Merck & Co. Inc. v. Apotex Inc., 2004 FC 1166

                                                                                                                                  Date: 20040823

                                                                                                                             Docket: T-2792-96

Citation: 2004 FC 1166

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

RICHARD MORNEAU, PROTHONOTARY:

[1]         This is a motion by the defendant and plaintiff by counterclaim (Apotex) for the determination of a series of questions arising out of the examination for discovery of a representative of the plaintiff Merck & Co., Inc. (Merck) and a representative of the plaintiff Merck Frosst Canada & Co. (Merck Frosst).

[2]         The set of questions to be determined were accumulated during the first and second phases of the examination for discovery of Merck and the first phase of the examination of Merck Frosst.

[3]         These same questions are in fact being brought to my attention again essentially as a result of the decision of the Federal Court of Appeal dated November 20, 2003, in the context of the present litigation, (2003), 312 N.R. 273 (the Federal Court of Appeal decision).

[4]         The Federal Court of Appeal decision allowed an appeal by Apotex from the decision of a Federal Court judge who had upheld my decision of August 21, 2002, in regard to objections raised during the first phase of the examination for discovery of Merck and Merck Frosst. At the conclusion of its decision, the Federal Court of Appeal ordered that I redetermine the motion by Apotex. This approach of the Federal Court of Appeal was logically the applicable route for determining the questions arising out of the second phase of Merck's examination for discovery (see the decision by Russell J. dated December 17, 2003, 2003 F.C. 1483, by which the Court deliberated on an appeal by Apotex from my decision of May 5, 2003, 2003 FCT 558).

Questions to answer and records to produce on an examination for discovery: applicable general principles

[5]         The redetermination required by the Federal Court of Appeal decision is necessary since, according to the Court, the Apotex motion for determination of the objections was not addressed in light of the primary consideration of relevance and the possible exceptions to that principle.

[6]         At paragraphs 10 and 15 of its decision, the Federal Court of Appeal reminds us of that principle and its exceptions, in the following words:

[10]          The Rules of Court provide as follows:

The jurisprudence in this Court on the scope of discovery is well settled. For convenience it is summarized in Reading & Bates Construction Co. and al v. Baker Energy Resources Corp. and al (1988) 24 C.P.R. (3^rd) 66 at 70-72 (F.C.T.D.). It is clear that the primary consideration is relevance. If a prothonotary or a judge does, however, find a question to be relevant he or she may still decline to order the question to be answered if it is not at all likely to advance the questioner's legal position, or if the answer to a question would require much time and effort and expense to obtain and its value would appear to be minimal, or where the question forms part of a "fishing expedition" of vague and far-reaching scope.

[. . . .]

[15]          In the present case I am not satisfied that the learned prothonotary directed his mind to specific questions of relevance. The relevance issues were not raised clearly before him in paragraph 19 of the respondents' submissions, on which he relied and which he adopted as his rationale. Further, his reasons suggest that his ultimate conclusion was based on what he understood to be the imperatives of case management and not on any test of relevance. In particular, he did not specifically conclude that the questions should not be answered because, although relevant, they would for example be abusive because calling for an opinion or because of their scope.

[Emphasis added]

[7]         In Reading & Bates, to which the Federal Court of Appeal refers us, Mr. Justice McNair, in a general six-point review, first defines in points 1 to 3 the parameters that determine whether a question or a document is relevant, and then, in points 4 to 6, sets out a series of circumstances or exceptions in which, on the off chance, at the end of the day, a question need not be answered or a document need not be produced.

[8]         The Court states, at pages 70 to 72:

1. The test as to what documents are required to be produced is simply relevance. The test of relevance is not a matter for the exercise of the discretion. What documents parties are entitled to is a matter of law, not a matter of discretion. The principle for determining what document properly relates to the matters in issue is that it must be one which might reasonably be supposed to contain information which may directly or indirectly enable the party requiring production to advance his own case or to damage the case of his adversary, or which might fairly lead him to a train of inquiry that could have either of these consequences: Trigg v. MI Movers Int'l Transport Services Ltd. (1986), 13 C.P.C. (2d) 150 (Ont. H.C.); Canex Placer Ltd. v. A.-G. B.C. (1975), 63 D.L.R. (3d) 282, [1976] 1 W.W.R. 644 (B.C.S.C.); and Compagnie Financiere and Commerciale du Pacifique v. Peruvian Guano Co. (1882), 11 Q.B.D. 55 (C.A.).

2.. On an examination for discovery prior to the commencement of a reference that has been directed, the party being examined need only answer questions directed to the actual issues raised by the reference. Conversely, questions relating to information which has already been produced and questions which are too general or ask for an opinion or are outside the scope of the reference need not be answered by a witness: Algonquin Mercantile Corp. v. Dart Industries Canada Ltd. (1984), 82 C.P.R. (2d) 36 (F.C.T.D.); affirmed 1 C.P.R. (3d) 242 (F.C.A.).

3. The propriety of any question on discovery must be determined on the basis of its relevance to the facts pleaded in the statement of claim as constituting the cause of action [...]

4. The court should not compel answers to questions which, although they might be considered relevant, are not at all likely to advance in any way the questioning party's legal position: Canex Placer Ltd. v. A.-G. B.C., supra; and Smith, Kline & French Laboratories Ltd. v. A.-G. Can. (1982), 67 C.P.R. (2d) 103 at p. 108, 29 C.P.C. 117 (F.C.T.D.).

5. Before compelling an answer to any question on an examination for discovery, the court must weigh the probability of the usefulness of the answer to the party seeking the information, with the time, trouble, expense and difficulty involved in obtaining it. Where on the one hand both the probative value and the usefulness of the answer to the examining party would appear to be, at the most, minimal and where, on the other hand, obtaining the answer would involve great difficulty and a considerable expenditure of time and effort to the party being examined, the court should not compel an answer. One must look at what is reasonable and fair under the circumstances: Smith, Kline & French Ltd. v. A.-G. Can., per Addy J. at p. 109.

6. The ambit of questions on discovery must be restricted to unadmitted allegations of fact in the pleadings, and fishing expeditions by way of a vague, far-reaching or an irrelevant line of questioning are to be discouraged: Carnation Foods Co. Ltd. v. Amfac Foods Inc. (1982), 63 C.P.R. (2d) 203 (F.C.A.); and Beloit Canada Ltee/Ltd. v. Valmet Oy (1981), 60 C.P.R. (2d) 145 (F.C.T.D.).

[Emphasis added]

[9]         Furthermore, the list of exceptions in points 2 and 4 to 6 of the Reading & Bates judgment, and the list cited by the Federal Court of Appeal in its decision at paragraphs 10 and 15 quoted earlier, are not, in my opinion, intended to be exhaustive.

[10]       In many situations, the balancing to which the Court refers in Reading & Bates in point 5 will be necessary.

[11]       Indeed, as mentioned in Faulding Canada Inc. v. Pharmacia S.p.A. (1999), 3 C.P.R. (4th) 126, at page 128:

[...] the general tendency of the courts to grant broad discovery must be balanced against the tendency, particularly in industrial property cases, of parties to attempt to engage in fishing expeditions which should not be encouraged.

[12]       Rule 242 of the Federal Court Rules, 1998 (the Rules) contains a warning to that effect. Paragraphs 242(1)(b) to (d) of the Rules read:

[13]       The balancing that must be done between, on the one hand, the usefulness of the information and, on the other hand, the trouble and inconvenience involved in obtaining it was noted in particular by Mr. Justice Strayer in Smith Kline and French Laboratories Ltd. v. Canada (A.G.) (1984), 1 C.P.R. (3d) 268, at page 271 and Westinghouse Electric Corp. v. Babcock & Wilcox Industries Ltd. (1987), 15 C.P.R. (3d) 447.

[14]       Moreover, in the Westinghouse judgment, the Court stated, at page 451:

The associate senior prothonotary refused to order discovery with respect to the items referred to in paras. 19, 20 and 21 of this same exhibit. In each case he regarded the request as too broad and in the context of his decision I understand this to mean that he concluded that the value of such materials as tending to prove or disprove any allegation of fact would be slight in comparison to the problems of production. I fully agree with the principle which he has applied and am unable to see that he was manifestly wrong in its application. Indeed, the defendants in respect of these demands appear to be engaged in a fishing expedition trying to find indications of doubt within the plaintiffs' own organization concerning patentability, doubts which may inspire the defendants but which, as far as I can see, are not logically probative as to the validity of the patent which is a matter for the court to determine by looking at the patent as explained by experts and by consideration of the law. Numerous affirmations within the plaintiffs' files as to the validity of the patent would not be logically probative of its validity, which is a matter of law, and I am unable to see how expressions of doubt in the same files would be of assistance to the defendants in presenting its case to the court.

[Emphasis added]

[15]       This passage therefore testifies more particularly that in a patent infringement action in which the defendant is attacking the validity of the patent, the Court has little inclination to force the plaintiff to engage in disproportionate research to support the allegations of invalidity raised by the defendant when, inter alia, the conclusions sought by this defending party pertain primarily to the interpretation that the Court will give to the patent claims in light of its reading of the patent, the state of the applicable law and any expert evidence adduced by the parties, and not in terms of what the plaintiff may have thought or argued in the past as to the validity of the patent.

[16]       Similarly, Mr. Justice Hugessen, in Eli Lilly and Co. v. Apotex Inc. (2000), 8 C.P.R. (4th) 413 (upheld on appeal, at 12 C.P.R. (4th) 127), stated the following at pages 414-15 concerning the relevance of the inventors' knowledge about the obviousness of an invention:

I am not prepared to order the plaintiffs to produce documents relating to the state of knowledge of prior art on the part of the inventors or of the patentees at the time of the issue of the patents in suit. Such knowledge can only be relevant to the pleaded issue of obviousness. The test for obviousness is, in my view, and there is ample authority to this effect, an objective test. The touchstone is the person skilled in the art, whether or not the invention would have been obvious to that person. The actual knowledge of the inventor or inventors is irrelevant.

[Emphasis added]

(See also the decision of the Supreme Court of Canada in Free World Trust v. Electro Santé Inc., [2000] 2 S.C.R. 1024, at page 1061.)

[17]       On the other hand, a party may not be required, on an examination for discovery, to answer a question that forces it to express an opinion, whether it is an expert opinion, its interpretation of a patent or its beliefs. In Philips Export B.V. v. Windmere Consumer Products Inc. (1986), 8 C.P.R. (3d) 505, it is stated, at page 508:

Question 467, which must be read with Q. 466, asks for the belief of the plaintiff. In both the Smith, Kline & French case and in Sperry Corp. v. John Deere Ltd. and al. (1984), 82 C.P.R. (2d) 1, it is stated that opinion cannot be asked, as a rule, of a person being examined who is not an expert and that a party cannot be asked to express its position in terms of mental attitudes.

[Emphasis added]

(See also Rivtow Straits Ltd. c. B.C. Marine Shipbuilders Ltd., [1977] 1 F.C. 735, at page 736.)

Context and analysis

[18]       Virtually all of the many objections to be determined have to do with the scope of Apotex's attack on the validity of the patent that is cited by the plaintiffs (hereinafter collectively referred to as "Merck") in their action for infringement.

[19]       In its action, which was filed in 1996, Merck alleges that Apotex has sold Lisinopril and thereby infringed its patent number 1,275,350 (the 350 patent or the disputed patent).

[20]       The Lisinopril compound is targeted in particular by claim 2 of the 350 patent and is used in practice in the treatment of hypertension, if I understand correctly, by limiting or inhibiting the action of enzymes in the human vascular system.

[21]       Through the numerous amendments to its statement of defence and counterclaim (the Apotex defence) made by Apotex between July 1997 and May 2002, Apotex denies in its defence any infringement of the 350 patent and argues - and this is the backdrop that concerns us here - the invalidity of this patent by raising a very extensive series of grounds of invalidity directed principally not so much against claim 2 but essentially against claims 1 and 5 of the disputed patent.

[22]       Claim 1 is addressed to the various compounds that can be produced from a formula described in this claim (formula 1 compounds). These are compounds analogous to and derived from Lisinopril. Claim 5 is addressed to pharmaceutical compositions established from formula 1 compounds mixed with "a pharmaceutically acceptable carrier".

[23]       In terms of context, it should be understood that the compounds contemplated by the disputed patent are part of a vast family of inhibitor compounds described as "ACE inhibitors" in which the letters ACE stand for Angiotension Converting Enzyme.

[24]       Paragraph 19 of the Apotex defence combines its 350 patent infringement allegations, which can be listed, as Merck does, as follows:

Improper divisional - One invention & anticipation: The invention applied for in divisional patent application No. 607,198 is not a patentable invention distinct from the 340 Original Application filed in Canada, is thus not a proper divisional application thereof, and is therefore anticipated by the prior art.

-            Defence and Counterclaim, para 19(a)-(a.2)

Improper divisional - wilful delay: The prosecution of the 340 Original Application and of divisional application No. 607,198 was conducted in such a way as to wilfully delay the issuance of the 350 Patent.

-            Defence and Counterclaim, para.19(i)-(i.1)

Patentable invention & anticipation: By reason of section 39(1) [former section 41(1)] of the Patent Act concerning product-by-process claims, the invention claimed in the 350 Patent was not one for which an application could be properly filed at the time the 340 Original Application was filed or at the time divisional application No. 607,198 was filed and by the time the subject-matter of the 350 Patent could have been patentable, it was anticipated.

-            Defence and Counterclaim, para. 19(b)

Overbreadth - Inutility (cannot be made): Compounds within the 350 Patent cannot be made.

-            Defence and Counterclaim, para 19(g)

Overbreadth - Inutility (activity): Compounds within the 350 Patent do not possess the anti-hypertensive utility promised.

-            Defence and Counterclaim, para. 19(g)

Overbreadth - Inutility (stability): Pharmaceutical composition claims within the 350 Patent are too broad, contain inoperable elements or lack utility in that they include compositions that cannot be made into stable pharmaceutical compositions.

-            Defence and Counterclaim, para. 19(1)

Overbreadth - Lack of sound prediction: The inventors did not have a sound basis to predict that all of the compounds claimed in the 350 Patent could be made, would have the claimed utility or could be made into stable pharmaceutical compositions.

-            Defence and Counterclaim, paras. 19(f), 19(n)

Obviousness: The invention in the 350 Patent is obvious in light of the state of knowledge of a person skilled in the art prior to the priority date of the 350 Patent.

-            Defence and Counterclaim, para. 19(n)

Sufficiency (stability): Contrary to section 34 of the Patent Act, the 350 Patent specification does not correctly and fully describe the invention, as well as its operation and use, specifically in order to allow a person skilled in the art to make stable pharmaceutical compositions comprising compounds claimed in the 350 Patent.

-            Defence and Counterclaim, paras. 19(m), 19(p)

Sufficiency - Section 53 (formulation/stability): Contrary to section 53 of the Patent Act, the specification of the 350 Patent contains less than is necessary for utilizing the compounds as medicines in pharmaceutical dosage forms, such omission having been made for the purpose of misleading persons skilled in the art.

-            Defence and Counterclaim, para. 19(o)

Inventorship: The four named co-inventors are not the actual inventors or the contribution of co-inventors was intentionally ignored.

-            Defence and Counterclaim, para. 19(j)

[25]       It is first and foremost the following ground of invalidity raised by Apotex that gives a very broad dimension to the grounds of invalidity it raises and accordingly to the information and records it is seeking.

[26]       As indicated earlier, in paragraphs 19(a) to (a.2) of its defence, Apotex argues that application number 607,198, filed on August 1, 1989, which resulted in the issuance of the disputed patent on October 16, 1990, is not a valid divisional application of the original application number 341,340 filed in Canada on December 6, 1979, within the meaning of subsection 36(2) of the Patent Act.

[27]       Although the text of subsection 36(2) of this Act has since been amended, it nevertheless read at all relevant times for the purposes of this case as follows:

[28]       In Apotex's submission, this finding of inappropriate division is necessary because, in its view, the invention contained in application 198 is the same as the one contained in the original application 340. That is its theory of the one invention.

[29]       Divisional application 198 is but one of the four divisional applications being detached from the original application 340. In Apotex's submission, action on the principal application and divisional applications was also drawn out by Merck so as to give the patent an undue advantage (see paragraphs 19(i) and (i.1) of the defence). (As context, we note that one of these divisional applications, number 518,334, filed in 1986 and dealing with the compound enalapril and its derivatives, resulted in the issuance of patent 1,275,349 on the same date as the one for the disputed patent. This patent is now the subject of similar litigation, in this case between Merck and Nu-Pharm Inc., a corporation associated with Apotex. The other divisional applications are numbers 518,335, 518,336 and 576,716.)

[30]       In Apotex's submission, the compounds developed around the year 1978 by Merck's inventors under a single program or project dealing with ACE inhibitors are found in part in the original 340 application filed on December 6, 1979. Since the subsequent separation of these compounds into divisional applications cannot be upheld under the one invention theory, any information bearing on compounds not included in the 350 patent but included in the original 340 application, or even not included in the 340 application, may be used to support the invalidity of the disputed patent.

[31]       In other words, Apotex argues that it absolutely must get a reply to all of its questions or searches for records that can enable it to find out what the inventors had done and knew at the time of the original 340 application, so as to be able to establish that the situation in terms of research and development at the time of the divisional application 198 in August 1989 was not in any way different from the one that existed at the time of the original 340 application in December 1979.

[32]       In short, Apotex is trying to bring down the 350 patent not only by arguing grounds of invalidity peculiar to the compounds entering into the 350 patent but also by comparing, by and large, the compounds within that patent with the compounds that are not. In a way, Apotex has launched an attack on the 350 patent from the outside.

[33]       To distinguish between the compounds used and not used in the 350 patent, Merck performed a certain allocation. This allocation is supported by the affidavit of Dr. André Charette. Apotex sought to attack Dr. Charette's impartiality and expertise. Without repeating in detail all of Apotex's criticisms of Dr. Charette or his allocation of the compounds, I do not think it can be argued that the industrial chair held by Dr. Charette puts him in some way in the pay of Merck. Although this chair is subsidized in part by Merck, the cross-examination of Dr. Charette clearly indicated that he is completely free in his administration of the funds that are entrusted to him for the purposes of this chair.

[34]       In regard to his expertise, Dr. Charette's experience in chiral molecules gives him sufficient and relevant expertise, in my opinion, in the identification of the chemical structures on which his allocation of the compounds is based.

[35]       Apotex also raises, as a further ground of attack that should, it says, lead this Court to exclude or assign very little weight to Dr. Charette's affidavit, the fact that he does not disclose the chemical structures of the compounds brought to his attention. According to the experts brought forward by Apotex in the context of this motion (Dr. Robert McClelland and Professor Garland Marshall), this means that Apotex and its experts are unable to verify the findings or results arrived at by Dr. Charette.

[36]       However, it is clear that this verification sought by Apotex was and would be possible since Merck has so far given Apotex the chemical structures of some 150 compounds out of a total of 226 compounds studied by Dr. Charette. It appears from the cross-examination of Apotex's experts that they were not informed of this fact by Apotex or its counsel and therefore had not seen these chemical structures before making their affidavits on this motion.

[37]       I therefore do not intend to accept any of the attacks Apotex has made against the affidavit of Dr. Charette. That affidavit will not be excluded from the relevant evidence. Moreover, I am prepared, for the purposes of this motion, to adopt the allocation of the compounds supported by Dr. Charette.

[38]       It turns out that Merck filed some 20,000 pages allocated over more than 2,076 documents with Apotex following the examination for discovery of Merck's representative, Dr. Wyvratt (also examined as one of the four co-inventors of the disputed patent, the other inventor who was examined being Dr. Patchett).

[39]       Merck's examination for discovery has so far lasted no fewer than 16 days. The documentation produced by Merck in the context of this exercise covers a mass of information affecting the compounds used in the 350 patent. It also deals with the history of the development of the inhibitors covered by the research program as well as some complex structure compounds so as to establish that the latter compounds can be made and have the promised usefulness.

[40]       Merck describes the information and documents produced as follows:

23.            Merck's 2076 productions (which currently constitute 8 boxes of documents) relate to the synthesis, pharmacological testing (in vitro and in vivo) and stability of all of the compounds that come within the 350 Patent and that were made by Merck, and to the synthesis and pharmacological testing of a large number of compounds falling within the following two categories:

a)              Historical compounds: About 10-15 additional compounds were produced to show the history of the development of this category of dipeptide ACE inhibitors, which started, according to the evidence, in March 1978 and resulted in the filing of the 340 Original Application in Canada on December 6, 1979.

b)              Rebuttal compounds: A large number of compounds (over 100) were produced to rebut Defendant's invalidity allegations that certain categories of compounds either cannot be made or do not have the utility promised. Merck has thus produced either compounds that specifically address these various invalidity categories or compounds that are close analogues thereof to show that the alleged compounds can be made and have the utility promised.

24.            Specifically, Merck's current set of productions is comprised of:

•                Documents relating to the prosecution of patent application No. 607,198 which led to the issuance of the 350 Patent.

•                "Delivery sheets" which pertain to individual compounds identified by an "L" number (such as L-154-732) and which indicate the compound's name and chemical formula, the reference to the synthesis laboratory notebook pages and the name of the person who made it, and whether the compound was sent for in vitro, in vivo or other tests. Delivery sheets were produced for about 150 compounds, including all 350 Patent compounds made by Merck, as well as historical and rebuttal compounds.

•                Extracts from laboratory notebooks showing the synthesis of compounds for which delivery sheets were produced.

•                Extracts from laboratory notebooks showing the testing done to verify the pharmacological activity of compounds for which delivery sheets were produced.

•                As Defendant knows, Merck has also produced summary bimonthly reports and their underlying bimonthly reports relating to the synthesis (from its New Lead Discovery department, "NLD") and to the pharmacological testing (from its Pharmacology department), of compounds for which delivery sheets have been produced, for the period from 1978 to 1983.

•                Merck has also produced summary and underlying bimonthly reports from its Pharmaceutical Research and Development department ("PR & D") relating to the formulation (stability) of lisinopril, for the period from 1979 to 1989.

•                Moreover, about 1700 of Merck's 2076 productions are testing data (including a large number of laboratory notebook pages), reports and memos relating to the stability testing and formulation development of lisinopril.

[41]       As paragraphs 70 to 77 of Merck's written submissions, reproduced below, illustrate, the production of the information and records already provided represented a huge burden for Merck and the production of the information and records sought by Apotex as further support for its one invention thesis and the resulting grounds of invalidity would be at least as taxing for Merck if not more so:            

70.            Indeed, the 16 days of discovery examination of Merck's representative and inventors, and the production of 8 boxes of documents disclosing a mass of information in relation to all of Defendants' allegations, including the preparation of productions and answers to a considerable number of undertakings and refusals ordered, have represented a significant burden for Merck, Merck Frosst and their examined representatives.

71.            The details of the time and labour associated with this discovery process are provided in the Affidavit of Mr. Edward W. Murray, Managing Counsel, Intellectual Property Litigation at Merck, attached hereto at Tab 1 (the "Murray Affidavit").

72.            The more than 2000 hours expended by Merck personnel to date to provide documentation in answer to Defendant's requests, the 16 days spent by Dr. Wyvratt attending the examination and the additional 3 to 4 weeks taken from his time to assist counsel in providing answers to Defendant's requests illustrate the unreasonable proportions this discovery has taken.

·                Affidavit of Edward W. Murray, sworn February 6, 2004, paras. 12, 16, Tab 1.

73.            The 315 requests Merck accepted or was ordered to answer were then limited to the 350 Patent compounds, as well as to historical and rebuttal compounds. Many of the questions then answered were already then only remotely relevant to Defendant's allegations and Merck only agreed to answer them in order to expedite Defendant's Motion.

74.            In light of the number (360) and scope (e.g. all compounds outside the 350 Patent but within the 340 Original Application, as well as compounds outside the 340 Original Application) of many of Defendant's requests herein at issue, Merck expects to spend at least as much time as described above providing answers to refusals ordered.

·                Affidavit of Edward W. Murray, sworn February 6, 2004, paras. 7-16, 21-24, Tab 1.

75.            This is in fact a conservative estimate since it is based on the number of compounds covered by Defendant's current requests which are specifically identified by L-numbers in Defendant's questions (which are also the subject of Professor Charette's Affidavit attached hereto).

76.            The estimate does not account for broad requests, such as requests for the production of all synthesis, in vitro and in vivo, testing data for all compounds covered by the 340 Original Application which Merck has made to date (see Questions 57 at Tab 22A-2 of Defendant's Motion Record). Such requests, not surprisingly, enlarge the scope of information and production beyond that even considered in the Murray Affidavit.

77.            In the circumstances, now 8 years after the institution of the proceedings, Merck submits that ordering the refusals at issue herein to be answered is neither necessary nor reasonable and would clearly be unduly onerous for Merck.

·                Affidavit of Edward W. Murray, sworn February 6, 2004, paras. 24-28, Tab1.

[42]       As we see, Merck's assessment as to its past and future duties is essentially supported by the affidavit of Edward W. Murray (the Murray affidavit).

[43]       Apotex also attacks this affidavit on a number of counts. Without likewise reproducing here in detail all of Apotex's allegations, we note that Apotex criticizes Murray for not having personal and direct knowledge of many of the things he relates.

[44]       I think it was permissible (see rule 81) and reasonable in the circumstances for Merck to be satisfied with producing the Murray affidavit. Murray, who in some respects has a supervisory role within Merck, held enough discussions with some key staff members in Merck (Dr. Wyvratt, Janet Salmons and Cathy Boyer) and thinks he is able to rely on what was thereby reported to him. I see nothing more to say about this approach. In fact, it would have been illogical and unreasonable for Merck to have acted otherwise and to have produced affidavits on behalf of the persons referred to above. Merck considers - rightly, in my view - that the institution of the examination for discovery has so far been more than extremely time-consuming. Murray was cross-examined on his affidavit for more than four hours. What would have been the result if four or five affidavits had been made? We must avoid, and I am sure Apotex is agreeable to this, hijacking the institution of the examination for discovery.

[45]       Moreover, and this applies to Dr. Charette as well, I do not think it should be concluded that Murray had assembled, with his affidavit in mind, the documents and information sought specifically by Apotex. The same conclusion applies as well in regard to Merck's own counsel. In my opinion, Apotex and its experts are simply wrong to assume the contrary. Nor do I see, in regard to the Murray and Charette affidavits, why the weight and credibility of these affidavits should be affected by the fact that Merck did not submit them prior to the redetermination stage. What Murray and Charette express in their affidavits was present at all relevant times and the need to make these affidavits simply pertained to the parameters recalled by the Court of Appeal in its decision. Following that decision I issued an order allowing the filing of these affidavits and allowing Apotex to reply to them, as it did. I do not think we need go over these past events again.

[46]       However, Apotex and its experts forcefully allege that the information and records still sought are relevant and necessary to Apotex's case and that Murray, by his silence concerning their relevance, serves to corroborate this in Apotex's favour.

[47]       I think that in this regard Murray is right not to become involved in the issue of relevance. That aspect is more a question of law. Murray has instead focussed on describing the onerous impact of the past and forthcoming searches. This is the aspect that Merck had to bring out because it is clear from the decided cases that the burden of producing any information or document is a factor that can preclude the production of information or a document independently of its relevance.

[48]       As to the necessity of the information that is sought, the views of Apotex's experts are to my way of thinking seriously affected by the fact that they were completely unaware of the information and documents that had in fact been conveyed to Apotex by Merck.

[49]       I have no intention therefore of excluding the Murray affidavit or preventing it from being given the weight it deserves.

[50]       Consequently, I think that any information and any document not yet produced that has to do, in Dr. Charette's opinion, with compounds outside the 350 patent are items of information that, while having some relevance according to the approach taken by Apotex, are nevertheless of minimal usefulness, and must yield in the face of the troubles and inconvenience of all kinds that the search for and production of such information can engender in this case. I think this is a fair and reasonable conclusion in the circumstances (see paragraphs 242(1)(c) and (d) of the Rules; paragraph [10] of the decision of the Federal Court of Appeal; point 5 of Reading & Bates, supra, paragraph [8], and paragraph [13] above, which refers to the Smith Kline and Westinghouse decisions). Thus I think Apotex has, in relation to the disputed patent, the information that is relevant to its invalidity theses, including the thesis about the scope of the claims or the thesis that the inventors did not have a valid prediction at the time.

[51]       Accordingly, in view of the preceding reasons as a whole, the following questions^[1] will not have to be answered:

Subcategory A1, questions 1 to 3, 5, and 6;

Subcategory A2, questions 1 to 4, 7, 8, 19, 20 to 22, 24, 29 to 31, 34, 35, 48, 52, 53, 56 to 60, 62, 63 and 68;

Subcategory A3, questions 1 to 5, 7 to 11, 13, 14, 16 to 19, 21 to 29, 31 to 40, 42, 44 to 53 and 55;

Subcategory A4, questions 3, 7, 13 to 17;

[52]       On the other hand and in addition, it seems to me that the determination of whether the purpose of the invention in application 198 is or is not different from that of the other divisional applications or the original application 340, is a conclusion that this Court will have to decide on the merits by a reading of all of these applications and with the assistance of expert witnesses. This is a question of legal interpretation. Accordingly, the following questions need not be answered:

Subcategory A6, questions 7 to 11, 14, 15, 20, 26, 27, 30, 34 to 36, 41, 42, 44 to 47, 57, 58, 60, 62, 63, 66 and 71 to 76;

Subcategory C2, questions 94, 104;

Subcategory C3, question 115.

[53]       Furthermore, as mentioned in paragraph [17] supra, a party cannot be required to answer a question that forces it to express an opinion, whether that opinion consists, for example, of expressing an expert opinion, giving its interpretation of a patent or expressing its beliefs in a particular situation. The state of mind of the inventors and the motives they might have had do not have to be explored either. Consequently, the following questions need not be answered:

Subcategory A2, questions 5, 6, 11 to 13, 15 to 18, 25, 28, 33, 37 to 47, 50, 51,54, 55, 61, 63, 64 to 67, 69 to 93;

Subcategory A3, questions 6, 15, 43, 56 and 57 (the latter two questions having been withdrawn as well at the hearing in June 2002);

Subcategory A4, questions 1, 2, 4, 6 and 8 to 19;

Subcategory A5, questions 5, 6, 8 to 10, 15 to 18, 20 to 24, 26, 27, 29, 39, 40, 45 to 47, 50, 51, 53 to 55 and 57;

Subcategory A6, all questions listed by Merck at page 453 of its motion record if the questions listed in the preceding paragraph (paragraph [52]) under this subcategory A6 are not excluded under the latter paragraph [52];

Subcategory A7, questions 1, 5, 19, 28, 29, 31 to 33;

Subcategory C1, questions 49 and 8;

Subcategory C2, questions 10, 100 to 103 and 117;

Subcategory C3, questions 113, 114, 116, 122 and 123;

Subcategory C4, questions 1 and 2;

Subcategory C5, questions 38 and 61;

Subcategory B2, questions 188, 215 and 260.

[54]       Finally, I think that any question by Apotex seeking to establish the inutility of compounds is in this case in the nature of a fishing expedition and need not be answered. It appears that Merck has not encountered in its experience any compounds or compositions falling under the 350 patent that cannot be made, that do not have sufficient activity or that cannot lead to stable pharmaceutical compositions. Nor has Apotex, which has the burden of establishing such grounds of invalidity, produced to this point its own data or results of tests that would support its allegations.

[55]       For any such question - and for any question not specifically covered by the preceding reasons - these questions will not have to be answered given the specific and precise grounds Merck advances in its written submissions in regard to each question.

[56]       In regard to the issue of whether Merck's representative, Dr. Wyvratt, and Merck Frosst's representative, Mr. Philippe Hébert, need to reappear for the continuation of their examination for discovery, in view of the preceding reasons, the result of which is to dismiss Apotex's motion as a whole, this question is answered in the negative.

[57]       The costs on this motion are awarded to Merck & Co., Inc. under column III of Tariff B. This provision encompasses the incidents, minor when all is said and done, that surrounded the filing of certain documents by Apotex.

                     "Richard Morneau"

                          Prothonotary

Montréal, Quebec

August 23, 2004

Certified true translation

Suzanne Gauthier, C.Tr., LL.L.

FEDERAL COURT

SOLICITORS OF RECORD

DOCKET:                                            T-2792-96

STYLE:                                                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)

PLACE OF HEARING:                      Montréal, Quebec

DATE OF HEARING:                        June 9 and 10, 2004

REASONS:                                         Richard Morneau, Prothonotary

DATED:                                              August 23, 2004

APPEARANCES:

SOLICITORS OF RECORD: