Broad Institute, Inc. v. Regents of the University of California

903 F.3d 1286 (Fed. Cir. 2018)· Docket No. 17-2065· Opinion by Judge Kimberly A. Moore (3-0 (Unanimous))

Ontological Knowledge Graph Fingerprint

Synthetic Biology, Genetics & Bio-Jurisprudence

Niche Legal Sub-Discipline Tags:

#crispr-germline-patent-gateActive Circuit Split

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.

↳ Statutory Hook: 35 U.S.C. § 102 & § 103 (Interference Priority)

#natural-gene-isolation-barConstitutional Bar

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.

↳ Statutory Hook: 35 U.S.C. § 101 (Product of Nature Doctrine)

Ontologically Correlated Precedents (1):Sorted by Shared Sub-Discipline Alignment

AMP v. Myriad Genetics100% MATCH

#natural-gene-isolation-bar#crispr-germline-patent-gate

Supreme (2013)Inspect Precedent

GOOD LAW · BINDING AUTHORITY

Governing Federal Circuit authority establishing eukaryotic gene-editing patent priority.

OPERATIVE SIGNALS & RISK DISSECTION

BINDING PRECEDENT

Operative Judicial Rule

Adapting bacterial CRISPR mechanisms to eukaryotic mammalian cells represents a non-obvious patentable invention.

Practical Tech Impact

Therapeutic biotech companies require separate commercial licenses for fundamental CRISPR mechanisms and human-cell delivery systems.

Precedential Standing & Risk

Binding Federal Circuit Precedent

Formal Judicial Holding:

“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.”

Factual Background:

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.

Procedural Posture & Issue:

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.

Judicial Reasoning & Statutory Construction

1.Lack of Reasonable Expectation of Success: The cellular environment of eukaryotes (chromatin structure, nuclear membranes) presented unpredictable technical hurdles.
2.Separate Inventions: A generic discovery in bacteria does not automatically anticipate successful eukaryotic human gene editing.

Doctrinal Significance & Precedential Legacy:

Broad v. UC Berkeley is the definitive precedent governing patent interference and obviousness in gene editing, creating dual licensing requirements for human genetic therapies.

Statutory Hooks & Precedents Cited:

35 U.S.C. § 10335 U.S.C. § 102KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)

Downstream Impact:

Created a bifurcated global patent landscape for CRISPR therapeutics (Vertex, Editas, CRISPR Therapeutics).Standard test for translating bacterial and computational biotech models into mammalian clinical applications.

Canonical Bluebook / APA Citation:Official CourtListener / Justia Repository

Broad Inst., Inc. v. Regents of the Univ. of Cal., 903 F.3d 1286 (Fed. Cir. 2018).