`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC
`
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`
`Patent Owner
`
`_______________
`
`Case IPR2019-00207
`Patent 9,517,219
`_______________
`
`PATENT OWNER’S OBJECTIONS TO REPLY EVIDENCE
`
`
`
`
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owner Almirall, LLC (“Almirall”)
`
`hereby objects to the admissibility of evidence Petitioners Amneal Pharmaceuticals
`
`LLC and Amneal Pharmaceuticals of New York, LLC (collectively, “Amneal”)
`
`submitted with their Reply to Patent Owner’s Response (Paper 28):
`
`Exhibit 1045: Almirall objects to Exhibit 1045 as lacking authentication
`
`under FRE 901. Exhibit 1045 appears to be a portion of a printout of a webpage.
`
`There is no evidence establishing that it contains true and correct content.
`
`Accordingly, Amneal has not provided evidence sufficient to support a finding that
`
`Exhibit 1045 “is what [Amneal] claims it is. See FRE 901. Almirall further objects
`
`to Exhibit 1045 as irrelevant under FRE 401 and 402. If the content is taken as
`
`true, the information on the printout relates to 2019. Petitioner has not established
`
`that Exhibit 1045 is a prior art publication that was available to the public. Exhibit
`
`1045 has no tendency to make any fact of consequence in determining this action
`
`more or less probable than it would be without this exhibit. Therefore, Exhibit
`
`1045 is inadmissible as not relevant.
`
`Exhibit 1046: Almirall objects to Exhibit 1046 as lacking authentication
`
`under FRE 901. Exhibit 1046 appears to be a proprietary technical data sheet from
`
`Lubrizol. There is no evidence establishing that it contains true and correct
`
`content. Accordingly, Amneal has not provided evidence sufficient to support a
`
` 1
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`finding that Exhibit 1045 “is what [Amneal] claims it is.” See FRE 901. Almirall
`
`further objects to Exhibit 1046 as inadmissible hearsay under FRE 801 and 802.
`
`Amneal relies on Exhibit 1046 for the truth of the matter asserted, but has provided
`
`no evidence of the truth of the assertions in Exhibit 1046. To the contrary, the
`
`exhibit states on its face that “no representations… of any kind are made as to [the]
`
`accuracy” of the information contained therein. Ex. 1046 at 1. Further, Petitioner
`
`has not established that Exhibit 1046 is a prior art publication that was available to
`
`the public. Exhibit 1046 has no tendency to make any fact of consequence in
`
`determining this action more or less probable than it would be without this exhibit.
`
`Therefore, Exhibit 1046 is further inadmissible under FRE 401 and 402 as not
`
`relevant.
`
`Exhibit 1047: Almirall objects to Exhibit 1047 as irrelevant under FRE 401
`
`and 402. Exhibit 1047 purports to have a publication date of February 2016, and is
`
`therefore not a prior art publication, and has no tendency to make any fact of
`
`consequence in determining this action more or less probable than it would be
`
`without this exhibit.
`
`Exhibit 1048: Almirall objects to Exhibit 1048 as irrelevant under FRE 401
`
`and 402. Exhibit 1048 purports to have a publication date of December 2012, and
`
`is therefore not a prior art publication, and has no tendency to make any fact of
`
` 2
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`consequence in determining this action more or less probable than it would be
`
`without this exhibit.
`
`Exhibit 1050: Almirall objects to Exhibit 1050 as irrelevant under FRE 401
`
`and 402 because Amneal did not rely upon or discuss this exhibit in its Reply. The
`
`only citation in its Reply to Exhibit 1050 is clearly an error: the pincite is to “¶36”,
`
`but Exhibit 1050 has no paragraph numbers (nor is there any way to count the
`
`handful of paragraphs in the document to arrive at thirty-six); nor does the content
`
`of the document correspond in any way to the content of the paragraph in which it
`
`is cited. Paper 28 at 15–16. The only other citation to this exhibit is in the Second
`
`Declaration of Dr. Michniak-Kohn. Ex. 1043 ¶ 63. Any use of this exhibit would
`
`be improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Almirall also objects to Exhibit 1050 as lacking authentication under
`
`FRE 901. Exhibit 1050 appears to be a proprietary technical data sheet from
`
`Noveon. There is no evidence establishing that it contains true and correct content.
`
`Accordingly, Amneal has not provided evidence sufficient to support a finding that
`
`Exhibit 1050 “is what [Amneal] claims it is.” See FRE 901. Almirall further
`
`objects to Exhibit 1046 as inadmissible hearsay under FRE 801 and 802. Amneal
`
`relies on Exhibit 1046 for the truth of the matter asserted, but has provided no
`
`evidence of the truth of the assertions in Exhibit 1050. To the contrary, the exhibit
`
` 3
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`states on its face that “no representations… of any kind are made as to [the]
`
`accuracy” of the information contained therein. Ex. 1050 at 1. Further, Petitioner
`
`has not established that Exhibit 1050 is a prior art publication that was available to
`
`the public. Exhibit 1050 has no tendency to make any fact of consequence in
`
`determining this action more or less probable than it would be without this exhibit
`
`Therefore, Exhibit 1050 is further inadmissible under FRE 401 and 402 as not
`
`relevant.
`
`Exhibit 1052: Almirall objects to Exhibit 1052 as irrelevant under FRE 401
`
`and 402 because Amneal did not substantively discuss this exhibit in its Reply.
`
`Any use of this exhibit would be improper incorporation by reference under 37
`
`C.F.R. § 42.6(a)(3). Almirall further objects to Exhibit 1052 as lacking
`
`authentication under FRE 901. Exhibit 1052 appears to be a printout of a portion
`
`of a spreadsheet titled “3Q2018EXCEL,” and Amneal’s expert Dr. Michniak-Kohn
`
`describes it as “the FDA DMF database that [she] downloaded” from a particular
`
`weblink. See Ex. 1043 ¶ 66 n.6. There is no evidence establishing that it contains
`
`true and correct content, nor does the content at the provided web address match
`
`that of Exhibit 1052. Accordingly, Amneal has not provided evidence sufficient to
`
`support a finding that Exhibit 1052 “is what [Amneal] claims it is.” See FRE 901.
`
`Almirall further objects to Exhibit 1052 as inadmissible hearsay under FRE 801
`
` 4
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`and 802. Amneal has provided no evidence of the truth of the assertions in Exhibit
`
`1052. Amneal further objects to Exhibit 1052 as irrelevant under FRE 401 and 402
`
`because Petitioner has not established that Exhibit 1052 was available to the public
`
`as of the date of invention.
`
`Exhibit 1053: Almirall objects to Exhibit 1053 as irrelevant under FRE 401
`
`and 402 because Amneal did not substantively rely upon or discuss this exhibit in
`
`its Reply. Any use of this exhibit would be improper incorporation by reference
`
`under 37 C.F.R. § 42.6(a)(3). Further, Exhibit 1053 purports to have a publication
`
`date of 2014, and is therefore not a prior art publication, and has no tendency to
`
`make any fact of consequence in determining this action more or less probable than
`
`it would be without this exhibit.
`
`Exhibit 1054: Almirall objects to Exhibit 1045 as lacking authentication
`
`under FRE 901. Exhibit 1054 appears to be a portion of a printout of a webpage.
`
`There is no evidence establishing that it contains true and correct content.
`
`Accordingly, Amneal has not provided evidence sufficient to support a finding that
`
`Exhibit 1054 “is what [Amneal] claims it is.” See FRE 901. Almirall further
`
`objects to Exhibit 1054 as irrelevant under FRE 401 and 402. If the content is
`
`taken as true, the information on the printout relates to 2019. Petitioner has not
`
`established that Exhibit 1054 is a prior art publication that was available to the
`
` 5
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`public. Exhibit 1054 has no tendency to make any fact of consequence in
`
`determining this action more or less probable than it would be without this exhibit.
`
`Therefore, Exhibit 1054 is inadmissible as not relevant.
`
`Exhibit 1057: Almirall objects to Exhibit 1057 as irrelevant under FRE 401
`
`and 402, and confusing the issues under Rule 403. Exhibit 1057 is a deposition
`
`transcript from IPR2018-00608, regarding a declaration of Dr. Julie Harper not
`
`filed or relied upon in this proceeding, and concerning the validity of the claims of
`
`a patent not challenged in this proceeding. Exhibit 1054 has no tendency to make
`
`any fact of consequence in determining this action more or less probable than it
`
`would be without this exhibit.
`
`Exhibits 1062–1074: Almirall objects to Exhibits 1062–1074 as irrelevant
`
`under FRE 401 and 402 because they have no tendency to make any fact of
`
`consequence in determining this action more or less probable than it would be
`
`without these exhibits. Almirall further objects to Exhibits 1062–1074 as lacking
`
`authentication under FRE 901. Exhibits 1062–1074 all purport to be printouts or
`
`partial printouts of webpages, but there is no evidence establishing that they
`
`contain true and correct content. Accordingly, Amneal has not provided evidence
`
`sufficient to support a finding that Exhibits 1062–1074 are what Amneal claims
`
`they are. See FRE 901. Almirall further objects to Exhibits 1062–1074 as
`
` 6
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
`
`of the truth of the assertions in Exhibits 1062–1074.
`
`Exhibit 1075: Almirall objects to Exhibit 1075 as irrelevant under FRE 401
`
`and 402, and confusing the issues under Rule 403. Exhibit 1075 is the declaration
`
`of Dr. Alexander Klibanov prepared for and filed in IPR2018-00608. It was not
`
`relied upon in this proceeding, and concerns the validity of the claims of a patent
`
`not challenged in this proceeding. Exhibit 1075 has no tendency to make any fact
`
`of consequence in determining this action more or less probable than it would be
`
`without this exhibit. Almirall further objects to Exhibit 1075 as needlessly
`
`cumulative under FRE 403. Amneal relies on Exhibit 1075 only as a seventh
`
`source to support the sentence “a POSA would have known that Aczone 5% Gel
`
`contained undissolved dapsone before 2012.” Paper 28 at 9–10.
`
`Any paragraphs in Exhibits 1043 and/or 1044 that rely on the exhibits
`
`identified above: Almirall objects to any paragraph of Exhibit 1043 (the second
`
`declaration of Dr. Michniak-Kohn) and/or any paragraph of Exhibit 1044 (the
`
`second declaration of Dr. Gilmore) that relies on any of the exhibits identified
`
`above, for the same reason(s) as the objection(s) to the underlying exhibit.
`
` 7
`
`
`
`
`
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`
`Dated: November 8, 2019
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`
`By: /James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
` 8
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Objections to Reply Evidence
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that the foregoing PATENT
`
`OWNER’S OBJECTIONS TO REPLY EVIDENCE was served by electronic
`
`mail on the following counsel of record for petitioner:
`
`Dennies Varughese (dvarughe-PTAB@skgf.com)
`Adam C. LaRock (alarock-PTAB@skgf.com)
`Tyler C. Liu (tliu-PTAB@skgf.com)
`PTAB@skgf.com
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW
`Suite 600
`Washington, DC 20005
`
`
`
`
`
`
`
`
`
`
`
`Dated: November 8, 2019
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`
`By: /James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`9
`
`
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
