Ottawa, Ontario, Thursday, this 14th day of June 2007
PRESENT: MADAM PROTHONOTARY MIREILLE TABIB
BETWEEN:
ALTANA PHARMA AG
- and -
THE MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
[1] In this Application for a prohibition order pursuant to section 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”), the Applicants have filed affidavit evidence from 13 expert witnesses. They did not seek or obtain leave pursuant to section 7 of the Canada Evidence Act (the “Act”), R.S.C. 1985, c. C-5 prior to filing these affidavits. The Respondent Novopharm Limited moves for an order that the Applicants comply with the limits set out in the section 7 of that Act. Although the Applicants deny being in breach of section 7, they move, by cross-motion, for leave to file all the expert evidence tendered if it is found that leave is required.
THE APPLICATION
[2] This Application was brought by the Applicants is in response to Novopharm’s Notice of Allegation in respect of its proposed pantoprazole sodium tablets, wherein Novopharm addresses Canadian Patents 2,089,748 (the “748 Patent”) and 2,092,694 (the “694 Patent”), and alleges that both patents are invalid, but that in any event, neither would be infringed if an NOC were issued for Novopharm’s proposed tablets.
[3] Pantoprazole is used in treating gastrointestinal disorders and ulcers, and its use as a proton pump inhibitor to reduce gastric acid secretion is not protected by current patents. Use of pantoprazole in the treatment of Helicobacter pylori infections, which is known to cause the majority of such gastrointestinal disorders, is however protected by the patents at issue. In very general terms, the 748 Patent claims the use of pantoprazole in combination with anti-microbial agents (also referred to as combination therapy) while the 694 patent claims a formulation of pantoprazole that is not resistant to gastric juices, and the use of pantoprazole without other anti-microbials for the treatment of H. pylori (also referred to as monotherapy). With respect to non-infringement, Novopharm alleges that it will not suggest, represent, induce or procure the use of its pantoprazole product for the treatment of H. pylori, either in monotherapy or combination therapy, and that its tablets will be enterically coated, that is, resistant to gastric juices.
SECTION 7 OF THE CANADA EVIDENCE ACT
[4] Section 7 of the Act reads as follows:
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7. Where, in any trial or other proceeding, criminal or civil, it is intended by the prosecution or the defence, or by any party, to examine as witnesses professional or other experts entitled according to the law or practice to give opinion evidence, not more than five of such witnesses may be called on either side without the leave of the court or judge or person presiding. |
7. Lorsque, dans un procès ou autre procédure pénale ou civile, le poursuivant ou la défense, ou toute autre partie, se propose d’interroger comme témoins des experts professionnels ou autres autorisés par la loi ou la pratique à rendre des témoignages d’opinion, il ne peut être appelé plus de cinq de ces témoins de chaque côté sans la permission du tribunal, du juge ou de la personne qui préside. |
[5] The Respondent urges that the correct construction of section 7 is to limit each party to five expert witnesses, regardless of the number of issues requiring expert evidence. Although I agree with the Respondent’s argument, this Court has made it clear that previous decisions of this Court have indeed determined that the limits imposed by section 7 are applicable to the issues in the case rather than to the case as a whole, and that there is no basis upon which a Prothonotary could distinguish these decisions (see: Merck & Co. v. Canada (Minister of Health), 2003 FC 1511). I am therefore clearly bound to interpret section 7 as applicable to issues in the case, and the Respondent will have to take its argument on that matter to a Judge of this Court or to the Court of Appeal.
[6] As a subsidiary argument, the Respondent submits that the Applicants have even exceeded the limit of five experts per issue and that the Applicants must be restricted to the affidavits of five of the 11 experts they have called on the issue of infringement.
OUGHT THE MATTER TO BE DEFERRED TO THE APPLICATION JUDGE?
[7] The Applicants submit that the matter of the admissibility of its expert affidavits should be deferred to the application Judge. It is well recognized that motions to strike or remove affidavit evidence in an application ought to be left to the determination of the Judge hearing the application except in clear and obvious cases or where deferring the determination would cause prejudice to the other party. The Applicants cite the general principles applied by this Court to motions to strike evidence in applications, and specifically rely on the decision of Mr. Justice Pinard in GlaxoSmithKline Inc. v. Apotex Inc., T-876-02, September 4, 2003, where he so exercised his discretion on a similar motion.
[8] It should be noted that the GlaxoSmithKline decision is unreported. In this electronic age, every judgement or order accompanied by formal reasons becomes a reported decision. Only “endorsed” or “speaking” orders, such as GlaxoSmithKline, end up being unreported. As such orders are not ordinarily reported, they are also not generally meant to have precedential value; they are addressed primarily to the parties and the appropriate appellate Court, who will be fully appraised of the procedural history and circumstances of the case and of the arguments made and raised by the parties. Thus, the “reasons” of the Court are usually stated in their bare essence, stripped of most context and of the majority of the facts and arguments considered, even if relevant, leaving only the most decisive elements of the case.
[9] The Court in GlaxoSmithKline applied the general principles cited above to the circumstances of the case, and did indeed defer determination of the Applicant’s motion to strike the Respondent’s evidence to the application Judge:
“Here, such determinations are so difficult to make that the Applicants themselves do not specify which affidavits or parts of affidavits must be struck. In the circumstances, the determination ought to be left to the judge hearing the main application (…)
[…]
In any event, it is not clear and obvious to me that the evidence served and filed by the Respondent Apotex Inc. comprises, with respect to any single issue, more than five expert affidavits”
(Emphasis mine)
[10] That is all we know of the case. The number of issues involved, or even the number of expert affidavits tendered by either side is not discussed. Whether any party urged that prejudice might be suffered if the matter was deferred to the merits is not mentioned.
[11] Each case must be determined on its own facts, and it is a matter of discretion whether to determine the issue or defer it to the application Judge, having regard to whether the matter is clear and whether prejudice will be caused to the other party by deferring the matter to the main hearing. It also bears repeating that proceedings under the Regulations are intended to be dealt with in a summary manner and determined expeditiously; in exercising this discretion, regard must be had as to whether an immediate determination would tend to further or to frustrate this intention.
[12] In the present instance, I have of course considered whether the issue is clear and obvious. However, I have also considered that the following factors require that a determination be made at this time.
[13] The Respondent did not unduly delay in bringing this motion. It was announced within a month of the service of the Applicants’ affidavits and served ten days later.
[14] If Novopharm is correct in its alternative submissions that the Applicants are limited to five experts on the issue of infringement, then the Applicants are not just a little over the limits imposed by section 7, but more than twice over it: instead of the affidavits of five expert witnesses, the Applicants have filed the affidavits of 11 expert witnesses on the infringement issue. If the matter is left for determination by the hearing Judge, the Respondent will be required to prepare its case, and file evidence, to meet all of the evidence tendered. Unless the Respondent’s evidence is prepared in a manner that strictly follows and responds to each of the Applicants’ affiants independently (a procedural straightjacket which is, in and of itself, of a prejudicial nature), it is almost unavoidable that responses to various parts of the evidence the Applicants’ experts will be contained in the same affidavits, binding together potentially inadmissible and admissible evidence. The intertwining process will most likely be completed through the cross-examination process and the distillation of the evidence in memoranda of fact and law. Thus, by the time the issue comes up for determination by the application Judge, there may simply be no effective relief available to the Respondent.
[15] Furthermore, should the Respondent prepare a response to every affidavit of every expert, it too will end up with some 11 experts, some of which it may not be able to rely upon. Alternatively, should the Respondent limit itself to five experts, it would run the risk that results of the litigation be influenced by the “numerical count of experts”. No party should be forced to make such gambles where the issue can be determined on a preliminary motion.
[16] There is also the very ideals of a summary process and expeditious determination to consider, ideals which are increasingly being trampled under the feet of stampedes of experts.
[17] Proceedings under the Regulations are getting ever longer and more unwieldy. It is increasingly rare for any of these proceedings to be determined within a year of filing; the norm is 18 months and getting longer and that is a direct result of the growing number of experts being called by the parties. Every additional expert increases the amount of time required for the parties to file their respective evidence. Every additional expert augments the logistical nightmare of scheduling dates and places for cross-examinations, and lengthens the time required for conducting cross-examinations. Every additional expert provides more fodder for motions to strike, motion to file reply or even sur-reply evidence. Every additional expert adds to the time required for the hearing of the application, and every additional day of hearing makes the application harder and longer to schedule. The toll taken by the proliferation of experts on the Court, and ultimately, on the parties, was recently expressed by Justice Johanne Gauthier of this Court in Eli Lilly Canada Inc. v. Apotex Inc., 2007 FC 455:
[5] However, it is worth mentioning that since the adoption of the Regulations, it appears that NOC proceedings have become more and more complex. Today, they can hardly be described as summary. In this instance, the applicant filed 10 affidavits in chief plus nine affidavits in reply, whereas Apotex filed 12 affidavits in chief and 11 more affidavits in sur-reply. The body of some of these affidavits contain more than 80 pages. A list of the many experts who supplied evidence along with their stated qualifications is attached as Appendix A.
[6] The hearing of the present applications lasted a full seven days and did not go longer only because the parties agreed to limit their representations to pointing the way to the most pertinent evidence that the Court should consider and to outlining the legal and procedural issues to be determined. There was little time to go through the voluminous books of authorities submitted by the parties even though they agree that some of the legal issues relating to “selection patents” are quite new and important. Indeed, Apotex implies that such patents are to figure in many future NOC proceedings and that, in the same manner that these patents are sometimes described as “second generation patents”, one could describe the procedure for addressing them as “second generation NOC”. Hopefully, we will find a more efficient way of dealing with these so-called “summary proceedings” given that, in this case, the need to limit the hearing to seven days meant that the Court had to review more than 100 cases as well as a very substantial amount of evidence after the hearing.
[7] As will become apparent later, a good portion of this evidence relates to issues which are simply not that relevant to the ultimate decision to be made. Each side raised numerous objections to the evidence presented by the other, including objections on the basis of hearsay and failure to put in evidence facts underlying the experts’ opinions. The objections also include attacks on the admissibility of certain evidence while both parties challenge the weight to be attributed to various experts’ opinion.
[8] This comment by the Supreme Court of Canada in R. v. D.D. (2000 SCC 43, [2000] S.C.J. No. 56 (QL)) is most appropriate and illustrates the need for reform or, at least, better management of expert evidence in NOC proceedings:
Finally, expert evidence is time-consuming and expensive. Modern litigation has introduced a proliferation of expert opinions of questionable value. The significance of the costs to the parties and the resulting strain upon judicial resources cannot be overstated. When the door to the admission of expert evidence is opened too widely, a trial has the tendency to degenerate into “a contest of experts with the trier of fact acting as referee in deciding which expert to accept.”
[18] To add to the burden of the Court, on the hearing of an application, the task of determining such esoteric issues as how many issues exist, whether to grant leave after the fact or to determine which portion of the evidence to strike, and which parts of the responding affidavits and cross-examinations go with which part of the evidence, does not bear contemplation.
[19] For these reasons, I find that in the circumstances, the issue of whether or not the Applicants have exceeded the limits imposed by section 7 of the Act ought to be determined, if reasonably possible, on this preliminary motion.
HOW MANY ISSUES ARE THERE IN THIS APPLICATION?
[20] In order to apply section 7 of the Act as interpreted in Merck v. Canada, it is essential to first determine how many issues there are and to identify same. Only then can it be determined whether the number of experts called in respect of each issue exceeds the permitted number.
[21] It is accordingly the first question I addressed to counsel for the parties at the hearing. Counsel for the Respondent provided a concise and clear answer: there are but two issues, invalidity of the patents and non-infringement.
[22] As for the Applicants, counsel identified 50 issues in this application:
As to the invalidity of the 748 patent: 11 issues;
On the non-infringement of the 748 patent: 12 issues;
On the invalidity of the 694 patent: 11 issues; and
On the non-infringement of the 694 patent: 16 issues.
[23] I leave aside invalidity issues: counsel for Novopharm concedes that invalidity is at least one issue, and the Applicants have only filed evidence from two experts in that regard (there is a disagreement between the parties as to whether the affidavit of Dr. Senn-Bifinger is an affidavit of opinion or of fact, but that is irrelevant: even if it were opinion, it would still add up to less than five expert witnesses on that issue).
[24] As to the non-infringement issues, counsel for the Applicants identified them as those listed in paragraphs 39 and 41 of their written submissions (see Appendix I at the end of these reasons).
[25] A simple reading of this list of issues illustrates its artificial and contrived nature. For example, items 39(a) to (d) are word-for-word the same as items 41(c) to (f), while items 39(e) and (f) are essentially the same, even if not using the exact words, as items 41(h) and (i). All these items, further, are essentially subsumed in item 39(f).
[26] I then asked counsel for the Applicants to identify to which of the 50 issues identified each of the experts was deposing. The complete list is attached as Appendix II at the end of these reasons.
[27] For the purpose of this discussion, suffice it to say that it turns out that no expert is testifying at all to issues 39(a) or 41(a) to (c); that nine experts testify to issues 39(c), (e), (f), 41(e) and (i), but “only” between six and eight as to issues 39(g), (i), (j), 41 (g) and (h). The only issues to which less than five experts testify are issues 39(b), 41 (d) and (f) (four experts each, but who had already opined on most other “issues”), and items 41(k) to (p) (two experts, who notably were the only two experts whose testimony is entirely independent from the other so called “issues”).
[28] Accordingly, even on the Applicants’ own identification of the issues in this application, it is plain that the Applicants have run afoul of section 7 of the Act in respect of nine of their experts. That is itself enough to grant the Respondent’s motion with respect to nine of the Applicants’ experts, namely, Drs. Corbin, Elliott, Dresser, Hood, Julien, Wolman, Whittaker and Low, and Mr. MacDonald.
[29] This determination, however, does not end the matter, since it leaves for determination whether the affidavits of Dr. McGinity and Professor Malfertheimer, also going to non-infringement but focussing on the formulation aspects, are also on the same “issue” and subject to leave being granted, or are on a distinct issue.
[30] As mentioned above, Novopharm takes the position that all matters relating to non-infringement are but different aspects of the single issue of infringement. Although the Applicants’ attempt to identify some fifty infringement issues is obviously contrived, it is fair to say that if infringement is not a single issue, then there are at most two infringement issues: the first going to infringement of the use claims of both patents, and the second going to infringement of the formulation claims of the 694 Patent.
[31] Contrary to the Applicants’ argument that each patent raises distinct infringement issues, all aspects of infringement of use claims clearly have in common and center upon whether Novopharm’s product will be sold, promoted or effective for the purpose of treating H. pylori infections and disorders. That neither patent raises different or distinct factual issues in relation to use claims is confirmed by the fact that none of the Applicants’ proposed experts on these matters distinguish between the two patents in their comments as to how and for what use Novopharm’s proposed product would be considered and prescribed. Thus, all evidence relating to infringing use applies interchangeably to both patents and these matters are, if a distinct “issue” from the infringement of the formulation claims of the 694 Patent, no more than a single issue.
[32] If there is an argument to be made that there are, in this application, two distinct infringement issues, one going to use, for which nine expert affidavits have been tendered, and the other to formulation, for which two expert affidavits have been tendered, the support for this argument rests exclusively on the distinctiveness of the affidavits themselves: none of the “use” experts opine on formulation, and none of the “formulation” experts opine on use. However, the distinctiveness of the opinions is not, in my view, the appropriate criterion for determining the number of issues in a proceeding or the number of experts a party may file without leave.
[33] It is easy to conceive that the same delineation would occur in expert affidavits addressing the many grounds of invalidity of a patent. Yet, the Federal Court of Appeal in Pharmascience Inc. v. Canada (Minister of Health) et al., 2007 FCA 140, at paragraph 41, has determined that validity of a patent is a single issue:
“[41] What the NOC Regulations require the second person to establish is, inter alia, that the patent is invalid or that it would not be infringed. In other words, the “issue” to be addressed is invalidity or non-infringement. The specific grounds on which the second person wishes to demonstrate invalidity, whether that be by obviousness, anticipation, overbreadth or lack of sound prediction, do not constitute separate issues for the purpose of issue estoppel but are merely different bases on which the second person may address the issue of invalidity. Consequently, multiple NOAs from the same generic relating to a particular pharmaceutical and alleging invalidity of a particular patent will generally not be permitted, even if different grounds for establishing invalidity are put forward in each. As a majority of this Court identified in P&G at paragraph 22, an exception to the application of this rule might be made in cases where facts material to the issue could not have been discovered with reasonable diligence at the time of the first litigation. No such exception applies in the present case, however. Pharmascience does not deny that it could have raised additional grounds of invalidity in the first NOA, but merely contends that splitting its claims is permissible within the scheme of the regulations.”
[34] In the very recent judgment of Eli Lilly Canada Inc. v. Novopharm Ltd. et al., 2007 FC 596, Mr. Justice Hughes of this Court judged that this determination specifically applied in the context of section 7 of the Act, if interpreted as limiting the number of experts on a per issue basis:
“[5] I pause to comment that the Canada Evidence Act, R.S. 1985, c. C-5, section 7 provides that a party cannot submit the evidence of more than five expert witnesses without leave of the Court. I am sure that certain jurisprudence of this Court has lead some to believe that this means five witnesses per issue. I leave that for another day.
[6] The Federal Court of Appeal in Pharmascience Inc. v. Canada (Minister of Health) et al. 2007 FCA 140 at paragraph 41 has told us that validity is a single issue. That is the only issue before the court in this proceeding.
[7] I remarked in open Court that the parties should limit themselves to five experts. This went unheeded largely because it was in the parties’ mutual interest to do so. It must be pointed out how difficult it is for a court in NOC proceedings to assimilate masses of purportedly expert opinions, predominantly on scientific matters, all in written form, often comprising several volumes. Judges are human, not computers.”
[35] I see no reason why this reasoning should not equally apply to the determination of the number of issues involved in allegations of non-infringement, such that the question of whether relevant claims of the patents would be infringed by the making, constructing, using or selling of the proposed drug would also be a single issue. After all, just as the determination that invalidity of a patent is a single issue that can form the basis of issue estoppel, so are allegations of non-infringement in respect of any specific formulation of a generic drug (see: AB Hassle et al. v. Apotex Inc. et al. (2005), 38 C.P.R. (4th) 216 (F.C.), aff’d 2006 FCA 51, at paragraphs 73 to 80, and Pharmascience (above), at paragraph 45).
[36] In addition to being consistent with the manner in which “issues” have been identified in NOC proceedings, the determination that invalidity and non-infringement are each a single issue for the purpose of section 7 of the Act is also consistent with the purpose and intent of section 7 of the Act and addresses the necessity for better and more efficient management of NOC proceedings as the summary proceedings they are meant to be.
[37] The purpose of section 7 is to limit the number of experts that may be called by the parties to what is considered a reasonable number, beyond which prior leave of the Court must be obtained by demonstrating that a greater number of experts is necessary for the determination of the issues, that there are no unnecessary duplications in the evidence, and that the additional strain on the time and resources of the Court and the parties is justified (see: Gorman v. Powell, [2006] O.J. No. 4233 (S.C.J.), Burgess v. Wu, [2005] O.J. No. 929 (S.C.J.) and Sopinka, John et al., The Law of Evidence in Canada, 2nd ed., 1999, at pp. 664-666).
[38] In order for this purpose to be achieved, the circumstances in which a party’s obligation to seek leave arises must be clear and easily ascertainable. Otherwise, a party may, as was the case here and in too many NOC proceedings, simply dump any number of expert affidavits into the record, leaving the onus on the Respondent to first discern how many issues might be involved, how clear the delineation is, and then determine whether it is worth it – both in terms of delay and of its own interest in calling a large number of experts – to mount a challenge. As the Court has found, to its dismay, in cases such as Eli Lilly v. Novopharm (above) and Eli Lilly v. Apotex (above), the parties, for a number of reasons, will not always do so. Uncertainty of application cannot but be a significant barrier to the parties’ exercise of self- or mutual restraint.
[39] It is also to be said that even if infringement and invalidity are considered to be distinct issues, the parties will, in most NOCs, still have the absolute right to introduce as many as 10 expert witnesses each: the same number that prompted by the Court’s comments as to the excessive number of expert opinions of questionable value in Eli Lilly v. Apotex (see list of experts in Appendix “A” to that judgement).
[40] I therefore find that non-infringement is a single issue in this application, which issue includes non-infringement of all claims of both patents (as discussed above, Novopharm’s allegations of non-infringement of the 694 Patent includes both formulation claims and claims for the use of the medicine, and the latter involves the same arguments and evidence as for the 748 Patent).
[41] The Applicants have filed the affidavits of 11 experts in respect of the infringement issue in this application, and six of them are therefore clearly inadmissible without leave.
THE APPLICANTS’ MOTION FOR LEAVE
[42] The parties have not brought to my attention any case from this Court in which the factors to be considered in determining whether leave should be granted to exceed the number of permitted experts have been discussed. A number of cases from the Ontario Courts have been cited by the Respondent, more particularly, Burgess v. Wu (above), where a list of eight factors was established. Most of these factors, however, are either not ascertainable in the circumstances of this case, influenced by the more restrictive interpretation given to section 12 of the Ontario Evidence Act (five experts per side, for the case as a whole), or of less relevance in proceedings under the Regulations than in the context of a trial.
[43] The parties, however, seem to agree that the paramount consideration is whether the proposed expert testimony is reasonably necessary to determine the issues in the case. The amount of duplication in the proposed opinions, and the number of distinct subjects involved, sometimes listed as separate factors, really are elements from which that necessity can be ascertained. I would add, as an important factor to be taken into consideration, the nature of the proceedings for which the evidence is to be called. As mentioned, NOC proceedings are intended to be summary in nature and expeditious. They do not finally determine the issues of validity and infringement between the parties. The “necessity” of presenting a full and complete evidentiary case on all aspects of all issues must be viewed from this perspective. An Applicant will succeed on such an application if it shows that any one of the Respondent’s allegation of non-infringement is not justified; it is not required to address or to succeed on every allegation of non-infringement.
[44] The Applicants’ motion seeks leave to rely upon the expert affidavits of all thirteen experts they have filed in this application, including those of Drs Fennerty and Marshall, opining on validity, without mentioning which five affidavits they would call as of a right for each issue and which affidavits are intended to be supplementary. The Applicants provided no “middle ground” position in the event the Court concluded that 11 infringement expert opinions was an excessive number; they did not provide the Court with an indication of which affidavits would form the core of their case if limited to five, how such limitation would affect their case or how whatever gaps in their case could reasonably be remedied with the addition of a more restricted number of experts than the full complement of 11 experts.
[45] The affidavits of Drs McGinity and Malfertheimer relate exclusively to the formulation aspects of infringement, and the Respondent does not appear to take issue with their necessity or usefulness. I am satisfied that they are necessary and not duplicative of each other.
[46] I am also satisfied that in putting their case forward on infringement of use claims, the Applicants probably need to rely on evidence from the point of view of both the prescribing physicians and the pharmacists who will dispense the medication. The Respondent’s submissions appear to accept this as well.
[47] I do not, however, accept the Applicants’ argument that the point of view of prescribing physicians cannot be adequately presented without presenting the evidence of physicians from a variety of provinces (namely, Ontario and British Columbia) and from a variety of specialities (namely, gastroenterologists and infectious disease specialists), in addition to survey evidence covering 410 physicians in Ontario and Quebec and representing both general practitioners and specialists. To that effect, the Applicants have filed the affidavits of Dr. Corbin (survey), Dr. Wolman (Ontario Gastroenterologist), Dr. Whittaker (B.C. Gastroenterologist) and Dr. Low (Ontario Infectious Disease). The evidence of these four experts is needlessly duplicative. Further, the evidence submitted by the Applicants to support their position that their case would not be complete without the opinions of all relevant specialists from all provinces is unconvincing. If Dr. Wolman’s evidence to that effect is accepted, the Applicants’ evidence as constituted is already inadequate as it fails to include direct opinions from any physician in all provinces other than BC and Ontario, of any infectious disease specialist in all jurisdictions other than Ontario or of any general practitioner at all. Furthermore, the issue, as concerns infringement, is simply whether the Respondent’s allegation of non-infringement is justified. Inducement or procurement with respect to one class of physicians in one province, if established, is all that is needed to overcome the Applicants’ burden on that issue. The Applicants’ case can be sufficiently presented with the evidence of one physician and one survey expert.
[48] The same comments are applicable to the Applicants’ affidavits from pharmacists. The Applicants’ evidence in that respect comprises the Affidavit of Dr. Corbin (survey), Dr. Elliott (Ontario community), Dr. Dresser (Ontario hospital), Dr. Hood (BC community), Dr. Julian (Quebec community) and Mr. MacDonald (formulary listings). I do not accept that the Applicants reasonably need to present evidence from pharmacists in three provinces (Ontario, Quebec and British Columbia) and in two types of environment (community and hospital), as well as survey evidence of 701 community pharmacists in Ontario and Quebec. Dr. Elliott’s affidavit in support of the Applicants’ motion for leave is as unconvincing as Dr. Wolman’s.
[49] Thus, the Applicants’ case with respect to pharmacists’ point of view can be sufficiently presented with the affidavit of one pharmacist and one survey expert.
[50] This leaves the formulary listings aspect. The Applicants have filed the affidavit of Mr. MacDonald, who is not a pharmacist, to provide evidence as to formulary listings across Canada. The Applicants’ representations and evidence as to why a formulary expert is needed in addition to pharmacists’ evidence is to the effect that:
“While physicians and pharmacists are familiar with formulary issues, from a “user” standpoint, neither a pharmacist nor a physician would be able to provide expert opinion on formulary lists across the country”.
(Emphasis mine)
[51] As I have determined with respect to pharmacists and physicians, evidence of the potential for infringement in all provinces is unnecessary in this litigation. The Applicants did not suggest that an understanding of how formularies are elaborated is necessary to the presentation of their case, such as would justify the introduction of Mr. MacDonald’s evidence as a distinct specialty. The Applicants’ submissions as to the necessity for that evidence were based on the need to bring evidence as to the formularies as they exist across the country. Formulary listings for all provinces are not likely to be useful in the absence of other evidence of physicians or pharmacists’ practices for all provinces. I also note that two of the pharmacists’ affidavits filed by the Applicants do discuss formulary listings, confirming that insofar as these are relevant to the Applicants’ case, there is no need for a specific “formularies expert” for the Applicants to make their case.
[52] In conclusion, the Applicants have not satisfied me that it is reasonably necessary for them to call more than three expert witnesses to present their case on infringement of use claims: one physician, one pharmacist and one to present the results of surveys of physicians and pharmacists. Counting the Applicants’ two experts on formulation issues, the Applicants’ case does not necessarily require more than five expert witnesses on the infringement issue. Furthermore, granting leave for additional experts in the circumstances of this case would not be consistent with the summary nature of these proceedings and the need for the expeditious determination thereof.
ORDER
THIS COURT ORDERS THAT:
1. The applicants may not rely on the evidence of more than five of the following expert witnesses whose affidavits have been served to date in this proceeding: Dr. Corbin, Dr. Dresser, Dr. Elliott, Dr. Hood, Dr. Julien, Dr. Low, Dr. Malfertheimer, Mr. MacDonald, Dr. McGinity, Dr. Whittaker and Dr. Wolman.
2. The Applicants shall advise the Court and the other parties, within 5 days of the date of this Order, as to which of the three experts’ evidence it shall be relying upon in this proceeding. All affidavits from the other experts listed in paragraph 1 of this Order shall be struck.
3. The Applicants’ motion is dismissed.
4. Costs of both motions to the Respondent Novopharm Limited.
“Mireille Tabib”
APPENDIX I
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T-1836-06, Responding Motion record (Motion to Strike Affidavit Evidence), court document 37, filed May 22, 2007
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Paragraph 39, issues, pages 140-141
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Paragraphs 41, issues, pages 142-143: |
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a. Novopharm will not seek approval for its proposed pantoprazole product for the H. pylori indication either on its own or as part of combination therapy.
b. The Novopharm labelling will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
c. The Novopharm Product Monograph will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
d. The Novopharm marketing materials will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
e. Novopharm’s proposed pantoprazole product will not be made, constructed, manufactured, used or sold by Novopharm for the H. pylori indication.
f. Novopharm will not represent to third parties that its proposed pantoprazole product can be used for the H. Pylori indication or in combination with an antibiotic drug or drugs for any other purpose. g. Claims 1-12 and 17-28 and claims 15, 16 and 44 (to the extent they are dependent on claims 1 to 12) will also not be infringed, since each of these claims required that pantoprazole and the Helicobacter-inhibiting anti-microbial agent are comprised in a single dosage form. Novopharm’s proposed pantoprazole product does not contain a Helicobacter-inhibiting antimicrobial agent.
h. Claims 13, 14, 29-43 (and any claims that depend on those claims) will not be infringed since each of these claims require that pantoprazole and the Helicobacter-inhibiting agent are comprised in a medicament package comprising discrete dosage forms and Novopharm’s proposed pantoprazole product will not be comprises in a medicament package containing pantoprazole and a Helicobacter-inhibiting agent.
i. Claims 15 and 17-30 (and any claims that depend on those claims) claim the use of pantoprazole in combination a Helicobacter-inhibiting agent for use in the regulation of a gastrointestinal disorder or as a gastrointestinal disorder regulant. Novopharm’s proposed pantoprazole product will not infringe these claims since it will not be approved for anything that could be understood as being use in the regulation of a gastrointestinal disorder or as a gastrointestinal disorder regulant.
j. The Novopharm labelling will not suggest the use of Novopharm’s proposed pantoprazole product in the regulation of a gastrointestinal disorder or as a gastrointestinal disorder regulant, and so claims 15 and 17-30 (and any claims that depend on those claims) of the 748 Patent will not be infringed.
k. The Novopharm Product Monograph will not suggest the use of Novopharm’s proposed pantoprazole product in the regulation of a gastrointestinal disorder or as a gastrointestinal disorder regulant, and so claims 15 and 17-30 (and any claims that depend on those claims) of the 748 Patent will not be infringed.
l. The Novopharm marketing materials will not suggest the use of Novopharm’s proposed pantoprazole product in the regulation of a gastrointestinal disorder or as a gastrointestinal disorder regulant, and so claims 15 and 17-30 (and any claims that depend on those claims of the 748 Patent will not be infringed. |
a. Only claims 1, 2, 6 7-19 and 26-31 explicitly include the use of pantoprazole or its pharmaceutically tolerated salts for combating or treating Helicobacter infections.
b. Claims 3, 4, 5 and 20-25 should be construed to include the use of pantoprazole or its pharmaceutically tolerate salts for combating or treating Helicobacter infections as an essential element.
c. Novopharm will not seek approval for its proposed pantoprazole product for the H. pylori indication either on its own or as part of combination therapy.
d. The Novopharm labelling will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
e. The Novopharm Product Monograph will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
f. The Novopharm marketing materials will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
g. Altana’s pantoprazole product is not approved for the treatment of H. pylori as monotherapy. h. Novopharm’s proposed pantoprazole product will not be made, constructed, manufactured, used or sold by Novopharm for the treatment of H. pylori, either alone or in combination.
i. Novopharm will not represent to third parties that Novopharm’s proposed pantoprazole product can be used for the treatment of H. pylori.
j. When Novopharm proposed pantoprazole product is ingested, the pantoprazole sodium contained therein functions as an inhibitor of gastric acid secretion and not as an antibacterial agent against Helicobacter or Helicobacter pylori.
k. The Novopharm marketing materials will not suggest the use of Novopharm’s proposed pantoprazole product for the H. pylori indication.
l. Pantoprazole sodium alone will not eradicate Helicobacter or Helicobacter pylori.
m. When pantoprazole sodium is administered in combination with antibiotic drugs for the treatment Helicobacter pylori, the pantoprazole sodium functions as a gastric acid suppressant as opposed to having an antibacterial effect per se.
n. Novopharm’s proposed pantoprazole product does not contain an additional pantoprazole formulation lacking an enteric coating and comprises only one formulation and the entirety of that formulation is resistant to gastric juice.
o. An essential element of claims 4, 9, 16, 22 and any claims dependent on those claims is a “shell” that is not resistant to gastric juice or substantially non-resistant to gastric juice. Novopharm’s proposed pantoprazole product does not comprise a shell that is not resistant to gastric juice or substantially non-resistant to gastric juice.
p. An essential element of claims 5, 10, 11, 12, 17-19, 23-25, 30 and 31 is a pantoprazole formulation that is a capsule. Novopharm’s proposed pantoprazole product is a tablet formulation and is not a capsule formulation and therefore, these claims will not be infringed by the Novopharm’s proposed pantoprazole product. |
APPENDIX II
Issues to which each expert testifies:
|
Dr. Corbin (survey of physicians and pharmacists): |
39 |
(b) (c) (d) (e) (f) (j) (k) (l)
|
41 |
(d) (e) (f) (h) (i)
|
|
Dr. Elliott (Ontario Community pharmacist): |
39 |
(b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l)
|
41
|
(d) (e) (f) (g) (h) (i)
|
|
Dr. Dresser (Ontario hospital pharmacist): |
39 |
(b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l)
|
41
|
(d) (e) (f) (g) (h) (i)
|
|
Dr. Hood (British Columbia community pharmacist): |
39 |
(c) (e) (f) (g) (h) (i) (k)
|
41
|
(e) (g) (h) (i)
|
|
Dr. Julien (Quebec community pharmacist): |
39 |
(b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l)
|
41
|
(d) (e) (f) (g) (h) (i)
|
|
Mr. MacDonald (formulary listings): |
39 |
(c) (e) (f) (i) (j) (k)
|
41
|
(e) (g) (h) (i)
|
|
Dr. Wolman (Ontario gastroenterologist): |
39 |
(c) (e) (f) (g) (i) (j) (k) (l)
|
41
|
(e) (g) (h) (i)
|
|
Dr. Whittaker (British Columbia gastroenterologist): |
39 |
(c) (e) (f) (g) (i) (j) (k) (l)
|
41
|
(e) (g) (h) (i)
|
|
Dr. Low (Ontario infectious disease specialist): |
39 |
(c) (e) (f) (i) (k)
|
41
|
(e) (g) (h) (i) |
|
Dr. McGinity (formulation): |
|
|
41
|
(k) (l) (m) (n) (o) (p)
|
|
Dr. Malfertheiner (formulation): |
|
|
41
|
(k) (l) (m) (n) (o) (p)
|
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1836-06
STYLE OF CAUSE: Altana Pharma Inc. and Altana Pharma AG v. Novopharm Limited and the Minister of Health
PLACE OF HEARING: Toronto, Ontario
REASONS FOR ORDER: MADAM PROTHONOTARY MIREILLE TABIB
APPEARANCES:
|
Lindsay Neidrauer Natalie Rizkalla-Kamel |
|
|
Mark Davis Julian Worsley |
NOVOPHARM LIMITED
|
SOLICITORS OF RECORD:
|
Gowling Lafleur Henderson LLP Toronto, Ontario
|
|
|
Heenan Blaikie LLP Toronto, Ontario
|
NOVOPHARM LIMITED
|
|
John H. Sims, Q.C. Deputy Attorney General of Canada |
FOR THE RESPONDENT THE MINISTER OF HEALTH
|