Merck & Co. Inc. v. Apotex Inc., 2005 FC 1251

Date: 20050914

Docket: T-2792-96

Citation: 2005 FC 1251

(Ottawa), (Ontario), this 14^th day of September, 2005

Present:           The Honourable Mr. Justice Simon Noël                             

BETWEEN:

                                                           MERCK & CO., INC.

MERCK FROSST CANADA & CO.

SYNGENTA LIMITED

ASTRAZENECA UK LIMITED

and

ASTRAZENECA CANADA INC.

                                                                                                                                             Plaintiffs

(Defendants by Counterclaim)

                                                                           and

                                                                  APOTEX INC.

                                                                                                                                           Defendant

(Plaintiff by Counterclaim)

                                            REASONS FOR ORDER AND ORDER

INTRODUCTION

[1]                This is an appeal by Apotex Inc. (Apotex) of an Order of the Case Management Prothonotary dated May 25^th, 2005 which granted Merck and Co., Inc. (Merck)'s Motion to Strike Apotex's fresh as Amended Statement of Defence and Counterclaim dated May 13^th, 2002 (the 2002 Defence). The reason being that it was not in conformity with a Court of Appeal Judgment dated December 22^nd, 2003(Merck and Co. Inc. v. Apotex Inc. (2002) 30 C.P.R. (4^th) 40 (F.C.A.) "The Court of Appeal Judgment") and with a May 2005 Defence which is in accordance with that judgment. (The said defence having been filed as part of a response to the Motion to Strike).

[2]                Apotex appeals the Prothonotary's decision and is asking this Court to review it de novo. Since time is of the essence, the hearing being scheduled for early January 2006, I have given this decision priority.

SUMMARY OF THE FACTS

[3]                The initial steps of the litigation between the parties began in 1993. A notice of allegation in respect of tablets of lisinopril was forwarded to the previous owner of the patent. It was alleged by Apotex that no claim for the medicine itself and no claim for the use of the medicine would be infringed because it had an inventory of lisinopril obtained before the patent in question was issued and that all it wanted was to sell the tablets gathered from their inventory. Such use does not constitute infringement (see Zeneca Pharma Inc. vs. Canada (Minister of National Health and Welfare) (1995) 61 C.P.R. (3d) 190 (F.C.T.D.), rev'd (1996) 69 C.P.R. (3d) 451 (F.C.A.) at page 194).

[4]                In December 1996, Merck and other Plaintiffs initiated these proceeding for infringement of the Canadian patent No. 1,275,350 (the 350 patent).

[5]                In July 1997, Apotex filed a first Defence and Counterclaim in which it was admitted that Apo-lisinopril, for which Apotex has obtained notice of compliance, has a pharmaceutical composition which included lisinopril. Apotex further admitted that lisinopril is a compound claimed in claims 1 and 2 of the 350 patent. Therefore, Apotex's only defence was based on the fact that it had acquired lisinopril prior to the issuance of the 350 patent.

[6]                The Defence was amended several times. In May 2002, the Case Management Prothonotary (Order dated May 2^nd, 2003) allowed Apotex to amend its Defence. The Defence was modified in such a way as to dilute and even neutralize the admissions made in its initial procedures. The decision of the Prothonotary was appealed and it was affirmed by the Federal Court on February 2003.

[7]                On further appeal by Merck and the other Plaintiffs to the Court of Appeal, the said Court set aside part of these decisions and denied the amendments related to the admissions made as described at paragraph 32 of Apotex's Notice of Motion (dated April 16^th, 2002) :

"Apotex' proposed amendments fall into four categories. The first category of amendments concerns the chemical compound known as lisinopril dihydrate. These amendments refine Apotex' existing defence of non infringement by (i) specifying that the lisinopril dihydrate that Apotex uses is not included within the scope of the Canadian letters patent No. 1,275,350 (350 Patent) which covers only the compound known as lisinopril and (ii) clarify that Apotex' existing allegation that its lisinopril drug product is exempt from infringement by virtue of Section 56 of the Patent Act, and is also non-infringing for the reason that it was made and sold pursuant to a compulsory licence prior to February 14^th, 1003, in accordance with subsection 12(2) of the Patent Act amendment Act, 1912, specifically relates to lisinopril dihydrate and not lisinopril."

The Court of Appeal refused these amendments, the Chief Justice dissenting. In its Order, the Court did not specify that a new Defence which would reflect the refusal of certain amendments should be filed within a certain time period.

[8]                Apotex filed an application for leave to appeal the Court of Appeal Judgment. This application was denied by the Supreme Court of Canada on May 6^th, 2004.

[9]                As of April 2005, Apotex had not filed a fresh as amended Statement of Defence and Counterclaim in conformity with the decision of the Court of Appeal even though the trial in this action is scheduled to begin January 9^th, 2006 for a period of more than 60 days and the parties were ordered to meet some pre-trial steps.

[10]            By notice of motion in early April 2005, Merck and the Plaintiffs sought an Order striking the 2002 Defence on the ground that it did not comply with the Court of Appeal Judgment. As part of its response, Apotex included a proposed Defence and Counterclaim which it felt took the Court of Appeal Judgment into account and was prepare to file if so required.

[11]            In response to the proposed Defence and Counterclaim of Apotex, Merck and the Plaintiffs argued that it did not in any way reflect the Court of Appeal Judgment and commented on what a proper defence should contain.

[12]            By Order dated May 25^th, 2005, the Case Management Prothonotary granted the Motion to Strike the 2002 Defence of Apotex after having noted that Apotex had not filed a Defence and Counterclaim which reflected the Court of Appeal Judgment. The Case Management Prothonotary also found that the 2002 Defence was vexatious, that the situation as presented might delay the fair trial of the action scheduled for January 2006 with experts reports in chief due for July 11, 2005, and that Apotex's proposed Defence and Counterclaim did not reflect the Court of Appeal's decision. In order to avoid any further motions with respect to the content of the Defence and Counterclaim, it was deemed that Apotex's fresh as amended Statement of Defence and Counterclaim would be the one attached to the instant Order so that it reflected the November 2000 Defence and Counterclaim.                                         

[13]            On June 7^th, 2005, Merck and the Plaintiffs were served the amended Fresh as Amended Statement of Defence and Counterclaim (the 2005 Defence) and an amended Reply and Defence and Counterclaim was served and filed on July 7^th, 2005. Merck and the Plaintiffs served their expert affidavits in chief on infringement in accordance with the pre-trial steps determined by the Case Management Prothonotary.

THE SUBMISSIONS OF APOTEX

[14]            In a summary way, Apotex submits that the Standard of Review to be applied is de novo since the appeal raises questions that are vital to the final issue of the case and that the Order demonstrates an error in law because it is wrong, being based on a wrong principle or upon a misapprehension of the facts (see Canada vs. Aqua-Gem Investments Ltd. [1993] 2 F.C. 425 (F.C.A.).

[15]            Apotex submits that in the present case, striking a Defence and Counterclaim is vital and that imposing a Defence and Counterclaim is illegal, the said Prothonotary not having the jurisdiction to do so. Therefore, according to Apotex, the Court should review the situation de novo. Apotex also argued that it was not obliged by the Court of Appeal Judgment to serve and file a new Defence and Counterclaim and that the Prothonotary was wrong when he wrote that "... Apotex's Defence of May 2002 is to be considered now to have been filed without leave of the Court and to depart, as far as the amendments described in paragraph 4 above are concerned, for Apotex' Defence of November 2000"; and that "Apotex defence of May 2002 was vexatious."

[16]            Furthermore, Apotex submits that the Prothonotary committed an error by imposing the Defence and Counterclaim since it did not reflect the Court of Appeal Judgment and that the Prothonotary did not have any residual discretion to reunite the pleadings.

THE SUBMISSIONS OF MERCK AND THE PLAINTIFFS

[17]            It is argued by the Plantiffs that when decisions of Case Management Prothonotaries are reviewed, it should be done with all due deference and that it is only in the clearest of cases of misuse of a discretion that an appeal of such decisions should be granted (see Aqua-Gem, precited and Sawridge Band vs. Canada [2002] F.C. 346).

[18]            Having said that and relying on Rule 221 of the Federal Court Rules (the Rules), Merck and the Plaintiffs submit that the Case Management Prothonotary had the authority to strike a party's pleadings, especially where a party does not abide with by Order of a Court (in our case the Court of Appeal Judgment of December 2003). It is also submitted that when striking a pleading, the Case Management Prothonotary has the inherent jurisdiction to ensure compliance with the process and protect it from abuse.

[19]            The decision to consider deem the 2005 Defence takes its jurisdictional foundation from Rules 53 and 385 of the Rules and that in order to permit the ongoing procedure to come to term, it was essential that such an Order be rendered to avoid further delays.

THE STANDARD OF REVIEW

[20]            Having in mind the guidelines established by Aqua-Gem already cited, when reviewing decisions of the Prothonotary and Judge Decary's comments on these Guidelines in the December 2003 Court of Appeal decision, the question to be answered in order to identify the standard of review is: Considering the particularities of this litigation, is it vital to the final issue of this case to have stricken the Defence and Counterclaim of Apotex and to have deemed the May 2005 Defence to be Apotex compliant pleadings?

[21]            Both parts of the Order of the Case Management Prothonotary (the striking of the Defence and the recognition of the May 2005 Defence) are so interrelated that they have to be addressed together. The Motion to Strike the Defence and Counterclaim triggers the other part of the Order. In both cases, the directives flowing from the 2003 Court of Appeal Judgment are the basis for each determination. To strike a whole Defence and Counterclaim in itself can only be perceived as being vital to the final issue of the case. Without a Defence and Counterclaim, there is not litigation of the issues. Furthermore, ordering that a Defence and Counterclaim be deemed compliant with a Party's pleadings by itself is vital to the final issues. The said deemed pleadings contain the arguments of the party. Therefore, the Standard of Review is de novo.

THE ANALYSIS

THE COURT OF APPEAL JUDGMENT

[22]            A good understanding of the Court of Appeal Judgment is essential in order to make the proper findings necessary to settle the present dispute.

[23]            As a reminder, Apotex, in 2002, proceeded to submit to the Case Management Prothonotary four categories of amendments. As it was noted in paragraph 7 of the present decision, only the first category of amendments were subject to an appeal with the Court of Appeal, the ones dealing with lisinopril dihydrate.

[24]            As already mentioned, the Chief Justice dissented and would not have granted the appeal. Decary J. wrote for the majority the Court of Appeal Judgment.

[25]            In order to get the zest of the Court of Appeal Judgment, I will quote some passages of the decision :

"Paragraph 27 :       The proposed amendments, in my view, represent a dramatic departure from the position until now advanced by Apotex in its pleadings. Its defence of non-infringement was essentially based on the fact that it had acquired lisinopril made prior to the issuance, on October 16, 1990, of the '350 Patent and on the fact that it had acquired lisinopril made under a Compulsory Licence issued to its supplier, Delmar. Apotex' pleadings in these and other proceedings has always assumed that were it not for those facts, there would be infringement of the '350 Patent. The construction of the Patent and the chemical composition of lisinopril has never been an issue.

Paragraph 28 :         The proposed amendments, clearly, would add a totally new defence to the Statement of Defence, a new defence that would go to the heart of the claim of the '350 Patent and require expert evidence that could not have been contemplated by the appellants at the discovery stage in view of the admissions already made in the pleadings and in the proceedings..."

Paragraph 46 :          We are dealing, here, with an attempt to withdraw an admission of infringement of a pharmaceutical patent. This is a serious matter...."

Paragraph 47 :         Assuming, for the sake of discussion, that there is a triable issue, I still would not allow the proposed amendments. They represent, as already noted, a radical departure from the position held by Apotex during the past ten years in proceedings before this Court. It repudiates admissions made in the pleadings of the present proceedings and during discovery as well as admissions made by counsel in the course of a previous proceeding closely associated with the present one. It casts a shadow on the integrity of the process through which Apotex obtained its NOC in 1996, a process which necessitated by section 5(1) of the NOC Regulations, inter alia, a demonstration of "bioequivalence" in order to obtain the NOC and which permitted Apotex to market a product for the past seven years. It questions for the first time the construction of a patent upon which Apotex itself has relied to gain favour with this Court. It questions the construction of the patent six years after the commencement of the proceedings and once the discovery process has been completed, ..."

Paragraph 52 :         I have reached the conclusion, paraphrasing the words of Bowman T.C.C.J. in Continental Leasing (supra, para. 31), that it is more consonent with the interests of justice that the withdrawal of admissions and the raising of a radically new defence be denied in the circumstances. This is not, it seems to me, a case of negligent conduct of litigation by counsel - even at that, one should be reminded of the words of Lord Griffiths in Ketteman (supra, para. 31) to the effect that courts can no longer afford to show the same indulgence towards the negligent conduct of litigation as was perhaps possible in a more leisured age. This is a case, rather, of a party attempting to derail litigation which has been pursued for several years by adding a defence which, it knows very well, does not reflect the true questions in controversy.

Paragraph 55 :         I would allow the appeal with costs here and in both instances below. I would set aside the orders of the applications judge and of the prothonotary in so far as they deal with the first category of amendments and I would deny the amendments described in paragraph 32 of Apotex' Notice of Motion as falling into the first category, i.e. those concerning the chemichal compound know as lisinopril dihydrate."

[26]            As already noted in paragraph 7 of the present decision, paragraph 32 of Apotex's Notice of Motion which contains the subject on which amendments were refused, was to specify : "... that the lisinopril dihydrate that Apotex uses is not included within the scope ..." of the 350 Patent which only covers the compound lisinopril. The Court of Appeal refused in a very clear and precise way any defence that would try to exclude the lisinopril dihydrate from the 350 Patent.

[27]            Apotex annexed a proposed Defence and Counterclaim as part of the documents and submissions in reply to Merck and the Plaintiffs Motion to Strike. As it will be seen, this Defence and Counterclaim demonstrated again that it still wanted to have a defence to show that lisinopril dihydrate was not part of the component of the 350 Patent.

[28]            Apotex has always admitted in no uncertain terms that lisinopril was contained in claims 1 and 2 of the 350 Patent. The admissions contained in all the Defences and Counterclaim filed up to the Defence and Counterclaim of 2002 were now diminished and replaced by the exclusion of the straightforward admissions (see paragraphs 1, 2 and 2a) of the proposed Defence and Counterclaim).

[29]            Apotex is trying to minimize the admissions made and keep at the same time a Defence that lisinopril dihydrate is not part of the 350 Patent.

[30]            This is not what the Court of Appeal Judgment said. It wanted the admissions to remain and no Defence was allowed that would pretend that lisinopril dihydrate was not part of the 350 Patent. In the proposed Defence and Counterclaim, Apotex was asserting is no uncertain terms the Defence that lisinopril dihydrate was not part of the 350 Patent (see paragraphs 1, 2, 2a), 6, 7, 8, 11 and 15).

THE MOTION TO STRIKE THE 2002 DEFENCE AND COUNTERCLAIM OF APOTEX

[31]            As a reminder, on May 6^th, 2004, the Supreme Court of Canada denied the Application for Leave to appeal of Apotex.

[32]            A year after, Apotex had still not filed a new Defence and Counterclaim in line with the Court of Appeal Judgment. Apotex argues that the Court of Appeal did not order that a new Defence and Counterclaim was to be filed and served and that it had tried to come to an agreement with the Plaintiffs but without success - on that last point, there is no evidence (by affidavit or otherwise) that would support the tentative discussion and the reasons for justifying Apotex's position to rely on the 2002 Defence and Counterclaim.

[33]            The hearing of the litigation is scheduled to begin in early January 2006 for a period of more than three months. It is also important to note that this litigation has been existent for close to ten years excluding the NOC procedures of the early nineties.

[34]            The Court does not agree with Apotex when it argues that it did not have any obligation to file a new Defence and Counterclaim in line with the Court of Appeal Judgment. It goes without saying that the Court of Appeal did not agree with the 2002 Defence and Counterclaim insofar as it concerns the admissions made and the references to lisinopril dihydrate. Therefore, the 2002 Defence and Counterclaim had to be redrafted, served and filed. This was not done.

[35]            In essence what Apotex is arguing is that it would have filed a new Defence and Counterclaim if the Court of Appeal would have so ordered. Since it did not, Apotex had no obligation to do so. This is not an appropriate approach. Parties have to assume the obligations and responsibilities that flow naturally from decisions of the Courts. If a party only follows the blatantly expressed orders of the courts, the whole procedural system will be affected. After all, litigants with their respective legal advisors, do not need to be told in every detail what they must to do.

[36]            By shirking their duties and by not responding to the Court of Appeal Judgment in a timely fashion, Apotex has put the Plaintiffs, the Case Management Prothonotary and the Court in a position of having to assume, at least in part, Apotex's duties. This is not acceptable.

[37]            If Apotex would have responded to the Court of Appeal Judgment in due time, the litigation would have been dealt with in a timely fashion.

[38]            In April 2005, Merck and the Plaintiffs had no other choice than to present a Motion to Strike the 2002 Defence and Counterclaim of Apotex. A pre-trial Order had to be followed and a proper Defence and Counterclaim had to be part of the record in order to have the case heard in January 2006.

[39]            Having read the documentation submitted, the submissions, and having had the benefit of reading the Order of the Case Management Prothonotary dated May 25^th, 2005, and having in mind Rule 221(1) c), d) and e), the Court finds the 2002 Defence and Counterclaim to be vexatious, that it would prejudice the fair trial of the action and that it clearly constitutes a major change from previous pleadings.

[40]            Furthermore, the 2002 Defence and Counterclaim of Apotex is clearly not in conformity with the Court of Appeal Judgment. Therefore, relying on Rule 221(1)f), the Court has the jurisdiction to strike the pleadings.

[41]            Having had the opportunity to read the 2002 Defence and Counterclaim and the 2000 Defence and Counterclaim (the procedure existing prior to amendments of 2002) and knowing that the Court of Appeal Judgment refused the amendments of the first category only, the Court cannot rewrite the paragraphs in such a way as to reflect all of the components of the present litigation. It has no other choice than to strike the whole 2002 Defence and Counterclaim. Apotex, through their lack of diligence, has deliberately put the Case Management Prothonotary and now this Court in an untenable position.

ALTERNATIVES

[42]            What are the options offered to the Court in the present circumstances? One option would be to order Apotex to file and serve, within a short period of time, a new Defence and Counterclaim which would reflect the Court of Appeal Judgment. Another option would be for the Court to use Apotex's proposed new Defence and Counterclaim annexed to the response to the Motion to Strike, and grant permission for Apotex to serve and file it. A third option would be to use the annexed Defence and Counterclaim of Apotex, reviewed in light of the Court of Appeal Judgment, as well as the 2000 Defence and Counterclaim, the 2002 Defence and Counterclaim, the response of Merck and the Plaintiffs on the proposed Defence and Counterclaim and structure these documents in such a way that all of the components are fully taken in consideration. This is the course followed by the Case Management Prothonotary. The fourth possibility would be to issue directives to Apotex to file and serve a Defence in line with the said directives.

[43]            The first option is not acceptable for the reasons that follow. First of all, it will incur a new delay which will most probably seriously question the timetable set up by the Prothonotary. It is recognized that Apotex would file a Defence and Counterclaim similar to the one annexed to the response to the Motion to Strike the 2002 Defence and Counterclaim. It would therefore be challenged by Merck and the Plaintiffs. More importantly, such a ruling would give some credence and support to the behaviour of Apotex in these proceedings, behaviour that should not be tolerated.

[44]            The second option cannot be adopted by the Court. A simple reading of the proposed Defence and Counterclaim indicates clearly that it does not conform with the Court of Appeal Judgement. The admissions are diluted in such a way that it permits a Defence that lisinopril dihydrate is not a component of the 350 Patent. It would also trigger a contestation by Merck and the Plaintiffs which would necessarily affect the timetable of the litigation. Finally, it would also give credence and support to Apotex behaviour which is not in the interests of justice.

[45]            The fourth option is also problematic. The issuance of Directives or an Order to that effect is not an ideal solution. It is not known what Apotex would do in such a case. The history of this file is an example. It would trigger further procedure and would give the administration of the file to Apotex. Lastly, such a procedure would be comparable to an injunction. The Court does not have the benefit of the positions of the parties on this option.

[46]            As the Case Management Prothonotary found, the Court finds that the third option should be followed. In an implicit way, it was invited to do so by the parties as Apotex annexed a new Defence and Counterclaim and Merck and the Plaintiffs fully commented on it. Furthermore, it keeps the momentum of the litigation going by meeting the deadlines established by the Case Management Prothonotary and it does not give any credence nor support to the behaviour of Apotex. Finally, it does not impose a Defence and Counterclaim on Apotex since it simply uses as a primary document the annexed Defence and Counterclaim of Apotex and shapes it in such a way as to make sure that it fully respects the Court of Appeal Judgment by including the admissions already made and excluding any iota of a Defence related to lisinopril dihydrarte not being a component of the 350 Patent. It would include all of the components of the 2000 Defence and Counterclaim plus the amendments contained in the three categories granted in 2002. Of course, the Counterclaim must remain. This is not imposing or redrafting a Defence. It is only identifying from what is on the record the Defence and Counterclaim that the Court of Appeal wanted as a follow up to the judgment rendered.

[47]            In order to be able to do so, the Court relies fully on Rules 53 and 385 of the Rules of the Court. Rule 53 is useful since the Court may, after making an Order to Strike a Defence, impose conditions, give directions and make any other Order that it considers just. Rule 385 on case management is also of some use. This action has been unresolved for more than ten years, the procedural steps before trial have all been determined, a date to begin the hearing has been set and no proper Defence and Counterclaim is on file. It is part of the Case management duties to make decisions that would ensure the just, most expeditious and least expensive determination of the proceedings on its merits. To this effect, Merck in the Motion to Strike asked the Court for " ....such other relief as to the Court may seem just."

[48]            As mentioned before but in a summary way, Apotex in the annexed Defence and Counterclaim takes the position that, despite the Court of Appeal's Judgment, it is entitled to :

a)         maintain its withdrawal of its admission of paragraphs 13 and 14 of the Statement of Claim;

b)         maintain its denial of paragraph 13 of the Claim and;

c)         maintain its comments on paragraphs 13 and 14 of the Claim in paragraphs 2a), 6 and 7 of its pleadings;

[49]            The Court of Appeal Judgment clearly stipulated that all the amendments of the first category were denied. This meant that the admissions must remain (lisinopril is a component of the 350 Patent) and the Defence that lisinopril dihydrate was not part of 350 Patent was rejected.

[50]            By doing what is described in paragraph 48 of the present decision, Apotex is diluting the admissions made and is keeping as a Defence the assertion that lisinopril dihydrate is not part of the 350 Patent. The Court of Appeal was clear when it said that the amendments sought " ... in the first category i.e. those concerning the chemical compound known as lisinopril dihydrate." were set aside.

[51]            By using paragraph 19(m)(v) of the 2002 Defence (which was not the subject of the Appeal), Apotex argues that the reference to "lisinopril dihydrate" is part of its Defence and that for consistency purposes what is described in paragraph 48 of the decision must remain. I disagree. Such an argument goes against the Court of Appeal Judgment. Paragraph 19(m)(v) must remain in the Defence (the Prothonotary did include the said paragraph) since it was not subject to appeal. It will not be the first time that a Defence lacks consistency. It will be left for the Trial Judge to clarify the issues as they are contained in the Defence.

[52]            The Court has analysed in detail the Defence and Counterclaim included as part of Annex "A" of the Prothonotary's Order dated May 25^th, 2005, on the basis of the Court of Appeal Judgment, the 2000 Defence and Counterclaim, the 2002 Defence and Counterclaim and the annexed Defence and Counterclaim included in the response to the Motion to Strike the 2002 Defence and Counterclaim. I have come to the conclusion that it keeps the admissions made (lisinopril is part of claims 1 and 2 of the components of the 350 Patent). It is also my opinion that it excludes any Defence related to lisinopril dihydrate not being a component of the 350 Patent, as the Court of Appeal Judgment stipulated. Furthermore, it keeps all the amendments contained in the three other categories (it includes paragraph 19(m)(v) of the 2002 Defence and Counterclaim) and includes all the other Defences contained in the past procedure and the Counterclaim.

[53]            I therefore find that the fresh as amended Defence and Counterclaim attached to Schedule "A" of the Order of the Case Management Prothonotary dated May 25^th, 2005 be deemed to be Apotex's compliant pleadings. There will not be any need for an Order to serve and file the said Defence and Counterclaim since it has already been served and filed and the Plaintiffs have responded to it.

[54]            Having described in detail the behaviour of Apotex in this litigation and having noted that it has put the Plaintiffs, the Case Management Prothonotary and the Court in a very unusual and questionable position, costs will be against Apotex in accordance with Column 5 of the Tariff "B" of the Rules, in favour of Merck and against the other Plaintiffs in accordance with Column 3 of the said Tariff.

                                               ORDER

THIS COURT ORDERS THAT :

-           The Motion to Strike amended Defence and Counterclaim of Apotex of May 2002 is granted;

-           The fresh as amended Defence and Counterclaim attached as schedule "A" to the Order of the Case Management Prothonotary dated May 25^th, 2005 is deemed to be Apotex's compliant pleadings;

-           Costs of this Motion in favour of Merck in accordance with Column "5" of the Tariff and in favour of the other Plaintiffs in accordance with Column "3" of the said Tariff.

                   "Simon Noël"                   

Judge

                                     FEDERAL COURT

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                           T-2792-96

STYLE OF CAUSE:               MERCK & CO. INC. ET AL v. APOTEX

PLACE OF HEARING:                     Montreal

DATE OF HEARING:                       August 29, 2005

REASONS FOR :                              The Honourable Justice S Noel

DATED:                                              September 14^th, 2005

APPEARANCES:                               Me Judith Robinson

Me Frédérique Amrouni

                                                            FOR PLAINTIFF MERCK & CO INC. and MERCK FROSST CANADA & CO

Me Nancy Pei

FOR PLAINTIFF SYNGENTA LIMITED ASTRAZENECA UK LIMITED and ASTRAZENECA CANADA INC

Me Miles Hastie

FOR DEFENDANT APOTEX

SOLICITORS OF RECORD:           OGILVY RENAULT Montreal Quebec

                                                            FOR PLAINTIFF MERCK & CO INC. and MERCK FROSST CANADA & CO

SMART & BIGGAR Toronto Ontario

FOR PLAINTIFF SYNGENTA LIMITED ASTRAZENECA UK LIMITED and ASTRAZENECA CANADA INC

GOODMANS LLP Toronto Ontario

FOR DEFENDANT APOTEX