The Israeli Patent Office issued a significant ruling on Patent Application No. 204013, partially revoking Amgen’s broad claims covering PCSK9-targeting antibodies used to lower LDL cholesterol.
The Dispute
Amgen applied for a patent on monoclonal antibodies that bind to PCSK9, a protein involved in cholesterol regulation. Blocking PCSK9 prevents the degradation of LDL receptors, thereby reducing “bad” cholesterol levels.
Sanofi opposed the patent, asserting that:
- The scientific community already knew that inhibiting PCSK9 could lower LDL levels.
- The patent claims were overly broad, attempting to cover all PCSK9-targeting antibodies.
- The invention lacked sufficient inventive step, as antibody development against known targets was an expected research direction.
The Decision
The Israeli Patent Office ruled in favor of Sanofi’s opposition in part, finding that:
- The general concept of inhibiting PCSK9 to reduce cholesterol was already established in prior scientific literature.
- Not all of Amgen’s claimed antibodies were sufficiently distinct to justify broad patent protection. Specifically, the patent protection was limited to 26 fully described antibodies, with broader claims being rejected.
- As a result, certain broad claims were revoked, while others—specifically covering antibodies with demonstrated advantages— remained .
This ruling highlights Israel’s strict approach to pharmaceutical patentability, emphasizing that broad antibody claims must be supported by clear inventive merit and detailed structural descriptions of the claimed antibodies