`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`MYLAN’S OPPOSITION TO
`BAUSCH’S MOTIONS TO SEAL
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`Page
`Introduction ...................................................................................................... 1
`Reasons for Opposition ................................................................................... 1
`A.
`Background ........................................................................................... 1
`B.
`Analysis ................................................................................................. 3
`C.
`Public Availability of NDA Studies ...................................................... 5
`D.
`Prejudice .............................................................................................. 11
`III. Conclusion ..................................................................................................... 12
`
`
`
`
`
`
`-i-
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`
`
`
`TABLE OF AUTHORITIES
`
`Pages
`
`Cases
`Argentum Pharms. v. Alcon Research, IPR2017-01053, Paper 27
`(informative) .....................................................................................................4, 5
`DePuy Synthes Prods. v. Veterinary Orthopedic Implants, 990 F.3d 1364
`(Fed. Cir. 2021) .................................................................................................3, 4
`Uniloc 2017 v. Apple Inc., 964 F.3d 1351 (Fed. Cir. 2020) ..................................4, 5
`Guidance
`Consolidated Trial Practice Guide (2019) ................................................................. 3
`Regulations
`37 C.F.R. §42.20 ........................................................................................................ 4
`37 C.F.R. §42.25 ........................................................................................................ 2
`37 C.F.R. §42.54 ........................................................................................................ 4
`
`
`-ii-
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`
`
`
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`I.
`
`INTRODUCTION
`Petitioner Mylan opposes patentee Bausch’s motions to seal (inclusive of
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`Papers 48 and 50) to the extent they seek to redact materials that are not
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`confidential. Currently-redacted material includes materials that are already
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`publicly available, including material publicly of record in this review. Bausch’s
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`blanket redactions impose undue prejudice on the public, the Board, and Petitioner.
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`That prejudice is quickly magnified as the parties prepare for oral argument, which
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`should be open to the public. Bausch’s motions should be denied, or at least
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`dismissed to require Bausch to provide an accurate accounting well before the oral
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`argument of all material Bausch has purportedly maintained in confidence.
`
`II. REASONS FOR OPPOSITION
`A. Background
`In Paper 26, Bausch moved to seal EX2023 (Shailubhai Decl.), EX2024
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`
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`(Davies Decl.), EX2025 (Waldman Decl.), EX2027 (SP-PH-001), and EX2028
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`(SP-PH-004), which were filed with Bausch’s response, and portions of Bausch’s
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`response discussing them. According to Bausch, EX2027 and EX2028—both of
`
`which Bausch redacts entirely—are “sensitive, non-public excerpts of Bausch’s
`
`New Drug Application (‘NDA’).” Paper 26, 1. The declarations and Patent Owner
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`Response are redacted where they cited EX2027 and EX2028. Paper 26, 2-3 (“The
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`confidential information consists of non-public excerpts of Bausch’s NDA.”).
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`Bausch counsel certified that the information “has not, to their knowledge, been
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`-1-
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`
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`published or otherwise made public.” Id., 4. Based on Bausch’s representations,
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`Mylan did not oppose the first motion. Id., 1.
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`
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`Bausch’s two later motions to seal (Papers 48 and 50) are also based on the
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`alleged confidentiality of EX2027 and EX2028. Because Mylan no longer believes
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`Bausch’s certification, it opposes these latter motions. This opposition is timely
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`under 37 C.F.R. §42.25(a)(1) for both motions.
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`
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`Paper 48 seeks to seal redacted portions of EX1060 (Davies Depo.), EX1063
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`(2d Peterson Decl.), EX1064 (Epstein Decl.), and Petitioner’s Reply. Again, these
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`redactions are predicated on the alleged confidentiality of EX2027 and EX2028.
`
`Paper 48, 2 (“The confidential information consists of non-public excerpts of
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`Bausch’s NDA.”). Paper 50 similarly seeks to seal Bausch’s surreply (Paper 49)
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`because it allegedly contains “non-public excerpts of Bausch’s NDA.” Paper 50, 2.
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`
`
`As the record developed, Mylan became concerned that Bausch’s
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`certification for the NDA studies was not accurate. Significantly, EX1067
`
`(Excerpts from File History of EP App. 02721604.3, retrieved from
`
`https://register.epo.org/regviewer (last visited March 23, 2023)), and EX1069
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`(Pharmacology Review(s), “TRULANCE (Plecanatide) Tablets”, Application No.
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`208745Orig1s000, Dec. 2, 2016, p. 1-322, retrieved from
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208745
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`Orig1s000PharmRedt.pdf (last visited March 23, 2023)), are publicly available on
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`-2-
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`
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`the internet and have been filed publicly in this case. EX1063, 24 n.3, 118 n.9.
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`Mylan’s counsel raised these concerns in person at a deposition and subsequently
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`in writing. For example, when Bausch asked Mylan whether it would oppose
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`Paper 48, Mylan stated:
`
`To the extent Patent Owner plans to seek to seal copies of, and
`references to, material that is already publicly available (e.g., publicly
`available HPLC or T-84 cGMP data Bausch submitted to the EPO),
`we do not understand what basis you would have for sealing that
`information here.
`
`Yet in Papers 48 and 50, Bausch counsel persisted in certifying that the redacted
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`information “has not, to their knowledge, been published or otherwise made
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`public.” Paper 48, 3; Paper 50, 3.
`
`B. Analysis
`The Board “balances the needs of the parties to submit confidential
`
`
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`information with the public interest in maintaining a complete and understandable
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`file history for public notice purposes.” Consolidated Trial Practice Guide, 22
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`(2019). Case law recognizes “a general right to inspect and copy public records
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`and documents, including judicial records and documents. This longstanding right
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`helps secure the integrity and transparency of the judicial process. There is
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`accordingly a presumption that judicial records should be available to the public.”
`
`DePuy Synthes Prods. v. Veterinary Orthopedic Implants, 990 F.3d 1364, 1369
`
`-3-
`
`
`
`
`
`(Fed. Cir. 2021) (cleaned up). A party “seeking confidentiality must present a
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`strong justification to overcome the presumption of public access.” Id. “Where, as
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`here, materials are … more than tangentially related to the underlying cause of
`
`action, a litigant must supply compelling reasons to shield them from public view.”
`
`Uniloc 2017 v. Apple, Inc., 964 F.3d 1351, 1358 (Fed. Cir. 2020) (cleaned up).
`
`
`
`The movant bears the burden to justify sealing. Id., 1362; 37 C.F.R.
`
`§42.20(c); Argentum Pharms. v. Alcon Research, IPR2017-01053, Paper 27
`
`(informative), 2. Meeting this burden requires a showing of good cause to seal.
`
`37 C.F.R. §42.54(a); Argentum, 2-3. “Good cause for sealing is established by a
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`sufficient explanation as to why the information sought to be sealed is confidential
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`information, a demonstration that the information is not excessively redacted, and a
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`showing that, on balance, the strong public interest in maintaining a complete and
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`understandable record is outweighed by the harm to a party, by disclosure of
`
`information and the need of either party to rely specifically on the information at
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`issue.” Argentum, 3-4 (cleaned up).
`
`
`
`In Argentum, the movant failed to identify a need to use the covered
`
`materials specifically, failed to identify a concrete harm if the covered materials
`
`were not kept confidential, and failed to confer on a reasonable scope for the
`
`protective order. Id., 4-6. The Board ordered the movant to try again. Id., 8-9. Yet a
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`party that fails to meet its burden in its initial motions is not entitled to a do-over to
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`-4-
`
`
`
`
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`narrow its request. Uniloc, 964 F.3d at 1363 (no abuse of discretion because “In
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`denying Uniloc’s sweeping motion to seal, the district court sent a strong message
`
`that litigants should submit narrow, well-supported sealing requests in the first
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`instance, thereby obviating the need for judicial intervention.”). In the present case,
`
`Bausch has provided even less basis than the movant in Argentum. Instead, Bausch
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`offers a bare, conclusory, and inaccurate certification that the contents of EX2027
`
`and EX2028 are confidential and non-public and that Bausch would be harmed by
`
`their disclosure.
`
`C. Public Availability of SP-PH-001 and SP-PH-002
`The chart beginning here and extending until page 10 provides an exemplary
`
`
`
`list of publicly available disclosures regarding SP-PH-001 and SP-PH-002. The
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`relevance of these publicly available disclosures to Bausch’s failure to satisfy its
`
`burden for sealing is self-evident.
`
`Sealed Pages
`
`EX2027, 1.
`
`EX1069, 22:
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`
`
`Public Information
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`-5-
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`
`
`
`
`Sealed Pages
`
`EX1069, 22-23:
`
`Public Information
`
`EX2027, 7-10,
`20.
`
`See also EX1001, Table 4 and corresponding SEQ ID NOs.
`
`EX1067, 102:
`
`EX2027, 11,
`21.
`
`
`
`
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`-6-
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`
`
`
`Sealed Pages
`
`EX2028, 1.
`
`
`
`EX1069, 23:
`
`
`EX1069, 23:
`
`Public Information
`
`EX2028, 7-8.
`
`EX1067, 138-39:
`
`EX2028, 9.
`
`See also EX1001, Table 4 and corresponding SEQ ID NOs.
`EX1001, 15:24-17:10 (EXAMPLE).
`
`
`
`
`
`-7-
`
`
`
`Sealed Pages
`EX2028, 10.
`
`EX1067, 130:
`
`Public Information
`
`
`
`
`
`-8-
`
`
`
`Sealed Pages
`EX2028, 11
`
`
`
`Public Information
`
`EX1001, 16:46-54:
`
`Synthetic peptides SP301, SP302, SP303 and SP304 were also
`tested for their activities at different pH values of the T84 cell-
`based assay. Whereas all of these peptides showed enhanced
`intracellular production of cGMP at pH's ranging from 5 to 7,
`SP304 showed the greatest enhancement in the range between
`6.5 and 7. It is important to note that the physiological pH of the
`large intestine is in a similar range, and, therefore, SP304 would
`be expected to be especially efficacious for colon cancer
`treatment.
`
`EX1067, 139:
`
`
`
`
`
`-9-
`
`
`
`
`
`Sealed Pages
`X2028, 12.
`
`
`EX1067, 129:
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`Public Information
`
`
`
`
`
`
`
`Other portions of EX2027 and EX2028 provide routine information, such as
`
`lists of abbreviations and signature blocks, for which a confidentiality justification
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`is difficult to imagine. Bausch, however, has the burden to demonstrate a need to
`
`redact and should have provided a justification for all redactions in the first
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`instance rather than simply redacting the entirety of two exhibits and all references
`
`to them. Moreover, if Bausch performs a reasonably diligent review of its records,
`
`it may become aware of more instances where information from EX2027 or
`
`EX2028 has been released to the public.
`
`
`
`Because the alleged confidentiality of the materials in EX2027 and EX2028
`
`-10-
`
`
`
`
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`is the sole basis for Bausch’s motions to seal the numerous confidential versions of
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`declarations and Papers filed in this case, Bausch should be required to show that
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`every redaction of the confidential papers and exhibits is justified.
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`D. Prejudice
`The prohibition against unrestrained sealing focuses on harms to the public
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`
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`and inconveniences to the tribunal. Without diminishing these harms, the harm to
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`the opposing party should be considered as well. Sealing imposes administrative
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`burdens on the opponent to obtain protective-order acknowledgments, maintain
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`documents in confidence, negotiate with the movant on redactions, and
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`conscientiously try to minimize reliance on sealed material to avoid excessive
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`redactions. Because Bausch abdicated its duty to evaluate the veracity of its non-
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`publication certification, Mylan has now undertaken the additional burden and
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`expense of filing this opposition to identify exemplary material Bausch has chosen
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`to designate confidential that is, in fact, publicly available. But even associating
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`what is already in the public domain with the pages of the sealed exhibits risks an
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`accusation of violating the protective order by disclosing the contents of EX2027
`
`and EX2028. Accordingly, this Opposition has been filed under seal, providing a
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`further illustration of the unnecessary burden imposed on the public, the Board,
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`and the parties by Bausch’s blanket confidentiality designations.
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`
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`Existing burdens will be magnified as the parties prepare for oral argument,
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`-11-
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`
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`which should be open to the public. An adversary should not be permitted to
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`impose such burdens unilaterally without a very good reason. Bausch is in the best
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`position to identify accurately what Bausch information is confidential (if any).
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`This burden certainly should not be shifted to the nonmovant or the Board. Mylan
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`requests that the Board strictly enforce its requirements for a motion to seal in this
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`case to eliminate all unsupported claims to confidentiality, and to do so before the
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`scheduled oral argument on June 14, 2023.
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`III. CONCLUSION
`
`Mylan does not oppose protection of legitimately confidential material, but
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`has suffered prejudice, including added cost and complexity, in working within the
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`protective order for materials that are not properly designated as confidential. The
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`public, the Board, and any reviewing court will also be prejudiced by undue
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`redactions. Bausch’s motions should be denied.
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`
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`
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`Dated: May 24, 2023
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` Respectfully submitted,
`
`
`
`
`/Jad A. Mills/
`Jad A. Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
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`-12-
`
`
`
`
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`CERTIFICATE OF SERVICE
`I certify that today this paper was served by email on Bausch’s counsel at:
`
`Justin J. Hasford
`
`Bryan C. Diner
`
`Joshua Goldberg
`
`Caitlin O’Connell
`
`Kyu Yun Kim
`
`Kassandra Office
`r
`
`
`and on MSN’s counsel at:
`
`
`Andrew Larsen
`
`Melissa Hayworth
`
`
`
`
`
`
`Dated: May 24, 2023
`
`
`
`
`justin.hasford@finnegan.com
`
`bryan.diner@finnegan.com
`
`joshua.goldberg@finnegan.com
`
`caitlin.o’connell@finnegan.com
`
`kyuyun.kim@finnegan.com
`
`kassandra.officer@finnegan.com
`
`alarsen@merchantgould.com
`
`mhayworth@merchantgould.com
`
`
`Respectfully submitted,
`
`/Christopher Kielman/
`Christopher Kielman
`
`
`
`-13-
`
`
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