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But edible biologics pose a fundamental challenge to
that system.

Because in the plant-based world, what matters most isn’t
just the protein—it’s the context. The plant becomes part of
the formulation. The line between product and process,
between expression and delivery, begins to blur. And that
blurring makes traditional IP strategies much harder to
enforce.

1. Genes Are Easy to Copy—Environments Are Not

In the edible model, the therapeutic agent is often a gene
sequence—something that can be synthesized, optimized,
and inserted into a plant. Once published or leaked, genetic
sequences are virtually impossible to protect. Unlike small
molecules, which require synthetic finesse, or monoclonals,
which involve proprietary cell lines, genes are digital code.

Anyone with a sequence and the right vector can reproduce
the protein—at least in theory.

So where is the moat?

In conventional biologics, patent strategy revolves around
the gene sequence: the monoclonal antibody’s variable
region, the engineered Fc domain, the nucleotide sequence
optimized for CHO cell expression. Control the sequence,
and you control the product.
But in plant-based biologics, that strategy falls apart. Why?

Because the therapeutic effect doesn’t come from the gene
alone—it comes from the entire expression ecosystem that
surrounds it.

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