Budapest Notification No. 303
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication by the Government of the Republic of Italy Relating to the Acquisition of the Status of International Depositary Authority by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER)

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 Republic of Italy, on December 2, 2014, of a written communication dated November 26, 2014, relating to the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER), which states that this Depositary Institution is located on the territory of Italy 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 Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER) shall acquire the status of International Depositary Authority under the Budapest Treaty on February 9, 2015, that is on the day of publication of this notification.

February 9, 2015

Text of the communication by the Republic of Italy relating to the acquisition of the status of international depositary authority by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER)

[Original: English]

COMMUNICATION

In accordance with Art. 7 of the Budapest Treaty on the "International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure", I have the honor to propose as an International Depositary Authority (IDA) the Italian Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER), housed in Brescia, Italy.

We offer our assurances, guaranteed also by the Italian Ministry of Health, that IZSLER "Bruno Ubertini" can and will meet every requirement of Article 6 of the above mentioned Treaty.

We are forwarding herewith an application from the Director General of IZSLER, Prof. Stefano Cinotti, for designating the same IZSLER as an IDA and a report containing all the information on the depositary institution as required by the Budapest Treaty.

I should be grateful if you, as soon as possible, could take the steps necessary to confer the IDA status to IZSLER and to publish, accordingly, all due information on the WIPO website.

IZSLER undertakes to operate as an International Depositary Authority as of the date on which the relevant accreditation is granted.

ANNEX

ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLA LOMBARDIA E DELL'EMILIA ROMAGNA "BRUNO UBERTINI" (IZSLER)

The writer, as General Manager of Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER) is asking to receive the Recognition of "International Depositary Authority" according to Article 7 of the Budapest Treaty.

The Biobank of Veterinary Resources (BVR) collection belongs to IZLER, Brescia, Italy at the following address: IZSLER, Public Health Organization, via A. Bianchi 9, 25124 Brescia, Italy.

According to Article 6 of the Budapest Treaty, myself, as General Manager, and on my personal responsibility declare that the Microorganism and Virus Collection is permanently existing for 70 years of the previous century, although it has become a service branch since 2012.

(i) According to Implementing Regulation, it has the personnel and equipment necessary for the scientific and administrative activities requested by the Budapest Treaty.

(ii) IZSLER is an impartial and objective organization.

(iii) For deposit purpose, it offers its service to all depositors at the same condition.

(iv) It accepts all microorganisms and viruses classified in the level risk 2;  it accepts to evaluate their viability and to store them, according to the Executive Regulation.

(v) It will distribute, according to the conditions and procedures of Executive Regulation, samples of each microorganism and virus deposited.

Other important information on collection of microorganisms and viruses are below reported.

(a) For storage of microorganisms and viruses under patent field procedure it will be requested fees ranging from 608.80 to 1'448.27 € (microorganisms) and from 788.92 to 1'086.96 € (viruses), according to the physic status (freeze dried or frozen) and temperature condition. Other fees are reported in the report enclosed to this request and they must be added with VAT taxes. Official languages for microorganism and virus collection will be Italian and English.

(b) Further information can be obtained from the report enclosed to this request:

(1) The catalogue of biological resources stored at IZSLER biobank that also includes microorganisms and viruses can be found at the following web site: www.ibvr.org. It is in English and it is updated in real time

(2) All information about biobank and its management are indicated in the report enclosed at this request

(3) Publications of the person responsible for biobank management are listed in the report enclosed to this request.

REQUEST FOR THE STATUS OF INTERNATIONAL DEPOSITORY AUTHORITY (IDA)

1) NAME AND ADDRESS OF DEPOSITORY INSTITUTION

Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini", (IZSLER) (C.F. - P.IVA 00284840170 N. REA CCIAA di Brescia 88834).
Via Bianchi, 9 – 25124 Brescia, Italy

Telephone: +3903022901
Facsimile: +390302425251
E-mail: info@izsler.it
Website: www.izsler.it

1a) NAME AND ADDRESS OF ENTITY IN CHARGE OF HANDLING DEPOSITS UNDER THE BUDAPEST TREATY

IZSLER Biobank of Veterinary Resource (IZSLER BVR)
Via Bianchi,
925124 Brescia
Italy

Telephone: +390302290 248 / 536
Facsimile: +390302290 392 / 386
E-mail: substr@izsler.it
Website: www.ibvr.org

IZSLER is a Veterinary Government Organization supported by Italian Ministry of Health. Its aims are the following:

- to guarantee Veterinary Service activities on:
- Animal health
- Food safety
- Zootechnic hygiene
- Animal welfare

IZSLER has several Reference Centers authorized by:

- Italian Ministry of Health
- OIE
- FAO.

2) GENERAL MANAGER OF THE INSTITUTE

Professor Stefano Cinotti

Coordinator of Biobank: Dr. Maura Ferrari

3) LEGAL INFORMATION OF IZSLER AND FUNDING AVAILABILITY THAT ALLOW TO PROVIDE ASSURANCE ON THE SUSTAINABILITY AND FUNCTIONING OF BIOBANK

IZSLER is a Public Technical-Scientific Body, with autonomous technical and administrative management. It offers services in the Public Veterinary branches i.e. the Regional and National Veterinary Services, Breeders and Consumers. It provides services as required by national and regional laws in the fields of animal health and food security.

Brescia is the Headquarter; however, there are 17 offsite laboratories in each province of Lombardi and Emilia Romagna Regions, that are the competence area. Currently IZSLER staff is composed of 657 people that can be subdivided into two main branches: Administrative and Technician. Within them there are departments in which specific activities are performed.

The Biobank of Veterinary Resources is an infrastructure of IZSLER and it is financially supported by IZSLER itself. The amount requested for its building has been over 600,000.00 €; however, this amount does not include the costs needed for the preparation of biological resources batches and for all quality controls made on each biological resource. Furthermore, it has been calculated that the general costs/year of the routine management are of about 350,000.00 €.

Several colleagues involved in different branches are involved in biobank infrastructure according to their expertise. In particular, for microorganisms and viruses, that are the biological resources of interest and involved in the present request; four colleagues are responsible for them (Leader people) and they are not only involved in the preparation and quality controls of the agents to be stored in biobank, but also in the coordination of the activities that are made in other laboratories of IZSLER and related to these types of pathogens. However, the Leaders have the responsibility to declare if a new pathogen, due to its own quality features, can be included in biobank.

Furthermore, other people are directly involved in the management of Biobank: registrations, deposit, distribution, and infrastructure monitoring.

All data are then transmitted to the IT Operative Unit for their publication on the web site of biobank.

According to that, it appears that several laboratories and about 40 people are involved in activities related to the preparation and control of microorganisms and viruses of IZSLER Biobank.

The biobank is a well-defined infrastructure with a controlled access limited to well-trained personnel as below reported. It covers a surface of 130 m².

Currently, technicians are involved in the routine management of biobank (registration, deposit, distribution) and in the infrastructure control.

Facilities and equipment

All laboratories involved are completely equipped with all instruments that are requested for the activity to be performed.

In particular, they are provided with incubators at different temperatures, microscopes, centrifuges, air flow cabinets, ultracentrifuges, instruments for molecular biology assays (PCR, Real time PCR) readers for ELISA tests, refrigerators, and freezers. Moreover, in biobank, together with refrigerators and freezers rooms, there are a cabinet for storage of the samples at room temperature, -80°C freezers, tanks for storage of samples at nitrogen vapor phase (-130°, -196°) and a new generation tank at vapor phase nitrogen that is used to store viruses at -80°C. Everything is controlled by IT systems and different programs are available for biobank management activity. All people are trained and biobank is working according to ISO 9001 2008 Quality Management System.

4) TYPE OF BIOBANK AND DENOMINATION

Biobank of Biological Resources of Interest in Veterinary Medicine. It is referred to as "Biobank of Veterinary Resources - BVR"

5) ORGANISATIONAL CHART OF "BIOBANK OF VETERINARY RESOURCES - BVR" OF IZSLER: AN OVERVIEW

Biobank infrastructure has been developed in June 2012, with the aim to collect and store in proper and centralized conditions, several types of biological resources. These samples have been collected and identified in the different laboratories of IZSLER, either at the Headquarter in Brescia or at the 16 different off-site Centres of IZSLER in Lombardi and Emilia Romagna regions.

All biological resources included in Biobank have been controlled in their main characteristics and quality features, in order to ensure their correct identity and to suggest the proper use.

The working process related to all types of biological resources and based on isolation, amplification/cultivation, control, storage and shipment is carried out in accordance with two quality assurance systems represented by UNI CEI EN ISO/17025 and ISO 9001:2008, respectively. The latter is only referred to Cell Culture Centre and to Biobank infrastructure.

The collected biological samples are obtained from different sources:

- other collections/biobanks
- pathological tissues and organs of animal origin (field samples);
- other laboratories. In this case, received samples can have different origin: reference or field samples (pathological material).

Information about all collected biological resources can be found at the following web site www.ibvr.org, by a real time up-dating

Biological Resources and leader people

The main biological resources are obtained from laboratories that are involved in a specific field. For each one, a reference person has been identified and he is responsible for the preparation and controls of biological resources stored in Biobank.

Storage areas

The infrastructure is subdivided into several storage areas; the modality of sample preservation is guaranteed by specific temperature conditions according to each collected biological resources:

- Room temperature cabinet
- Refrigerator room at +4°C
- Freezer room at -20°C
- Electrical freezers at -80°C
- Vapour phase nitrogen tank at -80°C
- Vapour and liquid phase nitrogen at -130 and -196°C, respectively
- Management office of the infrastructure

Informatics Technology (IT) system and management of Biological Resources

An IT system has been developed with the aim to have a complete traceability of all samples collected in the new infrastructure.

In particular, different and specific sheets filled with all data and information regarding each biological resource have been prepared. The user can register name, taxonomy (except for cell cultures), origin, tissue/sample of isolation, health condition of the involved animals/farms, quality parameters and other data related to the sample.

Furthermore, biological resources, that can be amplified (cell cultures, viruses, bacteria etc.), are subdivided in three different aliquots: one as backup system (security), one as master bank (used to prepare new working batches) finally, a working bank (routine job). Each new working batch is prepared from the master bank.

The workflow allows to reduce the variability and to preserve the reproducibility of the different batches of all biological resources.

For each sample, the system identifies the deposit area, the proper temperature of storage, the equipment/instrument type (refrigerator, freezer, liquid nitrogen tank) and the real position of the samples. Each vial is identified by a barcode (data matrix) system, in order to ensure the correct identification of the sample.

The new Biobank system also enables IZSLER to publish all biological resources available.

Facility controls and staff involved

The storage of biological resources in a Biobank offers several advantages. In particular, the identification of a bio repository infrastructure reduces the economic costs related to the necessity of specific storing area, permitting different ways to collect samples and their traceability. Moreover, in a centralized infrastructure all samples are routinely submitted to quality controls that are carried out at pre-determined intervals, to reduce risks of degradation or viability losses during time. Furthermore, the security and alarm systems of a Biobank infrastructure prevent the irretrievably damage of samples, in case of electric power failure or storage equipment damages. Finally, quality parameters are better standardized among the laboratories with less variability in findings.

Mechanical freezers, refrigerators and nitrogen tanks are monitored by a real-time temperature monitoring and alarm system. Furthermore, a specifically designed biobank software system has been developed to provide the possibility of monitoring the temperature values with an alarm service.

To avoid any damage due to an interruption of electrical power, there is a generator with locally controlled production of electrical power.

Access to biobank infrastructure is restricted to authorized staff or other people accompanied by them. The authorized staff enters by logging with a specific badge. Staff involved in biobank activity has been trained and training update is performed annually. All people involved have a responsibility toward specific objectives of biobank like to provide high quality biological resources, to register them to efficiently and promptly activate the service requested to the public. All staff will comply with the quality management system procedures and it must be informed on any amendment.

A person responsible for quality assurance (QA) management has been identified and his activity is performed in accordance with biobank coordinator.

Biosecurity

Dangerous biological materials, like those stored at IZSLER Biobank, are stored in area/tanks protected by security devices. All biobank is managed as high security area and protected with physical security measures that allow to protect against unauthorized access to facilities and to material stored. Biobank area is also equipped with 24 hour intrusion detection system.

At IZSLER biobank, only biological resources already collected in the different laboratories of the Institute and belonging to list B of OIE and those that are not listed in Article 265 bis of "Testo Unico delle leggi Sanitarie" are stored in the current Biobank infrastructure. In general only agents belonging to 1 and 2 biological risk levels are stored at IZSLER biobank.

Informatics system security

Each biological resource record contains specific data and they are protected by the IT system that ensures their backup. Available data that describe the biological resources, origin, and other characteristics are spread through electronic catalogue on the web site of Biobank.

Moreover, the security of information is assured by authentication and by password.

Services related to Biobank activity

Below are reported some activities that can be performed upon request.

A) Quality controls and characterization testing
All laboratories that are involved in Biobank can perform tests on biological resources received from other organisations. This activity can be carried out on all biological resources of the same type of those collected at Biobank of IZSLER.

B) Production
It can be possible, to produce higher quantities of some biological products such as microbiological agents, viruses, cell cultures, chemical compounds etc.

C) Other requests
They are mainly related to some biological resources, used for research purposes and requested as positive reference standard samples.

Deposit

The capacity of this infrastructure allows to deposit biological resources for different purposes.

In particular, the following types of deposits can be offered.

1) Safe deposit: It regards different types of biological resources that can be stored at the different temperatures in the corresponding areas (room temperature, refrigerators: freezers, cryogenic tanks) (already available).

2) Open deposit: That is activated following a request by a depositor. This type of deposit is in progress (now available).

Detailed information can be found at Biobank web site (www.ibvr.org; "deposit").

Administrative procedures

Requests will be received by-e-mail and only following the agreement of the rules regarding this deposit and formally accepted following signing by both parties (the Depositor and the General Manager of IZSLER or his Delegate) the material will be accepted and submitted to the viability testing as established by the Regulations under the Budapest Treaty rules. A formal receipt will be sent to the Depositor and it will confirm receipt of the material in proper conditions. Furthermore, it will also include a record of the result of viability testing.

Each Depositor will be identified with a code number. All information will be registered in the IT system to which access is permitted only to trained staff and protected by password authentication.

MICROORGANISMS THAT ARE ACCEPTED FOR DEPOSIT UNDER THE BUDAPEST TREATY AT IZSLER BIOBANK

1. REQUIREMENT FOR DEPOSIT

(a) Kinds of Microorganisms that May Be Deposited

- Animal bacteria isolated from tissues and organs and from food;
- Human and Animal viruses.

IZSLER accepts for deposit microorganisms according to Directive 2000/54/C, on the Protection of Workers from Risks related to Exposure to Biological Agents at work of 18 September 2000 (OJ L262 page 21-45). At IZSLER, animal pathogens of level risk 1 and 2 will be accepted. Those listed in article 265 and  265 bis of "Testo Unico delle Leggi Sanitarie", respectively will not be accepted for deposit.

Viruses of humans of level risk 1 and 2 will be accepted at IZSLER.

No mixed microbiological cultures will be accepted. They will be accepted if sent separately.

IZSLER reserves the right to refuse any biological resources that represent a high hazard or that, for technical reasons, cannot be processed.

Biological resources can be sent frozen or freeze-dried and their storage will be made at -20°C, and -80°C according to the method that allows a long-term preservation of vitality and maintenance of the characteristic of the material.

(b) Technical Requirements and Procedures

(i) Form and Quantity

IZSLER has the following requirements for the form of the microorganisms that are submitted for deposit.

Bacteria and viruses should be sent frozen or freeze-dried cultures. Twelve vials must be provided from a single preparation and at a concentration of no less than 10⁵ viable units /vial.

The material for deposit must be tested and free from contamination by foreign microorganisms by the Depositor

(ii) Time Requested for Viability Testing

The time requested for testing the viability of the different kinds of microorganisms is below indicated. It must outlined that for slow growing microorganisms, tests for viability must be longer and they are indicated in the bracket

Bacteria - average time 14 days (up to 3 weeks)
Human and Animal Viruses - average time 20 days

(iii) Depositor Checks and Renewal of Stocks

In general, IZSLER does not prepare batches of bacteria and viruses and when the batches are exhausted it requests the depositor to make a new deposit. Only in particular case and following previous written consent of the depositor, IZSLER can prepare a new batch of the material.  However, the depositor has to control the quality characteristics of the material.

A portion of each original material supplied by the depositor is stored as master deposit.

(c) Administrative Requirements and Procedures

(i) General

Language
The official language of IZSLER is Italian. Communications and correspondence are accepted in Italian and in English.

Contract
A contract between IZSLER and the depositor must be prepared. It has to be signed by the both parties and the depositor acknowledges the conditions of the deposit under the Budapest Treaty, the rules and requirements to be observed and the relative liability in the event of an incident.

In particular, depositor has to declare the following:

- quantity and form of the material to be deposited;
- characteristics and biological risk of the material;
- payment of the fees charged;
- to comply with the requirements of the Budapest Treaty and with those of IZSLER notified to WIPO.

Import and/or Quarantine Regulations
IZSLER requests an import authorization from Italian Ministry of Health.

No quarantine regulation must be followed by microorganisms that are accepted by IZSLER.

Transport of infectious material in Italy is subjected to the package conforming to international regulations of the transport of hazardous materials.

(ii) Making the Original Deposit

Requirements to be met by the Depositor
Depositors have to complete and sign the contract and deposit forms for the Budapest Treaty deposits. Each form is specific for each type of Biological Resource.

In the event of a later indication or amendment of the scientific description and/or proposed taxonomic designation, the depositor is required to complete a BP/7 form which may be requested from IZSLER by e-mail.

Sending of Biological Resource to be deposited must be previously agreed between two parties.

Original deposit documents have to be sent together with the biological resource; however, it is advised to send them before sending by e-mail.

Official Notifications to the Depositor
The receipt and the viability statement are communicated by transmission of "international forms" BP/4 and BP9, respectively. Other notifications are sent by individual letters.

Any attestation concerning a change of the technical description and/or the proposed taxonomic designation will be delivered on form BP/8.

Furthermore, any notification on the furnishing of samples to third parties will be sent to the Depositor on form BP/14.

Official forms will be sent to the depositor only after the results of viability testing and when deposit is accepted. Accession number will be the same of the registration number.

Unofficial Notifications to the Depositor
IZSLER will communicate by e-mail the date of deposit and number of deposit before the official statement of receipt and viability testing are made.

Supply of Information to a Patent Agent
IZSLER will provide, if requested, information to the patent agent.

(iii) Converting a previous deposit

Deposit of other types (open deposit, safe deposit) can be converted by the depositor into deposit under the Budapest Treaty. In this event the depositor has to indicate the date on which the original deposit was received, the accession number of the biological resource, the name and address of the depositor and the request of conversion of the deposit and to maintain deposit and distribution of the microorganism for research purposes during the period specified in rule 9.1. In this event the batch has to be moved from the previous to the new deposit. In alternative, the depositor prepares a new batch to be deposited under the Budapest Treaty. The new deposit is subjected to the rules and administrative requirements of the Budapest Treaty.

(iv) Making a New Deposit

The depositor has to complete the BP/2 model form in order to make a new deposit and to send copies of the documents mentioned in Rule 6.2.

Statements of the receipt and viability testing are sent on mandatory international forms BP/5 and BP/9.

2. FURNISHING OF SAMPLES

(a) Requests for Samples

IZSLER notifies third parties of the correct procedures to order patent microorganisms. In the case of requests of proof of entitlement, IZSLER will send to requesting party copies of the model request form BP/12.

Third party will receive a microorganism under patent regulations following providing evidence that he is allowed to work with such a microorganism.

Moreover, all documents, including permit importations, are requested by IZSLER to respond to requests from overseas, or a declaration stating that no authorization is necessary for the proper shipping of the microorganism.

(b) Notification of the Depositor

Depositors are informed by BP/14 form on the distribution of a patent microorganism to third party

(c) Cataloguing of the Budapest Treaty Deposits

IZSLER does not publish list of deposits under the Budapest Treaty in any published catalogue.

3. SCHEDULE OF FEES

Guidance for Deposits

IZSLER provides a written note for the request of deposit under the Budapest Treaty. It is at the home page of IZSLER (www.ibvr.org). Further information can be requested by E-mail.

IZSLER FEES UNDER THE BUDAPEST TREATY

Value Added TAX (VAT) is added according to Italian regulations.