Apotex Inc. v. Schering Corporation, 2018 ONSC 6810

COURT FILE NO.: CV-11-429541 MOTION HEARD: 20180508, 20180528 and 20180615 REASONS RELEASED: 20180831

SUPERIOR COURT OF JUSTICE – ONTARIO

BETWEEN:

APOTEX INC.

Plaintiff

• and-

SCHERING CORPORATION, SANOFI-AVENTIS, SANOFI-AVENTIS DEUTSCHLAND GmbH AND SANOFI-AVENTIS CANADA INC.

Defendants

BEFORE: MASTER M.P. McGRAW

COUNSEL: A. Mandlsohn and B. Heard Email: amandlsohn@smart-biggar.ca -for the Defendants Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc.

M. Richard Email: marc.richard@gowlingwlg.com -for the Defendant Schering Corporation

D. Cappe and M. Yasskin Email: dcappe@goodmans.ca -for the Plaintiff Apotex Inc.

REASONS RELEASED: August 31, 2018

NOTE: Pursuant to the Protective and Confidentiality Order of Justice Dunphy dated February 22, 2017 (the “Protective Order”) and the agreement of counsel, redactions have been made to these Reasons For Endorsement at paragraphs 30, 32 and 35.

Reasons For Endorsement

I. Introduction

1Three motions to compel answers to approximately 480 undertakings and refusals proceeded before this Court over 3 days. The motions were brought by the Defendants Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (collectively, “Sanofi”); the Defendant Schering Corporation (“Schering”, collectively with Sanofi, the “Defendants”) and the Plaintiff Apotex Inc. (“Apotex”).

2On a telephone case conference held on February 20, 2018, counsel estimated that there were approximately 300 undertakings and refusals in dispute. Therefore, these motions were scheduled to proceed on May 8 and 28, 2018. However, when the parties filed their motion materials, Sanofi was moving on approximately 335 questions and Schering and Apotex were moving on approximately 51 and 95 questions, respectively. By the end of submissions, approximately 101 questions remained in dispute. However, given the significant time spent narrowing the disputed questions by case management and discussions between counsel and determining which questions had already been or would be answered by agreement or additional productions, an additional day of court time was required.

II. The Parties and the Action

3A more detailed overview of this action, the regulatory context and the previous proceedings between these parties are set out in the pleadings and the Reasons of Dunphy J. dated May 27, 2016 on the Defendants’ motions to strike the Plaintiff’s claims (Apotex Inc. v. Schering Corporation, 2016 ONSC 3407). The following high level overview is sufficient for the purposes of the present motions.

4As set out in Dunphy J.’s Reasons, this action is the latest battlefront in the larger ongoing pharmaceutical industry litigation between “originators” like the Defendants (which introduce drugs to the market under branded names) and “generics” like Apotex (which subsequently bring those same drugs to the market under generic names). More specifically, this action is the most recent litigation between these parties dating back to 2003 with respect to the hypertension drug “ramipril” which was introduced for sale in Canada in 1994 under the trade-name “ALTACE” by a predecessor to Sanofi-Aventis Canada Inc. (“SAC”). ALTACE was manufactured by SAC pursuant to a license granted by Schering, the registered owner of the patent issued on March 20, 2001 as No. 1,341,206 which includes the compounds for ramipril (the “206 Patent”).

5The following is a summary of the previous proceedings and litigation between these parties with respect to ramipril:

i.) Apotex’s filing of an abbreviated new drug submission (“ANDS”) with the Minister of Health (the “Minister”) for its generic version of ramipril, called “Apo-Ramipril” on July 22, 2003 pursuant to the “Patented Medicines (Notice of Compliance) Regulations, SOR/93-133” (the “PMNOC Regulations”), which are made under the “Patent Act, R.S.C., 1985, c. P-4”, seeking a Notice of Compliance (“NOC”) pursuant to the “Food and Drugs Act, R.S.C. 1985” (the “PMNOC Proceedings”). The purpose of this process was to seek approval to permit Apo-Rampiril to be brought to the market. Pursuant to the PMNOC Regulations, Apotex was required to demonstrate that Apo-Ramipril was the chemical and functional equivalent of ALTACE, which had already been deemed to be safe and effective by the Minister. Apotex issued notices of allegation (“NOAs”) with respect to each patent registered on the Patent Register including the 206 Patent which, if successful, would permit an NOC to be issued to Apotex prior to the expiry of the existing patents;

ii.) prohibition proceedings commenced by SAC (joined by Schering with respect to the 206 Patent as licensor and original patent holder) in the Federal Court of Canada (“Federal Court”) in response to the NOAs to prevent the Minister from issuing an NOC to Apotex (the “Prohibition Proceedings”). The Federal Court dismissed the Prohibition Proceedings with respect to the 206 Patent on September 30, 2005 on the basis that the 206 Patent was invalid, later dismissing the Prohibition Proceedings with respect to 3 other ramipril patents on the basis that the patents were invalid or not infringed by Apo-Ramipril. After determining that 2 additional patents subsequently filed by SAC did not need to be addressed by Apotex, the Minister issued an NOC on December 12, 2006 permitting Apotex to bring Apo-Ramipril to the market;

iii.) an action commenced by the Defendants against Apotex in Federal Court on January 26, 2007 alleging infringement of the 206 Patent (the “Infringement Action”). Pursuant to the Reasons of Snider J. dated June 29, 2009, certain claims under the 206 Patent were declared void with the effect that the 206 Patent was declared to be void ab initio (Sanofi-Aventis Canada Inc. v. Apotex Inc., 2009 FC 676);

iv.) an action commenced by Apotex against the Defendants in Federal Court on August 11, 2009 for, among other things, compensation pursuant to s. 8 of the PMNOC Regulations which provides a statutory cause of action for generic companies which have been delayed and hindered in bringing drugs to the market by operation of the PMNOC Regulations and its use by originator companies. As set out in the Reasons of Snider J. dated May 11, 2012 (Apotex Inc. v. Sanofi-Aventis, 2012 FC 553)(the “Section 8 Reasons”), Apotex was awarded approximately $215 million (the “Judgment”) in the Section 8 Action. The Judgment was upheld by the Federal Court of Appeal (2014 FCA 68) and the Supreme Court of Canada (for reasons given by the Federal Court of Appeal in 2015 SCC 20) (collectively, the “Section 8 Action”, together with the PMNOC Proceedings, the Prohibition Proceedings and the Infringement Action, the “Previous Proceedings”). In or about October 2009, Apotex gave notice of its intention to discontinue non-section 8 claims for damages due to delay which it had advanced as alternative or additional relief in the Section 8 Action (the “Non-Section 8 Claims”), without prejudice to its right to assert the Non-Section 8 Claims in another jurisdiction.

6The current action is the continuation of the Non-Section 8 Claims. In its Amended Statement of Claim in this action issued on August 5, 2016 (the “Amended Claim”), Apotex alleges that the Defendants wrongfully delayed Apotex in bringing Apo-Ramipril to the market by the maintenance of the invalid 206 Patent.

7Apotex claims damages from the Defendants for lost profits under An Act concerning Monopolies, and Dispensation with penal laws, etc., (Ontario) R.S.O. 1897, c. 323 and the U.K. An Act concerning Monopolies and Dispensations with Penal Laws, and the Forfeitures thereof, 1624, 21 Jac. I, c. 3 (collectively, the “Monopolies Acts”) (both of which could treble any damages) and the Trade-Marks Act, R.S.C. 1985, c. T-13 (the “TM Act”). The total damage claims by Apotex may approach or exceed $500 million -$1 billion. Canadian sales of ALTACE from 2004-2006 exceeded $1 billion.

8Apotex alleges that, but for the registration of the 206 Patent, it would have received its NOC for Apo-Ramipril on or about April 26, 2004, the date when the Minister advised Apotex that the review of the ANDS had been completed (also referred to as a “patent hold date”). In the Section 8 Reasons, Snider J. found that April 26, 2004 was the appropriate patent hold date. This would have permitted Apotex to bring Apo-Ramipril to market on or about that date and therefore, as set out by Snider J. in the Section 8 Reasons, is the beginning of the relevant liability period. However, Apotex has more recently taken the position in this action that it would have received its NOC on November 10, 2003, approximately 5.5 months earlier.

9Apotex’s assertion that but for the invalid 206 Patent it would have brought Apo-Ramipril 5.5 months earlier has a material impact on its claim for damages and, by extension, what documents and information are relevant to this action. As explained by Snider J. at paragraph 5 of the Section 8 Reasons, in order to assess damages, the court is required to construct a hypothetical or “but for” world during a defined period of time in the past in order to determine what share of the market Apotex would have captured if it had been able to sell Apo-Ramipril. Therefore, the hypothetical world in which Apotex alleges that it would have been in a position to bring Apo-Ramipril to the market as early as November 10, 2003 is a material consideration on these motions.

10There is significant overlap between the underlying facts and issues related to the current action and the Previous Proceedings, particularly the Section 8 Action. Given this overlap, and the substantial number of documents produced in the Previous Proceedings, there are a significant number of documents which the parties have already exchanged and/or which are available that are responsive to the questions in dispute on these motions. As discussed below, these substantial productions and the additional productions sought, together with the significant amounts claimed by Apotex, put proportionality squarely at the forefront of these motions.

III. The Law and Analysis

Generally

11Rule 31.06 provides that:

(1) A person examined for discovery shall answer, to the best of his or her knowledge, information and belief, any proper question relevant to any matter in issue in the action….

12Rule 29.2.03 sets out the proportionality factors which apply to both oral and documentary discovery:

(1)In making a determination as to whether a party or other person must answer a question or produce a document, the court shall consider whether,

(a) the time required for the party or other person to answer the question or produce the document would be unreasonable;

(b) the expense associated with answering the question or producing the document would be unjustified;

(c) requiring the party or other person to answer the question or produce the document would cause him or her undue prejudice;

(d) requiring the party or other person to answer the question or produce the document would unduly interfere with the orderly progress of the action; and

(e) the information or the document is readily available to the party requesting it from another source.

(2) In addition to the considerations listed in subrule (1), in determining whether to order a party or other person to produce one or more documents, the court shall consider whether such an order would result in an excessive volume of documents required to be produced by the party or other person.

13Relevance, the scope of discovery and proportionality were canvassed comprehensively by Perell J. in Ontario v. Rothmans Inc., 2011 ONSC 2504 and Canadian Imperial Bank of Commerce v. Deloitte & Touche, 2013 ONSC 917. Discovery questions must be relevant to the issues as defined by the pleadings such that they must have probative value and adequately contribute to the determination of the truth or falsity of a material fact. Overbroad and speculative discovery and “fishing expeditions” are not permitted.

14I am also guided by Rule 1.04(1) which provides that the Rules of Civil Procedure shall be liberally construed to secure the just, most expeditious and least expensive determination of every civil proceeding on its merits together with Rule 1.04(1.1) which requires the court to make orders and give directions that are proportionate to the importance and complexity of the issues, and to the amount involved, in the proceeding. Given the volume of documents already produced in this action and the Previous Proceedings and the significant amounts at issue, proportionality and the underlying principles of Rule 1.04 are even more pronounced.

15Specifically, in the Section 8 Action and the Infringement Action, the same parties, represented by the same counsel, conducted 15 days of examinations, 2 long trials and appeals to the Federal Court of Appeal and the Supreme Court of Canada on many of the same issues in dispute in this action. The fact that a document was or was not sought or produced or a particular issue was or was not raised or disposed of in the Previous Proceedings, are not, on their own, determinative of this Court’s dispositions on these motions. However, the availability and previous production of documents and information is a highly relevant consideration with respect to proportionality. At the same time, it is imperative that expediency and expense be balanced against the fact that the claim for damages by Apotex in this action may approach or exceed $500 million-$1 billion.

16I have also taken into consideration that the parties have agreed that re-attendances on examinations for discovery will be necessary and that in many instances the information sought by the parties will be provided before trial by their respective experts. The option to ask further questions on re-attendance or in writing is often of great assistance in resolving disputed undertakings and refusals particularly in a case such as this where many of the requests are substantial and multi-layered. The parties were at times resistant to options such as rephrased questions or questions arising from answers provided, taking the position that the opposing party “had its shot” during examinations for discovery or subsequently in writing and should be prevented from further discovery. I am largely unreceptive to such positions given that providing information and documentation in stages and refining and narrowing requests is typically of great assistance in resolving disputed refusals motions. The benefits of such an approach are even more pronounced in a large, complex matter such as this with close to 500 questions in dispute, substantial productions to date and large amounts claimed.

17It was apparent during the first attendance that the parties had not fully considered which documents from the Previous Proceedings were responsive to the many disputed questions and requests on these motions. While the parties advised that they had reached an agreement in principle that the productions from the Section 8 Action would form part of the record (the “Production Agreement”), they had not determined with any precision or specificity what prior productions might be responsive to the questions and issues in dispute. Accordingly, I released an Interim Endorsement dated May 10, 2018, directing as follows:

“[2] ….In my view, given the number of outstanding questions and issues, the existence of substantial materials and productions from previous proceedings and the progress made on the first day of the motion, I am of the view that additional efforts by counsel are necessary to ensure that these motions proceed as efficiently as possible and consistent with the principles of proportionality.

3Prior to the next attendance, the parties shall do the following:

i.) Review all materials including all productions in all Federal Court proceedings in order to identify which documents and/or information may be fully or partially responsive to questions and issues in dispute on these motions and identify same for other counsel prior to the attendance and be prepared to speak to same on the next attendance;

ii.) Review all decisions and endorsements in all prior proceedings to identify any disputed issues on these motions or related issues that have been previously addressed or disposed of and identify same for other counsel prior to the attendance and be prepared to speak to same on the next attendance ;”

18As set out below, many of the disputed questions were resolved by agreement and/or case management during the motion or agreements made between counsel in between court attendances. All of this is summarized below and where no further steps are currently required or were agreed to, I have made no orders. The Item numbers below correspond with the charts filed by the parties.

The Sanofi Motion

19The Sanofi Motion initially included approximately 335 questions.

20Pending finalization of the Production Agreement, the following 48 Items on the Sanofi Motion are adjourned on consent on the terms set out below:

i. 9, 13, 28, 30, 31, 32, 33, 34, 69, 70, 232 (last request relating to documents from earlier litigation), 1, 2, 97 (conditional on Apotex updating its answer to include its position that “Apotex does not dispute that it would have had to address the 457 patent in the hypothetical world if it were listed on the Patent Register prior to Apotex’s approval”), 98, 99, 100, 106, 107, 109 (conditional on Apotex updating its answer to 97 to include its position re: 97), 110, 112, 113, 115, 116, 119, 122, 123, 211 (on the basis that Apotex has agreed to answer 210), 89, 93, 95, 185 (on the basis of Apotex’s position that “the relevant information will be captured by Item 184”, which it has agreed to answer under reserve of objection), 140, 147 (conditional on Apotex updating its answer to include its position in 143 that “there is no allegation that the mere existence of the 206 Patent caused harm to Apotex”), 208, 157, 54;

ii. 64 (with respect to 2001-2003), 66 (with respect to 2001-2003), 67 (with respect to 2001-2003), 105, 57, 58.

21Sanofi and Apotex also agreed on the following 82 Items:

i. Sanofi is not pursuing: Items 15 (on basis of Apotex’s answer/position to Item 15 and agreement to answer Item 18), 68, 71, 76 (on basis of answer/position provided and agreement to answer Item 3), 117, 121, 24 (on basis of answer/position provided), 88 (on basis of answer/position given and agreement to answer Items 84 and 87), 90, 234, 236 (on the basis of the answer/position provided and the understanding that Apotex is not claiming damages in respect of a combination product), 47 (with respect to “general agreements”), 48, 49 (on basis of answer/position provided), 50, 51, 56, 152, 235.

ii. The following Items, which Apotex has agreed to answer under reserve of objection, will be adjourned without prejudice to Sanofi’s right to pursue them at a later date, if necessary, including prior to trial: Items 114, 127, 209, 210, 212, 213, 223, 224, 225, 226, 37, 47 (with respect to “any agreements with respect to ramipril”), 52, 61, 101, 102, 153, 154, 155, 163, 164, 166, 169, 171, 173, 174, 175, 176, 177, 184, 189, 190 (on the basis that Apotex will answer under reserve of objection as to the activities and metes and bounds of making use. Sanofi maintains its position regarding the request for documents, which Apotex has not agreed to answer), 191, 192, 193, 194, 196, 207, 137, 138, 139, 214, 231, 104, 144, 218, 219.

iii. Apotex will answer under reserve of objection: 120, 220, 128, 129, 130, 131, 132, 215, 216, and 217.

22Approximately 36 Items on the Sanofi Motion remain in dispute and are addressed below (as set out below, some Items which were initially in dispute on the Sanofi Motion were addressed on the Schering Motion).

23In addressing the Items set out below, the following 7 Apotex productions which constitute its Affidavit of Documents are relevant to Apotex’s profits from the sale of Apo-Ramipril in both the “real world” and the “hypothetical world”, much of which is responsive to the information sought by Sanofi (and to a lesser extent, Schering):

i.) Production 1 - Sales; ii.) Production 2 - Freight and Distribution Costs; iii.) Production 3 - Selling General and Admin; iv.) Production 4 - Manufacturing capacity at Apotex production facilities; v.) Production 5 - Raw material purchases; vi.) Production 6 - Standard costs; vii.) Production 7 - Professional Allowances (collectively, the “Apotex Productions”).

24Items #4 and #5 - These Items represent significant requests in which Sanofi seeks all of the underlying input documents for each of the Apotex Productions updated to the present and on a monthly basis until trial. Sanofi submits that because the Apotex Productions are summary documents relevant to profits for the sale of Apo-Ramipril in both the real and hypothetical worlds, the underlying documents are also relevant and necessary so that its experts can verify and evaluate Apotex’s numbers. However, Sanofi’s suggestion that the Apotex Productions are simply summary documents is not supported by the productions themselves. Further, I am not satisfied that obtaining these documents would be as simple as “hitting a button” as Sanofi suggests. For example, Production 1 lists each of the approximately 385,000 individual sales of Apo-Ramipril up to and including October 2016, far from a summary document. Sanofi’s request for the underlying invoices for each sale would require the production of approximately 385,000 documents, which together with the corresponding purchase orders would double Sanofi’s request related to Production 1 alone to approximately 750,000 documents. Apotex estimates that the underlying productions for Productions 2-7 would be an additional 250,000 documents.

25In my view, compelling Apotex to produce potentially 1,000,000 additional documents would be disproportionate and unnecessary in the circumstances. The time, effort and cost of producing the requested documents would far outweigh the probative value they would add to these proceedings, particularly when it is apparent that there are significant productions in the Previous Proceedings which are responsive to Sanofi’s request which Sanofi acknowledges it has not yet re-reviewed and considered. My conclusion is further supported by the fact that one of Sanofi’s stated reasons for seeking the underlying documents is to “double check” the Apotex Productions and conduct a deeper review than it did in the Section 8 Action.

26As set out in greater detail in the Schering Motion, the Defendants submit that the professional allowances or “discounts” which Apotex gave to its customers (including rebates, distribution allowances, credit card discounts and free goods) are a significant, important issue in this action, particularly as they relate to large chains which comprise Apotex’s 4-5 major customers but also independents and wholesalers. Any allowances must be deducted from Apotex’s damage claims and may comprise 50% or more of the damages claimed. Apotex has agreed to re-produce every allowance document from the Previous Proceedings and to update the Apotex Productions (such production may also be covered in the Production Agreement) prior to trial for use by the Defendants’ experts. In the Section 8 Reasons, Snider J. also determined an appropriate professional allowance rate for Apo-Ramipril for the hypothetical world starting in April 2004.

27Sanofi has made no meaningful attempt to narrow this request or advance a more reasonable proposal. In the absence of a more viable, reasonable and proportionate production request, I conclude that the current proposed and previous efforts by Apotex are cost effective, reasonable, appropriate and proportionate in the circumstances and that no further efforts are required at this time. Once Sanofi has had an opportunity to review the productions, it may pose more targeted questions on re-attendance or in writing.

28Item #20 - Sanofi seeks samples of the relevant underlying accounting documents which demonstrate the chronology with respect to how Apotex arrived at the accounting entries for the professional allowances given to its customers. Apotex submits that it has already provided the information which Sanofi requires in order to reconstruct the chronology and “connect the dots” such that the underlying documents are unnecessary. Sanofi does not advise how many or which “samples” it seeks but asserts that what it is seeking would not be onerous for Apotex to produce. In my view, the underlying documents are relevant. However, I am satisfied that only the production of the underlying documents for one accounting entry as an example, to be chosen by Apotex, with explanation, is sufficient, reasonable and proportionate in the circumstances.

29Item #63 - Sanofi seeks copies of all of Apotex’s agreements with its customers that include any references to professional allowances or rebates which were not produced in the Previous Proceedings. This production request by Sanofi has no temporal limit, dating back 45 years to Apotex’s incorporation and relates to any drug ever sold by Apotex, not just Apo-Ramipril. In my view, this request is significantly overbroad and disproportionate and seeks information which is not relevant to the matters at issue in this action. Sanofi has made no attempt to narrow this request or even provided any starting point to address the overwhelming amount of documentation and information sought. I reject Sanofi’s submission that it requires this broad information beyond the temporal and subject limits of this action and the Previous Proceedings in order to determine any changes in the professional allowances rates and trends. Apotex is not required to take any further steps.

30Items #72 and #75 - Sanofi seeks the production of professional allowance reports filed by Apotex with the Ontario (every 6 months) and Quebec (annually) governments under Provincial legislation together with additional documents generated in response to changes in the applicable legislation. Sanofi also seeks agreements and documents with respect to [REDACTED].

31Apotex submits that it has already produced the only information relevant to allowances (or will produce from the Previous Proceedings pursuant to the Production Agreement). Similar to Sanofi’s other requests for underlying documents, it seeks copies of the Provincial filings in order to cross-reference them with Apotex’s other allowance productions or “double check”. There is no allegation that any information already produced by Apotex is inaccurate.

32Apotex’s answers to undertakings in the Section 8 Action, the Statement of Sanofi’s expert Ross Hamilton dated September 27, 2011 (the “Hamilton Statement”) and the discovery transcripts in this action confirm that [REDACTED].

33Apotex submits that it has produced more than 20 allowance documents including Production #7 which provides the rebate rates for all customers. Apotex also argues that neither Sanofi nor the Federal Court raised any issues or concerns regarding the production of information regarding professional allowances during the Section 8 Action and Sanofi’s discovery on professional allowances ran approximately 340 pages in the Section 8 Action. Apotex submits that no further productions should be ordered simply so that Sanofi can “double check” the information they received in the Section 8 Action.

34With respect to the Ontario and Quebec filings, I conclude that it is sufficient, reasonable and proportionate for Apotex to provide a summary of the professional allowance amounts reported to the Ontario and Quebec governments during the period when it has sold Apo-Ramipril. The actual professional allowance amounts reported are the material information which is relevant to Apotex’s damage claim. To the extent to which there are any remaining issues or questions arising, the underlying reports may be sought later after the amounts themselves are confirmed. Further, if the reports are publicly available, then Sanofi is free to obtain them on its own.

35With respect to the [REDACTED], the undertakings chart from the Section 8 Action relied on by Sanofi confirms that information was produced regarding rebates in response to a request in the Section 8 Action which is similar to these current Items. While Sanofi accepts that the [REDACTED] are not available, it submits that there “may” be additional information and documentation that may assist it in assessing the accuracy of the professional allowance or rebate information already produced. However, based on the record before me and the submissions of counsel, it is not clear whether or not any such documents exist, and, if they do, Apotex would be required to go into the SAP system and extract them at great time and cost. Similar to Item #325 from the Schering Motion below, I conclude that until Sanofi fully reviews all productions, in the Previous Proceedings and this action, it would not be reasonable, cost effective, expeditious or proportionate for Apotex to produce further documentation especially on the basis that there “may” be additional information which is relevant or helpful. Sanofi may pose further questions on re-attendance or in writing after it has reviewed the documents already produced and those that will be produced.

36Items #105 and #142 – Sanofi requests Apotex’s knowledge, information and belief in the real world as to whether it could have received approval to bring Apo-Ramipril to market in the real world prior to April 26, 2004 and if so, the basis for its position. Apotex has already agreed to permit further discovery upon re-attendance on this issue if it takes this position and to provide its position and basis prior to trial. I am satisfied that this a full response to and resolution of these Items and that no further steps are required by Apotex at this time.

37Items #91-#92 - Sanofi requests the production of any Apotex agreements which precluded customers who purchased Apo-Ramipril from purchasing products from Apotex’s competitors. Sanofi submits that any such agreements are relevant to determining the sales which Apotex would have made in the hypothetical world. Apotex submits that it has already produced relevant information regarding its own sales and those of its competitors, and additional information from the Section 8 Action and the Infringement Action will be produced, all of which reflect the sales made pursuant to the customer agreements in place at the relevant times. Therefore, the sales information already produced or available takes into account the terms of such customer agreements including any terms preventing Apotex customers from purchasing product from its competitors. In my view, it would not be proportionate to require Apotex to produce any actual agreements when the sales information already produced or to be produced sets out what sales actually took place based on any restrictive terms. Accordingly, I am not satisfied that production of the agreements themselves is necessary or would add anything other than more effort and cost. Accordingly, Apotex is not required to produce these agreements. However, I am satisfied that it is relevant to sales in the hypothetical world for Sanofi to know which customers of Apotex had such restrictive provisions in their agreements and Apotex shall advise accordingly.

38Items #40, #41 and #42 - These are a series of questions related to Apotex’s facilities where it produces Apo-Ramipril in Etobicoke, Ontario and its Signet campus in North York, Ontario (the “Facilities”). Sanofi seeks the total costs and supporting documents with respect to upgrades to the Facilities for various years between 2005 and 2008 updated on a monthly basis up to trial, together with costs and supporting documents for the purchase, installation and annual maintenance of encapsulation and packaging equipment and generally, the capacity of all machines which are “relevant or play a role” in the production of Apo-Ramipril. Sanofi submits that Production #4 reflects a significant increase in production from 2004-2009. Therefore, the information sought is relevant to Apotex’s allegation that it could have produced Apo-Ramipril earlier and in greater quantities in the hypothetical world (as the sole supplier of a generic version) than it could have in the real world given that this may have required greater investments in the Facilities which would be deducted from its alleged lost profits. Apotex submits that the documents already produced demonstrate that no upgrades or expansion of the Facilities would have been necessary. Apotex refers to Sanofi’s own Hamilton Statement, in which Mr. Hamilton relied on Apotex’s advice that it was not required to make any additional investments to accommodate the launch of Apo-Ramipril. Apotex confirms that Mr. Hamilton’s Statement and the information produced remains accurate and applies equally to the period prior to April 26, 2004 now claimed by Apotex. Apotex is also prepared to discuss updates to Production #4 prior to trial. Given the information and documentation produced in the Section 8 Action, this action and the conclusions of Sanofi’s own expert, together with Apotex’s confirmations and agreement to update, I am satisfied that no further steps are required at this time.

39Item #103 - Sanofi seeks all of Apotex’s internal documents including emails and memos “that comment in any way on Apotex’s delay in getting its approval for ramipril”. Sanofi submits that these documents are relevant to determining whether there were any other reasons Apotex may have been delayed which are unrelated to the Defendants or approval from the Minister. Apotex has already agreed to produce all external communications regarding delay and submits that the relevant issue is approval, not readiness to bring Apo-Ramipril to market. In my view, while I agree with Sanofi that “other” reasons that may have delayed Apotex in bringing Apo-Ramipril to market may be relevant, this request is overbroad and disproportionate. In particular, seeking “all documents that comment in any way on delay” (rather than on “other” reasons for delay) is unnecessary and disproportionate to the disputed issues. While a narrower request for information and documentation in this regard may be more reasonable, Sanofi has not proposed one. Sanofi may pose such questions on re-attendance or in writing.

40Items #162, #167-#168 - Sanofi seeks, among other things, all facts and documents related to alleged statements and representations by the Defendants that tended to discredit the business wares and services of Apotex which support its claim for damages under s. 7 (d) of the TM Act as set out at paragraph 73B of the Amended Claim. Sanofi also asks what about the statements was not true, what facts and documents related to this assertion and seeks all of the the email traffic, memos, internal notes of anyone at Apotex including Dr. Barry Sherman. Apotex has already agreed to answer Items 160-161 in which it will advise to whom the statements and representations set out at paragraphs 72 and 72A of the Amended Claim were made and Items 163-166 with respect to representations referenced in paragraphs 72A and 73 of the Amended Claim including with respect to the issuance of the NOC. Apotex submits that these answers not only provide the information which Sanofi seeks, in some cases it is more specific information. In my view, while the answers to be provided to Items 160-161 and 163-166 by Apotex are a sufficient starting point, Sanofi may be entitled to more information and production. However, at this time, it is reasonable, appropriate, cost-effective and proportionate for Apotex to answer Items 160-161 and 163-166 and for Sanofi to make any additional requests on re-attendance on examinations for discovery or in writing.

41Questions #180 and #182 - Sanofi seeks all of the facts, documents, files, complaints and newspaper, magazine, television and press that “touch on” Apotex’s reputation from April 2004 to the present and up to trial including all public and private statements (including complaints). Sanofi submits that the Amended Claim has “opened the door” to all “reputational elements” as it relates to Apotex’s business, and therefore, Sanofi needs to evaluate Apotex’s past reputation in order to assess whether the alleged statements have impacted its reputation. This is an overly broad and wide ranging request which, again, Sanofi has not attempted to narrow. Not only would compelling production of all of these documents be disproportionate, I am not satisfied that all of it is relevant, as Sanofi’s use of the phrase “touch on” might suggest. Just because a document may “touch on” matters at issue in litigation does not make it relevant or probative and ultimately producible. Further, Sanofi’s request is not limited to Apo-Ramipril. In any event, given how broad this request is, it is even difficult to break it down to a manageable level. At the motion, submissions and discussions ultimately focused on complaints made to Apotex directly and any public complaints, though neither party could provide any insight into to what documents might be available or the steps involved in obtaining them. Therefore, I conclude that a reasonable, proportionate first step would be for Apotex to make the appropriate inquiries and advise Sanofi regarding the nature, status and processes of Apotex’s complaints department including what documents might be available and for what time period.

42Item #187 - Sanofi requests, from 1993 to the present, or from April 2004 in the alternative, a list of all of the pharmaceutical patent litigation cases that Apotex was involved with in Canada (including NOC, infringement and validity cases) including the parties, dates, the patents and drugs involved and any press statements made by Apotex. Sanofi also seeks any internal documents with private or public statements with respect to Apotex’s “business model to bust patents and to litigate”. Sanofi argues that this information is relevant given that Apotex’s history of patent litigation contributes to its reputation and to whether it has suffered reputational damage or lost sales of Apo-Rampiril as result of the Defendants’ alleged representations which relate to patent litigation. Apotex submits that it advised Sanofi of all cases under s. 8 of the TM Act during the Previous Proceedings therefore, no further production is necessary. While, again, I conclude that Sanofi’s request is overbroad and not in all respects relevant to Apotex’s alleged reputational damage, there is more information which Apotex should provide in response. In determining what should be produced, I am satisfied that a list only (no other information) of all patent litigation cases (not limited to s.8 cases) from April 2004 to the present is relevant and probative of alleged reputational damage and is responsive and proportionate. I am not prepared to broaden any production order. Not only does it appear that this information is publicly available to Sanofi but Apotex has already produced a list of its s. 8 actions. I also conclude that Sanofi has not established that all documents with respect to Apotex’s “business model to bust patents and to litigate”, that is, the strategy underlying the litigation, is relevant. This question not only presumes that such a model or strategy exists, it is not probative or proportionate. It would not add anything given that it is the publicly known litigation that is at issue not any alleged underlying model. Further, I am also not satisfied that all press statements regarding all patent litigation are relevant or proportionate. While some may be relevant, this is another example of a request by Sanofi which could have benefited from some narrowing.

43Item #197: Sanofi seeks the underlying documents with respect to paragraph 74 of the Amended Claim where Apotex alleges that Sanofi made use of descriptions in association with ALTACE capsules that were materially false and likely to mislead the public as to the character or quality of ALTACE pursuant to s. 7 (d) of the TM Act . In Item 189, Apotex has agreed to provide an answer under reserve of objection with respect to the alleged misrepresentations. However, in Item #197, though the question is not worded clearly, it appears as if Sanofi is seeking the basis and underlying documents for Apotex’s pleading that ALTACE capsules did not have the legal character and quality protected by the patents, assuming it takes this position. In my view, it is sufficient for Apotex to advise Sanofi if it takes this position and if so, the basis for taking this position. Depending on the answer, documents can be requested and following up questions asked upon re-attendance or in writing.

44Items #202-#203: Sanofi seeks the facts and documents relevant to the “connection” between Apotex’s claims at paragraph 74 of the Amended Claim that it lost sales of Apo-Ramipril as a result of the alleged discrediting statements and the use of false descriptions by the Defendants to the alleged lost sales in paragraph 75 of the Statement of Claim including related documents. Apotex submits that these questions are incomprehensible and not distinct from other questions it has already agreed to answer and information and documents it has already produced. This includes Items 184-185 in which Apotex has agreed to provide under reserve of objection any facts or documents that support the assertion that the Defendants discredited Apotex’s business, wares and services. It is difficult to distinguish between what Sanofi is seeking and what Apotex has already agreed to produce. The only conclusion I am able to draw is that to the extent to which Apotex has not already agreed to or done so, it should produce any documents relevant to the connection between the Defendants’ alleged use of false descriptions and the damages claimed (which does not appear to be covered by Items 184-185).

45Item #237: This relates to Production 3B in which in which Apotex has provided its gross sales for Canada for all products, for Apo-Ramipril specifically and Apo-Ramipril as a percentage of gross sales from January 2002 through March 2016. Sanofi now requests the gross sales for every other Apotex product for this period on the basis that it is relevant to Apotex’s allegations of harm under the TM Act and the extent to which Apotex’s other products contribute to its reputation. Canadian pharmaceutical sales for every drug sold by all manufacturers are tracked by IMS Health which is available to Sanofi and has been produced by Apotex and more information will be produced as a result of further productions. Therefore, I am satisfied that it would not be proportionate to compel Apotex to produce additional information or the same information at this time. It may be the case that Sanofi will have additional questions on re-attendance, however, Apotex is not required to take any further steps at this time.

46Items #227-#228 : At paragraph 22 of its Reply to Sanofi’s Statement of Defence, Apotex denies that its claim in this action is precluded by estoppel or res judicata , asserting that any rights that it exercised in the Section 8 Action are concurrent and/or cumulative to the rights it seeks to exercise in this action. In these Items, Sanofi seeks the facts and documents that relate to this assertion of concurrent rights and asks how these rights differ from the rights that Apotex has already exercised in the Section 8 Action. Apotex submits that everything is as set out in their Reply, there are no documents relevant to this request and that the balance seeks a legal position, therefore, there is nothing to provide. While I accept Apotex’s submission that there are no documents or facts to produce which are specific to this pleading, I agree with Sanofi that Apotex’s legal position is relevant and that it is obligated to advise accordingly. The Divisional Court has held that where, as here, a party’s legal position is relevant and probative of issues in the action, the party is obligated to state its legal position (Six Nations of the Grand River Band v. Canada (Attorney General), 2000 CarswellOnt 1342 (Div. Ct.) at paras 9-14 ). Accordingly, Apotex shall advise Sanofi regarding its legal position in this regard and the basis for its position.

47Items #133 and #134 – Sanofi requests how much each of the ramipril patents individually caused or contributed to the alleged delay in bringing Apo-Apotex to the market, what strengths it was seeking approval for in the real world and when in the hypothetical world with respect to all strengths of Apo-Ramipril which it is seeking damages for and what documents support the damages in respect of each strength. For example, if Apotex is alleging in the hypothetical world that it would have had approval for the 15-milligram Apo-Ramipril tablets, what are the facts and documents that would support this claim. Apotex has agreed to advise what strengths it is seeking damages for, however, proposes that any further production be deferred until it has done so. Consistent with proportionality, I agree with Apotex that a reasonable first step would be to advise what strengths it is seeking damages for, at which point questions arising including further production requests can be made in writing or on re-attendance.

48Items #135 and #143 – Sanofi requests the factual information and documents that relate to how the issuance of a patent caused the delay and hindrance alleged by Apotex, and how the mere existence of. Apotex submits that there are no allegations that the mere registration and existence of the 206 Patent caused harm to Apotex. Accordingly, there is nothing for Apotex to answer unless Sanofi wishes to re-phrase the question.

49Item #146 – With respect to paragraph 70 of the Amended Claim, Sanofi requests the facts and documents in support of Apotex’s allegations that it was hindered, grieved, disturbed and disquieted by occasion and pretext pursuant to the Monopolies Acts. I disagree with Apotex’s assertion that it is not compelled to answer this question because it is improper, irrelevant, that the pleading speaks for itself or that this is a legal position. To the extent to which there is any information or documents which have not already been produced, in the Previous Proceedings or this action, or will be produced in response to other Items, Apotex shall produce such information and documentation and confirm its legal position.

50Item #149-#150 – With respect to paragraph 71 of the Amended Claim, Sanofi seeks particulars of the damages claimed by Apotex under the Monopolies Acts. As paragraph 71 also states that these damages will be particularized prior to trial in its expert reports, there is no obligation or requirement for Apotex to provide this information now. With respect to Item 150, Apotex confirms that the claim under the Monopolies Acts is as pleaded in the Amended Claim and applies to more than just the 206 Patent.

51Items #221-#222 – With respect to paragraph 18H of Apotex’s Reply, Sanofi requests whether Apotex agrees in listing ramipril patents other than the 206 Patent and commencing proceedings under the relevant regulations, Sanofi had the right to do so under the Patent Act and corresponding regulations. Apotex submits that these Items call for legal opinion and in any event, are disproportionate because Sanofi knows the answer. In my view, Sanofi is requesting Apotex’s legal position, which, as set out above, is relevant and probative. In my view, the most reasonable and proportionate resolution is for Apotex to confirm its legal position, even if this is simply confirming what answer or information it submits that Sanofi already knows or should know.

52Item #233 – With respect to its position that Apotex’s claims in this action are barred by operation of the Limitations Act (Ontario), Sanofi seeks the production of all emails, memos and other exchanges between Apotex and its counsel that relate to when Apotex first learned about the ramipril patents, its course of action and strategies. Sanofi submits that this is relevant to discoverability. Apotex asserts solicitor-client privilege over the documents and communications sought by Sanofi. Sanofi has provided no factual or legal basis for its assertion that these documents should be produced, in particular any legal submissions or factual basis that Apotex has waived privilege. Accordingly, Apotex is not required to produce any of the documentation or information requested.

The Schering Motion

53Given the significant overlap of information and documents sought by Schering and Sanofi, the Defendants coordinated their efforts and submissions on the remaining disputed Items on the Sanofi Motion were made on the Schering Motion. Where applicable, Schering has adopted Sanofi’s Item numbers in its chart, which is reflected below.

54The Schering Motion initially included approximately 51 Items. Schering has withdrawn Items 250, 251, 253, 256, 269, 272, 276, 281, 298, 309, 314, 321 and 331. Schering is not pursuing Items 252, 270, 271, 283-284 on the basis that Apotex has advised that answers have been or will be provided.

55Including some disputed Items from the Sanofi Motion, 20 Items remain in dispute on the Schering Motion and are considered below.

56Items #244, #246-#247, #249 – Schering requests Apotex’s position regarding whether Apotex had no obligation to send the Notice of Allegation regarding the 206 Patent to Schering, together with when Apotex first contemplated sending a Notice of Allegation, any working papers or drafts related to the Notice of Allegation and, if Apotex became aware in 2001 whether Apotex would have been permitted to send a Notice of Allegation. Schering submits that these questions are relevant to whether Schering caused any damages to Apotex as a result of the listing of the 206 Patent given that Schering did not list the 206 Patent and Apotex was not required to send a Notice of Allegation to Schering. Schering also submits that this is relevant to whether Apotex delayed in sending the Notice of Allegation and if it mitigated its damages. In Item 245, Apotex has agreed to answer why the Notice of Allegation was sent when it was and that the law with respect to sending the Notice of Allegation is known to Schering, therefore, any additional information is unnecessary and disproportionate. In my view, given that Apotex has already agreed to answer why the Notice of Allegation was sent when it was, I conclude that the only necessary, relevant and proportionate next step is for Apotex to confirm its position whether it had any obligation to send the Notice of Allegation to Schering. This may lead to questions arising from this answer which can be raised on re-attendance on discovery.

57Items #259-#268 – These Items relate to Apotex’s allegations of misrepresentations under the TM Act and causation as it relates to Schering and the allegations made at paragraphs 72-74 of the Amended Claim. Schering requests that Apotex advise what alleged false representations Schering made given that there must be a link between damages and trademark use, however, Schering did not have a trademark to use, did not use one, did not compete or have any goods. In this regard, Item 262 tracks the wording in s. 7 (d) of the TM Act . The specific information sought relates to whether the 206 Patent was mentioned in the product monograph for ALTACE, the packaging, the marketing materials, whether anyone used the ALTACE trademark, the names of any pharmacists who were told about the association between the 206 Patent and ALTACE products and any information Apotex has that the 206 Patent as mentioned in ALTACE branded products, what trademark was used that caused damages and what damages were caused. Apotex submits, among other things, that its position is as set out in the Amended Claim and refers to the decision of Dunphy J. (paragraphs 35 and 50) confirming what has been pleaded. Apotex has agreed to provide answers to Items 296-297, 299-300 regarding its claim under ss. 7(a) and 7(d) of the TM Act: what specific statements Apotex alleges Schering made that were false and misleading, to whom they were made and if Apotex itself was misled what damages were caused and did it take a course of action that caused it damage. Apotex submits that the additional information sought in Items 259-268 is unnecessary as it is subsumed within Items 296-297 and 299-300. With respect to information not covered by the forthcoming answers, I conclude that the names of any pharmacists who were told about the association between the 206 Patent and the ALTACE products is disproportionate and unnecessary. Further, much of the information sought by Schering is known to them and could be obtained by simply referring to the product monograph, packaging and marketing materials. After Apotex answers Items 296-297 and 299-300, Schering may ask additional questions arising on re-attendance or in writing.

58Item #273 – Schering requests, if Apotex brought an impeachment action pursuant to s. 60 of the Patent Act and succeeded in invalidating the patent, would it would have been open to generic manufacturers other than Apotex to come to market without any impediment caused by the patent. Schering submits that this is relevant to whether Apotex was in fact caused any damages or could have avoided any delay (any party can bring an impeachment action) and to whether or not Apotex made a tactical decision not to seek impeachment. I conclude that this question is not probative of any issues in this action and is not proportionate primarily because Schering asks a question for which it already knows the answer and avoids more proper, direct questions. While there would seem to be more direct questions which Schering could ask with respect to the issues underlying these questions, it has not posed one.

59Item #274 – Schering asks Apotex to advise how many instances it has faced where it has brought a product to market which been taken off the market due an interlocutory injunction. Schering has failed to establish how this question is relevant to any issues in this action and it does not need to be answered.

60Items #285-#292 - All of these Items relate to steps which Schering alleges Apotex could have taken to mitigate its damages. Schering alleges that Apotex could have avoided the delays associated with the PMNOC Regulations by preparing its own NDS, however, chose to proceed under the PMNOC Regulations and rely on Sanofi’s submissions. Therefore, Schering requests that Apotex advise if it could have prepared an NDS in respect of ramipril; if it ever prepares an NDS instead of an ANDS for any of its products; if by preparing an ANDS Apotex is permitted to or gets the benefit of comparing to a marketed product that already has provided extensive data to regulatory authorities for the purposes of approval without the process of submissions or clinical trials and whether this would result in a significant savings to Apotex; whether it chose to take this approach and whether Apotex could have filed an NDS several years before it actually filed its ANDS. Schering argues that these questions are relevant to whether Apotex suffered any damages or could have avoided any delay. Apotex submits that these questions are irrelevant, call for legal opinion and with respect to costs savings, expert opinion.

61I disagree with Apotex that all of these Items are irrelevant or do not need to be answered because they seek Apotex’s legal position (which Apotex again incorrectly conflates with legal “opinion”). However, I conclude that few of these Items are proportionate, largely because the answers are already known to Schering or they do not add anything to information already produced or known to the parties. In my view, what is reasonable and proportionate in the circumstances is for Apotex to advise whether it ever prepares an NDS as opposed to an ANDS with respect to its products and whether preparing an ANDS as opposed to an NDS results in significant savings to Apotex.

62Items #294-#295, #306, #308- These Items also relate to mitigation. Schering requests any documents relating to the development of the plan by Apotex to market Apo-Ramipril and its efforts to prepare the ANDS; any documents that “reflect Apotex’s thinking” as to when to initiate its launch; any plans pre-regulatory filing in terms of product development and post-regulatory filing as to Apotex’s strategy to bring Apo-Ramipril to the market as of a particular launch date; and all of the instances where Apotex has launched a product at risk into the market. Schering submits that these requests are relevant to the timing of when Apotex entered the market in the real world and when it could have entered into the market in the hypothetical world, particularly since Apotex may now take the position that the patent hold date is earlier than pleaded. Apotex submits that these Items are irrelevant and overbroad and that the Federal Court determined in the Section 8 Action that Apotex could have and would have come to market earlier without considering Apotex’s plan to market Apo-Ramipril and the preparation of the ANDS.

63In my view, this request is ambiguous, overbroad and disproportionate with respect to the scope of documents it seeks. In some instances these questions are also irrelevant, particularly insofar as they seek documents that merely “reflect Apotex’s thinking” on its plans and strategies with respect to Apo-Ramipril. Further, Sanofi conducted extensive discoveries during the Section 8 Action on these issues. As with numerous other questions posed by Schering, a narrower, proportionate request may be appropriate, but none has been proposed. I accept that, given the context of this action, speculative questions as they relate to the hypothetical world will be relevant moreso than in other contexts and that just because the Federal Court made certain findings or certain documents were produced in the Previous Proceedings does not on its own preclude further discovery in this action. However, the questions and requests must still be proportionate and relevant, and these ones are not. Schering has also not established that “all instances” in which Apotex launched a product at risk is relevant or proportionate, particularly given that there is no basis to conclude that other products are relevant to this request. Further, the fact is that Apotex did enter the market at risk with Apo-Ramipril. No further steps are required, at this time.

64Item #301 – With respect to paragraph 72A of the Amended Claim, Schering requests any documents, correspondence or communications in which Apotex alleges it was stated that the 206 Patent was valid and enforceable. While I do not accept Apotex’s submission that this question is based on a false premise, as set out above in the Sanofi Motion, Apotex has already agreed to answer Items 160-161 in which it will advise to whom the statements and representations set out at paragraphs 72 and 72A of the Statement of Claim were made and Items 163-166 with respect to the representations referenced in paragraphs 72A and 73 of the Amended Claim including with respect to the issuance of the NOC. Answering these Items is also responsive to Schering’s request in Item 301 and no further efforts are required at this time.

65Item #303- Schering seeks the production of any legal opinions with respect to the validity of the 206 Patent. Schering submits that Apotex has waived solicitor-client privilege, citing Teva Canada Limited v. Eli Lilly Canada Inc. et al 2016 FCC 1131 at para. 18. In Teva, Phelan J. held that the Plaintiff had waived privilege regarding legal opinions which were prima facie privileged by alleging in its pleadings that statements made by the Defendants regarding the validity of a patent were “baseless”. Phelan J. concluded that the existence and content of any legal opinions were relevant to whether the allegations made by the Defendants were “baseless”.

66I reject Schering’s submissions that Apotex has waived solicitor-client privilege over any of its communications. In my view, Teva does not establish a general rule that a party who alleges that a patent is invalid or a position is “baseless” waives privilege over any legal opinions it obtained with respect to that position. Rather, I conclude that Teva is not inconsistent with the law on deemed waiver of privilege as summarized by Perell J. in Creative Career Systems Inc. v. Ontario, 2012 ONSC 649, which requires two elements: i.) the presence or absence of legal advice is material to the lawsuit; and ii.) the party who received the legal advice must make the receipt of it an issue in the claim or defence ( Creative at para. 30). Citing the decision of Corbett J. in Guelph (City) v. Super Blue Box Recycling Corp., [2004] O.J. No. 4468 (S.C.J.), Perell J. states:

“….the deemed waiver occurs as a matter of the party’s choice. Waiver does not occur because the party discloses that he or she received legal advice, nor does it occur because the party admits that he or she relied on the legal advice; it occurs because the party chooses to use the legal advice as a substantive element of his or her claim or defence” ( Creative , at para. 31).”

67In my view, there is no basis to conclude that deemed waiver of privilege has occurred here. Schering has not demonstrated that Apotex has used the receipt of legal advice as a substantive element of their claim, whether by reference to the pleadings, positions taken in the proceedings or otherwise. In any event, given that the 206 Patent was found to be invalid in the Infringement Action, the production of any legal opinions would also be disproportionate and unnecessary. Apotex is not required to produce the documents sought by Schering.

68Item #304 – Schering asks whether the listing of the invalid patent would have also been damaging to other generic manufacturers on the basis that Apotex has claimed for all damages related to delayed generic entry due to the PMNOC Regulations . In my view, Schering has failed to establish the relevance of the potential damage to other generics. Apotex claims only for damages which it incurred, not other generics.

69Item #325 – These Items overlap to some extent with and pick up on Items 72 and 75 from the Sanofi Motion with respect to “trade spend” or professional allowances and rebates paid by Apotex to its customers. Schering submits this as this is the highest cost for generic manufacturers, it comprises the largest portion of Apotex’s claim. Apotex negotiated rebates with pharmacies and retail chains which could exceed 50% of the invoice amount which is therefore relevant to the amount of damages claimed. Given that Apotex’s claim could total $500 million - $1 billion, the amount of its trade spend is a significant amount which may comprise over 50% of its claim. Schering submits that it requires more information than was produced in the Section 8 Action and the Infringement Action regarding how the amounts were attributed to Apotex products during the relevant years. Schering acknowledges that it has received or has access to all of the documents from the Previous Proceedings including the Section 8 Action, and that it has not completed its review of all documents which it has been provided. However, Schering argues that the information it has received, including what it terms the summary document in Production 7, is too high level and that Apotex has produced insufficient information and documents including information regarding its 4-5 major customers. Therefore, Schering requests copies of all communications between Apotex and pharmacies evidencing these payments which Apotex has admitted are entered in its SAP system. Schering cites Eli Lilly Canada Inc. et al v. Teva Canada Ltd., 2015 FC 801 at para. 59 and Eli Lilly Canada Inc. et al v. Teva Canada Ltd., 2017 FC 88 for the proposition that this kind of detailed information is the subject of extensive evidence at trial in support of damage claims. As set out above, it has already been established that Apotex does not retain copies of its agreements regarding rebates once they are entered in the SAP system, even for its 4-5 major customers.

70Apotex submits that it has already produced sufficient information regarding rebates in this action, the Section 8 Action and the Infringement Action, and that it will re-produce every document relevant to rebates from the Previous Proceedings, particularly the Section 8 Action. This includes the information in Production 7 which is approximately 150 pages and sets out rebate levels for every Apotex customer. Apotex also cites the extensive examinations for discovery conducted by the Defendants in this action. Apotex further argues that the fact that Schering is now left asking for communications between Apotex and pharmacies demonstrates that it has received sufficient and significant relevant information. Further, as set out above, the Federal Court already established a reasonable rebate rate for Apo-Ramipril in the Section 8 Action and did so without the documents sought by Schering.

71A consideration of Schering’s request engages a difficult balancing act dictated by the proportionality principles, namely, the balance between large documentary requests requiring significant resources and claims for substantial damages, both of which are at play here. In balancing theses competing factors, I conclude that, notwithstanding the potential amount of damages at issue, requiring Apotex to produce all correspondence with individual pharmacies regarding rebates is overbroad, disproportionate in the effort and time required and would not add much anything, particularly given the documents and information produced in the Previous Proceedings and this action, some of which Schering admits it has not yet reviewed.

72Further, there is some overlap between Schering’s request and Items 72 and 75 from the Sanofi Motion, such that the information I have ordered to be provided by Apotex is partially responsive to Schering’s requests. As set out above, this includes a summary of the professional allowance amounts reported to the Ontario and Quebec governments with any remaining issues or questions arising raised later and the underlying reports may be sought later after the amounts themselves are confirmed. In my view, a similar approach is appropriate with respect to Schering’s request.

73While I agree with Schering that Apotex cannot use the fact of the Previous Proceedings to deny the production of relevant documents in this action, and that there may exist additional relevant documents, this does not negate the application of other factors and considerations particularly proportionality. Similar to Items 72 and 75, until such time as Schering has reviewed all of the productions which have been or will be produced, and asked any additional questions on re-attendance or in writing, no further steps are required. As both Schering and Sanofi submit that the most important rebate information relates to Apotex’s 5 largest customers, I would encourage the parties to focus questions arising and on re-attendance and/or in writing on these 5 major customers.

74Items #326 and #329 – Schering requests any documents related to what product grouping for the purpose of trade spend and rebates (particularly whether it was high level) Apotex was placing Apo-Ramipril in when it was being brought to the market. Schering also seeks a document similar to Production #3 which breaks out the trade spend expense allocated to Apo-Ramipril. As it appears from Apotex’s submissions that this information is already available in Production #3, I am not satisfied that any additional information should be produced at this time until counsel have had a further opportunity to discuss Production #3 and determine what more, if anything, is required.

The Apotex Motion

Generally

75There were initially 95 Items on the Apotex Motion.

76Apotex has withdrawn Items 1, 9, 18 and 20-22 from the Apotex Motion as it relates to SAC. Apotex is not pursuing Item 1 from its motion to compel Sanofi-Aventus Deutschland GmbH and Sanofi-Aventis, and Items 2 and 7 from its motion to compel SAC on the basis that Sanofi has advised that an answer has been or will be provided. Apotex and Sanofi have also resolved Items 13-16 and Apotex is not pursuing Item 19.

77Apotex and Schering have resolved Items 7, 9-13 and 36-66 from the Apotex Motion as it relates to Schering.

78The balance of the Items on the Apotex Motion remain in dispute: 45 in total, which includes 13 with respect to Sanofi and 32 with respect to Schering. These are considered in turn below.

Sanofi Questions

79Items #3-#6 - Apotex seeks to compel the production of additional documents with respect to profits earned from ALTACE, ALTACE HCT and G-Ramipril (the “Sanofi Ramipril Drugs”) prior to 2004. Specifically, Apotex seeks documents similar to the management profit and loss product contribution documents (actual) for 2000-2007; sales productions to the extent these drugs were sold in 2000-2001 and for 2008-2015; standard costs for November 2001 through 2002 and variance documents for 2000 and 2003. The documents sought are all similar to those already produced by Sanofi with respect to other years. Apotex submits that this information is relevant to its claim set out at paragraph 68 of the Amended Claim that upon expiry of the ‘087 Patent, it would have been in a position to bring Apo-Ramipril to market on May 14, 2002. As set out above, Apotex has more recently taken the position with respect to the 206 Patent that it would have received its NOC by November 10, 2003. Sanofi submits that it has produced all documents which are relevant to its profits as defined by the Amended Claim and the patent hold date as found by the Federal Court in the Section 8 Action.

80After discussions between counsel and case management, Apotex advised that it would agree to resolve these Items for production of the relevant documents back to 2002-2003, while Sanofi advised that it would agree to produce documents back to 2003. In my view, based on the parties’ new positions, the Amended Claim and the record, it is reasonable and proportionate that Sanofi produce the documents sought back to the year 2003.

81Item #8 – Similar to Items 3-6, and for many of the same reasons, Apotex seeks Sanofi’s financial statements for 2000-2003 which Apotex submits are relevant and necessary to Apotex’s assessment of SAC’s revenues and expenses. As set out above, Sanofi has altready produced profit and loss statements for and has advised how expenses were allocated to the Sanofi Ramipril Drugs. Between the productions in the Section 8 Action and productions in this action, it appears that Apotex already has the information sought for 2004-2015. In my view, as confirmed by Apotex, the relevant, probative information which it seeks is the allocation of expenses prior to 2004. Therefore, I conclude that it would be disproportionate and unnecessary for Sanofi to produce financial statements, a different form of information, than the allocation information which has already been produced by Sanofi and which Apotex has accepted is responsive. Accordingly, and consistent with my conclusion on Items 3-6, I conclude that it is reasonable and proportionate for Sanofi to produce, to the extent to which it is not covered by Items #3-#6, documentation with respect to overall revenues and the allocation of expenses to the Sanofi Ramipril Drugs for the year 2003.

82Items #10-#12 – Apotex seeks confirmation that Franca Mancino was the SAC employee who was responsible for filing Form IVs to list patents on the Patent Register from 2000-2006, to advise what steps SAC typically took in seeking to list patents and whether SAC followed its usual practice in seeking patent listings for each of the patents set out at paragraph 41 of the Amended Claim. Sanofi has confirmed that Ms. Mancino, SAC’s Director of Regulatory Affairs submitted the Form IVs. Sanofi advises that its position is that it was following a course of action, not that it was a proper or normal course of action. Sanofi submits that its usual practice at the time is not relevant, at most, only the steps with respect to Patent 206 are relevant. In my view, Sanofi’s position is partially responsive. I conclude that a more reasonable, specific and proportionate direction is for Sanofi to advise whether it was following its usual practice at the time, and if so, how it was different.

83Item #16 – At paragraph 44 of its Statement of Defence, Sanofi states that the alleged statements and representations referred to in paragraph 72A of the Amended Claim are privileged, including as statements made in court proceedings. Apotex requests that Sanofi advise if there is any other privilege that Sanofi asserts applies to those alleged statements and representations other than as a statement made in a court proceeding. Sanofi advises that it relies on any privilege legally available in the given circumstances. This lacks specificity. Apotex is entitled to know what privilege Sanofi is asserting, for which statements and representations and on what basis it does so. Sanofi shall advise Apotex accordingly.

84Item #17 – With respect to paragraph 45 of Sanofi’s Statement of Defence, Apotex asks why Sanofi’s statement that Apotex’s alleged consistent and public adoption of a strategy of aggressively pursuing patent litigation is relevant to Sanofi’s denial of the allegations set out at paragraph 73B of the Amended Claim. While there may be a relevant and proper question in this regard, Apotex has not posed one.

85Item #23 – Apotex requests that Sanofi advise regarding the basis for its allegation at paragraph 62 of Sanofi’s Statement of Defence that to the extent the provisions of the TM Act relied upon by Apotex apply to create a liability claim against Sanofi on these facts, they are unconstitutional. It is Sanofi’s position that and that its position is completely set out in its Statement of Defence and that the regulations under the TM Act provide a complete code. In order to clarify, I conclude that Apotex is entitled to know Sanofi’s position regarding the unconstitutionality of the TM Act and Sanofi shall advise Apotex accordingly.

86Items #24-#25 – At paragraph 12 of its Reply, Apotex states that Sanofi actively embarked on a campaign to encourage the Minister regarding Sanofi’s position that the 549 and 387 patents had to be addressed before the Minister issued the NOC. Apotex requests that Sanofi confirm if it had such communications with the Minister and if so, to produce these documents. Sanofi submits that these communications are not relevant given that the material issue is the Minister’s position on the 549 and 387 patents and whether or not Apotex was required to address them and, in any event, if Apotex wishes to advance this position, it should further amend the Amended Claim. What Sanofi’s position ignores is that Sanofi’s Reply forms part part of its pleadings and therefore, Apotex’s allegation that Sanofi embarked on such a campaign is pleaded in this action is relevant. Accordingly, to the extent to which Sanofi communicated with the Minister regarding its position on its position that Apotex should be required to address the 549 and 387 patents, it shall produce these communications and documents.

Schering Questions

87Items #1-#5 – Apotex seeks English translations of certain royalty report documents produced by Schering in German. Schering submits that it has produced royalty statements in English and therefore, Apotex knows the amount of royalty payments, net sales and milestone payments. Schering further submits that it does not intend to rely on these documents at trial and in any event, this information was produced in the Infringement Action. Based on discussions in court, it appears that Apotex narrowed its request to a translation of the breakdown of 1 of 3 pages or 1 document at most.

88In Deutsche Postbank AG v. Kosmayer, 2016 ONSC 7138, Master Brott ordered the translation of 647 documents in German on the basis that translation was consistent with Rule 1.04 and proportionality and would put the parties on a more level playing field. Similarly, I conclude in the present case that, particularly since there is only 1 page or 1 document which requires translation, Rule 1.04 and proportionality dictate that Schering, a large multinational corporation with employees conversant in German like the producing party in Deutsche , provide a translation, to the extent to which the information cannot otherwise be provided.

89Item #6 – Apotex seeks production of a letter dated September 16, 2004 between Schering and Sanofi referred to in Schering Quantification Production 3 which enclosed a report relating to royalties payable by Sanofi to Schering and an explanation of what is being referred to. Schering submits that since the royalties are based on net sales and Apotex has the rate and agreements with respect to the rate, the net sales information and the royalty statements, it does not require the letter. Since the letter refers to royalty payments, it is relevant to disputed issues in this action and being only one document, production is proportionate. Therefore, I conclude that Schering shall produce this letter.

90Item #8 – Apotex seeks production of a copy of the “notice of March 28, 2001” referred to in the letter at Schering Quantification Production 12, which is a number of documents relating to milestone payments from Sanofi to Schering. Apotex submits that this notice is relevant given that it is referred to in one of Schering’s productions. Similar to Item 6, Schering submits that Apotex already has the required documents to calculate milestone payments which will be unaltered by production of this notice. In my view, the notice is referred to in a document already produced by Schering and represents one specific identified document. Therefore, it is a relevant document and it would not be disproportionate for Schering to make best efforts to locate and produce it.

91Items #14-#35 – These Items arise from Apotex’s allegations in the Amended Claim that Schering, as the patent holder, agreed, authorized, assisted and cooperated with Sanofi with respect to, among other things, commencing the Prohibition Proceedings and therefore is jointly and severally liable with Sanofi. Other than Items 14-15, these all relate to Schering’s assertion of privilege over the information and documentation sought by Apotex.

92In Item 14, Apotex asks if Schering consulted with Sanofi on all responses and amendments prior to the submission of the 206 Patent to the Canadian Patent Office in accordance with Article 9 of the agreement at Confidential Schering Liability Production 43 and if so, when, with who and any related documentation. Schering has confirmed its position that it complied with all obligations under the agreement including Article 9 and since Apotex has the documentation related to the Prohibition Proceedings demonstrating Sanofi’s involvement, no further information should be required. Having reviewed the record, considered counsel’s submissions and reviewed Article 9 of the agreement in question, I am satisfied that Sanofi’s confirmation of its position, together with documents already produced, is responsive to this request by Apotex and no further steps are required at this time.

93Schering has already answered Item 15 by confirming that it did not prepare the Form IVs and does not know which of SAC or another Sanofi entity did. No further efforts are required.

94Items 16-35 relate to information and documentation regarding Schering’s alleged direction, permission, agreement, coordination and communications with Sanofi and/or its counsel with respect to the listing of the 206 Patent, the NOA, the Prohibition Proceedings, the Infringement Action and the Section 8 Action. Schering asserts common interest privilege and/or solicitor-client privilege over all of the information and documentation requested. Given my disposition below, I will not itemize all of the information and documentation requested by Apotex or the various positions taken by Schering except to comment that the amount of documentation is substantial and engages multiple complex issues of privilege and relevance. For example, Apotex claims that Schering is not entitled to assert common interest privilege in these circumstances where it was not a party to all of the Previous Proceedings. Schering submits, among other things, that it is entitled to assert both solicitor-client and common interest privilege and in some cases, privilege with respect to the involvement of patent agents also applies.

95Based on the record before me, and the lack of specific, more fulsome factual and legal submissions by the parties, I am unable to consider or make any determinations with respect to whether Schering’s claims of privilege over some or all of the documents and information sought in Items 16-35 are valid. Accordingly, these Items are adjourned sine die without prejudice to Apotex’s right to bring them back before me. If the parties are unable to agree upon productions which would resolve these Items, (including the production of non-privileged documents as I suggested to counsel), they can file additional evidence and proper and more comprehensive written legal submissions and schedule an attendance before me.

III. Order

96Given the substantial number of Items, orders and directions, I have not set out the terms of an Order. Counsel may submit a form of Order for my review and approval through the Masters Administration Office. The parties have advised that they will agree on the timelines for the delivery of all productions and answers which they have agreed upon and which I have ordered and directed above. The Order shall also provide that all materials shall be and remain sealed pursuant to the Protective Order.

97To the extent to which the parties cannot agree on the terms of an Order or require clarification regarding my orders and directions, a telephone case conference may be scheduled for that purpose. One will likely be required in any event to speak to issues related to the publishing of these Reasons and the Protective Order.

98If the parties cannot agree on the costs of these motions, a timetable for written costs submissions can be spoken to during the telephone case conference.