The detailed information for PTAB case with proceeding number IPR2018-01345 filed by CSL Behring LLC, CSL Behring GmbH, and CSL Behring Recombinant Facility AG, et al. against Bioverativ Therapeutics, Inc. on Jul 6, 2018. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2018-01345
Filing Date
Jul 6, 2018
Petitioner
CSL Behring LLC, CSL Behring GmbH, and CSL Behring Recombinant Facility AG, et al.
Respondent
Bioverativ Therapeutics, Inc.
Status
Institution Denied
Respondent Application Number
15043455
Respondent Tech Center
1600
Respondent Patent Number
9623091
Institution Decision Date
Jan 16, 2019

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Notice of Refund

Mar 14, 2019PAPERBOARD

Refund Request of Post Institution Fees

Feb 6, 2019PAPERPETITIONER

DECISION Denying Institution of Inter Partes Review 35 U.S.C. § 314

Jan 16, 2019PAPERBOARD

U.S. Patent No. 5,969,040, issued October 19, 1999

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 6,037,452, issued March 14, 2000

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 6,686,179, issued February 3, 2004

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent Publication No. 2003/0199043, published October 23, 2003

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent Publication No. 2005/0032174, published February 10, 2005

Oct 23, 2018EXHIBITPATENT OWNER

Declaration of John Pasi, M.B. Ch.B., Ph.D., October 23, 2018

Oct 23, 2018EXHIBITPATENT OWNER

Excerpts of File History for U.S. Patent No. 9,623,091

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 7,592,010, issued September 22, 2009

Oct 23, 2018EXHIBITPATENT OWNER

WO 2002/040544, published May 23, 2002

Oct 23, 2018EXHIBITPATENT OWNER

WO 2007/115724, published October 18, 2007

Oct 23, 2018EXHIBITPATENT OWNER

WO 2007/149406, published December 27, 2007

Oct 23, 2018EXHIBITPATENT OWNER

WO 2008/118507, published October 2, 2008

Oct 23, 2018EXHIBITPATENT OWNER

WO 2009/051717, published April 23, 2009

Oct 23, 2018EXHIBITPATENT OWNER

WO 2009/130198, published October 29, 2009

Oct 23, 2018EXHIBITPATENT OWNER

WO 2003/020764, published March 13, 2003

Oct 23, 2018EXHIBITPATENT OWNER

WO 2004/101740, published November 25, 2004

Oct 23, 2018EXHIBITPATENT OWNER

WO 2006/074199, published July 13, 2006

Oct 23, 2018EXHIBITPATENT OWNER

WO 2009/137254, published November 12, 2009

Oct 23, 2018EXHIBITPATENT OWNER

WO 2009/140015, published November 19, 2009

Oct 23, 2018EXHIBITPATENT OWNER

WO 2012/006624, Published January 1, 2012

Oct 23, 2018EXHIBITPATENT OWNER

Prescribing Information for Alprolix¿¿ (Revised: 06/2018) (Alprolix Label)

Oct 23, 2018EXHIBITPATENT OWNER

Andersen and Sandlie, The Versatile MHC Class I-related FcRn Protects IgG and Albumin from Degradation: Implications for Development of New Diagnostic and Therapeutics, Drug Metab. Pharmacokinet. 24(4): 318-332, 321 (2009)

Oct 23, 2018EXHIBITPATENT OWNER

Chaudhury et al., Albumin Binding to FcRn: Distinct from the FcRn-IgG Interaction, Biochemistry 45, 4983¿¿¿90 (2006)

Oct 23, 2018EXHIBITPATENT OWNER

Choo et al., Molecular cloning of the gene for human anti-haemophilic Factor IX, Nature 299, 178¿¿¿80 (1982)

Oct 23, 2018EXHIBITPATENT OWNER

Fischer, K., et al., Prophylaxis for severe haemophilia: clinical challenges in the absence as well as in the presence of inhibitors, Haemophilia, 14(Suppl. 3): 196-201 (2008)

Oct 23, 2018EXHIBITPATENT OWNER

Kaufman et al., Expression, Purification, and Characterization of Recombinant ¿¿-Carboxylated Factor IX Synthesized in Chinese Hamster Ovary Cells, The Journal of Biological Chemistry 261(21) 9622¿¿¿28 (1986)

Oct 23, 2018EXHIBITPATENT OWNER

Manco-Johnson MJ, et al., Advances in care of children with hemophilia, Semin Thromb Hemost. 29(6) 585-594 (2003)

Oct 23, 2018EXHIBITPATENT OWNER

Manco-Johnson MJ, et al., Prophylaxis versus Episodic Treatment to Prevent Joint Disease in Boys with Severe Hemophilia, The New England Journal of Medicine 357:6; 535-544 (2007)

Oct 23, 2018EXHIBITPATENT OWNER

Andersen et al., Cross-species Binding Analyses of Mouse and Human Neonatal Fc Receptor Show Dramatic Differences in Immunoglobulin G and Albumin Binding, The Journal of Biological Chemistry 285(7):4826-4836 (2010)

Oct 23, 2018EXHIBITPATENT OWNER

BeneFix Circular (Benefix Label) Dated November 16, 2004

Oct 23, 2018EXHIBITPATENT OWNER

Berntrop, Consensus perspectives on prophylactic therapy for haemophilia: summary statement, Haemophilia 9(Suppl. 1):1-4 (2003)

Oct 23, 2018EXHIBITPATENT OWNER

Chaudhury et al., The Major Histocompatibility Complex-related Fc Receptor for IgG (FcRn) Binds Albumin and Prolongs Its Lifespan, J. Exp. Med. 197(3), 315¿¿¿22 (2003)

Oct 23, 2018EXHIBITPATENT OWNER

Ducore et al., Alprolix (recombinant factor IX Fc fusion protein): extended half-life product for the prophylaxis and treatment of hemophilia B, 7(5) Expert Rev. Hematology 559 (2014)

Oct 23, 2018EXHIBITPATENT OWNER

Fischer, K., et al., Prophylaxis for severe haemophilia: clinical challenges in the absence as well as in the presence of inhibitors, Haemophilia, 14(Suppl. 3): 196-201 (2008)

Oct 23, 2018EXHIBITPATENT OWNER

Joint Claim Construction Worksheet filed on September 13, 2018 in Bioverativ Inc. et al. v. CSL Behring LLC et al., CA. No. 17-914 (GMS), dated September 13, 2018.

Oct 23, 2018EXHIBITPATENT OWNER

Levin et al., Lost in Translation, Bumps in the Road Between Bench and Bedside, JAMA 303(15) 1533-1534 (2010)

Oct 23, 2018EXHIBITPATENT OWNER

Petrini, P., What factors should influence the dosage and interval of prophylactic treatment in patients with severe haemophilia, Haemophilia 7, 99-102 (2001)

Oct 23, 2018EXHIBITPATENT OWNER

Schmidt and Bajaj, Structure-Function Relationships in Factor IX and Factor IXa, Trends in Cardiovascular Medicine 13(1) 39¿¿¿45 (2003)

Oct 23, 2018EXHIBITPATENT OWNER

Yoshitake et al., Complete nucleotide sequences of the gene for human factor IX (antihemophilic factor B), Biochemistry 24(14), 3736¿¿¿50 (1985)

Oct 23, 2018EXHIBITPATENT OWNER

Ober et al., Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies, International Immunology 13(12): 1551-1559 (2001)

Oct 23, 2018EXHIBITPATENT OWNER

Proetzel and Roopenian, Humanized FcRn Mouse Models for Evaluating Pharmacokinetics of human IgG Antibodies, Methods 65(1): 148-153 (2014)

Oct 23, 2018EXHIBITPATENT OWNER

Roopenian and Akilesh FcRn: the neonatal Fc receptor comes of age, Nature Review Immunology 7, 715¿¿¿25 (2007)

Oct 23, 2018EXHIBITPATENT OWNER

E. Santagostino, Prophylaxis in haemophilia B patients: unresolved issues and pharmacoeconomic implications, Haemophilia 16 (Suppl. 6), 13-17 (2010)

Oct 23, 2018EXHIBITPATENT OWNER

Schafer and Kolkhof, Failure is an option: learning from unsuccessful proof-of-concept trials, Drug Discovery Today 13, 913-916 (2008)

Oct 23, 2018EXHIBITPATENT OWNER

Zhang et al., Population pharmacokinetics of a new long-acting recombinant coagulation factor IX albumin fusion protein for patients with severe hemophilia B, Journal of Thrombosis and Haemostasis 14: 2132-2140 (2016)

Oct 23, 2018EXHIBITPATENT OWNER

Declaration of John Pasi, M.B. Ch.B., Ph.D., October 23, 2018

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 7,592,010, issued September 22, 2009

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent Publication No. 2003/0199043, published October 23, 2003

Oct 23, 2018EXHIBITPATENT OWNER

WO 2003/020764, published March 13, 2003

Oct 23, 2018EXHIBITPATENT OWNER

Patent Owner's Preliminary Response

Oct 23, 2018PAPERPATENT OWNER

Declaration of Allen R. Rines, October 23, 2018

Oct 23, 2018EXHIBITPATENT OWNER

Declaration of Brendan T. Jones, October 23, 2018

Oct 23, 2018EXHIBITPATENT OWNER

Excerpts of File History for U.S. Patent No. 9,623,091

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 5,969,040, issued October 19, 1999

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 6,037,452, issued March 14, 2000

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent No. 6,686,179, issued February 3, 2004

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Patent Publication No. 2005/0032174, published February 10, 2005

Oct 23, 2018EXHIBITPATENT OWNER

WO 2002/040544, published May 23, 2002

Oct 23, 2018EXHIBITPATENT OWNER

Notice of Accord Filing Date

Jul 23, 2018PAPERBOARD

IPR 2018-01345 Patent Owner Mandatory Notice

Jul 23, 2018PAPERPATENT OWNER

IPR 2018-01345 Patent Owner Power of Attorney

Jul 23, 2018PAPERPATENT OWNER

Petitioner's Updated Mandatory Notice

Jul 19, 2018PAPERPETITIONER

Petitioners' Amended Power of Attorney

Jul 19, 2018PAPERPETITIONER

US 7404956

Jul 6, 2018EXHIBITPETITIONER

US App 11043569

Jul 6, 2018EXHIBITPETITIONER

US App 15043455

Jul 6, 2018EXHIBITPETITIONER

USP 61363064

Jul 6, 2018EXHIBITPETITIONER

USP 61430819

Jul 6, 2018EXHIBITPETITIONER

Amevive

Jul 6, 2018EXHIBITPETITIONER

Bjorkman

Jul 6, 2018EXHIBITPETITIONER

Enbrel

Jul 6, 2018EXHIBITPETITIONER

Key

Jul 6, 2018EXHIBITPETITIONER

MASAC

Jul 6, 2018EXHIBITPETITIONER

McGraw

Jul 6, 2018EXHIBITPETITIONER

Monahan

Jul 6, 2018EXHIBITPETITIONER

Nilsson

Jul 6, 2018EXHIBITPETITIONER

Steen-Carlsson

Jul 6, 2018EXHIBITPETITIONER

Power of Attorney

Jul 6, 2018PAPERPETITIONER

US 9623091

Jul 6, 2018EXHIBITPETITIONER

US 20080260755

Jul 6, 2018EXHIBITPETITIONER

USP 61442079

Jul 6, 2018EXHIBITPETITIONER

USP 61438572

Jul 6, 2018EXHIBITPETITIONER

USP 61424555

Jul 6, 2018EXHIBITPETITIONER

USP 61470951

Jul 6, 2018EXHIBITPETITIONER

455 Final OA

Jul 6, 2018EXHIBITPETITIONER

455 Notice of Allowability

Jul 6, 2018EXHIBITPETITIONER

Anderson

Jul 6, 2018EXHIBITPETITIONER

Alprolix

Jul 6, 2018EXHIBITPETITIONER

Baggio

Jul 6, 2018EXHIBITPETITIONER

Lorenzo

Jul 6, 2018EXHIBITPETITIONER

Carlsson

Jul 6, 2018EXHIBITPETITIONER

Coppola

Jul 6, 2018EXHIBITPETITIONER

Fischer

Jul 6, 2018EXHIBITPETITIONER

Claim Construction Chart

Jul 6, 2018EXHIBITPETITIONER

Fischer 2003

Jul 6, 2018EXHIBITPETITIONER

Idelvion

Jul 6, 2018EXHIBITPETITIONER

Metzner

Jul 6, 2018EXHIBITPETITIONER

Muller

Jul 6, 2018EXHIBITPETITIONER

Pechtner

Jul 6, 2018EXHIBITPETITIONER

Petrini

Jul 6, 2018EXHIBITPETITIONER

Peters 2010

Jul 6, 2018EXHIBITPETITIONER

World Proceedings

Jul 6, 2018EXHIBITPETITIONER

Quinlan

Jul 6, 2018EXHIBITPETITIONER

Roth

Jul 6, 2018EXHIBITPETITIONER

Saenko

Jul 6, 2018EXHIBITPETITIONER

Schroeder

Jul 6, 2018EXHIBITPETITIONER

Schulte

Jul 6, 2018EXHIBITPETITIONER

Shapiro

Jul 6, 2018EXHIBITPETITIONER

Sockolosky

Jul 6, 2018EXHIBITPETITIONER

van Dijk

Jul 6, 2018EXHIBITPETITIONER

Hacker

Jul 6, 2018EXHIBITPETITIONER

Santagostino

Jul 6, 2018EXHIBITPETITIONER

Peters Abstract 2007

Jul 6, 2018EXHIBITPETITIONER

PTE Letter for US 8329182

Jul 6, 2018EXHIBITPETITIONER

455 Amd and Reply

Jul 6, 2018EXHIBITPETITIONER

Crisafulli Declaration

Jul 6, 2018EXHIBITPETITIONER

Peters 1.132 Declaration

Jul 6, 2018EXHIBITPETITIONER

Maher Declaration

Jul 6, 2018EXHIBITPETITIONER

IDS from prosecution history

Jul 6, 2018EXHIBITPETITIONER

Fee Authorization

Jul 6, 2018PAPERPETITIONER

Hall-Ellis Declaration

Jul 6, 2018EXHIBITPETITIONER

Initial Petition

Jul 6, 2018PAPERPETITIONER

Negrier Declaration

Jul 6, 2018EXHIBITPETITIONER