IPR2025-00505 case details

U.S. Patent No. 11,344,552 to Bayever et al. ("the '552 patent")

Conroy, et al., N. Engl. J. Med., 364(19):1817-25 (2011) (“Conroy”)

Certified English Translation of the Protocol of Conroy, et al.

Mahaseth, et al., Pancreas, 42(8):1311-15 (2013) (“Mahaseth”)

International Publication No. WO2013/188586 A1 to Bayever (“Bayever”)

Saif, Journal of the Pancreas, 15(3):278-79 (2014) (“Saif”)

Ko, et al., British J. of Cancer, 109(4):920-25 (2013) (“Ko”)

Cantore, et al., Oncology, 67(2):93-97 (2004) (“Cantore”)

Nichetti, et al., JAMA Network Open, 7(1):1-13 (2024) (“Nichetti”)

Nevala-Plagemann and Garrido-Laguna, Nature Reviews Clinical Oncology

Masi, et al., Annals of Oncology, 15:1766-72 (2004) (“Masi”)

Carnevale and Ko, Future Oncology, 12(4):453-464 (2016) (“Carnevale”)

Dean, et al., J Clin Oncol, 34(4 Suppl.):tps482 (2016) (“Dean”)

U.S. Provisional Application No. 62/208,209 to Bayever et al.

Ginocchi, et al., Annals of Oncology, 23(9 Suppl.):ix238 (2012) (“Ginocchi”

Conroy Supplementary Appendix, N. Engl. J. Med. (“Conroy Appendix”)

Wainberg, et al., Ann Oncol., 3l (Suppl. 3):S241 (2020)

Wainberg, et al., European Journal of Cancer, 151:14-24 (2021)

U.S. Non-Provisional Patent Application No. 15/241,106 to Bayever, et al.

Hatachi, et al., Cancer Diagn & Progn, 2(1):101-06 (2022)

Zaniboni, et al., Cancer Chemother Pharmacol., 69(6):1641-45 (2012)

Tsai, et al., J Gastrointest Oncol., 2(3):185-94 (2011)

U.S. Patent No. 8,147,867 to Hong, et al (“the ’867 patent”)

Press Release by Merrimack Pharmaceuticals, Inc. on August 1, 2011

International Publication No. WO 2016/094402 A1 to Bayever (“Bayever II”)

Alcindor, et al., Curr Oncol, 18(1):18-25 (2011)

U.S. Provisional Application No. 62/216,736 to Bayever et al.

U.S. Provisional Application No. 62/273,244 to Bayever et al.

U.S. Provisional Application No. 62/281,473 to Bayever et al.

U.S. Provisional Application No. 62/302,341 to Bayever et al.

U.S. Provisional Application No. 62/323,245 to Bayever et al.

Leucovorin Calcium Injection Label (2011)

Gemcitabine Injection Label (2012)

Abraxane Paclitaxel Label (2013)

XELODA Capecitabine Label (2000)

Camptosar FDA Label (2006)

Eloxatin Oxaliplatin Injection Label (2012)

Tarceva Erlotinib Tablets Label (2013)

Fluorouracil Injection Label (2012)

Conroy, et al., Curr Oncol Rep., 15(2):182-9 (2013)

Ko, J Clin Oncol, 29(28):3727–29 (2011)

Blazer, et al., ASCO Meeting Abstr. 32(Suppl. 3):275 (2014)

Alessandretti, et al., ASCO Meeting Abstr. 31 (Suppl. 15): e15176 (2013)

Paller, et al., Clin Cancer Res., 20(16); 4210–17 (2014)

Hamberg, et al., Eur J Cancer, 46(16):2870-78 (2010)

Hess, et al., Annals of Oncology, 21(12):2390-95 (2010)

Goel, et al., Anti-Cancer Drugs, 18(3):263-71 (2007)

Rachamalla, et al., Anticancer Drugs, 15(3):211-7 (2004)

Wildiers, Eur J Cancer, 43(15):2235-41 (2007)

Gajra, et al., J Geriatr Oncol, 6(2):133-40 (2015)

Shayne, et al., Cancer, 110(7):1611-20 (2007)

Sharma, et al., J Clinical Oncology, 32(3 Suppl.): 562 (2014)

Chang, et al., Cancer Chemother Pharmacol., 75(3):579-86 (2015)

Roy, et al., Annals of Oncology, 24(6):1567-73 (2013)

Slingerland, et al., Drug Discov Today, 17(3-4):160-66 (2012)

Chen, et al., J Clin Oncol, 26(15 Suppl.):2565 (2008)

Kim, et al., Cancer Res., 72(14 Suppl.): A41 (2012)

Hann, et al., Cancer Res, 67(9 Suppl.): 5648 (2007)

U.S. Non-Provisional Patent Application No. 62/343,313 to Bayever et al.

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National Cancer Institute, "FDA Approves Irinotecan Liposome..." (2015)

Declaration of Dr. Mark Retain

Petition: as filed

Notice: Power of Attorney