Apotex Inc. v. Janssen-Ortho Inc.

Apotex Inc. v. Janssen-Ortho Inc.
Court (s) Database
Federal Court of Appeal Decisions
Date
2009-06-22
Neutral citation
2009 FCA 212
File numbers
A-373-08
Notes
Digest
Decision Content
Date: 20090622
Docket: A-373-08
Citation: 2009 FCA 212
CORAM: NADON J.A.
LAYDEN-STEVENSON J.A.
TRUDEL J.A.
BETWEEN:
APOTEX INC.
Appellant
and
JANSSEN-ORTHO INC. and
DAIICHI SANKYO COMPANY, LIMITED
Respondents
and
THE MINISTER OF HEALTH
Respondent
Heard at Ottawa, Ontario, on April 28, 2009.
Judgment delivered at Ottawa, Ontario, on June 22, 2009.
REASONS FOR JUDGMENT BY: NADON J.A.
CONCURRED IN BY: TRUDEL J.A.
DISSENTING REASONS BY: LAYDEN-STEVENSON J.A.
Date: 20090622
Docket: A-373-08
Citation: 2009 FCA 212
CORAM: NADON J.A.
LAYDEN-STEVENSON J.A.
TRUDEL J.A.
BETWEEN:
APOTEX INC.
Appellant
and
JANSSEN-ORTHO INC. and
DAIICHI SANKYO COMPANY, LIMITED
Respondents
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR JUDGMENT
NADON J.A.
[1] This is an appeal from a decision of Shore J. dated June 17, 2008, 2008 FC 744, prohibiting the Minister of Health (the “Minister”) from issuing a Notice of Compliance (a “NOC”) to the appellant Apotex Inc. (“Apotex”) in respect of its levofloxacin hemihydrate tablets until the expiry of Canadian Patent No. 1,304,080 (the “ ’080 patent”).
[2] The proceedings which led to the issuance of the learned Judge’s order of prohibition were commenced by the respondents pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the “Regulations”).
[3] I conclude that the appeal must be allowed.
THE FACTS
The patent at issue:
[4] The ‘080 patent which issued to the respondent Daiichi-Sankyo Company, Limited (“Daiichi”), on June 23, 1992, discloses and claims levofloxacin, an antibiotic that treats the most severe forms of pneumonia. The patent expires on June 22, 2009.
[5] Daiichi is also the owner of Canadian Patent 1,157,840 (the “ ‘840 patent”) which expired on May 22, 2001. This patent disclosed and claimed the antibiotic ofloxacin, which Daiichi licensed to the respondent Janssen-Ortho Inc. (“Janssen”) for marketing in Canada.
[6] The only claim of the ‘080 patent which is at issue in these proceedings is claim 4, which reads:
S(-)-9-fluoro-3-methyl-10-1-piperazinyl)-7-oso-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxaine-6-carboxylic acid.
The parties are in agreement that another name for the compound described in claim 4 is levofloxacin.
[7] Levofloxacin is a chiral compound. Chiral compounds can exist in two different three-dimensional configurations, known as enantiomers. Enantiomers have the same two-dimensional structures, but are non-superimposable mirror images of each other. When the two enantiomers are present in a 50-50 mixture, the mixture is known as a racemate. In the case of levofloxacin, the racemate is given the name “ofloxacin”. Levofloxacin’s mirror enantiomer is called “dextrofloxacin”.
[8] While similar in many respects, enantiomers have different chemical properties and may have different biological effects when administered. The disclosure of the ‘080 patent reveals that levofloxacin has reduced toxicity, increased solubility and twice the antimicrobial activity as compared to racemic ofloxacin. The ‘080 patent also discloses processes to make levofloxacin substantially free of the dextrofloxacin enantiomer.
[9] As disclosed in the ‘080 patent, levofloxacin can exist in both hydrous and anhydrous forms. The anhydrous form (the anhydrate), consists of levofloxacin free from any associated water molecules. Hydrous levofloxacin (the hydrate) is formed of levofloxacin closely associated with water molecules. Levofloxacin hemihydrate is a type of hydrate.
[10] Janssen manufactures levofloxacin for sale in Canada. Apotex, a “generic” company or “second person” under the Regulations, seeks to obtain regulatory approval for its levofloxacin hemihydrate tablets. In accordance with section 5 of the Regulations, Apotex sent a Notice of Allegation (“NOA”) to Janssen, alleging, inter alia, that the ‘080 patent was invalid and that even if valid, its tablet would not infringe it.
[11] On September 2, 2005, Janssen and Daiichi responded to Apotex’s NOA by commencing proceedings under the Regulations for an order prohibiting the Minister from issuing a NOC to Apotex for its levofloxacin hemihydrate tablets until after the expiry of the ‘080 patent.
Previous litigation of the ‘080 patent:
[12] The ‘080 patent has already been the subject of legal proceedings in Canada. First, in Janssen-Ortho v. Novopharm Limited, 2004 FC 1631, 264 F.T.R. 202 (the “Novopharm proceedings”), Mosley J. of the Federal Court considered the ‘080 patent in the context of an application for prohibition under the Regulations brought by Janssen in response to a NOA filed by Novopharm Limited. Mosley J. held that Novopharm’s levofloxacin hemihydrate tablets infringed claim 4 of the ‘080 patent, but that claim 4 was invalid for obviousness. An appeal was launched to this Court by Janssen, but it was held to be moot because the NOC had already been issued to Novopharm by the Minister by the time the appeal was heard (see: 2005 FCA 6, 337 N.R. 259); motion for extension of time for leave to appeal to the Supreme Court refused, 2005 SCC 33, [2005] 1 S.C.R. 776.
[13] Second, as a result of Mosley J.’s decision and the dismissal of its appeal by this Court, Janssen commenced an action against Novopharm for infringement of the ‘080 patent. In Janssen-Ortho v. Novopharm Limited, 2006 FC 1234, 300 F.T.R. 166 (the “Novopharm trial”), Hughes J. found the ‘080 patent to be valid and allowed Janssen’s action. I should point out that because Novopharm had conceded that its product infringed claim 4 of the ‘080 patent, Hughes J. was not called upon to make specific findings in that regard.
[14] While coming to a conclusion different from that reached by Mosley J. on obviousness, Hughes J. noted that his colleague had not had the benefit of the extensive evidence before him and that he had not had the opportunity of seeing and hearing the witnesses who had appeared before him during the course of the trial.
[15] In Novopharm Limited v. Janssen-Ortho, 2007 FCA 217 (the “Novopharm appeal”), this Court upheld Hughes J.’s decision and found the ‘080 patent to be valid. Leave to appeal this Court’s decision was denied by the Supreme Court of Canada, 2007 S.C.C.A. No. 442 (Q.L.).
THE DECISION OF THE FEDERAL COURT
[16] Because he was of the view that “no demonstration has been made as to invalidity nor infringement” (see: para. 203 of his Reasons), Shore J. concluded that the respondents were entitled to an order of prohibition. In reaching that conclusion, he made the following findings.
[17] Shore J. held that claim 4 of the ‘080 patent, when properly construed, must include the hemihydrate form of levofloxacin because the patent specifically teaches, in example 7, how to produce levofloxacin hemihydrate. Shore J. also noted that claim 17 of the ‘080 patent includes the hemihydrate of all the compounds of claim 2, which includes levofloxacin.
[18] On the issue of infringement, Shore J. concluded that Apotex’s tablets would infringe Janssen’s ‘080 patent and, as a result, he rejected Apotex’s allegation that its product would not infringe because the ‘080 patent did not cover the hemihydrate form of levofloxacin. Shore J. noted that Apotex admitted that the active ingredient in its tablets was levofloxacin hemihydrate and that consequently, if claim 4 of the patent covered the hemihydrate, its allegation of non-infringement could not be justified.
[19] With respect to anticipation, Shore J. rejected Apotex’s argument that each claim of the ‘080 patent was anticipated by the prior disclosure of ofloxacin in the ‘840 patent. Shore J. relied on the findings made by Hughes J. in the Novopharm trial and concluded that Apotex had not provided any evidence that would justify a deviation from Hughes J.’s determination on this issue.
[20] On the question of obviousness, Shore J. rejected Apotex’s argument that the inventors were merely verifying predictable qualities of known compounds. On the contrary, Shore J. held that there could not have been verification because the inventors had found unexpected and unpredictable properties of new compounds.
[21] In order to analyse the question of obviousness, Shore J. determined what could be considered as prior art, and concluded that none of the prior art references alleged by Apotex would have led a skilled person directly and without difficulty to the invention disclosed in the ‘080 patent, i.e., levofloxacin and its unexpected beneficial properties. In particular, Shore J. did not accept as prior art the “Gerster papers”, which related to a poster that publicly disclosed the fact that the (-)- enantiomer of flumequine was the more antimicrobially active of the two enantiomers and, thus, more active than its racemate. Shore J. concluded that the Gerster papers did not contain sufficient information to enable a person of ordinary skill and knowledge in the field to understand the nature of the invention and carry it into practical use by purely mechanical skill, without the aid of inventive genius.
[22] Shore J. concluded that Apotex misconstrued the promise of the ‘080 patent and the utility of the invention. Shore J. referred to the findings of Hughes J. in the Novopharm trial, who had found that the utility of claim 4 of the ‘080 patent was that the (S)- or (-)- form of ofloxacin had increased antimicrobial activity, reduced toxicity and markedly high water solubility, giving it an expectation to be a very useful pharmaceutical agent.
[23] Shore J. held that the ‘080 patent was not void pursuant to subsection 30(1) of the Patent Act, R.S. 1985, c. P-4 (the “Patent Act”), which stipulates that the application may be deemed abandoned if the applicant fails to answer an examiner’s requirement. Apotex argued that Daiichi had not answered the required questions within the given timeframe, and that it had breached paragraphs 40(1)(a) and (c) of the Patent Rules, C.R.C., c. 1250 (the “Patent Rules”), on the basis that Daiichi had not provided the examiner with particulars of interference proceedings or with prior art cited against the application.
[24] With respect to paragraph 40(1)(c) of the Patent Rules, Shore J. concluded that there was no breach of this provision on the ground that Daiichi’s patent agent had innocently and inadvertently failed to answer within the time prescribed only one of the examiner’s eight questions. Shore J. noted that the patent agent did answer the question at a later stage.
[25] With respect to paragraph 40(1)(a) of the Patent Rules, Shore J. concluded that Daiichi’s patent agent had disclosed all of the prior art references cited against the corresponding U.S. and European applications. Shore J. appeared to accept that it was sufficient to provide the examiner with citations to requests for prior art, and that it was unnecessary to provide the documents themselves.
[26] Further, Shore J. rejected Apotex’s argument that Daiichi had breached its duty of candour as a result of the alleged breaches of paragraphs 40(1)(a) and (c) of the Patent Rules. Shore J. held that such a duty of candour did not exist in Canada and that even if such a duty were to be implied, there was nothing in the prosecution of the ‘080 patent to suggest that the applicant had failed to act with candour and in good faith.
[27] Finally, Shore J. considered whether, in the light of this Court’s decision in Sanofi-Aventis v. Novopharm Ltd., 2007 FCA 163, [2008] 1 F.C.R. 174, Apotex had provided “better evidence or a more appropriate legal argument” (this expression is taken from paragraph 50 of Sanofi-Aventis, supra, to which I shall shortly return) than that which had been offered in the Novopharm trial so as to entitle it to challenge the prohibition proceedings brought by the respondents.
[28] The learned Judge concluded that Apotex had not met the requirements set out in Sanofi-Aventis, supra, according to which either better evidence or better legal arguments had to be put forward in order to justify a relitigation of the same or similar issues. As a result, the Judge concluded that it was an abuse for Apotex to relitigate the issues which had been litigated in the Novopharm proceedings and in the Novopharm trial.
APOTEX’S SUBMISSIONS
[29] First, Apotex argues that Shore J. erred in his construction of claim 4 of the ‘080 patent. According to Apotex, claim 4 simply provides an unambiguous description of the molecule levofloxacin and resorting to the remainder of the specification to expand or contract the scope of the claim is impermissible. Apotex argues that Shore J. erred by departing from the text of claim 4, by adopting a results-oriented construction of the claim and by failing to distinguish claim 4 from the other claims in the ‘080 patent.
[30] Second, Apotex contends that Shore J. erred by rejecting its allegation of non-infringement. Apotex argues that there can be no infringement if its construction of claim 4 is correct, i.e. if the claim does not cover the hemihydrate form of levofloxacin.
[31] Third, Apotex says that Shore J. erred by concluding that the ‘080 patent was not invalid for anticipation. According to Apotex, the properties of levofloxacin and the process to make it are irrelevant in an analysis of anticipation. Furthermore, Apotex submits that since Shore J. held that the ‘840 patent discloses ofloxacin as a compound that contains levofloxacin, the ‘840 patent also necessarily disclosed levofloxacin to the skilled addressee. In fact, Apotex argues that the evidence clearly established that skilled addressees knew the techniques available to resolve enantiomers from racemic mixtures and that since Shore J. did not refer to this evidence, he must be taken to have ignored it. Apotex also contends that Shore J. appeared to have decided the question of anticipation by adopting the decision of Hughes J. in the Novopharm trial, instead of deciding the question based only on the evidence adduced before him.
[32] Fourth, Apotex submits that Shore J. erred by failing to assess the ‘080 patent as a selection patent. According to Apotex, the ‘080 patent purports to be a selection patent, but it fails to meet the test for one because levofloxacin does not possess special, substantial and unobvious advantages over ofloxacin and because no advantages are properly disclosed. In particular, Apotex argues that Shore J. made palpable and overriding errors in his appreciation of the record with respect to the level of activity, the toxicity, and the solubility of levofloxacin as compared with ofloxacin. Apotex also contends that Shore J. incorrectly stated that Novopharm had unsuccessfully made the same argument in the Novopharm trial when, in fact, Hughes J. had not analysed the ‘080 patent as a selection patent in that decision.
[33] Fifth, Apotex says that Shore J. erred by concluding that the ‘080 patent was not invalid for obviousness. Apotex argues that Shore J. made a number of palpable and overriding errors in his appreciation of the record and, in particular, that he failed to properly appreciate the evidence before him when he concluded that Daiichi’s competitors were not motivated to separate the enantiomers and that Daiichi had taken four years to accomplish the separation. To the contrary, Apotex submits that the evidence suggests that Daiichi’s competitors were indeed motivated to resolve ofloxacin and that during most of the four-year period, Daiichi was doing no work to resolve the enantiomers. Apotex also submits that Shore J. adopted the conclusions of Hughes J. in the Novopharm trial, even though the record before Shore J. could not lead him to the same conclusion. In addition, Apotex argues that Shore J. assessed obviousness on the wrong date, prior to the date of invention, and that this prevented him from considering various pertinent pieces of prior art, including the Gerster 1985 poster.
[34] Sixth, Apotex submits that Shore J. erred in failing to find that the application for the ‘080 patent was deemed abandoned. According to Apotex, Shore J. erred in concluding that answering 7 out of 8 requirements was sufficient to advance the application and in concluding that an innocent or inadvertent failure excuses an applicant from responding within the required delay. In fact, Apotex contends that such reasons for not responding to a requirement are not stipulated in the Patent Rules. Apotex also argues that Shore J. erred in holding that there was no applicable duty of candour or good faith, when the case law confirms that there is.
[35] Finally, Apotex submits that Shore J. erred in applying the test for abuse of process. According to Apotex, Shore J. applied an extreme form of estoppel that prevented it from having a fair hearing, and that, in effect, meant that the Novopharm trial defined its rights for all purposes. In particular, Apotex contends that Shore J. should not have required it to lead better evidence than in the Novopharm trial, given that neither Apotex nor Shore J. had access to the evidentiary record in that case. In addition, Apotex contends that the burden of proof was different in the Novopharm trial: Novopharm had the burden of proving invalidity, whereas in this case, it is the respondents who had the burden of proving that Apotex’s allegations were not justified. Apotex submits that since it is a first time litigant of the ‘080 patent, it should not have been required to meet a higher burden of proof, and that it is the respondents who should be barred from litigating against Apotex the issues which they have already litigated against Novopharm on two occasions.
THE ISSUES
[36] The appeal raises the following issues:
1. Did Shore J. err in his construction of claim 4 of the ‘080 patent?
2. Did Shore J. err in holding that Apotex’s marketing of its levofloxacin tablets would infringe claim 4 of Janssen’s ‘080 patent?
3. If Shore J. did not err in his conclusions on infringement, did he err in concluding that the ‘080 patent is not invalid? In particular, did Shore J. err in concluding that the patent is not invalid on the following bases: (a) Anticipation; (b) Obviousness; (c) Should Shore J. have analysed the ‘080 patent as a selection patent and found that it was an invalid selection patent?
4. Did Shore J. err in concluding that the ‘080 patent is not void for abandonment?
5. Did Shore J. err in applying the test for abuse of process?
ANALYSIS
[37] For the reasons that follow, I need only address the issue of abuse of process. I have already set out the submissions made by Apotex on this issue. The respondents, not surprisingly, do not agree with Apotex’s position. They say that Shore J. correctly applied the test for abuse of process and that the arguments raised on this issue by Apotex have already been weighed and considered by this Court against the interest in avoiding inconsistent results that threaten the integrity of the administration of justice. The respondents contend that Shore J. was entitled to decide issues of fact with reference to the findings in prior court decisions, such as the decision of Hughes J. in the Novopharm Trial. In addition, the respondents contend that the evidence from the Novopharm Trial was publicly available but Apotex made no effort to introduce it. The respondents also dispute Apotex’s argument that only the results of prior proceedings under the Regulations should be considered for abuse of process, and not the results of an action, because the burden on the generic in an action on invalidity is more onerous. The respondents submit that this argument disregards the effect on the administration of justice.
[38] In my view, the learned Judge clearly erred in concluding, as he does at paragraph 205 of his Reasons, that “the Court does agree with the applicants’ argument on the abuse of process”. Specifically, the Judge agreed with the respondents’ submissions that because the validity of the ‘080 patent had already been determined by the Federal Court in the Novopharm trial and by this Court in the Novopharm appeal, Apotex’s attempt in these proceedings to contest the validity of the patent as a selection patent was simply an attempt, under the guise of differently-cloaked arguments, to relitigate the issues which had been litigated in the Novopharm trial and in the Novopharm appeal. Since most, if not all, of the arguments made by Apotex in these proceedings had been considered and dealt with by the Federal Court and this Court, there was simply no basis for allowing Apotex to contest the validity of the ‘080 patent unless it had either “better evidence or a more appropriate legal argument”.
[39] In determining whether Apotex’s conduct in sending a NOA to the respondents and in contesting their application for prohibition constitutes an abuse of process, Shore J. considered this Court’s decision in Sanofi-Aventis, supra. On the basis of that decision, he found that a second person challenging a patent on grounds similar to those put forward in a prior litigation by another generic had to establish, as a condition precedent to the pursuance of its case, that it had either “better evidence or a more appropriate legal argument” to offer than that offered in the previous litigation.
[40] In Sanofi-Aventis, supra, Sexton J.A., writing for the majority, made the following remarks at paragraph 50 of his Reasons:
[50] Finally, Sanofi-Aventis and Schering argue that a finding of abuse of process in this case will lead to unfairness. They say that while first persons will not be permitted to defend against allegations by subsequent generics after the same allegation made by an earlier generic has been found to be justified, subsequent generics will be permitted to repeat allegations already made earlier by other generics even if the earlier allegations were found to be unjustified. However, there is no unfairness in this scenario. All parties are held to the same standard: they must each put forward their entire case, complete with all relevant evidence, at first instance. The innovator is prevented from relitigating an issue already decided in a proceeding to which it was a party with the aid of additional evidence it chose not to adduce in the earlier proceedings. Generics likewise must put forward their full case at the first opportunity. Multiple NOAs issued by the same generic relating to a particular drug and alleging invalidity of a particular patent will generally not be permitted, even if different grounds for establishing invalidity are put forward in each. However, where one generic has made an allegation but has failed to put forward the requisite evidence and argument to illustrate the allegation is justified, it would be unjust to preclude a subsequent generic, who is apprised of better evidence or a more appropriate legal argument, from introducing it. Although this situation may give rise to the possibility of an inconsistent result, this concern is overridden by the potential for unfairness to the generic that is barred from bringing forward its case simply because another generic’s approach was inadequate. In each situation, it is necessary to balance the effect of a proceeding on the administration of justice against the unfairness to a party from precluding it from bringing forward its case.
[Emphasis added]
[41] This is the paragraph on which the Judge specifically relies for his view on abuse of process in the present matter. It is also the paragraph on which the respondents rely in making their submissions on abuse of process. It is important to note that in Sanofi-Aventis, supra, the issue was whether a first person (Sanofi-Aventis), which had failed to establish in a prior NOC proceeding against a different generic company (Apotex) that an allegation of invalidity found in the NOA was not justified, abuses the NOC process by seeking to relitigate the same allegation of invalidity when made by a second generic company (Novopharm).
[42] In Sanofi-Aventis, supra, the question of abuse of process arose by reason of paragraph 6(5)(b) of the Regulations, which provides that on a motion by a second person, the Federal Court may dismiss an application for prohibition on the ground that it is redundant, scandalous, frivolous or vexatious, or that it is otherwise an abuse of process.
[43] In this appeal, however, the question is not whether the first person’s application constitutes an abuse of process, but rather whether the second person’s allegations found in its NOA amount to an abuse of process. Paragraph 6(5)(b) of the Regulations clearly does not apply in the present matter and this Court is not asked to dismiss an application for prohibition on a motion brought by a second person. There can be no doubt that Sexton J.A.’s comments in Sanofi-Aventis, supra, were made in obiter and, thus, are not binding and, in any event, they do not support the position adopted by the Judge.
[44] In my view, a fair reading of paragraph 50 of Sexton J.A.’s Reasons in Sanofi-Aventis, supra, does not lead to the conclusion that a second person can only put forward a NOA on grounds similar to those put forward by a different generic in other proceedings when it has better evidence to offer or better legal arguments to make. I believe that at paragraph 50 of his Reasons, Sexton J.A. was simply attempting to explain his view that notwithstanding the possibility that different judgments might be rendered with respect to identical or similar NOAs, fairness required that a generic, such as Apotex in the present case, which had not yet litigated the issues which it raised in its NOA, be allowed to have its day in court. In my view, it cannot be seriously argued that Sexton J.A. was advocating that an assessment of the second generic’s evidence and legal arguments had to be made before it could send its NOA and respond to the application for prohibition.
[45] I am therefore satisfied that nothing said in our decision in Sanofi-Aventis, supra, supports the Judge’s conclusion that a second person, unless it is in a position to show that it has “better evidence or a more appropriate legal argument”, cannot send a NOA to a patentee and, hence, respond to the patentee’s application for prohibition on grounds similar to those put forward by a different generic in other proceedings with the same patentee. I therefore conclude that the Judge erred in concluding as he did on the issue of abuse of process.
[46] Consequently, although Shore J. erred in his understanding of this Court’s opinion in Sanofi-Aventis, supra, the question which must now be answered is whether his error warrants our intervention. In other words, was the Judge’s assessment of the evidence before him tainted by his mistaken view on abuse of process?
[47] Because there was no abuse of process on the part of Apotex, the Judge was required to assess the evidence put before him by both parties independently of the findings made by Hughes J. in the Novopharm trial. I therefore turn to that question. Before answering it, however, it is worth repeating the arguments which Apotex makes in support of its assertion that the Judge erred in applying the test for abuse of process and that, as a result, this Court must intervene.
[48] Reduced to its essentials, Apotex’s position is that this was the first time that it raised the issues which are now before the Court and that, as a result, it was entitled to a fresh determination by the Judge of these issues on the evidence before him, which determination had to be made irrespective of the findings made and conclusions reached by Hughes J. in the Novopharm trial. Thus, it submits that it did not have a fair hearing and that its fate was determined by the Novopharm trial.
[49] Contrary to my colleague Madam Justice Layden-Stevenson, I am unable to conclude, as she does, that the Judge conducted an enquiry with respect to the issues before him, namely, claim construction, anticipation and obviousness, distinct from his analysis on abuse of process. Although the Judge purports to make findings of fact, I am uncertain as to the nature of these findings. Is he making truly independent findings or is he making findings in accordance with those made by Hughes J. in the Novopharm trial? Is he of the view that Apotex, in order to succeed, was bound to adduce evidence that was better and to muster more appropriate legal arguments than what had been adduced and submitted by Novopharm in its litigation?
[50] I am led to this conclusion in great part by the difficulty which I have had in understanding the Judge’s Reasons. I therefore propose to review the Judge’s Reasons to highlight that difficulty.
[51] The learned Judge expressly considered abuse of process and whether Apotex had provided “better evidence or a more appropriate legal argument” than had been provided in the Novopharm trial and the Novopharm appeal, both at the beginning of his analysis and subsequently at the end thereof. The Judge also appears to have had in mind the principles of abuse of process throughout the entire course of his Reasons.
[52] Commencing at paragraph 40 of his Reasons, under the heading “Abuse of Process Consideration”, the Judge sets out the principle established by this Court in Sanofi-Aventis, supra. Following that, he sets out, under the sub-heading “Better evidence”, the parties’ respective arguments as to whether Apotex has submitted better evidence than that which was before Hughes J. in the Novopharm trial. And then, under the sub-heading “More appropriate legal argument”, he sets out the “novel legal arguments” which Apotex submits that it has to offer in the present proceedings. He also sets out the respondents’ response thereto.
[53] Then, after having listed the witnesses, both expert and factual, who appeared before him, the Judge turned to the issue of claim construction. He states at paragraph 62 of his Reasons that all court decisions which have considered claim 4 of the ‘080 patent have construed it “in a way consistent with Justice Hughes’ construction [in the Novopharm trial]”.
[54] At paragraphs 63 and 64 of his Reasons, the Judge cites extensively the construction of claim 4 arrived at by Hughes J. in the Novopharm trial. He concludes on this issue by saying at paragraph 70 of his Reasons:
[70] Recognizing the decision of Justice Hughes and the subsequent agreement of that decision voiced in the Federal Court of Appeal judgment, presided by justice Karen Sharlow, claim 4 is construed as not placing any limitations on whether the compound is hydrated and to what degree:
S(-) Ofloxacin, different from that contained in the racemate, obtained in a reasonably pure state.
[Emphasis added]
[55] I am unable to understand the exact meaning of paragraph 70 of Shore J.’s Reasons. As I have a similar problem in regard to his reasons with respect to the other issues which were before him, I will continue my outline of his Reasons and then, at the end of this exercise, will state the reasons which lead me to conclude as I do that his assessment of the evidence was tainted by his misunderstanding of the concept of abuse of process.
[56] After his analysis of claim construction, the Judge turned to the issue of infringement, under the heading “Is Apotex’ allegation of infringement justified?”. This part of his Reasons runs from paragraph 71 to paragraph 83, which he conducts as follows at paragraphs 82 and 83:
[82] Justice Hughes concludes in the Novopharm Trial that the ‘840 patent did not contain any direction that the enantiomers of ofloxacin would be more active than the racemate nor does it instruct the reader as to how to effect such separation or to produce an enantiomer. (Novopharm Trial, above as described in para. 104).
Conclusion
[83] The Court concludes that Apotex’ 250 mg, 500mg and 750 mg tablets would infringe Janssen’s ‘080 patent.
[57] After his analysis of infringement, the Judge turned to the issue of invalidity under the heading “Are Apotex’ allegations of invalidity justified?”. This part of his Reasons commences at paragraph 84 and concludes at paragraph176. Here, the Judge deals with the issues of anticipation and obviousness at paragraphs 87 to 104 and at paragraphs 105 to 176 respectively.
[58] With respect to anticipation, after reviewing the arguments and the evidence, the Judge concludes at paragraphs 103 and 104, in the following terms:
[103] Justice Hughes determined, in the Novopharm Trial:
[104] Neither the ‘840 patent nor the publication contain any direction that the optical isomers of Ofloxacin would be more active than the racemate nor do either instruct the reader as to how to effect such separation or to produce an [enantiomer].
…
[108] The Supreme Court test requires that the “flag” be planted at the point of the claimed invention and that the direction as to how to arrive at that point must be so clear such that an ordinary person skilled in the art would in every case, without possibility of error, be led to that point. No such flag is planted and no such direction is given in either the ’840 patent or the Daiichi publication. There is no anticipation of what is claimed in claim 4 of the Patent.
[104] Apotex has not provided this Court with any evidence that would justify a deviation from Justice Hughes’ determination on this issue. Consequently, there is no anticipation of what is claimed in claim 4 of the ‘080 patent.
[59] There can be no doubt that the judge simply adopted Hughes J.’s findings in the Novopharm trial regarding anticipation.
[60] The Judge then turned to obviousness. In the course of his discussion of that issue, he determined whether claim 4 was inventive and constituted a valid claim. At paragraph 170, he made the following remarks:
[170] In the Novopharm Trial, Justice Hughes held that claim 4 of the ‘080 patent was inventive and a valid claim. His decision was upheld on appeal. In this application, the same issue is being raised along with the same prior art references and substantially the same evidence.
(Novopharm Trial, above at paras. 109-115; Novophann Appeal, above at paras. 23-45; Sanofi-Aventis v. Novopharm, above at para. 50, Eli Lilly, 2007 FC 596, above at 238-239.)
[61] The learned Judge’s final paragraph on obviousness is paragraph 176 and it reads:
[176] Based on the foregoing, this Court finds that the Respondent has failed to establish that claim 4 is invalid on the basis of obviousness or lack of inventive ingenuity. Consequently, the ‘080 patent was not obvious.
[Emphasis added]
[62] At paragraphs 177 to 187, the Judge dealt with a different issue, namely, whether the claims were broader than the invention made and whether they lacked sound prediction. He concludes on that issue as follows, at paragraph 187:
[187] Apotex misconstrues the promise of the ‘080 patent and the utility of the invention. Apotex states in its NOA that the “reported in vitro antimicrobial testing was but a single test relied upon in an attempt to predict levofloxacin's utility - that it would be a very useful pharmaceutical agent as compared with ofloxacin"; however, the ‘080 patent merely states that it is "expected" that levofloxacin will be a very useful pharmaceutical agent as compared to ofloxacin. Justice Hughes eloquently summarized the utility of claim 4 in the Novopharm Trial:
[126] …What the Patent asserts, at the end of the day, is set out at page 2. The S(-) form of Ofloxacin has increased antimicrobial activity, reduced toxicity and markedly high water solubility, giving it an expectation to be a very useful pharmaceutical agent. This statement is correct. To even find this distribution of attributes, namely, more of the beneficial properties and at least no more of the detrimental, was itself remarkable.
[63] Finally, at paragraphs 203 and 204 of his Reasons, the Judge comes to a crucial conclusion with regard to the issues which he has dealt with in the course of his Reasons:
[203] Subsequent to all considerations, on every issue raised, in this NOC proceeding, no demonstration has been made as to invalidity nor infringement. Recognition is given to the previous Federal Court Trial and Federal Court of Appeal proceedings that had, in effect, exhausted all analysis of the asserted ‘080 patent claims. No better evidence, nor more appropriate legal argument, has been submitted in the present proceeding.
[204] The Applicants are thus granted the prohibition order for which they applied.
[Emphasis added]
[64] It would appear that by reason of this conclusion, all analysis had been exhausted, the respondents having been granted the order sought. Unexpectedly, however, the Judge then moves on a new subject entitled “Abuse of Process Analysis and Conclusion”. I say unexpectedly because by then, as I have just indicated, the Judge has granted the remedy sought by the respondents and has indicated that the principle enunciated in Sanofi-Aventis, supra, has not been met.
[65] At paragraph 205, the Judge says that he agrees with the respondents’ submissions on abuse of process and then states at paragraph 210:
[210] Subsequent to the Federal Court of Appeal having disposed of this matter in direct regard, the resulting precedent from the Court of higher instance concludes the matter for this Court.
[66] I have reproduced those paragraphs of the Judge’s Reasons which, in my opinion, shed greater light on his reasoning. In other words, these paragraphs bear greater importance in determining whether his reasoning was tainted because of his mistaken view on abuse of process. In fact, in the course of his Reasons, the Judge refers on no less than 43 occasions to the decision and opinion of Hughes J. in the Novopharm trial. I am not saying nor suggesting that the number of references per se is the determining factor. However, when I read the Judge’s Reasons as a whole, I am left in considerable doubt as to whether he in fact conducted an assessment of the facts independent of that made by Hughes J. in the Novopharm trial.
[67] As I have already indicated, at paragraph 203 of his Reasons, immediately following what could be characterized as his analysis of the merits of the case, the Judge states in unequivocal terms that Apotex has not led better evidence nor has it put forward stronger legal arguments than what had been put before Hughes J. in the Novopharm trial. This conclusion seems to suggest that the Judge, in assessing the evidence before him, was attempting to determine whether the evidence led by Apotex was such so as to allow him to reach a conclusion different from that reached by Hughes J. in the Novopharm trial. The considerable number of references to both Hughes J.’s findings and conclusions provide, in my view, strong support for the argument that the Judge did not make findings independent of those made by Hughes J. If he did so, that is not sufficiently apparent, in my respectful view, from his Reasons.
[68] It is also remarkable that notwithstanding the fact that at paragraph 204 of his Reasons, the Judge grants the prohibition order sought by the respondents, he then continues his analysis by engaging once again in a discussion regarding abuse of process. After his conclusion that the prohibition order was granted, one would have expected the Judge to simply set out his order and deal with the issue of costs. This discussion of abuse of process appears to be, with all due respect, totally irrelevant. As I understand the Judge’s Reasons, this discussion does not lead to any conclusion other than the remarks found at paragraph 247:
[247] Viewed as a whole, the “new evidence” concerning inventive ingenuity is no more than conflicting evidence or a repetition of the evidence before Justice Hughes. As stated above, where the “better evidence” in the second case can