Eli Lilly Canada Inc. v. Apotex Inc. et al., (2008) 323 F.T.R. 56 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: February 05, 2008
• Jurisdiction: Canada (Federal)
• Citations: (2008), 323 F.T.R. 56 (FC);2008 FC 142

Eli Lilly Can. Inc. v. Apotex Inc. (2008), 323 F.T.R. 56 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. FE.020

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

(T-1364-05; 2008 FC 142)

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

Federal Court

Hughes, J.

February 5, 2008.

Summary:

Eli Lilly Canada Inc. applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing as an active ingredient a medicine commonly called raloxifene for a particular use being the treatment and prevention of osteoporosis, particularly in post menopausal women, until the expiry of patent no. 2,101,356.

The Federal Court dismissed the application.

Patents of Invention - Topic 1004

The specification and claims - General - Substances intended for food and medicine - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - An issue arose as to the construction of claims 1, 3, 15 and 17 of the patent - Apotex argued that the plain meaning of the words "osteoporosis" and "bone loss" in the claims meant any form of osteoporosis or bone loss however caused - However, Eli Lilly claimed that, when read in the context of the patent as a whole, the terms "osteoporosis" and "bone loss" referred only to osteoporosis and bone loss "which arises from a lack of estrogen" - The Federal Court construed the patent accordingly - The court construed two of the claims to apply to medicaments to treat bone loss or osteoporosis of any kind, while the other two claims were limited to where these conditions had certain causes - See paragraphs 25 to 57.

Patents of Invention - Topic 1004

The specification and claims - General - Substances intended for food and medicine - The Federal Court noted that, at one time, Canada as well as some other countries did not permit claims for a medicine per se - As a result claims became structured in certain ways so that, indirectly, some monopoly protection could be claimed - The court stated that presently in Canada claims directed to a medicine, and in particular to a previously known medicine could be structured in a variety of ways such as: "The use of an old medicine for the treatment of a new disorder (new use claim); The process for making an old medicine that is to be used in the treatment of a new disorder (process claim); The use of an old medicine when prepared by a certain process for the treatment of a new disorder (process-dependent claim); The use of an old medicine for the manufacture of a medicament for the treatment of a new disorder (Swiss claim). Each of these claims could arguably be said in 'spirit' or 'essence' to be directed to the new use of a known medicine, but each is structured differently" - See paragraphs 22 and 23.

Patents of Invention - Topic 1004

The specification and claims - General - Substances intended for food and medicine - The Federal Court discussed the "Swiss" style of drafting a patent claim for a medicine - The court explained that in Europe, historically, claims that were "susceptible of industrial application" were quite permissible but "methods of treatment of the human body ... by surgery or therapy and diagnostic methods" were not, with the saving provision that "substances or compositions, for use in any of these methods" were permitted to be claimed - Thus a new medicine could be claimed, but not a new use for an old medicine - The Swiss developed a way around this issue of claiming a new use for an old medicine by characterizing the manufacture of a pill for a new use as something that was "susceptible of industrial application" thus this type of claim became known as a "Swiss claim" - The court noted an example of drafting in the "Swiss" style as: "The use of [an old compound] in the manufacture of a medicament for the treatment of [a new disorder]" - See paragraphs 18 and 20.

Patents of Invention - Topic 1006

The specification and claims - General - Interpretation of - The Federal Court stated that construction of the patent claims was to be made by the court before consideration was given to issues of infringement and validity - The court stated further that construction was a task for the court alone and the role of an expert, if required, was limited to assisting the court in putting the court in the position of a person skilled in the art as of the relevant time - See paragraphs 25 and 26.

Patents of Invention - Topic 1006

The specification and claims - General - Interpretation of - The Federal Court stated that "the court must approach the matter of claim construction in an informed and purposive manner. Information is to be gained from the patent as a whole in order to determine the context in which the claims are to be considered, and from experts whose role is to provide assistance, if necessary, in respect of the technical meaning of the terms and concepts used in the claims" - See paragraph 30.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - [See first Patents of Invention - Topic 1004 and both Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See first Patents of Invention - Topic 1004 ].

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - Apotex argued that claims 1, 3, 15 and 17 of the patent were broader than the invention disclosed - The Federal Court examined the claims, holding that claims 1, 3 and 15 were overly broad - See paragraphs 179 to 184.

Patents of Invention - Topic 1501

Grounds of invalidity - General - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - Apotex Inc. alleged that the patent was invalid on a number of grounds - The Federal Court (Hughes, J.), stated that "I have deliberately bundled all of the topics listed in the title of this portion of these reasons, 'Anticipation/Obviousness/Sound Prediction/Sufficiency of Disclosure' together. There is one issue to be considered namely, the validity of the '356 patent. There is a tendency in the jurisprudence to pigeonhole arguments respecting validity into certain categories such as 'anticipation' or 'obviousness' and so forth. Each category has collected about itself an accumulation of jurisprudence. Each category tends to be argued separately creating, on occasion, contradictions, inconsistencies and gaps. This is an occasion when one should step back and examine the fundamentals of the patent system and determine whether a more holistic approach is appropriate" - See paragraph 64.

Patents of Invention - Topic 1502

Grounds of invalidity - Onus and standard of proof - The Federal Court discussed what party bears the burden of proof in Notice of Compliance proceedings when the validity of the patent is in issue - See paragraph 58.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - Apotex Inc. attacked the validity of the patent on the grounds of obviousness, sound prediction and sufficiency of disclosure - The Federal Court, considered these grounds together - The court held that the allegation of obviousness was not justified; however, the allegation in respect of lack of sound prediction was justified because the '356 patent lacked adequate disclosure - See paragraphs 153 to 184.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - Apotex Inc. argued that the patent was invalid because it was anticipated by prior publications - The Federal Court rejected Apotex's argument - See paragraphs 127 to 152.

Patents of Invention - Topic 1605

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

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 3006

Infringement of patent - Defences - Patent indistinguishable from prior art (Gillette defence) - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - Apotex alleged that it would not be infringing the patent by marketing its generic product based on the "Gillette defence" - That defence, based on Gillette Safety Razor Co. v. Anglo-American Trading Co. (House of Lords 1913), was that a person was simply doing something that was already part of the prior art, therefore, either the patent was invalid for anticipation as it claimed the prior art, or there was no infringement because if the patent was not claiming the prior art then it could not be claiming what was being practised by the defendant - The Federal Court noted that in this case there was no anticipation of what was claimed in the '356 patent - The sale by Apotex of raloxifene for the specific purpose of treating bone loss or osteoporosis in humans did not fall within the prior art - Although there were other reasons why the patent was invalid, anticipation was not one of those reasons - The court opined that if the patent was valid, at least four of the claims of the '356 patent would be infringed by Apotex if it received the NOC that it sought - See paragraphs 185 to 187.

Patents of Invention - Topic 5511

New substances licences - Food and medicine - General - [See all Patents of Invention - Topic 1004 ].

Practice - Topic 7028.1

Costs - Party and party costs - Entitlement to party and party costs - Successful party - Exceptions - Unproven matters - Eli Lilly Canada Inc. applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a drug containing a medicine commonly called raloxifene for the treatment and prevention of osteoporosis and bone loss, particularly in post menopausal women, until the expiry of patent no. 2,101,356 - The drug was sold in tablet form for oral administration, 60 mg strength, under the brand name EVISTA - Apotex Inc., in its notice of allegation, alleged that the patent was invalid because the named inventors were not true inventors and that the statement made in the petition for the patent that they were the inventors was untrue and wilfully made for the purpose of misleading - Apotex however made no mention of this allegation in its submissions to the court or in its memorandum - Counsel indicated that the matter was abandoned - The Federal Court stated that to raise an issue of fraud or even the type of fraud described in s. 53 of the Patent Act and not follow through with the matter, or fail to prove it, would have serious consequences when it came to the question of costs - In this case, the court reduced Apotex's costs by 25% - See paragraphs 59 to 63 and 188 to 192.

Cases Noticed:

Deprenyl Research Ltd. et al. v. Apotex Inc. et al. (1994), 77 F.T.R. 62; 55 C.P.R.(3d) 171 (T.D.), affd. (1995), 180 N.R. 323; 60 C.P.R.(3d) 501 (F.C.A.), refd to. [para. 19].

Bristol-Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc., [1998] EWHC Patents 300 (Ch. D.), affd. [2000] EWCA Civ. 169 (C.A.), refd to. [para. 21].

Whirlpool et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 25].

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. 25].

Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570, refd to. [para. 25].

Halford et al. v. Seed Hawk Inc. et al. (2006), 353 N.R. 60; 2006 FCA 275, refd to. [para. 26].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 26].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150, refd to. [para. 30].

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

Halford et al. v. Seek Hawk Inc. et al. (2004), 246 F.T.R. 1; 2004 FC 88, affd. (2006), 353 N.R. 60; 2006 FCA 275, refd to. [para. 52].

Nekoosa Packaging Corp. v. United Dominion Industries Ltd. - see Nekoosa Packaging Corp. et al. v. AMCA International Ltd. et al.

Nekoosa Packaging Corp. et al. v. AMCA International Ltd. et al. (1994), 56 C.P.R.(3d) 470 (F.C.A.), refd to. [para. 54].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 2008 FC 11, refd to. [para. 58].

Beloit Canada Ltd. v. Valmet Oy (1984), 78 C.P.R.(2d) 1 (T.D.), revd. (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 62].

Darcy v. Allin (Allein) (1602), 11 Co. Rep. 84 (Common Law Cts.), refd to. [para. 66].

Davenant v. Hurdis (1599), Moore K.B. 576, refd to. [para. 66].

Clothworkers of Ipswich Case, Re (1615), Godb. 252, refd to. [para. 66].

Cadbury Schweppes Inc. et al. v. FBI Foods Ltd. et al., [1999] 1 S.C.R. 142; 235 N.R. 30; 117 B.C.A.C. 161; 191 W.A.C. 161, refd to. [para. 69].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 71].

Merrell Dow Pharmaceuticals Inc. et al. v. Norton (H.N.) & Co. et al., [1996] R.P.C. 76; 189 N.R. 364 (H.L.), refd to. [para. 82].

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. 127].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2005] UKHL 59, refd to. [para. 129].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 56 C.P.R.(4th) 387 (F.C.A.), refd to. [para. 136].

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. 162].

Farbwerke Hoechst A/G v. Commissioner of Patents, [1966] Ex. C.R. 91, refd to. [para. 180].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 180].

Gillette Safety Razor Co. v. Anglo-American Trading Co. (1913), 30 R.P.C. 465 (H.L.), refd to. [para. 185].

Authors and Works Noticed:

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), pp. 1 to 13 [para. 65].

Moy, R. Carl, Moy's Walker on Patents (4th Ed. 2003) (Looseleaf Update), generally [para. 128].

Counsel:

Anthony Creber and Jeff Mutter, for the applicant;

Andrew Brodkin, Belle Van and Richard Naiberg, for the respondents.

Solicitors of Record:

John H. Sims, Q.C., Deputy Attorney General of Canada, Toronto, Ontario, for the respondents.

This application was heard in Ottawa, Ontario, on January 21 to 23, 2008, by Hughes, J., of the Federal Court, who delivered the following decision on February 5, 2008.