One Battle After Another: Broad Institute Wins at PTAB in CRISPR Dispute
Eric Furman, Ph.D. & Alistair J. McIntyre
Interference proceedings, though increasingly rare, are heavily evidence-based and determine which party is the first inventor when two or more applicants claim the same patentable invention. Sometimes, an inventor’s own documents can be damaging to a claim of prior invention.
FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Robert J. Hilton, Ph.D. & Susan M. Janicki, Ph.D.
The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges.
Well-Known Genus, Novel Method: A Post-Amgen Framework for Written Description & Enablement
Justin Culbertson, Ph.D. & Jason J. Jardine
Recent Federal Circuit decision draws a meaningful distinction between patents that claim a broad genus as the invention itself and those that claim a novel therapeutic method using a well‑known genus, signaling that method‑of‑use claims tied to specific treatments may face a narrower written‑description and enablement burden.
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