`
`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.
`
`
`
`Inter Partes Review No.: IPR2021-008811
`
`
`U.S. Patent No. 9,254,338 B2
`Filed: July 12, 2013
`Issued: February 9, 2016
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
`
`
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`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
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`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
`
`
`
`
`ii
`
`
`
`
`
`Patent Owner’s opposition misrepresents the law and the facts, and ultimately
`
`fails to rebut Petitioner’s showing that the challenged evidence is inadmissible.
`
`I. Ms. Weber Failed to Authenticate the Weber Exhibits.
`The authentication problems associated with the Weber Exhibits are glaring.
`
`Patent Owner (“PO”) does not dispute that Ms. Weber neither “authored [n]or
`
`maintained the documents,” or that they are not self-authenticating under Rule 902.
`
`(See Opp’n, 1-3). Instead, PO relies upon factually unsupported assertions that Ms.
`
`Weber “personally collected,” “reviewed,” and “confirmed that [the Weber
`
`Exhibits] are true and correct copies.” (Id., 2). But, nothing in PO’s July 27
`
`opposition brief changes the actual deposition testimony of Ms. Weber, which
`
`revealed serious authentication deficiencies.
`
`For example, the Weber Declaration declares: “Exhibit 2280 is a true and
`
`correct copy of Regeneron’s ‘ATU Sales Share Data: Wet AMD,’ copyrighted
`
`2021.” (Ex.2286, ¶32). At Ms. Weber’s deposition, Petitioner’s counsel probed the
`
`basis for this statement:
`
`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
`
`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
`
`see that?
`A. Yes.
`
`1
`
`
`
`
`
`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.
`
`
`(Ex.1150, 115:14-117:3 (objections omitted)). Ms. Weber’s testimony on Exhibit
`
`2133 is similarly exemplary of the authentication deficiencies of all Weber Exhibits:
`
`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.
`
`(Id., 47:4-25 (objections omitted)). Ms. Weber’s position and dates of employment
`
`at PO did not provide her with knowledge of PO’s document creation and record-
`
`2
`
`
`
`
`
`keeping procedure for these exhibits. (See, e.g., id., 33:3-37:19 (unable to answer
`
`questions on Ex.2060’s file path information, preparation, authorship, storage, and
`
`accessibility), 39:18-40:5, 47:7-12); Kolmes v. World Fibers Corp., 107 F.3d 1534,
`
`1542-43 (Fed. Cir. 1997) (witness’s “fail[ure] to testify concerning the record-
`
`keeping process” of when or how the documents were prepared insufficient for FRE
`
`803(6) purposes)). Importantly, Ms. Weber did not even speak to any of the
`
`custodians until after she submitted her declaration, further undermining the
`
`reliability of her sworn declaration attestation as to her “personal knowledge of the
`
`facts” and that each Weber Exhibit is a “true and correct copy.” (Ex.1150, 129:14-
`
`20). PO fails to address these substantive deficiencies. Ms. Weber’s deposition
`
`testimony presents an insurmountable barrier to PO’s attempt to satisfy its FRE 901
`
`authentication burden, warranting exclusion of the Weber Exhibits.
`
`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
`
`definition “hearsay.” Instead, PO, through testimony of Ms. Weber, attempts to
`
`establish that these exhibits fall within the “business record” exception. (Opp’n, 3-
`
`9). But, Ms. Weber’s testimony does not demonstrate sufficient personal knowledge
`
`of PO’s business practices for her to testify regarding these practices. (See supra,
`
`Section I). Ms. Weber cannot testify about whether the records were made or kept
`
`in the course of a regularly conducted business activity because she was never a
`
`3
`
`
`
`
`
`custodian of PO’s records or otherwise a qualified witness. (FRE 803(6) (records of
`
`a regularly conducted activity must be “shown by the testimony of the custodian or
`
`another qualified witness”)). And, PO’s contention that these exhibits are scientific
`
`reports does not support application of FRE 803(6). See Corning Inc. v. DSM IP
`
`Assets B.V., IPR2013-00043, Paper 97, 4-7 (P.T.A.B. May 1, 2014) (declining to
`
`invoke a Rule 803(6) exception to reports of scientific research and tests).
`
`III.
`
`Inadmissibility of Secondary Considerations Evidence and Testimony.
`Financial Documents: Contrary to PO’s assertions, (Opp’n, 10), Ms. Weber
`
`has not authenticated the Financial Documents (as discussed above). Nor has PO
`
`explained why they are not inadmissible hearsay. PO cites no factual support for its
`
`contention that these exhibits are “original Regeneron business records.” (Opp’n,
`
`10-11). And even if properly considered “business records,” Dr. Manning’s
`
`testimony—e.g., his inability to explain whether the data presented therein
`
`accounted for known expenses—indicates a lack of trustworthiness for the numbers
`
`presented therein. (Mot., 10-12); see FRE 803(6) (business record exception
`
`inapplicable if the source or preparation “indicate a lack of trustworthiness”). Dr.
`
`Manning’s reliance on employee interviews as only “confirmatory and background
`
`in nature,” and never the “sole source” for his opinions, has no bearing on
`
`admissibility. (See Opp’n, 12; Mot., 12). Thus, the Financial Documents and related
`
`expert opinions should be excluded. (See Mot., 9-12).
`
`4
`
`
`
`
`
`Marketing Documents: The challenged Marketing Exhibits and related expert
`
`opinions should be excluded under FRE 403. (Mot., 13-14). Notably, PO admits that
`
`Eylea is not always marketed for its purported “extended dosing regimen,”
`
`confirming the risk of unfair prejudice, confusion, and misleading the factfinder.
`
`(See Opp’n, 13 (“Eylea is marketed, at least in part, on the basis of its claimed
`
`extended dosing regimen”)). Further, the Board’s prior ruling (Ex.1116) was not a
`
`determination “that such materials do not constitute routine discovery or additional
`
`discovery that is in the interests of justice,” as PO suggests. (Opp’n, 13-14). Rather,
`
`the Board explicitly cited constraints in the schedule. (Ex.1116, 34-35, 44-45).
`
`Lack of Nexus: Dr. Manning’s commercial success opinions, (Ex.2052, ¶¶48-
`
`117), should be excluded under FRE 401-402. (Mot., 14-15). PO cannot dispute that,
`
`to be legally relevant, a nexus must be established. (Id., 14). Nonetheless, PO
`
`provides no justification for Dr. Manning’s failure to tie his commercial success
`
`opinions to the claimed regimen. Thus, his opinions should either be excluded as
`
`irrelevant or accorded no weight. Shimano Inc. v. Globeride, Inc., IPR2015-00273,
`
`Paper 40, 27-28 (P.T.A.B. June 16, 2016) (granting exclusion for unproven nexus).
`
`IV. Conclusion.
`The Board should exclude the challenged evidence because PO has failed to
`
`rebut Petitioner’s showing that the challenged evidence is inadmissible.
`
`
`
`
`
`5
`
`
`
`Dated: August 2, 2022
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/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
`
`
`Counsel for Petitioner
`
`
`
`6
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`Petitioner’s Reply to Patent Owner’s Opposition to Petitioner’s Motion to Exclude
`
`Evidence was served on August 2, 2022, via electronic mail by agreement of the
`
`parties, to the following counsel for record of Patent Owner:
`
`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
`
`
`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
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Paul J. Molino/
` Paul J. Molino (Reg. No. 45,350)
`
`
`
`
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
