UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-008811
`Patent 9,254,338 B2
`____________
`
`PATENT OWNER’S MOTION TO SEAL
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-008811
`Patent 9,254,338 B2
`____________
`
`PATENT OWNER’S MOTION TO SEAL
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`
`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
`
`Owner Regeneron Pharmaceuticals, Inc. moves to seal the following exhibits and
`
`documents:
`
` Ex. 2048 (Expert Declaration of Dr. Lucian V. Del Priore, M.D., Ph.D.);
`
` Ex. 2049 (Expert Declaration of Dr. Alexander M. Klibanov, Ph.D.);
`
` Ex. 2052 (Expert Declaration of Richard Manning, Ph.D.);
`
` Ex. 2059 (Regeneron Sample Analysis Report: PK06005-9-SA-01V1
`
`(2006));
`
` Ex. 2060 (Regeneron Pharmaceuticals Protocol VGFT-OD-0605, Table
`
`14.2.3/2a Summary of Proportion of Vision Loss from Baseline to Week
`
`96, Last Observations Carried Forward (Full Analysis Set));
`
` Ex. 2073 (Zaltrap non-comparability issue: Regeneron Sanofi Analytical
`
`Investigation Workshop (March 14, 2014));
`
` Ex. 2096 (Clinical Study Agreement Between Vitreoretinal Consultants
`
`and Regeneron Pharmaceuticals, Inc. (July 31, 2007));
`
` Ex. 2128 (VGFT-OD-0605 (VIEW 1 Trial) Protocol Signature Page);
`
` Ex. 2138 (Regeneron, “Physician ATU: Wave 2,” 2/2013);
`
` Ex. 2140 (Regeneron, “Physician ATU: Wave 5,” 11/2013);
`
` Ex. 2163 (Regeneron, “Physician ATU: Wave 4,” 8/6/2013);
`2
`
`
`
` Ex. 2169 (Regeneron, "Eylea Sample Disbursement 2013 to 2021," c.
`
`2021);
`
` Ex. 2170 (Regeneron, "US Eylea P&L LTD," 12/2021);
`
` Ex. 2176 (Regeneron, “Q4 2020 Performance Update Wet AMD, DME,
`
`MEfRVO & DR w/out DME,” 1/29/2021);
`
` Ex. 2197 (Regeneron, “Physician ATU – Benchmark Wave,” 9/15/2011);
`
` Ex. 2200 (Regeneron, “U.S. Eylea Historical Brand P&L” );
`
` Ex. 2205 (Regeneron, “DME Market Assessment,” 8/2014);
`
` Ex. 2208 (Regeneron, “Eylea MD ATU – Wave 2 Final Questionnaire,”
`
`12/19/2012);
`
` Ex. 2218 (Regeneron, “Eylea (aflibercept) Injection: Components of
`
`Reimbursement,” c. 2015);
`
` Ex. 2229 (Regeneron, WAC Pricing File, 5/2021);
`
` Ex. 2243 (American Society of Retina Specialists, “Preferences and
`
`Trends (PAT) Survey,” 2016);
`
` Ex. 2244 (American Society of Retina Specialists, “Preferences and
`
`Trends (PAT) Survey,” 2015);
`
` Ex. 2250 (American Society of Retina Specialists, “Preferences and
`
`Trends (PAT) Survey,” 2014);
`
`3
`
`
`
` Ex. 2259 (American Society of Retina Specialists, “Preferences and
`
`Trends Membership Survey,” 2009);
`
` Ex. 2263 (Regeneron, Eylea Sales Summary, c.2020);
`
` Ex. 2272 (Regeneron, “Eylea Q2 2021 Performance,” 8/2/2021);
`
` Ex. 2273 (Vestrum, Anti-VEGF Category Sales Shares, c. 2/2022);
`
` Ex. 2274 (Regeneron, “Eylea Wet AMD Line of Therapy Insights,”
`
`4/2020);
`
` Ex. 2275 (Regeneron, “Vestrum Anti-VEGF Market Share Adjustment
`
`Overview,” 5/10/2019);
`
` Ex. 2276 (Regeneron, “Eylea Q2 2020 Performance (Vestrum Projection
`
`Data),” 8/4/2020);
`
` Ex. 2277 (Regeneron, “Marketing Planning Process,” 9/2011);
`
` Ex. 2278 (Regeneron, “Wave 1 2021 Performance Update Wet AMD,
`
`DME, MEfRVO, and DR w/out DME,” 9/2021);
`
` Ex. 2285 (Regeneron, Eylea Gross & Net Sales P&L YTD, c.2021); and
`
` Paper No. 38 (Patent Owner’s Response in IPR2021-00881).
`
`These exhibits and documents are being filed concurrently with this Motion
`
`and Patent Owner’s Response. Petitioner has indicated that it does not oppose this
`
`Motion.
`
`4
`
`
`
`I.
`
`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
`The standard governing the Board’s determination of whether to grant a
`
`motion to seal is “good cause.” Garmin Int’l, Inc. v. Cuozzo Speed Techs LLC, Case
`
`IPR2012-00001, Paper 36 at 4 (April 5, 2013) (quoting 37 C.F.R. § 42.54). The
`
`Board aims 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.” Id.
`
`The documents, exhibits, and portions of exhibits that Patent Owner seeks to
`
`file under seal fall into six general categories, each of which meets the “good cause”
`
`standard to be maintained in the docket under seal and available only to the parties
`
`and Board. In each instance, the material is either the confidential information of a
`
`third party who has permitted its use in this proceeding subject to a protective order,
`
`or else consists of confidential business information that would cause competitive
`
`harm to Patent Owner were it to be disclosed publicly.
`
`Confidential Partner Technical Documents
`A.
`Exhibit 2073 is a presentation that was produced by Regeneron’s partner,
`
`Sanofi. It describes internal aflibercept manufacturing studies performed by Sanofi
`
`and contains data and results from those studies. The information contained in this
`
`exhibit is not publicly available and would cause competitive harm to Regeneron
`
`and Sanofi if disclosed on the public docket. Sanofi has consented to its use in this
`
`5
`
`
`
`proceeding provided that it is filed under seal subject to the Board’s Default
`
`Protective Order.
`
`B.
`
`Confidential Commercial and Financial Documents of Patent
`Owner and Others
`Exhibits 2169, 2170, 2200, 2218, 2229, 2263, and 2285 contain confidential
`
`financial information drawn from Patent Owner’s internal business records. These
`
`exhibits contain information such as profits and costs associated with Patent
`
`Owner’s activities in connection with Eylea®. The information is confidential
`
`business information that is not publicly available; it is competitively sensitive and
`
`its inclusion in the public docket would cause commercial harm to Patent Owner.
`
`Exhibits 2176, 2272, 2273, 2275, and 2276 contain confidential market
`
`metrics and projections that are compiled and provided by third party data provider,
`
`Vestrum Health (“Vestrum”). These documents include data analysis related to
`
`Patent Owner’s activities in connection with Eylea®. The information contained in
`
`these exhibits is not publicly available and would cause competitive harm to Patent
`
`Owner and Vestrum if disclosed on the public docket. Patent Owner agreed with
`
`Vestrum to maintain the confidentiality of the information disclosed in these
`
`exhibits.
`
`Exhibit 2274 contains confidential market metrics and projections that are
`
`compiled and provided by third party data provider, IQVIA. These documents
`
`6
`
`
`
`include data analysis related to Patent Owner’s activities in connection with Eylea®.
`
`The information contained in these exhibits is not publicly available and would cause
`
`competitive harm to Patent Owner and IQVIA if disclosed on the public docket.
`
`Patent Owner agreed with IQVIA to maintain the confidentiality of the information
`
`disclosed in this exhibit.
`
`Exhibits 2138, 2140, 2163, 2197, 2205, 2208, 2277, and 2278 contain
`
`confidential marketing plans and information prepared and compiled by Patent
`
`Owner. These documents include and/or reference Patent Owner’s marketing plans
`
`and its Awareness Trial and Usage (“ATU”) market research for Eylea®. The
`
`information contained in these exhibits is not publicly available and would cause
`
`competitive harm to Patent Owner if disclosed on the public docket. Public release
`
`of these documents could benefit Patent Owner’s competitors and would therefore
`
`cause competitive harm to Patent Owner.
`
`Exhibits 2243, 2244, 2250, and 2259 contain confidential information
`
`obtained from the American Society of Retina Specialists (ASRS). These documents
`
`include compiled survey information from ASRS member retina specialists. Only
`
`members of ASRS have access to this information and the documents themselves
`
`include restrictions on their publication. The information contained in these exhibits
`
`is not publicly available and may cause competitive harm to ASRS if disclosed on
`
`the public docket.
`
`7
`
`
`
`Confidential Regulatory Documents
`C.
`Exhibits 2059 and 2060 are portions of Patent Owner’s submissions to the
`
`FDA regarding the Eylea® product. These portions contain non-public, confidential
`
`details about Patent Owner’s manufacturing and clinical trials for Eylea®. These
`
`details include confidential manufacturing information and tests, experiment design
`
`and procedures, analysis, and results. Public release of these documents could
`
`benefit Patent Owner’s competitors, including those seeking to copy Patent Owner’s
`
`product, and would therefore cause competitive harm to Patent Owner.
`
`Confidential Agreements Regarding Clinical Trials
`D.
`Exhibits 2096 and 2128 are non-public, confidential agreements regarding
`
`Patent Owner’s clinical trials for Eylea®. These clinical study agreements set forth
`
`the confidential business and legal terms of Regeneron’s investigator agreements for
`
`Eylea®. Further, the investigator agreements include provisions acknowledging the
`
`confidential nature of the information contained therein and require that such
`
`information be maintained as confidential. The information contained in these
`
`exhibits is not publicly available and would cause competitive harm to Patent Owner
`
`and the named investigators if disclosed on the public docket.
`
`Declarations Including or Describing Confidential Information
`E.
`Exhibit 2048 is a declaration of Dr. Lucian V. Del Priore, an expert witness
`
`retained by Patent Owner who addresses what a person of ordinary skill would have
`
`8
`
`
`
`known at the time of invention of the ’338 Patent. Dr. Del Priore relies on Patent
`
`Owner’s confidential information in his declaration, and cites to confidential
`
`exhibits described above. Patent Owner moves to seal the specific portions of Dr.
`
`Del Priore’s declaration that reveal this confidential information. Pursuant to
`
`Paragraph 5(A)(ii) of the Board’s default protective order, a redacted copy of Dr.
`
`Del Priore’s declaration is being filed publicly with the same exhibit number.
`
`Exhibit 2049 is a declaration of Dr. Alexander M. Klibanov, an expert witness
`
`retained by Patent Owner who addresses the state of the relevant art as of the priority
`
`date of the ’338 Patent. Dr. Kilbanov relies on Patent Owner’s confidential
`
`information in his declaration, and cites to confidential exhibits described above.
`
`Patent Owner moves to seal the specific portions of Dr. Klibanov’s declaration that
`
`reveal this confidential information. Pursuant to Paragraph 5(A)(ii) of the Board’s
`
`default protective order, a redacted copy of Dr. Klibanov’s declaration is being filed
`
`publicly with the same exhibit number.
`
`Exhibit 2052 is a declaration of Dr. Richard Manning, an expert witness
`
`retained by Patent Owner who addresses the commercial success of Eylea®. Dr.
`
`Manning relies on Patent Owner’s confidential information in his declaration, and
`
`cites confidential exhibits described above. Patent Owner moves to seal the specific
`
`portions of Dr. Manning’s declaration that reveal this confidential information.
`
`Pursuant to Paragraph 5(A)(ii) of the Board’s default protective order, a redacted
`9
`
`
`
`copy of Dr. Manning’s declaration is being filed publicly with the same exhibit
`
`number.
`
`Patent Owner’s Response
`F.
`Paper No. 38 is Patent Owner’s Response. It relies on and addresses the
`
`confidential information disclosed in the exhibits mentioned above in categories A-
`
`E. Pursuant to Paragraph 5(A)(ii) of the Board’s default protective order, a redacted
`
`copy of Patent Owner’s Response is being filed publicly as Paper No. 38.
`
`Accordingly, Patent Owner moves to seal the foregoing exhibits and
`
`documents, and there is good cause for them to be maintained under seal.
`
`II.
`
`PROTECTIVE ORDER
`Pursuant to 37 CFR §§ 42.54 and 42.55(a), Patent Owner filed a motion for
`
`entry of the Board’s default protective order. See Paper No. 34. Petitioner did not
`
`oppose Patent Owner’s motion.
`
`III. CERTIFICATION
`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
`
`Petitioner regarding this motion to seal. Petitioner does not object to the motion to
`
`seal.
`
`10
`
`
`
`Dated: February 11, 2022
`
`Respectfully Submitted,
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4)(i) et seq. and 42.105(b), the undersigned
`
`Certifies that on February 11, 2022, a true and entire copy of this MOTION TO
`
`SEAL AND FOR ENTRY OF A PROTECTIVE ORDER was served via e-mail
`
`to the Petitioner at the following email addresses:
`
`MYL_REG_IPR@rmmslegal.com
`paul@ rmmslegal.com
`wrakoczy@ rmmslegal.com
`hsalmen@ rmmslegal.com
`nmclaughlin@rmmslegal.com
`lgreen@wsgr.com
`ychu@wsgr.com
`rcerwinski@geminilaw.com
`azalcenstein@geminilaw.com
`bmorris@geminilaw.com
`TRea@Crowell.com
`DYellin@Crowell.com
`SLentz@Crowell.com
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`12
`
`
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