The global patent priority split evaluating whether transferring prokaryotic guide-RNA CRISPR systems into eukaryotic human cells was obvious under 35 U.S.C. § 103.
The definitive Supreme Court rule holding that naturally occurring DNA sequences (such as BRCA1/BRCA2) are unpatentable products of nature, whereas synthetic cDNA remains eligible.
Governing Federal Circuit authority establishing eukaryotic gene-editing patent priority.
Editorial assessment, not a commercial citator result. Verify against the primary source before relying on it.
Adapting bacterial CRISPR mechanisms to eukaryotic mammalian cells represents a non-obvious patentable invention.
Therapeutic biotech companies require separate commercial licenses for fundamental CRISPR mechanisms and human-cell delivery systems.
Binding Federal Circuit Precedent
“Substantial evidence supported the PTAB's determination of no interference-in-fact. Eukaryotic application of CRISPR-Cas9 was a non-obvious inventive leap requiring separate patent claims from generic prokaryotic gene editing.”
UC Berkeley (Doudna/Charpentier) first demonstrated CRISPR-Cas9 gene editing in bacterial/prokaryotic cells in vitro. Broad Institute (Feng Zhang) subsequently engineered eukaryotic adaptations enabling CRISPR-Cas9 to edit plant, mouse, and human cells, securing accelerated patents.
On appeal from the Patent Trial and Appeal Board (PTAB) interference proceeding (Interference No. 106,048).
Issue: Whether adapting prokaryotic CRISPR-Cas9 gene editing to eukaryotic human cells was obvious to a person of ordinary skill in the art under 35 U.S.C. § 103.
Broad v. UC Berkeley is the definitive precedent governing patent interference and obviousness in gene editing, creating dual licensing requirements for human genetic therapies.
Regents of the Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286 (Fed. Cir. 2018).
