BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG v. BOEHRINGER INGELHEIM INTERNATIONAL GMBH, 2023 FC 584

Date: April 21, 2023 Docket: T-15-22 Citation: 2023 FC 584 Toronto, Ontario, April 21, 2023 PRESENT: Associate Judge Trent Horne BETWEEN: BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG AND BOEHRINGER INGELHEIM INTERNATIONAL GMBH Plaintiffs and PHARMASCIENCE INC. Defendant ORDER AND REASONS I.

Overview [ 1 ] These motions are about redactions. [ 2 ] In an action brought under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 , the plaintiffs redacted information from documents before they were disclosed to the defendant. [ 3 ] The plaintiffs made redactions on the basis that certain information is irrelevant, to comply with European data protection legislation, and to maintain patent agent and solicitor-client privilege.

The defendant challenges the propriety of the redactions, and seeks to compel unredacted versions of the documents. [ 4 ] For the reasons that follow, I am satisfied that the plaintiffs’ redactions based on compliance with European data protection legislation and privilege are appropriate. With a single exception, I am not satisfied that the plaintiffs have demonstrated that redactions based on relevance alone conceal information that is clearly irrelevant to the issues to be determined. II. Background [ 5 ] The documents in issue on this motion all originate from the plaintiffs (“BI”).

There are two motions to be adjudicated. [ 6 ] As a general principle, the party asserting something has the burden to prove it. For redactions based on relevance, a procedure was put in place to permit counsel for the defendant (“Pharmascience”) to review unredacted versions of most of the documents. After this review, Pharmascience elected to challenge the relevance redactions in about 40 documents. Since only a subset of BI’s redacted productions would be in issue, Pharmascience was directed to be the moving party on the motion for redactions based on relevance.

That limited the motion to only those documents that were actually in dispute. Even though Pharmascience is the moving party in this respect, BI bears the burden of justifying all redactions based on relevance. [ 7 ] For redactions based on assertions of compliance with European data protection legislation and privilege, it was apparent that the scope of the motion would not be narrowed in the event Pharmascience was the moving party. BI was therefore directed to be the moving party on a motion to justify redactions based on compliance with European data protection legislation and privilege. III.

Redactions – General Principles A. Relevance and confidentiality [ 8 ] The Federal Courts Rules SOR/98-106 ( " “ Rules ” " ) do not contemplate or authorize redactions to documents that are otherwise relevant. Where a document contains relevant information, it should be produced in its entirety and unredacted ( Janssen Inc v Apotex Inc , 2018 FC 407 at para 9 ). [ 9 ] It is not uncommon for the producing party to redact certain information before disclosing a document to the other side.

For example, where a document includes privileged communications, the document can be produced with only the privileged communication redacted. This balances the competing interests of making full disclosure of relevant information, and maintaining privilege.

This is practical, and avoids an " “all or nothing” " approach to production; it does not impair the receiving party’s right to full and complete disclosure of the case it has to meet. [ 10 ] What should be discouraged at the production stage is parsing documents that will be disclosed to make redactions on the basis of relevance. [ 11 ] It is self-evident that redactions based on relevance should be exceptional, sparingly applied, and clearly explained.

In the context of PM(NOC) proceedings such as this, with multiple patents in issue, extensive productions, and a compressed schedule, parties need to make strategic choices as to what pre-discovery motions are necessary, the best use of time during examinations for discovery, and

prioritizing questions to be pursued on any motions to compel. Redactions based on relevance inherently draw attention, invite questionsas to what was redacted and why, and result in lengthier or further motions. [12] The legal principles relating to redactions were addressed by prothonotary Aylen (as she then was, as that office was then titled) inan unreported decision in Pharmascience Inc v Meda, AB (Court file T-815-17) dated May 4, 2020 ("“Meda”"): [15] The starting point to any documentary discovery is that a party is obligated to produce relevant documents in theirentirety.

The redaction of information from a relevant document is therefore exceptional. However, there are circumstanceswhere this Court has recognized that the redaction of information may be permissible. Partial production may be madewhere the producing party can satisfy the Court that: (

a) the redacted portion is clearly irrelevant to the issues in dispute; and(

b) the redacted portion would clearly not assist in properly understanding those parts of the documents which are relevant.Redactions should only be resorted to, however, where important confidentiality concerns exist.

Where the parties haveenhanced confidentiality protections (such as through a protective agreement or a protective order), the case for redactions isweaker [see Eli Lilly Canada Inc v Sandoz Canada Incorporated, 2009 FC 345 at para 14; Janssen Inc v Apotex Inc, 2018FC 407 at para 9]. [16] Accordingly, any party that produces a document in redacted form bears the burden of demonstrating the propriety ofthe redactions made – namely, that the redacted information is clearly irrelevant to the issues in dispute, the redactedinformation would clearly not assist in properly understanding those parts of the documents which are relevant and thatredactions were made as a result of an important confidentiality concern.

In considering the propriety of any redactions, theCourt must engage in a balancing exercise, keeping in mind the rights of both parties, particularly in the face of any addedprotective measures in place beyond the implied undertaking rule. [17] In terms of the “clearly irrelevant” standard, relevance must be determined by the issues and facts as framed in thepleadings. The disclosure of documents is a matter of relevance and not of discretion (Novopharm Ltd v Eli Lilly CanadaInc, 2008 FCA 287 at para 56).

Where a relevancy determination must be made by the Court, a fair bit of latitude may beaccorded to the inquiry and the tendency is to broaden discovery [see Owen Holdings Ltd v Canada, (FCA), [1997] 3 CTC 351 at para 20 (FCA)]. [18] In the discovery context, a question will be relevant when there is a reasonable likelihood that it might elicitinformation which may directly or indirectly enable the party seeking the answer to advance its case or to damage the caseof its adversary, or which fairly might lead to a train of inquiry that may either advance the questioning party’s case ordamage the case of its adversary [see Canada v Lehigh Cement Limited, 2011 FCA 120 at para 34].

These same principlesapply in considering the potential relevance of redactions made by the Defendants. [19] However, it is important to keep in mind, however, that the threshold on this motion is lower. The Court is not asked todetermine whether redacted information is irrelevant, but rather whether the redacted information is clearly irrelevant. In thecriminal law context, the “clearly irrelevant” standard has been set quite low [see R v Stinchcombe, (SCC),[1991] 3 SCR 326; R v Hassan, 2014 ONSC 1345 at para 12]. [13] BI argues that, where a discrete

section of a document is considered to be irrelevant, that the "“clearly irrelevant”" standard does notapply, and that information can be redacted by the producing party if it is considered to be simply irrelevant.

In particular, BI relies onthe following paragraph in a decision of prothonotary (now associate judge) Tabib in Eli Lilly Canada Inc v Sandoz CanadaIncorporated, 2009 FC 345 in support of its argument that there should be differential treatment of independent sections of largedocuments, as compared to text within a disclosed part of a document: [14] I do not accept Lilly’s argument that where a document contains relevant information and is disclosed in an affidavit ofdocuments, the receiving party is in all cases entitled to production of the entire, unredacted document.

Very largedocuments that have identifiable and relatively independent sections lend themselves well to partial production. When itcomes to redacting portions of text within a disclosed part or

section of a document, redactions may also be permissible butthe following considerations should apply: The redacted portion should be clearly irrelevant to the issues in dispute andwould clearly not assist in properly understanding those parts of the documents which are relevant. Redactions should alsoonly be resorted to where important confidentiality concerns exist. In circumstances such as the present action, whereenhanced confidentiality protection is afforded to certain types of information, the case for redactions is weaker.

Where aredaction is nevertheless made and its propriety is contested, mechanisms should be provided for outside counsel for thereceiving party to view the unredacted document to ascertain the basis for the redactions. [14] BI argues that Meda is not a published decision, and therefore was not considered precedential by the Court. Whether or notprothonotary Aylen considered the decision precedential at the time it was released, I agree with the analysis and will follow it. [15] The clearly irrelevant standard should apply to all redactions for relevance.

The starting point is that if a document is relevant, itmust be produced in its entirety. Redactions can be appropriate, but should be sparingly used to avoid disputes during the discoveryphase of an action. In the context of redactions for relevance, clearly irrelevant is a high standard. It requires that it be self-evident,obvious or without doubt that the portion of a document sought to be concealed from the adversary would not assist in properlyunderstanding those parts of the documents which are relevant.

If relevance is debatable, the place for that debate is during theexaminations for discovery, and any subsequent motions to compel. [16] Where a redaction is made to protect an interest in confidential information, the producing party is expected to adduce evidence todemonstrate that harm could arise if the document was produced in an unredacted form. The discovery process inherently requiresparties to disclose information to each other that would otherwise be securely stored in the company archives.

If the recipient can be (oris expected to be) trusted to make limited and proper use of documents generally, the party intending to redact certain information basedon confidentiality concerns must explain and justify why that excerpt must be treated differently. There has to be a good reason why aportion of an otherwise relevant document should not be disclosed, including why the implied undertaking rule and/or the terms of any

protective order are insufficient to address any confidentiality concerns. B. European Data Protection Legislation [ 17 ] Boehringer Ingelheim Pharma GMBH & Co KG and Boehringer Ingelheim International GMBH are corporations incorporated under the laws of Germany.

As such, they are subject to the European Union’s General Data Protection Regulation 2016/79 ( " “GDPR” " ) and Germany’s Federal Data Protection Act ( Bundesdatenschutzgesetz , ( " “BDSG” " )). [ 18 ] BI asserts that some of the redactions it made were required by the GDPR and BDSG, including redactions to prevent the disclosure of personal data. [ 19 ] Given the number of European entities that have brought or defended proceedings in the Federal Court, it is perhaps surprising that the parties were unable to locate a decision of this Court addressing redactions made for the purpose of complying with the GDPR and BDSG. [ 20 ] BI filed an affidavit of Dr Henning Moelle, a litigation partner at the law firm Taylor Wessing in Frankfurt, Germany.

Dr Moelle is presented as an expert on EU and German data protection laws in the context of the pre-trial discovery process. Pharmascience cross- examined Dr Moelle, but did not submit expert evidence. [ 21 ] Pharmascience seeks to discredit the evidence of Dr Moelle because he did not attach his curriculum vitae to his report, as required by the Code of Conduct for Expert Witnesses, and that he works for a law firm that has been retained by one or more of the plaintiffs.

In considering the legal principles of what the GDPR and BDSG require, these criticisms will go to the weight given to Dr Moelle’s evidence. [ 22 ] The GDPR recognizes data protection as a fundamental human right of every natural person (Article 1(2)) and is directly applicable in all EU member states, including Germany. [ 23 ] For the purposes of this motion, the following

definitions from

Article 4 of the GDPR are relevant: For the purposes of this Regulation: • ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; • ‘processing’ means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; • ‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in the future; • ‘profiling’ means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person’s performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements; • ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person; • ‘filing system’ means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; • ‘controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law; • ‘processor’ means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller; [ 24 ] Dr Moelle states that the GDPR defines " “personal data” " very broadly, and thus applies to any data that concerns an individual, irrespective of the nature of the data and in particular, irrespective of how significant or sensitive the data may appear.

" “Personal data” " includes an individual’s name, address information (private and business address, phone number, email address, etc.), date of birth, sex, nationality or ethnic background, as well as any and all information about family members, lifestyle, religion, political beliefs, health, education, and employment.

Further, personal data includes any information about an individual’s actions or conduct or plans for the future, about opinions the individual has expressed, a person’s attendance at any meeting, and any communication he or she has made or received including the time and circumstances of the communication. [ 25 ] Dr Moelle further states that the GDPR generally applies to all personal data, irrespective of the circumstances under which the data

have been generated or the purpose for which they have been generated or collected. In particular, the GDPR similarly applies to personal data relating to the private life of an individual as well as to personal data which has been generated in a business context or strictly for business purposes. The GDPR therefore also applies to personal data of any individual whose data is contained in a company’s records (e.g. letters, e-mails, notes, memoranda) and whether the individual is internal to the company or not. [ 26 ] The GDPR applies to any " “processing” " of personal data.

" “Processing” " is broadly defined to include, among others, any form of use, disclosure or " “making available” " of personal data (Article 4(2)). [ 27 ] The GDPR applies to all private organizations and government authorities that act as " “controller” " of personal data, i.e. , those that determine the purpose and means of processing of personal data (Article 4(7)). The " “controller” " needs to be distinguished from the " “processor” " , which is an entity that merely processes personal data on behalf of the controller (Article 4(8)).

While the controller is entitled to make decisions about the processing including disclosure of personal data subject to the provisions of the GDPR, a processor would be prohibited from processing or disclosing the personal data without the approval of the controller. The controller may only approve any processing to the extent permitted by the provisions of the GDPR. [ 28 ] The GDPR prohibits processing of personal data, unless permitted by one of the exemptions in

Article 6: Processing shall be lawful only if and to the extent that at least one of the following applies:

a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes;

b) processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract;

c) processing is necessary for compliance with a legal obligation to which the controller is subject;

d) processing is necessary in order to protect the vital interests of the data subject or of another natural person;

e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

f) processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. Point (

f) of the first subparagraph shall not apply to processing carried out by public authorities in the performance of their tasks. [ 29 ] On its face, subsection

c) above would appear to address production in this action – documentary discovery is a legal obligation. But Dr Moelle explains that the disclosure of personal data in pre-trial discovery procedures cannot be justified under the exemption of compliance with legal obligations. Only EU laws or the domestic laws of the respective Member State ( i.e. German laws in the present case) can establish a legal ground for the processing of personal data under Article 6(1)(

c) of the GDPR. Obligations under the laws of third countries are not covered by this ground. [ 30 ] Pharmascience criticizes this evidence, and asserts that foreign law cannot be proven by bald and unsupported opinions. I note that Dr Moelle stated on cross-examination " “ …. this is the law. There’s no doubt about it” " , and that this conclusion is consistent with the findings in Harris v Bayerische Motoren Werke Aktiengesellschaft , 2022 ONSC 6435 ( " “ Harris ” " ) , particularly at para 118.

While the burden is not on Pharmascience on this issue, it offered no evidence to rebut that of Dr Moelle or submissions that the conclusions in Harris were wrong. [ 31 ] This leaves the exemption in subsection

f) of

Article 6 – processing can be lawful if it is necessary for the purposes of the legitimate interests pursued by the controller or by a third party . [ 32 ] According to Dr Moelle, to establish a legal ground for the disclosure of personal data in pre-trial discovery procedures under Article 6(1)(

f) of the GDPR and subsection 24(1) of the BDSG, the data controller ( i.e. BI) must make sure that two additional requirements are met: (

i) the disclosure must be “necessary” and (ii) the legitimate interest must not be overridden by the interest or fundamental rights and freedoms of the data subjects to have their personal data not disclosed or processed in any other way. [ 33 ] These requirements are referred to as the " “necessity test” " and the " “balancing of interests test” " . [ 34 ] Dr Moelle states that this is a strict test, and " “necessity” " is narrowly interpreted. It must be demonstrated that no reasonable alternative to the full disclosure of the personal data can satisfy the same objective.

In particular, the controller must specifically consider whether less invasive means than full disclosure of the personal data, such as disclosure of a redacted copy of a document, are available that still will satisfy the given purpose. [ 35 ] As for balancing of interests, Dr Moelle states that this balancing test must take into account the circumstances of the individual case, including the principle of proportionality, the nature of the personal data, the relevance of the personal data to the litigation, and whether the data subject could reasonably expect that their personal data may be disclosed in the litigation.

As a result of the balancing test, a controller may need to take measures to accommodate for any overriding interests of the data subject by not disclosing the document in pre-trial discovery at all or only in a redacted form.

[ 36 ] The only decision referred to by the parties on this issue is the decision of Justice Perell of the Ontario Superior Court of Justice in Harris . This was a class proceeding against BMW alleging that MINI Cooper vehicles distributed in Canada posed safety risks. There were two defendants - Bayerische Motoren Werke Aktiengesellschaft ( " “BMW Germany” " ) and BMW Canada Inc. The parties were unable to settle on a discovery plan.

In particular, the parties could not agree on the manner of producing documents, particularly whether BMW Germany could redact portions of documents to comply with its obligations under the GDPR and BDSG. [ 37 ] In Harris , each side presented expert evidence. The experts agreed that the term " “personal data” " in foreign privacy law is broadly defined, and includes information such as a person’s name, email address, employee position, employee number and opinions; data about a person’s professional activities; where a person lives or works; and data about a person’s family and friends.

The experts agreed that foreign privacy law applies to personal data of any person whose data is stored in a company’s records, whether or not that person is an employee. Thus, personal data includes data about persons with whom a company’s employees may have communicated or transacted, such as business partners or suppliers. The experts agreed that disclosure of any personal data is prohibited, unless the disclosing party can establish that the disclosure is permitted under an exemption.

The experts further agreed that the only exception that might apply is the " “Legitimate Interest Exception” " set out in Article 6(1)(

f) of the GDPR (paras 116-118). [ 38 ] The experts further agreed that, to rely on the legitimate interest exemption in Article 6(1)(

f) of the GDPR, there are two preconditions. The first precondition is necessity; the disclosure of the personal data must be " “necessary” " (the " “necessity test” " ). To satisfy the necessity test, the proposed disclosure must be " “strictly necessary” " ; there must be no reasonable alternative that can satisfy the same objective. The second precondition is superiority of the interest in disclosure.

The legitimate interest in disclosing the personal data must not be overridden by the rights and interests of the person whose information would be disclosed, " “the data subject” " , in preventing the disclosure. This is a " “balancing of interests test” " or " “proportionality test” " . Disclosure remains prohibited if the interests or fundamental rights of the data subject outweigh the interests of the controller or the third party to whom disclosure is to be made.

The experts agreed that the factors to be considered in carrying out the balancing of interests test include: (1) the reasonable expectations of the data subject; (2) the potential impacts on the data subject; (3) the nature of the data; and (4) the scope and manner of the processing ( i.e ., disclosure) (para 119). [ 39 ] Where the experts parted ways is described in Harris at para 124 . They did not agree on whether a " “layered approach” " was appropriate.

The plaintiff submitted that documentary production should be in accordance with Ontario’s Rules of Civil Procedure without any adjustment for comity with foreign privacy law. BMW asserted that foreign privacy law directs that personal data (information about a person’s identity) be redacted from documents disclosed and produced for litigation, and then these laws direct a process be undertaken if there is a justified need to un-redact the personal data (this two-step process is what was described as the " “layered approach” " ). [ 40 ] Justice Perell concluded at para 144: [144] I, therefore, conclude that Dr.

Piltz’s opinion that the layered approach is built into the Rules of Civil Procedure is correct. I therefore conclude that BMW-AG can produce redacted documents in accordance with the Rules of Civil Procedure provided that it is in the position to establish that: (

a) the redacted information is irrelevant to the issues, serving no legitimate purpose in resolving the issues; and (

b) disclosure of the information would cause significant harm to the producing party or would infringe public interests deserving of protection, which would be the interests of the person whose personal information is being disclosed. [ 41 ] Ultimately, Justice Perell directed that a modified form of an affidavit of documents be used, adding the following underlined text: " “ Save for personal data that is not relevant to any issue in the action , I have listed in

Schedule A those documents that are in the possession, control or power of the corporation (or partnership) and that it does not object to producing for inspection …” " (para 6). [ 42 ] Having regard to all of the above, I do not perceive a real conflict between the Court’s general approach to redactions based on relevance, and what would be required for compliance with the GDPR and BDSG.

If a party can establish that information proposed to be redacted from a document serves no legitimate purpose in resolving the issues, and disclosure of the information would cause significant harm to the producing party or would infringe public interests deserving of protection, that would justify a redaction for both relevance and compliance with the GDPR and BDSG . [ 43 ] If I was to paraphrase the test for redactions based on relevance, it would be that if a document is relevant, there has to be a really good reason to conceal part of it.

The Federal Court should, as a matter of comity, permit European litigants to discharge their documentary disclosure obligations in a manner that will not result in a contravention of foreign privacy law if it is reasonably possible to do so.

If personal information may not be clearly irrelevant, but is of such trivial relevance that it would not assist in the determination of the issues and redaction would not prejudice the receiving party, the Court should flexibly apply the clearly irrelevant standard to permit compliance with the GDPR and BDSG. [ 44 ] There is not always a bright line that separates the relevant from the irrelevant. What is relevant can be the subject of good faith debate between the parties, and involve judgment calls by the Court to resolve the issue.

An issue that was not addressed by Dr Moelle or Justice Perell is who is the final arbiter of relevance for the purposes of compliance with the GDPR and BDSG, specifically what happens if a European party has a good faith belief that certain personal information should be redacted, but a Canadian court disagrees, and is inclined to compel production. [ 45 ] Based on the record I have, it is difficult to accept that an order from a Canadian court compelling production of certain personal information, after a contested motion, would not satisfy the necessity and balancing of interests tests described above.

Put another way, if a European party states that a portion of a document should be redacted, a Canadian court is not powerless to disagree, and may compel production. Of course, any such order should consider and apply what the GDPR and BDSG require. C. Patent Agent Privilege [ 46 ] BI has redacted portions of certain documents based on claims of patent agent privilege.

[ 47 ] Subsection 16.1(1) of the Patent Act , RSC 1985, c P-4 ( " “ Patent Act ” " ) provides that patent agent privilege can apply if a communication is:

a) between a patent agent and their client;

b) intended to be confidential; and (

c) made for the purpose of seeking or giving advice with respect to any matter relating to the protection of an invention. [ 48 ] As I concluded in Janssen Inc v Sandoz Canada Inc , 2021 FC 1265 , not all communications with a patent agent will be privileged, only those that (among other things) are made for the purpose of " “protecting an invention” " .

For example, stating that a communication relates to patent strategy, without more, is insufficient to meet the test for patent agent privilege (para 23). [ 49 ] Pharmascience submits that patent agent privilege can only apply where the Court is able to identify the invention for which protection is being sought, and the client has instructed its patent agent to begin drafting a patent application to protect the invention.

Pharmascience further submits that the privilege would not apply where a patent application was voluntarily abandoned or rejected by the Canadian Intellectual Property Office ( " “CIPO” " ) because, in those circumstances, there is no " “invention” " . I cannot agree that such a narrow approach would be consistent with the text, context and purpose of the Patent Act . [ 50 ] The text of subsection 16.1(1) (

c) of the Patent Act attaches privilege to any matter relating to the protection of an invention. It is not limited to circumstances where an application has been filed, or is pending. [ 51 ] Consider a hypothetical situation where two inventors separately present an invention to the same patent agent. Both clients have a detailed discussion with the agent as to patentability, and receive a favourable patentability opinion. The first client, for financial or business reasons, decides not to file a patent application and treat the invention as a trade secret.

The second instructs the agent to file a patent application. [ 52 ] I cannot accept Pharmascience’s submission that the filing of a patent application, or clear instructions to a patent professional to draft one, is a necessary precondition. This would result in the first client being unable to assert privilege, but the second client able to assert privilege over the same kind of communication.

Both communications would relate to the protection of an invention. [ 53 ] Consider a further hypothetical situation where the same two inventors deal with the same patent agent, but only one receives a favourable patentability opinion. Both communications would be for the purpose of protecting an invention.

I cannot accept that the legislature only intended patent agent privilege to apply where a patent agent expressed a favourable patentability opinion, particularly when different agents may express different opinions. [ 54 ] I have particular difficulty with Pharmascience’s submission that where a patent application is rejected by CIPO, or is voluntarily withdrawn by the applicant, patent agent privilege would not apply. I do not agree with Pharmascience that there cannot be an " “invention” " unless and until CIPO issues a patent. The text of

section 16.1 does not support an

interpretation that privilege can be gained or lost depending on the existence or status of a patent application, or that an " “invention” " only exists for the purposes of that

section if a patent application has been clearly instructed, is pending, or a patent has issued. [ 55 ] I reach the same conclusion when considering

section 16.1 in the context of the Patent Act . " “ Invention ” " is defined in

section 2 to mean " “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter” " . Patent means " “letters patent for an invention” " . Had the legislature intended to restrict patent agent privilege to only live applications or issued patents, it would have expressly said so . [ 56 ] As for the purpose of

section 16.1, there are apparently no Parliamentary debates or other sources of information that may shed light on the intention of the legislature when it created patent agent privilege. For the purpose of the Patent Act as a whole, and as set out in Innovative Medicines Canada v Canada (Attorney General) , 2020 FC 725 at para 76 , “the policy rationale underlying the Patent Act is the patent bargain, or quid pro quo .

The patent bargain encourages innovation by offering an inventor exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge ( Teva Canada Ltd v Pfizer Canada Inc , 2012 SCC 60 at para 32 ).

Two central objectives of the Patent Act as a whole are to “advance research and development and to encourage broader economic activity” ( Free World Trust v Électro Santé Inc , 2000 SCC 66 at para 42 ; Harvard College v Canada (Commissioner of Patents) , 2002 SCC 76 at para 185 )”. [ 57 ] Limiting patent agent privilege to only apply in circumstances where a client instructs a patent agent to file and maintain an application could be a disincentive to retain an agent. There would be uncertainty as to if and for how long any privilege would apply.

A cautious client may be inclined to avoid the uncertainty, and maintain an invention as a trade secret. This would be contrary to the central objectives of the Patent Act described above. IV. Analysis A.

BI’s Motion [ 58 ] BI asks for a declaration that the portions of BI’s productions identified in an " “updated privilege log with excerpts” " contain privileged information, on the basis of solicitor-client or patent agent privilege, that privilege has not been waived, and the redactions are therefore justified. [ 59 ] To support its claims of patent agent privilege, BI relies on the affidavit of Markus Weymann, the Head of Global Patents Human Pharma Biologics, for Boehringer Ingelheim International GmbH.

Dr Weymann’s affidavit addressed the qualification process to become a European patent attorney, and the involvement of the patent department in BI’s development of therapeutic compounds. Dr. Weymann was provided copies of the documents for which privilege is claimed and asked to:

a) describe the nature of the redacted information;

b) advise whether the information (

i) originated from the BI patent department, (ii) originated from a BI employee seeking advice from the patent department, or (iii) originated from an in-house counsel at BI;

c) advise whether he agrees with the " “Basis for redaction” " in the Updated Privilege Log with Excerpts;

d) advise if the redacted information is intended to be confidential, and to his

knowledge has been maintained as confidential;

e) advise if the redacted information is believed to be, and was understood and treated as, privileged at BI; and

f) advise whether to his knowledge any privilege has been waived by BI. [ 60 ] Dr Weymann was cross-examined. Pharmascience places significant weight on the fact that BI refused to answer questions asking for the identity of the specific patent application sought to be protected by the communication.

As set out above, I do not agree that the party asserting patent agent privilege must connect the communication to a specific patent application in order for the privilege to apply. [ 61 ] Pharmascience does make a fair criticism of BI’s evidence when it points out that Dr Weymann did not attend any of the R&D meetings related to linagliptin, and that other current BI employees who did attend these meetings, and have direct knowledge of communications relating to patent protection, did not give evidence.

Dr Weymann’s inquiry to one of these persons was limited to the start date of their employment, not the nature and substance of the communications relating to patent protection. [ 62 ] As is often done on motions to determine claims of privilege, BI provided the Court with unredacted versions of the documents in the privilege log, but not to Pharmascience. I do not criticize this approach, but acknowledge that it puts Pharmascience in a difficult position. [ 63 ] I have reviewed each of the redactions made in the updated privilege log delivered to the Court on March 11, 2023.

Particularly in light of what the documents say on their face, I am satisfied that the redactions for patent agent privilege and solicitor client privilege were properly made. [ 64 ] BI asks for an order requiring Pharmascience and its counsel to delete and/or destroy all copies of the original versions of productions BI4000038, BI4000043, BI4000057, BI6000003, and BI6000006, as these were replaced with copies with privileged information redacted.

Since I have upheld the claims for privilege relating to these documents, such an order will be granted. [ 65 ] BI also asks for a declaration that it appropriately redacted personal data in its productions in compliance with its obligations pursuant to the GDPR and BDSG. [ 66 ] BI’s redactions based on compliance with GDPR and BDSG fall into two categories. Category A includes documents where redactions were made by the client for compliance with GDPR and BDSG. Category A documents were provided to BI’s Canadian counsel in a redacted form only.

Neither BI’s counsel nor the Court has seen what is under the redactions in that category. Category B includes documents where the redactions were made by BI’s Canadian counsel. Generally, unredacted versions of these documents were not provided to the Court. [ 67 ] BI submits that, generally, the names and positions of BI employees that did not have " “substantial involvement” " in the work relating to the patents in issue were redacted. Persons who were not considered to have substantial involvement include technicians who conducted experiments that were designed and supervised by others.

Patient information in documents relating to clinical trials was also redacted. Personal information that was not redacted includes the names of the inventors, authors of reports, and those who designed or carried out experiments and clinical trials. [ 68 ] In support of its motion for redactions based on compliance with GDPR and BDSG, BI filed an affidavit affirmed by Haris Hadzimuratovic, the same person who affirmed the affidavit of documents on behalf of the German plaintiffs.

His affidavit sets out the process by which redactions were made to prevent disclosure of irrelevant personal information. [ 69 ] Mr Hadzimuratovic states that the Category A documents include clinical trial documents that were located in an already redacted form. Mr Hadzimuratovic expresses a belief that these documents were redacted by BI employees to comply with GDPR and German domestic law.

For the Category B documents, Mr Hadzimuratovic states that he instructed counsel to redact personal information including the names and positions of BI employees who did not have substantial involvement in the work relating to the eight patents at issue in this action. Unredacted personal information included names of the inventors, authors of reports, individuals who designed and/or carried out experiments/clinical trials, and attendees of meetings relating to linagliptin and relevant combinations of linagliptin and other drugs.

He states that the names and positions of BI employees and other individuals who had minimal involvement with the work relating to the patents at issue in this action.

This includes, for example, the names and positions of technicians who conducted experiments under the supervision of inventors or other BI employees who had substantial involvement in the project. [ 70 ] Dr Moelle’s affidavit states that the protocol which BI and BI’s Counsel, respectively, implemented in redacting the personal data in the documents in Category A and Category B meets the requirements and limitations to which BI is subject under the GDPR and BDSG. [ 71 ] I have difficulty accepting that the Federal Court can make an order or declaration that a litigant has complied with foreign legislation, and expressed that concern during the hearing.

BI submitted that the relief on its motion could be re-cast as a declaration that the redactions were appropriate in light of the GDPR and BDSG.

While parties should not change what they are asking the Court to do during a hearing, the fundamental nature of the relief sought by BI is the same – to have the Court approve the redactions that were made in the context of BI’s discovery obligations in the Federal Court in light of the limitations imposed by the GDPR and BDSG. [ 72 ] Pharmascience criticizes Mr Hadzimuratovic’s evidence on the basis that he has no personal knowledge of why the redactions to the Category A documents were made, and could not advise if any of the pre-existing redactions obscured the names of the inventors or other individuals that had substantial involvement in the work described in the patents.

On cross-examination, he stated that the decision on what personal information to redact in Category B was left to counsel. [ 73 ] The parties have presented this issue as having an all or nothing outcome. Pharmascience raises fair criticisms of BI’s evidence.

But having regard to all of the evidence on the motion, and BI’s onus on the motion as the moving party, I am satisfied that BI has justified its redactions based on the GDPR and BDSG. [ 74 ] I am not satisfied that the existence of the implied undertaking rule, and a protective order with a solicitor’s eyes only term, are alone sufficient to address the necessity and balancing of interests tests described above. Otherwise, redactions for the purpose of compliance with the GDPR and BDSG would be exceedingly difficult to justify. Given the potential for significant consequences arising

from non-compliance with the GDPR and BDSG, and the importance of comity, such redactions should not be out of reach. [ 75 ] I agree with BI that it would be inefficient to expect, as a general principle, detailed evidence about every name or piece of personal information that is redacted from a series of productions. A party can introduce evidence as to the principles that guided the approach. I have not reviewed each document where redactions were made for this purpose, and do not know what is under the black boxes.

But on the evidence as a whole, I am satisfied that BI undertook a principled approach to these redactions. [ 76 ] In a number of instances, the redacted information is the name of a technician (e.g. a laboratory notebook indicates that there is a space for a technician’s name, and only the signature block has been redacted). If a particular test or the way it was conducted is in dispute, then the identity of the technician may be relevant. But it is reasonable to separately consider the inventors and others who designed, managed or oversaw the experiments, and the " “hands” " that did the task.

Again, I do not see the tests for redactions based on general relevance and compliance with GDPR and BDSG to be in real conflict.

If the identity of a technician is marginally or distantly relevant, and maintaining the redaction of their name is consistent with compliance with the GDPR and BDSG ( i.e. a good reason for the redaction) the redaction is appropriate. [ 77 ] Similarly, for patient information in documents related to clinical trials, I have difficulty accepting how the needs of Pharmascience in this litigation overcome the privacy interests of the patients. [ 78 ] Pharmascience does not bear the burden on this motion, but it has had extensive discovery on BI’s documents.

This is by no means determinative, but Pharmascience did not point to a document where a reasonable inference could be drawn that the redacted information was likely to conceal the identity or participation of a person who had meaningful involvement in the development of linagliptin. B. Pharmascience’s Motion [ 79 ] As set out above, Pharmascience does not challenge every redaction made by BI, rather only those redactions set out in a

schedule to its written representations. Within that schedule, Pharmascience has placed certain information within a red box, indicating that those portions are considered to be particularly relevant.

In the alternative, Pharmascience would be willing to receive disclosure of only those portions of the documents in the red boxes. [ 80 ] Before considering the specific documents at issue in Pharmascience’s motion, it is worthwhile to consider the steps in the discovery process. [ 81 ] Pursuant to subrule 222(1), a document is relevant " “if the party intends to rely on it or if the document tends to adversely affect the party’s case or to support another party’s case.” " Of course, a party is not entitled to disclosure of every document that is in the adverse party’s possession, power or control that " “might” " relate to the unadmitted allegations in the pleading.

Unless the party producing the affidavit intends to rely on a document at trial, it is not obliged to disclose it unless it is reasonable to suppose that the document would undermine its own case, advance its opponent's, or would fairly lead him to a train of inquiry, which may have either of these two consequences ( Novopharm Ltd v Eli Lilly Canada Inc , 2008 FCA 287 at paras 61-62 ). [ 82 ] As set out in more detail above, once a relevant document has been identified, the baseline assumption is that it will be produced in its entirety. [ 83 ] If a document is considered to be relevant and produced, that does not mean that the receiving party is entitled to ask extensive questions about everything in it, or obtain production of every document referenced in what is produced.

Parties may not conduct an " “autopsy” " form of discovery ( AstraZeneca Canada Inc v Apotex Inc , 2008 FC 1301 at para 19 ).

In the context of the issues on this motion, a portion of a document may not meet the " “clearly irrelevant” " standard to justify a redaction, but that does not necessarily mean that the same portion of the document leads to a proper and relevant line of inquiry, or that questions about it must be answered. [ 84 ] It is also necessary to consider these motions within the context of when they were brought. [ 85 ] Pharmascience has already had six days of discovery of BI’s corporate representative. Discovery motions were heard on February 28, 2023 for a full day.

On Pharmascience’s motion, its chart of disputed questions included over 500 items, and was several hundred pages long. A significant number of these questions (about 300) were argued to be proper because they went to the inventors’ course of conduct. [ 86 ] Among other defences, Pharmascience alleges that the asserted claims are invalid because they are obvious. In assessing obviousness, the actual course of conduct which culminated in the making of the invention can be considered.

I f the inventor and his or her team reached the invention quickly, easily, directly and relatively inexpensively, in light of the prior art and common general knowledge, that may be evidence supporting a finding of obviousness, unless the level at which they worked and their knowledge base was above what should be attributed to the skilled person. Their course of conduct would suggest that a skilled person, using his/her common general knowledge and the prior art, would have acted similarly and come up with the same result.

On the other hand, if time, money and effort was expended in research looking for the result the invention ultimately provided before the inventor turned or was instructed to turn to search for the invention, including what turned out to be fruitless " “wild goose chases” " , that evidence may support a finding of non-obviousness.

It would suggest that the skilled person, using his/her common general knowledge and the prior art, would have done no better ( Apotex Inc v Sanofi-Synthelabo Canada Inc , 2008 SCC 61 at paras 70-71 ) . [ 87 ] While the inventor’s course of conduct can be a relevant line of inquiry, it is not an incantation that can be used to justify otherwise irrelevant and disproportionate questions.

Invoking course of conduct alone does not justify an autopsy. [ 88 ] Particularly in light of the number of " “course of conduct” " questions that were not ordered answered on the discovery motion, I indicated at the outset of Pharmascience’s motion that it would be of assistance to understand why Pharmascience needs the information it is seeking in light of what it already has. Pharmascience’s written representations place broad reliance on course of conduct, but do not set out specific submissions that are informed by perceived shortcomings in the discovery conducted to date. Pharmascience submitted

that any disputes relating to further questions could be addressed during any subsequent discoveries, and any further motions to compel. [ 89 ] At this stage of the proceeding, I do not find Pharmascience’s position to be practical. While BI bears the burden of justifying its redactions, there is an overarching interest in managing this proceeding so that the discoveries are conducted in a manner that is consistent with the guiding principles in Rule 3.

It is not apparent whether the information sought by Pharmascience actually matters for the defence of the action, whether undoing some or all of BI’s redactions for relevance will ultimately result in further and extensive discovery questions based on vague assertions of course of conduct and another unwieldy discovery motion, or whether this motion is more about winning an argument than preparing for trial.

I share BI’s concern that the only practical result of granting the relief Pharmascience seeks will be further discovery disputes. [ 90 ] One of the justifications offered by Pharmascience for production of unredacted documents is that the disputed portions could be used to refresh a witnesses memory. As a general principle, I agree with BI that this assertion would lead to the absurd conclusion that every project presented at any meeting that any inventor at BI attended is relevant and all such documents are compellable—which is not the law.

A general statement that a document may " “refresh witness memory” " does not assist the determination of whether a passage is relevant (or clearly irrelevant) to the pleaded issues. [ 91 ] BI’s evidence on this motion is an affidavit from a law clerk. It attaches copies of documents, including unredacted copies of certain documents that were not made available to Pharmascience. It also attached a GDPR and relevance log, and an affidavit of documents. [ 92 ] I do not have direct evidence that BI would be harmed if any of the material that Pharmascience seeks to receive in an unredacted form is ordered produced.

BI asserts that information on licensing activities, costs, and product development strategy are commercially sensitive information and should not be disclosed to a competitor. The example included in BI’s written representations is minutes of a meeting that occurred in April 2004. Many of the other disputed documents are also about 20 years old. I acknowledge that the pharmaceutical industry is extremely competitive, but the parties are already disclosing documents and information to each other that they would otherwise maintain as a state secret.

I am unable to conclude, on the face of the documents alone, that BI’s redactions are justified based on confidentiality concerns. [ 93 ] BI also points to the number and kind of documents that have already been produced. The fact that the same kind of information that has been redacted may appear elsewhere in the productions does not justify redactions on the basis that the information is clearly irrelevant. [ 94 ] It can sometimes be plain and obvious on the face of a document that a part of it does not relate in any way to the issues to be determined, and is therefore clearly irrelevant.

But if a detailed explanation is required to justify a redaction for relevance, including what is or is not encompassed by the asserted patent claims, it is more difficult to meet the clearly irrelevant test. Particularly for redactions based on relevance alone, it is not an efficient use of the Court’s scarce resources to get into the weeds of the issues and make a line-by- line assessment of whether portions of a document are clearly irrelevant or not, particularly when dozens of documents are the subject of a motion. [ 95 ] The drug in issue in this action, linagliptin, is described as a DPP-4 inhibitor.

BI’s productions include documents relating to the development of linagliptin, which was assigned a certain internal code number. One of the issues on the redaction motion is whether portions of documents that refer to other BI DPP-4 inhibitors with different code numbers can be obscured. In general terms, Pharmascience seeks production of documents relating to these other DPP-4 inhibitors on the basis that it can inform the inventors’ course of conduct.

BI objects to production on the basis that at least some of these compounds were made after the relevant filing date. [ 96 ] BI’s evidence is that of a law clerk, and does not provide the details of what these other DPP-4 inhibitors are, or when they were made. I am hesitant to invite such evidence in any event. Recall that redactions based on relevance must be exceptional.

The Court should not invite a motion with a voluminous record and detailed technical evidence to assess whether a paragraph in an otherwise relevant document should be produced, particularly when the disclosing party is unable to establish that its commercial interests would be harmed by disclosure, and there is no claim for privilege. The better way to deal with this is to produce the document in its entirety in the first instance, have the discovery witness address any questions directed to other compounds, and deal with any refusals as part of a motion to compel.

To be clear, this does not mean that BI is obliged to produce every document relating to every DPP-4 inhibitor it ever developed, rather for those documents that are produced, redactions based on relevance must be sparingly applied. [ 97 ] Where this leaves me is being generally dissatisfied with the positions of both parties. With one exception, I am not satisfied that BI has met the " “clearly irrelevant” " standard for the redactions it has made.

At the same time, I am not satisfied that Pharmascience’s pursuit of these documents, at this stage of the proceeding, requires further examination for discovery. [ 98 ] I have reviewed all of the documents that are the subject of Pharmascience’s motion in light of the principles discussed above. With the exception of the document identified below, I am not satisfied that BI has established that the redacted portions are clearly irrelevant, and will therefore order that BI produce a version of the documents in

Schedule " “A” " to Pharmascience’s written representations dated February 28, 2023 that removes the redactions that were made on the basis of relevance. To the extent that there is also a redaction based on privilege or compliance with the GDPR and BDSG within the

section of a document that was redacted for relevance, the redactions for privilege and GDPR/BDSG compliance may be maintained. BI need only undo the redactions for these documents that were made on the basis of relevance. [ 99 ] I will maintain the redaction for page 5 of BI4000084. This brief

section relates to the cost of purchasing a

section of a database. While I am satisfied that BI has shown that this portion of the document is clearly irrelevant to the issues to be determined, the better course would have been to leave it in, and deal with any disputes on discovery. [ 100 ] In light of the concerns expressed above as to the overall utility of this motion in the context of the stage of the proceeding, I will also order that there be no further discovery of BI’s corporate representative, or any assignors who have already been examined, in respect of these documents. [ 101 ] In its written submissions, BI indicates that it is willing to unredact certain documents on a solicitor’s eyes only basis. There is a

solicitor’s eyes only term in the protective order, but it includes Pharmascience’s in-house counsel. Since I am not persuaded that BI will be harmed in the event uredacted versions of these document are produced to Pharmascience under the terms of the protective order, I will not make such an order. It is up to BI to determine whether it elects to designate any materials it is obliged to produce under the protective order. [ 102 ] In argument, BI requested that any order compelling production of documents be stayed for 30 days to permit them to exercise rights of appeal.

While such an order may be appropriate for documents for which privilege is claimed (and not previously disclosed to Pharmascience), Pharmascience’s counsel has already seen underneath the redactions based on relevance. Since Pharmascience has seen the documents, there is a solicitor’s eyes only term in the protective order, and I am not satisfied that BI has justified any relevance redactions on the basis of confidentiality concerns, no such stay will be included in the order. V.

Costs [ 103 ] The Court has full discretionary power over the amount and allocation of costs (subrule 400(1)). [ 104 ] At the conclusion of BI’s motion, the parties agreed that costs should be in the cause. I agree. [ 105 ] As for Pharmascience’s motion, it was the successful party, but in light of the overall result, costs will be awarded to Pharmascience in the cause. ORDER in T-15-22 THIS COURT ORDERS that : 1 . The claims for privilege for portions of documents reproduced in the updated privilege log submitted by the plaintiffs to the Court on March 11, 2023 were properly made.

The portions of documents reproduced in this updated privilege log need not be disclosed to the defendant, and may remain redacted. 2 . The defendant and its counsel shall delete and/or destroy all copies of the original versions of productions BI4000038, BI4000043, BI4000057, BI6000003, and BI6000006. The plaintiffs shall forthwith serve amended copies of these documents on the defendant. 3 .

Redactions made by the plaintiffs for the purposes of compliance with the European Union’s General Data Protection Regulation 2016/79 and Germany’s Federal Data Protection Act ( Bundesdatenschutzgesetz ) were properly made. 4 . Within 10 days of the date of this order, the plaintiffs shall produce a version of the documents in

Schedule " “A” " to Pharmascience’s written representations dated February 28, 2023 that removes only those redactions that were made on the basis of relevance, with the exception of page 5 of production BI4000084. 5 . There shall be no further discovery of the plaintiffs’ corporate representative(s), or any assignors who have already been examined, in respect of documents required to be produced by this order. 6 . Costs of the plaintiffs’ motion are in the cause. 7 .

Costs of the defendant’s motion are payable by the plaintiffs to the defendant in the cause. blank “Trent Horne” blank Associate Judge FEDERAL COURT SOLICITORS OF RECORD DOCKET: T-15-22 STYLE OF CAUSE: BOEHRINGER INGELHEIM (CANADA) LTD, BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG AND, BOEHRINGER INGELHEIM INTERNATIONAL GMBH v PHARMASCIENCE INC. PLACE OF HEARING: HELD BY VIDEOCONFERENCE DATE OF HEARING: mARCH 13, 2023 ORDER AND REASONS: HORNE A.J.

DATED: April 21, 2023 APPEARANCES : Urszula Wojtyra Katie Lee Ryan Wong For The Plaintiffs Scott Beeser Mary Murray For The Defendant SOLICITORS OF RECORD : Smart & Biggar LLP Barristers and Solicitors Toronto, Ontario For The Plaintiffs Aitken Klee LLP Barristers and Solicitors Ottawa, Ontario For The Defendant