The Amgen shadow
Amgen v. Sanofi raised the enablement bar for genus claims in a way that reverberated beyond antibodies. Materials, catalysts, and small-molecule libraries are all feeling the pressure. Three drafting patterns are holding up on the exam and in post-grant review.
Pattern 1 — Structural genus with disclosed representatives
Instead of a functional genus, claim a structural genus with 10-20 fully characterised representatives across the claimed space, plus a mechanistic rationale for why the structural feature drives the function.
Pattern 2 — Function-plus-screen
Claim the function but disclose a screening protocol that a POSITA can run without undue experimentation. Courts have accepted this where the screen is described with enough specificity to be reproducible.
Pattern 3 — Narrow-and-continue
File the narrow, fully enabled species first; keep a continuation open for the broader genus as the data matures. Slower, but survives challenge.
