throbber
Paper No. ____
`Date Filed: November 14, 2016
`
`
`
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`ROXANE LABORATORIES, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01461
`
`Patent No. 9,006,224
`
`
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 1
`
`
`

`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2001
`
`Expert Declaration Of Matthew H. Kulke,
`M.D., M.M.Sc.
`
`Kulke Decl.
`
`2002
`
`Curriculum Vitae of Matthew H. Kulke,
`M.D., M.M.Sc.
`
`Kulke C.V.
`
`2003
`
`Seeley, R. R., Stephens, T.D., & Tate, P.,
`Anatomy & Physiology, 3rd Edition,
`pages 585 – 586 (1995)
`
`Seeley
`
`2004
`
`Moertel, C.G., et al., “Streptozocin-
`Doxorubicin, Streptozocin-Fluorouracil,
`Or Chlorozotocin In The Treatment Of
`Advanced Islet-Cell Carcinoma,” New
`Engl. J. Med. 326(8):519-523 (1992)
`
`Moertel
`
`2005
`
`Laughlin, E.H., Coming To Terms With
`Cancer: A Glossary Of Cancer-Related
`Terms, page 4 (2002)
`
`Laughlin
`Cancer Glossary
`
`2006
`
`Hewitt, M.R. & Yu, K., “Treatment
`Update For Metastatic Pancreatic
`Cancer,” Community Oncol. 3(7):428-430
`(July 2006)
`
`Hewitt and Yu
`
`
`
`1
`
`

`
`Exhibit
`
`Description
`
`Abbreviation
`
`2007
`
`Yu, K.H. & Ahman, N.A., Chapter 25,
`“Diagnosis And Evaluation Of Pancreatic
`Ductal Adenocarcinoma,” Endoscopic
`Oncology: Gastrointestinal Endoscopy
`And Cancer Management (Faigel, D.O. &
`Kochman, M.L., eds. 2006)
`
`2008
`
`Motzer, R.J. & Russo, P., “Systemic
`Therapy For Renal Cell Carcinoma,” J.
`Urology 163:408-417 (2000)
`
`2009
`
`2010
`
`2011
`
`“Wyeth Pharmaceuticals Announces
`Termination Of Phase 3 Clinical Program
`With Oral Temsirolimus In Women With
`Metastatic Breast Cancer,” PR Newswire,
`AP Alert (March 16, 2006)
`
`Pazdur, R., et al. (eds.), Chapters 11, 14,
`16, & 19, Cancer Management: A
`Multidisciplinary Approach: Medical,
`Surgical, & Radiation Oncology, 9th
`Edition (2005)
`
`Kouvaraki, M.A. et al., “Fluorouracil,
`Doxorubicin, And Streptozocin In The
`Treatment Of Patients With Locally
`Advanced And Metastatic Pancreatic
`Endocrine Carcinomas,” J. Clin. Oncol.
`22(23):4762-4771 (2004)
`
`Yu
`
`Motzer
`
`Wyeth
`Press Release
`
`Pazdur
`
`Kouvaraki
`
`
`
`2
`
`

`
`Exhibit
`
`Description
`
`Abbreviation
`
`2012
`
`Delaunoit, Th., et al., “The Doxorubicin-
`Streptozotocin Combination For The
`Treatment Of Advanced Well-
`Differentiated Pancreatic Endocrine
`Carcinoma: A Judicious Option?,” Eur. J.
`Cancer 40:515-520 (2004)
`
`Delaunoit
`
`
`
`3
`
`
`
`
`
`

`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 1 was
`
`served on November 14, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
`/ Nicholas N. Kallas /
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`
`
`Dated: November 14, 2016
`
`
`
`
`
`
`
`
`
`4

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