see of two patents relating to pharmaceutical "inter­mediates" (i.e., chemical substances which were not themselves pharamceuticals, whose primary utility was in the synthesis and production of a pharmaceutical com­pound, trimethoprim, which had medically useful anti-bacterial properties). The plain­tiffs commenced a patent infringement action against the defen­dant. The validity of the patents was also in issue.

The Federal Court of Canada, Trial Divi­sion, in a decision reported 47 F.T.R. 81, declared certain claims in one of the patents to be invalid, but allowed the plaintiffs' infringement action respecting the valid claims. The defendant appealed.

The Federal Court of Appeal allowed the appeal in part.

Patents of Invention - Topic 1004

The specification and claims - Substances intended for food and medicine - The Patent Act, 1970, s. 41(1), provided that for inventions relating to "substances pre­pared or produced by chemical processes and intended for food or medicine, the specification, shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents" - The Federal Court of Ap­peal interpreted s. 41(1), holding that s. 41(1) applied to product claims for inter­mediates used to produce pharmaceutical products - The product claim, however, in order to be valid, must be in process-dependant form (i.e., the product claim must specify its depend­ency upon the particular process by which the product is made) - See para­graphs 15 to 19.

Patents of Invention - Topic 1004

The specification and claims - Substances intended for food and medicine - The plaintiffs were the owner and licensee of two patents for "inter­mediates" used to produce certain medi­cines (Patents '825 and '014) - The defendant challenged the validity of the patents arguing that s. 41(1) of the Patent Act, 1970, applied to the patents, such that the specification could not include claims for the substance itself - The trial judge declared two claims in Patent '825 invalid on the basis of s. 41(1) - The Federal Court of Appeal affirmed that s. 41(1) applied and affirmed the judge's ruling respecting Patent '825 - However, the trial judge erred in holding that one of the claims in Patent '014 was valid where it did not meet the require­ments of s. 41(1) - See paragraphs 20 to 38.

Patents of Invention - Topic 1130

The specification and claims - The de­scription - Claims for more than what was invented - The plaintiffs were the owner and licensee of two patents for "intermedi­ates" used to produce certain medicines - The defendant attacked the validity of one of the patents (Patent '014), arguing that the process claims of the patent were over-broad and lacked utility - The de­fendant argued that no process which was capable of so many results, not all of which have been or could possibly be tested, could be useful since some of the results are almost certain to lack utility - The Fed­eral Court of Canada, Trial Divi­sion, rejected the defendant's argument - The Federal Court of Appeal affirmed the ruling - See paragraphs 43 to 47.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and sub­stances intended for food and medicine - The plaintiffs were the owner and licensee of two patents for "intermedi­ates" used to produce certain medicines - The defendant attacked the validity of one of the patents (Patent '014), arguing that the process claims of the patent were over-broad and lacked utility - The Federal Court of Appeal affirmed that the patent was not invalid on these grounds - See paragraphs 43 to 47.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The plaintiffs were the owner and licen­see of two patents for "inter­mediates" used to produce certain medi­cines - The de­fendant attacked the validity of one of the patents (Patent '014), arguing that the process claims were over-broad and lacked utility - The Federal Court of Canada, Trial Division, discussed the doctrine of sound prediction in relation to the patent and held that the patent was not invalid for lack of utility or operability - The Federal Court of Appeal affirmed the ruling - See paragraphs 43 to 47.

Cases Noticed:

Parke, Davis & Co. v. Fine Chemicals of Canada Ltd., [1959] S.C.R. 219, refd to. [para. 29].

C.H. Boehringer Sohn v. Bell-Craig Ltd. (1963), 41 C.P.R. 1 (S.C.C.), refd to. [para. 30].

Proctor & 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. 35].

Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co. (1965), 50 C.P.R. 26 (S.C.C.), refd to. [para. 43].

May & Baker Ltd. v. Boots Pure Drug Co. (1948), 65 R.P.C. 255, refd to. [para. 45].

Rhone-Poulenc Société Anonyme v. Gilbert (Jules R.) Ltd. (1968), 55 C.P.R. 207, refd to. [para. 45].

Statutes Noticed:

Patent Act, R.S.C. 1970, c. P-4, sect. 41(1), sect. 41(2), sect. 41(3), sect. 41(4) [para. 7].

Counsel:

Malcolm Johnston, Q.C., Brigitte Fouil­lade and Harry B. Radomski, for the appel­lant;

Immanuel Goldsmith, Q.C., and John R. Morrissey, for the respondents.

Solicitors of Record:

Malcolm Johnston & Associates, and Goodman and Goodman, Toronto, Ontario, for the appellant;

Smart & Biggar, Toronto, Ontario, for the respondents.

This appeal was heard in Toronto, Ontario, on January 10, 11 and 12, 1995, before Hugessen, Strayer and Décary, JJ.A., of the Federal Court of Appeal. The decision of the court was delivered by Hugessen, J.A., on February 1, 1995.