`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-01104
`U.S. Patent No. 9,919,024
`__________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`Case No. IPR2022-01 104
`U.S . Patent No. 9,919,024
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Bausch Health Ireland
`
`Limited hereby submits a current listing of Patent Owner Exhibits.
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`titled
`International Publication Number WO 02/078683 A l
`Guanylate Cyclase Receptor Agonists for the Treatment of Tissue
`Inflammation and Carcinogenesis.
`
`International Publication Number WO 2005/016244 A2 titled
`Methods and Compositions for the Treatment of Gastrointestinal
`Disorders.
`
`Kunwar Shailubhai et al., "A Randomized, Double-blind, Placebo-
`Controlled, Single-, Ascending-, Oral-Dose Safety, Tolerability and
`Pharmacokinetic Study of SP-304 in Healthy Adult Human Male and
`Female Volunteers," Digestive Disease Week, San Diego: 2008.
`
`Christians Lab, Department of Anesthesiology, School of Medicine,
`available
`University
`Colorado,
`at
`of
`https://medschool.cuanschutz.edu/anesthesiology/research-
`innovation/basic-research-pis/christians-lab.
`
`Faculty Profile for Uwe Christians, MD, PhD., Department of
`Anesthesiology, School of Medicine, University of Colorado,
`https://som.ucdenver.edu/Profiles/Faculty/Profile/4832.
`
`for Uwe Christians, MD, PhD., available at
`Bibliography
`https :/ /www.ncbi.nlm.nih.gov/myncbi/ 12extkpeOjlgmf/bibliograph
`y/public.
`
`2007
`
`Reserved.
`
`2008
`
`2009
`
`Prescribing Information for Linzess (Revised 8/2021 ), available at
`https:/ /www .accessdata.fda.gov/drugsatfda _ docs/label/202 l /202811
`s0 18lbl.pdf.
`
`Marco van de Weert and Theodore W. Randolph, "Chapter 6 -
`Physical Instability of Peptides and Proteins," of PHARMACEUTICAL
`FORMULATION DEVELOPMENT OF PEPTIDES AND PROTEINS (Lars
`
`1
`
`
`
`Case No. IPR2022-01104
`U.S . Patent No. 9,919,024
`
`EXHIBIT
`
`DESCRIPTION
`Hovgaard, Sven Frokjaer and Marco van de Weert eds., Taylor &
`Francis Group 2013).
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Paul A. Bummer, "Chapter 2 - Chemical Considerations in Protein
`and Peptide Stability," of PROTEIN FORMULATION AND DELIVERY
`SECOND EDITION (Eugene J. McNally and Jayne E. Hastedt eds.,
`Informa Healthcare USA, Inc. 2008).
`
`Theodore W. Randolph and John F. Carpenter, "Engineering
`Challenges of Protein Formulations," AIChE Journal, 53(8): 1902-
`1907 (August 2007).
`
`NDA 208745, Medical Reviews, Center for Drug Evaluation and
`Research,
`available
`at
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/20 17/208745
`Origl s000MedR.pdf (Excerpted).
`
`NDA 208745, Synergy Pharmaceuticals, Inc., Final Clinical Study
`Report, A Randomized, Double-Blind, Placebo-Controlled, Single-,
`Ascending-, Oral-Dose Safety, Tolerability, and Pharmacokinetic
`Study of SP-304 in Healthy Adult Human Male and Female
`Volunteers (Excerpted) (Filed Under Seal).
`
`"Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in
`Chronic Constipation and Irritable Bowel Syndrome," Business
`Wire, April 07, 2008.
`
`Default Protective Order, Patent Trial and Appeal Board
`Consolidated Trial Practice Guide (November 2019) at 117-122.
`
`Dated: January 10, 2023
`
`Respectfully submitted,
`
`By : /Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
`Joshua L. Goldberg, Reg. No. 59,369
`
`2
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`Back-up Counsel
`Kassandra M. Officer Reg. No. 74,083
`Back-up Counsel
`Lauren J. Robinson Reg. No. 74,100
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`
`3
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Updated Exhibit List and Exhibit 2015 were served electronically via email on
`
`January 10, 2023, to counsel of record for the Petitioner at the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
`Nicole W. Stafford
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`dgregory@wsgr.com
`
`4876-6223-0546@mail.vault.netdocuments.com
`
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Date: January 10, 2023
`
`
`
`
`
`
`
`
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
