CRISPR Patent Ownership: CVC, Broad, and the Global Landscape
Takeaway: The fractured CRISPR patent landscape, with CVC and the Broad Institute holding key patents in different jurisdictions, means startups must perform meticulous global due diligence and potentially license from multiple entities to secure true freedom-to-operate.
The battle for CRISPR patent rights between the University of California (CVC) and the Broad Institute is not just a U.S. affair. It’s a complex, high-stakes chess match being played out in patent offices around the world, with different outcomes in different jurisdictions. For a synthetic biology company with global ambitions, understanding who owns what—and where—is absolutely critical. A license that gives you freedom-to-operate in the United States may not protect you in Europe or Asia.
This fragmented ownership creates a complex map that every founder in the space must navigate. While the situation is constantly evolving, here is a general overview of the global landscape.
The United States: A Split Decision
As discussed previously, the U.S. has seen a "split decision" that has favored both sides in different ways.
The Broad Institute: The USPTO granted the Broad Institute the first foundational patents covering the use of CRISPR/Cas9 specifically in eukaryotic cells. This is a powerful position, as most high-value commercial applications (like human therapeutics) involve eukaryotic systems. The U.S. courts have repeatedly upheld the validity of these patents, ruling that this was a non-obvious invention distinct from the earlier work of the CVC group.
CVC (UCB/University of Vienna/Charpentier): After a long fight, CVC was eventually granted patents in the U.S. as well. Their claims are generally seen as broader, covering the use of the CRISPR/Cas9 system in any environment, not just eukaryotes. This gives them a strong position for applications in prokaryotes (e.g., engineering microbes for industrial biotechnology) and potentially creates overlapping rights in the eukaryotic space that are still being contested.
The U.S. bottom line: For most commercial applications in the U.S., particularly in therapeutics, companies often need to negotiate licenses with both the Broad Institute and CVC to ensure they have clear freedom-to-operate.
Europe: A Different Outcome
The European Patent Office (EPO) has largely taken a different view, tending to favor the CVC group.
The EPO has granted broad patents to CVC that cover the use of CRISPR/Cas9 across all cell types, viewing their initial invention as foundational.
Conversely, the Broad Institute has faced significant challenges with its key European patents, with some being revoked on technical grounds related to filing deadlines and priority claims.
The European bottom line: In Europe, a license with the CVC group is generally seen as the most critical piece of the puzzle for securing freedom-to-operate.
Asia: A Mixed and Evolving Picture
The patent battles are also raging in key Asian markets like China and Japan, with both sides securing victories.
Both CVC and the Broad Institute have been granted patents in these jurisdictions.
The specific claims and the strength of each party's position can vary, requiring in-depth, country-by-country analysis.
Implications for a SynBio Startup
This complex and geographically fragmented patent landscape has profound strategic implications for your company:
Global FTO is Essential: You cannot assume that a U.S.-focused freedom-to-operate analysis is sufficient if you have any plans for international markets. You must conduct separate analyses for Europe and any other key jurisdictions you plan to enter.
Budget for Multiple Licenses: Your business plan and financial model must account for the reality that you may need to pay significant licensing fees to multiple patent holders to commercialize a single product globally. This "royalty stacking" can have a major impact on your cost of goods and overall profitability.
The Landscape is Still Evolving: The legal battles over CRISPR are far from over. New court decisions and patent grants continue to shift the landscape. Your IP strategy must be dynamic, with ongoing monitoring of the global patent situation.
Navigating the CRISPR patent world is a daunting task, but it is a core requirement for any company building in this space. It demands a sophisticated global IP strategy and a clear-eyed understanding that securing the rights to this transformative technology requires careful negotiation on multiple fronts.
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.