UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`__________
`
`Case IPR2021-00816
`Patent 9,220,631
`
`__________
`
`PATENT OWNERS’ SECOND MOTION TO SEAL
`
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`__________
`
`Case IPR2021-00816
`Patent 9,220,631
`
`__________
`
`PATENT OWNERS’ SECOND MOTION TO SEAL
`
`
`
`U.S. Patent No. 9,220,631
`Patent Owners Novartis Pharma AG, Novartis Technology LLC, and
`
`Novartis Pharmaceuticals Corporation (collectively, “Novartis”) respectfully renew
`
`their request that the Board seal Exhibits 2002, 2063–2064, and 2066–2088, which
`
`contain Novartis’s confidential research and development information, confidential
`
`information of third parties, and employee personal information. On October 28,
`
`2021, the Board granted Novartis’s motion for entry of a modified protective order,
`
`but denied Novartis’s first motion to seal. See IPR2021-00816, Paper No. 15. In
`
`its denial, the Board invited Novartis to file a second motion to seal with additional
`
`information. See id. at 7. Novartis addresses these issues in this renewed motion.
`
`In determining whether to grant a Motion to Seal, the Board must find “good
`
`cause” to seal the information in question and “strike a balance between the
`
`public’s interest in maintaining a complete and understandable file history and the
`
`parties’ interest in protecting truly sensitive information.” 37 C.F.R. § 42.54(a);
`
`Consolidated Trial Practice Guide November 2019 at 19. As described in the
`
`Consolidated Trial Practice Guide, the Board identifies confidential information in
`
`a manner “consistent with Federal Rule of Civil Procedure 26(c)(1)(G), which
`
`provides for protective orders for trade secret or other confidential research,
`
`development, or commercial information.” Id.
`
`The information that Novartis seeks to seal in this motion is either
`
`confidential research and development related to the subject matter of U.S. Patent
`
`
`
`U.S. Patent No. 9,220,631
`
`No. 9,220,631 (“the ’631 patent”) or is subject to contractual or statutory
`
`obligations of confidentiality to third party companies or individuals, as explained
`
`in more detail below. To the undersigned’s knowledge, the information sought to
`
`be sealed has not been published or otherwise made public. Public disclosure of
`
`Novartis’s confidential information would competitively harm Novartis’s business
`
`prospects and put Novartis at a competitive disadvantage relative to other similarly
`
`positioned companies in the same industry. In addition, we are advised by Swiss
`
`counsel that public disclosure of the third party confidential information or
`
`personal information of employees could subject Novartis to civil and criminal
`
`penalties under the laws of Switzerland. As such, good cause exists to seal the
`
`confidential versions of Exhibits 2002, 2063–2064, and 2066–2088.
`
`Novartis publicly filed a redacted version of Exhibit 2002 with its Patent
`
`Owner Preliminary Response (“POPR”). With this motion, Novartis is publicly
`
`filing redacted versions of Exhibits 2063–2064, and 2066–2088.1 These redactions
`
`are narrowly tailored to protect the confidential information of Novartis and third
`
`parties, and the personal information of employees, from public disclosure.
`
`1 Novartis previously requested that Exhibits 2063–2064, and 2066–2088 be sealed
`
`in their entirety, but is currently submitting redacted public versions.
`
`2
`
`
`
`U.S. Patent No. 9,220,631
`
`Exhibit 2002 (Picci Declaration)
`
`Exhibit 2002 is the Declaration of Marie Picci, a named inventor on the ’631
`
`patent. Novartis relies on Exhibit 2002 to support its argument that neither
`
`Chacornac (Ex. 1014)2 nor Wolgemuth (Ex. 1072)3 is prior art to the ’631 patent
`
`because Novartis conceived of the invention claimed in the ’631 patent prior to the
`
`publication of Chacornac and Wolgemuth, and diligently worked to reduce the
`
`invention to practice. See, e.g., Ex. 2002.005–.007, .009–.013; POPR at 42, 48.
`
`There are two categories of confidential information in Exhibit 2002 that
`
`Novartis seeks to seal: (1) Novartis’s proprietary research and development
`
`information, and (2) confidential information of third parties.
`
`First, portions of Exhibit 2002 contain information pertaining to Novartis’s
`
`research and development work related to the subject matter of the ’631 patent, and
`
`are therefore “confidential research [and] development . . . information” pursuant
`
`to FRCP 26(c)(1)(G). This work includes specific quantitative and qualitative
`
`details regarding the development of the subject matter claimed in the ʼ631 patent,
`
`such as dosage accuracy testing, syringe components under investigation, break-
`
`2 Chacornac (Ex. 1014) is a patent application filed on October 17, 2011 and
`
`published on April 19, 2012.
`
`3 Wolgemuth (Ex. 1072) is a reference dated October 2011.
`
`3
`
`
`
`U.S. Patent No. 9,220,631
`
`loose and slide force testing, particle testing, siliconization process, terminal
`
`sterilization process, and syringe packaging. See, e.g., Ex. 2002.006–.008, .0017–
`
`.0032. Public disclosure of this information would harm Novartis because insight
`
`into its research and development processes would provide a competitive
`
`advantage to Novartis’s competitors to Novartis’s detriment.
`
`Second, portions of Exhibit 2002 that Novartis seeks to seal contain third
`
`party confidential information that Novartis is legally obligated to protect from
`
`public disclosure. Novartis Pharma AG is a company organized under and
`
`governed by the laws of Switzerland. As set forth in the accompanying declaration
`
`of Martina Athanas, Articles 162 and 273 of the Swiss Criminal Code (“SCC”)
`
`prohibit the unauthorized disclosure or communication of manufacturing or
`
`business secrets to third parties, including foreign authorities, the opposing party or
`
`its counsel. Exhibit 2097, Declaration of Martina Athanas, ¶¶ 4, 8, 10. These
`
`provisions are designed to protect manufacturing and business secrets of entities
`
`and individuals against unauthorized disclosure by persons bound to confidentiality
`
`by contract or by law. Id. ¶¶ 8–14. Any information qualifies as manufacturing
`
`and business secrets under the SCC provided that the information impacts or
`
`relates to the economic success of a company. Id. ¶ 13. Swiss law protects all
`
`information relating to a company’s manufacturing and production process and any
`
`other elements of economic life over which the owner of a secret is presumed to
`
`4
`
`
`
`U.S. Patent No. 9,220,631
`
`have an interest in confidentiality. Id. These provisions, inter alia, prohibit
`
`disclosure of information regarding a companies’ manufacturing processes, plans,
`
`formulas, inventions, suppliers, organizational data, and information related to
`
`business relationships between companies. Id.
`
`Under Articles 162 and 273, Novartis is prohibited from disclosing such
`
`confidential information related to a third party unless the third party consents to
`
`that disclosure or the disclosure is made during legal assistance proceedings under
`
`the applicable Hague evidence convention. Id. ¶ 5. In connection with this
`
`proceeding and the related litigations, Novartis has diligently sought consent to
`
`disclose the information of the third parties referenced in Novartis’s documents.
`
`Id. ¶ 16. The companies that provided consent for Novartis to disclose their
`
`information in these proceedings did so only under an agreement that Novartis
`
`would disclose this information in such a way that would protect the information
`
`from public disclosure. Id. ¶ 34.
`
`The third party confidential information in Exhibit 2002 that Novartis seeks
`
`to seal includes information regarding Novartis’s business relationships with a
`
`third party and details of that third party’s syringe filling services. See, e.g., Ex.
`
`2022.0017–.0021. This information falls squarely within the manufacturing and
`
`business secrets covered by Articles 162 and 273. See Ex. 2097, ¶ 13. While the
`
`third party provided consent for Novartis to use its information in this proceeding,
`
`5
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`
`
`U.S. Patent No. 9,220,631
`
`Novartis is still obligated pursuant to provisions of the SCC to protect the third
`
`party’s information from public disclosure. Ex. 2097, ¶ 34. Novartis may be
`
`exposed to criminal penalties under the SCC and civil liabilities if this information
`
`is not sealed. Id. ¶ 15.
`
`Therefore, good cause exists to seal the confidential version of Exhibit 2002
`
`due to the presence of Novartis’s confidential information and confidential
`
`information from a third party, the disclosure of which would put Novartis and the
`
`third party at a competitive disadvantage.
`
`Exhibits 2063 & 2064
`
`Exhibit 2063 is an internal Novartis PowerPoint presentation, and Exhibit
`
`2064 is a technical report authored by a named inventor. Novartis relies on these
`
`documents in support of its argument that neither Chacornac nor Wolgemuth is
`
`prior art to the ’631 patent because Novartis conceived of the invention claimed in
`
`the ’631 patent prior to the publication of Chacornac and Wolgemuth and
`
`diligently worked to reduce the invention to practice. See, e.g., Ex. 2002.005–.007,
`
`.009–.013; POPR at 42, 48.
`
`In these exhibits, Novartis seeks to seal three categories of information: (1)
`
`Novartis’s proprietary development information, (2) business information of third
`
`parties, and (3) personal information of Novartis and third party employees.
`
`6
`
`
`
`U.S. Patent No. 9,220,631
`
`First, Exhibits 2063 and 2064 contain details pertaining to Novartis’s
`
`research and development work related to the subject matter of the ’631 patent, and
`
`is therefore “confidential research [and] development . . . information” pursuant to
`
`Fed. R. Civ. P. 26(c)(1)(G). This information includes the technical data generated
`
`from experiments on terminal sterilization and siliconization, the reasoning behind
`
`selecting certain components of the pre-filled syringe and syringe design, details
`
`on optimizing dosing accuracy, and particle testing. See, e.g., Ex. 2063.003, .008–
`
`.0010, 0018., .0057; Ex. 2064.006–008, .0017–.0018. Public disclosure of this
`
`information would harm Novartis because insight into its research and
`
`development processes would provide a competitive advantage to Novartis’s
`
`competitors to Novartis’s detriment.
`
` Second, Exhibits 2063 and 2064 include third party information regarding
`
`the confidential manufacturing process of the pre-filled syringe, such as details
`
`regarding the sterilization and siliconization process, relationships between
`
`Novartis and third parties related to the manufacture, packaging, and
`
`commercialization of the pre-filled syringe, and the types of syringes used in
`
`generating experimental data. See, e.g., Ex. 2063.0053, .0093, .0096; Ex.
`
`2064.0012. The confidential information redacted from Exhibit 2063 also relates
`
`to the contractual relationships between Novartis and a number of third parties in
`
`7
`
`
`
`U.S. Patent No. 9,220,631
`
`its research, development, and manufacturing processes. See, e.g., Ex. 2063.0064,
`
`.0082, .0096
`
` As discussed above, because Novartis is a Swiss-based company and
`
`because disclosure is made out of Switzerland, it is required under Swiss law to
`
`protect manufacturing and business secrets under Articles 162 and 273 of the SCC.
`
`Some of the third parties referenced in Exhibits 2063 and 2064 consented to
`
`disclosure of their information in this proceeding pursuant to a protective order, as
`
`addressed above. As such, this information is redacted in the public versions of
`
`Exhibits 2063 and 2064, but is unredacted in the versions filed under seal.
`
`Exhibits 2063 and 2064 also contain information from third parties who did
`
`not authorize disclosure of their information in these proceedings. Novartis is not
`
`legally permitted to disclose confidential information related to those parties that
`
`did not provide consent and could be subject to criminal penalties if this
`
`information is disclosed to unauthorized third parties, regardless of whether a
`
`protective order is in place. Ex. 2097, ¶¶ 9–11, 15, 33. Thus, information related
`
`to third parties that did not provide consent to disclosure is redacted in both the
`
`public and sealed versions of Exhibits 2063 and 2064. See, e.g., Ex. 2063.0093,
`
`.0096, .0098, .0107; Ex. 2064.002, .005, .006, .011, .020.
`
`Third, Exhibits 2063 and 2064 contain redactions that include the identity
`
`of a Novartis employee who approved the technical report as well as Novartis and
`
`8
`
`
`
`U.S. Patent No. 9,220,631
`
`third-party employees who authored other reports listed in Section 7 of Exhibit
`
`2064. See, e.g., Ex. 2063.001; Ex. 2064.0041–.0042.
`
`As a Swiss employer, Novartis has a legal duty to protect personal data of
`
`employees under the Swiss Data Protection Act (“DPA”) and the Swiss Code of
`
`Obligations (“SCO”). Ex. 2097, ¶ 4. The DPA protects all personal data of an
`
`employee, which includes all information relating to an identified or identifiable
`
`person. Id. ¶ 23, 24. This protection extends to job titles and company
`
`responsibilities. Information that, if combined, could permit an assessment of the
`
`essential characteristics of the personality of a natural person (a so-called
`
`“personality profile” under Article 3(d) of the DPA) benefit from an even higher
`
`layer of protection. Id. For example, CVs, certificates, resumes and qualifications
`
`with information on employee's character, interpersonal behavior or other personal
`
`characteristics would fall into this category. Id. The DPA also prohibits disclosure
`
`of personal information to the US unless the disclosing party complies with the
`
`general and special duty of care under Swiss law, e.g., if the employee consents to
`
`disclosure. Id. ¶¶ 6, 25–26, 28.
`
`As a result, Novartis is prohibited from disclosing information related to its
`
`employees, unless the employee consents to such disclosure or if such disclosure is
`
`essential, in a specific case, for the exercise or enforcement of legal claims before a
`
`court. Id. ¶¶ 28–30. The application of this exception in the DPA, however,
`
`9
`
`
`
`U.S. Patent No. 9,220,631
`
`requires that measures are in place (e.g., a protective order) prohibiting the use of
`
`the disclosed personal data for any other purpose and which, in particular, ensures
`
`that documents containing personal data will not be made public under any
`
`circumstances. Id. The protective order in place in these proceedings does not
`
`provide sufficient protection. Id. ¶ 31. The employee information that is redacted
`
`from both the sealed and public versions of Exhibits 2063 and 2064 relates to
`
`employees who did not provide consent, and therefore, public disclosure of this
`
`information may expose Novartis to criminal sanctions and civil liability under
`
`both the DPA and the SCO. See, e.g., Ex. 2063.001; Ex. 2064.0041–.0042.
`
`Thus, good cause exists to seal the confidential versions of Exhibits 2063
`
`and 2064 due to the presence of Novartis’s confidential information and
`
`confidential information of third parties, the disclosure of which would put
`
`Novartis and the third party at a competitive disadvantage. Additionally, there is
`
`good cause to seal the personal information of individuals employed by Novartis
`
`and third parties based on obligations under Swiss privacy laws.
`
`Exhibits 2066–2088
`
`Exhibits 2066–2088 are Meeting Minutes for Novartis team meetings related
`
`to the development of the ’631 patent, which demonstrate Novartis’s diligence
`
`from the date of conception to the date of reduction to practice. Novartis relies on
`
`these documents to support its argument that neither Chacornac nor Wolgemuth is
`
`10
`
`
`
`U.S. Patent No. 9,220,631
`
`prior art to the ’631 patent because Novartis conceived of the invention claimed in
`
`the ’631 patent prior to the publication of Chacornac and Wolgemuth and
`
`diligently worked to reduce the invention to practice. See, e.g., Ex. 2002.0017–
`
`.0032; POPR at 42, 48.
`
`Here again, Novartis seeks to seal three categories of information: (1)
`
`Novartis’s proprietary development information, (2) business information of third
`
`parties, and (3) personal information of Novartis and third party employees.
`
`First, Exhibits 2066–2088 contain Novartis internal communications
`
`pertaining to research and development activities related to the subject matter of
`
`the ’631 patent, and are therefore “confidential research [and] development . . .
`
`information” pursuant to Fed. R. Civ. P. 26(c)(1)(G). Exhibits 2066–2088 contain
`
`proprietary information regarding details on Novartis’s research strategy, such as
`
`the evaluation of physiochemical properties of the drug products and discussions
`
`on project feedback. See, e.g., Ex. 2066.001–.003; Ex. 2075.001–.005; Ex.
`
`2086.001–.006. Public disclosure of this information would harm Novartis
`
`because insight into its research and development processes would provide a
`
`competitive advantage to Novartis’s competitors to Novartis’s detriment.
`
`Second, Exhibits 2066–2088 also contain confidential information of third
`
`parties and should not be subject to public disclosure, including, for example, third
`
`party information regarding sterilization processes and timelines (Ex. 2070.003;
`
`11
`
`
`
`U.S. Patent No. 9,220,631
`
`Ex. 2082.005); third party information regarding filling sampling plans and
`
`technical runs (Ex. 2070.004); and third party lab trials and validation testing (Ex.
`
`2072.001; Ex. 2076.003).
`
`As discussed above, because Novartis is a Swiss-based company and
`
`because disclosure is made out of Switzerland, it is required under Swiss law to
`
`protect manufacturing and business secrets under Articles 162 and 273 of the SCC.
`
`While one of the third parties named in these documents provided consent to
`
`disclosure in this proceeding, Novartis remains obligated under contract and
`
`pursuant to provisions of the SCC to protect the third party’s information from
`
`public disclosure by making the documents available only under a protective order.
`
`Additionally, not all third parties referenced in these documents have
`
`authorized disclosure of their information. As discussed above, Novartis is legally
`
`obligated to prevent disclosure of information related to parties that did not provide
`
`consent, and could be subject to civil liabilities and criminal penalties if this
`
`information is disclosed to unauthorized third parties, regardless of whether a
`
`protective order is in place. Thus, information related to the third parties that did
`
`not provide consent to disclosure is redacted in the public and sealed versions of
`
`Exhibits 2066–2088. See, e.g., Ex. 2082.001; Ex. 2084.001.
`
`Third, Exhibits 2066–2088 contain personal information of Novartis and
`
`third party employees, including the identities of Novartis and third party
`
`12
`
`
`
`U.S. Patent No. 9,220,631
`
`employees and their roles and responsibilities. As discussed above, Novartis is
`
`legally obligated to prevent the public disclosure of employee information, and
`
`public disclosure of this information may expose Novartis to criminal sanctions
`
`and civil liability under the DPA and the SCO. Therefore, pursuant to those Swiss
`
`laws, personal information regarding Novartis and third party employees is
`
`redacted in both the public and sealed versions of these exhibits. See, e.g., Ex.
`
`2066.01; Ex. 2067.001; Ex. 2068.003; Ex. 2069.01.
`
`Good cause exists to seal Exhibits 2066–2088 due to the presence of
`
`Novartis’s confidential information and confidential information of third parties,
`
`the disclosure of which would put Novartis and the third party at a competitive
`
`disadvantage. Additionally, there is good cause to seal the personal information of
`
`individuals employed by Novartis and third parties based on obligations under
`
`Swiss privacy laws.
`
`*
`
`*
`
`*
`
`The information redacted from the public versions of Exhibits 2002, 2063–
`
`2064, and 2066–2088 is not essential to an understanding of the accompanying
`
`POPR and does not impede the public’s understanding of the file history of the
`
`’631 patent. Novartis’s public filing sets forth its argument that Novartis
`
`conceived of the invention claimed in the ’631 patent prior to the publication of
`
`Chacornac and Wolgemuth and diligently worked to reduce the invention to
`
`13
`
`
`
`U.S. Patent No. 9,220,631
`
`practice. See, e.g., POPR at 42, 48. The information that Novartis seeks to seal
`
`provides evidence supporting Novartis’s position, and this type of information is
`
`routinely sealed in IPR proceedings. See, e.g., Array Biopharma, Inc. v. Takeda
`
`Pharm. Co. Ltd., IPR2015-00754, Paper No. 62, at 3–6 (Aug. 12, 2016) (granting
`
`petitioner’s revised motion to seal exhibits covering the conception of the patent-
`
`at-issue, including the testing and synthesis of biologic compounds); Wright Med.
`
`Tech., Inc. v. Biomed. Enters., Inc., IPR2015-00786, Paper No. 37, at 2–3 (May 3,
`
`2016) (granting petitioner’s motion to seal exhibits covering confidential
`
`manufacturing details and product design); Masterimage 3D Inc. & Masterimage
`
`3D Asia, LLC, v. Reald, Inc., IPR2015-00035, Paper No. 79 at 20–21 (Apr. 20,
`
`2016) (granting Patent Owner’s Amended Motion to Seal exhibits regarding
`
`designs and concepts the Patent Owner considered, but did not commercially
`
`pursue due to technical and business reasons). Here, Novartis’s interest in
`
`maintaining its proprietary research and development information as confidential
`
`and its obligations of secrecy under Swiss privacy laws outweigh the public’s
`
`interest in accessing this information for the purposes of the patentability of the
`
`challenged claims in this proceeding. Accordingly, Novartis respectfully requests
`
`that the Board grant Patent Owners’ Second Motion to Seal Exhibits 2002, 2063–
`
`2064, and 2066–2088.
`
`14
`
`
`
`Dated: November 19, 2021
`
`U.S. Patent No. 9,220,631
`
`
`/Elizabeth J. Holland/
`By:
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
`
`15
`
`
`
`U.S. Patent No. 9,220,631
`CERTIFICATE OF SERVICE
`A copy of this Patent Owners’ Second Motion to Seal has been served on
`
`Petitioner’s attorneys of record as follows via electronic mail on this 19th day of
`
`November 2021:
`
`Elizabeth Stotland Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg No. 73,760)
`Natalie Kennedy (Reg No. 68,511)
`Andrew Gesior (Reg No. 76,588)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`Regeneron.IPR.Service@weil.com
`
`Brian E. Ferguson (Reg No. 36,801)
`Christopher M. Pepe (Reg No. 73,851)
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`Regeneron.IPR.Service@weil.com
`Attorneys for Regeneron Pharmaceuticals, Inc.
`
`Dated: November 19, 2021
`
`
`/Elizabeth J. Holland/
`By:
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
`
`
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