Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al., (2009) 357 F.T.R. 75 (FC)

• Judge: Mactavish, J.
• Court: Federal Court (Canada)
• Case Date: November 23, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 357 F.T.R. 75 (FC);2009 FC 1102

Lundbeck Can. Inc. v. ratiopharm Inc. (2009), 357 F.T.R. 75 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. NO.057

Lundbeck Canada Inc., H. Lundbeck A/S and Merz Pharma GmbH & Co. KGaA (applicants) v. ratiopharm Inc. and The Minister of Health (respondents)

(T-414-08; 2009 FC 1102)

Indexed As: Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al.

Federal Court

Mactavish, J.

November 23, 2009.

Summary:

The two patents at issue involved a drug known as memantine hydrochloride (memantine), for the treatment of individuals with moderate to advanced Alzheimer's disease. Memantine was sold in Canada under the brand name "EBIXA" by Lundbeck Canada Inc. A generic drug manufacturer, ratiopharm Inc., wanted to sell memantine in Canada, and sought a Notice of Compliance. It filed an abbreviated new drug submission, and compared its "ratio-MEMANTINE" drug to the EBIXA tablets. In its Notice of Allegation, ratiopharm alleged that the two patents were invalid on a number of bases, and that it would not infringe either patent if it was allowed to manufacture and sell its product. The respective owners of the patents and Lundbeck sought to prohibit the Minister of Health from issuing a Notice of Compliance to ratiopharm until the expiration of the patents.

The Federal Court dismissed the application. Certain of ratiopharm's allegations of invalidity were justified as they related to each of the patents in issue. Also, ratiopharm's allegation of non-infringement was justified, as it related to one of the patents.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - The two patents at issue involved a drug known as memantine hydrochloride (memantine), for the treatment of individuals with moderate to advanced Alzheimer's disease - Memantine was sold in Canada under the brand name "EBIXA" by Lundbeck Canada Inc. - A generic drug manufacturer, ratiopharm Inc., wanted to sell memantine in Canada, and sought a Notice of Compliance - It filed an abbreviated new drug submission, and compared its "ratio-MEMANTINE" drug to the EBIXA tablets - In its Notice of Allegation, ratiopharm alleged that the two patents were invalid on a number of bases, and that it would not infringe either patent if it was allowed to manufacture and sell its product - The respective owners of the patents and Lundbeck sought to prohibit the Minister of Health from issuing a Notice of Compliance to ratiopharm until the expiration of the patents - The Federal Court dismissed the application - The court concluded that certain of ratiopharm's allegations of invalidity were justified as they related to each of the patents in issue - Also, ratiopharm's allegation of non-infringement was justified, as it related to one of the patents - See paragraph 401.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof (incl. presumptions) - The Federal Court, in the context of an application for a prohibition order under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, addressed the burden and standard of proof - "With respect to the issue of infringement, where, as here, a generic manufacturer has alleged non-infringement in its [Notice of Allegation], the statements that it makes in this regard are presumed to be true. The onus is on the applicants to demonstrate, on a balance of probabilities, that the allegations of non-infringement are not justified. It will not be enough for an applicant to raise the possibility of infringement ... . Insofar as the validity of a patent is concerned, the patent will be presumed to be valid, in the absence of evidence to the contrary. If the generic fails to adduce any evidence on a ground of invalidity, the presumption is not rebutted. However, if the generic adduces some evidence which, if accepted, is capable of establishing the invalidity of the patent, thereby putting the allegations of invalidity 'in play', the burden will be on the applicant to establish on a balance of probabilities that all of the allegations of invalidity are not justified" - See paragraphs 22 to 25.

Patents of Invention - Topic 705

Application for grant - General - Disclosure and examination (incl. duty of candour) - The Federal Court stated that s. 73(1)(a) explicitly imposed a duty on patent applicants to "reply in good faith to any requisition made by an examiner in connection with an examination" - As a consequence, it was clear that there was a duty of candour on the part of applicants in the prosecution of a patent application in Canada - The only cases considering the scope of s. 73(1)(a) were the Federal Court decision in G.D. Searle & Co. v. Novopharm Ltd. (2007) and the decision of the Federal Court of Appeal reversing it - However, it was noteworthy that the Court of Appeal did not take issue with the trial judge's review of the law with respect to the duty of good faith - This court agreed with the analogy that the trial judge drew between an application for a patent and an ex parte court proceeding; i.e., a party seeking ex parte relief had the duty of ensuring that the court was apprised of all relevant facts - See paragraphs 316 to 331.

Patents of Invention - Topic 710

Application for grant - General - Abandonment - The respondent in this prohibition proceeding alleged that the subject patent should be deemed to have been abandoned for lack of good faith prosecution - The Federal Court found that the allegation was justified - The court reviewed the exchange of correspondence between the applicants' patent agents and the patent examiner, and concluded that the applicants failed to reply in good faith to a requisition made by the examiner - The examiner was concerned with obviousness - The agents provided the examiner with four less relevant items of prior art which "taught away" from pursuing the invention, yet failed to mention the one directly relevant study (Wenk) that came to the opposite conclusion - The fact that Wenk was identified by the agents in earlier correspondence did not take away from the fact that the response to requisition was not a full, fair or complete depiction of the teachings of the prior art - "A prior understanding of the prior art is clearly critical to patent examination. The duty of good faith imposed by paragraph 73(1)(a) ... requires that this prior art be fully and fairly described by applicants and their agents when answering requisitions from the Patent Office" - See paragraphs to 332 to 352.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - Before examining the issues raised by the parties in relation to questions of validity and infringement, the Federal Court set out the general principles governing the construction of the patents in issue - "The Court is to determine objectively, through the eyes of the person skilled in the art, what such a person would have understood the inventor or inventors to mean as of the relevant date ... . The claims of a patent are to be construed purposively, having regard to the intentions of the inventors as derived from the patent and with reference to the entire specification. A court should construe a patent with a judicial anxiety to support a useful invention ... . Expert assistance may be provided with respect to the meaning of certain terms, as well as the knowledge that a person skilled in the art would have had as of the relevant date" - See paragraphs 26 to 28.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The two patents at issue in this prohibition proceeding involved a drug known as memantine hydrochloride (memantine), which was the first drug approved for the treatment of moderate to severe Alzheimer's disease - The Federal Court reviewed the general principles governing the identification of the "person skilled in the art" - "The 'person skilled in the art' has been described as someone possessing a high degree of expert scientific knowledge and skill in the particular branch of the science to which the patent relates" - There was no disagreement between the parties as to the identification of the appropriate person skilled in the art for the purposes of construing the patents - "This hypothetical person may be described as 'a medicinal chemist and a clinician, such as a psychiatrist, neurologist or geriatrician, practicing in the field of dementia and Alzheimer's disease'" - See paragraphs 29 and 30.

Patents of Invention - Topic 1031

The specification and claims - Construction of a patent - Essential and non-essential elements - The subject patent (the '492 patent) was aimed at improving the current treatment of Alzheimer's disease - The claims at issue provided for a "synergistic pharmaceutical composition for treating mild cognitive impairment or dementia" - The construction question related to the word "synergistic" - The parties agreed that an additive effect would be expressed as 1 + 1 = 2, whereas a synergistic effect was described as 1 + 1 = 3 - The Federal Court found that it was an essential element of each of the claims in issue that each of the compositions claimed produced a synergistic effect, i.e., generated a result that was greater than the sum of its parts - "A claim to a synergistic effect requires some unexpected advantage: in particular, an advantage caused by an unpredictable cooperation between the elements of the combination. If the synergistic effect is to be relied upon, it must be possessed by everything covered by the claim and it must be described in the specification" - See paragraphs 221 to 230.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The two patents at issue involved a drug for the treatment of Alzheimer's disease - The relevant claims of one of the patents claimed an alleged new use of adamantane derivatives for the prevention or treatment of "cerebral ischemia" - The term "cerebral ischemia"was defined in the patent, different from its ordinary sense - If the term was construed as defined in the patent, then the manufacture or sale of the respondent's product would necessarily infringe the patent - The Federal Court concluded that "cerebral ischemia" referred to "an imbalance of neuronal stimulation mechanisms", as defined in the patent - "[A]lthough it is indeed the 'golden rule' of patent construction that a term in a patent claim should be given its plain and ordinary meaning, that rule is not inviolate. A term may bear a special or unusual meaning 'by reason either of a dictionary found elsewhere in the Specification or of technical knowledge possessed by persons skilled in the art'" - Moreover, a review of other portions of the patent disclosed that the term was not being used in its ordinary sense - See paragraphs 34 to 63.

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - [See Food and Drug Control - Topic 1302 ].

Patents of Invention - Topic 1503

Grounds of invalidity - General - Presumption of validity - [See Food and Drug Control - Topic 1302 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court noted the recent observation in the leading jurisprudence (Sanofi, S.C.C.) "that anticipation and obviousness are related concepts. However, although both require an examination of the prior art, that prior art must be treated differently depending on whether the issue is anticipation or obviousness. In examining an allegation of anticipation (or lack of novelty), the Court must determine whether the claimed invention has already been disclosed to the public in a single disclosure in such a way as to enable it to be put into practice ... In contrast, where lack of obviousness (or invention) is alleged, the Court may consider a number of prior disclosures that would have been known or found by a person skilled in the art, in order to determine whether an inventive step has been taken" - See paragraphs 67 to 70 - The court set out the four-step approach to an inquiry into whether a claimed invention was obvious, and noted what the party alleging obviousness must demonstrate when a "mosaic" of prior art was at issue - See paragraphs 140 to 145.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. Common general knowledge and mosaicing) - An issue for determination in this prohibition proceeding was which prior art could be relied upon by the respondent, a generic drug manufacturer, in relation to the issues of disclosure and enablement - The applicants objected to arguments based on the "Fleischhacker article" being advanced by the respondent in relation to the issue of anticipation - Although the article was referenced by the respondent in its Notice of Allegation (NOA) with respect to the issue of obviousness, nowhere was the article mentioned in the NOA in relation to the question of anticipation - The Federal Court held that it would consider the Fleischhacker article only in relation to the issue of obviousness - The NOA did not allow the applicants to properly assess their chances of success or failure in relation to the question of anticipation, as it related to the Fleischhacker article - Nor did it allow the applicants to make a fully informed decision as to whether or not to institute prohibition proceedings, thereby exposing themselves to the risk of damages under s. 8 of the Patented Medicines (Notice of Compliance) Regulations - See paragraphs 80 to 94.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. Common general knowledge and mosaicing) - The two patents at issue involved a drug ("memantine") for the treatment of Alzheimer's disease - The respondent, a generic drug manufacturer, submitted that the '453 patent was invalid for obviousness - The applicants conceded that the discovery of memantine's mechanism of action was not, by itself, inventive - At issue was whether it was obvious as of April of 1989 (one year prior to the date on which the application for the patent was filed in Canada) that memantine could be useful in treating cerebral ischemia, as the term was defined in the patent, including Alzheimer's disease - The respondent argued that in light of the applicants' expansive definition of "cerebral ischemia", it was clear from the prior art (four publications) that it was obvious to try using memantine for the treatment of conditions characterized by the imbalance of neuronal stimulation mechanisms, including, but not limited to, Alzheimer's disease - The Federal Court held that the publications rendered the invention obvious - What was different after the '453 patent was the understanding of memantine's mechanism of action - The mere explanation of the mechanism underlying a use already disclosed in the prior art could not, without more, give rise to an invention - It was clear from the publications that memantine was being used before April 14, 1989 to treat cerebral ischemia, including Alzheimer's disease - See paragraphs 146 to 193.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. Common general knowledge and mosaicing) - The invention claimed in one of the patents at issue (the '492) was the use of the synergistic pharmaceutical composition of memantine and acetylcholinesterase inhibitors for the treatment of mild cognitive impairment or dementia, including Alzheimer's - The respondent, a generic drug manufacturer, alleged that the '492 patent was invalid for obviousness - It submitted that it was more-or-less self-evident from two prior art documents, the Wenk and the Jain articles, that the drugs could and should be used in combination and would provide a benefit to humans - The Federal Court held that the allegations of obviousness were not justified - The word "obvious" in the phrase "obvious to try" meant "very plain" - Neither Wenk nor Jain, either on their own or taken together, taught anything about the synergistic effect that was achieved through the combined use of memantine and an acetylcholinesterase inhibitor - Moreover, it was not at all plain from this prior art that combination therapy would generate a synergistic effect - See paragraphs 250 to 253.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court stated that, insofar as the test for anticipation was concerned, the Supreme Court of Canada had recently held that two separate requirements must be established in order for there to be anticipation: prior disclosure and enablement - "'Prior disclosure' means that the prior art must disclose subject matter which, if performed, would inevitably or necessarily result in infringement of the patent ... 'Enablement' means that the person skilled in the art 'would have been able to perform the invention' without undue burden. The person skilled in the art is assumed to be willing to make trial and error experiments to get it to work ... [T]he Court held that if an inventive step is required to get the invention to work, the earlier publication will not have provided enabling disclosure ... In considering the issue of novelty or anticipation, the Court must look at the invention as claimed " - See paragraphs 72 to 77.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The two patents at issue involved a drug ("memantine") for the treatment of Alzheimer's disease - The respondent, a generic drug manufacturer, submitted that one of the patents (the '453 patent) was invalid for anticipation and cited four publications which, it said, anticipated the patent - The Federal Court found on a balance of probabilities that the allegation that the '453 patent was anticipated by two of the publications, and, to a limited extent, by the third, was justified (the court did not consider the final publication, given that the document was incomplete) - "The information provided by the '453 patent is more information about an old use of an old drug, namely the use of memantine to treat cerebral ischemia ..., including Alzheimer's disease. Merely explaining the mechanism of action which underlies the old use of memantine as described in the prior art cannot, without more, give rise to novelty" - See paragraphs 96 to 137.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The invention claimed in one of the patents at issue (the '492) was the use of the synergistic pharmaceutical composition of memantine and acetylcholinesterase inhibitors for the treatment of mild cognitive impairment or dementia, including Alzheimer's - The respondent, a generic drug manufacturer, alleged that the '492 patent was invalid for anticipation, and relied on two prior art documents, the Wenk and the Jain articles - The Federal Court held that the Wenk article did not anticipate the patent as it did not meet the disclosure requirement for anticipation - Moreover, it only speculated about the possible efficacy of the two classes of medication used in combination - Further, it did not teach the person skilled in the art that the combination would produce a synergistic effect - Finally, the mere suggestion of the possibility of future clinical studies that could demonstrate the potential effectiveness of combination therapies was not sufficient - No one, including Wenk, recognized or predicted that using memantine in conjunction with an acetylcholinesterase inhibitor would generate a synergistic effect - As was the case with the Wenk article, Jain did not anticipate the '492 patent - See paragraphs 235 to 249.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction -The two patents at issue involved a drug ("memantine") for the treatment of Alzheimer's disease - The respondent, a generic drug manufacturer, asserted that nowhere in one of the patents (the '453 patent) were there facts and reasoning from which utility could have been soundly predicted - The focus of the argument was that there was insufficient data in the patent specification that a safe dose of memantine would have the promised utility - The Federal Court held that the allegation of inutility was not justified - Regardless of the size of the dose required, the test data referenced in the specification of the '453 patent clearly demonstrated utility, including utility in tests performed on human cells - Further, both the factual basis and line of reasoning for the claimed utility were disclosed by the inventors in the specification - As a consequence, the person skilled in the art was given information sufficient to understand the invention, its basis and its application - While the fact that memantine worked in treating Alzheimer's disease was already known, the inventors of the '453 patent were able to soundly predict why that was - See paragraphs 194 to 215.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The '492 patent claimed the allegedly novel use of two known drugs (memantine and one of several specified acetylcholinesterase inhibitors), to be used in combination to provide a synergistic therapeutic effect in humans - The respondent, a generic drug manufacturer, alleged that the patent was invalid due to the absence of either demonstrated or predicted utility - The Federal Court held that the allegation of inutility was justified - In construing the '492 patent, the court found that it was an essential element of each of the claims in issue that each of the compositions claimed produced a synergistic effect - The court also found that the '492 patent did not contain the information required to satisfy the three-part test for sound prediction articulated by the Supreme Court of Canada in the AZT case - Moreover, the court found that the utility of the invention claimed by the '492 patent had not been demonstrated as of the Canadian filing date of May 8, 2003 - See paragraphs 254 to 296.

Patents of Invention - Topic 2890

Infringement of patent - Acts constituting an infringement - Inducing infringement - The Federal Court considered the appellate jurisprudence that observed that a generic drug manufacturer, such as the respondent in this prohibition proceeding, "may be implicated in the infringement of a patent by others, if the generic drug manufacturer induces that infringement ... Infringement by inducement can be established in a number of different ways. One way is through inferences reasonably drawn from the contents of the product monograph for the generic drug product. Other ways ... include through evidence relating to the dosage form of the generic product, or its labelling or marketing ... However, the Court [of Appeal] cautioned that an inducement to infringe cannot generally be inferred from the mere reference to a particular new use in the product monograph, for example, in the course of explaining contraindications or drug interactions, or as part of a list of scientific references" - See paragraphs 355 to 357.

Patents of Invention - Topic 2890

Infringement of patent - Acts constituting an infringement - Inducing infringement - The subject patent claimed the allegedly novel use of two known drugs (memantine and one of several specified acetylcholinesterase inhibitors), to be used in combination to provide a synergistic therapeutic effect in humans - The respondent, a generic drug manufacturer, alleged that its own memantine product did not involve a synergistic combination of the two pharmaceutical compositions, with the result that there would be no infringement of the patent - The applicants alleged that the respondent would induce or procure others to infringe the patent - Their argument focused on the respondent's product monograph, and "business case" evidence to support its contention - The circumstantial evidence suggested that the respondent's product might indeed end up being used in combination with acetylcholinesterase inhibitors for the treatment of Alzheimer's - The Federal Court found that inducement has not been established - The applicants had not established on a balance of probabilities that the respondent would either itself infringe the patent, or would induce others to do so - In the result, the respondent's allegation of non-infringement was justified - See paragraphs 216 to 400.

Cases Noticed:

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 2008 FC 1359, affd. (2009), 387 N.R. 347; 2009 FCA 94, refd to. [para. 20].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97; 2005 FCA 270, refd to. [para. 23].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 30; 2007 FCA 153, refd to. [para. 25].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 60 C.P.R.(4th) 81; 2007 FCA 209, refd to. [para. 25].

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. 26].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 27].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [para. 27].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 28].

Halford et al. v. Seed Hawk Inc. et al. (2006), 353 N.R. 60; 54 C.P.R.(4th) 130; 2006 FCA 275, refd to. [para. 28].

Ernest Scragg & Sons Ltd. v. Leesona Corp., [1964] Ex. C.R. 649; 45 C.P.R. 1, refd to. [para. 45].

Minerals Separation North American Corp. v. Noranda Mines Ltd. (1952), 69 R.P.C. 81 (P.C.), refd to. [para. 46].

Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570, refd to. [para. 52].

Forest Laboratories Inc. v. Cobalt Laboratories Inc., 2009 WL 1916935, refd to. [para. 66].

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. 68].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 69].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2009), 346 F.T.R. 42; 2009 FC 301, refd to. [para. 69].

Ratiopharm Inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 2009 FC 711, refd to. [para. 77].

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. 85].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 74 C.P.R.(4th) 85; 2009 FC 137, refd to. [para. 90].

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. 142].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, affd. (2009), 392 N.R. 96; 75 C.P.R.(4th) 443; 2009 FCA 222, refd to. [para. 145].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, affd. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401, 2006 FCA 64, leave to appeal refused (2006), 358 N.R. 391 (S.C.C.), refd to. [para. 195].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (2000), 262 N.R. 137 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 197].

Cipla Ltd. et al. v. Glaxo Group Ltd., [2004] EWHC 477 (Ch.), refd to. [para. 229].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, affd. (2009), 392 N.R. 243; 2009 FCA 97, leave to appeal refused [2009] S.C.C.A. No. 219, refd to. [para. 243].

Janssen-Ortho Inc. et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 1; 2008 FC 744, revd. (2009), 392 N.R. 71; 2009 FCA 212, refd to. [para. 314].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al. (2007), 296 F.T.R. 254; 56 C.P.R.(4th) 1; 2007 FC 81, revd. (2007), 361 N.R. 290; 58 C.P.R.(4th) 1; 2007 FCA 173, consd. [para. 320].

United States of America v. Friedland, [1996] O.J. No. 4399 (Gen. Div.), refd to. [para. 330].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al. (2007), 366 N.R. 231; 59 C.P.R.(4th) 24; 2007 FCA 167, refd to. [para. 355].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 296 F.T.R. 141; 51 C.P.R.(4th) 161; 2006 FC 861, refd to. [para. 369].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 352 N.R. 99; 53 C.P.R.(4th) 453; 2006 FCA 229, refd to. [para. 370].

Solvay Pharma Inc. et al. v. Apotex Inc. et al. (2008), 323 F.T.R. 1; 64 C.P.R.(4th) 256; 2008 FC 308, refd to. [para. 370].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 1; 45 C.P.R.(4th) 449; 2005 FC 1461, refd to. [para. 387].

AB Hassle et al. v. Genpharm Inc. et al. (2004), 329 N.R. 374; 38 C.P.R.(4th) 17; 2004 FCA 413, refd to. [para. 389].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6; 2003 FC 1443, refd to. [para. 390].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 73(1)(a) [para. 298].

Counsel:

Steven B. Garland and Colin B. Ingram, for the applicant;

Arthur B. Renaud, for the respondent (ratiopharm Inc.);

No one appeared for the respondent (Health Canada).

Solicitors of Record:

Smart & Biggar, Ottawa, Ontario, for the applicant;

Bennett Jones, LLP, Toronto, Ontario, for the respondent (ratiopharm Inc.);

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent (Health Canada).

This application was heard on September 14-16, 2009, at Ottawa, Ontario, by Mactavish, J., of the Federal Court, who delivered the following public reasons for judgment and judgment, dated November 23, 2009.