`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case IPR2018-01676
`
`Patent No. 8,603,044
`
`MYLAN PHARMACEUTICALS INC.
`
`OBJECTIONS T0 EVIDENCE SUBMITTED WITH
`
`PATENT OWNER RESPONSE
`
`37 CFR §42.64(b)(1)
`
`
`
`Case IPR2018-01676
`
`Patent No. 8,603,044
`
`I.
`
`OBJECTIONS
`
`Petitioner (“Mylan”) submits the following objections:
`
`1.
`
`Declarations of Dr. Alexander Slocum, Dr. Robin S. Goland
`
`(Exhibits 2107, 2108, 2111, 2112)
`
`Grounds for objection: FRE 801-804.
`
`To the extent that the declarants have not yet been made available for
`
`deposition, the declarations constitute hearsay.
`
`Grounds for objection: FRE 702, 703, 705.
`
`The declarations of Dr. Slocum and Dr. Goland do not provide sufficient
`
`facts or data, are not the product of reliable principles and methods, and have not
`
`applied the proper principles to the facts of this proceeding. In addition, the
`
`declarations do not disclose the underlying facts and data, and do not set forth the
`
`bases of their opinions.
`
`For example, Appendices A through F of Dr. Slocum’s Declaration
`
`(EX2107) do not set forth the principles used nor do they demonstrate the
`
`calculations used in generating the spreadsheets.
`
`Grounds for objection: FRE 402-403.
`
`The declarations of Dr. Slocum and Dr. Goland do not apply a proper
`
`obviousness standard, and are thus irrelevant to the grounds of challenge. In
`
`addition, to the extent the declarants are alleging secondary considerations, they do
`
`
`
`Case IPR2018-01676
`
`Patent No. 8,603,044
`
`not establish a nexus between those considerations and the claims, and are again
`
`irrelevant. The declarations are also prejudicial and confuse the issues as a result.
`
`To the extent the exhibits are admitted, their scope should be restricted to the
`
`purpose for which it was originally submitted. FRE 105.
`
`2.
`
`Animations (Exhibits 2117, 2147-2152, 2162, 2167, 2168,
`2206, 2207, 2211, 2215-2218)
`
`Grounds for objection: FRE 801-804, 901.
`
`The animations are offered, without sufficient foundation, purportedly to
`
`show animated operations of prior art and non-prior art injection pens. The
`
`animations are hearsay because they are offered for the truth of its content without
`
`satisfying any of the hearsay exceptions. In addition, the animations lack sufficient
`
`support to show that it is what Sanofi purports it to be.
`
`Grounds for Objection: 401-402.
`
`The animations are irrelevant to the extent they rely on an improper standard
`
`of obViousness.
`
`To the extent the exhibits are admitted, their scope should be restricted to the
`
`purpose for which they were originally submitted. FRE 105.
`
`3.
`
`Exhibits not discussed in Patent Owner Response (Exhibits
`2100-2106, 2111-2116, 2118-2135, 2138-2146, 2151, 2158-
`
`2161, 2166-2174, 2176-2201, 2203—2205, 2208-2210, 2212,
`2214)
`
`Grounds for objection: FRE 402-403.
`
`-2-
`
`
`
`Case IPR2018-01676
`
`Patent No. 8,603,044
`
`The exhibits are irrelevant as they are not discussed in the Patent Owner
`
`Response. These exhibits are also prejudicial and confuse the issues as a result.
`
`To the extent the exhibits are admitted, their scope should be restricted to the
`
`purpose for which they were originally submitted. FRE 105.
`
`4.
`
`Exhibits related to commercial pens (Exhibits 2136, 2137,
`2175)
`
`Grounds for objection: FRE 402-403.
`
`The exhibits, which relate to commercial pens and their properties, such as
`
`injection force, are irrelevant to the extent they rely on an improper standard of
`
`obViousness. These exhibits are also prejudicial and confuse the issues as a result.
`
`To the extent the exhibits are admitted, their scope should be restricted to the
`
`purpose for which they were originally submitted. FRE 105.
`
`Dated: 2 July 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`
`
`
`Case IPR2018-01676
`
`Patent No. 8,603,044
`
`CERTIFICATE OF SERVICE
`
`I certify that today I caused a true and correct copy of Mylan
`
`Pharmaceuticals Inc. Objections to Evidence Submitted with Patent Owner
`
`Response, on the Patent Owner at the email correspondence addresses of the
`
`Patent Owner as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`anish.desai@weil.com
`
`Sundip K. Kundu
`
`sundip.kundu@weil.com
`
`Kathryn M. Kantha
`
`kat
`
`n.kantha weil.com
`
`William S. Ansley
`
`sutton.ansley@weil.com
`
`Matthew D. Sieger
`
`matthew.sieger@weil.com
`
`Adrian C. Percer
`
`adrian.p_ercer@weil.com
`
`Brian C. Chang
`
`brian.chan weil.com
`
`WEIL, GOTSHAL & MANGES LLP Sanof1.IPR.Service@weil.com
`
`FISH & RICHARDSON
`
`PTABInbound@fr.com
`
`Dated: 2 July 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`
`
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
