Case Study: The Complexities of CRISPR/Cas9 Patent Disputes
Takeaway: The multi-billion dollar, decade-long legal battle over CRISPR/Cas9 ownership is the single greatest case study in biotech IP, teaching founders that even with Nobel Prize-winning science, who invented what—and where—is a complex legal question with profound commercial consequences.
No technology illustrates the high-stakes, complex, and often ferocious nature of biotech patent law better than CRISPR/Cas9. What began as a groundbreaking scientific discovery has morphed into a sprawling, global legal war between several major academic institutions, most notably the University of California, Berkeley (UCB or CVC) and the Broad Institute of MIT and Harvard.
The dispute is not just an academic turf war; it’s a battle to control a technology with the potential to revolutionize medicine, agriculture, and more, with billions of dollars in commercial licensing revenue on the line. For any synbio founder, understanding the core issues of this dispute is a masterclass in the nuances of patent law.
The Core of the Dispute: Who Invented What First?
At its heart, the CRISPR patent saga is about a simple question with a devastatingly complex answer: who first invented the use of the CRISPR/Cas9 system as a gene-editing tool in eukaryotic cells (the type of cells found in humans, animals, and plants)?
The CVC (UCB) Position: The team led by Jennifer Doudna (UCB) and Emmanuelle Charpentier was the first to publish, in a landmark June 2012 paper, how the CRISPR/Cas9 system could be used to cut DNA at a specific site in vitro (in a test tube). Their initial patent filing, based on this work, claimed the use of the system broadly across all cell types, both prokaryotic and eukaryotic. They argued that adapting the system to work in eukaryotic cells was an obvious next step for a person of ordinary skill in the field.
The Broad Institute Position: A team at the Broad Institute, led by Feng Zhang, was the first to publish evidence, in a January 2013 paper, that the system actually worked in eukaryotic cells. They filed a series of patent applications, taking advantage of an expedited review process, and were granted the first foundational patents covering this specific, commercially critical use case. They argued that successfully engineering the system to function in the complex environment of a eukaryotic cell was a significant, non-obvious inventive step.
The Legal Battlefield: Interference Proceedings
This conflict led to a series of "interference proceedings" at the U.S. Patent and Trademark Office (USPTO). An interference is a complex legal contest that was part of the old 'first-to-invent' U.S. patent system designed to determine which party was the first to invent a given technology.
The USPTO has, on multiple occasions, sided with the Broad Institute, concluding that their claims to the use of CRISPR/Cas9 in eukaryotes did not overlap with CVC's initial invention. The courts essentially ruled that knowing it could work in a test tube didn't make it obvious that it would work in a human cell. This has resulted in a fractured IP landscape where both institutions hold foundational, and seemingly conflicting, patent portfolios, leaving companies to navigate the uncertainty.
It is critical for founders to understand that this type of “interference proceeding” is now largely a relic of U.S. patent law. The CRISPR patents were filed under the old “first-to-invent” system. The America Invents Act (AIA), which took full effect in 2013, transitioned the U.S. to a “first-to-file” system, aligning it with the rest of the world. For any invention conceived of today, the battle is not over who invented it first, but who filed their patent application first. This makes the speed and strategy of your patent filings more critical than ever.
Key Lessons for SynBio Founders:
The CRISPR dispute is more than a legal drama; it offers critical, practical lessons:
The Importance of "Reduction to Practice": This case highlights a key patent law concept. An invention isn't just an idea; it's the successful demonstration of that idea working. Broad's ability to show the system working in eukaryotic cells—the actual "reduction to practice"—was a decisive factor in them being awarded their key patents.
Filing Strategy Matters: Broad's aggressive patent prosecution strategy, including using expedited examination, allowed them to get their patents granted quickly, giving them a powerful early position.
Breadth vs. Specificity: CVC's initial claims were incredibly broad. Broad's were narrower and more specific to the commercially relevant environment (eukaryotic cells). The courts, in this case, favored the specific, demonstrated use over the broader, more conceptual claim.
IP Due Diligence is Paramount: For any startup using CRISPR, this fractured landscape means that a thorough FTO analysis and potentially licensing IP from both major patent holders is a commercial necessity, adding significant cost and complexity.
Meticulous Record-Keeping is Your Shield: The entire interference was an evidentiary battle. The ability of both sides to produce dated, detailed lab notebooks and records was fundamental to their legal arguments. It's a powerful reminder that good 'legal hygiene' and documentation are critical for defending your inventions.
The CRISPR saga is a powerful reminder that in the world of deep tech, the battles for innovation are fought not only in the lab but also in the courtroom. The outcome of these legal fights can shape the direction of an entire industry for decades to come.
Disclaimer: This post is for general informational purposes only and does not constitute legal, tax, or financial advice. Reading or relying on this content does not create an attorney–client relationship. Every startup’s situation is unique, and you should consult qualified legal or tax professionals before making decisions that may affect your business.