The Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna “Bruno Ubertini” (IZSLER) aquired the status of International Depositary Authority under the Budapest Treaty on February 9, 2015.
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was introduced in 1980 in an effort to implement such recommendations. The States party to this Treaty constitute a Union for the international recognition of the biological material deposit to overcome the difficulties which arose from different national patent regulations.
According to the Treaty, certain scientifically recognized independent culture collections could obtain the status of an "International Depositary Authority" (IDA) for microorganisms, sets out the minimum standards for such collecting authorities, and also sets out the guidelines for the deposit. Under the Treaty a deposit made in the IDA is recognized as valid by all Contracting States of the Budapest Union. Such an institution acquires the status of “international depositary authority” through the furnishing, by one of the Contracting States, of assurances to the Director General of the World Intellectual Property Organization (WIPO) (http://www.wipo.int/portal/en/index.html) to the effect that the said institution complies and will continue to comply with definite requirements, including, in particular, that it will be available, for the purposes of the deposit of microorganisms, to any “depositor”, that it will accept and store the deposited microorganisms and that it will furnish samples thereof to anyone entitled to such samples but to no one else.
According to Rule 9 of the Budapest Treaty, IZSLER keeps strict secrecy regarding the deposit, its nature and the depositor. All material and information is handled strictly confidentially. Furthermore, strains deposited under the Budapest Treaty will by no means included in the IZSLER catalogues or any openly available lists.
IZSLER accepts and store as patent deposits: 1) animal bacteria isolated from tissues and organs and from food, 2) human and animal viruses of level risk 1 and 2, 3) bacteriophages and 4) plasmid in host strain or as purified DNA . 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. IZSLER accepts for deposit all microorganisms and viruses classified in the level risk 2, according to EEC Directive 2000/54/EC on the Protection of Workers from Risks Related to Exposure to Biological Agents at Work of 18 September 2000.
Biological resources can be sent frozen or freeze-dried and their storage will be made at -20°C, -80°C and in vapour phase nitrogen according to the method that allows a long term preservation of vitality and maintenance of the characteristic of the material.
Every deposit is assigned a unique accession number on arrival that is provisional until the patent has proved viable and purity evaluated following quality control testing, depending on the type of patent deposit.
The average time requested for testing the viability is: 14 days (up to 3 weeks) for bacteria, 20 days for viruses and bacteriophage, and 8-10 days for plasmids.
Once viability testing has been completed by IZSLER, a certificate of deposit with viability testing results is provided to the depositor.
All deposits must be preceded by:
Biohazard Risk Assessment Form
To ensure that the material arrives safely and is handled appropriately, the following guidelines should be followed.
Type of Patent Deposit
Quality Controls Tests Performed
Viability of virus performed according to instructions provided by the depositor on the patent deposit form
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.
A batch may be rejected if:
Patent Depository fees
Frozen at -80°C
Frozen liquid nitrogen
From embryonated chicken embyos
From cell coltures
Issuance of viability testing
Furnishing of a sample (Plus shipping cost)
Communication of information or issuance of an attestation € 50
Fees are added with Value Added TAX (VAT) according to Italian regulations.
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 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.
To ask for a deposit, please use the following forms: