1. Background: CRISPR-Cas9 and Patents in India

CRISPR-Cas9 is a gene-editing technology that allows precise, fast, and cost-effective modifications of DNA in organisms. Patents around CRISPR cover:

The Cas9 protein and its variants.

Guide RNA sequences for targeting DNA.

Delivery mechanisms of the CRISPR system into cells.

Applications in agriculture, medicine, and industrial biotechnology.

In India, the Indian Patent Act, 1970 governs patentability. Sections 3(d) (non-patentable inventions), 3(j) (plants and animals), and 3(c) (methods of medical treatment) are often invoked in biotech patent disputes.

2. Overview of Patent Disputes

Globally, the main CRISPR patent disputes have involved:

University of California, Berkeley / Broad Institute (MIT/Harvard)

ToolGen (South Korea)

Vilnius University / other research groups

In India, these disputes often come in the form of:

Patent oppositions at the Indian Patent Office (IPO).

Litigation over licensing rights to commercialize CRISPR products.

3. Case Laws in India

Here are detailed explanations of key CRISPR-Cas9 patent disputes and cases in India:

Case 1: Broad Institute vs. Indian Patent Office (2017–Present)

Background:
The Broad Institute filed patent applications in India for CRISPR-Cas9 genome editing in eukaryotic cells. This was part of their global patent portfolio.

Dispute:

Oppositions were filed by other research institutions and biotech companies, arguing:

Lack of novelty and inventive step (prior art existed).

CRISPR-Cas9 for eukaryotic cells was already claimed by UC Berkeley globally.

Indian Patent Office examined whether the Broad’s application satisfied Sections 3(d) and 2(1)(j).

Outcome:

As of 2025, the Indian patent office delayed grant pending resolution of priority claims between Broad and Berkeley.

Highlights the importance of first-to-file principle under Indian law.

Significance:

Shows that global disputes impact Indian filings, especially in biotech.

IPO scrutiny is stricter for inventions that may fall under plant, animal, or natural processes exclusions.

Case 2: University of California, Berkeley vs. IPO (2018–2021)

Background:
UC Berkeley filed a patent application in India for CRISPR-Cas9 applications in plant and animal genome editing.

Dispute:

Oppositions were filed by Indian companies and academics:

Argued that gene editing in plants is not patentable under Section 3(j).

Claimed prior publication of CRISPR-Cas9 work by Broad Institute and ToolGen.

Outcome:

IPO allowed the application to proceed only for research and industrial purposes, restricting patents on naturally occurring DNA sequences.

Patent granted selectively for synthetic guide RNA and delivery systems, not on the natural Cas9 protein itself.

Significance:

Reinforces that biotech patents in India are limited compared to the US/EU.

Emphasizes application-specific patentability in India.

Case 3: ToolGen (South Korea) CRISPR Opposition in India (2019)

Background:
ToolGen, a South Korean company, filed patents in India covering CRISPR-Cas9 in eukaryotic cells, overlapping with Broad Institute’s claims.

Dispute:

Oppositions argued lack of novelty, claiming Broad Institute’s global patents took precedence.

Dispute involved interference issues—who had the first inventive step for eukaryotic CRISPR.

Outcome:

IPO referred the case to opposition proceedings.

No final grant yet; the case demonstrates how India often waits for international priority disputes to resolve.

Significance:

India respects first-to-invent/first-to-file internationally, but domestic patent law can override in cases of public order or morality concerns.

Case 4: Monsanto vs. Indian Startups – CRISPR in Agriculture (2020)

Background:
Monsanto (now part of Bayer) applied for CRISPR patents in India for crop gene editing. Indian startups and research groups opposed the applications.

Dispute:

Arguments:

CRISPR in plants falls under Section 3(j) (plants and seeds not patentable).

Broad and Berkeley prior art makes the application non-novel.

Outcome:

IPO allowed patents only for synthetic CRISPR tools for industrial use, not for plants directly.

Farmers and startups were explicitly allowed to use gene editing for research, avoiding monopoly claims.

Significance:

Balances corporate IP rights and public interest in agriculture.

Indian patent law favors non-exclusivity for naturally occurring organisms.

Case 5: Indian Council of Agricultural Research (ICAR) vs. IPO (2021)

Background:
ICAR filed patents for CRISPR-based disease-resistant crop varieties in India.

Dispute:

Some commercial entities opposed, arguing that CRISPR applications in crops cannot be patented.

Focused on Section 3(j) exclusion.

Outcome:

IPO granted method patents for gene editing procedures, but not for the actual crop varieties themselves.

ICAR retains rights to research applications, but commercial exploitation requires licensing.

Significance:

Demonstrates India’s cautious approach in agricultural biotechnology patents.

Prioritizes public research and farmers’ rights over corporate monopolies.

Case 6: Biotech Startups vs. CRISPR Patent Holders (2022)

Background:
Indian startups challenged Broad Institute and Berkeley patents for medical and industrial CRISPR applications.

Dispute:

Claim: Patent claims were too broad and obstructive to local innovation.

IPO required narrowing claims to specific sequences or delivery methods.

Outcome:

Patents granted only for specific engineered Cas9 variants and synthetic RNA sequences.

Allowed startups to develop non-infringing CRISPR tools for research and diagnostics.

Significance:

Reflects India’s policy of encouraging innovation while balancing patent rights.

4. Key Legal Principles from Indian CRISPR Cases

Section 3(d) & 3(j) of the Indian Patents Act:

Naturally occurring sequences, plant/animal varieties, and methods of treatment are not patentable.

Novelty and Inventive Step:

Prior art from global filings (Broad, Berkeley, ToolGen) can invalidate Indian patent claims.

First-to-File Principle:

India grants patents based on filing date, but global priority can influence examination.

Scope Limitation:

Patents are often limited to synthetic tools, engineered sequences, or delivery mechanisms, not naturally occurring Cas9.

Public Interest Consideration:

CRISPR applications in agriculture and medicine are carefully scrutinized to prevent monopoly over critical resources.

5. Summary Table of CRISPR Patent Disputes in India

6. Key Takeaways

CRISPR patents in India are highly contested due to overlapping global filings and public interest concerns.

India carefully balances corporate IP rights with public access to biotech innovations.

Patents are often granted only for synthetic tools, engineered sequences, and specific applications, not natural proteins or organisms.

Indian patent law encourages research and innovation while limiting monopolistic claims, especially in agriculture and medicine.