Eli Lilly Canada Inc. v. Apotex Inc. et al., 2007 FC 455

• Judge: Gauthier, J.
• Court: Federal Court (Canada)
• Case Date: April 27, 2007
• Jurisdiction: Canada (Federal)
• Citations: 2007 FC 455;(2007), 311 F.T.R. 21 (FC)

Eli Lilly Can. Inc. v. Apotex Inc. (2007), 311 F.T.R. 21 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. MY.015

Eli Lilly Canada Inc. (applicant) v. Apotex Inc. and The Minister of Health (respondents) and Eli Lilly and Company Limited (respondent/patentee)

(T-156-05; T-787-05; 2007 FC 455)

Indexed As: Eli Lilly Canada Inc. v. Apotex Inc. et al.

Federal Court

Gauthier, J.

April 27, 2007.

Summary:

The drug olanzapine was the subject of Canadian Patent 2,041,113 which was made and marketed in Canada by Eli Lilly Canada Inc. under the brand name "Zyprexa". Olanzapine was an antipsychotic medicine used to treat patients who suffered from various forms of mental illness, particularly schizophrenia. Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations that would allow Apotex Inc., a generic drug manufacturer, to make and sell 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets of olanzapine.

The Federal Court granted the prohibition orders sought by Eli Lilly.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation - Apotex Inc. filed a Notice of Allegation (NOA) respecting olanzapine (the '113 Patent), an antipsychotic medicine used to treat mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations - Eli Lilly objected to Apotex raising a ground of invalidity that was not raised in its NOA (i.e., Eli Lilly submitted that Apotex failed to state in its NOA that the '113 Patent was not "a valid selection patent" and did not mention its various allegations why the '113 Patent did not meet the criteria of a selection patent) - Apotex argued that the issue of selection was put forth by Eli Lilly as a defence to the allegation of double patenting in the NOA and therefore Apotex was entitled to respond - The Federal Court held that if Apotex wanted to challenge the basis of the selection and the validity, sufficiency or accuracy of the facts set out in the disclosure, it had to include all those legal allegations and all related factual allegations in its NOA - The court stated that it would not put on Eli Lilly the burden of actually proving that the disclosure of the '113 Patent was sufficient to enable a person skilled in the art to get the advantages described in it because Apotex has failed to allege insufficiency as a ground of invalidity - See paragraphs 84 to 125.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - The drug olanzapine was the subject of Canadian Patent 2,041,133 which was made and marketed in Canada by Eli Lilly Canada Inc. under the brand name "Zyprexa" - Olanzapine was an antipsychotic medicine used to treat patients who suffered from various forms of mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations that would allow Apotex Inc., a generic drug manufacturer, to make and sell 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets of olanzapine - The Federal Court granted the prohibition orders sought by Eli Lilly - See paragraphs 1 to 385.

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - Apotex Inc. filed a Notice of Allegation (NOA) respecting olanzapine, an antipsychotic medicine used to treat mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations - Eli Lilly filed a motion to strike a document (an article) which was included in the NOA, claiming that Apotex was using the article for a "new" purpose - That article entitled: "In Vitro Thiomethylation", was listed in the NOA under the heading "Documents Subsequent to 1980", was only described by Apotex as disclosing a particular formula - Later, however, it was used by two Apotex experts to support their view of the prior art - The Federal Court refused to strike the document - The court stated that the true remedy in this situation was to seek the right to reply and Eli Lilly had done just that - Here, the Prothonotary correctly gave Eli Lilly the right to reply - See paragraphs 59 to 71.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof ) - [See Food and Drug Control - Topic 1302 ].

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof - Apotex Inc. filed a Notice of Allegation (NOA) respecting olanzapine (the '113 Patent), an antipsychotic medicine used to treat mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) under the Patented Medicines (Notice of Compliance) Regulations - A dispute arose as to who had the burden of proof and how that burden was affected by the presumption of validity in s. 43(2) of the Patent Act - The Federal Court held that the applicant for a prohibition order under the NOC Regulations (in this case Eli Lilly) had the burden of establishing its entitlement to that order - The court stated that presumption of validity in s. 43 could not be determinative in NOC proceedings if the record contained any evidence that, if accepted, was capable of rebutting the presumption - See paragraphs 224 to 245.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - The Federal Court stated that there were two general classes of chemical patents: (1) the originating patent where there was an originating invention involving the discovery of a new reaction or new compound (or genus); and (2) a selection patent, which was based on a selection from related compounds derived from the original compound (or genus) and which had been described in general terms and claimed in the originating patent - The court discussed generally the concept of selection patents - The court stated, inter alia, that it was satisfied that, contrary to the situation involving patents for new use of a known compound, an inventor could claim a selected compound without referring to its special advantages in the claim - See paragraphs 84 to 125.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Apotex Inc. filed a Notice of Allegation (NOA) respecting olanzapine (the '113 Patent), an antipsychotic medicine used to treat mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations - Apotex challenged the validity of the patent on the basis of s. 53 of the Patent Act (i.e., arguing that the patent was void because it could be inferred on the basis of the evidence in this case that information provided to the patent examiner by Eli Lilly was misleading) - The Federal Court noted that there was no direct evidence of knowledge or of an intention to mislead on the part of Eli Lilly - Further, on the basis of the evidential record produced by Apotex, it was also clear that the court could not infer an intention to deceive which was an essential element to establish the validity of Apotex's allegation made pursuant under s. 53 - Therefore, the Court was not satisfied that Apotex had met its evidential burden and that the presumption of validity (s. 43) was spent - See paragraphs 365 to 382.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court reviewed the general principles respecting the concept of obviousness - See paragraphs 296 to 307.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court referred to the test for obviousness - See paragraph 296.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents -The drug olanzapine, the subject of Canadian Patent 2,041,133 (a selection patent), was made and marketed in Canada by Eli Lilly Canada Inc. under the brand name "Zyprexa" - Olanzapine was an antipsychotic medicine used to treat patients who suffered from various forms of mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations that would allow Apotex Inc., a generic drug manufacturer, to make and sell 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets of olanzapine - Apotex alleged that the invention as described in the patent was invalid for obviousness - The Federal Court held that the patent was not invalid for obviousness - See paragraphs 296 to 359.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See second Patents of Invention - Topic 1604 ].

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - The Federal Court reviewed the general principles relating to the concept of anticipation, noting that there were two requirements for anticipation: enablement and disclosure - The court stated that with respect to selection patents, although the general principles applied, their application was somewhat modified - Selection patents were one of two general classes of chemical patents, namely: (1) the originating patent where there was an originating invention involving the discovery of a new reaction or new compound (or genus); and (2) a selection patent, which was based on a selection from related compounds derived from the original compound (or genus) and which had been described in general terms and claimed in the originating patent - The court stated that different analysis was required to determine whether a claim to a selected compound was anticipated by a prior patent that claimed a broad class or genus encompassing the selected member(s) - The court elaborated on this analysis - See paragraphs 247 to 268.

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - The drug olanzapine, the subject of Canadian Patent 2,041,133 (a selection patent), was made and marketed in Canada by Eli Lilly Canada Inc. under the brand name "Zyprexa" - Olanzapine was an antipsychotic medicine used to treat patients who suffered from various forms of mental illness, particularly schizophrenia - Eli Lilly applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations that would allow Apotex Inc., a generic drug manufacturer, to make and sell 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets of olanzapine - Apotex alleged that the invention as described in the patent was invalid for anticipation (i.e., it was fully disclosed in a prior patent and a prior article) - The Federal Court held that the originating patent did not anticipate the claims in the '133 patent nor was olanzapine anticipated by the prior literature - See paragraphs 247 to 295.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Olanzapine - [See second Patents of Invention - Topic 1604 ].

Cases Noticed:

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. 4].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 4].

R. v. D.D. (2000), 259 N.R. 156; 136 O.A.C. 201; 2000 SCC 43, refd to. [para. 8].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 68].

Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc. et al. (2005), 331 N.R. 373; 2005 FCA 50, refd to. [para. 68].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 82].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1283, refd to. [para. 82].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, refd to. [para. 85].

I.G. Farbenindustrie A.G.'s Patents, Re (1930), 47 R.P.C. 289 (Ch. Div.), refd to. [para. 86].

Du Pont (E.I.) de Nemours & Co. Application, Re, [1982] F.S.R. 303 (H.L.), refd to. [para. 86].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2006), 358 N.R. 135; 2006 FCA 421, refd to. [para. 86].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 104].

Pharmacia Corp. v. American Co., [2002] R.P.S. (C.A.), refd to. [para. 107].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 303 F.T.R. 284; 2006 FC 1471, refd to. [para. 115].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339; 2002 FCA 290, refd to. [para. 118].

Bayer AG et al. v. Novopharm Ltd. et al. (2006), 289 F.T.R. 263; 2006 FC 379, refd to. [para. 120].

P.S. Partsource Inc. v. Canadian Tire Corp. (2001), 267 N.R. 135; 2001 FCA 8, refd to. [para. 140].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 146 F.T.R. 249; 80 C.P.R.(3d) 550 (T.D.), affd. (1999), 249 N.R. 15; 3 C.P.R.(4th) 286 (F.C.A.), refd to. [para. 143].

Ward v. Samson Cree Nation No. 444 et al., [2001] F.T.R. Uned. 668; 2001 FCT 990, refd to. [para. 143].

Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1996), 69 C.P.R.(3d) 49 (T.D.), refd to. [para. 143].

Bruno v. Canada (Attorney General) et al., [2003] F.T.R. Uned. 751; 2003 FC 1281, refd to. [para. 143].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 160].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241, refd to. [para. 172].

R. v. Lavallee, [1990] 1 S.C.R. 852; 108 N.R. 321; 67 Man.R.(2d) 1, refd to. [para. 183].

R. v. Abbey, [1982] 2 S.C.R. 24; 43 N.R. 30, refd to. [para. 190].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 203, footnote 51].

Goodman Estate v. Geffen, [1991] 2 S.C.R. 353; 127 N.R. 241; 125 A.R. 81; 14 W.A.C. 81, refd to. [para. 225].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 228].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2004] 2 F.C.R. 269; 328 N.R. 149; 37 C.P.R.(4th) 289; 2004 FCA 393, refd to. [para. 228].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 2006 FCA 64, refd to. [para. 231].

Diversified Products Corp. and Brown Fitzpatrick Lloyd Patent Ltd. v. Tye-Sil Corp. (1991), 125 N.R. 218; 35 C.P.R.(3d) 350 (F.C.A.), refd to. [para. 234].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (2002), 296 N.R. 130; 2002 SCC 77, refd to. [para. 235].

Circle Firm Enterprises Inc. v. Canadian Broadcasting Corp., [1959] S.C.R. 602, refd to. [para. 236].

Powell v. Cockburn, [1977] 2 S.C.R. 218; 8 N.R. 215, refd to. [para. 236].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 238].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al. (1996), 197 N.R. 241; 67 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 244].

Free World Trust v. Electro Santé Inc. et al. (2000), 263 N.R. 150; 2000 SCC 66, refd to. [para. 247].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 247].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (C.A.), refd to. [para. 248].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2005] UKHL 59, refd to. [para. 250].

Kirin-Amgen Inc. et al. v. Hoechst Marion Roussel Ltd. et al., [2005] 1 All E.R. 667; 331 N.R. 1; [2004] UKHL 46, refd to. [para. 252].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, refd to. [para. 253].

Beecham Group Ltd. v. Bristol Laboratories International S.A. (1978), 16 R.P.C. 521 (H.L.), refd to. [para. 258].

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Rambaxy UK Ltd. v. Warner-Lambert Co., [2006] EWCA Civ 876 (C.A.), [2005] EWHC 2142 (Pat.), refd to. [para. 258].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (1997), 134 F.T.R. 201 (T.D.), refd to. [para. 267].

Steel Co. of Canada Ltd. v. Sivaco Wire and Nail Co. (1973), 11 C.P.R.(2d) 153 (F.C.T.D.), refd to. [para. 298].

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Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 298].

Farbwerke Hoechst Aktiengessellschaf v. Halocarbon (Ontario) Ltd. and Halocarbon Products Corp., [1979] 2 S.C.R. 929; 27 N.R. 582, refd to. [para. 299].

Bayer Aktiengesellschaft et al. v. Apotex Inc. (1995), 60 C.P.R.(3d) 58 (Gen. Div.), refd to. [para. 301].

Hallen v. Brabantia (U.K. Ltd.), 1991 R.T.C. 195, refd to. [para. 309].

IVAX Pharmaceutical (U.K. Ltd.) v. Chugai Seiyaku Kabushiki Kaisha, [2006] EWHC 756 (Pat.), refd to. [para. 309].

Abbott Laboratories Ltd. et al. v. Nu-Pharm Inc. et al. (1998), 231 N.R. 326; 83 C.P.R.(3d) 441 (F.C.A.), refd to. [para. 339].

Merck-Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 160 F.T.R. 161; 84 C.P.R.(3d) 492 (T.D.), affd. (2000), 259 N.R. 88; 8 C.P.R.(4th) 48 (F.C.A.), refd to. [para. 339].

CertainTeed Corp. v. Canada (Attorney General) et al. (2006), 289 F.T.R. 312; 2006 FC 436, refd to. [para. 352].

Pharmascience v. Sanofi-Aventis Canada Inc. - see Aventis Pharma Inc. et al. v. Pharmascience Inc. et al.

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Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 43(2) [para. 224]; sect. 53 [para. 367].

Authors and Works Noticed:

Canada, Manual of Patent Office Practice, s. 11.12 [para. 97].

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), pp. 89, 90 [para. 87].

Hayhurst, William L., The Art of Claiming and Reading a Claim, in Henderson, Gordon F., Patent Law of Canada (1994), generally [para. 96].

Henderson, Gordon F., Patent Law of Canada (1994), generally [para. 96].

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (1992), p. 142 [para. 178]; para. 12.88 [para. 180].

Terrell on the Law of Patents (16th Ed. 2006), c. 7 [para. 90, footnote 34].

White, T.A. Blanco, Patents for Inventions and the Protection of Industrial Designs (5th Ed. 1983), pp. 4-110, 4-224, 4-303, 4-511 [para. 90, footnote 34].

Counsel:

Anthony Creber, Jay Zakaib, John Norman and Cristin Wagner, for the applicant, Eli Lilly Canada Inc.;

H.B. Radomski, Andrew R. Brodkin, Richard Naiberg and Sorelle A. Simmons, for the respondent, Apotex Inc.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the applicant;

Goodmans LLP, Toronto, Ontario, for the respondent.

This matter was heard at Ottawa, Ontario, on February 19-27, 2007, by Gauthier, J., of the Federal Court, who delivered the following decision on April 27, 2007.