UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner
`__
`
`
`
`
`
`Case IPR2023-00512
`U.S. Patent No. 8,846,628
`Issued: September 30, 2014
`
`Title:
`ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF
`
`
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`Doc # NY/32417550v3
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner
`__
`
`
`
`
`
`Case IPR2023-00512
`U.S. Patent No. 8,846,628
`Issued: September 30, 2014
`
`Title:
`ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF
`
`
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`Doc # NY/32417550v3
`
`
`
`
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Apotex Inc. (“Petitioner”)
`
`submits the following objections to evidence served by Celgene Corporation
`
`(“Patent Owner”) with Patent Owner’s Preliminary Response (“POPR”) (Paper
`
`No. 7), in the above-captioned proceeding. These objections are timely under 37
`
`C.F.R. § 42.64(b)(1) because they are being filed within ten (10) business days of
`
`institution of trial. Petitioner’s objections provide notice to Patent Owner that
`
`Petitioner may move to exclude these exhibits under 37 C.F.R. § 42.64(c).
`
`Petitioner’s objections apply equally to Patent Owner’s reliance on the exhibit in
`
`any subsequently-filed documents.
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence and
`
`“’628 patent” means U.S. Patent No. 8,846,628. Exhibit descriptions provided in
`
`Table 1 are from Patent Owner’s exhibit list and are used for identification
`
`purposes only. The use of an exhibit description does not indicate that Petitioner
`
`agrees with that description or characterization of the document.
`
`Notwithstanding these objections, Petitioner expressly reserves the right to
`
`rely on any evidence submitted by Patent Owner, including on the ground that such
`
`evidence constitutes a party admission.
`
`Petitioner objects to Exhibit 2001 as incomplete, lacking relevance, and
`
`because any probative value is substantially outweighed by the danger of undue
`
`prejudice (due to confusing the issues, misleading the fact finder, undue delay,
`
`
`
`- 2 -
`
`Doc # NY/32417550v3
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`wasting time, and/or needlessly presenting cumulative evidence). See Fed. R.
`
`Evid. 106, 401, 402, and 403. Petitioner also objects to Exhibit 2001 for lacking
`
`relevance to the extent it relies on or cites to a document with a purported date that
`
`is after the priority date of the ’628 patent. See Fed. R. Evid. 401, 402, and 403.
`
`Petitioner also objects to Exhibit 2001 to the extent it relies on out of court
`
`statements for their truth, thus constituting impermissible hearsay. See Fed. R.
`
`Evid. 801-804. Petitioner also objects to Exhibit 2001 to the extent it relies on a
`
`document lacking proper authentication. See Fed. R. Evid. 901-902.
`
`Petitioner further objects to the following paragraphs of Exhibit 2001:
`
`• ¶ 41 for the same reasons as those presented below for Exhibit 2042 in
`
`Table 1, due to its reliance on Exhibit 2042. Petitioner further objects to
`
`all paragraphs that rely on this paragraph for the same reasons;
`
`• ¶ 47 for the same reasons as those presented below for Exhibit 2025 in
`
`Table 1, due to its reliance on Exhibit 2025. Petitioner further objects to
`
`all paragraphs that rely on this paragraph for the same reasons;
`
`• ¶ 64 for the same reasons as those presented below for Exhibit 2016 in
`
`Table 1, due to its reliance on Exhibit 2016. Petitioner further objects to
`
`all paragraphs that rely on this paragraph for the same reasons;
`
`
`
`- 3 -
`
`Doc # NY/32417550v3
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`• ¶ 70 for the same reasons as those presented below for Exhibit 2023 in
`
`Table 1, due to its reliance on Exhibit 2023. Petitioner further objects to
`
`all paragraphs that rely on this paragraph for the same reasons.
`
`Petitioner further objects to Patent Owner’s exhibits and Patent Owner’s
`
`reliance on them for the reasons set forth below in Table 1 and the Objection Key.
`
`Exhibit
`2002
`
`Table 1.
`Patent Owner’s Description
`FDA approves Onureg® (azacitidine tablets) for
`acute myeloid leukemia (“FDA Approves
`Onureg®”)
`2006 Canadian Product 200mg Onureg® Product
`Information
`2007 Canadian Product 300mg Onureg® Product
`Information
`2008 Canadian Product Monograph Onureg®
`2013
`European Commission Decision 17.6.21
`2016
`FASTtrack 2010 (“FASTtrack”)
`National Cancer Institute 1978 (“National
`Cancer Institute”)
`2023
`2025 Onureg® Label
`International Pat. Appl. Pub. No.
`WO2009/139888 (“WO2009/139888”)
`U.S. Pat. Pub. No. US20040186065A1
`(“Ionescu-065”)
`2030
`2035 U.S. Pat. No. 6,887,855 (“Ionescu-855”)
`2036 U.S. Pat. No. 7,078,518 (“Ionescu-518”)
`2037 U.S. Pat. No. 7,772,199 (“Ionescu-199”)
`U.S. Pat. Pub. No. US20060247189 (“Ionescu-
`189”)
`U.S. Pat. Pub. No. US20100298253 (“Ionescu-
`253”)
`2039
`2040 Ward 2007 (“Ward”)
`2042 Gibson Supplemental
`
`2026
`
`2038
`
`Objections
`B, C, D, E, F, G, H
`
`B, C, D, E, F, G, H
`
`B, C, D, E, F, G, H
`
`B, C, D, E, F, G, H
`B, C, D, E, F, G, H
`B, C, D, E, F, G
`A, C, D, E
`
`B, C, D, E, F, G
`B, C, D, E, H
`
`C, D, E, H
`
`C, D, E, H
`C, D, E, H
`C, D, E, H
`C, D, E, H
`
`C, D, E, H
`
`C, D, E, H
`A, C, D, E
`
`
`
`- 4 -
`
`Doc # NY/32417550v3
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`
`
`
`Petitioner further objects to Patent Owner’s reliance on Exhibit 1022, in
`
`particular the Declaration of Dr. Charles L. Beach under 37 C.F.R. § 1.132
`
`(“Beach Decl.”), as relying on out of court statements for their truth, thus
`
`constituting impermissible hearsay.
`
`
`
`
`
`
`
`- 5 -
`
`Doc # NY/32417550v3
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`Objection Key:
`
`A: FRE 106 (incomplete) the document is an incomplete writing.
`B:
`FRE 401/402/403 (relevance) the document is not relevant to any issue in
`this IPR proceeding because the purported date of the document is after the priority
`date of the ’628 patent.
`C:
`FRE 401/402 (relevance) the document is not relevant to any issue in this
`IPR proceeding.
`D:
`FRE 403 (unduly prejudicial, waste of time, confusing) the document is not
`relevant to any issue in the IPR proceeding because any probative value is
`substantially outweighed by the danger of undue prejudice, confusing the issues,
`undue delay, misleading the factfinder, or wasting time.
`E:
`FRE 403 (cumulative) the document is not relevant to any issue in the IPR
`proceeding because any probative value is substantially outweighed by the danger
`of needlessly presenting cumulative evidence.
`F:
`FRE 801-804 (hearsay) the document contains out of court statements that
`Patent Owner relies on for their truth, thus constituting impermissible hearsay.
`G: FRE 901-902 the document lacks proper authentication and is not self-
`authenticating.
`H: Not relied upon by any expert or cited in any paragraphs of an expert
`declaration.
`
`
`
`
`
`
`- 6 -
`
`Doc # NY/32417550v3
`
`
`
`Dated: August 3, 2023
`
`
`
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`/s/ Vishal C. Gupta
`
`Vishal C. Gupta (Reg. No. 67,284)
`John J. Molenda (Reg. No. 47,804)
`Tyler Doh (Reg. No. 80,274)
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Tel: (212) 506-3900
`
`Robert Kappers (Reg. No. 70,202)
`STEPTOE & JOHNSON LLP
`227 West Monroe Street
`Suite 4700
`Chicago, IL 60606
`Tel: (312)-577-1300
`
`Counsel for Petitioner
`
`
`
`- 7 -
`
`Doc # NY/32417550v3
`
`
`
`IPR2023-00512
`Petitioner’s Objections to Evidence
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNER’S EVIDENCE by email to the electronic service addresses for Patent
`
`Owner:
`
`Lead Counsel
`Heather M. Petruzzi,
`Reg. No. 71,270
`Wilmer Cutler Pickering Hale and Dorr
`LLP
`2100 Pennsylvania Avenue N.W.
`Washington, DC 20037
`Tel: 202-663-6028
`Email:
`Heather.Petruzzi@wilmerhale.com
`
`Back-up Counsel
`Laura Macro, Ph.D.,
`Reg. No. 80,908
`Wilmer Cutler Pickering Hale and Dorr
`LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6446
`Email: Laura.Macro@wilmerhale.com
`
`Gabriel J. Rosanio, Ph.D.,
`Reg. No. 81,426
`Wilmer Cutler Pickering Hale and Dorr
`LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6363
`Email:
`Gabriel.Rosanio@wilmerhale.com
`
`
`
`/s/ Vishal C. Gupta
`Lead Counsel
`Vishal C. Gupta
`Reg. No. 67,284
`
`Counsel for Petitioner
`
`- 8 -
`
`Doc # NY/32417550v3
`
`
`Dated: August 3, 2023
`
`
`
`
`
`
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
