Paper No. ________
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MYLAN TECHNOLOGIES, INC.
`Petitioner,
`
`v.
`
`NOVEN PHARMACEUTICALS, INC.
`Patent Owner.
`
`
`Patent No. 9,730,900
`
`Title: TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`_______________
`
`Inter Partes Review No. IPR2018-00174
`____________________________________________________________
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`AS OF SEPTEMBER 5, 2018
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MYLAN TECHNOLOGIES, INC.
`Petitioner,
`
`v.
`
`NOVEN PHARMACEUTICALS, INC.
`Patent Owner.
`
`
`Patent No. 9,730,900
`
`Title: TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`_______________
`
`Inter Partes Review No. IPR2018-00174
`____________________________________________________________
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`AS OF SEPTEMBER 5, 2018
`
`
`
`
`
`
`IPR2018-00174
`Updated Exhibit List
`
`
`
`Ex #
`
`2001
`
`EXHIBIT LIST
`
`Description
`
`Declaration of Dr. Adrian C. Williams
`
`2002
`
`Curriculum Vitae of Dr. Adrian C. Williams
`
`2003 Minivelle® Product Label
`
`2004
`
`J. Hadgraft and R. Guy, Feasibility Assessment in Topical and
`Transdermal Delivery, in TRANSDERMAL DRUG DELIVERY 3-4 (R.
`Guy & J. Hadgraft eds., 2d ed. 2003)
`
`2005
`
`J. Hadgraft, Passive enhancement strategies in topical and
`transdermal drug delivery, 184 INT’L J. PHARMACEUTICS 1-6 (1999)
`
`2006
`
`2007
`
`B. Barry, Transdermal Drug Delivery, in AULTON’S PHARMACEUTICS
`– THE DESIGN AND MANUFACTURE OF MEDICINES 565, 571-72, 577
`(M. Aulton ed., 3d ed. 2007)
`
`A. Williams & B. Barry, Urea analogues in propylene glycol as
`penetration enhancers in human skin, 36 INT’L J. PHARMACEUTICS
`43-50 (1989)
`
`1
`
`
`
`
`
`
`
`Ex #
`
`2008
`
`
`
`IPR2018-00174
`Updated Exhibit List
`
`Description
`
`K. Brain & R. Chilcott, Physicochemical Factors Affecting Skin
`Absorption, in PRINCIPLES AND PRACTICE OF SKIN TOXICOLOGY 83-92
`(R. Chilcott and S. Price eds., 2008)
`
`2009
`
`Esclim® Product Label
`
`2010
`
`2011
`
`2012
`
`2013
`
`J. Mantelle, et al., Effect of Silicone/Acrylic PSA Blends on Skin
`Permeation, 26 PROCEEDINGS OF THE INTERNATIONAL SYMPOSIUM ON
`CONTROLLED RELEASE OF BIOACTIVE MATERIALS 415-16 (Rev. July
`1999) (“the Mantelle Article”)
`
`A. Williams & B. Barry, Chemical Permeation Enhancement, in
`ENHANCEMENT IN DRUG DELIVERY 233, 248-50 (E. Touitou & B.
`Barry eds., 2007)
`
`A. Williams & B. Barry, The enhancement index concept applied to
`terpene penetration enhancers for human skin and model lipophilic
`(oestradiol) and hydrophilic (5-fluorouracil) drugs, 74 INT’L J.
`PHARMACEUTICS 157-168 (1991)
`
`K. Walters & K. Brain, Dermatological Formulation and
`Transdermal Systems, in DERMATOLOGICAL AND TRANSDERMAL
`FORMULATIONS 338-43 (K. Walters, ed., 2002)
`
`2
`
`
`
`
`
`
`
`Ex #
`
`2014
`
`
`
`IPR2018-00174
`Updated Exhibit List
`
`Description
`
`Google Scholar search results obtained March 7, 2018 – citations of
`Kim et al., Penetration Enhancement of β2-Selective Agonist,
`Tulobuterol, Across Hairless Mouse Skin, J. Pharm. Invest. 33: 79-84
`(2003), available online at https://scholar.google.com/scholar?cites=
`7903453726087495818&as_sdt=2005&sciodt=0,5&hl=en
`
`2015
`
`A. Ghosh et al., Current Pharmaceutical Design on Adhesive Based
`Transdermal Drug Delivery Systems, 21 CURR. PHARM. DESIGN
`2771-2783 (2015)
`
`2016
`
`U.S. Patent No. 8,029,820
`
`2017
`
`2018
`
`2019
`
`B. Godin & E. Touitou, Transdermal skin delivery: Predictions for
`humans from in vivo, ex vivo and animal models, 59(11) ADV. DRUG
`DELIV. REVIEWS 1152-1161 (2007)
`
`R. Hinz et al., In vitro percutaneous penetration: evaluation of the
`utility of hairless mouse skin, 93(1) J. INVEST. DERMATOL. 87-91
`(1989)
`
`J. Bond & B. Barry, Hairless mouse skin is limited as a model for
`assessing the effects of penetration enhancers in human skin, 90(6) J.
`INVEST. DERMATOL. 810-813 (1988)
`
`3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00174
`Updated Exhibit List
`
`Description
`
`R. Subedi et al., Influence of formulation variable in transdermal
`drug delivery system containing zolmitriptan, 419 INT’L J.
`PHARMACEUTICS 209-214 (2011)
`
`Ex #
`
`2020
`
`2021
`
`R. Subedi et al., Formulation and in vitro evaluation of transdermal
`drug delivery system for donezil, 42 J. PHARMA. INVEST. 1-7 (2012)
`
`2022
`
`2023
`
`J. Mantelle, DOT Matrix® Technology, in MODIFIED RELEASE DRUG
`DELIVERY TECHNOLOGY 405-14 (Rathbone et al. eds., 2d ed. 2008)
`(“the Mantelle Chapter”)
`
`J. van de Sandt et al., In vitro predictions of skin absorption of
`caffeine, testosterone, and benzoic acid: a multi-centre comparison
`study, 39 REG. TOXICOL. PHARMACOL. 271–281 (2004)
`
`2024
`
`Binding Settlement Term Sheet between Petitioner and Patent Owner
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/ Jason N. Mock /
`Courtenay C. Brinckerhoff
`Registration No. 37,288
`
`Jason N. Mock
`Registration No. 69,186
`
`Foley & Lardner LLP
`Counsel for Patent Owner
`
`4
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`IPR2018-00174
`Updated Exhibit List
`
`The undersigned hereby certifies that a copy of the foregoing Updated
`
`Exhibit List is being served on September 5, 2018, by filing it through the PTAB
`
`E2E System as well as by email directed to the attorneys of record for the
`
`Petitioner at the following addresses:
`
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By: / Jason N. Mock /
`Courtenay C. Brinckerhoff
`Registration No. 37,288
`
`Jason N. Mock
`Registration No. 69,186
`
`Counsel for Patent Owner
`Foley & Lardner LLP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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
