UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`PHARMACOSMOS A/S
`Petitioner
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`
`
`
`
`
`Patent No. 7,754,702
`Issue Date: July 13, 2010
`Title: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`
`
`
`Inter Partes Review No. 2015-01490
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S OBJECTIONS TO
`EVIDENCE AND SUBMISSION OF SUPPLEMENTAL EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(2)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`PHARMACOSMOS A/S
`Petitioner
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`
`
`
`
`
`Patent No. 7,754,702
`Issue Date: July 13, 2010
`Title: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
`
`
`
`
`Inter Partes Review No. 2015-01490
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S OBJECTIONS TO
`EVIDENCE AND SUBMISSION OF SUPPLEMENTAL EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(2)
`
`
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`Petitioner Pharmacosmos A/S (“Petitioner”) hereby submits its Response to
`
`Patent Owner Objections to Evidence served on January 27, 2016 and related
`
`supplemental evidence.
`
`PETITIONER’S RESPONSES TO PATENT
`OWNER’S OBJECTIONS TO EVIDENCE
`
`PATENT OWNER’S OBJECTION NOS. 1 AND 2 RELATING TO
`WO2004037865 AND ITS TRANSLATION (Exhibit Nos. 1002 and 1003)
`
`Patent Owner objects to Exhibit 1002 (International Patent Publ. No.
`
`WO2004037865 (“Geisser”) under 37 C.F.R. §§ 41.61(a)1 and 42.63(b) contending
`
`that “[t]his foreign language exhibit is not accompanied by an admissible
`
`translation and affidavit.”
`
`Relatedly, Patent Owner objects to Exhibit 1003 (Certified Translation of
`
`Geisser) under FRE 602, 603, 604, and 701 and 37 C.F.R. §§ 42.2, 42.61(a), and
`
`42.63(b), contending that 1) the translator has not been shown to have personal
`
`knowledge of the matters asserted and is not eligible to offer opinion testimony; 2)
`
`the translator’s certification is not under oath; 3) the translator has not been shown
`
`to be qualified; and 4) the Exhibit 1003 does not qualify as an “affidavit”.
`
`
`
`
`1 37 C.F.R. § 41.61(a) relates to the issuance of a Right of Appeal Notice under §
`
`1.953. Petitioner assumes this was a typographical error and that Patent Owner
`
`intended to cite § 41.62(a).
`
`1
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`PETITIONER’S RESPONSE
`
`Petitioner disagrees with Patent Owner’s objections, including its assertion
`
`that Geisser is not accompanied by an admissible certified translation and a
`
`certificate of the translation’s authenticity. On June 24, 2015, the filing date of the
`
`Petitioner’s Petition for Inter Partes Review, Geisser was accompanied by Exhibit
`
`1003, which included both a certified English translation and a Translator
`
`Certification attesting that the translation is a “true, full and accurate translation of
`
`[Geisser]”. Notably, the Patent Owner has not pointed to any particular defects in
`
`the accuracy of the translation.
`
`Without waiver of the right to respond further to Patent Owner’s objections
`
`in the event that Patent Owner seeks to exclude Geisser and/or to the extent the
`
`Patent Owner seeks to challenge any portions of the Geisser translation or affidavit
`
`in any other manner, Petitioner submits herewith Supplemental Evidence to
`
`alleviate Patent Owner’s objections thereto. See Exhibit 1053. Exhibit 1053
`
`contains a Declaration of a translator attesting that the translation is a true, full, and
`
`accurate translation with the understanding that willful misstatements would
`
`subject the affiant to the penalties of perjury.
`
`2
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`PATENT OWNER’S OBJECTION NO. 3 RELATING TO VAN ZYL-SMIT
`(Exhibit 1006)
`
`Patent Owner objects to Exhibit 1006 under FRE 801 and 802, simply
`
`stating “Hearsay and hearsay within hearsay.”
`
`PETITIONER’S RESPONSE
`
`Petitioner disagrees with Patent Owner’s objections to van Zyl-Smit and
`
`maintains that van Zyl-Smit should be admissible in these proceedings because it is
`
`not hearsay and/or falls within a hearsay exception. Prior art references submitted
`
`as a printed publication under 35 U.S.C. § 102(a) are not hearsay because they are
`
`offered for what they describe, and not to prove the truth of the matters asserted.
`
`See, e.g., EMC Corporation v. PersonalWeb Technologies, LLC, IPR2013-00084,
`
`slip op. at 48 (PTAB May. 15, 2014) (Paper 64) (confirming that prior art was not
`
`hearsay because it was not offered to prove what it describes); Joy Techs., Inc. v.
`
`Manbeck, 751 F. Supp. 225, 233 n.2 (D.D.C. 1990) (same), judgment aff’d, 959
`
`F.2d 226 (Fed. Cir. 1992); FRE 801(c) 1972 Adv. Comm. Note (“If the
`
`significance of an offered statement lies solely in the fact that it was made, no issue
`
`is raised as to the truth of anything asserted, and the statement is not hearsay.”).
`
`Petitioner reserves the right to respond further to Patent Owner’s objections
`
`in the event that Patent Owner seeks to exclude van Zyl-Smit and/or to the extent
`
`3
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`the Patent Owner seeks to challenge any portions of van Zyl-Smit in any other
`
`manner.
`
`PATENT OWNER’S OBJECTION NO. 4 RELATING TO THE
`PRESCRIBING INFORMATION FOR FERAHEME® (Exhibit 1024)
`
`Patent Owner objects to Exhibit 1024 under FRE 401 and 402, contending
`
`that it lacks relevance.
`
`PETITIONER’S RESPONSE
`
`Petitioner disagrees with Patent Owner’s objections to Exhibit 1024 and
`
`maintains that it should be admissible in these proceedings. Petitioner cites to
`
`Exhibit 1024 as evidence that ferumoxytol, recited in the ‘702 Patent, is the generic
`
`name for Feraheme® and contains iron oxide coated with polyglucose sorbitol
`
`carboxymethylether. See Paper 1 at 6 and n.3. Furthermore, U.S. Patent
`
`Publication No. 2003/0232084 (“Groman”; Ex. 1004) issued as U.S. Patent No.
`
`7,871,597 (“the ‘597 patent”; Ex. 1019). The ‘597 patent is included in the F.D.A.
`
`Orange Book Listing for Feraheme®, thus, further demonstrating that Groman
`
`discloses iron oxide coated with polyglucose sorbitol carboxymethyl ether. See
`
`Ex. 1016; see also Paper 1 at 20. As such, while Exhibit 1024 is cited to show the
`
`state of the art at or around the time of the invention, it is not relied upon to make
`
`Petitioner’s prima facie case. Moreover, the fact that Exhibit 1024 was published
`
`after the priority date of the ‘702 Patent is immaterial. See Liberty Mutual v.
`
`4
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`Progressive Casualty Insurance, CBM2012-00002, slip op. at 64 (PTAB January
`
`23, 2014) (Paper 66) (“It is well settled that references that have publication dates
`
`after the critical date may be cited to show the state of the art at or around the time
`
`of the invention.” (citing Eli Lilly and Co. v. Barr Labs., Inc., 251 F.3d 955, 969-
`
`70 (Fed. Cir. 2001))).
`
`Petitioner reserves the right to respond further to Patent Owner’s objections
`
`in the event that Patent Owner seeks to exclude the Prescribing information for
`
`Feraheme® and/or to the extent the Patent Owner seeks to challenge any portions
`
`of the Prescribing information for Feraheme® in any other manner.
`
`PATENT OWNER’S OBJECTION NO. 5 RELATING TO THE
`FERAHEME (FERUMOXYTOL) DRUG SAFETY COMMUNICATION
`(Exhibit 1025)
`
`Patent Owner objects to Exhibit 1025 under FRE 401 and 402, contending
`
`that it lacks relevance.
`
`PETITIONER’S RESPONSE
`
`Petitioner disagrees with Patent Owner’s objections to Exhibit 1025 and
`
`maintains that it should be admissible in these proceedings. Exhibit 1025 is cited
`
`to provide full disclosure to the Board as it pertains to the administration of
`
`ferumoxytol and, although it was published only recently, discloses that the
`
`protocol for administration of ferumoxytol has been revised from injection over 17
`
`5
`
`
`
`
`
`Patent No. 7,754,702
`
`IPR2015-01490
`
`
`
`seconds to intravenous administration over at least 15 minutes. See Paper 1 at 16.
`
`It is not relied upon to make Petitioner’s prima facie case. Moreover, the fact that
`
`Exhibit 1025 was published after the priority date of the ‘702 Patent is immaterial.
`
`See Liberty Mutual v. Progressive Casualty Insurance, CBM2012-00002, slip op.
`
`at 64 (PTAB January 23, 2014) (Paper 66) (“It is well settled that references that
`
`have publication dates after the critical date may be cited to show the state of the
`
`art at or around the time of the invention.” (citing Eli Lilly and Co. v. Barr Labs.,
`
`Inc., 251 F.3d 955, 969-70 (Fed. Cir. 2001))).
`
`Petitioner reserves the right to respond further to Patent Owner’s objections
`
`in the event that Patent Owner seeks to exclude the Feraheme (ferumoxytol) Drug
`
`Safety Communication and/or to the extent the Patent Owner seeks to challenge
`
`any portions of the Feraheme (ferumoxytol) Drug Safety Communication in any
`
`other manner.
`
`
`
`
`
`6
`
`
`
`5-01490
`IPR201
`
`Patent
`
`
`
`No. 7,7544,702
`
`
`
`PEETITIONEER’S SUPPPLEMENNTAL EVIIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`SSubject to aand withouut waiver oof the foreggoing respponses, thee followingg is a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`descripttion of the Supplemeental Evideence attach
`
`
`
`ed hereto:
`
`
`
`1.
`
`
`
`Affiddavit of Elllen C. Riemmschneiderr (Petitioneer Exhibit
`
`
`
`
`
`
`
`
`
`
`
`Respectfufully submiitted,
`
`
`
`BAKER
`
`
`
`BOTTS LL.L.P.
`
`
`
`
`
`
`
`Februaary 10, 20116
`
`
`
`
`Date
`
`
`
`
`
`
`
`/s/ Lisa KKole
`
`
`
`
`RNEYS FOOR
`ATTOR
`
`
`OS PHARMMACOSMO
`
`
`
`Lisa Kolee (PTO Reeg. No. 35,
`225)
`
`TO Reg. NNo. 53,202
`
`Steven LLendaris (P
`
`Paul Raggusa (PTO
`
`Reg. No. 338,587)
`
`
`Jennifer TTempesta
`(PTO Reg
`
`Baker Bootts L.L.P.
`
`
`30 Rockeefeller Plazza
`
`
`New Yorrk, NY 101112
`
`
`Telephonne: (212) 4408-2500
`08-2501
`
`Facsimilee: (212) 40
`
`Email: lissa.kole@bbakerbotts.ccom
`
`
`
`
`
`steven.lenndaris@baakerbotts.ccom
`
`
`paul.raguusa@bakerrbotts.com
`
`
`
`jennifer.ttempesta@@bakerbottss.com
`
`)
`
`. No. 59,0221)
`
`
`
`
`
`7
`
`
`
`1053).
`
`
`
`
`
`IPR2015-01490
`
`
`
`Patent No. 7,754,702
`
`CERTIFICATE OF SERVICE ON PATENT OWNER
`UNDER 37 C.F.R. § 42.105(a)
`
`The undersigned hereby certifies that the foregoing PETITIONER’S
`
`
`
`
`
`RESPONSE TO PATENT OWNER’S OBJECTIONS TO EVIDENCE AND
`
`SUBMISSION OF SUPPLEMENTAL EVIDENCE PURSUANT TO 37 C.F.R §
`
`42.64(b)(2), and accompanying Exhibit 1053, is being served on February 10,
`
`2016, by filing through the Patent Review Processing System and delivering a
`
`copy via email to the counsel for Patent Owner at the addresses of record:
`
`
`
`
`
`Respectfully submitted
`
`
`
`
`
`
`
`/s/ Lisa Kole
`
`Lisa Kole (PTO Reg. No. 35,225)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`Telephone: (212) 408-2500
`Facsimile: (212) 408-2501
`Email: lisa.kole@bakerbotts.com
`
`George E. Quillin
`Michael D. Kaminski
`Foley & Lardner L.L.P
`3000 K Street, N.W., Suite 600
`Washington, D.C. 20007
`Email: gquillin@foley.com
`mkaminski@foley.com
`
`
`
`8
`
`
`
`Dated: February 10, 2016
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
