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     Date: 20001110

     Docket: T-2792-96

MONTRÉAL, QUEBEC, THE 10th DAY OF NOVEMBER, 2000

PRESENT: RICHARD MORNEAU, PROTHONOTARY



Between:

     MERCK & CO. INC.

     MERCK FROSST CANADA & CO.

     ZENECA LIMITED

     ASTRAZENECA UK LIMITED and

     ASTRAZENECA CANADA INC.

     Plaintiffs

     (Defendants by Counterclaim)

     AND

     APOTEX INC.

     Defendant

     (Plaintiff by Counterclaim)



     REASONS FOR ORDER AND ORDER


RICHARD MORNEAU, PROTHONOTARY:




[1]          This is a motion by the defendant Apotex under Rule 75 for leave to file an amended amended statement of defence and counterclaim (the amended defence) based on the draft statement of defence attached to its motion record.



[2]          The motion was argued at some length. I will not, however, reiterate each of the arguments made in support of and, particularly, against the motion.

Principles to be applied where amendments sought



[3]          On page 4 of Jagna Limited and Groupe Tremca Inc. v. Transpavé Inc., unreported, September 12, 1997, file T-786-93, I referred to these principles as follows:

     In regard to the applicable principles for amending pleadings, the following passage from Canderel Ltd v. Canada (1993), [1994] 1 F.C. 3 (C.A.), at page 10, accurately reflects the generous approach the Court should take in such matters:
. . . [W]hile it is impossible to enumerate all the factors that a judge must take into consideration in determining whether it is just, in a given case, to authorize an amendment, the general rule is that an amendment should be allowed at any stage of an action for the purpose of determining the real questions in controversy between the parties, provided, notably, that the allowance would not result in an injustice to the other party not capable of being compensated by an award of costs and that it would serve the interests of justice.
     It might be added, as an aside, that, as in the case of an application to strike out a pleading, an amendment should be allowed unless the amendment is clearly and obviously doomed (see Raymond Cardinal et al. v. Her Majesty the Queen, unreported, F.C.A., January 31, 1994, file A-294-77, [Heald, Décary and Linden JJ.A]).



[4]          It seems to me that this general rule must be paramount in determining the motion before me.

Background and analysis



[5]          It must be understood that at the time this motion was brought, the case had not even reached the stage of examinations for discovery yet, although the initial statement of claim dates back to December 31, 1996.



[6]          Since then, in fact, the plaintiffs' statement of claim has been amended four times, the last time as recently as August 22, 2000, and those amendments cannot be characterized as purely cosmetic in nature.



[7]          With respect to disclosure of documents between the parties, this step seems to have been undertaken recently, as affidavits of documents were exchanged in June 2000, and the plaintiffs sent some documents to the defendant in September 2000.



[8]          Moreover, the parties, and especially the plaintiffs, have brought a number of motions over the course of this proceeding to date. It cannot therefore be said that this motion is such as would prevent a speedy resolution of the case. Nor can I say at the outset that the amendments requested will significantly broaden the litigation between the parties--litigation which is already being vigorously pursued by the plaintiffs. Overall, the amendments requested cannot be seen, in the context of this case, as resulting in prejudice that would not be compensable or as being purely a tactic to delay the resolution of the action.



[9]          Furthermore, it cannot seriously be argued that these amendments are an attempt to complicate or cloud the issues by attacking not only claim 2, but also claims 1 to 6 of the patent at issue. The very beginning of paragraph 19 of the statement of defence already in the file attacks claims 1 to 6.



[10]          I also do not believe that the various proceedings between the parties over the last several years can be relied on by the plaintiffs as the main support for the argument that the defendant has been aware of the grounds for attacking the validity of patent '350 since March 1994 (files T-1454-93 and T-1968-93; cases under the Patented Medicines (Notice of Compliance) Regulations) or at least since February 1995 (file T-1160-92), and that those grounds which the defendant intends to assert now, should, therefore, have been incorporated into its defence and counterclaim. Even if it were conceded that those proceedings effectively made the defendant aware of the grounds of attack, it does not appear to me that the plaintiffs have proven that the fact that these grounds are being asserted now would cause them prejudice that would not be compensable by costs. Delay in asserting a ground of defence is not in itself fatal (see Scottish & York Insurance Co. v. Canada, [1999] F.C.J. No. 277 (QL) (F.C.A.) and Pronovost v. Usitech Nov. inc., [2000] F.C.J. No. 221 (QL) (Proth.)).



[11]          On the other hand, however, with respect to file T-1160-92, it is fair to say that since that action was abandoned by mutual agreement of the parties in December 1998, prosecution of this case amounts to reviving the plaintiffs' same action, in response to which the defendant is presenting a defence that is similar to although more detailed than the one in February 1995 in which three main grounds of attack were raised.



[12]          In addition, there is also some merit to be found in the defendant's argument that file T-1160-92, as well as a more recent file, T-753-99, can be seen as having already brought the defendant's grounds of attack to the attention of the plaintiffs. It is therefore fair to say that to a very large extent the plaintiffs cannot claim to be surprised by the inclusion of those grounds of attack in this case.



[13]          That being said, we now need to review the different categories of amendments being sought to see whether, based on the general rule stated in paragraph [3], it is clear and obvious that the purpose of the amendments is to determine the real questions in controversy between the parties: in this case, the possible grounds of invalidity with respect to patent '350.



[14]          The background to these amendments and the categories into which they are broken down are summarized as follows on page 50 of the defendant's motion record:

12.      As a consequence of counsel's research in this action, review of pleadings and productions, discussions with outside experts and involvement in other proceedings, it became apparent that further amendments to Apotex' pleading were required. These amendments consist of responses to the latest amended Claim, cosmetic changes and allegations that further delineate, clarify or expand the grounds of invalidity being asserted.
13.      As to the latter category of amendments, the grounds of invalidity at issue are: (a) allegations of lack of sound basis for prediction of utility; (b) enumeration of compounds of the '350 Patent that do not possess the utility claimed or that cannot be made; (c) a specific attack as to the invalidity of pharmaceutical composition claims in the '350 Patent; (d) a statutory defence based on section 34 of the Patent Act; (e) an obviousness plea; and (f) a statutory defence based on section 53(1) of the Patent Act.



[15]          With respect to the amendments in the first three paragraphs of the amended statement of defence, they are intended to respond to the most recent amendment to the statement of claim and the parties agree that they are allowable.



[16]          With respect to the "cosmetic" amendments, the amendments in paragraphs 19(f)(ii) and 19(j) are allowable, on the consent of the parties. With respect to paragraph 19(g), the defendant has undertaken to identify the claims in question more accurately.



[17]          To return to paragraph19(f), I am satisfied, based on paragraph 9(a) of the affidavit of Ivor M. Hughes sworn in support of this motion, that the clarifications provided by these amendments are allowable. As well, as a result of the approach now taken by the defendant in the main paragraph of 19(f), the "overbreadth" attack in that paragraph is, in my view, really not the same as the one that Mr. Justice Hugessen found to be unacceptable and struck on January 27, 2000.



[18]          In addition, I am satisfied, based on paragraphs 9(b) to 9(f) of the Hughes affidavit, as I was in the case of paragraph 9(a) of that affidavit, that the amendments discussed in those paragraphs are allowable. However, the defendant shall make the corrections suggested at the hearing of the motion to paragraphs 19(m)(i) and (ii), 19(n) and 19(o) of the amended statement of defence.



[19]          With respect to the interface between paragraphs 19(f) and 19(n) of the amended statement of defence, it does not appear to me at this stage to be clear and obvious that these two paragraphs cannot coexist; in other words, that each of them cannot exist relatively independently of the other.



[20]          Accordingly, I would allow the motion for leave and grant the defendant leave to serve and file an amended amended statement of defence and counterclaim within seven days of this order, similar to the one attached to its notice of motion, and having regard to the reasons for order set out above.



[21]          With respect to the timetable to be followed in this case, since the parties have indicated they can agree on this issue, counsel for each party shall, within 20 days of the date this order becomes final, submit to the Court--jointly if possible--a schedule setting out the next steps to be taken in the case. Any schedule that the parties propose shall be restricted to the essential steps to be taken and shall be mindful of the need to proceed swiftly.





[22]          Finally, in keeping with the general rule stated in Canderel, I would order that the defendant bear the costs of this motion.


Richard Morneau

     Prothonotary



Certified true translation


Mary Jo Egan, LLB

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