Big Molecule Watch
February 21, 2024

PTAB Institutes Celltrion and Biocon IPRs on Regeneron Aflibercept Dosing Patent

Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s U.S. Patent 11,253,572 (“the ’572 patent”) and joined the two IPR proceedings with a pending IPR proceeding filed by Samsung Bioepis Co., Ltd (IPR2023-00884), which had previously been instituted on November 17, 2023.

The ’572 patent issued on February 22, 2022, and is generally directed to methods for treating angiogenic eye disorders by sequentially administering multiple doses of aflibercept to a patient.  Celltrion’s petition (IPR2024-00260), filed on December 14, 2023, challenged the patentability of all 30 claims of the ’572 patent.  Four days later, Biocon filed a petition (IPR2024-00298), also challenging all claims of the ’572 patent.  Celltrion and Biocon both moved for joinder of their petitions with Samsung’s pending IPR.  Celltrion and Biocon’s petitions included the same arguments and the same combinations of prior art as were advanced in Samsung’s IPR petition.  Those arguments contained a mixture of anticipation and obviousness bases for unpatentability.

On January 26, 2024, the PTAB panel held a conference call between Celltrion, Biocon, Samsung, and Regeneron, at which time Regeneron informed the PTAB panel that it would not oppose the pending motions for joinder.  Regeneron also informed the PTAB panel that it waived its right to file a preliminary response to Celltrion and Biocon’s IPR petitions.  A few days later, the PTAB panel instituted Celltrion and Biocon’s IPR petitions for the same reasons as Samsung’s IPR petition and joined the three IPR proceedings together.  The proceedings are now consolidated as IPR2023-00884.

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