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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
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`Inter Partes Review No.: IPR2021-008811
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`U.S. Patent No. 9,254,338 B2
`Filed: July 12, 2013
`Issued: February 9, 2016
`Inventor: George D. Yancopoulos
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`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
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`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
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`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
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`TABLE OF CONTENTS
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`Ms. Weber Failed to Authenticate the Weber Exhibits. .................................. 1
`I.
`The Business Records Exception to Hearsay Does Not Apply. ...................... 3
`II.
`Inadmissibility of Secondary Considerations Evidence and Testimony. ........ 4
`III.
`IV. Conclusion. ...................................................................................................... 5
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`i
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`TABLE OF AUTHORITIES
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`Cases
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`Corning Inc. v. DSM IP Assets B.V.,
`IPR2013-00043, Paper 97 (P.T.A.B. May 1, 2014) ............................................... 4
`Kolmes v. World Fibers Corp.,
`107 F.3d 1534 (Fed. Cir. 1997) .............................................................................. 3
`Shimano Inc. v. Globeride, Inc.,
`IPR2015-00273, Paper 40 (P.T.A.B. June 16, 2016) ............................................. 5
`Rules
`Fed. R. Evid. 401 ....................................................................................................... 5
`Fed. R. Evid. 402 ....................................................................................................... 5
`Fed. R. Evid. 403 ....................................................................................................... 5
`Fed. R. Evid. 803(6) ...............................................................................................3, 4
`Fed. R. Evid. 901 ....................................................................................................... 3
`Fed. R. Evid. 902 ....................................................................................................... 1
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`ii
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`Patent Owner’s opposition misrepresents the law and the facts, and ultimately
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`fails to rebut Petitioner’s showing that the challenged evidence is inadmissible.
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`I. Ms. Weber Failed to Authenticate the Weber Exhibits.
`The authentication problems associated with the Weber Exhibits are glaring.
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`Patent Owner (“PO”) does not dispute that Ms. Weber neither “authored [n]or
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`maintained the documents,” or that they are not self-authenticating under Rule 902.
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`(See Opp’n, 1-3). Instead, PO relies upon factually unsupported assertions that Ms.
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`Weber “personally collected,” “reviewed,” and “confirmed that [the Weber
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`Exhibits] are true and correct copies.” (Id., 2). But, nothing in PO’s July 27
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`opposition brief changes the actual deposition testimony of Ms. Weber, which
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`revealed serious authentication deficiencies.
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`For example, the Weber Declaration declares: “Exhibit 2280 is a true and
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`correct copy of Regeneron’s ‘ATU Sales Share Data: Wet AMD,’ copyrighted
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`2021.” (Ex.2286, ¶32). At Ms. Weber’s deposition, Petitioner’s counsel probed the
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`basis for this statement:
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`Q. Who drafted the original document that became Exhibit 2280?
`A. I don’t know.
`Q. Was the original -- is the original document that became Exhibit 2280
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`stored electronically at Regeneron?
`A. I don’t know.
`Q. Is it stored as a hard copy?
`A. I don’t know.
`Q. Paragraph thirty-two of your declaration states copyrighted 2021. Do you
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`see that?
`A. Yes.
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`1
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`Q. Do you see any indication on the document itself on Exhibit 2280 that it
` was copyrighted 2021?
`A. No.
`Q. What's the basis for your statement in your declaration?
`A. It was provided by counsel.
`Q. Look at Exhibit 2280, do you see any of the words “ATU sales share data
`wet AMD”?
`A. No.
`Q. And looking at Exhibit 4, Eric Yang is identified as the custodian for this
`document, for this exhibit. Did you speak with Mr. Yang about Exhibit
`2280?
`A. Yes, counsel and I did.
`Q. Was this conversation after you submitted your declaration?
`A. Yes.
`Q. Are there any details regarding that conversation reflected in your
`declaration?
`A. No.
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`(Ex.1150, 115:14-117:3 (objections omitted)). Ms. Weber’s testimony on Exhibit
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`2133 is similarly exemplary of the authentication deficiencies of all Weber Exhibits:
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`Q. Who drafted the original document that became Exhibit 2133?
`A. I do not know.
`Q. Is this document stored electronically on Regeneron’s servers?
`A. I don’t know.
`Q. Is it stored as a hard copy at Regeneron?
`A. I don’t know.
`Q. Did you create Exhibit 2133?
`A. No.
`Q. Who created Exhibit 2133?
`A. I don’t know.
`Q. What did you do to ensure that Exhibit 2133 is a true and correct copy of
` Regeneron’s earnings call transcript of February 13, 2012?
`A. I sat with counsel and we reviewed the document.
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`(Id., 47:4-25 (objections omitted)). Ms. Weber’s position and dates of employment
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`at PO did not provide her with knowledge of PO’s document creation and record-
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`2
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`keeping procedure for these exhibits. (See, e.g., id., 33:3-37:19 (unable to answer
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`questions on Ex.2060’s file path information, preparation, authorship, storage, and
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`accessibility), 39:18-40:5, 47:7-12); Kolmes v. World Fibers Corp., 107 F.3d 1534,
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`1542-43 (Fed. Cir. 1997) (witness’s “fail[ure] to testify concerning the record-
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`keeping process” of when or how the documents were prepared insufficient for FRE
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`803(6) purposes)). Importantly, Ms. Weber did not even speak to any of the
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`custodians until after she submitted her declaration, further undermining the
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`reliability of her sworn declaration attestation as to her “personal knowledge of the
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`facts” and that each Weber Exhibit is a “true and correct copy.” (Ex.1150, 129:14-
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`20). PO fails to address these substantive deficiencies. Ms. Weber’s deposition
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`testimony presents an insurmountable barrier to PO’s attempt to satisfy its FRE 901
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`authentication burden, warranting exclusion of the Weber Exhibits.
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`II. The Business Records Exception to Hearsay Does Not Apply.
`PO does not dispute that any of Exhibits 2059-60, 2096, or 2128 are by
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`definition “hearsay.” Instead, PO, through testimony of Ms. Weber, attempts to
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`establish that these exhibits fall within the “business record” exception. (Opp’n, 3-
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`9). But, Ms. Weber’s testimony does not demonstrate sufficient personal knowledge
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`of PO’s business practices for her to testify regarding these practices. (See supra,
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`Section I). Ms. Weber cannot testify about whether the records were made or kept
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`in the course of a regularly conducted business activity because she was never a
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`3
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`custodian of PO’s records or otherwise a qualified witness. (FRE 803(6) (records of
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`a regularly conducted activity must be “shown by the testimony of the custodian or
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`another qualified witness”)). And, PO’s contention that these exhibits are scientific
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`reports does not support application of FRE 803(6). See Corning Inc. v. DSM IP
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`Assets B.V., IPR2013-00043, Paper 97, 4-7 (P.T.A.B. May 1, 2014) (declining to
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`invoke a Rule 803(6) exception to reports of scientific research and tests).
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`III.
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`Inadmissibility of Secondary Considerations Evidence and Testimony.
`Financial Documents: Contrary to PO’s assertions, (Opp’n, 10), Ms. Weber
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`has not authenticated the Financial Documents (as discussed above). Nor has PO
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`explained why they are not inadmissible hearsay. PO cites no factual support for its
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`contention that these exhibits are “original Regeneron business records.” (Opp’n,
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`10-11). And even if properly considered “business records,” Dr. Manning’s
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`testimony—e.g., his inability to explain whether the data presented therein
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`accounted for known expenses—indicates a lack of trustworthiness for the numbers
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`presented therein. (Mot., 10-12); see FRE 803(6) (business record exception
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`inapplicable if the source or preparation “indicate a lack of trustworthiness”). Dr.
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`Manning’s reliance on employee interviews as only “confirmatory and background
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`in nature,” and never the “sole source” for his opinions, has no bearing on
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`admissibility. (See Opp’n, 12; Mot., 12). Thus, the Financial Documents and related
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`expert opinions should be excluded. (See Mot., 9-12).
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`4
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`Marketing Documents: The challenged Marketing Exhibits and related expert
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`opinions should be excluded under FRE 403. (Mot., 13-14). Notably, PO admits that
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`Eylea is not always marketed for its purported “extended dosing regimen,”
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`confirming the risk of unfair prejudice, confusion, and misleading the factfinder.
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`(See Opp’n, 13 (“Eylea is marketed, at least in part, on the basis of its claimed
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`extended dosing regimen”)). Further, the Board’s prior ruling (Ex.1116) was not a
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`determination “that such materials do not constitute routine discovery or additional
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`discovery that is in the interests of justice,” as PO suggests. (Opp’n, 13-14). Rather,
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`the Board explicitly cited constraints in the schedule. (Ex.1116, 34-35, 44-45).
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`Lack of Nexus: Dr. Manning’s commercial success opinions, (Ex.2052, ¶¶48-
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`117), should be excluded under FRE 401-402. (Mot., 14-15). PO cannot dispute that,
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`to be legally relevant, a nexus must be established. (Id., 14). Nonetheless, PO
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`provides no justification for Dr. Manning’s failure to tie his commercial success
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`opinions to the claimed regimen. Thus, his opinions should either be excluded as
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`irrelevant or accorded no weight. Shimano Inc. v. Globeride, Inc., IPR2015-00273,
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`Paper 40, 27-28 (P.T.A.B. June 16, 2016) (granting exclusion for unproven nexus).
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`IV. Conclusion.
`The Board should exclude the challenged evidence because PO has failed to
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`rebut Petitioner’s showing that the challenged evidence is inadmissible.
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`5
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`Dated: August 2, 2022
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`Respectfully Submitted,
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`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
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`/Paul J. Molino/
`Paul J. Molino
`Registration No. 45,350
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 843-6260
`paul@rmmslegal.com
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`Counsel for Petitioner
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`6
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the foregoing
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`Petitioner’s Reply to Patent Owner’s Opposition to Petitioner’s Motion to Exclude
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`Evidence was served on August 2, 2022, via electronic mail by agreement of the
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`parties, to the following counsel for record of Patent Owner:
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`Alice S. Ho (Lim. Rec. No. L1162)
`Victoria Reines
`Jeremy Cobb
`Arnold & Porter Kaye Scholer LLP
`601 Massachusetts Ave., N.W.
`Washington D.C. 20001
`Tel: 202.942.5000
`Fax: 202.942.5999
`Alice.Ho@arnoldporter.com
`Victoria.Reines@arnoldporter.com
`Jeremy.Cobb@arnoldporter.com
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`Deborah E. Fishman (Reg. No. 48,621)
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4519
`Telephone: 650.319.4710
`Facsimile: 650.319.4573
`Deborah.Fishman@arnoldporter.com
`David.Caine@arnoldporter.com
`RegeneronEyleaIPRs@arnoldporter.com
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`Daniel Reisner
`Matthew M. Wilk
`Arnold & Porter Kaye Scholer LLP
`250 West 55th Street
`New York, New York 10019-9710
`Telephone: 212.836.8000
`Fax: 212.836.8689
`Daniel.Reisner@arnoldporter.com
`Matthew.Wilk@arnoldporter.com
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`/Paul J. Molino/
` Paul J. Molino (Reg. No. 45,350)
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