Date : 20020821
Docket: T-2792-96
Montréal, Quebec, August 21, 2002
Before: Richard Morneau, prothonotary
BETWEEN:
MERCK & CO., INC.
MERCK FROSST CANADA & CO.
SYNGENTA LIMITED
ASTRAZENECA UK LIMITED and
ASTRAZENECA CANADA INC.
Plaintiffs
(cross-defendants)
and
APOTEX INC.
Defendant
(cross-plaintiff)
ORDER
Appendix A - Questions to be answered
Category 1
Category 2
- · The complete documents of the documents already produced by Merck must be produced (this covers the 25 questions at the top of page 18 of Merck's written submissions (hereinafter "Merck's page 18"));
- · The question page 1937, l. 8-22.
Category 12
Category 14
Category 17
Appendix B - Questions to be answered
Category 5
Category 6
These questions must be answered in writing in accordance with the agreement made between the parties. Apotex will be entitled to proceed with the examinations for discovery on any question reasonably arising from the questions to be answered here. The whole will be completed in accordance with the existing schedule formulated in this Court's order dated December 21, 2001.
Apotex's motion is otherwise dismissed.
Costs on this motion are awarded to Merck & Co., Inc.
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Prothonotary |
Montreal Québec,
August 21, 2002
Certified true translation
For: Suzanne M. Gauthier, C. Tr., LL.L.
Date : 20020821
Docket: T-2792-96
Neutral citation: 2002 FCT 895
BETWEEN:
MERCK & CO., INC.
MERCK FROSST CANADA & CO.
SYNGENTA LIMITED
ASTRAZENECA UK LIMITED and
ASTRAZENECA CANADA INC.
Plaintiffs
(cross-defendants)
and
APOTEX INC.
Defendant
(cross-plaintiff)
REASONS FOR ORDER
RICHARD MORNEAU, PROTHONOTARY:
[1] On this occasion the Court has before it a quite voluminous motion by the defendant and cross-plaintiff (Apotex) asking the Court to resolve a considerable number of questions arising from the examination for discovery of a representative of the plaintiff Merck and Co., Inc. ("Merck") and a representative of the plaintiff Merck Frosst Canada & Co. ("Merck Frosst"). In fact, when Apotex's motion record was filed, the latter disclosed that nearly 800 questions and 133 undertakings were still in dispute between the parties.
[2] In view of the large number of questions outstanding (two days were set aside to hear this motion), the parties undertook to submit these questions to the Court in the form of some 26 categories. It is quite obvious that this categorization was necessary and everyone agreed that decision on the questions in dispute could reasonably only be made using the various categories submitted.
[3] In other words, the individual questions in each category should not be viewed individually. It should be borne in mind that 7 out of the 26 categories contained at the outset over 50 questions each, and that of those 7 categories one, namely category 13, contained some 168 questions. Although the parties were able to reduce the number of questions in dispute before the hearing (Apotex's Appendix C and Merck's Appendix 2, inter alia, were outside the dispute), the number of questions in the categories remains very large.
[4] As appears from several decisions already rendered in this matter, the statement of claim on which dates back to December 19, 1996, the cause of action involved allegations of infringement and invalidity of a patent dealing with the medication Lisinopril, namely patent No. 1,275,350 ("patent 350" or "the disputed patent"). That medication is used in the treatment of hypertension by, if the Court understands correctly, the action of enzymes in the human body.
[5] Seventeen of the 26 categories of questions submitted for decision by Apotex (those in Appendix A) were put in the course of the examination for discovery of the plaintiff Merck's representative, who was also examined as one of the inventors of the invention covered by the disputed patent. This was Dr. Matthew Wyvratt. The inventors of the said patent were four in number, and another inventor, Dr. Arthur Patchett, was also examined on discovery by Apotex. Nine categories of questions (those in Appendix B) were raised in the examination of a Merck Frosst representative, Dr. Philippe Hébert.
[6] The principal problem before the Court in this motion is whether the Court should take the approach recommended by Apotex and, essentially, allow any relevant question arising from the allegations not admitted in the proceedings, or specifically here the questions based on paragraph 19 of Apotex's defence and counterclaim ("the defence"), or whether the Court should regard this as an opportunity to limit the scope of the examination which Apotex is conducting so as to move the case at bar forward as quickly as possible, within the spirit of Rule 3 of the Federal Court Rules (1998) ("the Rules"). Paragraph 19 of Apotex's defence brings together challenges to the validity of the patent which, like Merck, may be grouped as follows:
(a) Is the invention applied for in divisional patent application No. 607,198 a patentable invention distinct from the '340 Original Application filed in Canada, i.e. is it a proper divisional application, and is it still patentable over the prior art before November 19, 1987?
· Defence and Counterclaim, sub-paragraphs 19(a) and 19(b)
(b) Do the '340 Original Application and patent application No. 607,198 and the '350 Patent correctly and fully describe the invention, as well as its operation and use, as applied for and claimed therein?
· Defence and Counterclaim, sub-paragraph 19(m)
(c) Numerous compounds within the '350 Patent cannot be made.
· Defence and Counterclaim, sub-paragraph 19(g)
(d) Numerous compounds within the '350 Patent do not possess the anti-hypertensive utility promised or such compounds are not effective as ACE inhibitors.
· Defence and Counterclaim, sub-paragraphs 19(g) and (j)
(e) Claims for pharmaceutical compositions are too broad, contain inoperable elements, lack utility or comprise material deficiencies, contrary to section 34 of the Patent Act.
· Defence and Counterclaim, sub-paragraphs 19(f), (k), (l) and (m)
(f) The inventors did not have a sound basis to predict the utility of the class of compounds claimed.
· Defence and Counterclaim, sub-paragraph 19(f)
(g) The invention in the '350 Patent would be obvious in the light of the knowledge of a person skilled in the art.
· Defence and Counterclaim, sub-paragraph 19(n)
(h) The prosecution of the '340 Original Application and of the divisional applications was conducted in such a way as to wilfully delay the issuance of the '350 Patent.
· Defence and Counterclaim, sub-paragraph 19(i)
(i) The four co-inventors are not the actual inventors and/or the contribution of co-inventors was intentionally ignored;
· Defence and Counterclaim, sub-paragraph 19(j)
(j) Contrary to section 53 of the Patent Act, the teachings of the '350 Patent contain less than is necessary for utilizing the compounds as medicines.
· Defence and Counterclaim, sub-paragraph 19(o)
[7] According to Apotex, in view of the various sections of paragraph 19 of its defence, neither Merck nor even the Court can seek to limit the examination for discovery of the Merck representative to questions short of those that might be raised by any of the sections of paragraph 19 of Apotex's defence. In Apotex's submission, the wording of its paragraph 19 is there, unquestionably, and Apotex is accordingly entitled to a full examination for discovery of Merck and of Merck Frosst. Of course, though there is no need to cite it here, a considerable weight of traditional authority can be relied on in support of Apotex's viewpoint.
[8] However, this theoretical approach to things comes up against a practical reality in such a way that the Court may wish to see the case move forward in accordance with Rule 3 and its powers of case management. (The case at bar has been a specially managed proceeding since May 13, 1999.)
[9] As mentioned before, the action in this case dates back to December 1996. Since then, the wording of the various pleadings by the parties has been subject to repeated amendments obtained through motions which were bitterly argued before prothonotaries, and even on appeal.
[10] It is difficult to deny that the challenge to the validity of the patent made by Apotex is quite far-reaching in the grounds of challenge.
[11] In fact, as discussed earlier, Apotex alleged inter alia in paragraphs 19(a) to (a.2) that application No. 607,198 which led to the issuing of the patent in dispute is not, within the meaning of s. 36(2) of the Patent Act, R.S.C. 1985, c. P-4, a valid complementary application to the principal application No. 341,340, since the invention in application 198 is the same as that contained in application 340. In a similar vein, the invention which has presumably been intended at all times, and since the period of application 340, as the same single invention _ the "one invention argument" _ is encumbered by a series of deficiencies which are such as to make the patent in dispute invalid.
[12] According to Apotex, in order to make all these distinctions it must have an answer to all its questions enabling it to know what the inventors did and knew at the time of the principal application 340, so it can determine whether the situation at the time of application 340 of December 6, 1979 _ the base of the pyramid, to use Apotex's terms at the hearing _ remained the same at the time of the complementary application 198 on August 1, 1989, the period seen here as the apex of the pyramid. The disputed patent was issued on October 16, 1990.
[13] The complementary application 198 is only one of four complementary applications emerging or originating from the principal application 340. In Apotex's submission, action on the principal application and complementary applications was also drawn out by Merck so as to give the patent an undue advantage (see paragraph 19(i) and (i.1) of the defence).
[14] It appeared that in order to establish its challenges to validity as a whole Apotex depended largely on the information and documents which Merck and Merck Frosst might have.
[15] It is thus not surprising that the examination for discovery of the Merck representative has so far lasted for twelve days (that of Merck Frosst lasted for one day). Thirteen days to hold part of an examination for discovery seems to me, even in the context of the world of pharmaceutical intellectual property, a considerable exercise which undoubtedly gives rise to hundreds and hundreds of questions, if not more. This can be the only explanation of the number of questions still under objection.
[16] It appeared that the affidavits of documents so far filed by Merck and the examination conducted of it have so far resulted in the production for Apotex of some 2,000 documents, totalling 20,000 pages.
[17] It seems relatively clear that if Apotex can freely and directly test its challenges as a whole, as formulated in paragraph 19 of its defence, in the examination for discovery of Merck and Merck Frosst, this access to the base of the pyramid at this stage of the record would mean that the aforementioned examination would continue for a number of days and would involve the additional production of great many other documents, requiring extensive research. Undoubtedly, judging from the past, this exercise would involve further motions to decide objections arising out of questions resulting from the questions authorized.
[18] To counter all of this, Merck and Merck Frosst asked the Court to support the approach taken by them in the examination for discovery conducted by Apotex: hence their objections.
[19] Merck summarized as follows, in paragraphs 18 and 19 of its written submissions made in opposition to Apotex's motion, its attitude or approach to the exercise undertaken in the examination of its representative (Merck Frosst adopted Merck's position for all of the motion in question):
18. In approaching its analysis, Merck has established 20 categories of issues to which the undertakings, advisements and refusals noted during the discovery examination relate. Merck considers that it is appropriate to answer questions falling within the following 9 categories. In fact, it had either given undertakings during discovery or later agreed to answer advisements coming within these following categories:
1) Compounds, including lisinopril, analogues and derivatives which come within the scope of Formula I in Claim 1 of the '350 Patent (Category 1 compounds), as well as compounds produced in rebuttal to paragraph 19(g) of the Defence and Counterclaim (Category 2 compounds) and compounds produced to show the history of the development leading to the issuance of the '350 Patent (Category 3 compounds);
2) processes to make Category 1, 2 and 3 compounds;
3) pharmaceutical activity of Category 1 and 2 compounds;
4) stereo-chemistry of Category 1 and 2 compounds;
5) formulation of Category 1 compounds;
6) questions pertaining to Merck's development of Category 1 and 3 compounds, from the period of March 1978 through to the '340 Original Application filing date of December 6, 1979;
7) Merck's development, making and testing of Category 1 and 2 compounds after December 6, 1979, which confirm the soundness of the prediction made in the '340 Original Application filed on that date and the soundness of the prediction in the '350 Patent;
8) requests pertaining to the production of documents underlying current productions or referred to therein and which pertain to Category 3 compounds; and
9) miscellaneous points, such as production of better copies, clarification of terms, verification of redactions, including making available redacted portions of documents for counsel's eyes only so that said counsel can appreciate that no relevant compounds or matters have been redacted.
19. On the other hand, Merck has refused to answer questions pertaining to the following matters, on the grounds that these questions are improper and irrelevant, as more fully discussed below:
a) Compounds, including enalapril, analaprilat, analogues and derivatives thereof, which are the subject matter of Canadian Patent No. 1,275,349 (Category 4 compounds). The enalapril patent was issued on the same day as the '350 Patent from another divisional patent application (No. 518,334) filed in 1986 from the same parent '340 Original Application;
b) combination products (diuretics, salts, etc.);
c) compounds within the '340 Original Application other than compounds comprised in Categories 1 and 4 above;
d) compounds that do not come with the '340 Original Application;
e) questions calling for expert evidence pertaining to prior art, common general knowledge and the like;
f) questions calling for expert evidence on technical or scientific matters such as chemical process, compound construction, stereo-chemistry and the like;
g) questions seeking to establish the "rationale" for the development, the characterization of the development work and results therefrom;
h) Merck developments, even those pertaining to ACE inhibitors, that took place prior to March 1978 and which do not relate to compounds coming with the broad Formula I of the '340 Original Application, such as lactams, phosphoryl and mercapto (Squibb) derivatives;
i) questions that, by their size and scope, are too broad, would require considerable time, effort and expense to answer, or that pertain to unspecified compounds;
j) questions calling for the interpretation of the Patent or of other documents;
[20] At the hearing, Merck maintained that three additional paragraphs could be added to the list in its paragraph 19, which may be cited as follows:
19. k) irrelevant questions;
l) questions that relate to U.S. and European patent law;
m) questions that relate to Merck's interpretation of provisions in the Patent Act or of legislative changes thereto.
[21] In short, it can be seen from paragraph 18 of Merck's written submissions that the latter suggests concentrating most of the information to be provided on the compounds relating to patent 350, and very little information on what is not within patent 350. The result of this approach by Merck is to largely reject the questions under objection under the motion at bar. It is rather like a reverse pyramid approach: a lot of information at the apex of the pyramid (which comes within patent 350) and little information on what appears to be the broad base of the pyramid.
[22] In the circumstances, I am prepared to approve and accordingly adopt this approach by Merck so as to limit the scope of the examination held by Apotex and move the case forward expeditiously, within the meaning of Rule 3.
[23] As mentioned earlier, the case at bar has been a specially managed proceeding since May 13, 1999, and together with Hugessen J. I am responsible for the management in the present case.
[24] It seems clear that the Federal Court of Appeal recognizes that the person responsible for a specially managed proceeding has a discretion broad enough to move the case forward, since in Sawridge Band v. Canada, [2001] F.C.J. No. 1684, at para. 11, it adopts the following position stated by the Alberta Court of Appeal:
We would take this opportunity to state the position of this Court on appeals from orders of case management judges. Case management judges must be given latitude to manage cases. This Court will interfere only in the clearest case of a misuse of judicial discretion. This approach was well stated by the Alberta Court of Appeal in Korte v. Deloitte, Haskins and Sells (1995), 36 Alta. L.R. (3d) 56, at 58, and is applicable in these appeals. We adopt these words as our own.
This is a very complicated lawsuit. It is the subject of case management and has been since 1993. The orders made here are discretionary. We have said before, and we repeat, that case management judges in those complex matters must be given some "elbow room" to resolve endless interlocutory matters and to move these cases on to trial. In some cases, the case management judge will have to be innovative to avoid having the case bog down in a morass of technical matters. Only in the clearest cases of misuse of judicial discretion will we interfere.
(My emphasis)
(See also the judgment of Gibson J. in Microfibres Inc. v. Annabel Canada Inc. et al., 2001 FCT 1336, judgment of December 5, 2001.)
[25] Consequently, unless I intervene herein below with regard to a group of questions contained in one category of Appendices A or B, or in one of the subcategories as established by Merck in its written submissions based on the major categories created by Apotex at the outset, Apotex's motion will be dismissed with costs in keeping with the approach set out by Merck in paragraphs 18 and 19 of its written submissions, and in its submissions on the categories or subcategories of questions.
Appendix A - Questions to be answered
Category 1
Category 2
- · The complete documents of the documents already produced by Merck must be produced (this covers the 25 questions at the top of page 18 of Merck's written submissions (hereinafter "Merck's page 18"));
- · The question page 1937, l. 8-22.
Category 12
Category 14
Category 17
Appendix B - Questions to be answered
Category 5
Category 6
|
Prothonotary |
Montréal, Quebec
August 21, 2002
Certified true translation
For: Suzanne M. Gauthier, C. Tr., LL.L.
| FEDERAL COURT OF CANADA TRIAL DIVISION Date : 20020821
Docket: T-2792-96
BETWEEN: MERCK & CO., INC. MERCK FROSST CANADA & CO. SYNGENTA LIMITED ASTRAZENECA UK LIMITED and ASTRAZENECA CANADA INC.
Plaintiffs (cross-defendants)
and
APOTEX INC.
Defendant (cross-plaintiff)
REASONS FOR ORDER
|
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
FILE: T-2792-96
STYLE OF CAUSE: MERCK & CO., INC.
MERCK FROSST CANADA & CO.
SYNGENTA LIMITED
ASTRAZENECA UK LIMITED and
ASTRAZENECA CANADA INC.
Plaintiffs
(cross-defendants)
and
APOTEX INC.
Defendant
(cross-plaintiff)
PLACE OF HEARING: Montréal, Quebec
DATE OF HEARING: June 19 and 20, 2002
REASONS FOR ORDER BY: RICHARD MORNEAU, PROTHONOTARY
DATE OF REASONS: August 21, 2002
APPEARANCES:
| Judith Robinson Nelson Landry Frédérique Amrouni |
for the plaintiffs (cross-defendants) Merck & Co., Inc. and Merck Frosst Canada & Co. |
| Denise Lacombe |
for the plaintiffs (cross-defendants) Syngenta Limited, AstraZeneca UK Limited and AstraZeneca Canada Inc. |
| David Scrimger |
for the defendant (cross-plaintiff) |
SOLICITORS OF RECORD:
| Ogilvy, Renault Montréal, Quebec |
for the plaintiffs (cross-defendants) Merck & Co., Inc. and Merck Frosst Canada & Co. |
| Smart & Biggar Toronto, Ontario |
for the plaintiffs (cross-defendants) Syngenta Limited, AstraZenaca UK Limited and AstraZeneca Canada Inc. |
| Goodman, Phillips & Vineberg Toronto, Ontario |
for the defendant (cross-plaintiff) |