UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD.,
`MYLAN LABORATORIES LIMITED,
`TEVA PHARMACEUTICALS USA, INC.
`and FRESENIUS KABI USA, LLC,
`
`Petitioners
`
`v .
`
`ELI LILLY AND COMPANY,
`
`Patent Owner.
`
`Case IPR2016-003181
`U.S. Patent 7,772,209
`
`
`
`
`
`
`
`
`
`
`PETITIONER SANDOZ INC.’S OBJECTIONS TO SUPPLEMENTAL
`EVIDENCE
`
`
`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`proceeding.
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD.,
`MYLAN LABORATORIES LIMITED,
`TEVA PHARMACEUTICALS USA, INC.
`and FRESENIUS KABI USA, LLC,
`
`Petitioners
`
`v .
`
`ELI LILLY AND COMPANY,
`
`Patent Owner.
`
`Case IPR2016-003181
`U.S. Patent 7,772,209
`
`
`
`
`
`
`
`
`
`
`PETITIONER SANDOZ INC.’S OBJECTIONS TO SUPPLEMENTAL
`EVIDENCE
`
`
`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`proceeding.
`
`
`
`Petitioner Sandoz Inc. (“Sandoz”) hereby objects pursuant to 37 C.F.R.
`
`§ 42.64(b)(1) and the Federal Rules of Evidence to the admissibility of the
`
`purported supplemental evidence listed below, which was served by Eli Lilly and
`
`Company (“Lilly”) on October 24, 2016, in IPR2016-00318. Sandoz further
`
`objects to Lilly’s reliance on and citations to the evidence subject to the following
`
`objections. Nothing contained herein shall be deemed to withdraw any objections
`
`in Sandoz’s Objections to Evidence previously served on Lilly on October 7, 2016.
`
`I.
`
`Exhibit 2125 (Krinsky Declaration)
`
`Sandoz objects to Exhibit 2125 under Fed. R. Evid. 402, 403, 602, 702, and
`
`802, and as in violation of 37 C.F.R. § 42.53. Much of the content of Dr.
`
`Niyikiza’s testimony from a prior trial (Exhibit A to the Declaration) concerns
`
`topics that are not relevant or for which any relevance is substantially outweighed
`
`by its potential to cause unfair prejudice, waste time, or needlessly prolong the
`
`proceedings and should thus be excluded under Fed. R. Evid. 402 and 403.
`
`Sandoz further objects to the extent that Dr. Niyikiza’s trial testimony
`
`includes content over which he had no personal knowledge under Fed. R. Evid.
`
`602 and for which he is not qualified to testify as an expert witness under Fed. R.
`
`Evid. 702.
`
`Further, Dr. Niyikiza’s trial testimony is not only inadmissible hearsay in
`
`this proceeding under Fed. R. Civ. P. 802, but much of it constitutes double
`
`1
`
`
`
`hearsay, including at least one passage on which Lilly relies in its Patent Owner’s
`
`Response. Paper No. 36, PO Resp. at 59 (quoting Ex. 21162 at 845).
`
`Finally, Dr. Niyikiza’s trial testimony should be excluded as in violation of
`
`the applicable regulations governing this proceeding, which require that
`
`“[u]ncompelled direct testimony must be submitted in the form of an affidavit” and
`
`that such testimony be subject to cross examination under 37 C.F.R.
`
`§ 42.51(b)(1)(ii). 37 C.F.R. § 42.53(a).
`
`Also, Exhibit 2125 describes Exhibits 2111-13 as true and correct copies of
`
`trial exhibits. However, this does not cure all of Sandoz’s original objections to
`
`those Exhibits. See Paper 39, Sandoz’s Objections at 5-7. Therefore, Sandoz
`
`maintains the following objections:
`
`Sandoz objects to Exhibit 2111 under Fed. R. Evid. 402, 403, and 802.
`
`Sandoz objects to Exhibit 2111, which appears to be a non-public document
`
`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
`
`the claimed invention would have been obvious based on the information publicly
`
`available in the prior art. Any purported probative value of this exhibit is
`
`substantially outweighed by its potential to cause unfair prejudice, waste time, or
`
`needlessly prolong the proceedings and should thus be excluded under Fed. R.
`
`
`2 Exhibit 2116 contains excerpts from Dr. Niyikiza’s trial testimony.
`
`2
`
`
`
`Evid. 402 and 403. Sandoz further objects to the statements in the document as
`
`impermissible hearsay under Fed. R. Evid. 802.
`
`Sandoz objects to Exhibit 2112 under Fed. R. Evid. 402, 403, and 802.
`
`Sandoz objects to Exhibit 2112, which appears to be a non-public document
`
`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
`
`the claimed invention would have been obvious based on the information publicly
`
`available in the prior art. Any purported probative value of this exhibit is
`
`substantially outweighed by its potential to cause unfair prejudice, waste time, or
`
`needlessly prolong the proceedings and should thus be excluded under Fed. R.
`
`Evid. 402 and 403. Sandoz further objects to the statements in the document as
`
`impermissible hearsay under Fed. R. Evid. 802.
`
`Sandoz objects to Exhibit 2113 under Fed. R. Evid. 402, 403, and 802.
`
`Sandoz objects to Exhibit 2113, which appears to be a non-public document
`
`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
`
`the claimed invention would have been obvious based on the information publicly
`
`available in the prior art. Any purported probative value of this exhibit is
`
`substantially outweighed by its potential to cause unfair prejudice, waste time, or
`
`needlessly prolong the proceedings and should thus be excluded under Fed. R.
`
`Evid. 402 and 403. Sandoz further objects to the statements in the document as
`
`impermissible hearsay under Fed. R. Evid. 802.
`
`3
`
`
`
`II. Exhibit 2127 (Letter to FDA)
`Exhibit 2127 removes the redactions from Exhibit 2099. However, this does
`
`not cure all of Sandoz’s original objections to Exhibit 2099. See Paper 39,
`
`Sandoz’s Objections at 4. Therefore, Sandoz maintains the following objections:
`
`Sandoz objects to Exhibit 2099 under Fed. R. Evid. 402 and 403. Exhibit
`
`2099 is not cited in the Patent Owner’s Response or the accompanying declarations
`
`of Lilly’s experts and should be excluded as irrelevant under Fed. R. Evid. 402 and
`
`403. Sandoz reserves its right to submit additional objections to this exhibit if
`
`Lilly later cites or relies on this exhibit.
`
`III. Exhibit 2128 (Letter to FDA)
`Exhibit 2128 removes the redactions from Exhibit 2101. However, this does
`
`not cure all of Sandoz’s original objections to Exhibit 2101. See Paper 39,
`
`Sandoz’s Objections at 4-5. Therefore, Sandoz maintains the following objections:
`
`Sandoz objects to Exhibit 2101 under Fed. R. Evid. 402 and 403. Exhibit
`
`2101 is not cited in the Patent Owner’s Response or the accompanying declarations
`
`of Lilly’s experts and should be excluded as irrelevant under Fed. R. Evid. 402 and
`
`403. Sandoz reserves it right to submit additional objections to this exhibit if Lilly
`
`later cites or relies on this exhibit.
`
`
`
`
`
`4
`
`
`
`Dated: October 31, 2016
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing document was
`served on October 31, 2016 via email to the following individuals at the email
`addresses below.
`
`Dov P. Grossman (Reg. No. 72,525)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
`
`David M. Krinsky (Reg. No. 72,339)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
`
`Adam L. Perlman
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5244
`aperlman@wc.com
`
`James P. Leeds (Reg. No. 35,241)
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
`
`John C. Demeter (Reg. No. 30,167)
`Eli Lilly and Company
`
`
`
`
`
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`demeter_john_c@lilly.com
`
`
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`
`
`
`
`Dated: October 31, 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
