Lundbeck Canada Inc. v. Canada (Minister of Health) et al., (2009) 343 F.T.R. 53 (FC)

• Judge: Harrington, J.
• Court: Federal Court (Canada)
• Case Date: February 25, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 343 F.T.R. 53 (FC);2009 FC 146

Lundbeck Can. Inc. v. Can. (2009), 343 F.T.R. 53 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. MR.012

Lundbeck Canada Inc. (applicant) v. The Minister of Health and Genpharm ULC (respondents) and H. Lundbeck A/S (respondent/patentee)

(T-372-07)

Lundbeck Canada Inc. (applicant) v. The Minister of Health and Apotex Inc. (respondents) and H. Lundbeck A/S (respondent/patentee)

(T-991-07)

Lundbeck Canada Inc. (applicant) v. The Minister of Health and Cobalt Pharmaceuticals Inc. (respondents) and H. Lundbeck A/S (respondent/patentee)

(T-1395-07; 2009 FC 146)

Indexed As: Lundbeck Canada Inc. v. Canada (Minister of Health) et al.

Federal Court

Harrington, J.

February 25, 2009.

Summary:

Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent in 2014. The respondents made allegations that the patent was invalid.

The Federal Court allowed Lundbeck's application and issued prohibition orders.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for obviousness given the prior art - The Federal Court held that patent '452 was valid - The difference between the prior art and the inventive concept of the invention was that, while the prior art disclosed the racemate citalopram useful as an antidepressant, it did not disclose or enable its enantiomers or even predict whether either of them would be useful as an antidepressant - The prior art did not allow the skilled addressee to "have come directly and without difficulty to the solution thought by the patent", i.e. the resolution of the racemate in sufficient quantity to permit the testing disclosed in the patent - Resolution was the inventive step - Once a sufficient quantity had been obtained, the testing to allow a prediction that escitalopram was useful as an antidepressant was mundane - It was the same test used for citalopram itself - The resolution of citalopram was not obvious - It was not more or less self-evident that resolution ought to work - There were almost an infinite number of parameters known to persons skilled in the art - The only trials carried out up to 1988 were by Lundbeck - They certainly were not routine - They were prolonged and arduous - They succeeded in inventing escitalopram - See paragraphs 53 to 124.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1584 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for anticipation - Patent '452 entitled "Enantiomers of Citalopram and Derivatives Thereof" stated in the abstract of the disclosure that the invention related to the two novel enantiomers of citalopram and to their use as antidepressant compounds - U.S. patents '193 and '884, or at least '193, were said to be the patents from which Canadian patent '452 was selected - Apart from the U.S. patents, the respondent relied on papers published in 1983, 1985 and 1986, which discussed depression and drugs that inhibited serotonin uptake - The Federal Court held that patent '452 was valid - The articles taught away from the invention covered by the '452 patent - They did not disclose escitalopram as useful in the treatment of depression and were in no way enabling - See paragraphs 50 to 52.

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - Patent '452 entitled "Enantiomers of Citalopram and Derivatives Thereof" stated in the abstract of the disclosure that the invention related to the two novel enantiomers of citalopram and to their use as antidepressant compounds - U.S. patents '193 and '884, or at least '193, were said to be the patents from which Canadian patent '452 was selected - Patent '193 disclosed a formula which might generate a few hundred different compounds - Citalopram was specifically claimed - Neither U.S. patent made mention of stereochemistry in general, or the enantiomers of citalopram in particular, much less claimed them - The Federal Court held that escitalopram was not a selection patent - The evidence was clear that if the subject matter of either prior U.S. patent were worked, the result would be a racemate, not an enantiomer - Consequently it could not be said that patent '452 formed part of either U.S. patent, and so the selection patent argument fell for lack of prior disclosure - See paragraphs 43 to 49.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for lack of usefulness - The Federal Court held that patent '452 was valid - The inventor did not promise that escitalopram was better than citalopram as an antidepressant, although there were now indications that it was indeed the case - Although there was no evidence that escitalopram had been tested on humans that was not a condition precedent to obtaining a patent, as opposed to obtaining food and drug administration approvals - The testing disclosed was on rodents, the same testing which had been done on citalopram - Since citalopram was a useful antidepressant and escitalopram was more potent with no indication of adverse side effects, it followed that the prediction was a sound one - Usefulness was promised, usefulness was predicted and usefulness was delivered - Only a scintilla of utility was required - See paragraphs 133 and 134.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1723 ].

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 - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for insufficiency - Apotex submitted that the '452 patent was invalid because it disclosed that escitalopram might be useful in the treatment of obesity and alcoholism, but provided no particulars thereof - The Federal Court held that patent '452 was valid - A failure to define the way an invention was produced or built would invalidate a patent on the grounds of insufficiency - A patent was sufficient as long as the patentee described what the invention was, its usefulness and described how a person skilled in the art could put it into practice by producing it - The patent made no promise or claim in regard to the treatment of obesity and alcoholism and so supporting data was not required - The claim portion of the patent specification took precedence over the disclosure portion - See paragraph 135.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for insufficiency - Apotex submitted that the '452 patent was invalid because even if it established that escitalopram was useful as an anti-depressant, it did not do so with respect to R-citalopram - The Federal Court held that patent '452 was valid - In the claim portion of the specification no promise whatsoever was made that R-citalopram was useful as an anti-depressant - Maybe it was - Maybe it was not - However, the patent could not fall because of something which was not claimed - At most, the patent disclosed R-citalopram and so it would be much too late for anyone to now seek patent protection - See paragraph 136.

Patents of Invention - Topic 1803

Grounds of invalidity - Prior knowledge and use - Particular patents - Lundbeck Canada Inc. applied for orders under the Patented Medicine (Notice of Compliance) Regulations prohibiting the Minister of Health from authorizing Genpharm ULC, Apotex Inc. and Cobalt Pharmaceuticals Inc. (the respondents) from manufacturing and selling their generic versions of escitalopram until the expiry of its patent ('452) in 2014 - The respondents asserted that patent '452 was invalid for anticipation by prior use - The respondents asserted that the body resolved citalopram into its two enantiomers on its own - The Federal Court held that patent '452 was valid - The evidence was outright conjecture - The precise configuration of the receptors within the body was not known, and there was no reason to believe that the R-enantiomer was completely inactive - The tests disclosed in the '452 patent suggested that there was some activity within the R-enantiomer, albeit even though it was some 60 to 130 times less potent than escitalopram - Furthermore, Rochat obtained his partially resolved citalopram by drawing human blood samples which suggested that the body did not resolve citalopram into substantially pure escitalopram and R-citalopram - The distinction between conjecture and inference was most important - See paragraphs 125 to 129.

Cases Noticed:

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299; 80 C.P.R.(3d) 368, refd to. [para. 4].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al. (2005), 334 N.R. 55; 39 C.P.R.(4th) 449; 2005 SCC 26, refd to. [para. 4].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2008), 381 N.R. 125; 69 C.P.R.(4th) 251; 2008 SCC 61, refd to. [para. 4].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 310 F.T.R. 185; 55 C.P.R.(4th) 271; 2007 FC 300, refd to. [para. 4].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 30; 2007 FCA 153, refd to. [para. 5].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 61 C.P.R.(4th) 305; 2007 FC 971, refd to. [para. 5].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 59 C.P.R.(4th) 416; 2007 FCA 163, refd to. [para. 6].

Sanofi-Aventis Inc. et al. v. Laboratoire Riva Inc. et al. (2007), 315 F.T.R. 59; 58 C.P.R.(4th) 109; 2007 FC 532, refd to. [para. 6].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. et al. (2004), 264 F.T.R. 202; 35 C.P.R.(4th) 353; 2004 FC 1631, refd to. [para. 11].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 57 C.P.R.(4th) 6; 2006 FC 1234, affd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, leave to appeal refused (2007), 383 N.R. 397 (S.C.C.), refd to. [para. 11].

Generics (U.K.) Ltd. & Ors. v. Lundbeck (H.) A/S, [2007] EWHC 1040; [2007] R.P.C. 32, revd. [2008] R.P.C. 19; [2008] EWCA Civ. 311, refd to. [para. 13].

Forest Labs. Inc. v. Ivax Pharms. Inc. (2006), 438 F. Supp.2d 479 (D. Del.), affd. (2007), 501 F.3d 1263 (Fed. Cir.), refd to. [para. 14].

Alphapharm Pty. Ltd. v. Lundbeck (H.) A/S, 2008 FCA 559, refd to. [para. 15].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 29].

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; 2000 SCC 67, refd to. [para. 29].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 267 F.T.R. 243; 37 C.P.R.(4th) 487; 2005 FC 9, refd to. [para. 29].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [para. 32].

Beloit Technologies Inc. v. Valmet Paper Machinery Inc., [1997] EWCA Civ. 993; [1997] R.P.C. 489 (C.A.), refd to. [para. 34].

Du Pont de Nemours (E.I.) & Co. (Witsiepe's) Application, Re, [1982] F.S.R. 303 (H.L.), refd to. [para. 37].

I.G. Farbenindustrie A-G's Patents, Re (1930), 47 R.P.C. 289 (Ch. Div.), refd to. [para. 38].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 39 C.P.R.(4th) 202; 2005 FC 390, affd. (2006), 358 N.R. 135; 59 C.P.R.(4th) 46; 2006 FCA 421, refd to. [para. 39].

May & Baker Ltd. and Others v. Boots Pure Drug Co., [1950] UKHL 1; [1950] R.P.C. 23, refd to. [para. 40].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2008), 328 F.T.R. 241; 2008 FC 593, refd to. [para. 43].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 44].

Synthon BV v. SmithKline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59; [2006] R.P.C. 10, refd to. [para. 44].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 2008 FC 1359, refd to. [para. 46].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 55].

Pozzoli SPA v. BDMO SA, [2007] EWCA Civ. 588, refd to. [para. 55].

Merck & Co. et al. v. Apotex Inc. et al. (2004), 253 F.T.R. 178; 32 C.P.R.(4th) 203; 2004 FC 567, refd to. [para. 75].

Ship Ikarian Reefer, Re - see National Justice Compania Naviera S.A. v. Prudential Assurance Co.; Ship Ikarian Reefer, Re.

National Justice Compania Naviera S.A. v. Prudential Assurance Co.; Ship Ikarian Reefer, Re, [1993] 2 Lloyd's Rep. 68 (Q.B.), revd. [1995] 1 Lloyd's Rep. 455 (C.A.), refd to. [para. 75].

KSR Intern. Co. v. Teleflex Inc. (2007), 127 S. Ct. 1727 (U.S.S.C.), refd to. [para. 78].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 103].

Ciba Ltd. v. Commissioners of Patents, [1956-1960] Ex. C.R. 142; 27 C.P.R. 82, affd. [1959] S.C.R. 378, refd to. [para. 110].

Kent Trade and Finance Inc. et al. v. JPMorgan Chase Bank et al. (2008), 388 N.R. 39; 2008 FCA 399, refd to. [para. 118].

Atlantic Engraving Ltd. v. Rosenstein (2002), 299 N.R. 244; 23 C.P.R.(4th) 5; 2002 FCA 503, refd to. [para. 118].

Merrell Dow Pharmaceuticals Inc. et al. v. Norton (H.N.) & Co. et al., [1996] R.P.C. 76; [1996] UKHL 14; 189 N.R. 364 (H.L.), refd to. [para. 127].

Minister of Employment and Immigration v. Satiacum (1989), 99 N.R. 171 (F.C.A.), refd to. [para. 129].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725; 46 C.P.R.(4th) 244, refd to. [para. 132].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 21 C.P.R.(4th) 499, refd to. [para. 133].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, refd to. [para. 134].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185; 60 D.L.R.(4th) 223; 25 C.P.R.(3d) 257, refd to. [para. 135].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 67 C.P.R.(4th) 23; 2008 FCA 108, refd to. [para. 135].

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].

Authors and Works Noticed:

Davies, Stephen G., Tetrahedron: Asymmetry, generally [para. 64].

Elati, Chandrashekar R., Kolla, Naveenkumar, and Mathad, Vijayavitthal T., Organic Process Research & Development (2007), generally [para. 116].

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 204 [para. 32].

Counsel:

Marie Lafleur and Julie Desrosiers, for the applicant and the respondent/patentee in T-372-07, T-991-07 and T-1395-07;

No one appearing for the respondent, The Minister of Health;

Bradley White and Marcus Klee, for the respondent, Genpharm ULC in T-372-07;

Andrew Brodkin and Richard Naiberg, for the respondent, Apotex Inc. in T-991-07;

Douglas Deeth and Heather Watts, for the respondent, Cobalt Pharmaceuticals Inc. in T-1395-07.

Solicitors of Record:

Fasken Martineau duMoulin LLP, Montréal, Quebec, for the applicant and the respondent/patentee in T-372-07, T-991-07 and T-1395-07;

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

Osler, Hoskin & Harcourt LLP, Ottawa, Ontario, for the respondent, Genpharm ULC in T-372-07;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc. in T-991-07;

Deeth Williams Wall LLP, Toronto, Ontario, for the respondent, Cobalt Pharmaceuticals Inc. in T-1395-07.

These applications were heard between December 1 and 18, 2008, at Montreal, Quebec, by Harrington, J., of the Federal Court, who delivered the following judgment on February 25, 2009.