1. Introduction

CRISPR patent disputes are legal conflicts concerning ownership, inventorship, priority, validity, infringement, licensing and commercial exploitation of inventions relating to CRISPR-Cas gene-editing technology.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a revolutionary gene-editing technology that allows scientists to modify DNA by targeting particular genetic sequences. The CRISPR-Cas9 system is widely used in biotechnology, pharmaceutical research, agriculture, disease treatment and genetic engineering.

The development of CRISPR technology has generated significant intellectual property disputes because several universities, research institutions and biotechnology companies have claimed patent rights over important aspects of the technology.

The most important legal controversy concerns the competing patent claims of:

The University of California, Berkeley.

The University of Vienna.

The Broad Institute of MIT and Harvard.

The biotechnology companies associated with commercial CRISPR licensing.

The central legal question is:

Who owns the patent rights to CRISPR technology, and who has the legal authority to commercialise inventions based on it?

CRISPR patent disputes are particularly important because patent ownership can determine who controls access to gene-editing technologies, who receives licensing revenue and whether competing companies can develop gene-editing therapies without infringing existing patents.

2. Legal Nature of CRISPR Patent Disputes

CRISPR patent disputes arise under several branches of intellectual property law.

A. Patent ownership disputes

These disputes concern which inventor, institution or company legally owns an invention involving CRISPR technology.

Questions include:

Who first developed the relevant inventive concept?

Who contributed to the invention?

Whether researchers assigned their patent rights to universities or employers.

Whether multiple institutions can claim ownership.

Whether contractual arrangements transfer patent rights.

B. Inventorship disputes

Inventorship is different from ownership.

An inventor is a natural person who contributed to the conception of the claimed invention. A university or biotechnology company may own the patent through assignment, but it cannot ordinarily be identified as the human inventor.

A dispute may arise when researchers disagree about whether their scientific contributions justify recognition as inventors.

C. Patent priority disputes

Priority disputes concern which patent application has the earlier legally recognised filing or priority date for the claimed invention.

Earlier filing does not automatically establish that an applicant invented the technology first. Priority depends on the applicable patent statute, entitlement to the priority claim and the requirements for adequate disclosure.

D. Patent infringement disputes

Infringement occurs when a person or company performs an act reserved to the patent owner without permission, subject to statutory exceptions.

CRISPR-related infringement may involve:

Manufacturing gene-editing components.

Using patented Cas enzymes.

Developing patented guide-RNA systems.

Commercialising protected gene-editing methods.

Producing genetically modified cells using patented techniques.

E. Patent validity disputes

A CRISPR patent may be challenged because the invention:

Is not novel.

Involves no inventive step.

Is insufficiently disclosed.

Does not enable the claimed invention.

Claims subject matter that is not patentable.

Has incorrect inventorship or entitlement.

Extends beyond the original disclosure.

3. Landmark CRISPR Patent Dispute: University of California v Broad Institute

Most important CRISPR patent dispute

United States · Patent Trial and Appeal Board and Federal Circuit

The dispute between the University of California (UC), the University of Vienna and Emmanuelle Charpentier (collectively CVC) and the Broad Institute, MIT and Harvard is the most significant patent-priority controversy in CRISPR technology.

A. Background of the dispute

In 2012, Jennifer Doudna and Emmanuelle Charpentier published groundbreaking research demonstrating that CRISPR-Cas9 could be programmed to cut DNA at specific locations.

Their research established an important foundation for programmable gene editing.

Subsequently, Feng Zhang and researchers associated with the Broad Institute developed and demonstrated CRISPR-Cas9 applications in eukaryotic cells, including cells of plants and animals.

Both research groups filed patent applications claiming important aspects of CRISPR technology.

The central dispute concerned whether CVC's earlier research and patent filings established priority over Broad's claims relating to the application of CRISPR-Cas9 in eukaryotic cells.

B. First major decision: Regents of the University of California v Broad Institute (2018)

Case: Regents of the University of California v Broad Institute, Inc., 903 F.3d 1286 (Fed. Cir. 2018).

The US Court of Appeals for the Federal Circuit upheld the Patent Trial and Appeal Board's determination that there was no interference-in-fact between the relevant claims in the first interference proceeding.

The court did not decide that Broad was the original inventor of all CRISPR technology.

Instead, it determined that the competing claims in that proceeding were sufficiently different that the statutory requirements for an interference were not satisfied.

Legal significance:

Patent claims must be compared carefully rather than treating an entire technology as one indivisible invention.

Different applications of the same scientific platform may support separate patent rights.

A patent dispute concerning one technical application does not necessarily determine ownership of every aspect of the underlying technology.

C. Second major decision: Regents v Broad Institute (2022)

In February 2022, the Patent Trial and Appeal Board decided a second interference proceeding involving CRISPR-Cas9 systems used in eukaryotic cells.

The PTAB found in favour of Broad on the relevant priority issue.

The decision concerned claims involving a CRISPR-Cas9 system using a single-guide RNA to edit or cleave DNA in eukaryotic cells.

The distinction between the original CRISPR discovery and its application in eukaryotic cells was central to the dispute.

Legal significance:

The case demonstrated that patent rights may depend on the particular technical application claimed, rather than simply on who first discovered the broader scientific principle.

D. Federal Circuit decision (2025)

Case: Regents of the University of California v Broad Institute, Inc., Nos. 22-1594 and 22-1653 (Fed. Cir. May 12, 2025).

The Federal Circuit partially affirmed and partially vacated the PTAB's decision.

It required the PTAB to reconsider priority under the correct legal standard, particularly in relation to conception and the evidence supporting the competing claims.

The court also affirmed the finding that CVC's earliest application lacked sufficient written-description support for the relevant invention.

Legal significance:

Patent priority requires evidence of conception of the claimed invention.

Scientific publications and patent disclosures must be assessed against the actual claims.

An early filing date does not automatically establish priority for subject matter inadequately disclosed in the application.

Patent offices must apply the correct legal standard when evaluating inventorship and priority evidence.

E. Latest development: PTAB decision of 26 March 2026

Important 2026 development

Following the Federal Circuit's remand, the PTAB reconsidered the dispute and again ruled in favour of Broad on the relevant priority question.

It concluded that CVC had not established conception of the relevant claimed embodiment before Broad's actual reduction to practice on 5 October 2012.

The decision concerned the particular interference claims, not every CRISPR patent held by CVC. UC's existing patents covering other CRISPR-Cas9 compositions and methods were not automatically cancelled by this decision.

Berkeley News+2

Overall legal principle: Patent priority is determined by the invention actually claimed and legally supported by the evidence, not simply by scientific reputation, the date of a landmark publication or the general discovery of a technology.

4. Important CRISPR Patent Disputes in Australia

Australia provides an important example of how CRISPR patent rights are examined through patent opposition proceedings, judicial review and statutory patentability requirements.

The principal legislation is the Patents Act 1990 (Cth).

A. ToolGen Incorporated v Fisher (No 2) [2023] FCA 794

Federal Court of Australia · 14 July 2023

This case concerned a ToolGen patent application relating to CRISPR-Cas9 genome editing in eukaryotic cells.

The dispute involved several fundamental patentability questions:

Whether the original priority document sufficiently disclosed the claimed invention.

Whether the invention could be performed by a skilled person.

Whether the claims were novel.

Whether the claims involved an inventive step.

Whether the patent specification adequately supported the claims.

Whether the proposed CRISPR technology required undue experimentation.

The Federal Court upheld important objections to the patent application.

In particular, the Court found that the earlier priority document did not provide an enabling disclosure of the relevant claimed invention and that the claims suffered from deficiencies concerning novelty, inventive step, clarity and support.

Legal significance:

This decision demonstrates that a biotechnology applicant cannot secure an earlier priority date merely by referring generally to a scientific technique.

The priority document must disclose the claimed invention sufficiently for a person skilled in the relevant field to perform it.

It also establishes the importance of scientific reproducibility and adequate technical disclosure in CRISPR patent applications.

CaseChat AU

B. ToolGen Incorporated v Fisher (No 3) [2024] FCA 539

Federal Court of Australia · 23 May 2024

This proceeding concerned an application to amend ToolGen's CRISPR patent application following difficulties with its prosecution and opposition history.

The dispute involved an alleged obvious mistake in the patent documentation and whether the proposed amendment could properly be allowed.

The Court considered the requirements governing amendments to patent specifications and the legal consequences of mistakes in patent documents.

Legal significance:

Patent applications must be drafted and maintained with technical accuracy.

Amendments are controlled by statutory requirements.

An alleged drafting mistake does not automatically justify any desired amendment.

Patent applicants must ensure that amendments remain legally permissible and do not introduce unsupported subject matter.

The case illustrates the procedural complexity of securing patent protection for CRISPR inventions.

Pearce IP

C. Australian CRISPR patent opposition landscape

Australian CRISPR patent disputes have also involved applications by ToolGen and Sigma-Aldrich.

Some patent claims have concerned:

RNA-guided endonucleases.

Single-guide RNA systems.

CRISPR-mediated DNA cleavage.

Insertion and substitution of genetic material.

Genome editing in eukaryotic cells.

The Australian patent opposition system allows challenges based on novelty, inventive step, sufficiency and other statutory requirements.

Importantly, the existence of a granted patent does not establish that every commercial use of CRISPR necessarily infringes it. The actual claims, territorial scope and conduct of the alleged infringer must be examined.

DLA Piper+1

5. Legal Framework Governing CRISPR Patents in India

India is particularly important because it has a growing biotechnology, pharmaceutical and agricultural research sector.

The principal legislation is the Patents Act, 1970, together with the applicable patent rules.

A. Section 2(1)(j): Definition of invention

An invention must constitute a new product or process involving an inventive step and be capable of industrial application.

A CRISPR invention may qualify if it satisfies these requirements.

Examples include:

A novel engineered Cas enzyme.

A new guide-RNA composition.

An improved gene-editing process.

A novel delivery mechanism for CRISPR components.

B. Section 2(1)(ja): Inventive step

An invention must involve a technical advance or economic significance, or both, and must not be obvious to a person skilled in the art.

A CRISPR patent application may be rejected where the claimed modification represents an obvious adaptation of existing gene-editing technology.

C. Section 3(c): Discovery of living things

The mere discovery of a scientific principle or a naturally occurring substance is not patentable.

Consequently, discovering a naturally occurring CRISPR sequence does not automatically create patent rights.

However, a genuinely engineered, novel and sufficiently disclosed technical invention may require separate consideration.

D. Section 3(i): Medical treatment methods

Methods of medicinal, surgical, curative, prophylactic, diagnostic or other treatment of human beings, and similar treatment of animals, fall within the statutory exclusion.

This is particularly relevant where a CRISPR patent claims a method of treating a genetic disease.

A distinction must be made between a therapeutic method and a patentable product or technical process that is not itself excluded.

E. Section 3(j): Plants and animals

Plants and animals in whole or any part thereof, other than microorganisms, are excluded, as are essentially biological processes for production or propagation of plants and animals.

Accordingly, claims relating to genetically modified plants or animals must be carefully assessed against this provision.

F. Section 3(b): Public order and morality

Inventions whose primary or intended use or commercial exploitation could be contrary to public order or morality, or cause serious prejudice to human, animal or plant life or health or the environment, may be excluded.

This provision may become relevant in disputes involving unsafe or ethically problematic genetic engineering inventions.

G. Section 10: Contents of patent specifications

Patent specifications must sufficiently and clearly describe the invention, its operation or use and the method by which it is performed.

For CRISPR technology, the specification may need to explain:

The relevant Cas protein.

The guide-RNA structure.

The target DNA sequence.

The editing mechanism.

Experimental procedures.

Reproducibility and technical limitations.

H. Section 48: Rights of patentees

A patent owner has exclusive rights, subject to the Act, to prevent unauthorised third parties from making, using, offering for sale, selling or importing the patented product in India, or using a patented process and exploiting the resulting product.

I. Section 107: Defences in infringement proceedings

The grounds available under Section 107 include the grounds on which a patent may be revoked under Section 64.

This allows defendants to challenge the validity of patents in infringement litigation.

J. Section 107A: Certain acts not to be considered infringement

The statutory Bolar exception and specified parallel-import provisions are relevant.

In particular, certain acts undertaken solely for uses reasonably related to developing and submitting information required under regulatory law are protected.

This can be important for pharmaceutical and biotechnology research.

6. Other Important Patent Law Cases Relevant to CRISPR Disputes

Although these cases do not all concern CRISPR directly, their principles are highly relevant to disputes involving biotechnology patents.

A. Diamond v Chakrabarty, 447 U.S. 303 (1980)

Court: Supreme Court of the United States.

The dispute concerned whether a genetically engineered microorganism could be patented.

The Court held that a human-made microorganism with markedly different characteristics from naturally occurring organisms could constitute patentable subject matter.

Importance for CRISPR:

Distinguishes natural discoveries from human-engineered inventions.

Supports patent protection for qualifying engineered biological materials.

Establishes an important foundation for biotechnology patent law.

B. Association for Molecular Pathology v Myriad Genetics, Inc., 569 U.S. 576 (2013)

Court: Supreme Court of the United States.

The dispute concerned patents over isolated human DNA and synthetic DNA.

The Court held that naturally occurring DNA does not become patentable merely because it has been isolated. However, complementary DNA (cDNA) may be patentable where it is not naturally occurring in the relevant form.

Importance for CRISPR:

A naturally occurring DNA sequence cannot automatically be claimed as a patentable invention merely because scientists have identified or isolated it.

Engineered CRISPR components must be evaluated according to their actual technical characteristics and applicable patentability requirements.

C. Mayo Collaborative Services v Prometheus Laboratories, Inc., 566 U.S. 66 (2012)

Court: Supreme Court of the United States.

The Court considered patent claims involving the relationship between drug metabolite levels and the appropriate dosage of medication.

It held that claims directed to a natural law cannot become patentable merely by adding conventional or routine steps.

Importance for CRISPR:

A patent applicant cannot obtain exclusive rights over a natural biological relationship simply by incorporating routine laboratory procedures.

The claimed invention must contain a patentable technical contribution.

D. Amgen Inc. v Sanofi, 598 U.S. 594 (2023)

Court: Supreme Court of the United States.

The dispute concerned the enablement requirement for patents claiming a broad class of antibodies.

The Court held that patent claims must be sufficiently enabled across their full scope.

Importance for CRISPR:

This principle is particularly important when applicants claim:

All CRISPR-Cas systems.

Multiple Cas protein variants.

Broad categories of guide RNAs.

Numerous genetic targets.

Different organisms and cellular environments.

A patent cannot necessarily claim a vast technological field based on a limited number of disclosed examples.

E. Regents of the University of California v Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)

Court: US Court of Appeals for the Federal Circuit.

This case concerned written-description requirements for biotechnology patent claims.

The Court emphasised that a patent specification must demonstrate that the inventor possessed the claimed invention at the relevant time.

Importance for CRISPR:

An applicant must demonstrate possession of the claimed CRISPR invention rather than merely express an aspiration to develop a particular gene-editing system.

F. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46

Court: House of Lords, United Kingdom.

The case concerned patent construction and infringement involving recombinant erythropoietin.

The House of Lords examined how patent claims should be interpreted in the context of the specification and relevant technical knowledge.

Importance for CRISPR:

The precise language of patent claims is critical. Courts must determine whether the accused gene-editing technology falls within the properly construed claims.

7. Major Grounds for Challenging CRISPR Patents

8. CRISPR Patent Infringement and Commercial Liability

CRISPR patent infringement can arise when a biotechnology company commercially exploits patented technology without an appropriate licence.

A. Direct infringement

Direct infringement may occur where a company manufactures or commercially uses a patented CRISPR composition or process without permission.

For example, a pharmaceutical company may use a patented Cas9 system to manufacture genetically edited cells for commercial distribution.

Whether infringement exists depends on the patent claims and applicable national law.

B. Indirect infringement

Indirect infringement may involve supplying components or facilitating another person's infringement.

For example, a company might supply specialised guide-RNA components knowing that they are intended for an infringing commercial process.

The legal requirements for indirect infringement vary between jurisdictions.

C. Research and experimental-use disputes

An important question is whether CRISPR research conducted by universities and laboratories falls within a research exemption.

The position differs across jurisdictions:

United States: The experimental-use defence is narrow, although statutory safe harbours may apply in specified circumstances.

Australia: Section 119C of the Patents Act 1990 provides an experimental-use defence for qualifying acts.

India: Section 47(3) permits use of patented inventions for experiment or research, including imparting instruction to pupils.

D. Licensing disputes

CRISPR technology is often commercially exploited through licensing arrangements.

Licensing disputes may concern:

Royalty calculations.

Exclusive and non-exclusive rights.

Field-of-use restrictions.

Sublicensing arrangements.

Patent ownership representations.

Improvements developed by licensees.

Termination of licences.

Rights to commercialise therapeutic applications.

E. Patent thickets and overlapping rights

A patent thicket exists where multiple overlapping patents cover different elements of a technological platform.

CRISPR commercialisation may require rights relating to Cas proteins, guide RNAs, delivery systems, cell engineering and particular therapeutic applications.

Consequently, a company may need multiple licences to develop a single commercial product.

9. Ethical and Public-Interest Dimensions of CRISPR Patent Disputes

CRISPR patent disputes are not merely commercial disagreements. They also raise questions about access to important medical technologies.

A. Access to life-saving treatment

Excessive licensing costs may increase the price of gene-editing therapies.

B. Publicly funded research

Where public universities and government-funded institutions develop CRISPR technologies, disputes arise over whether private commercial control is consistent with public research objectives.

C. Genetic inequality

Exclusive control over gene-editing technology may create unequal access to advanced treatments.

D. Agricultural biotechnology

Patent disputes involving genetically modified crops can influence agricultural research, seed markets and farmers' access to improved varieties.

E. Human germline editing

Patent ownership does not automatically confer regulatory permission to perform human germline editing. Patent law and bioethical regulation operate independently.

F. Competition law

Exclusive licensing and restrictive contractual arrangements may raise competition concerns where they substantially restrict access to essential research or commercial markets.

10. Important Indian Case Laws Relevant to CRISPR Patent Disputes

A. Novartis AG v Union of India (2013) 6 SCC 1

Court: Supreme Court of India.

The Court rejected a patent application relating to a new form of an existing pharmaceutical substance because the requirements of Section 3(d) were not satisfied.

Application to CRISPR: A minor modification of an existing Cas protein or gene-editing composition cannot automatically justify a fresh patent. The applicant must demonstrate the required novelty, inventive step and patentability.

WIPO+1

B. Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries (1979) 2 SCC 511

Court: Supreme Court of India.

The Court explained the principles of inventive step and obviousness in patent law.

A mere workshop improvement or ordinary modification of existing technology is insufficient to establish an inventive step.

Application to CRISPR: A routine modification of guide RNA or an existing Cas enzyme may not qualify for patent protection if it would be obvious to a skilled biotechnology researcher.

WIPO+1

C. Monsanto Technology LLC v Nuziveedu Seeds Ltd. (2019) 3 SCC 381

Court: Supreme Court of India.

The dispute involved genetically modified cotton seeds incorporating Monsanto's patented Bt technology and the relationship between patent rights and plant variety legislation.

The Supreme Court set aside the High Court's decision and remanded the matter for consideration on the merits.

Application to CRISPR: This case is relevant to disputes involving genetically edited agricultural products, patent protection for biotechnology inventions and the interaction between patent law and plant variety legislation.

It also demonstrates why agricultural biotechnology disputes may involve multiple regulatory and intellectual property regimes.

11. Remedies Available in CRISPR Patent Disputes

In India, relevant provisions include Sections 25, 48, 64, 84, 104, 108 and 107A of the Patents Act, 1970.

12. International Comparison of CRISPR Patent Protection

A particularly important distinction is that patent rights are territorial. A decision concerning priority in the United States does not automatically determine patent ownership in Australia, India or Europe.

13. Critical Legal Issues and Emerging Challenges

The future of CRISPR patent litigation will involve several difficult legal questions.

1. AI-assisted inventorship: Whether researchers using artificial intelligence to identify gene-editing systems can establish human inventorship.

2. Multi-institutional ownership: How patent rights should be allocated when researchers from different universities collaborate.

3. Gene-editing delivery systems: Whether separate patents over delivery mechanisms create overlapping commercial monopolies.

4. Broad functional claims: Whether a patent applicant can claim an entire class of gene-editing technologies based on limited experimental evidence.

5. Research accessibility: Whether restrictive licences interfere with scientific research and development.

6. CRISPR-based medicines: Whether companies developing gene therapies require multiple licences covering different technological components.

7. Genetic data and patent rights: How commercial exploitation of genetic information interacts with privacy, consent and intellectual property law.

8. Human germline editing: Whether patents involving reproductive genetic modification should receive protection in light of public policy and ethical restrictions.

14. Conclusion

CRISPR patent disputes demonstrate the complexity of protecting scientific discoveries through intellectual property law.

The dispute between the University of California and the Broad Institute illustrates that patent priority depends on the particular invention claimed, the evidence of conception and the adequacy of the original patent disclosure.

The Australian decisions in ToolGen Incorporated v Fisher demonstrate the importance of sufficiency, enablement, novelty and inventive step in biotechnology patent applications.

Indian decisions such as Novartis v Union of India, Bishwanath Prasad v Hindustan Metal Industries and Monsanto v Nuziveedu Seeds provide important principles for determining whether CRISPR-related inventions deserve patent protection.

Ultimately, the law must balance three competing interests:

Protecting genuine scientific innovation and rewarding inventors.

Preventing unjustified monopolies over fundamental biological technologies.

Ensuring affordable access to important medical and agricultural innovations.

The central legal principle is that CRISPR technology is not automatically owned by the first researcher to publish a scientific discovery. Patent ownership must be established through valid claims, proper inventorship, legally supported priority, sufficient disclosure and compliance with the applicable national patent legislation.

Research note: The cited CRISPR-specific proceedings are primarily US and Australian decisions. The Indian judgments discussed above establish analogous patent-law principles; they are not direct judgments deciding ownership of CRISPR-Cas9 patents.

15. Important Authorities for Academic and Legal Research

Regents of the University of California v Broad Institute, 903 F.3d 1286 (Fed. Cir. 2018).

Regents of the University of California v Broad Institute, Nos. 22-1594 and 22-1653 (Fed. Cir. 2025).

PTAB, Interference No. 106,115, decision of 26 March 2026.

ToolGen Incorporated v Fisher (No 2) [2023] FCA 794.

ToolGen Incorporated v Fisher (No 3) [2024] FCA 539.

Diamond v Chakrabarty, 447 U.S. 303 (1980).

Association for Molecular Pathology v Myriad Genetics, 569 U.S. 576 (2013).

Amgen Inc. v Sanofi, 598 U.S. 594 (2023).

Novartis AG v Union of India (2013) 6 SCC 1.

Monsanto Technology LLC v Nuziveedu Seeds Ltd. (2019) 3 SCC 381.

Useful primary and research sources:

US Federal Circuit judgment – Regents v Broad (2025).

2026 PTAB decision – Berkeley News report.

ToolGen v Fisher (No 2) – Australian judgment.

CRISPR/Cas patent disputes – Australian legal analysis.

Novartis v Union of India – WIPO Lex.