UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`V.
`
`NOV ARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`Case IPR202 l -00816
`Patent 9,220,631
`
`DECLARATION OF MARTINA ATHANAS IN SUPPORT OF
`NOV ARTIS'S SECOND MOTION TO SEAL
`
`Novartis Exhibit 2097.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`V.
`
`NOV ARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`Case IPR202 l -00816
`Patent 9,220,631
`
`DECLARATION OF MARTINA ATHANAS IN SUPPORT OF
`NOV ARTIS'S SECOND MOTION TO SEAL
`
`Novartis Exhibit 2097.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`I, Martina Athanas, hereby declare as follows:
`
`1. I am a senior associate at the law firm Bar & Karrer AG,
`
`Brandschenkestrasse 90, 8002 Zurich, Switzerland, Swiss counsel for Patent
`
`Owners Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and
`
`Novartis Technology LLC ( collectively, "Novartis"). I am a member in
`
`good standing of the Swiss Bar.
`
`2. I submit this declaration in support ofNovartis's Second Motion to Seal,
`
`which seeks to protect third party information and personal information in
`
`Exhibits 2002, 2063, 2064, and 2066-2088.
`
`3. I was involved with Novartis's Swiss compliance review and redaction of
`
`the documents presented in Exhibits 2002, 2063, 2064, and 2066-2088. I
`
`have personal knowledge of the facts stated in this Declaration and am
`
`competent to testify to the same.
`
`4. Relevant to this proceeding, the production by Novartis of data from
`
`Switzerland to the Patent Trial and Appeal Board ("PTAB") and to
`
`Regeneron (including its outside counsel) falls mainly under two areas of
`
`Swiss law that affect the disclosure of information and documents from
`
`Switzerland to foreign authorities and/or third parties:
`
`a. Protection of manufacturing and business secrets ( article
`
`1
`
`Novartis Exhibit 2097.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`162 and 273 SCC) 1; and
`
`b. Protection of personal data (Swiss Data Protection Act
`
`("DP A" 2
`) and employment law, which impose duties of care
`
`on an employer contained in the Code of Obligations;
`
`"SC0" 3).
`
`1 An unofficial English translation of the SCC provided by the Swiss
`
`government for information purposes only is available on the following
`
`website: https://www.admin.ch/opc/en/classified(cid:173)
`
`compilation/19370083/202007010000/31 l.O.pdf (last accessed on 18
`
`November 2021).
`
`2 An unofficial English translation of the DP A provided by the Swiss
`
`government for information purposes only is available on the following
`
`website: https://www.admin.ch/opc/en/classified-
`
`compilation/ 19920153/201903010000/23 5 .1. pdf (last accessed 18
`
`November 2021 ).
`
`3 An unofficial English translation of the DP A provided by the Swiss
`
`government for information purposes only is available on the following
`
`website: https://www.admin.ch/opc/en/classified
`
`compilation/ 19110009/202004010000/220. pdf ( 18 November 2021).
`
`2
`
`Novartis Exhibit 2097.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`5. Most importantly, amongst the provisions of the SCC, article 162 SCC
`
`penalizes the breach of certain contractual or statutory duties of
`
`confidentiality. Thus, if Novartis has a contractual or statutory duty to keep
`
`confidential a third party's manufacturing or business secrets, it cannot
`
`lawfully disclose such protected information to third parties, including the
`
`PT AB and Regeneron and its outside counsel, unless such disclosure is
`
`made in the course of legal assistance proceedings under the applicable
`
`Hague evidence convention, or provided that the affected third party
`
`consents to the disclosure.
`
`6. In addition, Swiss data protection and employment laws allow for the cross(cid:173)
`
`border disclosure of personal data to the US under limited circumstances
`
`only. The disclosure of private and sensitive personal data from Switzerland
`
`to the US is prohibited. Any violation of the applicable Swiss law would
`
`expose both Novartis and those acting on its behalf to criminal sanctions
`
`and/or civil claims (e.g., cease and desist, damage claims).
`
`Manufacturing and Business Secrets
`
`7. The unofficial English translation of article 162 SCC (published by the
`
`Swiss Confederation) reads as follows:
`
`3
`
`Novartis Exhibit 2097.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`"Any person who betrays a manufacturing or trade secret that he is under a
`
`statutory or contractual duty contract not to reveal, any person who exploits
`
`for himself or another such a betrayal, is liable on complaint to a custodial
`
`sentence not exceeding three years or to a monetary penalty".
`
`8. Article 162 SCC is designed to protect manufacturing and business secrets
`
`of entities and individuals against unauthorized disclosure by persons bound
`
`to confidentiality by contract or by law.
`
`9. The provisions of the SCC apply to criminal offenses that are committed in
`
`Switzerland (article 3 SCC). An offense is deemed to have taken place either
`
`where the offending party acted or where the consequences of that action
`
`occurred (article 8 SCC). As in the present case, a breach of article 162 SCC
`
`occurs if disclosure is made by a person in Switzerland to a third person who
`
`is located abroad, e.g., by email, fax, telephone or ordinary mail. 4 The Swiss
`
`Federal Supreme Court held that even embarking on a journey abroad with
`
`information from Switzerland with the intention to disclose data abroad
`
`4 GRAF, Strafbewehrter Geheimnisverrat im grenziiberschreitenden Kontext, SJZ
`
`112/2016, p. 195.
`
`4
`
`Novartis Exhibit 2097.005
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`would justify the applicability of Swiss criminal law. 5 The disclosure of
`
`documents to the PT AB or to Regeneron as part of the IPR process falls
`
`under article 162 SCC.
`
`1 0.Article 162 SCC prohibits any disclosure of a secret by rendering it
`
`accessible to a third party, irrespective of how such disclosure is made. This
`
`is confirmed in Swiss case law and legal literature according to which
`
`"betrayal" (respectively, "verrat" in German or "revele" in French) within the
`
`meaning of article 162 SCC is defined as the unauthorized disclosure or the
`
`communication of manufacturing and business secrets to third persons. 6
`
`11.In particular, the Swiss Federal Supreme Court held that a secret is disclosed
`
`by anyone who brings it to the attention of an unauthorized third party or at
`
`least enables that person to gain knowledge of it. The concept of disclosure
`
`5 Decision of the Swiss Federal Supreme Court, BGE 104 IV 175, consid. 3a;
`
`Decision of the Federal Criminal Court, CA. 2019. 6, consid. 1.1.3.4; GRAF,
`
`Strafbewehrter Geheimnisverrat im grenziiberschreitenden Kontext, SJZ 112/2016,
`
`p. 196.
`
`6 Decision of the Swiss Federal Criminal Court, SK 2013.11, consid. 2.1.4; BSK
`
`StGB - NIGGLI/HAGENSTEIN, article 162, N 3 and 25; PK StGB -TRECHSELIJEAN(cid:173)
`
`RICHARD, article 162, N 8.
`
`5
`
`Novartis Exhibit 2097.006
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`covers any form of disclosure of the secret, in particular oral or written
`
`communication as well as the handing over of documents or other objects
`
`which reveal the secret. 7
`
`12.A secret within the meaning of article 162 SCC is any information (i) that is
`
`not publicly known or readily accessible, (ii) that the interested person or
`
`persons intend to keep secret (which may be evidenced by contractually
`
`agreed confidentiality obligations), and (iii) as to which there is a valid
`
`interest in keeping it secret. 8
`
`13 .Any information qualifies as a manufacturing and business secret under
`
`article 162 SCC provided that the information impacts or relates to the
`
`economic success of a company. 9 Manufacturing secrets cover any
`
`information that is related to the manufacturing of a product and include,
`
`7 Decision of the Swiss Federal Supreme Court, 68_1403/2017, consid. 1.2.1;
`
`Decision of the Swiss Federal Criminal Court, SK 2013.11, consid. 2.1.4.
`
`8 Decision of the Federal Supreme Court, BGE 80 IV 22, consid. 2a; BSK StGB -
`
`NIGGLI/HAGENSTEIN, article 162, N 10.
`
`9 Decision of the Federal Supreme Court, 103 IV 284, consid. 2b; PK StGB -
`
`TRECHSEL/JEAN-RICHARD, article 162, N 6.
`
`6
`
`Novartis Exhibit 2097.007
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`inter alia, manufacturing processes, plans, formulas and inventions. 10
`
`Business secrets encompass for example suppliers, customer lists,
`
`organizational data, calculations of prices, marketing information,
`
`information about the merger or acquisition of a company as well as the
`
`acquisition of licenses for certain production processes. 11
`
`14. The obligation to keep such information secret can derive from a statute or
`
`from a contract. Pursuant to the principle of the freedom of contract, the
`
`parties to a contract are free to agree upon a confidentiality provision. 12
`
`Therefore, the scope and content of the manufacturing or business secrets
`
`depend on the specific content of the confidentiality clause agreed between
`
`Novartis and the respective contractual partner. The contractual secrecy
`
`10 Decision of the Swiss Federal Supreme Court, BGE 103 IV 283, consid. 2b.
`
`11 Decisions of the Swiss Federal Supreme Court, BGE 118 lb 547, consid. 5a;
`
`BGE 103 IV 283, consid. 2b and 2c; BGE 109 lb 47, consid. 5c; 18_284/2012,
`
`consid. 4.3; BGE 141 IV 39, para. A (acquisition of licenses for certain production
`
`processes).
`
`12 Article 19 SCO.
`
`7
`
`Novartis Exhibit 2097.008
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`obligation survives the termination of the contract under which it has been
`
`created. 13
`
`15.To the extent that Novartis has a contractual duty to maintain another party's
`
`business secrets ( e.g., based on contractual confidentiality obligations),
`
`disclosure of such protected information to third parties, such as the PT AB
`
`and Regeneron, would not only result in civil claims against Novartis, but
`
`may also lead to criminal charges against Novartis employees and/or
`
`Novartis counsel pursuant to article 162 SCC.
`
`16. With the aim to allow an efficient but legally compliant production process,
`
`Novartis reviewed its agreements and sought affected third parties' consent
`
`to disclosure.
`
`17.Information constituting manufacturing or business secrets under article 162
`
`SCC has been disclosed unredacted in the sealed versions of the Exhibits in
`
`the Novartis documents (i) if a review of the agreements has been conducted
`
`and revealed that no contractual confidentiality obligation of Novartis exists,
`
`or (ii) if the party protected under the confidentiality obligation has
`
`consented to such disclosure.
`
`13 PK StGB-TRECHSEL/JEAN-RICHARD, article 162, N 7.
`
`8
`
`Novartis Exhibit 2097.009
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`18.As long as third parties have not waived their right to secrecy, the only
`
`legally permissible alternative under Swiss law is to either redact the
`
`protected information or to pursue legal assistance proceedings under the
`
`Hague convention.
`
`19 .In the interest of time and to avoid and delay in the document production,
`
`Novartis has, therefore, under the supervision of our firm, engaged in cost
`
`and labor intensive efforts of redacting information subject to Swiss criminal
`
`law as set for the above.
`
`20. On the basis of article 162 SCC Novartis did not redact information in the
`
`documents produced to protect its own manufacturing or business secrets but
`
`only those of third party entities and individuals.
`
`Personal Data
`
`21. The DP A applies to the processing of personal data in Switzerland ( article 2
`
`(l)(a) DPA). 14
`
`14 ROSENTHAL/JOHRI, Handkommentar zum Datenschutzgesetz, 2008, article 6
`
`DPA, N 15; pursuant to article 2(2)(c) DPA, the DPA does not apply to
`
`international judicial assistance proceedings. Hence, no data protection issue arises
`
`if documents are transferred to US authorities in the context of mutual legal
`
`assistance.
`
`9
`
`Novartis Exhibit 2097.0010
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`22. The term processing of personal data includes any operation related to
`
`personal data, in particular the collection, storage, use, alteration, disclosure,
`
`archiving and destruction of personal data (article 3(g) DPA). The
`
`communication from Switzerland of personal data abroad is considered as
`
`processing of personal data and falls within the ambit of the DP A. The
`
`"physical ownership" of the documents produced is not a relevant criteria for
`
`the DPA's applicability. Therefore, to the extent that documents to be
`
`disclosed to the PT AB or Regeneron contain data relating to third parties or
`
`employees, such disclosure must be in compliance with the DP A.
`
`23.Personal data is defined as all information relating to an identified or
`
`identifiable person (article 3(a) DPA). The DPA provides for an enhanced
`
`standard of protection for so-called "sensitive personal data," a category
`
`encompassing data on religious, ideological, political or trade union-related
`
`views or activities, health, the intimate sphere or the racial origin, social
`
`security measures or administrative or criminal proceedings and sanctions
`
`(article 3( c) DPA). Further, so-called personality profiles benefit from an
`
`additional layer of protection. Personality profiles are defined as collections
`
`of data that permits an assessment of the essential characteristics of the
`
`personality of a natural person (article 3( d) DPA). Human resources files
`
`can be an example of such personality profiles, particularly if they contain
`
`10
`
`Novartis Exhibit 2097.0011
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`CV s, certificates and qualifications with information on employee's
`
`character, interpersonal behavior or other personal characteristics. 15
`
`24.Besides reputational damage, a breach of the DP A gives the aggrieved party
`
`a right to obtain an injunction prohibiting the disclosure of personal data and
`
`the right to claim compensation for the financial prejudice incurred (i.e.,
`
`civil liability for damages). 16 Criminal liability for breach of the DPA
`
`primarily attaches to the unlawful processing of sensitive personal data and
`
`personality profiles. 17
`
`25. The Swiss general data protection principles provide that personal data may
`
`only be processed and thus disclosed abroad in a manner that is transparent
`
`to the affected individuals or entities; for the purpose for which it was
`
`15 ROSENTHAL/JOHRI, 2008, article 6 DPA, N 59.
`
`16 Article 15(1) DPA in connection with article 28a(3) Swiss civil Code ("SCivC")
`
`and article 41 et seq. SCO. The unofficial English translation of the SCivC
`
`provided by the government for information purposes only is available on the
`
`followingwebsite: https://www.admin.ch/opc/en/classified(cid:173)
`
`compilation/19070042/202007010000/210.pdf (last accessed on 18 November
`
`2021).
`
`17 Article 35 DPA.
`
`11
`
`Novartis Exhibit 2097.0012
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`initially collected and that purpose must at least be evident from the
`
`circumstances; and the processing must be proportionate. 18 The principle of
`
`proportionality requires that any type of processing is restricted to what is
`
`necessary.
`
`26.An additional set of duties arises pursuant to article 6 DP A in the event of a
`
`cross-border disclosure of personal data. Pursuant to article 6(1) DPA
`
`personal data must not be disclosed abroad if the privacy of the data subjects
`
`would be seriously endangered thereby, in particular due to the absence of
`
`legislation in the country of destination that guarantees adequate data
`
`protection.
`
`27.From a Swiss perspective, the US is deemed to have inadequate data
`
`protection standards. Therefore, the transfer of personal data to the US per se
`
`constitutes a violation of the data subjects' privacy rights. 19 This has also
`
`18 Article 4(3) and (4) DPA.
`
`19 Decisions of the Swiss Federal Supreme Court, 4A_250/2018, consid. 4 and
`
`4A_83/2016, consid. 3.1; various decisions of the Commercial Court of the Canton
`
`of Zurich, inparticularHG140186-O, consid. 5.3.4; HG150018-O, consid. 2.3.4.3.;
`
`HG150254-O, consid II.1.2.2 or HE190100-O; consid. 6.3.1;
`
`ROSENTHAL/JOHRI, article 6 DP A, N 27.
`
`12
`
`Novartis Exhibit 2097.0013
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`been reiterated by the European Court of Justice under the application of the
`
`GDPR in its recent decision Schrems vs. Facebook. 20
`
`28.Article 6(2) DP A provides for a number of exceptions pursuant to which the
`
`disclosure of personal data from Switzerland to the US may be permissible.
`
`Under subsection ( d) of article 6(2) DP A, such disclosure may be made if it
`
`is essential, in a specific case, for the exercise or enforcement of legal claims
`
`before a court.
`
`29. The application of article 6(2)( d) DP A requires that the disclosure is limited
`
`to information which is indeed necessary for the specific proceedings and
`
`that measures are in place ( e.g., protective orders) prohibiting the use of the
`
`disclosed personal data for any other purpose. 2 1
`
`30.However, making personal data available to the public in the US would no
`
`longer be justified on the basis of article 6(2)( d) DP A and would constitute a
`
`breach of the affected data subjects' privacy rights. In this case, the affected
`
`2° Court of Justice of the European Union, Judgment in Case C-311/18, Data
`
`Protection Commissioner v Facebook Ireland and Maximillian Schrems, 16 July
`
`2020.
`
`21 ROSENTHAL/J6HRI, article 6 DPA, N 67-72.
`
`13
`
`Novartis Exhibit 2097.0014
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`individuals or entities could have the disclosure of their data prohibited by a
`
`Swiss court and claim damages.
`
`31.As an alternative to the full anonymization of all personal data, an
`
`amendment to the protective order can be implemented which ensures that
`
`documents including personal data will not be filed to any public record. We
`
`understand that in this proceeding such protective order has not been
`
`implemented and that there is, thus, a risk that even the sealed version of the
`
`documents which contain personal data could be made accessible to the
`
`public. Therefore, in compliance with Swiss law, all personal data of
`
`employees or third party individuals have been redacted, unless the affected
`
`employee has provided Novartis with a consent to disclose its information
`
`pursuant to article 6(2)(b) DP A.
`
`Novartis's Exhibits
`
`32.I have reviewed the public and sealed versions of Exhibits 2002, 2063, 2064,
`
`and 2066-2088, and I confirm that these documents contain information that
`
`is protected from disclosure under Swiss law.
`
`33.The information that is redacted in the sealed versions of Exhibits 2063,
`
`2064, and 2066-2088 contains either business secrets of a third party who
`
`did not provide consent to disclosure of its information or personal data
`
`14
`
`Novartis Exhibit 2097.0015
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`protected by the DP A from individuals who have not provided consent to
`
`disclose.
`
`34.Additionally, there is additional information redacted from the public
`
`versions of Exhibits 2002, 2063, 2064, and 2066-2088 that relates to the
`
`business secrets of third parties and/or personal data from individuals that
`
`consented to disclosure of their information, but did so under an agreement
`
`that the information would be restricted to those involved with the
`
`proceeding under a protective order.
`
`35.Therefore, Novartis's redactions of third party business secrets and personal
`
`data in Exhibits 2002, 2063, 2064, and 2066-2088 are in accordance with
`
`Swiss privacy laws.
`
`I, Martina Athanas, hereby declare that the foregoing Declaration is true and
`
`correct.
`
`, ated:
`
`Martina Athanas
`
`15
`
`Novartis Exhibit 2097.0016
`Regeneron v. Novartis, IPR2021-00816
`
`
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