Janssen-Ortho Inc. et al. v. Novopharm Ltd., (2006) 301 F.T.R. 166 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: October 17, 2006
• Jurisdiction: Canada (Federal)
• Citations: (2006), 301 F.T.R. 166 (FC);2006 FC 1234

Janssen-Ortho Inc. v. Novopharm Ltd. (2006), 301 F.T.R. 166 (FC)

MLB headnote and full text

Temp. Cite: [2006] F.T.R. TBEd. OC.041

Janssen-Ortho Inc. and Daiichi Pharmaceutical Co. Ltd. (plaintiffs) v. Novopharm Limited (defendant)

(T-2175-04; 2006 FC 1234)

Indexed As: Janssen-Ortho Inc. et al. v. Novopharm Ltd.

Federal Court

Hughes, J.

October 17, 2006.

Summary:

The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin", specifically claim 4. The patent application was filed on June 19, 1986. The patent was issued on June 23, 1992. The defendant admitted infringement, but disputed the claim's validity.

The Federal Court held that claim 4 was valid and had been infringed. The court issued an injunction. A separate trial was to proceed respecting the quantum of damages.

Editor's note: In prior litigation, the court found that Novopharm's allegation that the relevant claims of the patent were invalid was "justified" pursuant to s. 6(2) of the Patented Medicines (Notice of Compliance) Regulations. See Janssen-Ortho Inc. et al. v. Novopharm Ltd. et al. (2004), 264 F.T.R. 202 (F.C.T.D.), appeal dismissed as moot (2005), 337 N.R. 259 (F.C.A.), leave to extend time to appeal denied (2005), 345 N.R. 174 (S.C.C.). Those findings were held not to constitute res judicata in this case, which was an action for infringement under the Patent Act, R.S.C. 1985, c. P-4 (i.e., the "old" Patent Act), which applied to patents applied for before October 1, 1989.

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin", specifically claim 4 - The patent application was filed on June 19, 1986 - The defendant admitted infringement, but disputed the claim's validity - In prior litigation, the court had found that the defendant's allegation that the relevant claims of the patent were invalid on the basis of obviousness was "justified" pursuant to s. 6(2) of the Patented Medicines (Notice of Compliance) Regulations - The Federal Court held that those findings did not constitute res judicata in the present case, which was an action for infringement under the old Patent Act, which applied to patents applied for before October 1, 1989 - Here the court had to make a finding of validity or otherwise on the basis of "balance of probabilities" on the evidence before it - The standard of "justification" was somewhat different than that of validity, on the balance of probabilities on the evidence led - The court found that the defendant had failed to establish that claim 4 was invalid on the basis of obviousness or lack of inventive ingenuity - See paragraphs 74 and 116.

Patents of Invention - Topic 1004

The specification and claims - General - Substances intended for food and medicine - The plaintiffs sued for infringement of a patent, relating to the antimicrobial drug levofloxacin, specifically claim 4 - The defendant admitted infringement, but disputed the claim's validity - The Federal Court stated that the "claim does not address medical properties or uses, nor does it need to. Where the compound is new, it is sufficient that its utility is set out in the specification. It need not be included in the claim." - See paragraph 96.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin", specifically claim 4 - The defendant admitted infringement, but disputed the claim's validity - The Federal Court held that it was to construe the claim as of the date that the patent was granted - Construction was an objective exercise, to be pursued through the eyes of an ordinary person skilled in the art as of that date in the context of the rest of the specification, giving a purposive construction to the claim with that background - Here, the ordinary person skilled in the art could be ascertained from the language of the specification - That person would be someone with at least a first level university education, and at least a few years of experience concerned with chemical compounds and deriving optically active compounds therefrom particularly in the area of compounds having medicinal uses - See paragraphs 88 to 91.

Patents of Invention - Topic 1128.1

The specification and claims - The description - Sufficiency of description of invention - The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin", specifically claim 4 - The defendant argued, inter alia, that claim 4 was ambiguous in failing to specify which level of purity, if any, was required by the claim - The Federal Court rejected the argument - The court stated that "claim 4, as properly construed, does not require any explanation or parameter respecting purity. ... The ordinary person skilled in the art would know ... that the compound is reasonably pure so as to its job for instance as an antimicrobial agent. No specific number or range, or other definition is required" - See paragraphs 117 and 119.

Patents of Invention - Topic 1128.1

The specification and claims - The description - Sufficiency of description of invention - [See Patents of Invention - Topic 1502 ].

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - The plaintiffs sued for infringement of a patent (issued in 1992) relating to the antimicrobial drug "levofloxacin", specifically claim 4 - The defendant argued, inter alia, that the toxicity and solubility data failed to provide a correct full and clear description as required by s. 34(1) of the Patent Act - The Federal Court rejected the argument - Although the data presented in the patent as to toxicity and solubility was scant, it did not affect the patent's validity - What the patent asserted was that the S(-) form of ofloxacin had increased antimicrobial activity, reduced toxicity and markedly high water solubility, giving it an expectation to be a very useful pharmaceutical agent - That statement was correct - To even find this distribution of attributes, namely, more of the beneficial properties and at least no more of the detrimental, was itself remarkable - While one would have hoped for more and better data than that presented in the patent, there was presently no mechanism in the Patent Office for compelling an applicant to submit further data or to substantiate the data presented in the patent - The possibility of invalidation existed, but the data presented in the patent was not so insufficient as to warrant invalidation in this case - See paragraphs 118 and 119 to 127.

Patents of Invention - Topic 1509

Grounds of invalidity - General - Commercial success - Effect of - The Federal Court stated that "Evidence of commercial success is said to be an aid in determining whether what has been claimed as an invention is truly inventive. However, this evidence is, at best, secondary and is to be treated with caution as many factors having nothing to do with inventiveness such as marketing skills, marketing power, lack of any alternatives, pricing and more can contribute to commercial success " - See paragraph 70.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court stated that "anticipation and obviousness are both questions of fact but each must be approached differently. Anticipation means that your claimed invention, whether or not it was inventive, was already known to the public, thus cannot be the subject of a monopoly subsequently given to any one person. Obviousness means that while the claimed invention may not have been presumably known, it is nonetheless not something that a person can monopolize since it is something that a person skilled in the art would have been expected to come up with in any event." - See paragraph 100.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court discussed the test for obviousness - See paragraphs 109 to 113.

Patents of Invention - Topic 1583

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Commercial success - Effect of - [See Patents of Invention - Topic 1509 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin" (date of invention - December 1985), specifically claim 4 - The defendant argued, inter alia, that the claim lacked inventive ingenuity - The Federal Court disagreed - The claimed invention was one of the enantiomers (the S(-) enantiomer) of ofloxacin, a known compound, in a reasonably pure form - The separation of racemic compounds into their enantiomers was known, but of lesser significance in the medicinal chemical world of the early to mid 1980's - Known techniques and devices for separation of racemic compounds into their enantiomers could only produce minute quantities of impure material, scarcely enough to interest anyone in activity - Only the plaintiff Daiichi was motivated to pursue the matter - Once pressed, it found ways to produce enough (-) enantiomer to identify it as the S configuration and to determine that it exceeded ofloxacin as an antibiotic and was at least as good in respect of toxicity; solubility was greater - With some marketing effort, levofloxacin found a respectable place in the marketplace - It was not the greatest invention, not "eureka", but of sufficient "inventive ingenuity" to merit valid patent protection as set out in claim 4 - See paragraphs 114 and 115.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The plaintiffs sued for infringement of a 1992 patent relating to the antimicrobial drug "levofloxacin" (date of invention - December 1985), specifically claim 4 - Levofloxacin was a (-) optical isomer of ofloxacin - The defendant argued that claim 4 was anticipated by the prior disclosure of ofloxacin - Ofloxacin was described in (1) Canadian patent '840, granted in 1984, and owned by the plaintiff Daiichi and (2) a publication by Daiichi personnel in a scientific journal in March 1983 - The defendant claimed that the publication abstract told a person skilled in the art that ofloxacin was a (±) racemate and useful as an antimicrobial medicine - The defendant claimed that an ordinary person skilled in the art: (1) upon reading the publication, would know that one or other of the optical isomers of the racemates would have greater activity than the racemate; and (2) would have had, as of the early 1980s, common place apparatus and techniques available to separate the isomers from the racemates - The Federal Court held that obviousness was not proved - Neither the '840 patent nor the publication contained any direction that the optical isomers of ofloxacin would be more active than the racemate nor did either instruct how to effect such separation or to produce an optical isomer - See paragraphs 101 to 108.

Patents of Invention - Topic 3102

Infringement of patent - Remedies - Damages or accounting of profits - The plaintiffs sued for infringement of a patent relating to the antimicrobial drug "levofloxacin", specifically claim 4 - The defendant admitted infringement, but disputed the claim's validity - The Federal Court held that claim 4 was valid and had been infringed - The court stated that the award of profits was an equitable remedy and it was necessary for a party seeking an equitable remedy to show some basis for the exercise of equity - Here the plaintiffs had made no showing whatsoever and the court had no reason, other than the plaintiffs' success, for making such an award - Accordingly, it would not award the election of profits - See paragraph 132.

Patents of Invention - Topic 3827

Infringement actions - Damages - Profits - Accounting - [See Patents of Invention - Topic 3102 ].

Practice - Topic 4225

Discovery - Examination - Persons who may be examined - General - The plaintiffs resisted the calling of one of the defendant's witnesses (Dr. Gerster) on the basis that they had not been provided adequate discovery - The Federal Court stated that the plaintiffs were well aware of the defendant's position respecting Gerster's evidence - Further, there was no provision in the Federal Courts Rules for examination of a factual witness, by way of discovery, before trial - The plaintiffs themselves could have called Gerster as a witness and, if he did not attend voluntarily, used letters rogatory to compel that evidence - The court had given the plaintiffs an opportunity to receive a "will say" of Gerster's proposed evidence from the defendant before he testified and an opportunity to amend and expand upon their expert evidence if so advised, which they did by supplementary evidence - See paragraph 10.

Cases Noticed:

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. 57].

Créations 2000 Inc. et al. v. Canper Industrial Products Ltd. et al. (1988), 22 F.T.R. 180; 22 C.P.R.(3d) 389 (T.D.), affd. (1990), 124 N.R. 161; 34 C.P.R.(3d) 178 (F.C.A.), refd to. [para. 70].

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, appeal dismissed as moot (2005), 337 N.R. 259; 40 C.P.R.(4th) 1; 2005 FCA 6, application for extension of time to apply for leave to appeal denied, [2005] 1 S.C.R. 776; 345 N.R. 174; 40 C.P.R.(4th) 1; 2005 FCA 6, refd to. [para. 74].

Novartis AG et al. v. Apotex Inc. et al. (2002), 298 N.R. 348; 22 C.P.R.(4th) 450; 2002 FCA 440, refd to. [para. 74].

Ortho-McNeil Pharmaceutical Inc. et al. v. Mylan Laboratories Inc. et al. (2004), 348 F. Supp.2d 713, refd to. [para. 75].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 77].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553, refd to. [para. 77].

Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570, refd to. [para. 77].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 285 F.T.R. 1; 46 C.P.R.(4th) 244; 2005 FC 1725, refd to. [para. 89].

Halford et al. v. Seed Hawk Inc. et al. (2006), 353 N.R. 60; 2006 FCA 275, refd to. [para. 90].

Monsanto Canada Inc. et al. v. Schmeiser et al. (2001), 202 F.T.R. 78; 12 C.P.R.(4th) 204 (F.C.), affd. (2002), 293 N.R. 340; 21 C.P.R.(4th) 1 (F.C.A.), affd. [2004] 1 S.C.R. 902; 320 N.R. 201, refd to. [para. 96].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 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. 96].

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R. 9, refd to. [para. 98].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 99].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 99].

Rothmans, Benson & Hedges Inc. et al. v. Imperial Tobacco Ltd. (1993), 152 N.R. 292; 47 C.P.R.(3d) 188 (F.C.A.), refd to. [para. 100].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 105].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2005] UKHL 59; [2006] 1 All E.R. 685; [2006] R.P.C. 10, refd to. [para. 106].

Smithkline Beecham plc's (Paroxetine Methanesulfonate) Patent, Re - see Synthon BV v. Smithkline Beecham plc.

Société Technique de Pulvérisation Step v. Emson Europe Ltd., [1993] R.P.C. 513 (C.A.), refd to. [para. 110].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 111].

Molnlycke AB v. Procter & Gamble Ltd. (No. 5), [1992] F.S.R. 549 (Patents Ct.), refd to. [para. 113].

Molnlycke AB v. Procter & Gamble Ltd., [1994] R.P.C. 49 (Ch.), refd to. [para. 113].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 195, refd to. [para. 113].

Zenitz, Re, 33 F.2d 924, refd to. [para. 113].

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. 122].

Merck & Co. et al. v. Apotex Inc. (2006), 354 N.R. 355; 2006 FC 524, refd to. [para. 132].

Minnesota Mining & Manufacturing Co. v. Johnson & Johnson Ltd., [1976] R.P.C. 671 (C.A.), refd to. [para. 133].

Authors and Works Noticed:

Caldwell, John, Do Single Enantiomers have Something Special to Offer (2001), generally [para. 114].

Counsel:

Neil Belmore, Ken Clark and Roger Tam, for the plaintiff, Janssen-Ortho Inc.;

Michael E. Charles, Andrew I. McIntosh and Joshua Spicer, for the plaintiff, Daiichi Pharmaceutical Co. Ltd.;

David W. Aitken, Bradley White, Marcus Klee and Geoffrey North, for the defendant.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Toronto, Ontario, for the plaintiff, Janssen-Ortho Inc.;

Bereskin & Parr, Toronto, Ontario, for the plaintiff, Daiichi Pharmaceutical Co. Ltd.;

Osler, Hoskin & Harcourt LLP, Ottawa, Ontario, for the defendant.

This appeal was heard at Toronto, Ontario, on September 5-28 and October 3-5, 2006, by Hughes, J., of the Federal Court, who delivered the following decision on October 17, 2006.