Eli Lilly & Co. et al. v. Apotex Inc., (2009) 351 F.T.R. 1 (FC)

JudgeGauthier, J.
CourtFederal Court (Canada)
Case DateNovember 13, 2008
JurisdictionCanada (Federal)
Citations(2009), 351 F.T.R. 1 (FC);2009 FC 991

Eli Lilly & Co. v. Apotex Inc. (2009), 351 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. OC.028

Eli Lilly and Company and Eli Lilly Canada Inc. (plaintiffs) v. Apotex Inc. (defendant)

Apotex Inc. (plaintiff by counterclaim/defendant) v. Eli Lilly and Company and Eli Lilly Canada Inc. (defendants by counterclaim/plaintiffs) and Shionogi & Co. Ltd. (defendant by counterclaim)

(T-1321-97; 2009 FC 991)

Indexed As: Eli Lilly & Co. et al. v. Apotex Inc.

Federal Court

Gauthier, J.

October 1, 2009.

Summary:

Eli Lilly & Co. (Lilly U.S.), owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor®. Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed the patents by using bulk cefaclor in its Apo-cefaclor product which was imported from overseas manufacturers who used infringing processes to make cefaclor. Apotex challenged the validity of the patents. Apotex also filed a counterclaim raising Competition Act issues.

The Federal Court allowed the plaintiffs' infringement action. The court found that at least one valid claim in each of the eight patents were infringed by Apotex by its importation, manufacture, export, sale and offers for sale of cefaclor in Canada. The court held that the plaintiffs were entitled to elect either an accounting of profits or all damages sustained by reason of sales directly lost as a result of the infringement, to be assessed by reference. The plaintiffs were awarded interest and costs. The counterclaim was dismissed.

Damages - Topic 1318

Exemplary or punitive damages - Patent infringement - [See Patents of Invention - Topic 3821 ].

Equity - Topic 1003

Equitable relief - General - When refused - The Federal Court discussed the concept of disentitlement - The court stated that "... in order for disentitlement to be operative a defendant must establish a link between 'the alleged unlawful behaviour and the equitable remedy sought by the patent holder that could support an unclean hands defence' ..." - See paragraphs 633 to 635.

Equity - Topic 1003

Equitable relief - General - When refused - [See Patents of Invention - Topic 3101 ].

Evidence - Topic 7004.1

Opinion evidence - Expert evidence - General - Participation of counsel in prepartation of expert opinion - The Federal Court stated that "Normally there is nothing wrong with being assisted by one's lawyer in drafting one's report but despite the court's flexibility in that respect, one must not lose sight of the principle expressed in National Justice Compania Riviera S.A. v. Prudential Assurance Co. ('the Ikarian Reefer'), [1993] 2 Lloyd's Rep. 68 to the effect that 'expert evidence should be seen as the independent product of the expert uninfluenced as to form or content by the exigencies of litigation: Whitehouse v. Jordan [1981] 1 WLR 246 at 256, per Lord Wilberforce' (emphasis added). Certainly the more the lawyers are involved the more careful an expert must be in reviewing the text proposed to ensure that it truly reflects his or her views ..." - See paragraph 62.

Interest - Topic 3502

Statutory interest - On judgments - Commencement of - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging infringement of its patents by importation - Apotex challenged the validity of the patents - The Federal Court allowed the action, finding that at least one valid claim in each of the eight patents were infringed by Apotex, entitling the plaintiffs to elect either an accounting of profits or damages - Further, the plaintiffs were entitled to post-judgment interest, not compounded, at the rate of five percent (5%) per annum, as established by s. 4 of the Interest Act (Can. 1985) - The court stated that post judgment interest would commence upon the final assessment of the monetary damage amount or profits amount, until then pre-judgment interest would prevail - See paragraphs 675 and 884.

Interest - Topic 3506

Statutory interest on judgments - Rate of interest - [See Interest - Topic 3502 ].

Interest - Topic 5008

Interest as damages (prejudgment interest) - General principles - Prejudgment interest - Entitlement - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging infringement of its patents by importation - Apotex challenged the validity of the patents - The Federal Court allowed the action and found that at least one valid claim in each of the eight patents were infringed by Apotex, entitling the plaintiffs to elect either an accounting of profits or damages - Further, the plaintiffs were entitled to pre-judgment interest on the award of damages (if elected), not compounded, at a rate to be calculated separately for each year since infringing activity began at the average annual bank rate established by the Bank of Canada as the minimum rate at which it made short-term advances to the banks listed in Schedule 1 of the Bank Act (1985) - The court stated, however, that such award was conditional upon the reference judge not awarding interest under s. 36(4)(f) of the Federal Courts Act - See paragraphs 665 to 674 and 884.

Interest - Topic 5009

Interest as damages (prejudgment interest) - General principles - Prejudgment interest - Calculation of (incl. rate) - [See Interest - Topic 5008 ].

Interest - Topic 5010

Interest as damages (prejudgment interest) - General principles - Calculation of interest - Simple or compound - [See Interest - Topic 5008 ].

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - At issue in this case were issues of patent infringement and validity of eight patents relating to cefaclor, sold under the registered name of Ceclor® - The Federal Court stated that before considering the issues of infringement and validity, the court had to construe the claims at issue in this proceeding - The court referred to the principles of construction applicable in this situation - See paragraphs 87 to 90.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - Lilly U.S. owned eight patents relating to cefaclor, sold under the registered name of Ceclor® - The medicine was put on the market in 1980 - Lilly U.S. and its Canadian subsidiary Lilly Canada sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada - Apotex counterclaimed, challenging the validity of the patents - The Federal Court determined who was a "person skilled in the art" for purposes of construing the patents in issue - See paragraphs 91 to 94.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - The Federal Court discussed the principles applicable respecting the common general knowledge of "persons skilled in the art" for purposes of construction of a patent and for purposes of assessing the prior art put forth to establish validity - The court stated that "The very general statements made recently by the Supreme Court of Canada that '[c]ommon general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time' (Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 ... or that a posita [person skilled in the art] is expected to be 'reasonably diligent in keeping up with advances in the field to which the patent relates' and that their common knowledge 'undergoes continuous evolution and growth' (Whirlpool, para. 74) must be read together with other classic comments that are still applicable" - The court thereafter reviewed the prior cases respecting common general knowledge of a person skilled in the art - See paragraphs 95 to 105.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - The Federal Court, in a patent infringement/validity case stated that "During the trial, the court noted on several occasions that there was little evidence to establish that the numerous publications, patents, applications relied upon by various experts were part of the common general knowledge of the posita [person skilled in the art] at the relevant time. While this was to a certain extent cured through the cross-examinations, it remains that too little attention was given to such matters which are of prime importance, not only to construe the claims, but also to assess the prior art put forth to establish invalidity. This is particularly significant when, like in this case, one is considering older patents issued at a time when a posita did not have the benefit of electronic versions of scientific publications and could not use the internet or other sophisticated research tools to locate relevant information" - See paragraph 95.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - The Federal Court discussed the principles applicable respecting the common general knowledge of a "person skilled in the art" for purposes of construction of a patent and for purposes of assessing the prior art put forth to establish validity - The court referred to a discussion on the proof required to establish common general knowledge - See paragraph 100.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - The Federal Court stated that "The distinction between common general knowledge and prior art which is part of the state of the art for the purpose of assessing anticipation and obviousness tends to diminish in modern times because of the sophistication of search engines and the availability of electronic publications and databases. Nevertheless, the degree to which a particular publication was 'generally regarded as a good basis for further action' (General Tire, at p. 483) is still very relevant when one considers issues such as obviousness, where mosaicing is permitted in certain circumstances" - See paragraph 104.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Cefaclor - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, sold under the registered name of Ceclor® - The medicine was put on the market in 1980 - The other plaintiff, Lilly Canada, was a wholly owned Canadian subsidiary of Lilly U.S., which alleged that it had rights under the patentee - Lilly U.S. and Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada made using an infringing process - The Federal Court construed the claims of the individual patents accordingly - See paragraphs 106 to 210.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Lilly U.S. owned eight patents relating to cefaclor, including the '007 patent - Lilly sued Apotex Inc., a generic drug manufacturer, alleging infringement by importation - Apotex challenged the validity of patent '007, arguing that claim 17 (the only valid claim left at this point), was deficient and did not contain all the information necessary for a person skilled in the art to practice and use the invention claimed - The Federal Court rejected Apotex's argument, stating that the evidence relied upon was simply insufficient to meet the burden of proof - The court expressed surprise that this argument was pursued given the paucity of evidence supporting it and the fact that all the experts who tried to make the kinetic complex following the instructions of the '007 patent, succeeded the first time they tried and had no difficulty differentiating the kinetic complex from the thermodynamic product - See paragraphs 613 to 625.

Patents of Invention - Topic 1133

The specification and claims - The description - Particular patents - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals - [See Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1501

Grounds of invalidity - General - [See Patents of Invention - Topic 1502 ].

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - The plaintiffs (Lilly) sued Apotex Inc., alleging patent infringement by importation - Validity of the patents was in issue - The parties disagreed on what a party asserting invalidity (i.e., Apotex) had to prove - Lilly, relying on Apotex Inc. v. Wellcome (SCC 2002), argued that Apotex had to prove that the decision of the Commissioner of Patents to approve the patents at issue was unreasonable (i.e., that the court should engage in a form of judicial review of the Commissioner's decision applying deference and the standard of reasonableness) - The Federal Court rejected Lilly's argument - An assessment of validity required one to examine the claims of a patent, properly constructed, against the requirements of the Patent Act - That approach, without reference to principles of administrative law, had been the standard judicial practice for more than a hundred years - Wellcome 2002 did not change the law in that regard - In any event, it was unclear what would be the subject of this type of judicial review as the Commissioner's decision to grant a patent came with no reasons, no explanation and no context - "In sum, the importation of administrative law principles into the assessment of invalidity has not been thoroughly canvassed by appellate authorities and would constitute a significant departure from the Supreme Court of Canada's well-established jurisprudence concerning pleas of invalidity. Absent further clarification on how the concept of deference is to be integrated into the established invalidity analysis, the Court is reluctant to employ administrative law principles in its analytic framework in this regard" - See paragraphs 348 to 370.

Patents of Invention - Topic 1508

Grounds of invalidity - General - Re divisional applications - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their process patents for cefaclor by importation of bulk cefaclor made overseas using infringing processes and using it in its Apo-cefaclor product - Lilly had obtained four of the patents by assignment from Shionogi & Co., a Japanese pharmaceutical company (the Shionogi patents) resulting from an original application and three divisional applications - Apotex claimed that the Shionogi patents were invalid for lack of subject matter - An issue arose as to whether Shionogi was required by the Commissioner of Patents to divide its patent application because if so, then according to Consolboard Inc. v. MacMillan Bloedel (SCC 1981), none of the divisional applications were open to attack by reason only of the granting of the original patent, that is, for lack of subject matter for more than one patent - The Federal Court held that there was insufficient evidence to conclude that this case was distinguishable from the Consolboard (1981) case - See paragraphs 371 to 376.

Patents of Invention - Topic 1526

Grounds of invalidity - Want of subject matter - General - The Federal Court discussed what it meant for a patent to "lack subject matter" - The court stated that "... Fox [The Canadian Law and Practice Relating to Letters Patent for Inventions] teaches that in a wider sense, the question of subject matter is directed to ascertaining whether a device or process 'falls within those classes of things designed to be protected by the patent law'. However, Fox also speaks of a more restrictive meaning which in sum directs the inquiry as to whether the production of the device or process 'was obvious or involved the exercise of the inventive faculty. [...] This enquiry, in the English cases usually discussed under the heading of obviousness, is directed to ascertaining whether [...] its production was sufficiently important and worthy to entitle it to the grant of monopoly rights.' (pp. 15-16) In that context, the Court sometimes loosely refer to lack of subject matter when what was claimed was not inventive but the Court finds that this expression should now be avoided. Even though it may be correct, strictly speaking, to say that there is no patentable subject matter if there is no invention, it is better to address the following aspects of a patentable invention - novelty, inventiveness, utility - under more specific headings and to reserve 'lack of subject matter' as the heading under which one deals with whether or not the invention falls between those classes of things designed to be protected by the patent law. Certainly, the heading which one chooses to present one's argument cannot change the fact that one cannot have, two kicks at the can, by simply presenting its position under distinct headings ..." - See paragraphs 377 to 379.

Patents of Invention - Topic 1533

Grounds of invalidity - Want of subject matter - Substances prepared by chemical processes and intended for food or medicine - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their patents by importation - Apotex claimed that four of the patents (the '007 patent and three process patents) lacked subject matter because they claimed nothing more than the inherent properties of a known compound - Also, as the usefulness of the kinetic complex in cephalosporin chemistry was disclosed in detail in the '007 patent (disclosure or specification only), there was no distinct "subject matter" supporting the process patents - The Federal Court held that the first argument had no application whatsoever in this case - Also, given that the only claim found valid in the '007 patent (claim 17) was a process claim, that argument appeared to be moot - Further, the second point was also unsound - The court held that although Apotex used the expression "subject matter", to refer to the inventiveness, what Apotex was really saying was that there was only one invention, the allegedly new kinetic compound, and, by claiming it in the '007 patent, Lilly was not entitled to the Lilly process patents (i.e., it should have put all the claims in a single patent) - However, it was clear that the discovery of the kinetic complex itself was not the invention in any of the process patents - See paragraphs 380 to 390.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court discussed the legal test for obviousness, noting that in the case before the court, it was dealing with patents subject to the pre-October 1, 1989, version of the Patent Act, in which there was no express statutory test for obviousness - Rather, as noted by Justice Rothstein in the 2008 Supreme Court decision in Sanofi-Synthelabo v. Apotex, that doctrine was developed by necessary implication based on the requirement of an "invention" as defined in s. 2 of the Patent Act - The court thereafter reviewed the legal principles set out in Sanofi respecting obviousness - See paragraphs 412 to 414.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor - Four of the patents (the '007 patent and three process patents (the Lilly process patents) were owned originally by Lilly U.S. and the other four were obtained by assignment from a Japanese company (the Shionogi patents) - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patents for cefaclor by importing bulk cefaclor made overseas by manufacturers using infringing processes and using it in its Apo-cefaclor product - Apotex challenged the validity of the patents on the ground of obviousness - With respect to the '007 patent only claim 17 was being challenged on this basis as the other impugned claims in that patent were found to be invalid on other grounds - The Federal Court held that Apotex had failed to meet the burden of establishing obviousness - See paragraphs 426 to 583.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - In the context of an attack on a patent on the ground of obviousness, the Federal Court discussed the notion of "mosaicing" which illustrated what one needed to establish before the court could consider together individual prior art publications that were not necessarily part of the common general knowledge - The court quoted Terrell on the Law of Patents: "The 'mosaicing' of individual documents or prior uses is not permissible, unless it can be shown that the skilled person, confronted with a particular citation, would turn to some other citation to supplement the information provided by the first. Whether he would do so is a question of fact" - See paragraphs 416 to 419.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - In the context of an attack on a patent on the ground of obviousness, the Federal Court discussed when post art could be considered as evidence of what was common knowledge or what was part of the state of the art at the relevant time - See paragraphs 420 to 424.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - [See all Patents of Invention - Topic 1030.1 ].

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court discussed the test for anticipation in light of the 2008 Supreme Court decision in Sanofi-Synthelabo v. Apotex - The court stated that in order to anticipate, a prior art document that was considered must meet both the requirements of disclosure and enablement - With respect to disclosure, the prior art document had to disclose subject matter which, if performed, would necessarily result in infringement of the patent being challenged - That prior art document had to be read by the person skilled in the art with an open mind, trying to understand what that prior art document meant - The court understood that the law, as discussed in Beloit Canada Ltd. v. Valmet Oy (FCA 1986), General Tire (UKCA 1972) and Free World Trust (SCC 2000) were still relevant on the issue of disclosure, but the Beloit test had been refined in respect of enablement - See paragraphs 391 to 395.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their patents for cefaclor by importation - Validity was in issue - Apotex claimed that four of the patents (the '007 patent and three process patents) were invalid on the basis of anticipation by prior art (i.e., articles by D.G. Coe and H.N. Rydon) - The Federal Court found that claims 1 and 8 in the '007 patent were invalid on this ground; however, claim 17 was not anticipated by what was disclosed in the prior art by Coe and Rydon - Although the anticipation argument was abandoned respecting the process patents, the court reviewed the prior art and opined that there was not one single prior art document that disclosed all the essential elements of the claims in issue in the process patents - See paragraphs 399 to 410.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [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 - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor - Four of the patents (the '007 patent and three process patents (the Lilly process patents)) were owned originally by Lilly U.S. and the other four were obtained by assignment from a Japanese company (the Shionogi patents) - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging infringement by importation - Apotex challenged the validity of the patents on the ground of lack of utility - Apotex claimed that several of the claims in the patents at issue were overbroad; they allegedly included claimed embodiments that were inoperable - The Federal Court was not satisfied that Apotex provided evidence of sufficient weight to support its allegation that the '007 patent or the Lilly process patents contained embodiments that were not useful or whose usefulness could not be soundly predicted by the inventor on the basis of the various experiments described in the patents and the relevant common general knowledge - Apotex simply did not meet its burden - The court also held that Apotex had not met its burden with respect to impugned claims in the Shionogi patents - See paragraphs 583 to 612.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court held that to establish sound prediction there had to be: "i) a factual basis for the prediction; ii) an articulable sound line of reasoning; and, iii) proper disclosure" - See paragraph 584.

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 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - Cefaclor - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada and using it in the manufacture of its Apo-cefaclor product - The plaintiffs claimed that the cefaclor was made by overseas manufacturers (Lupin and Kyong Bo) using processes which infringed the patents owned by Lilly U.S. - The Federal Court held that the plaintiffs established on a balance of probabilities that the cefaclor received by Apotex from Lupin between May 23, 1997 and June 3, 1998, infringed four of the patents (i.e, the cefaclor was made using a kinetic complex covered by the plaintiffs' patents) - However, the plaintiffs did not meet their burden in respect of cefaclor shipped to Apotex by Lupin after of June 4, 1998 - The court also found that the cefaclor made by Kyong Bo infringed certain claims of the patents in issue - See paragraphs 224 to 262.

Patents of Invention - Topic 2889

Infringement of patent - Acts constituting an infringement - Importation of product made using process patented in Canada (infringement by importation) - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their process patents for cefaclor by importation of bulk cefaclor made overseas using infringing processes and using it in its Apo-cefaclor product - Apotex argued that the Canadian jurisprudence applying the English doctrine of "infringement by importation" should not be followed - The Federal Court reviewed the case law in detail - The court held that Apotex's argument that the distinctions between Canadian and British law should render British jurisprudence (incl. the Saccharin (1900) and Wilderman (1925) cases) of little assistance on this issue was unpersuasive - The court stated that notwithstanding the differences between Canadian and British patent laws, Canadian courts continued to look to British jurisprudence to inform the analysis of intellectual property laws - Also an argument by Apotex that the United States approach to this issue should be preferred was unconvincing - The court stated that in sum it agreed with Lilly that it was too late to turn back the clock on the application of the general principles set out in the prior Canadian case law which established that importation of products made abroad that were the subject of patented process claims in Canada was prohibited - That prohibition was widely recognized and was well-settled law in Canada - See paragraphs 270 to 318.

Patents of Invention - Topic 2889

Infringement of patent - Acts constituting an infringement - Importation of product made using process patented in Canada (infringement by importation) - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their process patents for cefaclor by importation of bulk cefaclor made overseas using infringing processes and using it in its Apo-cefaclor product - Apotex recognized that there was Canadian jurisprudence applying the English doctrine of "infringement by importation" (incl. Saccharin (1900) and Wilderman (1925)) - Apotex argued that the Saccharin doctrine as qualified by Wilderman should be limited by United States and European legislation and jurisprudence interpreting those documents - The Federal Court noted that Parliament had not intervened in this area even after the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) - The court opined that what Apotex sought was a re-writing of Canadian patent laws in order to limit the application of over a century's worth of jurisprudence - While European and U.S. statutory provisions might be of assistance in analysing Canadian laws, they could not serve to displace the well-settled jurisprudence on infringement by importation - The court concluded that not only could it not redefine and limit the test applicable in Canada respecting infringement by importation and use, but that it should not do so - See paragraphs 319 to 329.

Patents of Invention - Topic 2889

Infringement of patent - Acts constituting an infringement - Importation of product made using process patented in Canada (infringement by importation) - The plaintiffs (Lilly) claimed that Apotex Inc., a generic drug manufacturer, infringed their process patents for cefaclor by importation of bulk cefaclor made overseas by two manufacturers (Lupin and Kyong Bo) using infringing processes and using it in its Apo-cefaclor product - The Federal Court discussed the test for establishing infringement by importation - Here it was not disputed that if the Kyong Bo process had been carried out in Canada it would have infringed certain of the process patents and that Lupin used a process covered by certain of the patents until 1998 - The court stated that "The only real difficulty in applying the test in this case arises from the fact that making cefaclor is a very complex process, involving more steps than what was required to make the various compounds previously discussed in the case law. But this alone should not prevent the application of the doctrine. Certainly technical complexity should not enable a party to deprive in whole or in part, directly or indirectly, of the full enjoyment of the monopoly conferred by a patent" - The court concluded that Lilly's patented process was an "important" part of the process used by Lupin and Kong Bo to make the cefaclor that was used by Apotex in Canada - See paragraphs 270 to 341.

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - Cefaclor - [See Patents of Invention - Topic 2888 ].

Patents of Invention - Topic 3013

Infringement of patent - Defences - Use of patented product related to development and submission of information to government authorities (regulatory use exemptions) - The plaintiffs (Lilly), owners of patents for cefaclor, sued Apotex Inc., a generic drug manufacturer, alleging patent infringement by importation - Apotex raised the exemption in s. 55.2(1) of the Patent Act (i.e. some product was exempt because it was used for purposes of submission of information to the government) - Lilly claimed that this exemption was not available because the in-process sampling and the reserve samples had a dual purpose (i.e., they were not set aside simply to meet government requirements but also for internal quality controls) - The Federal Court held that the argument that this exemption should be strictly construed had been rejected in the jurisprudence and that the courts had not limited the exemption solely to material actually provided to a regulator - The critical issue was whether the court was satisfied that the materials purported to have been used for research and development formulation, reserve samples and in-process samples were not sold or used for any similar purpose - The fact that those quantities could serve a dual purpose was irrelevant - The court held that the exact quantities that fell under this exemption in this case would be determined on a reference - See paragraphs 342 to 346.

Patents of Invention - Topic 3101

Infringement of patent - Remedies - General - Lilly owned patents relating to cefaclor, including four assigned to it by Shionogi - Lilly sued Apotex Inc. for patent infringement - Apotex raised patent validity and Competition Act issues arising from the assignments of the Shionogi patents - Apotex argued that Lilly's conduct vis-à-vis the Shionogi patents disentitled Lilly from any relief (equitable or otherwise) for infringement - Apotex argued further that even if its Competition Act claims were time-barred, Lilly's otherwise anticompetitive acts excused Apotex from patent infringement liability under the doctrine of equitable set-off - The Federal Court questioned whether it could consider the equitable set-off argument in the main action because it was not mentioned in the defence, but rather only in the counterclaim - The court, in any event, considered the merits of Apotex's argument, concluding that in this particular case Apotex could not invoke its allegations of anticompetitive behaviour to evade its liability for infringement through disentitlement or equitable set-off - The court stated that "... an assignment of patent rights may give rise to anti-competitive consequences. However, to the extent they do so, such claims must be adjudicated within the confines of the Competition Act. If judgment is obtained, it can then be set-off against any judgment dealing with infringement damages. To allow otherwise would allow for a fusion of two statutory regimes whose object and purpose are fundamentally distinct" - See paragraphs 626 to 645.

Patents of Invention - Topic 3102

Infringement of patent - Remedies - Damages or accounting of profits - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging infringement by importation - Apotex challenged the validity of the patents - The Federal Court found at least one valid claim in each of the eight patents were infringed by Apotex's importation, manufacture, export, sale and offers for sale of cefaclor in Canada - The court held that the plaintiffs were entitled to elect either an accounting of profits or all damages sustained by reason of sales directly lost as a result of the infringement, to be assessed by reference - The court rejected an argument by Apotex that Lilly's alleged anticompetitive conduct with regard to four of the patents which it obtained by assignment was a valid basis for denying Lilly the right to elect - Nor was a delay of 11 years to bring the matter to trial excessive in the circumstances - See paragraphs 646 to 656.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, sold under the registered name of Ceclor® - The other plaintiff, Lilly Canada, was a wholly owned Canadian subsidiary of Lilly U.S., which alleged that it had rights under the patentee - Lilly U.S. and Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada which had been made using an infringing process - Apotex challenged Lilly Canada's standing, arguing that a bare assertion of a corporate relationship was not sufficient - Lilly Canada claimed that it had an express licence respecting the patents at issue and had been selling Ceclor® in Canada since 1980 - Also Lilly Canada relied on a 1991 distributorship agreement with Lilly U.S. - The Federal Court held that Lilly Canada had properly established its standing based on an express licence from the patentee - In any event, there was no doubt that Lilly Canada derived its rights from the patentee - See paragraphs 75 to 86.

Patents of Invention - Topic 3788

Infringement actions - Evidence - Presumptions - The plaintiff drug companies, in a patent infringement suit, sought to rely on the presumption in s. 55.1 of the Patent Act: "In an action for infringement of a patent granted for a process for obtaining a new product ["produit" in the French version], any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process" - The plaintiffs claimed that because of the North American Free Trade Agreement (NAFTA) the word "product" ("produit") was substituted with the word "substance" (same in French) and meant a product that had not been sold on the market before - The Federal Court noted that the words "product" and "substance" were used interchangeably by the Supreme Court of Canada in Harvard College v. Canada (2002) - The word "product" had to be given the same meaning as it received throughout the Patent Act - It was used in the definition of "invention" - The court opined that by changing "substance" to "product", the legislator was simply bringing the provisions in line with NAFTA - The court stated that "substance" appeared to be a more restrictive expression that could, for example, hardly apply to a new hairdryer, whereas the presumption was meant to apply to any new product - See paragraphs 211 to 217.

Patents of Invention - Topic 3788

Infringement actions - Evidence - Presumptions - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - The medicine was put on the market in 1980 - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada which was made using an infringing process - The plaintiffs sought to rely on the presumption arising under s. 55.1 of the Patent Act: "In an action for infringement of a patent granted for a process for obtaining a new product , any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process" - The Federal Court held that the presumption was either not applicable to the patents in issue or did not need to be applied to determine the merits of the infringement allegations in this case - See paragraphs 211 to 217.

Patents of Invention - Topic 3788

Infringement actions - Evidence - Presumptions - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada from an overseas supplier (Lupin), made using an infringing process - The plaintiffs asked the court to apply the common law presumption discussed in Hoffmann-LaRoche v. Apotex (Ont. H.C. 1983) that the burden of proving what process was used by its supplier (Lupin) was on Apotex - The Federal Court noted that the supplier (Lupin) was actually willing to cooperate in this case and Apotex knew this, but did not disclose it to the plaintiffs or to the court - Moreover, given the special contractual undertaking of Lupin to assist Apotex, Apotex was in a much better position to provide admissible and credible evidence as to the process actually used by Lupin - The court stated that had it been satisfied that Lilly had taken reasonable steps to obtain this information, rather than relying on an undertaking from Apotex to look through their file, the court would have been willing to apply this presumption given the particular circumstances of this case - However, even if Lilly could not benefit from this common law presumption, it could still rely on inferences that could reasonably be made based on the evidence produced to establish certain facts - See paragraphs 218 to 223.

Patents of Invention - Topic 3789

Infringement actions - Evidence - Burden of proof - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - Four of the patents were obtained by assignment from a Japanese company (the Shionogi patents) - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging that Apotex infringed their patent rights by importing bulk cefaclor into Canada from overseas suppliers (Lupin and Kyong Bo) who used infringing processes to manufacture the cefaclor - At trial, contrary to the agreed facts, Apotex claimed that Kyong Bo was acting under a licence from Shionogi and that it had presented sufficient evidence to shift the burden of proof to the plaintiffs to present cogent evidence that no such licence existed - The Federal Court stated that apart from being contrary to an admitted fact, Apotex's position seemed to be based on a misunderstanding of the nature of the proceedings - This was an infringement action, not a notice of compliance proceeding where the plaintiffs had to prove the allegations of Apotex were unjustified - The court opined that pursuing this argument which had little chance of success unduly lengthened the trial process, placed undue burden on the court and increased costs for all - See paragraphs 263 to 269.

Patents of Invention - Topic 3821

Infringement actions - Damages - General - The plaintiff, Lilly U.S., owned eight patents relating to cefaclor, an antibiotic sold under the registered name of Ceclor® - Lilly U.S. and its Canadian subsidiary, Lilly Canada (the plaintiffs) sued Apotex Inc., a generic drug manufacturer, alleging infringement by importation - Apotex challenged the validity of the patents - The plaintiffs sought punitive damages because of Apotex's conduct in the prosecution of the action - The Federal Court allowed the infringement action, holding that the plaintiffs were entitled to an accounting of profits or damages - However, the court held that punitive damages were not appropriate here because the impugned conduct was more appropriately dealt with in the context of an award of costs - The court stated that punitive damages were used to obtain the objectives of punishment, deterrence and denunciation where general damages were insufficient to do so; therefore, the conduct which attracted such an award had to be rationally connected to the conduct for which compensation was awarded - That was not the case here - See paragraphs 657 to 664.

Patents of Invention - Topic 3827

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

Patents of Invention - Topic 3881

Infringement actions - Costs - General - Lilly sued Apotex Inc., a generic drug manufacturer, alleging patent infringement by importation - Lilly claimed that Apotex's conduct in the course of the action warranted solicitor and client costs (e.g., the failure to provide proper documents relating to manufacturing processes, late discovery productions, wasteful experiments rendered necessary by Apotex's failure to provide proper discovery, lack of notice for testing conducted by Apotex, deficient pleadings, lack of pre-trial cooperation, unnecessary duplication of expert's evidence and especially the failure to disclose communications with its overseas manufacturer concerning its manufacturing processes, etc.) - The Federal Court allowed the infringement action and held that Lilly was entitled to costs - Apotex had acted in a way which unnecessarily lengthened the duration of the proceedings and an elevated award of costs was appropriate here - However, it would be excessive to simply grant the costs of the whole proceeding on a solicitor client basis - The court therefore gave the parties the opportunity to make further submissions on which matters attracted what costs - See paragraphs 676 to 681 and 884.

Practice - Topic 1850

Pleadings - Counterclaim and set-off - Set-off - Equitable set-off - The Federal Court referred to the principles underlying equitable set-off - See paragraphs 637 to 639.

Practice - Topic 1850

Pleadings - Counterclaim and set-off - Set-off - Equitable set-off - [See Patents of Invention - Topic 3101 ].

Practice - Topic 7453

Costs - Solicitor and client costs - Entitlement to - Delaying tactics and unduly prolonging proceedings - [See Patents of Invention - Topic 3881 ].

Trade Regulation - Topic 506

Competition - General - Civil remedy - Competition Act, s. 36 - The plaintiff, Lilly U.S., owned patents relating to cefaclor, four of which it obtained by assignment from another company, Shionogi, in 1995 - Lilly U.S. and its Canadian subsidiary (the plaintiffs) sued Apotex Inc., alleging patent infringement by importation - Apotex counterclaimed, seeking damages against the plaintiffs under s. 36 of the Competition Act - Apotex claimed that Shionogi and Lilly U.S., by the assignments of the patents, had conspired to lessen competition contrary to s. 45 of the Act - The Federal Court dismissed the counterclaim, holding that it was time-barred by the two year limitation period in s. 36(4)(a)(i) (i.e., given that the date of the assignment was April 27, 1995, the limitation period expired in 1997) - The court rejected arguments that the discoverability principle extended the limitation period, that the limitation period should run only from when "Apotex was provided notice that every alternate process that Apotex had employed was asserted by Lilly to be infringing" (2001) or that the s. 36(4) of the Competition Act contemplated ongoing conduct - In any event, the court opined that Apotex had not established either damage or causation as required by s. 36 - Therefore, an analysis as to whether the Shionogi assignment was contrary to s. 45 was not required - See paragraphs 683 to 880.

Trade Regulation - Topic 506

Competition - General - Civil remedy - Competition Act, s. 36 - The plaintiff, Lilly U.S., owned patents relating to cefaclor, four of which it obtained by assignment from another company, Shionogi, in 1995 - Lilly U.S. and its Canadian subsidiary (the plaintiffs) sued Apotex Inc., alleging patent infringement by importation - Apotex counterclaimed, seeking damages against the plaintiffs under s. 36 of the Competition Act - Apotex claimed that the Shionogi assignments were part of a conspiracy to lessen competition contrary to s. 45 of the Act - The Federal Court dismissed the counterclaim, holding that it was time-barred - The court, however, addressed an argument by Apotex that if damages were awarded on the counterclaim, they should be assessed by applying an evidentiary standard that "... assigns probabilities of occurrence to all events which 'are not merely speculative' and for which only the sum of the probabilities assigned to each need cross the balance of probabilities threshold of more than 50%. This, Apotex argues, is necessary because the determination of causality and quantification of loss requires a comparison between occurrences in the actual world and a hypothetical 'but for world'. For Apotex, this 'but for world' encompasses a number of scenarios in which the Shionogi patents have not been assigned to Lilly" - The court concluded that the normal test for causation applied - See paragraphs 757 to 770.

Trade Regulation - Topic 513

Competition - General - Limitation period - [See first Trade Regulation - Topic 506 ].

Words and Phrases

Kinetically controlled product - The Federal Court discussed the meaning of this phrase as used in a patent claim respecting cefaclor - See paragraphs 125 to 141.

Cases Noticed:

R. v. R.E.M., [2008] 3 S.C.R. 3; 380 N.R. 47; 260 B.C.A.C. 40; 439 W.A.C. 40; 235 C.C.C.(3d) 290; 2008 SCC 51, refd to. [para. 8, footnote 5].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 60].

National Justice Compania Riviera S.A. v. Prudential Assurance Co.; Ship Ikarian Reefer, Re, [1993] 2 Lloyd's Rep. 68 (Q.B.), refd to. [para. 62].

Whitehouse v. Jordan, [1981] 1 W.L.R. 246, refd to. [para. 62].

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. 75].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495; 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), refd to. [para. 84].

Signalisation de Montréal Inc. v. Services de Béton Universels ltée et al., [1993] 1 F.C. 341; 147 N.R. 241 (F.C.A.), refd to. [para. 85].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 87].

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. 87].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 87].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 88].

Halford et al. v. Seed Hawks Inc. et al. (2004), 246 F.T.R. 1; 2004 FC 88, affd. (2006), 353 N.R. 60; 275 D.L.R.(4th) 556; 2006 FCA 275, refd to. [para. 89].

D.M.I. Inc. v. Deere & Co., 755 F.2d 1570; 225 U.S.P.Q. (BNA) 236 (U.S.Cir.), refd to. [para. 89].

Hoffmann-LaRoche Ltd. v. Mayne Pharma (Canada) Inc. et al., [2005] F.T.R. Uned. A41; 41 C.P.R.(4th) 505; 2005 FC 814, refd to. [para. 90].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 96].

Generics (UK) Ltd. v. Daiichi Pharmaceutical Co. et al., [2009] EWCA Civ. 646 (C.A.), refd to. [para. 96, footnote 30].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457; [1971] F.S.R. 417 (C.A.), refd to. [para. 97].

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.), refd to. [para. 98].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 99].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 99].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541; 142 D.L.R.(3d) 117, refd to. [para. 110].

Merrell Dow Pharmaceuticals Inc. et al. v. Norton (H.N.) & Co. et al., [1997] B.M.L.R. 201; 189 N.R. 364; [1996] R.P.C. 76 (H.L.), refd to. [para. 131].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, refd to. [para. 131].

Harvard College v. Commissioner of Patents, [2002] 4 S.C.R. 45; 296 N.R. 1; 2002 SCC 76, refd to. [para. 214].

Hoffmann-La Roche Ltd. v. Apotex Inc. (1983), 41 O.R.(2d) 84; 145 D.L.R.(3d) 270 (H.C.), affd. (1984), 47 O.R.(2d) 287; 11 D.L.R.(4th) 320 (C.A.), refd to. [para. 218].

SmithKline Beecham Pharma Inc. v. Apotex Inc. - see SmithKline Beecham Inc. et al. v. Apotex Inc. et al.

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 221, footnote 77].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 245 F.T.R. 243; 31 C.P.R.(4th) 214; 2003 FC 1428, refd to. [para. 221, footnote 77].

McDougall v. Black & Decker Canada Inc. et al. (2008), 440 A.R. 253; 438 W.A.C. 253; 62 C.P.C.(6th) 293; 2008 ABCA 353, refd to. [para. 255].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 328 F.T.R. 41; 2007 FC 898, refd to. [para. 271].

Elmslie v. Boursier (1869), L.R. 9 Eq. 217, refd to. [para. 272].

Von Heyden v. Neustadt (1880), 14 Ch. D. 230 (C.A.), refd to. [para. 272].

Saccharin Corp. v. Anglo-Continental Chemical Works Ltd. (1900), 17 R.P.C. 307, refd to. [para. 272, footnote 103].

Beecham Group Ltd. v. Bristol Laboratories Ltd., [1978] R.P.C. 153; [1977] F.S.R. 215 (H.L.), refd to. [para. 272, footnote 103].

Wilderman v. Berk (F.W.) & Co. (1925), 42 R.P.C. 79, refd to. [para. 272].

Brown v. Duchesme (1856), 60 U.S. 183; 15 L.Ed. 595, refd to. [para. 273, footnote 104].

Dowagiac Manufacturing Co. v. Minnesota Moline Plow Co. (1915), 235 U.S. 641; 35 S. Ct. 221, refd to. [para. 273, footnote 104].

Deepsouth Packing Co. v. Laitram Corp. (1972), 406 U.S. 518; 92 S. Ct. 1700, refd to. [para. 273, footnote 104].

Microsoft Corp. v. AT&T Corp. (2007), 550 U.S. 437; 127 S. Ct. 1746, refd to. [para. 273, footnote 104].

Auer Incandescent Light Manufacturing Co. v. O'Brien (1897), 5 Ex. C.R. 243, refd to. [para. 279].

Toronto Auer Light Co. v. Colling (1899), 31 O.R. 18 (Div. Ct.), refd to. [para. 280].

Badische Anilin und Soda Fabrik v. Johnson (Henry) & Co. and Basle Chemical Works, Bindschedler, [1897] 2 Ch. 322 (C.A.), affd. [1898] A.C. 200 (H.L.), refd to. [paras. 281, 282].

Badische Anilin und Soda Fabrik v. Hickson, [1905] 2 Ch. 495, affd. [1906] A.C. 419, refd to. [para. 282].

Saccharin Corp. v. Reitmeyer & Co., [1900] 2 Ch. 659; 17 R.P.C. 606, refd to. [para. 283].

Pfizer Corp. v. Ministry of Health, [1965] A.C. 512; [1965] 1 All E.R. 450 (H.L.), refd to. [para. 285].

Beecham Group Ltd. v. Bristol Laboratories Ltd. et al., [1967] R.P.C. 406; [1967] F.S.R. 283 (C.A.), refd to. [para. 286].

Beecham Group Ltd. v. Bristol Laboratories Ltd. et al., [1978] R.P.C. 153 (H.L.), refd to. [para. 286].

Hoffmann-LaRoche & Co. v. Commissioner of Patents, [1955] S.C.R. 414; 23 C.P.R. 1, refd to. [para. 295].

American Cyanamid Co. v. Frosst (Charles E.) & Co., [1965] 2 Ex. C.R. 355; 47 C.P.R. 215, refd to. [para. 295, footnote 113].

Union Carbide Canada Ltd. v. Trans-Canadian Feeds Ltd., [1966] Ex. C.R. 884, refd to. [para. 297].

Rhone-Poulenc S.A. v. Micro Chemicals Ltd., [1964] Ex. C.R. 819; 44 C.R.R. 193, refd to. [para. 299].

Rhone-Poulenc v. Gilbert (1967), 35 Fox Pat. C. 174 (Ex. Ct.), affd. [1968] S.C.R. 950; 69 D.L.R.(2d) 353, refd to. [para. 301].

Leesona Corp. v. Giltex Hosiery Ltd. (1971), 2 C.P.R.(2d) 211, refd to. [para. 302].

Farbwerke Hoechst Aktiengessellschaf v. Halocarbon (Ontario) Ltd. and Halocarbon Products Corp., [1974] 2 F.C. 266; 15 C.P.R.(2d) 105 (T.D.), revd. (1976), 13 N.R. 330 (F.C.A.), revd. [1979] 2 S.C.R. 929; 27 N.R. 582; 104 D.L.R.(3d) 51, refd to. [paras. 303, 304].

Wellcome Foundation Ltd. et al. v. Apotex Inc. (1991), 47 F.T.R. 81; 39 C.P.R.(3d) 289 (T.D.), refd to. [para. 305].

Merck & Co. et al. v. Apotex Inc., [2007] 3 F.C.R. 588; 354 N.R. 51; 2006 FCA 323, refd to. [para. 344].

F.H. v. McDougall, [2008] 3 S.C.R. 41; 380 N.R. 82; 260 B.C.A.C. 74; 439 W.A.C. 74; 2008 SCC 53, refd to. [para. 349].

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. 350].

M.K. Plastics Corp. v. Plasticair Inc. (2007), 313 F.T.R. 208; 61 C.P.R.(4th) 1; 2007 FC 574, refd to. [para. 355].

Harvard College v. Commissioner of Patents (Can.), [2000] 4 F.C. 528; 290 N.R. 320 (F.C.A.), refd to. [para. 356, footnote 126].

JAY-LOR International Inc. et al. v. Penta Farm Systems Ltd. et al. (2007), 313 F.T.R. 1; 59 C.P.R.(4th) 228; 2007 FC 358, refd to. [para. 358].

New Brunswick (Board of Management) v. Dunsmuir, [2008] 1 S.C.R. 190; 372 N.R. 1; 329 N.B.R.(2d) 1; 844 A.P.R. 1; 2008 SCC 9, refd to. [para. 358].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 2009 FC 676, refd to. [para. 358, footnote 127].

Gosselin v. Canada (Attorney General) (2006), 289 F.T.R. 7; 2006 FC 3, refd to. [para. 362].

Genencor International Inc. v. Commissioner of Patents et al., [2009] 1 F.C.R. 361; 329 F.T.R. 109; 2008 FC 608, refd to. [para. 366].

Pason Systems Corp. v. Commissioner of Patents et al., [2007] 2 F.C.R. 269; 295 F.T.R. 1; 2006 FC 753, refd to. [para. 366].

Dow Chemical Co. v. Canada (Attorney General) et al., [2007] F.T.R. Uned. 842; 63 C.P.R.(4th) 89; 2007 FC 1236, refd to. [para. 366].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 372].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd. (1978), 39 C.P.R.(2d) 191 (F.C.T.D.), refd to. [para. 374].

Commissioner of Patents v. Farbwerke Hoechst Aktien-Gesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49, refd to. [para. 375, footnote 129].

Laboratoires Servier et al. v. Apotex Inc. et al. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 379, footnote 133].

Riello Canada Inc. v. Lambert (1986), 3 F.T.R. 23; 8 C.I.P.R. 286 (T.D.), refd to. [para. 381, footnote 136].

Scott Paper Co. v. Minnesota Mining and Manufacturing Co. (1981), 53 C.P.R.(2d) 26 (F.C.T.D.), refd to. [para. 381, footnote 136].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 43 C.P.R.(4th) 81; 2005 FC 1421, refd to. [para. 381, footnote 136].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, refd to. [para. 394].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 395].

Pozzoli SPA v. BDMO SA, [2007] EWCA Civ. 588 (C.A.), refd to. [para. 413].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 414, footnote 144].

Lilly ICOS LLC v. Pfizer Ltd., [2001] 1 F.S.R. 16; 59 B.M.L.R. 123 (Ch. Pat.), refd to. [para. 418].

Webber v. Vestas-Celtic Wind Technology Ltd., [2007] EWHC 2636 (Pat.), refd to. [para. 419, footnote 146].

Generics (U.K.) Ltd. et al. v. H. Lundbeck Als, [2008] EWCA Civ. 311; 101 B.M.L.R. 52 (C.A.), refd to. [para. 419, footnote 146].

Scinopharm Taiwan Ltd. v. Eli Lilly & Co., [2009] EWHC 631 (Pat.); [2009] All E.R. (D.) 282 (Mar.), refd to. [para. 419].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al., [2001] 4 F.C. 518; 208 F.T.R. 105; 2001 FCT 770, affd. [2003] 1 F.C. 118; 291 N.R. 168; 2002 FCA 216, refd to. [para. 426, footnote 154].

Commissioner of Patents v. Ciba Ltd., [1959] S.C.R. 378, refd to. [para. 572, footnote 230].

Canada Trustco Mortgage Co. v. Pierce et al. (2005), 197 O.A.C. 369; 254 D.L.R.(4th) 79 (C.A.), refd to. [para. 631].

Volkswagen Canada Inc. v. Access International Automotive Ltd., [2001] 3 F.C. 311; 271 N.R. 363; 2001 FCA 79, refd to. [para. 633].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2008), 379 N.R. 383; 66 C.P.R.(4th) 6; 2008 FCA 175, refd to. [para. 633].

Procter & Gamble Co. v. Kimberley-Clark of Canada Ltd. (1990), 29 C.P.R.(3d) 545 (F.C.A.), refd to. [para. 633].

Visx Inc. v. Nidek Co. et al. (1994), 87 F.T.R. 96; 58 C.P.R.(3d) 51 (T.D.), refd to. [para. 634].

Henriksens Rederi A/S v. PHZ Rolimpex, [1973] 3 All E.R. 589 (C.A.), refd to. [para. 636].

Saskatchewan Wheat Pool v. Feduk, [2004] 2 W.W.R. 69; 232 Sask.R. 161; 294 W.A.C. 161; 2003 SKCA 46, refd to. [para. 637].

Federal Commerce & Navigation Co. v. Molena Alpha Inc., [1978] 3 All E.R. 1066 (C.A.), affd. [1979] A.C. 757 (H.L.), refd to. [para. 638].

Old Mac's Pty. Ltd. v. Cavallo Horse & Rider Inc. et al., [2007] B.C.T.C. Uned. D01; 157 A.C.W.S.(3d) 944; 2007 BCSC 726, refd to. [para. 638].

Cam-Net Communications v. Vancouver Telephone Co. (1999), 132 B.C.A.C. 52; 215 W.A.C. 52; 182 D.L.R.(4th) 436; 1999 BCCA 751, refd to. [para. 638].

Allied Signal Inc. v. Du Pont Canada Inc. and Complax Corp. (1995), 184 N.R. 113 (F.C.A.), refd to. [para. 647].

Beloit Canada Ltd. v. Valmet-Dominion Inc. - see Voith (J.M.) GmbH v. Beloit Corp.

Voith (J.M.) GmbH v. Beloit Corp., [1997] 3 F.C. 497; 214 N.R. 85 (F.C.A.), refd to. [para. 648].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 2006 FC 524, refd to. [para. 648].

Allied Signal Inc. v. Du Pont Canada Inc. and Complax Corp. (1998), 142 F.T.R. 241; 78 C.P.R.(3d) 129 (T.D.), refd to. [para. 651, footnote 274].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al., [1996] 3 F.C. 40; 197 N.R. 241 (F.C.A.), refd to. [para. 657].

Hill v. Church of Scientology of Toronto and Manning, [1995] 2 S.C.R. 1130; 184 N.R. 1; 84 O.A.C. 1; 24 O.R.(3d) 865, refd to. [para. 657].

Whiten v. Pilot Insurance Co. et al., [2002] 1 S.C.R. 595; 283 N.R. 1; 156 O.A.C. 201; 2002 SCC 18, refd to. [para. 658].

Broome v. Cassell & Co., [1972] A.C. 1027, refd to. [para. 659].

Eli Lilly & Co. et al. v. Apotex Inc., [2004] 1 F.C.R. 360; 238 F.T.R. 261; 2003 FC 978, refd to. [para. 661].

Bank of America Canada v. Mutual Trust Co. et al., [2002] 2 S.C.R. 601; 287 N.R. 171; 159 O.A.C. 1; 2002 SCC 43, refd to. [para. 668].

Alberta v. Nilsson (2002), 320 A.R. 88; 288 W.A.C. 88; 220 D.L.R.(4th) 474; 2002 ABCA 283, refd to. [para. 671].

Sands Motor Hotel Ltd. v. Edmonton (City) (2005), 376 A.R. 365; 360 W.A.C. 365; 2005 ABCA 402, refd to. [para. 671, footnote 280].

Morriss v. British Columbia (2007), 246 B.C.A.C. 26; 406 W.A.C. 26; 281 D.L.R.(4th) 702; 2007 BCCA 337, refd to. [para. 672].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241; 114 D.L.R.(4th) 419, refd to. [para. 716].

Eli Lilly & Co. et al. v. Apotex Inc., [2007] F.T.R. Uned. 222; 156 A.C.W.S.(3d) 807; 2007 FC 367, refd to. [para. 726, footnote 295].

Harmegnies v. Toyota Canada, J.E. 2007-842; 2007 QCCS 539, affd. J.E. 2008-584; 2008 QCCA 380, refd to. [para. 726, footnote 295].

A.P.I. Alarm Inc. v. D'Arterio et al., [2009] O.T.C. Uned. 848 (Sup. Ct.), refd to. [para. 726, footnote 295].

Transamerica Life Insurance Co. of Canada v. Canada Life Assurance Co. (1995), 25 O.R.(3d) 106; 41 C.P.C.(3d) 75 (Gen. Div.), refd to. [para. 728].

351694 Ontario Ltd. et al. v. Paccar of Canada Ltd. et al. (2004), 264 F.T.R. 12; 2004 FC 1565, refd to. [para. 736, footnote 303].

R. v. Nova Scotia Pharmaceutical Society et al. (No. 2), [1992] 2 S.C.R. 606; 139 N.R. 241; 114 N.S.R.(2d) 91; 313 A.P.R. 91; 93 D.L.R.(4th) 36, refd to. [para. 738].

R. v. Northern Electric Co., [1955] 3 D.L.R. 449 (Ont. H.C.), refd to. [para. 741].

R. v. Container Materials Ltd., [1942] S.C.R. 147; [1942] 1 D.L.R. 529, refd to. [para. 742].

R. v. Aetna Insurance Co. et al., [1978] 1 S.C.R. 731; 15 N.R. 117; 20 N.S.R.(2d) 565; 27 A.P.R. 565; 75 D.L.R.(3d) 332, refd to. [para. 744].

No. 1 Collision Repair & Painting (1982) Ltd. v. Insurance Corp. of British Columbia et al., [1998] B.C.T.C. Uned. 288; 4 C.C.L.I.(3d) 135; 78 A.C.W.S.(3d) 834 (S.C.), varied (2000), 141 B.C.A.C. 1; 231 W.A.C. 1; 2000 BCCA 463, refd to. [para. 747, footnote 307].

Athey v. Leonati et al., [1996] 3 S.C.R. 458; 203 N.R. 36; 81 B.C.A.C. 243; 132 W.A.C. 243, refd to. [para. 759].

Hanke v. Resurfice Corp. et al., [2007] 1 S.C.R. 333; 357 N.R. 175; 404 A.R. 333; 394 W.A.C. 333, refd to. [para. 764].

Barker et al. v. Montfort Hospital et al. (2007), 223 O.A.C. 201; 278 D.L.R.(4th) 215; 2007 ONCA 282, refd to. [para. 766].

Bowes v. Edmonton (City) et al. (2007), 425 A.R. 123; 418 W.A.C. 123; 42 M.P.L.R.(4th) 192; 2007 ABCA 347, refd to. [para. 767].

Schwarzkopf et al. v. McLaughlin et al., [2008] B.C.T.C. Uned. 394; 168 A.C.W.S.(3d) 787; 2008 BCSC 730, refd to. [para. 768].

Ticketnet Corp. v. Air Canada (1997), 105 O.A.C. 87; 154 D.L.R.(4th) 271 (C.A.), refd to. [para. 768].

Laboratoires Servier (Les) v. Apotex Inc., [2008] EWHC 2347 (Ch. D.), refd to. [para. 768].

Eli Lilly & Co. et al. v. Apotex Inc. et al. (1995), 101 F.T.R. 33; 63 C.P.R.(3d) 245 (T.D.), refd to. [para. 778].

Monsanto Canada Inc. et al. v. Rivett (2009), 343 F.T.R. 203; 2009 FC 317, refd to. [para. 871].

Bayer Aktiengesellschaft et al. v. Apotex Inc., [2001] O.T.C. 2; 10 C.P.R.(4th) 151 (Sup. Ct.), affd. (2002), 155 O.A.C. 117; 16 C.P.R.(4th) 417 (C.A.), refd to. [para. 871].

Koch Marine Inc. v. D'Amica Societa di Navigazione A.R.L.; Ship Elena D'Amico, [1980] 1 Lloyd's Rep. 75 (Q.B. Comm. Div.), refd to. [para. 877, footnote 413].

Statutes Noticed:

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), para. 28(1)(b) [para. 321].

Competition Act, R.S.C. 1985, c. C-34, sect. 36 [para. 718]; sect. 36(4)(a)(i) [para. 728]; sect. 45 [para. 719].

North American Free Trade Agreement, para. 1709(5)(b) [para. 321].

Patent Act, R.S.C. 1985, c. P-4, sect. 55.1 [para. 212]; sect. 55.2(1) [para. 342].

Authors and Works Noticed:

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), pp. 15 [paras. 377, 378]; 16 [para. 378]; 219 [para. 90, footnote 25]; 391, 392 [para. 323].

Hayhurst, William L., The Art of Claiming and Reading a Claim, in Henderson, Gordon F., Patent Law of Canada (1994), p. 177 [para. 123, footnote 45].

Henderson, Gordon F., Patent Law of Canada (1994), p. 177 [para. 123, footnote 45].

Spaggiari, A., Blaszczak, L.C., and Prati, F., Low-Temperature Deacylation of N-Monosubstituated Amides (2004), 6 Organic Letters 3885, generally [para. 64, footnote 17].

Terrell on the Law of Patents (16th Ed. 2006), pp. 6-39 [para. 100]; 7-62 [para. 417, footnote 145]; 276, paras. 7, 8 [para. 573].

Counsel:

Anthony Creber, Patrick Smith, John Norman, William Vanveen and Isabel Raasch, for the plaintiffs (defendants by counterclaim);

Harry Radomski, David Scrimger, Miles Hastie, Sandon Shogilev, Ben Hackett and Belle Van, for the defendant (plaintiff by counterclaim);

Steven Garland, Timothy Stevenson, Colin Ingram and A. David Morreau, for the defendant by counterclaim.

Solicitors of Record:

Gowling Lafleur Henderson, LLP, for the plaintiffs (defendants by counterclaim);

Goodmans, LLP, for the defendant (plaintiff by counterclaim);

Smart & Biggar, for the defendant by counterclaim.

This case was heard in Ottawa, Ontario, between April 21 and November 13, 2008, and on December 9, 2008, by Gauthier, J., of the Federal Court, who delivered the following decision on October 1, 2009.

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