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`IPR2020-00324
`Patent 8,114,833
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`MYLAN INSTITUTIONAL LLC,
`Petitioner,
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`v.
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`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-00324
`Patent 8,114,833
`______________
`
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`PATENT OWNER’S MOTION TO SEAL AND FOR ENTRY OF A
`PROTECTIVE ORDER PURSUANT TO 37 C.F.R. § 42.54
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`IPR2020-00324
`Patent 8,114,833
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`Patent Owner Novo Nordisk A/S (“Novo Nordisk”) hereby moves for entry
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`of the Protective Order appended as Addendum A and further moves to seal its
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`Patent Owner Response and certain Exhibits, including two declarations, submitted
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`with its Patent Owner Response as described herein. Novo Nordisk and Petitioner
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`Mylan Institutional LLC (“Mylan”) have discussed this Motion, and Mylan does not
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`oppose this Motion.
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`I. MOTION FOR ENTRY OF A PROTECTIVE ORDER
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`Pursuant to 37 CFR § 42.54(a), a motion to seal must be accompanied by a
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`proposed protective order and a certification that the parties have met-and-conferred
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`regarding the issue. On September 16, 2020 and September 18, 2020, Novo Nordisk
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`emailed counsel for Mylan to notify Mylan of Novo Nordisk’s intent to file the
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`Motion and propose that the parties adopt the Board’s default protective order
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`(appended as Addendum A). Mylan had no objections to the requests made in this
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`Motion. Novo Nordisk respectfully requests that the Board’s default protective
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`order be entered in this proceeding.
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`II. MOTION TO SEAL
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`Pursuant to the stipulated protective order and 37 C.F.R. §§ 42.54 and 42.55,
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`Novo Nordisk moves to seal (i) its Patent Owner Response submitted concurrently
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`with this motion; (ii) the Declarations of Peter M. Tessier, Ph.D. (Ex2022) and
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`Dorthe Kot Engelund (Ex2023), submitted in support of its Patent Owner Response;
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`and (iii) the following additional Exhibits submitted in support of its Patent Owner
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`IPR2020-00324
`Patent 8,114,833
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`Response:
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`• Exhibits 2050-53
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`• Exhibits 2055-60
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`• Exhibits 2062-75
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`Novo Nordisk has also concurrently with this Motion filed redacted, non-
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`confidential versions of the Patent Owner Response (Paper 21) and the Declaration
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`of Peter M. Tessier, Ph.D. (Ex2080), which Novo Nordisk consents may be made
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`available on the public docket. The Declaration of Dorthe Kot Engelund (Ex2023)
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`and Exhibits 2050-53, 2055-60, and 2062-75, however, are confidential in their
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`entirety and are submitted to the Board with this motion for filing under seal. Novo
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`Nordisk is serving Mylan, concurrently with this Motion, copies of all Papers and
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`Exhibits being filed today, including those under seal, as well as redacted non-
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`confidential versions of Paper 21 and Exhibit 2080.
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`The standard for granting a motion to seal is “for good cause.” 37 C.F.R. §
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`42.54. Good cause exists here because the Patent Owner Response and Exhibits that
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`are the subject of this Motion contain confidential, non-public research and
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`development information in the form of proprietary clinical and scientific data. See
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`also, e.g. Ex2024 at ¶¶ 7-16 (establishing Ex2051, Ex2055, Ex2057, Ex2058,
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`Ex2059, Ex2060, Ex2064, Ex2068, and Ex2072 as Novo Nordisk business records);
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`-2-
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`Ex2025 at ¶¶ 7-9 (establishing Ex2068 as a Novo Nordisk business record). In other
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`IPR2020-00324
`Patent 8,114,833
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`inter partes review proceedings, the Board has held that confidential information
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`similar to the information in Novo Nordisk’s Patent Owner Response and Exhibits
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`thereto should remain under seal. See, e.g. Apotex Inc. v. Wyeth LLC, IPR2014-
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`00115, Paper 93 (PTAB Apr. 20, 2015) (granting motion to seal with respect to
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`confidential research and development documents that were not publicly available);
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`Celltrion, Inc. v. Genentech, Inc., IPR2016-01667, Paper 20 (PTAB Aug. 18, 2017)
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`(granting motion to seal with respect to “non-public research development
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`information in the form of proprietary clinical and scientific data concerning
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`rituximab, and confidential information about drug development and regulatory
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`approval strategies”). Moreover, the public policy for making all information filed
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`in inter partes review proceedings available to the public should not apply here
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`because the information that Novo Nordisk requests to keep confidential does not
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`affect the rights of the public.
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`III. CONCLUSION
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`For the foregoing reasons, Novo Nordisk respectfully requests that the Board
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`grant this motion to seal and for entry of a protective order.
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`-3-
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`Dated: September 18, 2020
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`IPR2020-00324
`Patent 8,114,833
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`Respectfully submitted,
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`/s/ Jeffrey J. Oelke (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`Lead Counsel
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`Ryan P. Johnson
`Laura T. Moran
`Back-Up Counsel
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`Fenwick & West LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 430-2600
`joelke@fenwick.com
`ryan.johnson@fenwick.com
`laura.moran@fenwick.com
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`Counsel for Patent Owner Novo Nordisk A/S
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`-4-
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`IPR2020-00324
`Patent 8,114,833
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on September 18, 2020,
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`the foregoing document is being served by filing this document through the Patent
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`Trial and Appeal Board End to End System, as well as by delivering a copy via
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`electronic mail upon the following counsel of record for the Petitioner:
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`Brandon M. White (Reg. No. 52,354)
`Perkins Coie LLP
`700 Thirteenth Street, N.W., Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`BMWhite@perkinscoie.com
`White-ptab@perkinscoie.com
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`
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`Lara Dueppen (Reg. No. 65,002)
`Perkins Coie LLP
`1888 Century Park East
`Suite 1700
`Los Angeles, CA 90067
`Telephone: (310) 788-3349
`LDueppen@perkinscoie.com
`Dueppen-ptab@perkinscoie.com
`Liraglutide@perkinscoie.com
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`Date: September 18, 2020
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`Respectfully submitted,
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`/s/ Jeffrey J. Oelke (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`Lead Counsel
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`-5-
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`ADDENDUM A
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`Standing Protective Order
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`IPR2020-00324
`Patent 8,114,833
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`This standing protective order governs the treatment and filing of confidential
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`information, including documents and testimony.
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`1.
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`Confidential information shall be clearly marked “PROTECTIVE ORDER
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`MATERIAL.”
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`2.
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`Access to confidential information is limited to the following individuals
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`who have executed the acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the
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`proceeding and other persons who are named parties to the proceeding.
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`(B) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(C) Experts. Retained experts of a party in the proceeding who further
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`certify in the Acknowledgement that they are not a competitor to any party, or a
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`consultant for, or employed by, such a competitor with respect to the subject matter of
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`the proceeding.
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`(D)
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`In-house counsel. In-house counsel of a party.
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`(E) Other Employees of a Party. Employees, consultants, or other
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`persons performing work for a party, other than in-house counsel and in-house counsel’s
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`support staff, who sign the Acknowledgement shall be extended access to confidential
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`information only upon agreement of the parties or by order of the Board upon a motion
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`-6-
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`IPR2020-00324
`Patent 8,114,833
`brought by the party seeking to disclose confidential information to that person. The
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`party opposing disclosure to that person shall have the burden of proving that such
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`person should be restricted from access to confidential information.
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`(F) The Office. Employees and representatives of the Office who have a
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`need for access to the confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and representatives shall
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`include the Director, members of the Board and their clerical staff, other support
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`personnel, court reporters, and other persons acting on behalf of the Office.
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`(G) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are reasonably
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`necessary to assist those persons in the proceeding shall not be required to sign an
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`Acknowledgement, but shall be informed of the terms and requirements of the Protective
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`Order by the person they are supporting who receives confidential information.
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`3.
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`Persons receiving confidential information shall use reasonable efforts to
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`maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which
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`persons not authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality
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`of the information, which efforts shall be no less rigorous than those the recipient
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`uses to maintain the confidentiality of information not received from the disclosing
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`party;
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`IPR2020-00324
`Patent 8,114,833
`(C) Ensuring that support personnel of the recipient who have access
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`to the confidential information understand and abide by the obligation to maintain the
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`confidentiality of information received that is designated as confidential; and
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`(D) Limiting the copying of confidential information to a reasonable
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`number of copies needed for conduct of the proceeding and maintaining a record of
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`the locations of such copies.
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`4.
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`Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`(A) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the Board
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`under seal, together with a non-confidential description of the nature of the confidential
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`information that is under seal and the reasons why the information is confidential and
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`should not be made available to the public. The submission shall be treated as
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`confidential and remain under seal, unless, upon motion of a party and after a hearing on
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`the issue, or sua sponte, the Board determines that the documents or information do not
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`qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the
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`information submitted to the Board, the submitting party shall file confidential and non-
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`confidential versions of its submission, together with a Motion to Seal the confidential
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`version setting forth the reasons why the information redacted from the non-confidential
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`version is confidential and should not be made available to the public. The non-
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`-8-
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`IPR2020-00324
`Patent 8,114,833
`confidential version of the submission shall clearly indicate the locations of information
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`that has been redacted. The confidential version of the submission shall be filed under
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`seal. The redacted information shall remain under seal unless, upon motion of a party
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`and after a hearing on the issue, or sua sponte, the Board determines that some or all of
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`the redacted information does not qualify for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties.
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`Information designated as confidential that is disclosed to another party during
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`discovery or other proceedings before the Board shall be clearly marked as
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`“PROTECTIVE ORDER MATERIAL” and shall be produced in a manner that
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`maintains its confidentiality.
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`Standard Acknowledgement of Protective Order. The following form may be
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`used to acknowledge a protective order and gain access to information covered by the
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`protective order.
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`-9-
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`IPR2020-00324
`Patent 8,114,833
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`MYLAN INSTITUTIONAL LLC,
`Petitioner,
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`v.
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`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-00324
`Patent 8,114,833
`______________
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`Standard Acknowledgement for Access to Protective Order Material
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`-10-
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`IPR2020-00324
`Patent 8,114,833
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`Standard Acknowledgment for Access to Protective Order Material
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`I
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`, affirm that I have
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`read the Protective Order; that I will abide by its terms; that I will use the confidential
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`information only in connection with this proceeding and for no other purpose; that I
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`will only allow access to support staff who are reasonably necessary to assist me in
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`this proceeding; that prior to any disclosure to such support staff I informed or will
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`inform them of the requirements of the Protective Order; that I am personally
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`responsible for the requirements of the terms of the Protective Order and I agree to
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`submit to the jurisdiction of the Office and the United States District Court for the
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`Eastern District of Virginia for purposes of enforcing the terms of the Protective
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`Order and providing remedies for its breach.
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`[Signature]
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`-11-
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