Ottawa, Ontario, March 3, 2020
PRESENT: Case Management Judge Mireille Tabib
BETWEEN:
BAYER INC. and
BAYER INTELLECTUAL PROPERTY GMBH
Plaintiffs
and
APOTEX INC.
Defendant
REASONS FOR ORDER
[1] These reasons are issued in the context of an action for patent infringement brought pursuant to s 6(1) of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133, as amended (the “Regulations”
). In the course of hearing motions to rule on objections to discovery questions, I made a number of rulings on questions seeking “the position”
of the plaintiffs (“Bayer”
) on issues raised in the action. I upheld most of Bayer’s objections, on the basis that the questions improperly sought opinions or particulars of pleadings. I gave brief reasons at the hearing, but indicated that I would issue detailed reasons at a later date. The following are those reasons.
I. THE PROCEDURAL CONTEXT
[2] The common issues of the refusals motion were heard concurrently with similar motions in three other actions commenced pursuant to s 6(1) of the Regulations (Bayer Inc et al v Teva Canada Ltd, T-1960-18, Bayer Inc et al v Taro Pharmaceuticals Inc, T-435-19 and Bayer Inc et al v Sandoz Canada Inc, T-806-19). These reasons apply to all four motions and a copy will be placed on each file.
[3] Bayer alleges that the four defendant pharmaceutical manufacturers, who intend to market generic versions of its rivaroxaban product, will infringe the same two patents listed against Bayer’s product, namely, Canadian Patent 2,823,159, claiming a composition of amorphous rivaroxaban, and Canadian Patent 2,547,113, claiming a medicine containing rivaroxaban in hydrophilized form. In response, all four defendants have alleged that Bayer’s asserted patents are invalid on a variety of grounds, including obviousness, overbreadth, insufficiency of disclosure and lack of utility.
[4] By orders dated February 14, 2019 and August 1, 2019 (reported at 2019 FC 191 and 2019 FC 1039, respectively), the Court ordered that the common invalidity issues for all four actions proceed to a common trial, while the infringement issues would be tried in subsequent, individual hearings. The parties then cooperated in conducting joint discoveries of the inventors and of Bayer’s Canadian and German representatives on common invalidity issues. The common discovery of Bayer’s representatives lasted four days. Each of the generics then separately examined Bayer’s representatives on issues relating to infringement. Bayer commendably allowed its representatives to answer most questions under reserve of objections pursuant to Rule 95(2) of the Federal Courts Rules when the representative or counsel were in a position to do so.
[5] The majority of the hundreds of objections presented to the Court for determination were accordingly requests for production of further documents or for further inquiries to be made on issues of objective facts. I have ruled on those questions from the bench at the hearing in summary form and the parties have been instructed to include those rulings in joint draft orders.
II. THE OBJECTIONS
[6] The objections to which the present reasons relate are of a different kind. They can generally be described as questions relating to Bayer’s “position”
in respect of such matters as: patent construction, the inventive steps, the patents’ utility, the knowledge of the person skilled in the art, etc. Over 30 such questions were specifically addressed at the hearing. Many more were included in the refusals charts, but they either became moot when Bayer advised that it was no longer asserting one of the three patents originally pleaded, or were resolved between the parties in the course of the hearing. The questions to which these reasons relate, together with the determinations made on each one, are set out in Annex “A”
to these reasons.
[7] The formulation of the questions vary. Some ask to advise in what way Bayer asserts that particular paragraphs of the defence contain mischaracterizations or incomplete statements of the patents, of the prior art or of certain documents. Some ask what facts underlie or relate to Bayer’s denial of certain allegations of the statement of defence. In addition to denying invalidity allegations of the statement of defence, Bayer also made certain positive assertions of a general nature, such as that “a person of skill in the art would have been able to practice the invention without undue effort or prolonged experimentation”
, that utility was “soundly predicted”
, that the invention was the result of “arduous, non-routine work”
by the inventors, that the inventors demonstrated “inventive ingenuity”
. Some of the questions that are the subject of objections ask what facts underlie or relate to those general assertions. Other questions seek particulars of these general statements, such as what utility is referred to, what Bayer asserts is the practical use of the invention, what Bayer says is the arduous, non-routine work, what Bayer says is the inventive step, or what Bayer asserts was the sound line of reasoning.
[8] Most, if not all of these questions, as formulated, refer directly to Bayer’s Reply. In many cases, they also directly refer to the paragraphs of the Statements of Defence that Bayer denied. In all cases, it is plain, and counsel for the defendants freely admitted that what the defendants were seeking with the questions was the position that Bayer intends to adopt on these issues; essentially, what Bayer intends to argue at trial. It should be emphasized here that the vast majority of the questions at issue do not seek the communication of new documents or to elicit objective facts that might be within Bayer’s information, knowledge or belief. After such lengthy and thorough examinations, including the examination of the inventors, it is clear that all objective facts have been communicated, including Bayer’s and the inventors’ information, knowledge or belief as to these facts. What the defendants seek to elicit by those questions is how Bayer, through its counsel and experts, intends to interpret or put together these facts at trial to prove or argue that the patents are valid.
[9] Counsel for the defendants very candidly admitted that the questions were in large part driven by the defendants’ frustration with the lack of particularity of Bayer’s pleadings, especially given the quantity of intricate details the defendants consider they have provided in their statements of defence as to their theory of the case. The defendants submit that answers to these questions are necessary to allow them to know the case they need to meet at trial and not be taken by surprise.
III. THE DEFENDANTS’ ARGUMENTS
[10] Counsel for Apotex – who presented the case for the defendants at the hearing on those specific questions – forcefully argued that it was proper for the defendants to seek information as to Bayer’s position on issues raised in the pleadings by way of discovery questions. Counsel referred to the following cases in support of its arguments:
[11] Apotex Inc v Bristol-Myers Squibb Canada Co 2019 FCA 194. The Federal Court of Appeal in that case dismissed an appeal from the rulings of a Prothonotary, refusing to compel answers to discovery questions seeking “details regarding allegations in the respondents’ amended reply”
. The Court of Appeal wrote, at para 8:
In saying this, we might not have exercised our discretion in the same way as the Prothonotary. In most circumstances, early disclosure of facts, evidence and positions advances the efficiency of the proceedings.
(Emphasis added)
[12] The defendants interpret that case as confirming that it is appropriate to seek, on discovery, details of an opponent’s pleadings and its “positions”
on the issues.
[13] Montana Band v R 1999 CanLII 9366 (FCTTD), [2000] 1 FC 267, and particularly, paragraphs 5, 27 and 28, which read as follows:
5 The general purpose of examination for discovery is to render the trial process fairer and more efficient by allowing each party to inform itself fully prior to trial of the precise nature of all other parties' positions so as to define fully the issues between them. It is in the interest of justice that each party should be as well informed as possible about the positions of the other parties and should not be put at a disadvantage by being taken by surprise at trial. It is sound policy for the Court to adopt a liberal approach to the scope of questioning on discovery since any error on the side of allowing questions may always be corrected by the trial judge who retains the ultimate mastery over all matters relating to admissibility of evidence; on the other hand, any error which unduly restricts the scope of discovery may lead to serious problems or even injustice at trial.
27 In my view, the proper approach is to be flexible. Clearly the kinds of questions which were aptly criticized in Can-Air, supra note 5 can easily become abusive. On the other hand, a too rigid adherence to the rules therein laid down is likely to frustrate the very purpose of examination on discovery. While it is not proper to ask a witness what evidence he or she has to support an allegation, it seems to me to be quite a different thing to ask what facts are known to the party being discovered which underlie a particular allegation in the pleadings. While the answer may have a certain element of law in it, it remains in essence a question of fact. Questions of this sort may be essential to a discovery for the purposes of properly defining the issues and avoiding surprise; if the pleadings do not state the facts upon which an allegation is based then the party in whose name that pleading is filed may be required to do so.
28 Likewise, while the jurisprudence is divided on the point, it is my view that it is proper on discovery (although it may not be so at trial) to ask a party as to the facts underlying a particular conclusion of law; questions of this sort on discovery are essential for the purposes of properly defining the issues and avoiding surprise. Again, it is central to remember that the deponent speaks not for him or herself but for the party.
(Emphasis added)
[14] Counsel for the defendants argued that the questions they have asked are therefore permissible, as they are precisely the kind of questions seeking the facts underlying particular conclusions of law found in the pleadings.
[15] Finally, the defendants referred the Court to A. Pellerin & Fils Ltée v Entreprises Denis Daveau Inc. (1997) 1997 CanLII 4917 (FCTTD), 133 FTR 164, 77 CPR (3d) 217, particularly at paras 19-20, in which the Court ruled proper four questions asking whether various aspects of patent claims were “an essential element of the invention”. The defendants therefore argue that those questions that seek Bayer’s understanding of what is the invention and what are the inventive elements are proper.
[16] The defendants appeared to concede that the information they seek could also have been the subject of requests for particulars. However, they argued that requiring parties to bring motions for particulars is inefficient and contrary to the principles of proportionality and of promoting the just, most expeditious and least expensive determination of the issues embodied in Rule 3 of the Federal Courts Rules, especially in the context of fast track proceedings under the Regulations.
IV. ANALYSIS
A. The Case Law
[17] The defendants’ reliance on Montana Band and on Bristol-Myers Squibb focuses on dicta that describe obtaining “the position” of the parties as a valid purpose of discovery, and on the fact that the questions at issue appeared to seek “details” or “particulars” of pleadings. From there, the defendants leap to the conclusion that discovery questions that seek particulars of an opponent’s pleadings, or its position on an issue that is clearly raised in the pleadings, are always appropriate. The case of Pellerin is held up as a case in point.
[18] What the defendants’ arguments ignore is that both Montana Band and Pellerin expressly recognized and applied the jurisprudential rule that questions seeking expert opinion or opinions of law are, and have always been, improper. Both of these cases exemplify the principle that where objections are based on the alleged impropriety of a question (as opposed to its relevance), the Court’s task is to determine whether the question properly seeks the party’s information, knowledge or belief of a fact, or improperly asks the witness to provide an expert opinion or an opinion of law. As mentioned at paragraph 23 of Montana Band:
There is of course no question that examination on discovery is designed to deal with matters of fact. “Pure” questions of law are obviously an improper matter to put to a deponent. It is likewise with argumentative questions and questions which ask a party to state what evidence it proposes to lead at trial. But the line is rarely clear or easy to draw. Questions may mix fact and law or fact and argument; they may require the deponent to name a witness; they may still be proper. So too, questions relating to facts which may have legal consequences or which may themselves be the consequence of the adoption of a certain view of the law are nonetheless questions of fact and may be put on discovery.
(Emphasis added)
[19] Whenever this Court has held disputed questions to be proper despite the fact that they might to some degree depend on legal conclusions, opinions or technical knowledge, it has consistently done so on the basis that the questions fundamentally sought the communication of relevant facts. Relevant facts, in the cases referred to by the defendants, included the institutional understanding of the party’s own document (Montana Band, para 19); institutional knowledge of historical facts (Montana Band, paras 18 and 20); the factual basis upon which decisions were made (Montana Band, para 29); the party’s belief as to the substance of its own invention, as a matter of fact (Pellerin, paras 19 and 20); and the witness’ understanding of technical terms (Pellerin, paras 29-30). The Court notes here that the specific questions at issue in Bristol-Myers Squibb are not set out in the reasons and that the case appears to have been argued on the basis of relevance rather than on whether the questions were proper.
[20] Conversely, the Court in Montana Band held that questions seeking the legal basis for certain decisions, and questions seeking admissions of law, were improper (para 30). In Pellerin, questions seeking to clarify the innovative nature of an invention, even if clearly based on the pleadings, was also held to be improper as seeking expert opinion (paras 25 to 27).
[21] The well-established principle is that expert opinion and questions of law are not proper subjects for discovery and that, when drawing the line between what is proper or not, the Court should consider the importance or predominance of the factual component. This was recognized as a clear and accepted position of law inApotex Inc. v Pharmascience Inc. 2004 FC 1198, at paras 19 and 20. It was discussed at length in Bard Peripheral Vascular Inc. v WL Gore & Associates Inc 2015 FC 1176 at paras 38 to 41, and it was specifically applied by the Federal Court of Appeal in Eurocopter v Bell Helicopter Textron Canada Ltd 2010 FCA 142.
[22] It cannot be thought that the Federal Court of Appeal intended, in Bristol-Myers Squibb, to alter the well-settled law on this issue merely by remarking on the beneficial effect of early disclosure of “facts, evidence and positions”. The Court further notes that it has specifically been stated, in the case of Sperry Corp. v John Deere Ltd (1984) CPR (2d) 1 (FC) at para 52 (followed in Phillips Export BV v Windmere Consumer Products Inc. (1986) 1986 CanLII 7747 (FCTTD), 8 CPR (3d) 505, at para 26), that a party “is not obliged to answer questions as to its position”.
[23] The early disclosure of facts, evidence and positions is undisputedly desirable. However, it is also necessary to ensure that examinations for discovery are properly used for the purpose of communicating relevant facts, rather than seeking advance disclosure of an opponent’s expert reports or legal arguments. These imperatives are not incompatible; they can be reconciled by understanding that the Federal Courts Rules provide different procedural mechanisms for disclosure, including examinations for discovery and requests for particulars, which are distinct and governed by different rules.
[24] The distinction between the two was clearly made and applied in Samson Indian Nation & Band v Canada 2001 FCT 765. The Court was seized in that case with a motion to compel answers to discovery questions as well as two other motions seeking further and better particulars. The Court characterized these motions, at para 1, as “various means to obtain information in regard to the respective cases [the Crown] has to meet in light of the pleadings”. The Court went on to explain, at para 6:
The defendants rely on the modern approach to disclosure and the Crown's entitlement to know the case it has to meet at trial. Disclosure by pleadings, by particulars, by written examination or by oral examination for discovery is intended by the Court's rules to ensure the parties are aware of the case each hopes to establish and the other party is to meet, to clarify the issues on which the parties differ, to enhance the possibility of settlement of some or all issues, and for issues that do go to trial, to avoid surprise and to permit efficient use of time by counsel and the Court.
[25] The Court then conducted a review of the case law discussing the divide between fact and law and what is appropriate or not on discovery. The Court then summarizes the issues before it on the discovery motion, as follows (para 11):
A general objection to the defendants' motion as it applies to many questions at issue is that the questions are improper in discovery, in form or wording, for they seek particulars regarding the plaintiffs' pleadings. It is urged that particulars, or further particulars, be sought by written demands. That is urged particularly in this case where the plaintiffs' representatives in discovery were not personally responsible for pleadings and could only be expected to respond after consulting counsel. The defendants urge that they simply seek information to which they are entitled in order to prepare a defence. In view of the unusual arrangements for trial to commence before discoveries of the whole case are completed, that information should be provided in any way possible. The plaintiffs urge that questions in discovery, demands for particulars and written interrogatories, though they may serve the same general purposes, are well-established processes and are not interchangeable.
(Emphasis added)
[26] The Court then ruled, at paragraphs 13 and 20, that those questions “that relate to particulars sought in relation to the plaintiffs’ amended statement of claim” and those that “seek information about matters underlying the plaintiffs’ pleadings, matters ordinarily pursued by demand for particulars, and matters that, in the circumstances, cannot be expected to be known [by the deponent]” are “inappropriate in discovery”.
[27] Samson Indian Band underscores the distinction to be made between what can properly be asked on discovery and what should instead be sought by way of particulars. Questions that seek to elicit facts are appropriate on discovery. Those that seek to elicit opinion, including particulars of what pleadings mean and what is intended to be argued at trial, are not proper discovery questions and should instead be pursued by way of requests for particulars.
[28] In the course of the hearing in this matter, the Court engaged in a protracted exercise of examining each question to determine whether, notwithstanding its apparent formulation, it essentially sought the communication of facts – even if the identification of those facts might be informed by the party’s own understanding of the facts alleged in the pleadings – and those which probed the meaning, intent or scope of the pleadings, or the position Bayer intended to take on issues of mixed fact and law or expert opinion. The former were ordered to be answered insofar as Bayer had information knowledge or belief of any objective fact, other than matters of expert opinion. The latter were held to be inappropriate as seeking opinions of expertise or law that should more properly be sought by way of particulars.
[29] Of the questions to which these reasons relate, 28 were held to be improper and 10 were found to be predominantly factual and ordered to be answered on a factual basis. As mentioned, the individual rulings are set out in Annexe “A” to these reasons.
[30] The Court very much doubts, however, that it was time well spent to review each question, referring back to pleadings that run to several hundreds of paragraphs, to identify and compel answers that could be considered predominantly factual. From the defendants’ point of view, those were undoubtedly Pyrrhic victories. It was already quite apparent that, to the extent Bayer was in possession of technical or scientific data, information, knowledge or belief relevant to the proceedings, it had already shared or undertaken to share it, and that the defendants’ intention was very much to elicit admissions on issues of expert opinions and Bayer’s positions on the pleadings. That, the defendants did not obtain.
B. The Efficiency Argument
[31] As mentioned earlier, the defendants submit that it is inefficient to require parties to seek clarification of their opponent’s pleadings and positions on the issues by way of motions for particulars. However, this is not simply a matter of case management or of dispensing a party from compliance with the Rules. As set out in the analysis above, the law on the issue is settled and binding. The permitted scope of an examination for discovery is limited to facts, and questions seeking an opinion are not proper or permitted.
[32] Even if I am wrong and would have discretion to compel answers to questions seeking opinions (including particulars of pleadings that are not predominantly factual), I am not satisfied that doing so would, in this case or generally, achieve the just, most expeditious and least expensive determination of issues.
[33] The questions at issue are suffused with complex conclusions of scientific opinion and law. As mentioned, they are not within a party’s ability to answer without the assistance of experts and counsel. It is unrealistic to believe that such questions, if answered on discovery or as undertakings, could be held or used against the party at trial as an admission. As Apotex itself recognized in Bristol-Myers Squibb, above, such questions should be answered “subject to expert opinion”.
[34] On the other hand, particulars, whether provided in answer to an informal request or ordered pursuant to a motion, are binding on the parties as if they were pleadings. This equally applies to allegations that are informed by a party’s understanding of the applicable law, and allegations that pertain predominantly to complex conclusions of scientific facts that would require proof by expert opinion.
[35] Particulars, like pleadings, can only be amended with leave of the Court. This is not so with answers to discovery questions. Pursuant to Rule 245, answers given on discovery may be corrected as soon as the person discovers that the answer is no longer correct or complete. Thus, an answer provided on discovery expressing an expert or legal opinion is always subject to be corrected or completed upon obtaining a further, better or divergent opinion. Further, unlike pleadings or particulars, the probative value and binding nature of such discovery answers as “admissions”
are subject to challenge at trial, giving rise to arguments and debate that disrupt, rather than assist, the expeditious trial of issues.
[36] Finally, one cannot think how it might be felt efficient to read into a discovery transcript a laundry list of prepared questions seeking particulars of pleadings or expert opinion. Answers to such questions must generally be mediated by lawyers and experts, even where a party agrees to answer them, and will therefore generally be provided as answers to undertakings after discovery. There is no good reason to force a party’s representative to sit through the reading of such questions when that could be done just as easily by way of informal request for particulars.
[37] To the extent, therefore, that what a party truly desires is certainty as to the case it has to meet and a narrowing of the issues, discovery questions seeking “the position”
of its opponent are not the appropriate tool. Using the discovery process is not as effective or efficient in achieving that goal as a request for particulars.
[38] Counsel’s arguments at the hearing at times appeared to reflect a common misconception amongst members of the bar to the effect that motions for particulars are seldom granted by the Court and that a party loses the right to obtain particulars as soon as it has pleaded over. That belief is correct only insofar as it applies to requests for particulars for the purpose of pleading. However, it has long been recognized that particulars may be sought at different times in the course of a proceeding, and that at each stage, they serve different needs and their availability obey different criteria.
[39] A good overview of the jurisprudence and summary of the applicable law can be found in Coe Newnes/McGehee ULC v Valley Machinery Works Ltd 2005 FC 685, at para 5 to 8. It is sufficient for the purpose of the present discussion to note that particulars are typically ordered either at an early stage, before pleadings are closed, or much later, after discoveries are complete and in preparation for trial. Particulars for pleadings are typically much narrower and are limited to what the requesting party needs in order to plead intelligently. Particulars for trial, on the other hand, are ordered precisely to perfect a party’s understanding of the case for trial, to narrow issues and for “picking up loose ends which may have been left over from discovery of documents and examinations for discovery”
(CAT Production Ltd v Macedo (1984) 1984 CanLII 5844 (FCTTD), 1 CPR (3d) 517, at para 520). In between these two stages, and while it is unusual, the Court nevertheless retains discretion to order that particulars be provided before or during discoveries, where necessary.
[40] These reasons should not be taken as inviting the defendants to now bring a motion for particulars for trial, or as a determination that the questions at issue are proper as requests for particulars. Indeed, it seems to the Court that the answer to most, if not all of the defendants’ questions will be found in Bayer’s final claims construction chart, due March 17, 2020 and in its expert reports. The current schedule requires expert reports in chief to be delivered by March 31, 2020 and in response, by June 19, 2020, thus well before the September 2020 start of the trial. If, at that time, the defendants still feel that particulars are needed in order to prepare for trial, there will be ample time left to request them.
"Mireille Tabib"
Prothonotary
ANNEX A
REFUSALS FROM DISCOVERY OF VENESSA COCUZZOLI HELD SEPTEMBER 9-10, 2019
CATEGORY 2
Item No. 27: To advise in what way or ways Bayer asserts that Apotex’s characterization of the 113 Patent and its claims and their terms in each of paragraphs 23-33 and 35-75 of Apotex’s Statement of Defence is not complete (see paragraph 17 of Bayer’s Reply). – Ruled improper
Item No. 28: To advise in what way or ways Bayer asserts that Apotex’s characterization of the 113 Patent and its claims and their terms in each of paragraphs 23-33 and 35-75 of Apotex’s Statement of Defence is not accurate (see also paragraph 17 of Bayer’s Reply). – Ruled improper
Item No. 29: To advise in what way or ways Bayer asserts that Apotex has selectively paraphrased from the 113 Patent in each of paragraphs 23-33 and 35-75 of Apotex’s Statement of Defence (see paragraph 17 of Bayer’s Reply in T-2093-18). – Ruled improper
Item No. 30: To advise in what way or ways Bayer asserts that Apotex has used erroneous paraphrasing from the 113 Patent in each of paragraphs 23-33 and 35-75 of Apotex’s Statement of Defence (see paragraph 17 of Bayer’s Reply in T-2093-18). – Ruled improper
Item No. 31: To advise in what way Bayer asserts that Apotex has provided a construction of the 113 Patent that is inconsistent with the language of the Patent as construed by a person of ordinary skill in the art (see paragraph 17 of Bayer’s Reply in T-2093-18). – Ruled improper
Item No. 32: To advise in what way Bayer asserts that Apotex has paraphrased the 113 Patent in a manner that is inconsistent with the language of the Patent as construed by a person of ordinary skill in the art (see paragraph 17 of Bayer’s Reply in T-2093-18). – Ruled improper
Item No. 33: To advise in what way Bayer asserts that Apotex has used erroneous language to characterize Apotex’s construction of the 113 Patent as referenced in paragraph 18 of Bayer’s Reply in T-2093-18. – Ruled improper
Item No. 34: To advise what clear and definite meaning Bayer is referring to in paragraph 18 of its Reply where it asserts that the claims of the 113 Patent have a clear and definite meaning that would be understood by the person of ordinary skill in the art at the relevant time. – Ruled improper
Item No. 51: To identify the specific facts that relate to Bayer’s denial of Apotex’s allegations in paragraphs 190-192 and 194-202 of its Statement of Defence [paragraphs 22-24 of Appendix “A”
of the Fresh as Amended Defences as limited in paragraph 6 of Appendix “A”
of Bayer’s Fresh as Amended Replies] (see paragraph 31 of Bayer’s Reply [paragraph 6 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
CATEGORY 3
Item No. 123: To advise what facts relate to Bayer’s denial in paragraph 59 of Bayer’s Reply [paragraph 36 of Appendix “A”
of Bayer’s Fresh as Amended Replies]. – Ruled improper
Item No. 175: To advise in what ways Bayer asserts that Apotex has mischaracterized the prior art and common general knowledge (see paragraph 91 of Bayer’s Reply [paragraph 56 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 235: To advise what facts underlie Bayer’s denial of the allegations set out in paragraphs 432, 433 and 436 of Apotex’s Statement of Defence [paragraphs 279, 280 and 283 of Appendix “A”
of the Fresh as Amended Defences] (see paragraph 113 of Bayer’s Reply [paragraph 78 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
CATEGORY 5
Item No. 56: To advise what the subsequent data is that Bayer asserts could be used to modify the Benke Declaration apart from the 2017 dog studies (see paragraph 32 of Bayer’s Reply [paragraph 7 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). - Ruled proper as seeking data, answer provided at the hearing to be confirmed.
Item No. 59: To advise what conclusions arising from the Benke Declaration Bayer asserts require further context and data (see paragraph 32 of Bayer’s Reply [paragraph 7 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 61: If there is further data, other than the 2017 dog studies, that Bayer is asserting is required in paragraph 32 of its Reply [paragraph 7 of Appendix “A”
of Bayer’s Fresh as Amended Replies], to advise what that further data is. – Ruled proper as seeking data.
Item No. 69: To advise whether Bayer has any knowledge, information or belief as to why Dr. Benke was not able to practise the invention of the 113 Patent using a mixer granulated composition as he describes in his Declaration. – Ruled proper as seeking factual information, knowledge and belief as to why mixer granulation yielded the results observed. Does not imply agreement with the interpretation of the Declaration.
Item No. 96: To advise whether, in making the denials in paragraph 43 of Bayer’s Reply [paragraph 19 of Appendix “A”
of Bayer’s Fresh as Amended Replies], Bayer is asserting that the tablets prepared by mixer granulation discussed in the Benke Declaration are not comprised of rivaroxaban in hydrophilized form. – Ruled proper as seeking whether the denial is factually based on Bayer’s information, knowledge or belief as to what, factually, the tablets contained.
CATEGORY 6
Item No. 62: To advise whether there are specific facts that underlie Bayer’s denial of Apotex’s allegations in paragraphs 210-213 of the Statement of Defence [paragraphs 32-35 of Appendix “A”
of the Fresh as Amended Defences] (see paragraph 33 of Bayer’s Reply [paragraph 8 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 67: To advise what facts underlie Bayer’s assertion in paragraph 34 of its Reply [paragraph 9 of Appendix “A”
of Bayer’s Fresh as Amended Replies] that a person of ordinary skill in the art would be able to practise the invention of the 113 Patent without undue effort or prolonged experimentation. – Ruled proper to the extent it seeks actual facts of which Bayer might be aware that are relevant to that assertion; for example if Bayer is aware of a person whom it believes is a person of skill in the art who attempted to follow the Patent, that fact and the result of the attempt are relevant facts. Bayer is not required to provide an opinion or to identify facts already communicated upon which an expert might reach an opinion.
CATEGORY 7
Item No. 90: To advise what utility Bayer is referring to in paragraph 42 of its Reply [paragraph 18 of Appendix “A”
of Bayer’s Fresh as Amended Replies]. – Ruled improper
Item No. 91: To advise what aspect or aspects of the utility Bayer asserts was demonstrated as of the Canadian filing date (see paragraph 42 of Bayer’s Reply [paragraph 18 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – An undertaking was given and is to be answered.
Item No. 92: To advise what aspect or aspects of the utility Bayer asserts was soundly predicted as of the Canadian filing date (see paragraph 42 of Bayer’s Reply [paragraph 18 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – An undertaking was given and is to be answered.
Item No. 93: To advise as to the factual basis or bases for any sound prediction and the line of reasoning for any prediction of utility made (see paragraph 42 of Bayer’s Reply [paragraph 18 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled proper as seeking facts, to be answered to the extent an identifiable reasoning was made.
Item No. 95: To advise whether Bayer is asserting that the utility of the claimed subject matter is the use of compositions containing rivaroxaban in hydrophilized form in the prophylaxis or treatment of thromboembolic diseases (see paragraph 43 of Bayer’s Reply [paragraph 19 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 98: To advise what Bayer asserts is the relevant and/or practical use for the subject matter of the claims of the 113 Patent. – Ruled improper
Item No. 99: To advise whether, in paragraph 44 of Bayer’s Reply [paragraph 20 of Appendix “A”
of Bayer’s Fresh as Amended Replies] Bayer is asserting that in the within litigation the relevant and or practical utility of the subject matter of the claims of the 113 Patent is anything other than providing improved absorption behaviour and significant increase in bioavailability. – Ruled improper
Item No. 100: to advise what aspect of the factual basis and sound line of reasoning Bayer asserts would have been part of the skilled person’s common general knowledge (see paragraph 45 of Bayer’s Reply [paragraph 21 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 125: to advise what Bayer’s knowledge, information and belief is regarding the inventive concepts and/or subject matter of the asserted claims of the 113 Patent (see paragraph 60 of Bayer’s Reply [paragraph 37 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
CATEGORY 8
Item No. 112: To advise what precisely Bayer says is the arduous and non-routine experimentation that Bayer conducted to arrive at the claimed invention (see paragraph 56 of Bayer’s Reply [paragraph 33 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 132: To advise what Bayer asserts is the inventive step of the asserted claims of the 113 Patent. – Ruled improper
Item No. 134: To advise what facts underlie Bayer’s denial of Apotex’s allegations at paragraphs 310, 319, 320 and 325-337 of the Statement of Defence [paragraphs 137, 147, 148 and 153-165 of Appendix “A”
of the Fresh as Amended Defences] (see paragraph 62 of Bayer’s Reply [paragraph 39 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 135: To advise what Bayer’s knowledge, information and belief is regarding the difference between the state-of-the-art and the inventive concept and/or subject matter of the claims of the 113 Patent (see paragraph 62 of Bayer’s Reply [paragraph 39 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 139: To advise what Bayer’s knowledge, information or belief is as to why preformulation studies that would be conducted by the skilled person for rivaroxaban would not include the determination of rivaroxaban’s solubility and rate of dissolution (see paragraph 62 of Bayer’s Reply [paragraph 39 of Appendix “A”
of Bayer’s Fresh as Amended Replies] and paragraph 326 of Apotex’s Statement of Defence [paragraph 154 of Appendix “A”
of the Fresh as Amended Defences]). – Ruled improper
Item No. 140: To advise what Bayer’s knowledge, information and belief or understanding is as to why the skilled person would not use known techniques to increase the dissolution rate of solubility of rivaroxaban upon learning of rivaroxaban’s poor water solubility (see paragraph 62 of Bayer’s Reply [paragraph 39 of Appendix “A”
of Bayer’s Fresh as Amended Replies] and paragraph 326 of Apotex’s Statement of Defence [paragraph 154 of Appendix “A”
of the Fresh as Amended Defences]). – Ruled improper
CATEGORY 9
Item No. 144: To the extent that Bayer has information, knowledge or belief as to why the preparation of rivaroxaban in hydrophilized form would not occur as the inevitable result of preparing a composition of rivaroxaban by wet granulation, then Bayer will advise (see paragraph 62 of Bayer’s Reply [paragraph 39 of Appendix “A”
of Bayer’s Fresh as Amended Replies] and paragraph 329 of Apotex’s Statement of Defence [paragraph 157 of Appendix “A”
of the Fresh as Amended Defences]) – Ruled proper as seeking facts
CATEGORY 14
Item No. 248: To advise in what way Bayer says that Apotex has mischaracterized claim 4 of the 159 Patent and claim 5 of the 310 Patent (see paragraph 138 of Bayer’s Reply [paragraph 95 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
CATEGORY 15
Item No. 252: To advise what Bayer’s knowledge, information and belief is regarding whether and how the amorphous rivaroxaban described in the 940 Application differs from the amorphous rivaroxaban described in the 159 Patent (see paragraph 141 of Bayer’s Reply [paragraph 98 of Appendix “A”
of Bayer’s Fresh as Amended Replies]). – Ruled improper
Item No. 253: To advise what Bayer’s knowledge, information and belief is as to why the amorphization process described in the 940 Application will not lead to the subject matter of the 159 Patent (see paragraph 141 of Bayer’s Reply [paragraph 98 of Appendix “A”
of Bayer’s Fresh as Amended Replies]) – Ruled proper and to be answered insofar as Bayer has facts and data, other than expert opinion prepared for this litigation, that it knows or believes provides an answer to this question. Bayer is not required to identify within the information already provided, information from which an expert might be able to form an opinion
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET:
T-2093-18
STYLE OF CAUSE:
BAYER INC. AND BAYER INTELLECTUAL PROPERTY GMBH v APOTEX INC.
PLACE OF HEARING:
Ottawa, Ontario
DATE OF HEARING:
January 8-10, 2020
ORDER AND REASONS:
TABIB P.
DATED:
march 3, 2020
APPEARANCES:
RYAN STEEVES BENJAMIN PEARSON WILLIAM FOSTER
For The PLAINTIFFS
SANDON SHOGILEV
For The DEFENDANT APOTEX INC.
FAYLENE LUNN
For The Defendant tEVA CANADA LIMITED (T-1960-18)
BEN WALLWORK
For The Defendant TARO PHARMACEUTICALS INC. (T-435-19)
CAROL HITCHMAN KELLY MCCLELLAN
For The Defendant SANDOZ CANADA INC. (T-806-19)
SOLICITORS OF RECORD:
GOWLING WLG Barristers and Solicitors Ottawa, Ontario
For The PLAINTIFFS
GOODMANS LLP Barristers and Solicitors Toronto, Ontario
For The DEFENDANT APOTEX INC.
OSLER, HOSKIN & HARCOURT LLP Barristers and Solicitors Ottawa, Ontario
For The Defendant TEVA CANADA LIMITED
FINEBERG RAMAMOORTHY LLP Barristers and Solicitors Toronto, Ontario
For The Defendant TARO PHARMACEUTICALS INC.
SPRIGINGS Barristers and Solicitors Toronto, Ontario
For The Defendant SANDOZ CANADA INC.