`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner.
`_____________________
`
`Case IPR2023-00478
`Patent 10,272,083 B2
`_____________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`(as of June 8, 2023)
`
`
`
`
`
`
`LIST OF EXHIBITS
`
`1008
`
`No. Description
`1001 U.S. Patent No. 10,272,083 to Hamdy et al. (the “ʼ083 patent”)
`1002 Declaration of John P. Fruehauf, M.D., Ph.D.
`1003 Declaration of Sylvia Hall-Ellis, Ph.D.
`1004
`Prosecution History of U.S. Patent No. 10,272,083
`(Application No. 15/112,968)
`1005 U.S. Patent No. 9,758,524 to Barf, et al. (“Barf”)
`1006
`PCT International Publication No. WO2013/010868 to Barf, et al.
`(“Barf-PCT”)
`1007 U.S. Provisional Application No. 61/509,397 to Barf, et al.
`(“Barf Provisional”)
`Bruce D. Cheson, et al., Advancements in the Treatment of B-Cell
`Malignancies (International Conference on Malignant Lymphoma),
`CLINICAL ADVANCES IN HEMATOLOGY & ONCOLOGY, Vol. 11, Issue 9,
`Supplement 12 (Sept. 2013) (“Cheson”)
`Ranjana H. Advani, et al., Bruton Tyrosine Kinase Inhibitor Ibrutinib
`(PCI-32765) Has Significant Activity in Patients With
`Relapsed/Refractory B-Cell Malignancies, J. CLINICAL ONCOLOGY,
`31(1):88-94 (Jan. 2013) (“Advani”)
`John C. Byrd, et al., Acalabrutinib (ACP-196) in Relapsed Chronic
`Lymphomatic Leukemia, N. ENGL. J. MED. 374(4):323-32 (Jan. 2016)
`(“Byrd”)
`1011 U.S. Provisional Application No. 61/929,742
`1012 U.S. Provisional Application No. 61/974,665
`1013 U.S. Provisional Application No. 62/035,777
`1014
`Stefano A. Pileri, et al., Mantle cell lymphoma, HAEMATOLOLGICA
`94(11):1488-92 (2009) (“Pileri”)
`1015 M. Dreyling, et al., How to manage mantle cell lymphoma, LEUKEMIA
`28:2117-31 (2014) (“Dreyling”)
`1016
`IMBRUVICA™ (ibrutinib) Prescribing Information (2014)
`1017 U.S. Food and Drug Administration Office of Clinical Pharmacology
`Review of IMBRUVICA™ (ibrutinib), Application No. NDA 205552
`(Jan. 2014)
`
`1009
`
`1010
`
`
`
`1020
`
`1022
`
`1019
`
`No. Description
`1018 Akintunde Akinleye, et al., Ibrutinib and novel BTK inhibitors in
`clinical development, J. OF HEMATOLOGY & ONCOLOGY 6:59 (2013)
`(“Akinleye”)
`Claire V. Hutchinson, et al., Breaking good: the inexorable rise of
`BTK inhibitors in the treatment of chronic lymphocytic leukaemia,
`BRITISH J. OF HAEMATOLOGY 166:12-22 (2014) (“Hutchinson”)
`Jennifer R. Brown, et al., Phase 1 Study Of Single Agent CC-292, a
`Highly Selective Bruton’s Tyrosine Kinase (BTK) Inhibitor, In
`Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL), BLOOD
`122(21):1630 (2013) (“Brown”)
`1021 Daniel W. Pierce, et al., Target Engagement, Pathway Inhibition, and
`Efficacy Of The Bruton’s Tyrosine Kinase (Btk) Inhibitor CC-292,
`BLOOD 122(21):4169 (2013) (“Pierce”)
`Simon Rule, et al., A Phase I Study Of The Oral Btk Inhibitor ONO-
`4059 In Patients With Relapsed/Refractory B-Cell Lymphoma, BLOOD
`122(21):4397 (2013) (“Rule”)
`1023
`Prosecution History of U.S. Patent No. 9,758,524
`1024 U.S. Food and Drug Administration, Good Review Practice: Clinical
`Review of Investigational New Drug Applications (Dec. 2013) (“FDA
`2013 Good Review Practice”)
`1025 U.S. Patent No. 7,732,454 (“Verner”)
`1026
`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline; Availability, 59
`Fed. Reg. 55,972 (Nov. 9, 1994)
`1027 U.S. Food and Drug Administration, Guidance for Industry - S9
`Nonclinical Evaluation for Anticancer Pharmaceuticals (March 2010)
`(“S9 Guidance”)
`1028 U.S. Food and Drug Administration, Guidance for Industry -
`Estimating the Maximum Safe Starting Dose in Initial Clinical Trials
`for Therapeutics in Adult Healthy Volunteers (July 2005) (“MSSD
`Guidance”)
`Erica K. Evans, et al., Inhibition of Btk with CC-292 Provides Early
`Pharmacodynamic Assessment of Activity in Mice and Humans, J.
`PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS 346:219-228
`(Aug. 2013) (“Evans”)
`
`1029
`
`
`
`1032
`
`1033
`
`1034
`
`1035
`1036
`
`No. Description
`1030
`Tjeerd Barf, et al., Irreversible Protein Kinase Inhibitors: Balancing
`the Benefits and Risks, J. MED. CHEM. 55:6243-62 (2012) (“Barf
`2012”)
`1031 Amit Mahipal, et al., Risks and Benefits of Phase 1 Clinical Trial
`Participation, CANCER CONTROL 21:193-99 (July 2014) (“Mahipal”)
`Sarah Brumskill, et al., Conference Scene: Recent developments in the
`understanding and treatment of hematological malignancies, INT’L J.
`HEMATOLOGIC ONCOLOGY, Vol. 2, No. 5, published online at
`https://doi.org/10.2217/ijh.13.52 (Oct. 8, 2013) (“Brumskill”)
`Toshio Yoshizawa, et al., ONO-4059—a Potent and Selective
`Reversible Bruton’s Tyrosine Kinase (Btk) Inhibitor: Single Agent,
`Twice Daily (BD) Dosing and Dosing with Food Results in Sustained,
`High Trough Levels of ONO-4059, Translating into 100% Tumour
`Remission in a TMD-8 Xenograft Model, BLOOD, 124(21):4502 (2014)
`(“Yoshizawa”)
`Plaintiffs’ Initial Infringement Contentions to Defendant Sandoz Inc.,
`C.A. No. 22-154-GBW-SRF (Consolidated) (D. Del. Sept. 26, 2022)
`CALQUENCE® (acalabrutinib) Prescribing Information (2017)
`Jan de Jong, et al., Effect of CYP3A perpetrators on ibrutinib exposure
`in healthy participants, PHARMACOLOGY RESEARCH & PERSPECTIVES,
`Vol. 3, Issue 4 (2015) (“de Jong”)
`1037 Dominique Levêque, Evaluation of Fixed Dosing of New Anticancer
`Agents in Phase I Studies, ANTICANCER RESEARCH 28:3075-78 (2008)
`(“Levêque”)
`ZYDELIG® (idelalisib) Prescribing Information (2014)
`TASIGNA® (nilotinib) Prescribing Information (2007)
`JAKAFI™ (ruxolitinib) Prescribing Information (2011)
`LYNPARZA™ (olaparib) Prescribing Information (2014)
`Betty Y. Chang, et al., Egress of CD191CD51 cells into peripheral
`blood following treatment with the Bruton tyrosine kinase inhibitor
`ibrutinib in mantle cell lymphoma patients, BLOOD 122(14):2142
`(2013) (“Chang”)
`1043 Yan Bao, et al., Tyrosine Kinase Btk Is Required for NK Cell
`Activation, J. Biological Chemistry 287(28):23769 (2012)
`
`1038
`1039
`1040
`1041
`1042
`
`
`
`No. Description
`1044 Declaration Of Charles B. Klein In Support Of Motion For PHV
`Admission
`1045 Declaration Of Eimeric Reig-Plessis In Support Of Motion For PHV
`Admission
`Complaint in Acerta Pharma B.V. et al. v. Sandoz Inc.,
`Case No. 1:22-cv-00164-GBW, Dkt. 1 (D. Del. Feb. 4, 2022)
`
`1046
`
`
`
`
`
`
`
`Dated: June 8, 2023
`
`
`WINSTON & STRAWN LLP
`1901 L Street NW
`
`
`Washington, DC 20036
`
`Reg. No. 60,115
`Telephone: 202-282-5000
`Fax: 202-282-5100
`
`
`
`Email: acalabrutinibIPR@winston.com
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Jovial Wong/
`Jovial Wong
`Lead Counsel for Petitioner
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on June 8, 2023,
`
`I caused to be served true and correct copies of the foregoing “PETITIONER’S
`
`UPDATED EXHIBIT LIST” by electronic mail on counsel of record for Patent
`
`Owner as follows:
`
`Stanley E. Fisher (Reg. No. 55,820)
`David I. Berl (Reg. No. 72,751)
`Williams & Connolly LLP
`680 Maine Avenue SW, Washington, D.C., 20024
`sfisher@wc.com
`dberl@wc.com
`Calquence-AZ@wc.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: June 8, 2023
`
`
`WINSTON & STRAWN LLP
`1901 L Street NW
`
`
`Washington, DC 20036
`
`Reg. No. 60,115
`Telephone: 202-282-5000
`Fax: 202-282-5100
`
`
`
`Email: acalabrutinibIPR@winston.com
`
`
`
`Respectfully submitted,
`
`/Jovial Wong/
`Jovial Wong
`Lead Counsel for Petitioner
`
`
`
`
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
