Trials@uspto.gov
`571-272-7822
`
` Paper No. 59
`Entered: June 25, 2020
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX, INC.,
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`____________
`
`IPR2019-00400
`Patent 8,633,194 B2
`____________
`
`
`
`Before ROBERT A. POLLOCK, RYAN H. FLAX, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Unopposed Renewed Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`571-272-7822
`
` Paper No. 59
`Entered: June 25, 2020
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX, INC.,
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`____________
`
`IPR2019-00400
`Patent 8,633,194 B2
`____________
`
`
`
`Before ROBERT A. POLLOCK, RYAN H. FLAX, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`
`
`
`
`ORDER
`Granting Patent Owner’s Unopposed Renewed Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194 B2
`
`In our Final Written Decision, we denied the Parties’ Joint Motion to
`
`Seal (Paper 35) confidential, non-public versions of Exhibits 1039, 1042,
`1043, and Paper 33 without prejudice, because Patent Owner failed to
`identify precisely what information is considered confidential and did not
`demonstrate good cause to grant the request. Paper 57, 43, 45. We invited
`Patent Owner to renew its request, accompanied by “a statement that the
`information sought to be redacted is not cited, directly or indirectly, in this
`Decision,” or “[t]o the extent such statement cannot be made, Patent Owner
`shall propose a substitute version of the affected Exhibit(s) and provide an
`explanation of any differences.” Id. at 43.
`Patent Owner filed an Unopposed Renewed Motion to Seal the
`confidential, non-public version of Exhibit 1042 (filed January 16, 2020 and
`marked as “Parties and Board Only”). Paper 58 (“Motion” or “Mot.”). Patent
`Owner also submitted a revised redacted, public version of Exhibit 1042 that
`“removed a number of proposed redactions” compared to the previous
`public version.1 Mot. 1. Patent Owner has withdrawn its request to seal
`Exhibit 1043 and Paper 33. Id. Patent Owner indicates that Petitioner does
`not oppose the Motion. Id. For the reasons stated below, Patent Owner’s
`Motion is granted.
`Relevant to this motion, the Office Patent Trial Practice Guide states:
`3. A party intending a document or thing to be sealed may file a
`
`
`1 With our authorization (Ex. 3006), Patent Owner emailed the revised
`redacted Exhibit 1042 to the Board on June 22, 2020. Ex. 3007. We note that
`the footer of this exhibit bears Petitioner’s initial destination: “Ex. 1042 Un-
`redacted Non Public Version.”
`
`2
`
`
`
`IPR2019-00400
`Patent 8,633,194 B2
`
`
`motion to seal concurrent with the filing of the document or
`thing. § 42.14. The document or thing will be provisionally
`sealed on receipt of the motion and remain so pending the
`outcome of the decision on motion.
`4. Protective Orders: A party may file a motion to seal where the
`motion contains a proposed protective order, such as the default
`protective order in Appendix B. 37 C.F.R § 42.54. Specifically,
`protective orders may be issued for good cause by the Board to
`protect a party from disclosing confidential information.
`37 C. F. R. § 42.54. Guidelines on proposing a protective order
`in a motion to seal, including a Default Protective Order, are
`provided in Appendix B. The document or thing will be protected
`on receipt of the motion and remain so, pending the outcome of
`the decision on motion.
`Consolidated Office Patent Trial Practice Guide November 2019 (“CTPG”)
`at 19–20.2
`“There is a strong public policy for making all information filed in a
`quasi-judicial administrative proceeding open to the public, especially in an
`inter partes review which determines the patentability of claims in an issued
`patent and therefore affects the rights of the public.” Garmin Int’l v. Cuozzo
`Speed Techs., LLC, IPR2012–00001, Paper 34 at 1–2 (PTAB Mar. 14,
`2013). For this reason, except as otherwise ordered, the record of an inter
`partes review trial shall be made available to the public. See 35 U.S.C.
`§ 316(a)(1); 37 C.F.R. § 42.14. Motions to seal may be granted for good
`cause; until the motion is decided, documents filed with the motion shall be
`sealed provisionally. See 37 C.F.R. §§ 42.14, 42.54(a). The moving party
`bears the burden of showing that there is good cause to seal the record. See
`
`
`2 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`3
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`IPR2019-00400
`Patent 8,633,194 B2
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`37 C.F.R. § 42.20(c); see Argentum Pharm. LLC v. Alcon Research, Ltd.,
`Case IPR2017-01053, Paper 27 (Jan. 19, 2018) (informative) (factors for
`showing good cause to seal information).
`As set forth in the CTPG, confidential information that is sealed
`subject to a protective order ordinarily will become public 45 days after final
`judgment in a trial. CTPG at 21–22. A party seeking to maintain
`confidentiality of information may file a motion to expunge the information
`before it becomes public (see 37 C.F.R. § 42.56); however, if the existence
`of the information is identified in a final written decision following trial,
`there is an expectation that the information will be made public. Id. at 22.
`This rule “balances the needs of the parties to submit confidential
`information with the public interest in maintaining a complete and
`understandable file history for public notice purposes.” Id.
`Patent Owner states that “Exhibit 1042 is the Opening Expert Report
`of Sarfaraz K. Niazi, Ph.D, which was filed in a related district court action
`and designated therein by Patent Owner as ‘Restricted Confidential
`Information-Subject to Protective Order.’” Mot. 2. According to Patent
`Owner,
`[the] proposed redactions of Exhibit 1042 are limited to
`confidential commercial information regarding the commercial
`products Xyzal® and Xyzal Allergy 24 HR®, specifically
`excerpts of New Drug Application (“NDA”) Nos. 22-157 and 20-
`9090 and statements that identify the composition of these drug
`products. . . . The information Patent Owner seeks to seal is
`highly sensitive product information, specifically information
`that would reveal the composition and formulation of the
`commercial products subject to NDA Nos. 22-157 and 20-9090.
`See EX2008 (explaining Patent Owner’s interest in NDAs held
`4
`
`
`
`IPR2019-00400
`Patent 8,633,194 B2
`
`
`by Sanofi Aventis US LLC); see also EX3005 (unsealed version
`of EX2008). This information has not been made public by either
`party or by the United States Food and Drug Administration, and
`is not otherwise available to the public to Patent Owner’s
`knowledge.
`Mot. 2–3.3
`Patent Owner contends disclosure of this information would be
`harmful to its business interests, while public interest in the redacted
`information is minimal because the Board does not rely on the
`material, directly or indirectly, in the Final Written Decision. Mot. 3.
`Upon reviewing the Motion and Exhibit 1042, we agree with Patent
`Owner that the information at issue is confidential information. See Mot. 2–
`3; see also 37 C.F.R. § 42.2 (“Confidential information means trade secret or
`other confidential research, development, or commercial information.”).
`Considering the sensitivity of the information and the potential competitive
`harm were the information disclosed publicly at this time, and that we do not
`rely on this information in our Final Written Decision, we determine good
`cause has been shown for granting this request. Further, the revised redacted,
`public version of Exhibit 1042 appears to be tailored narrowly to redact only
`confidential information. We find Patent Owner’s desire to keep this
`information confidential is not outweighed by the public interest in
`
`
`3 Although we expressly stated that Patent Owner should “provide an
`explanation of any differences” between two versions of a substituted
`document, given the limited differences between the two versions of Exhibit
`1042 and Patent Owner’s explanation of the remaining redactions, any non-
`compliance is de minimus. Paper 57, 43.
`5
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`IPR2019-00400
`Patent 8,633,194 B2
`
`maintaining a complete and understandable record of these proceedings. The
`confidential information contained in Exhibit 1042 is subject to the Board’s
`default protective order. See Papers 18 and 57.
`
`Having considered Patent Owner’s arguments for sealing
`selected portions of Exhibit 1042, we determine that Patent Owner has
`demonstrated good cause for its request. See 37 C.F.R. § 42.54(a).
`
`
`ORDER
`In consideration of the foregoing, it is:
`ORDERED that Patent Owner’s Motion to seal the confidential, non-
`public version of Exhibit 1042 is granted;
`FURTHER ORDERED that the originally-filed redacted, public
`version of Exhibit 1042, filed January 16, 2020, shall be expunged and the
`revised redacted, public version of Exhibit 1042, submitted via email on
`June 22, 2020, shall serve as record in these proceedings.
`
`
`
`6
`
`
`
`IPR2019-00400
`Patent 8,633,194 B2
`
`For PETITIONER:
`
`Jitendra Malik
`Alissa Pacchioli
`Joseph Janusz
`Lance Soderstrum
`KATTEN MUCHIN ROSENMAN LLP
`Jitty.malik@kattenlaw.com
`Allisa.pacchioli@kattenlaw.com
`Joe.janusz@kattenlaw.com
`Lance.soderstrum@kattenlaw.com
`
`For PATENT OWNER:
`
`James Trainor
`Robert Counihan
`Erica Sutter
`FENWICK & WEST LLP
`jtrainor@fenwick.com
`rcounihan@fenwick.com
`esutter@fenwick.com
`
`7
`
`
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