Paper No. 22
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: November 30, 2021
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`______________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Second Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: November 30, 2021
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`______________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Second Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`Introduction
`
`Novartis Pharma AG, Novartis Technology LLC, and Novartis
`Pharmaceuticals Corporation (collectively, “Novartis” or “Patent Owner”)
`filed a Second Motion to Seal Exhibits 2002, 2063, 2064, and 2066–2088.
`Paper 18, 1 (“Sec. Mot.”). Along with the Second Motion, Novartis filed
`redacted public versions of Exhibits 2063–2064 and 2066–2088.1 We
`denied an earlier unopposed motion to seal but granted leave to file the
`current amended motion before us. See Paper 15, 10 (holding Patent
`Owner’s Motion to Seal (Paper 10) is denied without prejudice). For the
`reasons set forth below, Patent Owner’s Second Motion is granted.
`Motion to Seal
`“There is a strong public policy for making all information filed in a
`
`quasi-judicial administrative proceeding open to the public.” Garmin Int’l v.
`Cuozzo Speed Techs., LLC, IPR2012–00001, slip op. at 1–2 (PTAB Mar. 14,
`2013) (Paper 34). The record for an inter partes review shall be made
`available to the public, except as otherwise ordered, and a document filed
`with a motion to seal shall be treated as sealed until the motion is decided.
`35 U.S.C. § 326(a)(1); 37 C.F.R. § 42.14. The standard for granting a
`motion to seal is “good cause.” 37 C.F.R. § 42.54; see also Argentum
`Pharms. LLC v. Alcon Res., Ltd., IPR2017-01053, Paper 27 at 3–4 (PTAB
`Jan. 19, 2018) (Informative) (describing the “good cause” standard). The
`moving party bears the burden of showing that the relief requested should be
`granted. 37 C.F.R. § 42.20(c). That includes showing that the information
`is truly confidential, and that such confidentiality outweighs the strong
`
`
`1 Novartis filed a redacted public version of Exhibit 2002 with its Patent
`Owner Preliminary Response.
`
`
`
`2
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`public interest in having an open record. See Argentum, Paper 27 at 3–4
`(“[A] movant to seal must demonstrate adequately that (1) the information
`sought to be sealed is truly confidential, (2) a concrete harm would result
`upon public disclosure, (3) there exists a genuine need to rely in the trial on
`the specific information sought to be sealed, and (4), on balance, an interest
`in maintaining confidentiality outweighs the strong public interest in having
`an open record.”).
`Novartis seeks to seal Exhibits 2002, 2063, 2064, and 2066–2088,
`which purportedly “contain Novartis’s confidential research and
`development information, confidential information of third parties, and
`employee personal information.” Sec. Mot. 3. Novartis states that “the
`information sought to be sealed has not been published or otherwise made
`public,” and such “disclosure of Novartis’s confidential information would
`competitively harm Novartis’s business prospects and put Novartis at a
`competitive disadvantage.” Id. at 2. Novartis relies on the accompanying
`declaration of Martina Athanas, which also details the requirements
`established by Articles 162 and 273 of the Swiss Criminal Code (“SCC”)
`that prohibit the unauthorized disclosure or communication of certain
`manufacturing and employee information. Ex. 2097; Sec. Mot. 4. We find
`Patent Owner’s showing persuasive and further address each set of exhibits
`below.
`
`Exhibit 2002 (Declaration of Marie Picci)
`Exhibit 2002 is a declaration of named inventor Marie Picci. Sec.
`Mot. 3. As noted above, Novartis filed a corresponding redacted public
`version of Exhibit 2002. The Second Motion avers that the redacted
`information pertains to “two categories of confidential information in
`
`
`
`3
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`Exhibit 2002 that Novartis seeks to seal: (1) Novartis’s proprietary research
`and development information, and (2) confidential information of third
`parties.” Id. Novartis explains how this information is pertinent to key
`issues in this proceeding such as conception and reduction to practice in
`order to predate alleged prior art references. Id.
`The Second Motion explains how the first category of confidential
`information pertains to Novartis’s research and development work related to
`the subject matter of the ’631 patent. Sec. Mot. 3. Novartis explains how
`the information includes specific quantitative and qualitative details
`regarding the development of the subject matter, such as dosage accuracy
`testing, syringe components under investigation, break-loose and slide force
`testing, particle testing, siliconization process, terminal sterilization process,
`and syringe packaging. Id. at 3–4.
`The second category of confidential information pertains to portions
`of Exhibit 2002 that contain third party confidential information that
`Novartis is legally obligated to protect from public disclosure because
`Novartis Pharma AG is a company organized under and governed by the
`laws of Switzerland. Id. at 4. Relying on the Declaration of Martina
`Athanas (Ex. 2097), Novartis details how and why certain information must
`be maintained as confidential to comply with Swiss law. Id. For example,
`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.
`Novartis’ declarant, who aided in the Swiss compliance review and
`redaction of the documents presented in Exhibits 2002, 2063, 2064, and
`
`
`
`4
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`2066–2088, testifies that 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. Ex. 2097 ¶¶ 3–5, 34.
`We find this testimony persuasive.
`We determine that Novartis has established good cause for redacting
`the information it seeks to keep confidential in Exhibit 2002. Novartis has
`proven that the information is truly confidential, pertinent to the ongoing
`trial, and that such confidentiality outweighs the strong public interest in
`having an open record.
`
`Exhibits 2063 and 2064
`Exhibit 2063 is an internal Novartis PowerPoint presentation, and
`Exhibit 2064 is a technical report authored by a named inventor. Sec.
`Mot. 6. The Second Motion avers that “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.” For similar reasons as
`noted above, Novartis relies on these documents in support of its argument
`that it conceived and reduced to practice the subject matter claimed in the
`’631 patent prior to the publication of certain alleged prior art. Id.
`Novartis explains how Exhibits 2063 and 2064 contain details
`pertaining to Novartis’s research and development work related to the
`subject matter of the ’631 patent, and thus how the information is
`confidential research and development information. Id. at 7. Novartis
`provides pinpoint cites and shows that the “information includes the
`technical data generated from experiments on terminal sterilization and
`
`
`
`5
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`siliconization, the reasoning behind selecting certain components of the pre-
`filled syringe and syringe design, details on optimizing dosing accuracy, and
`particle testing.” Id. (citing Ex. 2063, 3, 8–10, 18, 57; Ex. 2064, 6–8, 17–
`18).
`
`Novartis provides additional citation and explanation as to how
`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. Sec. Mot. 7 (citing Ex. 2063, 53, 93, 96;
`Ex. 2064, 12). Novartis further explains that “[t]he confidential information
`redacted from Exhibit 2063 also relates to the contractual relationships
`between Novartis and a number of third parties in its research, development,
`and manufacturing processes.” Id. at 7–8 (citing Ex. 2063, 64, 82, 96).
`Novartis, relying on the testimony of Martina Athanas, also contends that
`Exhibits 2063 and 2064 contain information from third parties who did not
`authorize disclosure of their information in these proceedings and Novartis
`is not legally permitted to disclose confidential information related to those
`parties that did not provide consent. Id. (citing Ex. 2097 ¶¶ 9–11, 15, 33).
`Finally, as a Swiss employer, Novartis has a legal duty to protect
`personal data of employees, and certain redactions in Exhibits 2063 and
`2064 relate to the identity of a Novartis employee who approved the
`technical report as well as Novartis and third-party employees who authored
`other reports listed in Section 7 of Exhibit 2064. Id. at 7–8. (citing
`Ex. 2063, 1; Ex. 2064, 41–42; Ex. 2097 ¶¶ 4, 23–26, 28–31).
`
`
`
`6
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`We determine that Novartis has established good cause for redacting
`the information it seeks to keep confidential in Exhibits 2063 and 2064.
`Novartis has proven that the information is truly confidential, pertinent to
`the ongoing trial, and that such confidentiality outweighs the strong public
`interest in having an open record.
`Exhibits 2066–2088
`Exhibits 2066–2088 are Patent Owner’s team Meeting Minutes. Sec.
`Mot. 10. Novartis contends that these Meeting Minutes are related to the
`development of the ’631 patent, and they demonstrate Novartis’s diligence
`from the date of conception to the date of reduction to practice. Id. Again,
`Novartis seeks to establish Novartis conceived of the subject matter claimed
`in the ’631 patent prior to the publication of alleged prior art and diligently
`worked to reduce the subject matter to practice. Id. at 10–11. Similar to
`above, 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.”
`Id. at 11.
`We have considered Patent Owner’s evidence and explanation for
`each of these three categories of confidential information, and for the same
`reasons already highlighted above, we find the arguments persuasive.
`Specifically, we agree that “[g]ood 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. Sec. Mot. 13. Finally, we
`agree “there is good cause to seal the personal information of individuals
`
`
`
`7
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`employed by Novartis and third parties based on obligations under Swiss
`privacy laws.” Id.
`
`Conclusion
`In reviewing the Second Motion as well as Exhibits 2002, 2063, 2064,
`and 2066–2088, we are persuaded of good cause to seal these exhibits.
`Novartis has provided the public with redacted versions of these exhibits that
`establish the context without disclosing the confidential information sought
`to be protected. Accordingly, we grant Patent Owner’s Second Motion to
`Seal the unredacted versions of Exhibits 2002, 2063, 2064, and 2066–2088.
`
`
`Order
`
`Accordingly, it is:
`ORDERED that Patent Owner’s Second Motion to Seal (Paper 18) is
`granted, and the unredacted versions of Exhibits 2002, 2063, 2064, and
`2066–2088 shall remain under seal.
`
`
`
`
`
`
`
`
`
`
`
`
`8
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`For PETITIONER:
`Elizabeth Weiswasser
`Anish Desai
`Brian Ferguson
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`brian.ferguson@weil.com
`christopher.pepe@weil.com
`
`For PATENT OWNER:
`Elizabeth Holland
`William James
`Linnea Cipriano
`Joshua Weinger
`GOODWIN PROCTER LLP
`eholland@goodwinprocter.com
`wjames@goodwinlaw.com
`lcipriano@goodwinlaw.com
`jweinger@goodwinprocter.com
`
`
`
`
`
`9
`
`
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