`
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-01104
`U.S. Patent No. 9,919,024
`__________________
`
`PATENT OWNER’S MOTION TO SEAL AND
`ENTER DEFAULT PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`Introduction
`Patent Owner Bausch Health Ireland Limited requests that the confidential
`
`versions of the Patent Owner’s Preliminary Response and Exhibit 2013 be sealed
`
`under 37 C.F.R. § 42.54. Good cause to seal these documents exists because a public
`
`version of the Patent Owner’s Preliminary Response has also been filed, and the
`
`redacted information, along with the entirety of the information in Exhibit 2013, is
`
`sensitive, non-public excerpts of Bausch’s New Drug Application (“NDA”) 208745.
`
`Petitioner does not oppose this motion to seal or the entry of the default protective
`
`order, provided that Petitioner may seek additional restrictions to the default order
`
`if Petitioner’s confidential information is proposed to be submitted later.
`
`II. Governing Rules and PTAB Guidance
`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, but a party may file a
`
`concurrent motion to seal and the information at issue is sealed pending the outcome
`
`of the motion.
`
`Similarly, 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
`
`1
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`provisionally sealed on receipt of the motion and remain so
`pending the outcome of the decision on the motion.
`
`It is, however, only “confidential information” that is protected from disclosure. 35
`
`U.S.C. § 316(a)(7) (“The Director shall prescribe regulations -- . . . providing for
`
`protective orders governing the exchange and submission of confidential
`
`information”). In that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756,
`
`48760 (Aug. 14, 2012) provides:
`
`The rules 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.
`* * *
`Confidential Information: The 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. § 42.54.
`
`Identification of Confidential Information
`The confidential information consists of non-public excerpts of Bausch’s
`
`III.
`
`NDA 208745. This information is contained in the following documents:
`
`• Patent Owner’s Preliminary Response in pages 10, 64, 65.
`
`• Exhibit 2013
`
`2
`
`
`
`
`IV. Good Cause Exists for Sealing the Confidential Information
`The Board’s rules identify confidential information in a manner consistent
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`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 New Drug Applications and
`
`Abbreviated New Drug Applications contain confidential commercial information
`
`that should be protected from public disclosure. See Sandoz, Inc. v. EKR
`
`Therapeutics, LLC, IPR2015-00005, paper 21. Here, the information that Patent
`
`Owner seeks to seal is information contained in Bausch’s NDA 208745, which was
`
`filed confidentially with the Food and Drug Administration (“FDA”) in order to
`
`obtain FDA approval to market its innovative pharmaceutical product. Specifically,
`
`Patent Owner seeks to seal the entirety of Exhibit 2013 because it is excerpts of the
`
`NDA, the entirety of which is confidential, and redaction would not be practical. In
`
`addition, Patent Owner seeks to seal the portions of the Patent Owner’s Preliminary
`
`Response, pages 10, 64, 65, that cite or substantially describe the NDA. Accordingly,
`
`there is good cause to grant this motion to seal.
`
`III. PROPOSED PROTECTIVE ORDER
`
`Pursuant to 37 C.F.R. § 42.54(a), the parties propose that the default
`
`protective order found in Appendix B of the Trial Practice Guide be entered.
`
`3
`
`
`
`
`IV. CERTIFICATION OF NON-PUBLICATION
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`
`
`The undersigned counsel certifies the information sought to be sealed by this
`
`Motion to Seal has not, to their knowledge, been published or otherwise made public.
`
`Patent Owner has made efforts to maintain the confidentiality of this information in
`
`a related district court proceeding. In that district court proceeding, the information
`
`that Patent Owner presently moves to seal has been produced and designated
`
`“Highly Confidential Information.”
`
`V. CONCLUSION
`
`For the reasons set forth above, Patent Owner respectfully requests the Board
`
`grant this motion to seal and enter the default Protective Order.
`
`Dated: October 7, 2022
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`By: /Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
`Joshua L. Goldberg, Reg. No. 59,369
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`4
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for the Patent Owner
`
`5
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`
`
`
`
`
`MOTION TO SEAL AND ENTER DEFAULT PROTECTIVE ORDER was
`
`served electronically via email on October 7, 2022, in their entirety on the
`
`following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`4863-5899-2145@mail.vault.netdocuments.com
`
`Richard Torczon
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
`Nicole W. Stafford
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`dgregory@wsgr.com
`
`The Petitioner has consented to service by electronic mail.
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Date: October 7, 2022
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
