UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case No. IPR2016-01578
`Patent 8,338,470
`____________
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`PETITIONER’S SUPPLEMENTAL EVIDENCE SUBMITTED WITH
`PETITIONER’S RESPONSE TO PATENT OWNER OBJECTIONS
`
`
`
`
`
`
`
`
`1
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case No. IPR2016-01578
`Patent 8,338,470
`____________
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`PETITIONER’S SUPPLEMENTAL EVIDENCE SUBMITTED WITH
`PETITIONER’S RESPONSE TO PATENT OWNER OBJECTIONS
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`Patent Owner, Hospira, Inc., respectfully submits the following objections to
`
`exhibits filed by Petitioner on March 8, 2017, in conjunction with its Response to
`
`Patent Owner Objections (“Response to Objections”). These objections are made
`
`within five business days of the date upon which the evidence was served.
`
`The following chart lists Patent Owner’s objections to the admissibility of
`
`the supplemental evidence served on March 8, 2017, and the basis for those
`
`objections:
`
`Objected to Exhibit
`
`Basis for Objection
`
`Exhibit 1064, ¶ 4
`
`Exhibit 1064, ¶ 6
`
`FRE 702: Dr. Yaman is not qualified to testify as an
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding,
`
`including
`
`stereochemistry
`
`and
`
`dexmedetomidine. Moreover, Dr. Yaman’s opinion
`
`is not based on sufficient facts or data. Therefore,
`
`Dr. Yaman’s expert declaration is inadmissible
`
`expert testimony under FRE 702.
`
`FRE 901: Dr. Yaman testifies to the authenticity
`
`and publication date of Exhibit 1066. However, Dr.
`
`2
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`Exhibit 1064, ¶ 7
`
`Exhibit 1065
`
`Yaman has presented no evidence that he has
`
`personal knowledge regarding the date upon which
`
`the cited reference was made publicly available, or
`
`whether the document is a true and correct copy of
`
`the reference published on the specified date.
`
`FRE 602/901: Dr. Yaman incorporates by reference
`
`Mr. Tully’s testimony regarding the authenticity and
`
`publication dates of several exhibits. However, Dr.
`
`Yaman has presented no evidence that he has
`
`personal knowledge regarding the dates upon which
`
`the cited references were made publicly available, or
`
`whether the documents are true and correct copies
`
`of references published on the specified dates.
`
`37 CFR §11.307: Mr. Tully is counsel of record for
`
`Petitioner in this proceeding. In submitting a
`
`declaration
`
`testifying
`
`to
`
`the authenticity and
`
`publication dates of exhibits submitted by the
`
`Petitioner, Mr. Tully has made himself a witness in
`
`this proceeding as well. This conduct is in violation
`
`3
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`Exhibit 1065, ¶¶ 5-8, 10-
`22, 24-29, 31
`
`Exhibit 1065, ¶ 9
`
`Exhibit 1066
`
`of 37 CFR §11.307, which precludes a practitioner
`
`from acting as both an advocate and necessary
`
`witness in the proceeding.
`
`FRE 602/901: Mr. Tully testifies to the authenticity
`
`and publication dates of several exhibits. Mr. Tully
`
`has presented no evidence that he has personal
`
`knowledge regarding the dates upon which the cited
`
`references were made publicly available, or whether
`
`the documents are true and correct copies of
`
`references published on the specified dates.
`
`37 CFR §42.65(a): The cited paragraph includes
`
`testimony regarding United States patent law and
`
`patent examination practice, which is inadmissible
`
`under 37 CFR §42.65(a).
`
`FRE 901: This exhibit has not been authenticated.
`
`Petitioner has not provided admissible evidence
`
`regarding the origin of the document or whether the
`
`document is a true and correct copy.
`
`4
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`FRE 802: This exhibit cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
`
`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`because Petitioner has not authenticated the exhibit
`
`or provided admissible evidence regarding the date
`
`upon which it became publicly available.
`
`FRE 401-403: At least because this exhibit has not
`
`been authenticated and proven to have been publicly
`
`available prior to January 4, 2012, the exhibit is
`
`irrelevant
`
`to
`
`this proceeding and
`
`therefore
`
`inadmissible, and/or its probative value, if any, is
`
`substantially outweighed by a danger of one or more
`
`of the following: unfair prejudice, confusing the
`
`issues, and/or wasting time.
`
`5
`
`
`
`
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`Respectfully submitted,
`BAKER BOTTS L.L.P.
`
`
`
`
`
`
`
`March 15, 2017
`Date
`
`
`
`
`
`
`
`
`
`
`
`
`
` / Sandra S. Lee /
`
`Sandra S. Lee (Reg. No. 51,932)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`
`Lead Counsel for Patent Owner
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
`
`
`Patent Owner’s Objections to Supplemental Evidence for IPR2016-01578
`
`CERTIFICATE OF SERVICE
`
`In accordance with 37 C.F.R. §§ 42.6(e) and 42.105(a), this is to certify that
`
`I caused to be served a true and correct copy of the foregoing PATENT
`
`OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO PETITIONER’S
`
`SUPPLEMENTAL EVIDENCE SUBMITTED WITH PETITIONER’S
`
`RESPONSE TO PATENT OWNER OBJECTIONS was served on the
`
`Petitioner via electronic mail at the following correspondence addresses:
`
`Paul S. Tully: tully@mbhb.com
`
`Kevin E. Noonan: noonan@mbhb.com
`
`Andrea Orth: orth@mbhb.com
`
`
`
`
`
`March 15, 2017
`
`Date
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` / Sandra S. Lee /
`
`Sandra S. Lee (Reg. No. 51,932)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`
`Lead Counsel for Patent Owner
`
`
`
`
`
`
`
`
`
`7
`
`
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
