Amneal Pharmaceuticals, Inc. et al. vs. Genentech Inc. et al.

Explore the PTAB proceeding IPR2026-00260 filed by Amneal Pharmaceuticals, Inc. et al. on 2026-05-26. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2026-00260

Filing Date

2026-05-26

Accorded Filing Date

2026-05-26

Institution Decision Date

—

Last Modified Date

2026-09-23

Proceeding Type

IPR

Termination Date

—

Trial Status

Pending

Parties & Counsel

Petitioner

Amneal Pharmaceuticals, Inc. et al.

Represented By

Green, Loraet al

Patent Owner / Respondent

Genentech Inc. et al.

Represented By

Fletcher, Thomaset al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 18486053

Respondent Patent Number 12030959

External Links

Espacenet

Google Patents

Respondent Inventor Ryan Patrick OWEN et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

86 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name MORRISON & FOERSTER LLP

Customer Number 25226

Address 755 PAGE MILL RD, PALO ALTO, CA, 94304-1018, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
38651	Michael Ward	415-268-6237
39933	Robert Cerpa	650-813-5715
40130	Catherine Polizzi	650-813-5651
45640	Jonathan Bockman	202-791-8570
46813	Parisa Jorjani	415-268-7000
48231	Mehran Arjomand	213-892-5630
50713	Patricia Tsao	415-268-6642
51934	Christine Lekutis	415-268-7060
52285	Shannon Reaney	650-813-5600
52395	Jie Zhou	650-813-5922
55748	Jian Xiao	650-813-5736
56398	Matthew Kreeger	415-268-7000
57254	Karen Potter	858-314-7521
60243	Seth Snyder	212-698-3500
60287	Adam Brausa	415-362-6666
60609	Alex Yap	408-918-7605
63950	Jillian Pesin-Fulop	617-648-4772
64178	Mark Mcbriar	617-648-4782
69080	Lisa Silverman	650-813-5735
70339	John Chapman	650-813-5726
71051	Jean Nguyen	213-892-5295
71568	Nathan Vogler	262-260-4253
71792	Anita Choi	415-268-6445
71907	Christopher Gloria	202-791-8572
72137	Joshua Crawford	410-440-7686
72195	Cory Ellison	415-268-7452
72552	Jeffrey Schmidt	858-314-7617
73237	Qiwen Zhong	858-314-5431
73248	Meghan Poon	650-813-4108
73258	Ethan Weiner	650-813-4119
73282	Bryan Blumenkopf	213-892-5269
73475	Kevin Jones	415-268-7483
73637	Yunan Yuan	415-268-6857
74291	Steven Sundberg	650-849-3147
75272	Wei Tang	415-268-6347
75807	Benjamin Oswald	202-887-1500
75895	Tony Kwok	213-892-5360
76198	Erin Sully	858-314-7647
76553	Forrest Mcclellen	415-268-7000
76842	Claire Bendix	415-268-6130
76868	Marisa Sanders Levene	908-343-4509
77034	Yuying You	205-240-2417
77895	Rebecca Weires	415-268-7000
78321	Paige Chandler	858-314-5424
78804	Garreth Mccrudden	248-479-8040
79346	Lea Polito	617-648-4801
79382	Kelsey Roberts Kingman	650-889-0114
79763	Sarah Bloch	415-268-6423
79832	Michelle Bradley	650-283-0180
800045	Yujia Sun	212-336-4263
800060	Yi Qu	617-447-7126
800111	Xinhui Zhang	213-892-5601
80029	Thomas Keane	617-368-0502
80270	Jeffrey Young Jr	202-498-8458
80277	Elizabeth Freeman Rosenzweig	415-268-7262
80495	Paige Smith	617-648-4763
80608	Alayna Choo	202-572-6754
80614	Jessica Hsieh	858-314-7706
80633	Thomas Dawson	617-648-4718
80779	Martin Ellinger	858-314-7615
80817	Emily Hamman	617-648-4778
80994	Briana Mittleman	913-522-0582
81228	Adrienne Cohen	415-268-6854
81337	Deborah Pohlmann	857-234-5168
81412	Emily Roberts	141-523-18674
81644	Wendy Fong	165-081-36498
81715	Abagail Burrus	617-648-4700
81729	Edith Pierre-Jerome	858-314-7651
81738	Laura Westergard	858-720-5100
81953	Linda Yen	650-813-5600
82002	Manjing Zhang	415-832-9037
82156	Emily Howard	213-269-7512
82304	Sierra Lear	415-205-9525
82346	Caleb Jadrich	161-778-56515
82420	Corey Garyn	212-336-4439
82482	Samuel Redford	858-933-5440
82515	Elizabeth Cooke	161-764-84804
82587	Juliana Ilmain	646-764-4845
82594	Andrew Murtha	617-648-4767
82629	Kiran Sutaria	408-772-4580
82697	Keunbong Do	415-268-7536
82834	Elizabeth Newman	858-209-9302
82903	Michael Kim	650-544-0047
82998	Yocelyn Recinos	646-712-4790
83119	Anushree Gulvady-Hayes	617-368-0914
L1414	Felicia Burns	415-812-8453

Proceeding Documents

Director Discretionary Decision: Refer RESPONSE

2026-09-23 FILING PARTY: BOARD

Download

1057

Angela Morris, How Top US Patent Courts Compare on Median Time-to- Trial Statistics, Docket Navigator (June 27, 2022), https ://brochure. docketnavigator. com/how-top-us-patent-courts-compareon- median-time-to-trial-statistics/ Exhibit

2026-09-04 FILING PARTY: PETITIONER

Download

1056

Lex Machina, Patent Litigation Report (2025) Exhibit

2026-09-04 FILING PARTY: PETITIONER

Download

1054

XOLAIR® (omalizumab) Pricing I Cost, XOLAIR, https://www.xolair.com/ cost.html Exhibit

2026-09-04 FILING PARTY: PETITIONER

Download

1061

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, THE WHITEHOUSE (May 12, 2025) Exhibit

2026-09-04 FILING PARTY: PETITIONER

Download

Amneal Pharmaceuticals, Inc. et al. vs. Genentech Inc. et al.

Proceeding Overview

Parties & Counsel

Petitioner

Amneal Pharmaceuticals, Inc. et al.

Represented By

Patent Owner / Respondent

Genentech Inc. et al.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Director Discretionary Decision: Refer RESPONSE

Angela Morris, How Top US Patent Courts Compare on Median Time-to- Trial Statistics, Docket Navigator (June 27, 2022), https ://brochure. docketnavigator. com/how-top-us-patent-courts-compareon- median-time-to-trial-statistics/ Exhibit

Lex Machina, Patent Litigation Report (2025) Exhibit

XOLAIR® (omalizumab) Pricing I Cost, XOLAIR, https://www.xolair.com/ cost.html Exhibit

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, THE WHITEHOUSE (May 12, 2025) Exhibit

Dr. Rand Paul Introduces Legislation to Cut Bureaucratic Red Tape and Lower Drug Prices, Sen. Rand Paul (Apr. 8, 2025) Exhibit

Actual Medicinal Product (AMP) - Xolair 300mg/2ml Solution for Injection Pre-Filled Syringes (Novartis Pharmaceuticals UK Ltd), DICTIONARY OF MEDICINES AND DEVICES BROWSER Exhibit

Klobuchar, Grassley Introduce Bipartisan Bills to Reduce Drug Prices by Promoting Competition and Taking on Big Pharma, Sen. Amy Klobuchar (Mar. 26, 2025) Exhibit

Petitioner's Updated Exhibit List NOTICE

Executive Order No. 14273, Lowering Drug Prices by Once Again Putting Americans First, 90 Fed. Reg. 16441 (April 15, 2025) Exhibit

Notice of Petitioner's Sotera Stipulation OTHER

AAM, The U.S. Generic & Biosimilar Medicines Saving Report (September 2025), https://accessiblemeds.org/wpcontent/ uploads/2025/09/ AAM-2025-Generic-Biosimilar-Medicines- Savings-Report-WEB. pdf/ Exhibit

Fact Sheet: President Donald J Trump Announces Actions to Lower Prescription Drug Prices, THE WHITE HOUSE (Apr. 15, 2025), https :/ /www. whi tehouse. gov /fact-sheets/2025/04/fact-sheet-presidentdonald- i-trump-announces-actions-to-lower -prescription-drug-prices/ Exhibit

Opposition to Patent Owner's Request for Discretionary Denial RESPONSE

Ex. 2006 Exhibit

Ex. 2001 Exhibit

Ex. 2002 Exhibit

Ex. 2007 Exhibit

Patent Owners' Request for Discretionary Denial RESPONSE

Ex. 2003 Exhibit

Ex. 2005 Exhibit

Ex. 2004 Exhibit

Ex. 2008 Exhibit

Notice: Mandatory Notice NOTICE

Notice: Power of Attorney NOTICE

Notice: Notice filing date accorded NOTICE

EX1036 - Caroline Nilsson et al. (2014(("Nilsson") Exhibit

EX1042 - (Dec. 2018) (“Gupta”) Exhibit

EX1028 - Crisoforo Incorvaia et al, Current and future applications (2008) Exhibit

EX1035 - Francesca Mori (Sept. 2021) Exhibit

Inter Partes Review Petition of U.S. Patent 12,030,959 PETITION

EX1053 - (“NLM Press Release”) Exhibit

EX1031 - Hugh A. Sampson (2011) Exhibit

EX1014 - 2 to 20 years Exhibit

EX1026 - Robert A. Wood et al., Protocol design and synopsis (Nov. 2022) Exhibit

EX1021 - Clinical trial NIH-PR (2019) Exhibit

EX1007 - XOLAIR® Prescribing Information, FOOD AND DRUG ADMIN. (Jul. 2021). Exhibit

EX1032 - Jessica H. Savage et al., Kinetics of mast cell, basophil (2012) Exhibit

EX1001 - U.S. Patent No. 12,030,959 to Owen et al. (July 9, 2024) (“US959”) Exhibit

EX1017 - Wanda Phipatanakul (2021) Exhibit

EX1046 - (May 5, 2009) (“Sandström”) Exhibit

EX1019 - XOLAIR® Prescribing Information, FOOD AND DRUG ADMIN. (Mar. 2014) Exhibit

EX1041 - (March/April 2022) (“Saab”) Exhibit

EX1051 - XOLAIR® Prescribing Information, FOOD AND DRUG ADMIN. (Jul. 2016) Exhibit

EX1052 - (2015) (“Lowe”) Exhibit

EX1043 - (Jan. 14, 2019) (“Crisafulli”) Exhibit

EX1010 - Abstract for Maurizio Mennini et al. (2017) Exhibit

EX1011 - FDA Grants Breakthrough Therapy Designation for Xolair (2018) Exhibit

EX1015 - Birth to 24 months Exhibit

EX1049 - (2003) (“Leung”) Exhibit

EX1033 - PROTOCOL CoFAR-11, Omalizumab as Monotherapy (2024) Exhibit

EX1004 - Excerpts of prosecution history of U.S. Application 18/486,053 Exhibit

EX1039 - Masaya Takahashi, (Dec. 12, 2017) ("Takahashi") Exhibit

EX1013 - Birth to 24 months (2009). Exhibit

EX1047 - (Jan. 2019) (“Nishima”) Exhibit

EX1008 - Andrew J. MacGinnitie et al., Omalizumab (2016) Exhibit

EX1005 - NCT03881696, Omalizumab, Version 26 Exhibit

EX1040 - C. Martorell-Calatayud, (May 6, 2016) (“Martorell-Calatayud”) Exhibit

EX1025 - Abstract for Pena Peloche (2011) Exhibit

EX1027 - Rui Zhu et al., Pharmacokinetics (2021) Exhibit

EX1044 - (Dec. 21, 2016) (“Navinés-Ferrer”) Exhibit

EX1018 - Judit Crespo (2021) Exhibit

EX1006 - Stefanie Arasi et al., Omalizumab as monotherapy for food allergy Exhibit

EX1037 - Sara Manti (2021) ("Manti") Exhibit

EX1024 - Pena Peloche (2011). Exhibit