IPWatchdog

Rare Disease Treatment Patents after Amgen: Can Claims Cover Untested Genetic Mutations?

On October 14, 2026, the Food and Drug Administration (FDA) announced the Rare Disease Framework Initiative. The goal of this effort is quite essential for patients with rare (orphan) diseases – to develop an approach for assessing medicines for orphan diseases with a focus on the evidence that can be gathered for this assessment. The FDA proposes to include disease characteristics, patient needs, patient population size, and characteristics of orphan medications. The initiative does not itself

By IPWatchdog

1 min read
Rare Disease Treatment Patents after Amgen: Can Claims Cover Untested Genetic Mutations?
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