Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`Paper No. 103
`Entered: July 8, 2022
`
`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
`JAMIE T. WISZ, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Third, Fourth, and Fifth Motions to Seal;
`Granting Patent Owner’s Motion for Entry of Second Modified Default
`Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`Paper No. 103
`Entered: July 8, 2022
`
`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
`JAMIE T. WISZ, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Third, Fourth, and Fifth Motions to Seal;
`Granting Patent Owner’s Motion for Entry of Second Modified Default
`Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`Introduction
`
`I.
`Novartis Pharma AG, Novartis Technology LLC, and Novartis
`Pharmaceuticals Corporation (collectively, “Novartis” or “Patent Owner”)
`filed a Third Motion to Seal portions of the Patent Owner’s Response (Paper
`35, “PO Resp.”), portions of Patent Owner’s Motion to Amend (Paper 37,
`“MTA”), and Exhibits 2099–2115, 2119–2121, 2123, 2124, 2126, 2128–
`2134, 2136–2148, 2150, 2155–2159, 2166–2172, 2194, 2201, 2203–2206,
`2208, 2224, and 2254. Paper 38, 1 (“Third Mot.”). Along with the Third
`Motion, Patent Owner filed redacted public versions of the exhibits listed
`above, excepting Exhibits 2099–2115, 2132, and 2194, which were subject
`to a protective order in a related proceeding before the International Trade
`Commission (“ITC”) regarding U.S. Patent No. 9,220,631 (“the ’631
`patent”) and contain third party confidential information. Redacted public
`versions of Patent Owner’s Response (Paper 40) and Motion to Amend
`(Paper 36) have also been filed.
`In its Third Motion, Patent Owner also moves for entry of a Second
`Modified Default Protective Order (Ex. 2323), and Petitioner does not
`oppose. Third. Mot. 1.
`Patent Owner also filed a Fourth Motion to Seal Exhibits 2337 and
`2338.1 Paper 85, 1 (“Fourth Mot.”). Patent Owner did not file a redacted
`public version of Exhibit 2337, which was subject to the ITC protective
`order and contains third party confidential information.
`
`
`1 Exhibit 2338 has been expunged.
`
`
`
`2
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`Patent Owner also filed a Fifth Motion to Seal portions of Patent
`Owner’s Surreply to Petitioner’s Reply (Paper 92, “Surreply”), Exhibits
`2339, 2345, and 2347 (unredacted versions), and Exhibits 2341–2344, 2346,
`and 2348–2352. Paper 90, 1 (“Fifth Mot.”). Along with the Fifth Motion,
`Patent Owner filed public redacted versions of Exhibits 2339, 2345, and
`2347 (Exs. 2339, 2345, and 2347) and a redacted public version of Patent
`Owner’s Surreply to Petitioner’s Reply (Paper 93). Patent Owner has not
`filed redacted public versions of Exhibits 2341–2344, 2346, and 2348–2352,
`which were subject to the ITC protective order.
`For the reasons set forth below, Patent Owner’s Third, Fourth, and
`Fifth Motions to Seal are granted.
`II. Motion to Seal Legal Standard
`“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
`public interest in having an open record. See Argentum, Paper 27 at 3–4
`
`
`
`3
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`(“[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.”).
`
`III. Patent Owner’s Motions to Seal
`In its Third Motion, Patent Owner attests that the documents it seeks
`to seal contain truly confidential information. Third Mot. 2 (stating
`“Novartis’s confidential research and development related to the subject
`matter of U.S. Patent No. 9,220,631 (“the ’631 patent”), Novartis’s
`confidential commercial information, third party confidential information, or
`information that is subject to contractual or statutory obligations of
`confidentiality to third party companies or individuals . . . . has not been
`published or otherwise made public”). Patent Owner also attests a concrete
`harm would result upon public disclosure of the information. Id. at 2
`(stating disclosure “would competitively harm Novartis’s and/or the third
`parties’ business prospects and put these companies at a competitive
`disadvantage” and “could subject Novartis to civil and criminal penalties
`under the laws of Switzerland”). Patent Owner attests that it relies on these
`documents to support its arguments regarding, for example, secondary
`considerations of non-obviousness. Id. at 3. Patent Owner further attests
`that the redactions in the documents it seeks to seal are “narrowly tailored.”
`Id.
`
`Patent Owner makes similar attestations in its Fourth and Fifth
`Motions to Seal. Fourth Mot. 2–3; Fifth Mot. 2–3.
`
`
`
`4
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`We find Patent Owner’s showing persuasive in establishing good
`cause to seal the identified documents, and we individually address each of
`Patent Owner’s Third, Fourth, and Fifth Motions to Seal in more detail
`below.
`
`i.
`
`1. Third Motion
`Exhibits 2099–2115, 2119–2121, 2123, 2124, 2126, 2128–
`2134, 2136–2148, 2150, 2155–2159, 2166–2172, 2194, 2201,
`2203–2206, 2208, 2224, and 2254
`Exhibits 2120, 2126, 2128–2131, 2136–2145, 2150, 2224, 2254 are
`Patent Owner’s confidential technical documents, including presentations
`discussing research and development of the ʼ631 patent and project
`timelines, reports prepared for submission to regulatory authorities, and
`emails regarding creating a product. Third Mot. 3. Exhibits 2119, 2121,
`2123, 2124, 2132–2134, 2146, 2147, and 2155–2159 are Patent Owner’s
`confidential commercial information, specifically contracts between Patent
`Owner and third parties. Id. at 7. Exhibits 2099–2115, 2148, and 2194 are
`third party (i.e., Genentech, Inc.) confidential documents produced in the
`related ITC investigation. Id. at 9. Exhibits 2166–21722 are Patent Owner’s
`confidential internal business and financial documents, and declarations
`discussing those documents. Id. at 10. Exhibits 2201, 2203–2206, and 2208
`are Patent Owner declarations, filed in support of Patent Owner’s briefs, that
`contain information regarding Patent Owner’s and third party proprietary
`technical and development information, confidential business information of
`
`
`2 Patent Owner also lists Exhibit 2173. Third Mot. 10. However, this
`appears to be a harmless typographical error, as Exhibit 2173 has not been
`filed in this case.
`
`
`
`5
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`third parties, and references to exhibits with confidential information (e.g.,
`Exhibits 2099–2115, 2119–2121, etc.). Id. at 11–13.
`Patent Owner filed corresponding public redacted versions of these
`exhibits, with the exception of Exhibits 2099–2115, 2132, and 2194, which
`appear to have been subject to a protective order in the related ITC
`investigation. Patent Owner asserts that “[t]hese documents were part of the
`record developed in the ITC action, and in that action, these documents were
`subject to a protective order requiring that these documents only be
`accessible by outside counsel.” Third Mot. 10. Patent Owner further
`explains that “[t]he parties to this IPR proceeding have agreed to modify the
`protective order in this action to extend the same level of protection for these
`documents as was provided in the ITC action.” Id. Patent Owner makes
`similar assertions in each motion to seal regarding documents subject to a
`protective order in the ITC proceeding. See, e.g., Fourth Mot. 3–4.
`We note Exhibits 2099–2115, 2132, and 2194 contain confidential
`information of third parties, were deemed to be protected in the related ITC
`investigation, and do not appear to be central to the dispute in the present
`case.
`
`Based on Patent Owner’s various attestations and its filing of public
`redacted versions, we determine that Patent Owner has sufficiently shown
`that the information sought to be sealed is truly confidential, would result in
`harm if disclosed, is pertinent to the ongoing trial, and that maintaining
`confidentiality outweighs the strong public interest in having an open record.
`As such, Patent Owner has established good cause for sealing Exhibits
`2099–2115, 2119–2121, 2123, 2124, 2126, 2128–2134, 2136–2148, 2150,
`
`
`
`6
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`2155–2159, 2166–2172, 2194, 2201, 2203–2206, 2208, 2224, and 2254.
`Patent Owner Response and Motion to Amend
`ii.
`Patent Owner seeks to seal the unredacted versions of the Patent
`Owner Response and Motion to Amend, which “discuss the confidential
`information disclosed in the Exhibits that Novartis currently seeks to seal” in
`its Third Motion. Third Mot. 14. Patent Owner states that the information
`redacted from the public versions “does not impede the public’s
`understanding of the file history of the ’631 patent.” Id.
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record, and for reasons similar to those discussed above
`in this Order, we are further persuaded that Patent Owner’s showing
`establishes good cause for redacting the information it seeks to keep
`confidential in the Patent Owner Response and Motion to Amend.
`2. Fourth Motion
`
`Exhibit 2337
`i.
`Exhibit 2337 is a deposition transcript of Petitioner’s expert witness,
`James Agallaco, taken in the related ITC investigation. Fourth Mot. 3.
`According to Patent Owner, Exhibit 2337 contains information on Patent
`Owner’s business relationships with third parties as well as third party
`confidential business information. Id. Patent Owner explains that public
`disclosure of this transcript would result in harm, and that Patent Owner
`relies on Exhibit 2337 “to rebut [Petitioner’s] arguments concerning the
`claims of the ’631 Patent.” Id. at 2–3.
`Patent Owner has not filed a public redacted version of Exhibit 2337.
`However, Exhibit 2337 contains confidential information of non-parties, was
`
`
`
`7
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`deemed to be protected in the related ITC investigation, and does not appear
`to be central to the dispute in the present case.
`For reasons similar to those already discussed in this Order, we
`determine Patent Owner’s showing is persuasive to establish good cause to
`seal Exhibit 2337.
`
`i.
`
`3. Fifth Motion
`Exhibits 2339, 2345, and 2347 (unredacted versions), and
`Exhibits 2341–2344, 2346, and 2348–2352
`Exhibits 2339, 2341, 2345, 2347, and 2348 are cross-examination
`deposition transcripts of Petitioner’s witnesses taken in this IPR proceeding.
`Fifth Mot. 2. According to Patent Owner, these depositions discuss
`confidential information. Id. at 3. Exhibit 2346 is a deposition transcript of
`a third party witness taken in this IPR proceeding. Id. The deposition
`discusses multiple documents that contain third party confidential and
`proprietary development, research, and sales information. Id. Exhibits
`2342–2344 and 2349–2352 are Petitioner’s documents (containing
`confidential and proprietary research, development, manufacture, and
`business information), which were part of the record developed in the ITC
`investigation. Id. at 4.
`Patent Owner has not filed public redacted versions of Exhibits 2341–
`2344, 2346, and 2348–2352. However, these exhibits contain Petitioner’s
`and third party confidential information, were deemed to be protected in the
`related ITC investigation, and do not appear to be central to the dispute in
`the present case.
`For reasons similar to those already discussed in this Order, we
`determine Patent Owner’s showing is persuasive to establish good cause to
`
`
`
`8
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`seal Exhibits 2339, 2345, and 2347 (unredacted versions), and Exhibits
`2341–2344, 2346, and 2348–2352.
`Patent Owner’s Surreply
`ii.
`Patent Owner seeks to seal the unredacted version of its Surreply (the
`Surreply discusses the confidential information in Exhibits 2339 and 2341–
`2352). Fifth Mot. 2. We determine that this paper contains confidential
`information, disclosure of which would harm Patent Owner and/or third
`parties. Furthermore, at the present time, the redacted information does not
`appear to be essential for the public’s understanding. We determine Patent
`Owner’s showing is persuasive to establish good cause for redacting the
`information it seeks to keep confidential in the Patent Owner Surreply.
`IV. Conclusion on Motions to Seal
`In reviewing Patent Owner’s Third, Fourth, and Fifth Motions,
`Petitioner’s Motion to Seal, and relevant documents, we are persuaded of
`good cause to seal these papers and exhibits.
`Accordingly, we grant Patent Owner’s Third Motion to Seal the
`unredacted versions of Patent Owners’ Response, Patent Owner’s Motion to
`Amend, and Exhibits 2099–2115, 2119–2121, 2123, 2124, 2126, 2128–
`2134, 2136–2146, 2148, 2150, 2155–2159, 2166– 2172, 2194, 2201, 2203–
`2206, 2208, 2224, and 2254.
`We further grant Patent Owner’s Fourth Motion to Seal Exhibit 2337.
`We further grant Patent Owner’s Fifth Motion to Seal portions of
`Patent Owner’s Surreply to Petitioner’s Reply, Exhibits 2339, 2345, and
`2347 (unredacted versions), and Exhibits 2341–2344, 2346, and 2348–2352.
`Second Modified Default Protective Order
`V.
`Our rules provide for entry of a protective order when necessary to
`
`
`
`9
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`protect confidential information filed in a proceeding. See 37 C.F.R.
`§§ 42.14, 42.54. Patent Owner’s Second Modified Default Protective Order
`(Ex. 2323) includes proposed changes to the Modified Default Protective
`Order of record (Ex. 2091).3 Further, as noted above, Patent Owner explains
`that the parties to this IPR proceeding have agreed to modify the protective
`order in this action to extend the same level of protection to certain
`documents as was provided in the ITC action. See Third Mot. 10; Ex. 2323.
`The changes to the Modified Default Protective Order appear reasonable.
`Accordingly, we grant Patent Owner’s Motion to enter the Second
`Modified Default Protective Order (Paper 38).
`VI. Order
`
`Accordingly, it is:
`ORDERED that Patent Owner’s Third Motion to Seal (Paper 38) is
`granted, and the unredacted versions of Patent Owner’s Response (Paper
`35), Patent Owner’s Motion to Amend (Paper 37), and Exhibits 2099–2115,
`2119–2121, 2123, 2124, 2126, 2128–2134, 2136–2148, 2150, 2155–2159,
`2166– 2172, 2194, 2201, 2203–2206, 2208, 2224, and 2254 shall remain
`under seal;
`FURTHER ORDERED that Patent Owner’s Fourth Motion to Seal
`(Paper 85) is granted, and Exhibit 2337 shall remain under seal;
`FURTHER ORDERED that Patent Owner’s Fifth Motion to Seal
`(Paper 90) is granted, and Patent Owner’s Surreply to Petitioner’s Reply
`(Paper 92), Exhibits 2339, 2345, and 2347 (unredacted versions), and
`
`
`3 We previously granted Patent Owner’s Motion to enter a Modified Default
`Protective Order (Paper 9). Paper 15. Patent Owner attests that the
`proposed changes to the previously entered Modified Default Protective
`Order (Ex. 2091) are shown in Exhibit 2324. Third Mot. 1.
`10
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`Exhibits 2341–2344, 2346, and 2348–2352 shall remain under seal; and
`FURTHER ORDERED that Patent Owner’s Motion to enter the
`Second Modified Default Protective Order (Paper 38) is granted, and the
`Second Modified Default Protective Order (Exhibit 2323) is hereby entered.
`
`
`
`
`
`
`
`
`
`
`11
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`FOR PETITIONER:
`
`Anish Desai
`Elizabeth Weiswasser
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`anish.desai@weil.com
`elizabeth.weiswasser@weil.com
`christopher.pepe@weil.com
`
`
`
`
`For PATENT OWNER:
`
`Elizabeth Holland
`Nicholas Mitrokostas
`William G. James
`ALLEN & OVERY LLP
`elizabeth.holland@allenovery.com
`nicholas.mitrokostas@allenovery.com
`william.james@allenovery.com
`
`
`Linnea Cipriano
`Duncan Greenhalgh
`Joshua Weinger
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinprocter.com
`
`
`
`
`12
`
`
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
