Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al., 2007 FC 81

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: January 24, 2007
• Jurisdiction: Canada (Federal)
• Citations: 2007 FC 81;(2007), 296 F.T.R. 254 (FC)

Searle & Co. v. Novopharm Ltd. (2007), 296 F.T.R. 254 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. FE.010

G.D. Searle & Co. and Pfizer Canada Inc. (applicants) v. Novopharm Limited and the Minister of Health (respondents)

(T-1067-05; 2007 FC 81)

Indexed As: Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al.

Federal Court

Hughes, J.

January 24, 2007.

Summary:

A drug manufacturer (Searle) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance permitting a generic drug manufacturer (Novopharm) from selling 100 mg and 200 mg capsules containing a medicine known as celecoxib (sold as Celebrex) before the expiry of Searle's '567 patent. Novopharm's Notice of Allegation submitted that the application for the '567 patent had been abandoned and that the allegations in claims 4 and 8 of the '567 patent were invalid for obviousness, lack of utility or insufficiency. The patent dealt with compounds that treated inflammation without the side effect of irritating the gastric system.

The Federal Court dismissed the application. Although rejecting the allegation of invalidity respecting utility and sufficiency, the court held that the allegation of invalidity was justified on the basis of abandonment and obviousness.

Patents of Invention - Topic 710

Application for grant - General - Abandonment - A drug manufacturer (Searle) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance that would permit a generic drug manufacturer (Novopharm) from selling a generic version of a medicine known as celecoxib (sold as Celebrex) before the expiry of Searle's '567 patent in 2014 - Novopharm's Notice of Allegation submitted that the application for the '567 patent had been abandoned and that the allegations in claims 4 and 8 of the '567 patent were invalid for obviousness, lack of utility and insufficiency of description of the claims - The patent dealt with compounds that treated inflammation without the undesired side effect of irritating the gastric system - The Federal Court dismissed the application - Although rejecting the allegation of invalidity on the basis of utility and the sufficiency of the claim, the allegation of invalidity was justified on the basis of abandonment and obviousness - As of the claim date for assessing obviousness (Canadian filing date), there was a prior art disclosure (pre-existing research) that rendered celecoxib obvious on the basis that a person skilled in the art would be led to the claimed invention "directly and without difficulty" - Abandonment was deemed to have occurred under s. 73(1)(a) of the Patent Act where Searle had not replied in good faith to a requisition made by the patent office examiner in connection with the prosecution of the patent - Searle misled the examiner by failing to disclose information that would have materially influenced the examiner's assessment - See paragraphs 59 to 109.

Patents of Invention - Topic 1128.1

The specification and claims - The description - Sufficiency of description of invention - [See Patents of Invention - Topic 710 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 710 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - [See Patents of Invention - Topic 710 ].

Words and Phrases

Justified - The Federal Court stated that "justified", as found in the phrase "none of those allegations is justified", in s. 6(2) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, meant the ordinary civil burden of proof on a balance of probabilities - See paragraphs 40 to 41.

Cases Noticed:

Procter & Gamble Co. v. Bristol-Myers Canada Ltd. (1979), 39 C.P.R.(2d) 145 (F.C.T.D.), refd to. [para. 30].

Abbott Laboratories v. Canada (2005), 45 C.P.R. (4th) 81 (F.C.), dist. [para. 31].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 43 C.P.R.(3d) 81 (F.C.), refd to. [para. 35].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 903; 2006 FC 1547, refd to. [para. 36].

Pfizer Canada Inc. v. Canada (2006), 46 C.P.R. (4th) 481 (F.C.), refd to. [para. 39].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 307 F.T.R. 271; 2006 FC 1558, refd to. [para. 39].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 39].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2004), 328 N.R. 149; 37 C.P.R.(4th) 289 (F.C.A.), refd to. [para. 41].

Digital Control Inc. v. Charles Machine Works (2006), 437 F.3d 1309 (Fed. Cir. C.A.), refd to. [para. 63].

Ranbaxy Australia Property Ltd. v. Warner-Lambert Co. LLC (No. 2), [2006] F.C.A. 1787 (Aust. F.C.), refd to. [para. 64].

Fada Radio Ltd. v. Canadian General Electric Co., [1927] 1 S.C.R. 520, refd to. [para. 65].

Bourgault Industries Ltd. v. Flexi-Coil Ltd. (1999), 237 N.R. 74; 86 C.P.R.(3d) 221 (F.C.A.), refd to. [para. 66].

Dutch Industries Ltd. v. Commissioner of Patents et al., [2002] 1 F.C. 325; 301 N.R. 152 (F.C.A.), refd to. [para. 67].

Johnson & Johnson Inc. et al. v. Boston Scientific Ltd., [2005] 4 F.C.R. 110; 263 F.T.R. 242 (F.C.), refd to. [para. 68].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 70].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al. (2006), 354 N.R. 88; 2006 SCC 49, refd to. [para. 70].

Noranda Mines Ltd. v. Minerals Separation North American Corp., [1947] Ex. C.R. 306, refd to. [para. 71].

Kingstreet Investments Ltd. et al. v. New Brunswick (Minister of Finance) et al. (2007), 355 N.R. 336; 309 N.B.R.(2d) 255; 799 A.P.R. 255; 2007 SCC 1, refd to. [para. 73].

Monsanto Co. v. Merck & Co., [2000] EWHC Patents 154 (Ch. Div.), refd to. [para. 90].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 93].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 97].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161 (F.C.), affd. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401 (F.C.A.), refd to. [para. 98].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35 (F.C.), refd to. [para. 102].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 27(5) [para. 29]; sect. 73 [para. 53].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 6(2) [para. 7].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Robert H.C. MacFarlane and Christine M. Pallota, for the applicants;

John F. Rook, Q.C., Dino P. Clarizio and Dominique T. Hussey, for the respondent, Novopharm Ltd.;

No one appearing for the respondent, Minister of Health.

Solicitors of Record:

Bereskin & Parr, Toronto, Ontario, for the applicants;

Bennett Jones LLP, Toronto, Ontario, for the respondent, Novopharm Ltd.;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This application was heard on January 8-11, 2007, at Toronto, Ontario, before Hughes, J., of the Federal Court, who delivered the following judgment on January 24, 2007.