PFIZER, INC.

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New BPCIA Complaint: Genentech Files Suit Against Tanvex Regarding Its Proposed Herceptin Biosimilar

06/06/2022 | 12:09pm EDT

Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex's submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab). Genentech asserts that Tanvex's process for manufacturing TX05 infringes three patents: U.S. Patent No. 10,662,237, generally directed to viral filtration methods, and U.S. Patent No. 10,808,037 and U.S. Patent No. 8,574,869, both of which are generally directed to methods to inhibit reduction of disulfide bonds by sparging pre-harvest or harvest cell culture fluid. Genentech states in its complaint that the parties exchanged information under the BPCIA and agree upon the three patents to litigate. Genentech seeks a declaration of infringement, and monetary damages in the event Tanvex imports, manufactures or launches TX05 in the United States before expiration of the asserted patents.

This is Genentech's fifth BPCIA litigation against a trastuzumab biosimilar developer. Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars. In 2017, Genentech also reached a settlement with Mylan in relation to Genentech's patents for HERCEPTIN (trastuzumab), in which Mylan agreed to withdraw two IPR challenges. Each company has commercially launched their trastuzumab biosimilars in the United States-Amgen launched KANJINTI (trastuzumab-anns) in July 2019, Mylan launched OGIVIRI (trastuzumab-dkst) in December 2019, Pfizer launched TRAZIMERA (trastuzumab-qyyp) in February 2020, Teva launched HERZUMA (trastuzumab-pkrb) in March 2020, and Samsung Bioepis launched ONTRUZANT (trastuzumab-dttb) in April 2020.

Stay tuned to Big Molecule Watch for developments on this new BPCIA case.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Kevin DeJong
Goodwin Procter LLP
100 Northern Avenue
Boston
MA 02210
UNITED STATES
Tel: 212813 8800
E-mail: JScalzi@goodwinlaw.com
URL: www.goodwinprocter.com

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Financials (USD)
Sales 2022 102 B - -
Net income 2022 32 675 M - -
Net cash 2022 11 522 M - -
P/E ratio 2022 8,85x
Yield 2022 3,25%
Capitalization 280 B 280 B -
EV / Sales 2022 2,64x
EV / Sales 2023 3,35x
Nbr of Employees 79 000
Free-Float 59,0%
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Albert Bourla Chairman, Chief Executive & Operating Officer
David M. Denton Chief Financial Officer & Executive Vice President
Mikael Dolsten Executive VP, President-Research & Development
Lidia L. Fonseca Executive VP, Chief Digital & Technology Officer
Aida Habtezion Chief Medical Officer
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