Budapest Notification No. 308
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication by the Government of the United Mexican States Relating to the Acquisition of the Status of International Depositary Authority by the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CM-CNRG)

The Director General of the World Intellectual Property Organization (WIPO) presents his compliments to the Minister for Foreign Affairs and has the honor to notify the receipt from the Government of the United Mexican States, on July 10, 2015, of a written communication dated July 8, 2015, relating to the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CM-CNRG), which states that this Depositary Institution is located on the territory of Mexico and includes a Declaration of Assurances to the effect that the Institution complies and will continue to comply with the requirements concerning the acquisition of the status of International Depositary Authority specified in Article 6(2) of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure done at Budapest on April 28, 1977, and amended on September 26, 1980.

Pursuant to Article 7(2)(b), the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CM-CNRG) shall acquire the status of International Depositary Authority under the Budapest Treaty on August 25, 2015, that is on the day of publication of this notification.

August 25, 2015


Text of the communication by the United Mexican States relating to the acquisition of the status of international depositary authority by the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CM-CNRG)

[Original: Spanish]

COMMUNICATION

The Permanent Mission of Mexico to the United Nations Office and other International Organizations in Geneva presents its compliments to the Director General of the World Intellectual Property Organization (WIPO) and has the honor to present the application of the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CNRG) of the National Institutes of Forestry, Agricultural and Livestock Research (INIFAP) to be recognized as an International Depositary Authority under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28, 1977, and amended on September 26, 1980.

Accordingly, the Permanent Mission communicates that the Colección de Microorganismos del Centro Nacional de Recursos Genéticos (CM-CNRG) complies with and will continue to satisfy the conditions listed in Article 6(2) of the Budapest Treaty to be recognized as an International Depositary Authority.


ANNEX

Acquiring the status of International Depository Authority for the Colección de Microorganismos del INIFAP Centro Nacional de Recursos Genéticos (CM-CNRG)

1. Legal status

The National Institutes of Forestry, Agricultural and Livestock Research (INIFAP) is a Decentralized Public Organization, with a legal personality and own assets. It is recognized as a Public Research Center and is competent to make technical, operational and administrative decisions, within the scope of the Law on Science and Technology, and to manage its budget, pursuant to the Federal Law on Treasury Liability and Budget.

The Institute aims to contribute to sustainable rural development, improving competitiveness and maintaining the natural resource base. It works jointly and responsibly with other public and private institutions and organizations associated with rural Mexico and generate scientific knowledge and technological innovation in agriculture, livestock and forestry, as a way of meeting the needs and demands of industrial food chains and the range of producers.

INIFAP was created on August 23, 1985 from the merger of the National Institutes for Research for Forestry (INIF), Agriculture (INIA) and Livestock (INIP). It became a Decentralized Public Organization working under the then Secretary of Agriculture and Hydraulic Resources. On October 2, 2001 it was recognized as a Decentralized Public Organization with its legal personality and own assets. On June 16, 2003 it was recognized as a Public Research Center, affording it access to the advantages granted by the Law on Science and Technology, including increased independence and operating capacity with a view to achieving institutional excellence. Annexed to this document is the current Organizational Statute of INIFAP, published on March 23, 2007 in the Official Journal of the Federation, describing its attributions, organs and administrative structure.

As can be seen from the Organizational Statute (Article 4, Section V), INIFAP is empowered to sign agreements, conventions, contracts and other legal instruments with the public sector at federal, state and municipal levels and with the private sector, nationally and internationally, which is of relevance to its recognition as an International Depository Authority (IDA).

The National Center of Genetic Resources (CNRG) is a research unit under the Central Pacific Regional Research Center of the National Institute of Forestry, Agricultural and Livestock Research (CIRPAC-INIFAP). Hence, CIRPAC-INIFAP is fully empowered to sign legal documents with national and international entities with regard to any subject relating to the work of the CNRG.

A name and an acronym have been registered with the World Federation for Culture Collections (WFCC). They are "Coleccion de Microorganismos del Centro Nacional de Recursos Geneticos" (CNRG Microorganism Collection) and "CM-CNRG". Hereinafter, references to the CNRG Microorganism Collection or to the CM-CNRG are to the collection of microorganisms that is hosted by the National Center of Genetic Resources, which is part of the organizational structure of the CIRPAC-INIFAP. This collection was created to preserve microbial germ plasm related to the diverse activities of the food, agriculture, forestry, water management and fishing industries and the food security of the population.

2. Name and Address

Colección de Microorganismos del CNRG (CM-CNRG).
Boulevard de la Biodiversidad No. 400
Col. Rancho las Cruces,
Tepatitlán de Morelos, Jalisco, C.P. 47600
Mexico

Telephone: +52378-1065020 ext. 5107 5207, 5202.
Email: cm-cnrg@inifap.gob.mx
Internet: under construction, to be hosted on the webpage of CIRPAC-INIFAP: www.inifapcirpac.gob.mx

3. Facilities and equipment

The infrastructure of the microbial genetic resources laboratory, which is where the CM-CNRG is located, is designed to meet Biosafety Level 2, pursuant to the World Health Organization (WHO) international guidelines for handling microorganisms included in Risk Group 2 and some in Risk Group 3. It has common working areas and containment rooms for each type of microorganism or type of germ plasm; bacteria, fungi, viruses, cell cultures and genetic material extractions.

These areas are equipped with Class 2 biosafety cabinets, micro-incinerators, specific equipment destined for individual types of microorganism, autoclaves and receptacles for biological waste and residue. These areas are used to carry out processes involving inoculation, harvesting, characterization and isolation of microorganisms from different sources and the tasks specific to the collection of microorganisms.

Laboratory staff are educated in microorganisms and are trained to handle them. In any case, access to these areas is subject to the use of safety glasses, laboratory gowns and disposable coveralls to guarantee the safety of laboratory staff and the aseptic conditions for working with microorganisms, pursuant to Level 2 biosafety guidelines for handling microorganisms, allowing more confidence and safety in their management.

Staff working at the CM-CNRG have the skills and training needed to guarantee the handling and preservation of microorganisms deposited in the Collection across a range of procedures and according to depositors' needs.

4. Staff

With regard to the scientific standing of the CM-CNRG, and in particular to the talent of the staff conducting the work in the laboratory for microbial genetic resources, of the 12 researchers, seven hold Doctorates in science and five Master's degrees in science. Only two belong to the National System of Researchers, but that is understandable given the team's youthfulness: the average length of time working at INIFAP is only 2.5 years.

Furthermore, the CNRG Microorganism Collection is recognized both nationally and internationally, thanks to its registrations with the World Federation for Culture Collections, the World Data Center for Microorganisms, No. 1006, and the Latin-American Federation for Culture Collections, No. SI-56, (http://www.wfcc.info/ccinfo/collection/col_by_country/m/52/).

Currently there are 1,856 deposits in the Collection: bacteria, cyanobacteria, actinomycetes, fungi and yeasts. The scientific standing of the Collection is boosted by its scholarly productivity including the publication of articles in indexed journals, book chapters and research projects and the high quality training of professionals.

Team members are supported in their work by scientists at the laboratories of genomic sciences and of genetic analysis services for agriculture and by administrative, legal and general support staff.

The fundamental operational principles of the CM-CNRG are impartiality and objectivity. As mentioned, it is institutional policy to provide services under the same conditions to all customers.

5. Organisms subject to deposit at the CM-CNRG

(i) The CM-CNRG accepts the following deposits of microorganisms and materials: microalgae, animal viruses, plant viruses, bacteria (non-pathogenic), bacteria (pathogenic), bacteriophages, mammalian embryos and gametes, eukaryotic DNA, hybridomas, fungi (pathogens), fungi (non-pathogenic), human cell cultures, yeasts (non-pathogenic), nematodes, viroids, animal cell cultures, plant cell cultures, mycoplasmas, plasmids (in host), plasmids (without host), protozoa (non-parasitic), DNA of microorganisms, RNA of microorganisms, genomic libraries, microbial consortia.

6. Technical requirements and procedures

The CM-CNRG uses at least three methods for long-term preservation: deep freezing at -80°C, cryogenic preservation in liquid nitrogen at -196°C and freeze-drying.

For this, the laboratory has three deep freezers, each with the capacity for 3,000 strains; shelves to store freeze-dried strains and cryogenic tanks with capacity for 600,000 cryogenic tubes stored in liquid nitrogen.

The so-called "seed lots" preservation system used is for all deposits, guaranteeing the viability, purity and genetic stability of preserved microorganisms.

To strengthen the system, innovative methods of defining and identifying of microorganisms are routinely introduced. Furthermore, the laboratory uses identification and definition protocols based on phenotype and genotype methods and traditional, miniaturized, semiautomatic and automatic methods based on mass spectrometry and flow cytometry. Furthermore it has, inter alia, spectrophotometers, microscopy systems and ELISA systems.

With regard to genotype methods, the laboratory has end-point and real time thermal cyclers to identify genes, ionic sequences and pyrosequencers to analyze microbial communities, to estimate microbial diversity and to identify new microorganism species.

A database has been designed to manage deposits, allowing differential treatment for core collections and active collections. This also allows the systematization of passport data related to collection data, morphological, biochemical and genetic definitions and information on the preservation protocol.

Furthermore, CM-CNRG's infrastructure enables it to offer services related to the deposit of microorganisms including public and restricted deposits and soon Budapest Treaty deposits of patentable strains. All these services are provided with a strict emphasis on the documentation required for accepting deposits to the CM-CNRG, the most important of which are agreements between the depositor and the Collection, agreements on the transfer of material, deposit files, public catalogue availability and procedures manuals for the reception, assessment, admission and handling of each type of deposit.

The CM-CNRG, working through the CIRPAC-INIFAP, has the legal, administrative and technical capacity to accept deposits and to issue deposit receipts and viability certificates, pursuant to the Implementing Regulation of the Budapest Treaty, for the types of microorganism listed in Point 5.

The services offered by the CM-CNRG are as follows:

(a) Public deposits of microorganism strains. Strains deposited publically are made available to the national and international scientific community as a microorganism pool for various fields: economics, academia, research, agri-food, etc. Clients: research and education institutions, agri-food, chemical, pharmaceutical companies, etc..

(b) Restricted deposits (Black boxes). This is a special service for the long-term storage of microorganisms for which the depositor has requested restricted distribution. The CM-CNRG maintains the strains and ensures their viability. Their authenticity is the responsibility of the depositor. Any information relating to the deposit and the nature of the microorganism deposited is treated with absolute confidentiality. Clients: public and private entities whose production is based on microorganisms, e.g., those in the pharmaceutical, grape and wine and (dairy) food industries.

(c) Freeze-drying and cryogenic preservation upon request. This service involves preserving strains upon the express request of an applicant and for a predetermined number of strains only, given that in many cases, there is insufficient infrastructure to carry out these preservation processes. Clients: education and research institutions, companies in the agri-food, chemical, pharmaceutical, agricultural and livestock and vaccine industries, etc..

(d) Phenotype and genotype strain identification. This service is designed to ensure the reliable identification of microorganisms in line with international standards for the different types of microorganism, including the use of molecular techniques that in certain cases allow the definition and classification of different groups of microorganisms. Clients: education and research institutions, companies working in the agri-food, chemical, pharmaceutical, agricultural and livestock and vaccine industries, etc..

(e) Distribution of reference strains. This purpose of this service is the distribution of reference strains of microorganisms, known to be traceable and for use in validation processes in the field of microbiology. These types of strain can be shipped to anywhere in Mexico, given that they are essential references in processes of the pharmaceutical and food industries required by a number of instruments such as, amongst others, the Mexican Pharmacopeia and the Codex Alimentarius. Clients: public and private entities whose production is based on microorganisms such as those in the pharmaceutical, grape and wine and agri-food industries.

(f) Patent deposits. Once the CM-CNRG is recognized as an International Depository Authority by the World Intellectual Property Organization (WIPO) and pursuant to the rules of the "Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure", it will offer a national and international service. Mexico does not currently have a recognized IDA institution.

The legal instruments used by the CIRPAC-INIFAP and that are applicable to the CM-CNRG for the provision of goods and services usually include specific clauses on secrecy and confidentiality to protect the interests of those entities with which agreements, conventions, contracts and other binding instruments are signed. It is therefore deemed that the CM-CNRG has the necessary infrastructure, human resources and equipment to fulfil the role of IDA.

7. Administrative requirements and procedures

7.1 Languages

The official languages of the CM-CNRG are Spanish and English.

7.2 Contracts

The depositor must complete the CM-CNRG request form, which forms a contract binding the depositor to:

- provide all information required by the CM-CNRG;
- pay the corresponding tariffs;
- indemnify the CM-CNRG against any claim that could be filed against it as a consequence of the sending of samples, unless such claims arise from the negligence of the CM-CNRG;
- refrain from withdrawing deposits during the period necessary for their due storage;
- authorize the CM-CNRG to supply samples in compliance with the patent procedure requirements in force at that time.

When an organism has been accepted as a deposit, the CM-CNRG will notify the depositor, recalling the obligations set out in the terms and conditions of contract.

7.3 Regulations of imports and quarantine

The CM-CNRG administers neither the import/export procedures nor the quarantine process required for the deposit of material.

7.4 Original deposits

Depositors must meet the formal request and access requirements employed by the CM-CNRG for deposits under the Budapest Treaty, analogous to Form BP/1.

7.5 Official notifications to the depositor

Receipts and viability statements are published using the compulsory international forms BP/4 and BP/9 respectively. Attestations concerning later indications or amendments of the scientific description and/or proposed taxonomic designation are published using Form BP/8. Notifications of the furnishing of samples of deposited microorganisms are published using Form BP/14. Other notifications will not be carried out using standard forms.

7.6 Unofficial notifications to the depositor

The CM-CNRG will honor requests for nonofficial notifications by telephone, fax or email, providing the date of the deposit and the entry number, during the period between receipt of the organism and the issuance of the official receipt. Nevertheless, the depositor will also be informed that any such information is provisional and dependent on the outcome of viability/identity tests.  The CM-CNRG will also communicate the results of the viability analysis before they are published by means of the corresponding certificate.

7.7 Supply of information to legal representatives or patent attorneys

The CM-CNRG may request the depositor to inform it of the names and addresses of legal representatives or patent attorneys. Upon request, the CM-CNRG will supply copies of sample receipts, viability states and any other information to the depositor, legal representative and/or patent attorney.

7.8 Conversion of prior deposits

The CM-CNRG does not hold any deposit made pursuant to patent procedures, except where provided for by the Budapest Treaty.

7.9 New deposits

Upon making a new deposit, the depositor will be asked to complete Form BP/2 and to attach the most relevant documents required under Article 4 of the Budapest Treaty. Receipts and viability certificates for new deposits will mandatorily be published using international Forms BP/5 and BP/9.

8. Supply of strains

8.1 Sample requests

The CM-CNRG will inform third parties of the correct procedure for requests. Where requests require proof of authorization, the CM-CNRG will supply the requesting party with the request forms used by intellectual property offices.

For requests coming from abroad, the CM-CNRG will assume that the requesting party is familiar with the requirements for importation to its country.

All samples sent by the CM-CNRG will be prepared as individual lots.

8.2 Notifications to the depositor

The depositor will be informed officially, in writing and by email, when a sample of a deposited organism has been sent to a third party.

8.3 Catalogue of Budapest Treaty deposits

The CM-CNRG will publish lists of Budapest Treaty deposits in its catalogues only with prior written authorization from the depositor under terms established by the CM-CNRG.

9. List of fees

The CM-CNRG sets its tariffs (see the following table), for preservation services, sending certificates, declaring viability, delivering samples, etc.

Fees established by CM-CNRG

Type of service Cost
Deposit of cell cultures (Rule 6.1) $ 12,650
Deposit of other types of microorganism (Rule 6.1) $ 10,450/strain
New deposit $ 1,430/strain
Storage extension beyond the period provided for by the Budapest Treaty (Rule 9) $ 440/year and strain
Issuance of viability certificates (upon request) $ 2,145/certificate and strain
Reissuance of viability certificates $ 1,870
Furnishing of samples (Rule 11) $ 2,145
Providing information (Rule 7.6) $ 2,145/communication and strain

All fees are in Mexican pesos.

Prices do not include value added tax (IVA), which will be added to the final amount.

10. Start date for the CM-CNRG as an International Depository Authority

The CM-CNRG will start functioning as an International Depository Authority as of the date on which it is granted accreditation by WIPO pursuant to the Budapest Treaty.