Budapest Notification No. 380
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication by the Kingdom of Spain Relating to Changes in the Schedule of Fees Charged, the Discontinuance of Performance of Tasks in Relation to Certain Kinds of Microorganisms Deposited and the Refusal to Accept Certain Kinds of Microorganisms by the Colección Española de Cultivos Tipo (CECT)

The Director General of the World Intellectual Property Organization (WIPO) presents his compliments and has the honor to notify the receipt, on March 6, 2026 of a communication dated March 6, 2026 from the Kingdom of Spain relating to changes in the schedule of fees charged, the discontinuance of the performance of tasks in relation to certain kinds of microorganisms deposited and the refusal to accept certain kinds of microorganisms by the Colección Española de Cultivos Tipo (CECT), an International Depositary Authority (IDA) under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (Budapest Treaty), done at Budapest on April 28, 1977, and amended on September 26, 1980 (see Budapest Notification No. 106 of April 27, 1992).

In accordance with Rule 12.2(c) of the Regulations under the Budapest Treaty, the fee relating to the communication of information (Rule 7.6) is applicable as from January 1, 2026; the other fees shall take effect on May 8, 2026, that is, on the thirtieth day following the publication of the changes by the International Bureau of WIPO.

April 8, 2026

Text of the communication by the Kingdom of Spain relating to changes in the schedule of fees charged, the discontinuance of the performance of tasks in relation to certain kinds of microorganisms deposited and the refusal to accept certain kinds of microorganisms by the Colección Española de Cultivos Tipo (CECT)

[Original: Spanish]

Further to our previous communication dated February 17, 2026, I enclose this updated and revised letter regarding information on the Spanish Type Culture Collection (CECT) in its capacity as an international depositary authority for microorganisms for patent purposes.

In accordance with Rule 12.2 of the Regulations under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, I am pleased to inform you that the fees charged by the CECT in its capacity as an international depositary authority for microorganisms for patent purposes have been amended as follows:

Furthermore, in accordance with Rule 5 of the Regulations under the Budapest Treaty, I must inform you that the CECT is currently unable to accept new deposits of bacteria, archaea, filamentous fungi or yeast that are considered genetically modified organisms (GMOs) of risk group 2 (RG2), as set forth in Spanish law under Act 9/2003, of April 25, establishing the legal procedure for the confined utilization, voluntary liberation and commercialization of genetically modified organisms.

This restriction is a result of amendments to the Act that provide for stricter requirements that CECT facilities do not currently meet.

The CECT is working to upgrade its laboratories to meet those new requirements.  However, it is as yet unable to provide an estimated time frame for obtaining the necessary authorization.

The new regulations also affect the production of new batches, viability testing and supply of samples with regard to strains already deposited with the CECT that are classified as RG2 GMOs.

In those cases, the CECT plans to partner with nearby laboratories authorized to work with RG2 GMOs to conduct such activities when necessary.  Fast service in such cases cannot be guaranteed.

Lastly, I would kindly ask you also to consider amending the detailed requirements and practices relating to the CECT as set forth in the attachment to this letter.

Attachment to Communication

COLECCIÓN ESPAÑOLA DE CULTIVOS TIPO (CECT)

Edificio 3 CUE. Parc Cientific Universitat de Valencia
Catedrático Augustín Escardino, 9 46980 Paterna (Valencia)

Telephone: (34-963) 54 46 12
E-mail: patentescect@uv.es
Internet: http://www.uv.es/cect

1. Requirements for Deposit

a. Kinds of Microorganisms that May Be Deposited

Bacteria, archaea, filamentous fungi and yeast that can be preserved without significant alteration of their properties through freezing or freeze-drying may be deposited. The strains must belong to a risk group up to level 3(**) according to the Spanish legislation (Guía Técnica para la Evaluación y Prevención de Riesgos relacionados con la Exposición a Agentes Biológicos del Instituto Nacional de Seguridad e Higiene en el Trabajo, RD 664/1997 de 12 Mayo).  Microorganisms classified in risk group 3(**) are those that may pose a limited risk of infection to workers, as they are not typically transmitted by the airborne route.

Genetically manipulated organisms and isolated DNA belonging to Class 1 according to Spanish regulations (Law 9/2003 and bylaw 452/2019) may be accepted.

Strains requiring special cultivation conditions may be accepted, provided they do not require equipment or expertise not available at the CECT.  Additional fees may apply in such cases (available upon request).

The CECT does not accept the deposit of the following types of biological material: algae, cyanobacteria, embryos, protozoa, animal cell lines, plant cell lines, mycoplasms, plant seeds, isolated plasmids, viruses and bacteriophages.

Notwithstanding the above, the CECT reserves the right to refuse any material deemed to present an unacceptable risk or which cannot be appropriately handled at the CECT facilities.

b. Technical Requirements and Procedures

i. Form and Quantity

The depositor must submit five replicates of a pure culture of the strain, either in Petri dishes or slants (in 10-15 ml tubes).

ii. Time Required for Viability Testing

The minimum time required for testing the viability of bacteria, archaea and yeast samples is two to three days, and for fungus strains four to six days.

However, depositors should note that viability testing may require significantly longer duration for some strains (up to several weeks).

iii. Depositor Checks and Renewal of Stocks

Where appropriate, the CECT prepares frozen and freeze-dried batches by subculturing the material supplied by the depositor.  Alternative preservation methods are used for microorganisms showing low viability after freeze drying. When existing batches are running low, new sets are prepared from the first batch generated.

Upon request, strains may be delivered to the depositor for authenticity verification. In such cases, administrative and shipping costs will be charged.

c. Administrative Requirements and Procedures

i. General

Language. The official languages of the CECT are Spanish and English.

Contract. Depositors are required to complete and sign a deposit form, which constitutes a contract whereby they agree to:

• not withdraw the deposit during the prescribed storage period;

• fill in a patent claiming the use of the microorganism within 4 years;

• keep contact details updated and designate authorized representatives;

• send the material following CECT requirements and cover transport costs;

• authorize CECT to distribute samples under the Budapest Treaty and indemnify CECT against any claims resulting from such distribution, unless CECT is negligent;

• acknowledge that CECT gains usage rights to the strain in accordance with the Budapest Treaty and the Convention of the Biological Diversity, after the Budapest Treaty storage period;

• acknowledge that CECT may provide minimal required biosafety/genetic engineering information to Spanish authorities, stressing confidentiality.

Import and/or Quarantine Regulations. The CECT may accept strains officially classified as controlled microorganisms, i.e., subject to special regulations.  It is the depositor's responsibility to ascertain and comply with all applicable transport and importation requirements into Spain.

ii. Making the Original Deposit

Requirements to Be Met by the Depositor. Depositors must complete the CECT's application and accession forms for deposits under the Budapest Treaty.

Official Notifications to the Depositor. The receipt and viability statement are issued on mandatory "international forms" BP/4 and BP/9, respectively.  Attestation of receipt of a later indication or amendment of the scientific description and/or proposed taxonomic designation is issued on model form BP/8.  Notification of the furnishing of samples to third parties is issued on model form BP/14.  For other official notifications, individual correspondence is used instead of standard forms.

Unofficial Notifications to the Depositor.  Upon request, the CECT may inform the depositor by telephone of the date of deposit and the accession number after receipt of the microorganism and prior to the issuance of the official receipt.  However, this information is provisional and subject to the outcome of the viability testing.

Supply of Information to a Patent Agent. The CECT may provide the patent agent with copies of the receipt, the viability statement and other relevant information upon request by the depositor.

iii. Converting a Previous Deposit

Deposits made outside the provisions of the Budapest Treaty may be converted into deposits under the Treaty by the original depositor, regardless of whether they were made for patent purposes.  The same fees and administrative requirements apply as for an original deposit under the Treaty.  Both the original deposit date and the date of receipt of the conversion request are recorded on "international form" BP/4.

iv. Making a New Deposit

When making a new deposit, the depositor must complete model form BP/2 and provide the documentation required under Rule 6.2.  The receipt and the viability statement are issued on mandatory "international forms" BP/5 and BP/9.

2. Furnishing of Samples

a. Requests for Samples

The CECT advises third parties on the procedures for submitting a valid request.  For requests requiring proof of entitlement, the CECT provides the requester with model form BP/12.  It is the applicant's responsibility to comply with all relevant importation requirements, including obtaining and providing any necessary permits for international shipments.  All furnished samples are derived from batches prepared by the CECT.

b. Notification of the Depositor

The depositor is informed, via model form BP/14, when samples of their microorganism have been supplied to third parties.

c. Cataloguing of Budapest Treaty Deposits

During the mandatory storage period as defined in rule 9.1, the CECT does not include Budapest Treaty deposits in its public catalog.

3. Schedule of Fees

4. Guidance for Depositors

The CECT provides guidelines for depositing strains in the CECT on its website and is available to provide additional information by telephone or by e-mail.