The uncertain future of antibody claims


Benjamin Pelletier

The uncertain future of antibody claims

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Amgen v Sanofi continues the Federal Circuit’s trend of undermining certain antibody claims, explains Benjamin Pelletier of Haynes and Boone.

A long string of decisions from the US Court of Appeals for the Federal Circuit has undermined support for purely functional antibody epitope claims through the written description and enablement requirements of 35 USC §112. 

The latest chapter in this series of cases, Amgen v Sanofi, Aventisub, issued in February, appears to place the final nail in the coffin of these highly valuable claims. 

In Amgen, the patents in suit (US nos 8,829,165 and 8,859,741) are based on Amgen’s discovery that a protein ligand, called PCSK9, binds to and disables low density lipoprotein (LDL, or “bad cholesterol”) receptors, and that this ligand/receptor interaction can be blocked by antibodies that bind to a specific epitope on PCSK9, thereby helping patients achieve better cholesterol levels. 

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