throbber
Paper 12
`Filed Nov. 27, 2017
`
`Filed on behalf of Argentum Pharmaceuticals LLC
`
`By:
`
`Kevin B. Laurence
`Laurence & Phillips IP Law LLP
`1940 Duke Street, Suite 200
`Alexandria, Virginia 22314
`Tel: 703.448.8787
`Fax: 703.439.1624
`klaurence@lpiplaw.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`
` COSMO TECHNOLOGIES LIMITED,
`Patent Owner
`
`
`
`
`
`
`
`Inter Partes Review No. IPR2018-00080
`U.S. Patent No. 9,320,716 B2
`
`PETITIONER’S EXHIBIT LIST
`
`
`
`

`

`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits this Exhibit List.
`
`Description
`
`Filed
`Exhibit
`1001 U.S. Patent No. 9,320,716 to Villa et al., “Controlled Release and Taste
`Masking Oral Pharmaceutical Compositions”
`1002 U.S. Patent No. 8,784,888 to Villa et al., “Controlled Release and Taste
`Masking Oral Pharmaceutical Composition”
`Reserved
`1003
`1004 Reserved
`1005 Reserved
`1006 Declaration of Hartmut Derendorf, Ph.D.
`1007 Curricula Vitae of Hartmut Derendorf, Ph.D.
`1008 U.S. Patent No. 5,681,584 to Savastano et al., “Controlled Release
`Drug Delivery Device”
`1009 U.S. Patent No. 5,811,388 to Friend et al., “Delivery of Drugs to the
`Lower GI Tract”
`1010 U.S. Patent No. 6,239,120 to Hallgren et al., “Method and Means for
`Treating Glomerulonephritis”
`1011 U.S. Patent Appl. Pub. No. 2006/0134208 to Villa et al., “Controlled
`Release and Taste Masking Oral Pharmaceutical Composition”
`1012 Markman Opinion and Order in Cosmo Technologies Limited v.
`Alvogen Pine Brook, LLC., C.A. No. 15-193-LPS, ECF Nos. 167, 168
`(D. Del. Sept. 7, 2016).
`1013 Amendment and Response to Advisory Action filed on February 21,
`2014 in U.S. Patent Appl. No. 13/617,138
`Substitute Specification (Clean Copy) filed on April 29, 2013 in U.S.
`Patent Appl. No. 13/617,138
`Amendment After Final filed on April 29, 2013 in U.S. Patent Appl.
`No. 13/617,138
`
`1014
`
`1015
`
`
`
`
`
`
`
`
`
` 2
`
`

`

`Description
`
`Filed
`Exhibit
`1016 Amendment and Response to Office Action filed on July 1, 2013 in
`U.S. Patent Appl. No. 13/617,138
`1017 U.S. Patent No. 6,607,751 to Odidi et al., “Controlled Release Delivery
`Device for Pharmaceutical Agents Incorporating Microbial
`Polysaccharide Gum”
`1018 Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone
`in Active Crohn’s Disease, Gut, 41:209-214 (1997)
`1019 Reserved
`1020 Reserved
`1021 Reserved
`1022
`PCT International Publication No. WO 96/36318, “Three-Phase
`Pharmaceutical Form With Constant and Controlled Release of
`Amorphous Active Ingredient for Single Daily Application”
`1023 U.S. Patent No. 5,342,625
`to
`Hauer et
`al.,
`
`“Pharmaceutical Compositions Comprising Cyclosporins”
`PCT International Publication No. WO 99/39700, “Pharmaceutical
`compositions in form of nanoparticles comprising lipidic substances
`and amphiphilic substances and related preparation process”
`FDA Inactive Ingredient Guide 1996/1997
`1025
`1026 Handbook of Pharmaceutical Excipients (Wade and Weller, eds., 2d
`ed. 1994)
`1027 Reserved
`1028 Remington: The Science and Practice of Pharmacy, Vol. 1 (1995)
`1029 Reserved
`1030 Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`1031 Reserved
`
`1024
`
`1032 Entocort® EC Highlights of Prescribing Information
`
`
`
`
`
`
`
` 3
`
`

`

`Description
`
`Filed
`Exhibit
`1033
`
`1035
`
`Svensson et al., Hydration of an Amphiphilic Excipient, Gelucire
`44/14, 2004, <hal-00015990>
`1034 U.S. Patent No. 6,395,300 to Straub et al., “Porous Drug Matrices and
`Methods of Manufacture Thereof”
`Flanders et al., The Control of Drug Release From Conventional Melt
`Granulation Matrices, Drug Development & Industrial Pharmacy,
`13(6):1001-1022 (1987)
`1036 Gandhi et al., Extrusion and Spheronization in the Development of
`Oral Controlled-Release Dosage Forms, Pharmaceutical Sci. & Tech.
`Today 2(4):160 (1999)
`1037 US Patent Formulation”
`1038 Daly et al., The Effect of Anionic Surfactants on the Release of
`Chlorpheniramine from a Polymer Matrix Tablet, Int’l J. of
`Pharmaceutics, 18:201-05 (1984)
`S.S. Davis, The Design and Evaluation of Controlled Release Dosage
`Forms for Oral Delivery, S.T.P. Pharma 3(5):412-417 (1987)
`International Publication No. WO 2005/075002 to Taguchi et al.
`1040
`1041 English Translation of International Publication No. WO 2005/075002
`to Taguchi et al. and corresponding Translation Certification
`International Publication No. WO 2005/007835 to Wang
`1042
`1043 Ohno-Matsui, In vitro and in vivo characterization of iris pigment
`epithelial cells cultured on amniotic membranes, Molecular Vision,
`Vol. 12, pp. 1022-1032 (August 2006)
`1044 Hanada et al., Multilayered Amniotic Membrane Transplantation for
`Severe Ulceration of the Cornea and Sclera, American J. of
`Ophthalmol., Vol. 131, No. 3, pp. 324-331 (March 2001)
`1045 Qiu et al., Design of sustained-release matrix systems for a highly
`water-soluble compound, ABT-089, Int’l J. of Pharmaceutics 157:43-
`52 (1997)
`1046 M. Efentakis et al., The Influence of Surfactants on Drug Release from
`a Hydrophobic Matrix, Int’l J. Pharm. 70:153-58 (1991)
`
`1039
`
`
`
`
`
` 4
`
`

`

`
`
`
`
`Description
`
`Filed
`Exhibit
`1047 Uceris® website, https://www.uceris.com/tablet/ (accessed on March
`5, 2017)
`Santarus’ CEO Discusses FDA Approval Of UCERIS (Budesonide)
`For The Induction Of Remission In Patients With Active, Mild To
`Moderate Ulcerative Colitis (Transcript) (Jan. 15, 2013)
`1049 Uceris® Instant Savings Program
`1050 Transcript of the Second Quarter 2014 Earnings Conference Call of
`Salix Pharmaceuticals, Ltd.
`1051 L.W. Doner, Determining Sugar Composition of Food Gum
`Polysaccharides by HPTLC, Chromatographia 2001, 53, May (No.
`9/10)
`1052 Amendment filed on January 15, 2013 in U.S. Patent Appl. No.
`13/617,138
`Specification of U.S. Patent Application No. 10/009,532
`
`1048
`
`1053
`
`1054
`1055
`1056
`
`Specification of 12/210,969 application
`Specification of 13/249,839 application
`Specification of 13/462,409 application
`
`1057
`
`Final Office Action of March 6, 2013 in U.S. Patent Appl. No.
`13/617,138
`1058 Applicant-Initiated Interview Summary of April 23, 2013 in U.S.
`Patent Appl. No. 13/617,138
`1059 Original Specification as filed on September 14, 2012 in U.S. Patent
`Appl. No. 13/617,138
`1060 Orange Book Listing of Uceris® (accessed on March 8, 2017)
`1061 Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`1062 N. Robinson, Surface Interaction of Lecithin and Lysolecithin, J. of
`Pharmacy and Pharmacology, 12(1) 609-616 (1960)
`
`
`
` 5
`
`

`

`1063 E-mail regarding retention of Dr. Palmieri
`1064 E-mail regarding deposition of Dr. Derendorf
`
`
`Dated: November 27, 2017
`
`
`
`Respectfully Submitted,
`
`
`
`
`
`
`
`By:
`
`/Kevin B. Laurence/
`Kevin B. Laurence
`Registration No. 38,219
`
`Back-up Counsel for Petitioner,
`Argentum Pharmaceuticals LLC
`
`
`
`
`
` 6
`
`

`

`CERTIFICATE OF SERVICE
`
`I hereby certify that on Nov. 27, 2017, a copy of the foregoing EXHIBIT
`
`LIST and Exhibits 1063–1064 were served via email upon the following
`
`counsel of record for the patent owner, as consented to by said counsel:
`
`Gary N. Frischling: gfrischling@irell.com
`Yite John Lu: yjlu@irell.com
`IRELL & MANELLA LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, California 90067
`
`Dated: November 27, 2017
`
`Respectfully submitted,
`
`/Kevin B. Laurence/
`Kevin B. Laurence, Registration No. 38,219
`Back-up Counsel for Petitioner
`
`LAURENCE & PHILLIPS IP LAW LLP
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket