Patented Material Deposit

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

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.

Secrecy

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.

Patent Deposit Requirements

1)   Biological Material accepted as Patent Deposit

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.

2)   Guidelines for submission of biological material

All deposits must be preceded by:

 


BP/1 Statement in the case of an Original Deposit (Rule 6.1)

 

 

 To ensure that the material arrives safely and is handled appropriately, the following guidelines should be followed.

  • The material should be clearly labeled and identified. The designation on the vial labels should agree with the strain designation that have been listed on the deposit forms. When packaging vials, put all similarly labeled vials together in the package. When shipping frozen material, use enough dry ice in an insulated shipping container to ensure the material is adequately frozen upon arrival at IZSLER, taking into account any delays in transport;
  • provide material only in the required form and quantity;
  • provide a biohazard statement;
  • pay all necessary fees including all charges for the transportation of deposits to IZSLER;
  • observe the terms and conditions of the Budapest Treaty;
  • accept the terms and conditions of deposit of samples in IZSLER;
  • deposits must be covered by the appropriate regulatory documentation before being accepted.

3) Quality testing of Patent Deposits

Type of Patent Deposit

Quality Controls Tests Performed

Virus

Viability of virus performed according to instructions provided by the depositor on the patent deposit form

Bacteria

Viability test

Purity test

 Bacteriophage  
Viability of bacteriophage performed according to instructions provided by the depositor on the patent

 Plasmid in host strain/Plasmid DNA
 
Viability test/Transformation of plasmid DNA in a suitable host strain

 

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.

4) How to submit Patent Deposits

  • Complete the following forms: Biohazard Risk Assessment Form and BP/1 Statement in the Case of an Original Deposit (Rule 6.1). In particular, depositor has to declare: the quantity and form of the material to be deposit, the characteristics and biological risk of the material. The Biohazard Risk Assessment is a legal requirement in accordance with the Italian Health and Safety Laws. When completing the risk assessment, ensure that the possible pathogenicity of the microorganism to humans is indicated.
  • Submit completed forms to IZSLER.
  • Await notification from IZSLER prior to sending the patent deposit.
  • Acept the fees charged and comply with the requirements of the Budapest Treaty and of IZSLER (notified to WIPO).
  • Use correct packaging: packages should be clearly labelled with the storage temperature, sender’s contact information and the reference number. Transport of infectious material in Italy is subjected to the package conforming to international regulations of the transport of hazardous materials.
  • A patent deposit cannot be accepted unless 12 identical samples prepared from a single batch are supplied.
  • In case of bacteriophage, 12 frozen vials (1 mL each with a titre of at least 108 pfu/mL) are needed.
  • In case of plasmids in host strain, 12 lyphilized vials plus 3 agar cultures. In case of plasmids as purified DNA, 12 frozen vials (25 micrograms each). A suitable host strain needs to be deposited in an active form (2 slants).
  • Overseas depositors must contact IZSLER in advance, at least 48 hours before, for advice about the shipping of the microorganisms. IZSLER must be informed of the number of ampoules being sent, the method of transportation and the estimated time of arrival. If dispatch is by air, must be told to IZSLER the flight number and destination, waybill number and handling agent for delivery.

 

A batch may be rejected if:

  • The package is damaged in any way that could compromise containment
  • Appropriate transport temperatures have not been maintained
  • Vials are not completely sealed
  • Vials are not clearly labelled
  • 12 identical vials prepared from a single batch have not been provided.

Patent Depository storage fees

Patent Depository fees

Euros (€)

Bacteria

Freeze dried

608.80

Frozen at -80°C

701.27

Frozen liquid nitrogen

1448.27

Viruses

From embryonated chicken embyos

788.92

From cell coltures

1086.96

Bacteriophages

Frozen at -80°C

701.27

Frozen liquid nitrogen

1448.27

Plasmids

Freeze dried

608.80

Frozen at -80°C

701.27

 

Viability fees

Viability testing

Euros (€)

Issuance of viability testing

60

Bacteria

100

Virus

150


Bacteriophage

100

Plasmid

 110

Distribution fees

Furnishing of a sample (Plus shipping cost)

Euros (€)

Bacteria

105

Virus

400


Bacteriophage

400

Plasmid

105

Other fees

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:

Form BP/2 Statement in the Case of a New Deposit with the Same International Depositary Authority (Rule 6.2) Form BP/2 Statement in the Case of a New Deposit with the Same International Depositary Authority (Rule 6.2)
Form BP/3 Statement in the Case of a New Deposit with Another International Depositary Authority (Rule 6.2) Form BP/3 Statement in the Case of a New Deposit with Another International Depositary Authority (Rule 6.2)
Form BP/4 Receipt in the Case of an Original Deposit (Rule 7.1) (International Form) Form BP/4 Receipt in the Case of an Original Deposit (Rule 7.1) (International Form).pdf
Form BP/5 Receipt in the Case of a New Deposit (Rule 7.1) (International Form) Form BP/5 Receipt in the Case of the New Deposit (Rule 7.1) International Form)
Form BP/6 Receipt in the Case of a Transfer (Rule 7.1) (International Form) Form BP/6 Receipt in the Case of a Transfer (Rule 7.1) (International Form)
Form BP/7 Communication of the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.1) Form BP/7 Communication of the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.1)
Form BP/8 Attestation Concerning the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.2) Form BP/8 Attestation Concerning the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.2)
Form BP/9 Viability Statement (Rule 10.2) (International Form) Form BP/9 Viability Statement (Rule 10.2) (International Form)
Form BP/10 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.1) Form BP/10 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.1)
Form BP/11 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.2(ii)) Form BP/11 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.2(ii))
Form BP/12 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(a)) Form BP/12 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(a))
Form BP/13 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(b)) Form BP/13 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(b))
Form BP/14 Notification of the Furnishing of Samples of Deposited Microorganisms (Rule 11.4(g)) Form BP/14 Notification of the Furnishing of Samples of Deposited Microorganisms (Rule 11.4 (g))

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