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So when an edible biologic appears, even with compelling
data, the reflex is to hesitate. Better to wait for more trials.
Better to watch someone else take the risk. Better to stay
within the framework that’s already legally and politically
safe.

And that caution—understandable as it may be—becomes a
barrier. Not to safety. But to access.

Because until the FDA and its global counterparts create
explicit pathways for edible biologics, developers are left
walking blind through a system that wasn’t built for them.

Regulatory limbo isn’t about bad science. It’s about
outdated structure.

And until that structure evolves, edible biologics will
remain stuck—not because they’re ineffective, but
because the rules were written before the plants got
involved.

6.3 – Intellectual Property Disruption

In the world of traditional biologics, intellectual property is
the fortress. Every therapeutic monoclonal antibody, every
cell line, every purification step is layered with patents—
filings that protect not just the molecule, but the method,
the delivery system, and the manufacturing process. This is
how pharmaceutical companies maintain exclusivity and
pricing power long after the original discovery.

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