ANALYSIS OF THE BUDAPEST TREATY AND THE

INTERNATIONAL RECOGNITION OF DEPOSITORIES FOR

MICROORGANISMS

B.A., LLB [HONS]; 2020 – 2025

SEMESTER: 10th

COURSE NAME: BIOTECHNOLOGY AND PATENT LAW

COURSE CODE: LAW551

SUBMISSION TO: PROFESSOR DR. MALAY ADHIKARI

SUBMISSION BY:

MANISHKA SEAL - SECTION A; A90811120004

 Introduction

Background of the Budapest Treaty:

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for
Patent Procedures, commonly referred to as the Budapest Treaty, is an international
agreement established in Budapest, Hungary, on April 28, 1977. It officially came into effect
on August 19, 1980, and was later amended on September 26, 1980. The Treaty is
administered by World Intellectual Property Organization (WIPO).

This treaty specifically addresses the role of microorganisms in the international patent
process. It mandates that all member states must recognize microorganisms deposited in an
International Depository Authority (IDA), regardless of the country where the depository is
located. As a result, patent applicants are no longer required to submit microorganisms
separately to each national patent office where they seek protection.

Importance of Microorganism Depositories in Biotechnology Patents:

Microorganism depositories play a crucial role in both biotechnology and patent protection,
serving as essential repositories for preserving and providing access to biological materials.
Their significance extends across scientific research, industrial applications, and intellectual
property rights. The significance of such depositories, however, is summarized below:

 Ensuring Accessibility and Preservation: Microorganisms are fundamental to

various scientific and industrial processes, including pharmaceuticals, agriculture, and
environmental biotechnology. Depositories provide a standardized system for the
long-term storage and preservation of microorganisms, ensuring their stability,
viability, and availability for future use.
 Facilitating Patent Protection: Since many biotechnological inventions involve
living microorganisms, their physical deposit is often required as part of the patent
application process. Microorganism depositories, recognized under the Budapest
Treaty, eliminate the need for multiple submissions to national patent offices,
ensuring that the deposited material is available for examination while maintaining its
confidentiality.

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  Supporting Scientific Research and Innovation: Depositories serve as a valuable
resource for researchers, enabling access to a wide range of characterized
microorganisms. This facilitates advancements in medicine, genetic engineering,
biofuel development, and food technology, driving innovation in biotechnology.
 Standardization and Compliance: Internationally recognized International
Depository Authorities (IDAs) ensure that deposited microorganisms meet global
standards for authentication, storage, and distribution. This harmonization fosters
transparency, legal certainty, and ease of access for inventors and researchers
worldwide.
 Encouraging Global Collaboration: By providing a centralized system for
microorganism deposits, depositories promote international cooperation in
biotechnology. Researchers and industries across different countries can access the
same biological materials, enabling joint development of new technologies and
solutions to global challenges.

Microorganism depositories are indispensable in biotechnology and patent protection,

ensuring security, accessibility, and compliance in handling biological materials. Their role
under the Budapest Treaty streamlines the patenting process while fostering scientific
progress and innovation on a global scale.

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 Budapest Treaty: Overview and Key Provisions

History and Development of the Treaty:

The main feature of the Budapest Treaty is that a contracting State which allows or requires
the deposit of microorganisms for the purposes of patent procedure must recognize, for such
purposes, the deposit of a microorganism with any "international depository authority",
irrespective of whether such authority is on or outside the territory of the said State.

To obtain a patent, an invention must be disclosed, typically through a written description.

However, if the invention involves a microorganism, disclosure must be done by depositing a
sample with a specialized institution, as written descriptions are insufficient. The term
"microorganism" is broadly defined to include any biological material necessary for
disclosure, especially in the food and pharmaceutical industries. The Treaty simplifies the
process by allowing a single deposit of a microorganism with an "international depositary
authority" to suffice for patent procedures in all contracting States and recognized regional
patent offices, such as the EPO, EAPO, OAPI, and ARIPO. An "international depositary
authority" is a scientific institution, often a "culture collection," capable of storing
microorganisms. These institutions gain their status through assurances from their host
country's government to the Director General of WIPO that they meet the Treaty’s
requirements. As of February 20, 2025, there were 52 such authorities worldwide, including
seven in the UK, four in South Korea, and three each in China, India, Italy, Poland, Russia,
and the USA. Other countries with these authorities include Australia, Japan, Portugal, Spain,
Belgium, Bulgaria, Canada, Chile, the Czech Republic, Finland, France, Germany, Hungary,
Latvia, Mexico, Morocco, the Netherlands, Slovakia, and Switzerland.

The Treaty benefits patent applicants by reducing costs and increasing security. Instead of
multiple deposits in each country where a patent is sought, a single deposit with one authority
is sufficient. This uniform system of deposit, recognition, and sample provision enhances the
depositor's security. The Treaty does not establish a budget but creates a Union and an
Assembly of member States, whose main role is to amend the Regulations. Member States
are not required to pay contributions to WIPO or establish an "international depositary
authority."
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The Budapest Treaty, concluded in 1977, is open to States party to the Paris Convention for
the Protection of Industrial Property (1883). Ratification or accession instruments must be
deposited with the Director General of WIPO.

Purpose and Scope:

The Budapest Treaty removes the necessity to deposit microorganisms in each country where
patent protection is desired. According to the Treaty, depositing a microorganism with an
"international depositary authority" fulfils the deposit requirements of the national patent
laws of treaty members. These authorities are equipped to store biological materials and have
established procedures to ensure compliance with the Budapest Treaty. These procedures
include maintaining the deposit for the patent's duration and providing samples only to
authorized individuals or entities.

The creation of "international depositary authorities" offers several benefits to both patent
applicants and contracting states. For patent applicants, the need to deposit in multiple
countries is significantly reduced, as a single deposit with any "international depositary
authority" meets the national disclosure requirements of all member states, thus lowering
costs. Using a single authority also enhances the security of the deposit and provides a
distribution mechanism. Contracting states benefit from the treaty's uniform standards,
ensuring effective deposit and public availability without needing to establish their own
recognized depositaries.

As of January 1, 2009, there were 72 Contracting Parties to the Budapest Treaty and 37
"international depositary authorities" across 22 countries.

Main Features of the Treaty:

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for
the Purposes of Patent Procedure, adopted in 1977, includes several key features:

 International Recognition: Contracting States must recognize the deposit of

microorganisms with any "international depository authority" (IDA) for patent
purposes, regardless of the IDA's location.

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  Disclosure Requirement: For inventions involving microorganisms, disclosure is
achieved through the deposit of a sample with an IDA, as written descriptions are
insufficient.
 Uniform Standards: The Treaty establishes uniform standards for the deposit,
recognition, and provision of microorganism samples, enhancing the security and
reliability of the deposit process.
 Cost Reduction: Patent applicants benefit from reduced costs, as a single deposit
with an IDA satisfies the disclosure requirements of all member states.
 List of IDAs: As of February 20, 2025, there are 52 IDAs in various countries,
including the UK, South Korea, China, India, and the USA.
 Administrative Structure: The Treaty creates a Union and an Assembly of member
States, responsible for amending the Regulations. Member States are not required to
pay contributions to WIPO or establish their own IDAs.
 Eligibility: The Treaty is open to States party to the Paris Convention for the
Protection of Industrial Property (1883). Ratification or accession instruments must be
deposited with the Director General of WIPO.

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 Role and Functioning of Internationally Recognized Depositories

Background and Functions of Depositories:

The United Kingdom initially proposed the international treaty on the deposit of
microorganisms. This treaty was adopted in Budapest in 1977 and came into effect in 1980.
At that time, 18 countries, including France, the USA, the UK, and Italy, ratified the treaty.
The primary goal of the treaty is to facilitate the deposit of live microorganisms for patent
purposes. To achieve this, member countries must establish International Depositary
Authorities (IDAs) where depositors can securely store live microorganisms. Today, more
than 80 countries are part of the treaty, and there are 39 IDAs across 22 countries.

In 2001, India became part of Budapest treaty and currently there are two IDAs, Microbial
Culture Collection (MCC) in National Centre for Cell Science (NCCS), Pune and Microbial
Type Culture Collection and Gene Bank (MTCC) at Institute of Microbial Technology
(IMTECH), Chandigarh respectively [8]. Along with two IDAs, India has thirteen more
culture collection centers known as designated repositories, storing different kinds of
biological resources and are recognized by National Biodiversity Authority (NBA).

The main functions of IDAs are as follows:

 Storage of microorganisms for patent purposes
 Long term storage of microorganisms in safe manner
 Furnishing of samples as per the requirement
 Creates an environment of good microbiological practices
 Identification and characterization of samples
 Gives accession number to samples
 Maintain secrecy of deposited microorganisms
 Provides human resource work such as training program related to microbial
techniques
 Protection of environment
 Proper transport of sample.

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Criteria for Recognition as an International Depository Authority (IDA):
Any culture collection centre can become IDA but it has to give assurance to members of
Budapest treaty and World Intellectual Property Organization (WIPO) that it will deposit
microorganism from any depositors, it will accept and store microorganism in safe and proper
manner and furnish the sample to any authorized person as per the requirement in strict
manner, obeying all the rules and regulations of Budapest treaty.

Procedure for Deposit in International Depository Authority:

To deposit microorganisms with an International Depository Authority (IDA) under the
Budapest Treaty, one needs to submit a completed application form (e.g., BP/1), provide a
description of the microorganism, and ensure the culture is pure and viable. The Budapest
Treaty aims to facilitate international patent procedures by recognizing deposits of
microorganisms in IDAs for patent purposes. It ensures that a single deposit with an IDA
satisfies the deposit requirements of patent applications in all countries that are parties to the
treaty. The treaty covers inventions involving microorganisms, and all states party to it are
obliged to recognize microorganisms deposited as part of the patent disclosure procedure
with an IDA.

Requirements for Deposit:

 Type of Material: The microorganisms must be deposited in a pure and viable form.
 Viability Testing: The IDA will conduct viability tests to ensure the culture remains
viable.
 Storage: The IDA is responsible for storing the deposited microorganisms in a way
that ensures their continued viability and prevents contamination.
 Administrative Requirements: Depositors must complete an IDA application form
(e.g., BP/1) and provide necessary information about the microorganism, including its
description, chemicals, media, and storage protocols.
 Secrecy: The IDA must comply with the requirements of secrecy regarding deposited
strains.
 Impartiality and Objectivity: The IDA must be impartial and objective in its
operations.
 Furnishing Samples: The IDA must furnish samples of the deposited microorganism
under the conditions and in conformity with the procedure prescribed in the
Regulations.
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Key Steps in the Deposit Process:
 Identify an IDA: An IDA that is recognized under the Budapest Treaty must be
identified / found.
 Complete the Application Form: The necessary application form (e.g., BP/1) with all
the required information must be filled out.
 Submit the Microorganism: The microorganism with the chosen IDA, ensuring it is in
a pure and viable state, must be deposited.
 Viability Testing: The IDA will conduct viability tests to ensure the culture remains
viable.
 Storage: The IDA will store the deposited microorganism in a way that ensures its
continued viability.
 Receipt and Viability Statement: The IDA will issue a receipt to the depositor and any
required viability statement.
 Furnishing Samples: The IDA will furnish samples of the deposited microorganism to
authorized parties.
 Compliance with Regulations: All procedures must comply with the regulations under
the Budapest Treaty.
 Fees: The required fees must be paid, in accordance with the regulations under the
Budapest Treaty.
 Permissions: Necessary permissions must be obtained for transportation and deposit,
as per applicable laws.
 Patent Application: The deposit must be referenced in the patent application.

Rights and Responsibilities of Depositories and Depositors:

The rights and responsibilities of IDAs are:
 Storage and Maintenance: IDAs are responsible for storing and maintaining
deposited microorganisms in a safe and viable manner, ensuring their long-term
preservation.

 Viability Verification: They must verify the viability of each deposit and store it
according to the regulations of the Budapest Treaty.

 Issuing Documents: IDAs issue receipts, viability statements, and other official
notices related to the deposit.

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  Maintaining Secrecy: They are obligated to maintain the secrecy of deposited
organisms, as per Rule 9.2 of the Budapest Treaty regulations.

 Furnishing Samples: IDAs must furnish samples under the conditions and
procedures outlined in Rule 11 of the Budapest Treaty regulations.

 Impartiality and Accessibility: IDAs must be impartial and available to any

depositor under the same conditions.

 Good Microbiological Practices: IDAs create an environment of good

microbiological practices.

 Identification and Characterization: They are responsible for identifying and

characterizing the samples.

 Accession Numbers: IDAs assign accession numbers to the samples.

 Training and Resources: They may provide training and resources related to
microbial techniques.

 Environmental Protection: IDAs are also responsible for protecting the

environment.

The rights and responsibilities of Depositors:

 Deposit for Patent Purposes: Depositors have the right to deposit microorganisms
with an IDA to satisfy the deposit requirements for patent applications in member
states of the Budapest Treaty.
 Obtaining Necessary Permissions: Depositors must obtain necessary permissions
for transportation and deposit as per applicable law.
 Signing Agreements: Depositors must sign documents pertinent to "Patent Deposit"
contracted with the IDA, defining the liabilities of each party.
 Providing Information: The depositor must provide the IDA with all necessary
information about the microorganism, including its name, origin, and any relevant
characteristics.
 Undertakings for Sample Furnishing: The depositor may need to undertake certain
obligations when requesting samples, such as not making the culture available to
third parties or using it outside the purview of the law.
 Maintaining Secrecy: Depositors are responsible for maintaining the secrecy of the
deposited microorganisms until the patent application is made public.
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 Challenges and Limitations of Budapest Treaty:

Challenges faced by the Budapest Treaty:

The Budapest Treaty, while facilitating international patent procedures for microorganisms,
faces challenges and limitations, including potential for delays in access to deposited
samples, concerns about the viability of stored microorganisms, and the need for ongoing
maintenance of culture collections.

 Delays in Access to Samples: The treaty allows for the deposit of microorganisms
with an International Depositary Authority (IDA), which then stores the
samples. However, access to these samples can be delayed, particularly during the
patent application process, which can hinder research and development. The treaty's
rules regarding sample access are complex, and there can be disagreements on who is
entitled to a sample.
 Viability and Long-Term Storage: Ensuring the long-term viability of stored
microorganisms is a significant challenge. The treaty requires IDAs to maintain the
viability of deposited strains, but this can be difficult, especially for certain types of
microorganisms. If a strain becomes non-viable, it can invalidate a patent claim based
on that microorganism.
 Maintenance of Culture Collections: Maintaining culture collections and ensuring
their continued operation is an ongoing challenge for IDAs. This requires significant
resources, including personnel, equipment, and infrastructure. The closure or
limitation of an IDA can disrupt the patent process and potentially lead to the loss of
deposited microorganisms.
 Scope of the Treaty: The treaty primarily focuses on the deposit of microorganisms
for patent purposes, and it does not address other issues related to the use and transfer
of these organisms. This can lead to conflicts with other international agreements,
such as the Nagoya Protocol on access to genetic resources.
 Complexity of the Rules: The treaty and its regulations can be complex and difficult
to understand, which can lead to errors and delays in the patent process. The rules
regarding the deposit of microorganisms, the furnishing of samples, and the
maintenance of culture collections are detailed and require careful attention.
 Lack of Standardization: There is a lack of standardization in the requirements for
deposit and the procedures for furnishing samples across different IDAs. This can
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 create confusion and delays for applicants who are trying to comply with the treaty's
requirements.
 Cost: The cost of depositing microorganisms and obtaining samples can be
significant, which can be a barrier for some applicants. The fees charged by IDAs can
vary, and there are also costs associated with the preparation and shipment of
samples.
 Legal Interpretation: The legal interpretation of the treaty's provisions can vary
across different countries, which can lead to inconsistencies in the patent
process. This can create uncertainty for applicants who are trying to obtain patent
protection for their inventions.

Possible Reforms and Future Improvements:

The Budapest Treaty, facilitating international recognition of microorganism deposits for
patent procedures, could see future improvements by streamlining processes, enhancing
digital access to deposits, and expanding the scope of accepted materials, while also
addressing potential challenges like ensuring long-term viability and managing intellectual
property rights.

 Streamlining the Process and Enhancing Digital Access:

 Simplified Deposit Procedures: The treaty could benefit from further simplification of
the deposit process, potentially through online platforms for submission and
management of deposits, reducing paperwork and improving efficiency.
 Digital Access to Deposited Materials : Facilitating digital access to deposited
microorganisms, such as through digital repositories or databases, could enhance
research and development, while ensuring the security and integrity of the deposited
material.
 Standardized Procedures: Developing standardized procedures for deposit, storage,
and furnishing of samples across all International Depositary Authorities (IDAs)
would ensure consistency and reduce potential inconsistencies.

 Expanding the Scope of Accepted Materials:

 Beyond Microorganisms: Consider expanding the scope of materials accepted under
the treaty to include other biological entities, such as cell lines, plasmids, and even

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 certain types of RNA, as long as they are necessary for disclosure in patent
applications.
 Specific Organisms: The treaty could address the specific needs of different types of
microorganisms, such as those requiring specialized storage conditions or those with
unique challenges in preservation.

 Addressing Challenges and Ensuring Long-Term Viability:

 Ensuring Long-Term Viability: The treaty could strengthen provisions for ensuring
the long-term viability and availability of deposited microorganisms, including
establishing clear protocols for storage, preservation, and resubmission in case of loss
or degradation.
 Managing Intellectual Property Rights: Clarifying the intellectual property rights
associated with deposited microorganisms, particularly in relation to access and use,
could help foster innovation and collaboration.
 Addressing Ethical Concerns: The treaty could address potential ethical concerns
related to the use of deposited microorganisms, such as those with potential health or
environmental risks, through the development of clear guidelines and regulations.

 Strengthening the Treaty's Role:

 Promoting Wider Adoption: Encouraging more countries to become parties to the
treaty, and promoting greater cooperation among IDAs, would enhance the treaty's
effectiveness and global reach.
 Monitoring and Evaluation: Regularly monitoring and evaluating the treaty's
effectiveness, and adapting it to changing scientific and technological developments,
would ensure its continued relevance and utility.
 Collaboration with Other International Bodies: Strengthening collaboration with other
international organizations and bodies, such as the World Health Organization
(WHO) or the Food and Agriculture Organization (FAO), could enhance the treaty's
impact on global health and food security.

Conclusion:
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The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for
Patent Procedures has significantly streamlined the patenting process for biotechnological
inventions involving microorganisms. By allowing a single deposit with an International
Depositary Authority (IDA) to satisfy the deposit requirements of all member states, the
Treaty reduces costs and enhances the security and reliability of microorganism deposits. The
establishment of IDAs ensures the long-term preservation and availability of biological
materials, fostering global collaboration and innovation in biotechnology. Despite its
benefits, the Treaty faces challenges such as ensuring the viability of stored microorganisms,
managing the complexity of its rules, and addressing the cost and legal interpretation issues.
Overall, the Budapest Treaty remains a crucial instrument in the international patent system,
promoting scientific progress and innovation.

Recommendations:
 Streamline Deposit Procedures: Simplify the deposit process by developing online
platforms for submission and management, reducing paperwork, and improving
efficiency.
 Enhance Digital Access: Facilitate digital access to deposited microorganisms
through digital repositories or databases, ensuring security and integrity while
promoting research and development.
 Standardize Procedures: Develop standardized procedures for deposit, storage, and
furnishing of samples across all IDAs to ensure consistency and reduce potential
inconsistencies.
 Expand Scope of Accepted Materials: Consider including other biological entities,
such as cell lines, plasmids, and certain types of RNA, necessary for patent disclosure.
 Ensure Long-Term Viability: Strengthen provisions for the long-term viability and
availability of deposited microorganisms, including clear protocols for storage,
preservation, and resubmission.
 Manage Intellectual Property Rights: Clarify intellectual property rights associated
with deposited microorganisms, particularly regarding access and use, to foster
innovation and collaboration.
 Address Ethical Concerns: Develop clear guidelines and regulations to address
potential ethical concerns related to the use of deposited microorganisms, especially
those with health or environmental risks.
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  Promote Wider Adoption: Encourage more countries to join the Treaty and promote
greater cooperation among IDAs to enhance its effectiveness and global reach.
 Monitor and Evaluate: Regularly monitor and evaluate the Treaty's effectiveness,
adapting it to changing scientific and technological developments to ensure continued
relevance and utility.
 Collaborate with International Bodies: Strengthen collaboration with other
international organizations, such as WHO and FAO, to enhance the Treaty's impact
on global health and food security.

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