Paper No. __
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290)
`
`Filed: July 29, 2016
`
`PETITIONER’S MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`AND MOTION TO ENTER DEFAULT PROTECTIVE ORDER
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290)
`
`Filed: July 29, 2016
`
`PETITIONER’S MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`AND MOTION TO ENTER DEFAULT PROTECTIVE ORDER
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION...............................................................................3
`
`INTRODUCTION ............................................................................. ..3
`
`TABLE OF CONTENTS
`
`I.
`
`I.
`
`II.
`
`GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`
`GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`II.
`INFORMATION IN EXHIBITS 2109 AND 2082 AND PATENT OWNER’S
`RESPONSE...............................................................................................................4
`
`INFORMATION IN EXHIBITS 2109 AND 2082 AND PATENT OWNER’S
`
`RESPONSE ............................................................................................................. ..4
`
`III.
`
`III.
`
`CERTIFICATION OF NON-PUBLICATION................................7
`
`CERTIFICATION OF NON-PUBLICATION .............................. ..7
`
`IV.
`
`CERTIFICATION OF CONFERENCE WITH OPPOSING
`IV.
`PARTY PURSUANT TO 37.C.F.R. § 42.54..........................................................8
`PARTY PURSUANT TO 37.C.F.R. § 42.54 ........................................................ ..8
`
`CERTIFICATION OF CONFERENCE WITH OPPOSING
`
`V.
`
`V.
`
`VI.
`
`VI.
`
`PROPOSED DEFAULT PROTECTIVE ORDER..........................8
`
`PROPOSED DEFAULT PROTECTIVE ORDER ........................ ..8
`
`CONCLUSION....................................................................................8
`
`CONCLUSION .................................................................................. ..8
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper No. 37 (PTAB, Apr. 5, 2013) ......................................... 3
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper No. 21 (PTAB, Apr. 24, 2014) ....................................... 3
`STATUTES
`35 U.S.C. § 316(a)(1)................................................................................................. 2
`35 U.S.C. § 316(a)(7)................................................................................................. 3
`OTHER AUTHORITIES
`37 C.F.R. § 42.14 ...................................................................................................1, 2
`37 C.F.R. § 42.20(c)...................................................................................................3
`37 C.F.R. § 42.54 ...............................................................................................1, 3, 5
`Federal Rules of Civil Procedure 26(c)(1)(G) ...........................................................3
`Office Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012)................3
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`In its June 21, 2016, Decision relating to both Case IPR2015-00902 and
`
`Case IPR2015-00903, the Patent Trial and Appeal Board (the “Board”) found
`
`deficiencies in both the Patent Owner’s Motion to Seal and Stipulated Protective
`
`Order. Paper 85. Thus, the Board denied both without prejudice. Id. at 8. In its
`
`Decision, the Board ordered that the Patent Owner may file the default protective
`
`order or an amended protective order and revised motion to seal addressing the
`
`identified deficiencies on or before July 31, 2016. Id. at 8-9. In a related Decision
`
`of the same day, in Case IPR2015-00902, the Board denied without prejudice
`
`Petitioner’s Motion to Seal. Paper 86. In that Decision, the Board ordered that a
`
`party may file a revised or new motion to seal on or before July 31, 2016. Id. at 4.
`
`Accordingly, pursuant to 37 C.F.R. §§ 42.14 and 42.54 InnoPharma
`
`Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC
`
`(collectively, “InnoPharma”), Mylan Pharmaceuticals Inc., and Mylan Inc.
`
`(collectively, “Mylan”) (InnoPharma and Mylan collectively, “Petitioner”)
`
`respectfully move to seal Exhibit 2109 in its entirely, and portions of Exhibit 2082
`
`and Patent Owner’s Response (Paper No. 32), which were submitted by Senju
`
`Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma
`
`Holdings Corp. (collectively, “Patent Owner”). Exhibit 2109 contains
`
`InnoPharma’s Abbreviated New Drug Application (“ANDA”). Exhibit 2082,
`
`3
`
`
`
`which contains Patent Owner’s expert Declaration of Robert O. Williams, III,
`
`Ph.D. (the “Williams Declaration”), and Patent Owner’s Response cite to or
`
`substantially describe the confidential information in Ex. 2109 that Petitioner seeks
`
`to seal. Petitioner certifies that the information identified as confidential in this
`
`motion has not been published or otherwise made public.
`
`Having noted the deficiencies discussed by the Board in its Decision (Paper
`
`85), Petitioners also respectfully request entry of the Default Protective Order.
`
`Patent Owner does not oppose this motion.
`
`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`INFORMATION IN EXHIBITS 2109 AND 2082 AND PATENT
`OWNER’S RESPONSE
`Under 35 U.S.C. § 316(a)(1), the default rule is that all papers filed in an
`
`inter partes review are open and available for access by the public, and a party
`
`may file a concurrent motion to seal and the information at issue is sealed pending
`
`the outcome of the motion.
`
`37 C.F.R. § 42.14 provides:
`
`The record of a proceeding, including documents and things,
`
`shall be made available to the public, except as otherwise
`
`ordered. A party intending a document or thing to be sealed shall
`
`file a motion to seal concurrent with the filing of the document
`
`or thing to be sealed.
`
`The document or thing shall be
`
`4
`
`
`
`provisionally sealed on receipt of the motion and remain so
`
`pending the outcome of the decision on the motion.
`
`The rules promulgated by the USPTO “aim to 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.” Office Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). It is, however, only
`
`“confidential information” that is protected from disclosure. 35 U.S.C. § 316(a)(7).
`
`The moving party has the burden of establishing “good cause” for sealing
`
`documents containing confidential information. Garmin Int’l, Inc. v. Cuozzo Speed
`
`Techs. LLC, IPR2012-00001, Paper 37 at 4 (PTAB, Apr. 5, 2013); see also 37
`
`C.F.R. §§ 42.20(c), 42.54.
`
`The Board’s rules identify 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. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760
`
`(Aug. 14, 2012). Accordingly, the Board has recognized that an ANDA contains
`
`confidential commercial information that should be protected from public
`
`disclosure. See Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-00005, paper 21
`
`(PTAB, Apr. 24, 2014).
`
`5
`
`
`
`The Exhibits that Petitioner moves to seal contain confidential and highly
`
`sensitive proprietary information. The information the parties seek to seal has not
`
`been made public by any party or by the Food and Drug Administration (“FDA”),
`
`and is not otherwise available to the public. At issue is InnoPharma’s ANDA,
`
`which was filed confidentially with the FDA in order to obtain FDA approval to
`
`market InnoPharma’s generic pharmaceutical product. The information the parties
`
`seek to seal contains InnoPharma’s highly sensitive, confidential development
`
`information and technical, business information. Petitioner InnoPharma’s product
`
`has not yet been marketed and remains confidential. If InnoPharma’s confidential
`
`information is made public, InnoPharma’s competitors could exploit its
`
`confidential information and gain an unfair competitive advantage over
`
`InnoPharma. Exhibit 2109 is only an excerpt of the much larger InnoPharma
`
`ANDA and redaction of this excerpt would not be practical; therefore, petitioner
`
`requests that Exhibit 2109 be sealed in its entirety.
`
`The Williams Declaration (Ex. 2082) describes the confidential information
`
`contained in the ANDA in connection with secondary considerations of non-
`
`obviousness. Exhibit 2082, ¶171, 194. In particular, the chart at ¶194 shows the
`
`generic bromfenac product components described in Exhibit 2109. Accordingly,
`
`Petitioner requests that these portions of the Williams Declaration be sealed. The
`
`redactions to paragraph 171, 194 as reflected in the redacted version of the
`
`6
`
`
`
`Williams Declaration that was previously filed by Patent Owner and is currently
`
`publicly available adequately redacts the confidential information contained in the
`
`ANDA.
`
`Similarly, page 51 of the Patent Owner’s Response reflects the confidential
`
`information contained in the ANDA. Specifically, the third sentence of the second
`
`full paragraph of page 51 of the Patent Owner’s Response discusses the
`
`InnoPharma’s ANDA product and cites to paragraph 171 of the Williams
`
`Declaration. Accordingly, Petitioner requests that these portions of the Patent
`
`Owner’s Response be sealed. The redactions to page 51 as reflected in the
`
`redacted version of the Patent Owner’s Response that was previously filed by
`
`Patent Owner and is currently publicly available (Paper No. 32) adequately redacts
`
`the confidential information contained in the ANDA.
`
`Because public disclosure of the contents of these documents, or
`
`descriptions of those contents, would disclose confidential business terms in a
`
`highly competitive market, even to co-Petitioner Lupin, Petitioner requests that
`
`Exhibit 2109 and the portions of the Williams Declaration and Patent Owner’s
`
`Response that substantially describe the ANDA exhibits be sealed, as
`
`“PROTECTIVE ORDER MATERIAL.”
`
`III. CERTIFICATION OF NON-PUBLICATION
`On behalf of Petitioner, undersigned counsel certifies the information
`
`7
`
`
`
`identified in Exhibits 2109 and 2082 and the Patent Owner’s Response, to its
`
`knowledge, has not been published or otherwise made public.
`
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37.C.F.R. § 42.54
`On July 28, 2016, counsel for Petitioner contacted Patent Owner’s counsel
`
`via e-mail regarding Petitioner’s intent to file this Motion to Seal. On July 28,
`
`2016, Patent Owner’s counsel agreed not to oppose this Motion to Seal.
`
`V.
`
`PROPOSED PROTECTIVE ORDER
`Petitioner respectfully requests entry of the Default Protective Order. Upon
`
`entry of the Default Protective Order, attached here as Appendix A, Petitioner
`
`designates Exhibit 2109 and redacted portions of Exhibit 2082 and the Patent
`
`Owner’s Response as “PROTECTIVE ORDER MATERIAL.” Confidential
`
`versions of Exhibits 2082 and 2109 and the Patent Owner’s Response were
`
`previously filed. Non-confidential versions of Exhibit 2082 and the Patent
`
`Owner’s Response that redact the information Petitioner seeks to seal were
`
`previously filed.1
`
`VI. CONCLUSION
`
`1 To the extent that Patent Owner seeks to refile any version of Exhibit 2109,
`
`Exhibit 2082, or the Patent Owner’s Response, Petitioner has requested that Patent
`
`Owner again redact the confidential information as specified in this motion.
`
`8
`
`
`
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`grant the instant Motion to Seal Exhibits 2109 and 2082 and the Patent Owner’s
`
`Response.
`
`Date: July 29, 2016
`
`1.
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`9
`
`
`
`APPENDIX A
`
`APPENDIX A
`
`10
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC.
`Petitioner
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`__________________
`
`Case IPR2015-00902 (Patent 8,669,290)
`__________________
`
`DEFAULT PROTECTIVE ORDER
`
`11
`
`
`
`Standing Protective Order
`
`This standing protective order governs the treatment and filing of confidential
`
`information, including documents and testimony.
`
`1.
`
`Confidential information shall be clearly marked “PROTECTIVE ORDER
`
`MATERIAL.”
`
`2.
`
`Access to confidential information is limited to the following individuals
`
`who have executed the Acknowledgment appended to this order:
`
`(A)
`
`Parties. Persons who are owners of a patent involved in the
`
`proceeding and other persons who are named parties to the proceeding.
`
`(B)
`
`Party Representatives. Representatives of record for a party in the
`
`proceeding.
`
`(C)
`
`Experts. Retained experts of a party in a proceeding who further
`
`certify in the Acknowledgement that they are not competitor to any party, or
`
`a consultant for, or employed by, such a competitor with respect to the
`
`subject matter of the proceeding.
`
`(D)
`
`In-house counsel. In-house counsel of a party.
`
`(E) Other Employees of a Party. Employees, consultants or other persons
`
`performing work for a party, other than in-house counsel and in-house
`
`counsel’s support staff, who sign the Acknowledgement shall be extended
`
`access to confidential information only upon agreement of the parties or by
`1
`
`
`
`order of the Board upon a motion brought by the party seeking to disclose
`
`confidential information to that person. The party opposing disclosure to that
`
`person shall have the burden of proving that such person should be restricted
`
`from access to confidential information.
`
`(F)
`
`The Office. Employees and representatives of the Office who have a
`
`need for access to the confidential information shall have such access
`
`without the requirement to sign an Acknowledgement. Such employees and
`
`representatives shall include the Director, members of the Board and their
`
`clerical staff, other support personnel, court reporters, and other persons
`
`acting on behalf of the Office.
`
`(G)
`
`Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who are
`
`reasonably necessary to assist those persons in the proceeding shall not be
`
`required to sign an Acknowledgement, but shall be informed of the terms
`
`and requirements of the Protective Order by the person they are supporting
`
`who receives confidential information.
`
`3.
`
`Persons receiving confidential information shall use reasonable efforts to
`
`maintain the confidentiality of the information, including:
`
`2
`
`
`
`(A) Maintaining such information in a secure location to which persons
`
`not authorized to receive the information shall not have access;
`
`(B) Otherwise using reasonable efforts to maintain the confidentiality of
`
`the information, which efforts shall be no less rigorous than those the
`
`recipient uses to maintain the confidentiality of information not received
`
`from the disclosing party;
`
`(C)
`
`Ensuring that support personnel of the recipient who have access to
`
`the confidential information understand and abide by the obligation to
`
`maintain the confidentiality of information received that is designated as
`
`confidential; and
`
`(D) Limiting the copying of confidential information to a reasonable
`
`number of copies needed for conduct of the proceeding and maintaining a
`
`record of the locations of such copies.
`
`4.
`
`Persons receiving confidential information shall use the following
`
`procedures to maintain the confidentiality of the information:
`
`(A) Documents and Information Filed With the Board.
`
`(i) A party may file documents or information with the Board under
`
`seal, together with a non-confidential description of the nature of the
`
`confidential information that is under seal and the reasons why the
`
`information is confidential and should not be made available to the
`3
`
`
`
`public. The submission shall be treated as confidential and remain
`
`under seal, unless, upon motion of a party and after a hearing on the
`
`issue, or sua sponte, the Board determines that the documents or
`
`information do not to qualify for confidential treatment.
`
`(ii) Where confidentiality is alleged as to some but not all of the
`
`information submitted to the Board, the submitting party shall file
`
`confidential and nonconfidential versions of its submission, together
`
`with a Motion to Seal the confidential version setting forth the reasons
`
`why the information redacted from the non-confidential version is
`
`confidential and should not be made available to the public. The
`
`nonconfidential version of the submission shall clearly indicate the
`
`locations of information that has been redacted. The confidential
`
`version of the submission shall be filed under seal. The redacted
`
`information shall remain under seal unless, upon motion of a party
`
`and after a hearing on the issue, or sua sponte, the Board determines
`
`that some or all of the redacted information does not qualify for
`
`confidential treatment.
`
`(B) Documents and Information Exchanged Among the Parties.
`
`Information designated as confidential that is disclosed to another party
`
`during discovery or other proceedings before the Board shall be clearly
`4
`
`
`
`marked as “PROTECTIVE ORDER MATERIAL” and shall be produced in
`
`a manner that maintains its confidentiality.
`
`(j)
`
`Standard Acknowledgement of Protective Order. The following form may
`
`be used to acknowledge a protective order and gain access to information covered
`
`by the protective order:
`
`5
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC.
`Petitioner
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`__________________
`
`Case IPR2015-00902 (Patent 8,669,290)
`__________________
`
`STANDARD ACKNOWLEDGMENT FOR ACCESS TO
`PROTECTIVE ORDER MATERIAL
`
`I __________________________________________, affirm that I have
`
`read the Protective Order; that I will abide by its terms; that I will use the
`
`confidential information only in connection with this proceeding and for no other
`
`purpose; that I will only allow access to support staff who are reasonably necessary
`
`to assist me in this proceeding; that prior to any disclosure to such support staff I
`
`informed or will inform them of the requirements of the Protective Order; that I am
`
`personally responsible for the requirements of the terms of the Protective Order
`
`and I agree to submit to the jurisdiction of the Office and the United States District
`6
`
`
`
`Court for the Eastern District of Virginia for purposes of enforcing the terms of the
`
`Protective Order and providing remedies for its breach.
`
`[Signature]
`
`7
`
`
`
`Date: July 29, 2016
`
`Respectfully submitted,
`
`By: /Jitendra Malik/
`Jitendra Malik, Lead Counsel
`Reg. No. 55823
`Bryan L. Skelton, Ph.D.
`Reg. No. 50893
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703
`Telephone: 919-862-2200
`Fax: 919-862-2260
`
`Lance Soderstrom
`Reg. No. 65405
`ALSTON & BIRD LLP
`90 Park Avenue
`15th Floor
`New York, New York 10016-1387
`Telephone: 212.210.9400
`Fax: 212.210.9444
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street, 16th Floor
`Los Angeles, California 90071
`Telephone: (213) 576-1000
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma
`
`8
`
`
`
`Licensing LLC, InnoPharma Inc.,
`InnoPharma LLC, Mylan
`Pharmaceuticals Inc., and Mylan Inc.
`
`9
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 29th day of July, 2016, a complete copy of the foregoing
`
`Petitioner’s Motion to Seal and Motion to Enter Default Protective Order was
`
`served on counsel of record for the Patent Owner:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`10
`
`
`
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`11
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