Samsung Bioepis Fails to Invalidate Regeneron Patents in S. Korea

Samsung Bioepis Fails to Invalidate Regeneron Patents in S. Korea
(Source: Samsung Bioepis)

Samsung Bioepis has faced setbacks in its attempt to invalidate two South Korean patents held by Regeneron Pharmaceuticals, Inc., as the Korean Intellectual Property Trial and Appeal Board (KIPTAB) issued decisions in October and November 2024, rejecting Samsung Bioepis's invalidation petitions.

The patents in question—KR1406811, covering "VEGF Antagonist Formulations Suitable for Intravitreal Administration," and KR1131429, titled "VEGF Traps and Therapeutic Uses Thereof"—remain intact following KIPTAB's rulings of partial dismissal and partial rejection. Samsung Bioepis had initiated the challenges in late 2022, with the board taking nearly two years to conclude the proceedings.

According to Regeneron, the '811 patent describes formulations of VEGF-specific fusion protein antagonists suitable for intravitreal injection, including stable liquid and lyophilizable forms. The protein antagonist is characterized by an amino acid sequence identified as SEQ ID NO:4. Meanwhile, the '429 patent focuses on nucleic acid molecules and multi-binding proteins that bind VEGF, with Regeneron asserting the utility of its VEGF traps in treating VEGF-related diseases through localized administration.

Both patents target VEGF inhibition technology, critical in developing treatments for ophthalmic conditions and systemic VEGF-related diseases, including cancer and inflammatory disorders.

In a parallel development, Samsung Bioepis filed an inter partes review (IPR) with the U.S. Patent Trial and Appeal Board (PTAB) in November 2024, challenging Regeneron's U.S. patent US11084865B2, which is part of the same family as the South Korean '429 patent. The outcome of this IPR could influence ongoing global disputes surrounding Regeneron's VEGF-related intellectual property portfolio.

▶Related Article: Samsung Bioepis Renews Bid To Invalidate Regeneron Eye Drug Patent (2025. 03. 22.)


By PatenTrip

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