THE SYSTEM OF INTERNATIONAL DEPOSITARY AUTHORITIES

THEIR DUTIES AND RESPONSIBILITIES

Dagmar Fritze, INPI, Brazil, 2008

• biotechnology and biomedicine were booming in the60ies and 70ies

• increasing demand for ready availability of livingbiological material for the emerging biotechnological and medical industries

• WFCC had been formed: ICCC-I was held in Japan in 1968,additional regional substructures were being set up

• traditional in-house research collections were beingtransformed into service culture collections

• patentability of living biological material was finallyaccepted by most countries on the premises that thismaterial is deposited with a service culture collection; e.g. European Patent Convention, Rule 28, 1973.

Foundation of IDAs needs to be seen in the context of international developments and as a response to

emerging biotechnology

• An invention is disclosed by means of a writtendescription ;

Where an invention involves a microorganism orthe use of a microorganism, disclosure is notpossible in writing but can only be effected by themaking available of a culture independently fromthe patentee

• Patent offices are not equipped to handle microorganisms;

Preservation requires special expertise and equipment to keep them viable, to protect them fromcontamination and to protect health or theenvironment from contamination. The furnishing of samples also requires specialized expertise and equipment

The raison d‘ être of IDAs

Before the Budapest Treaty :

individual service culture collections were recognized nationally as a national patent repository

e.g. 1974 DSM(Z) is recognized by the German Governmentunder Rule 28 by the European Patent Officeand later also by individual other patent offices

The raison d‘ être of IDAs

Budapest Treaty on the International Recognition of theDeposit of Microorganisms for the Purposes of Patent

Procedure

adopted in Budapest 1977

coming into force 1980

Regulations (Rules) amended 1981 and 2002

coining the term ‘International Depositary Authority‘

[Note: the BT intentionally uses the term 'deposita ry ' and not 'deposito ry ' – marking the important difference, that the collections would not act as mere 'tanks' in which some material is stored, but would take over the important custodial responsibility of the microbiologically trained party in the process chain of patent application]

• The main feature of the BT is that a contracting statewhich allows or requires the deposit of microorganisms for the purposes of patent proceduremust recognize, for such purposes, the deposit of a microorganism with any “international depositaryauthority”, irrespective of whether such authority is on or outside the territory of the said state.

• What the Treaty calls an “international depositaryauthority” is a scientific institution - typically a “culturecollection” - which is capable of storingmicroorganisms.

The raison d‘ être and definition of an IDA

The raison d‘ être and definition of an IDA

● status of “international depositary authority” isacquired through the furnishing , by one of theContracting States, of assurances to the DirectorGeneral of WIPO to the effect that this institutioncomplies and will continue to comply with certainrequirements, including, in particular, that it

● will be available , for the purposes of thedeposit of microorganisms, to any“depositor” (person, firm, etc.)

● that it will accept and store the depositedmicroorganisms and

● that it will furnish samples thereof to anyone entitled to such samples but to no one else .

assurances may be furnished also by certainintergovernmental industrial property organizations(see Article 9(1)(a)).

• these assurances to the seriousness and continuedexistence are addressed to all the Contracting States of the Budapest Union

• Consequently, it may be expected that the assuranceswill be strictly respected, and, if they are notrespected , the Contracting States may take away thestatus of international depositary authority.

The raison d‘ être and definition of an IDA

This term is used in the original text of the Budapest Treaty (formulated in 1977 ). Today, a modern definition of WIPO says that, taking into account scientific progress, the term ‘microorganism’ should be understood in the context of the patent system to embrace any living biological matter, that can be deposited and is accepted by an IDA.

The European Patent Convention (EPC) additionally specifies in its Rule 28 :

• for patent purposes living biological material is accepted;

• living biological material is characterized by containing genetic information which renders the entity capabl e of self-reproduction or capable of being reproduced in a bi ological system.

A note with respect to the term 'microorganism' in patent matters:

What Kind of Biological Material isSubsumed under the Term Microorganism?

TRADITIONAL MICROBIOLOGY

ALGAE PROTOZOA

FUNGI

BACTERIAARCHAEA

VIRUSES

PLANT, ANIMAL, HUMAN CELL CULTURES

GENETIC MATERIAL

SEEDS

1981 First IDAS: ATCC, CBS, DSM(Z), IPOD (ex NIBH, ex FRI) and NRRL recognized by WIPO

1982 – ‘84 CCAP, CNCM, ECACC, IMI, NCTC, NCYC, and NCIMB

1986 – ’88 NBIMCC, NCAIM, NMI, NRCA, VKM and VKPM

1990 – ’93 BCCM, CCM, CCY, CECT, KCCM, KCLRF, and KCTC

1995 – ’98 ABC, CCTCC, CGMCC, DBVPG, MSCL and NMLHC

2000 – ’05 BNA, IAFB, MTCC, NIBSC and PCM

IDAs as of 31st January ’08: 37

BT Member States as of 31st of January ‘08: 68

RECOGNITION OF STATUS OF IDA

IDAs world-wide

DSMZ

IDAs OF THE WORLD

SAFE

= protected from destruction by fire

= from theft

= from flooding

= from physical factors influencingsurvival rates (bright light, heat, thawing)

= technical / handling failure(mislabelling, breakdown of electricity)

= improper laboratory handling

The safe and long term storage is a central dutyfor IDAs - What does safe mean?

Phase ContrastMicroscope; standardmagnification: x40; x100

Dissecting Microscope; standard magnification: x0,8 – x2

MACROSCOPIC EXAMINATION

MACROSCOPIC EXAMINATION

MACROSCOPIC EXAMINATION

MACROSCOPIC EXAMINATION

MICROPHOTOGRAPH OF A SIMPLE AQUEOUS MOUNT OF A SPOREFORMING ORGANISM

Bacillus subtilis subsp. subtilis DSM 10T

MICROPHOTOGRAPH OF AN AGAR-SLIDE PREPARATION OF A SPOREFORMING ORGANISM

Other areas of responsibility that need to becovered by IDAs

• good microbiological practice

• biosafety, biosecurity measures

• protection of employees

• protection of environment

• diligent processing of deposits and releases

• proper transport

Some examples for the legal background forresponsibilities:

● Convention on Biological Diversity

● Bonn Guidelines on Access to Genetic Resources

● Cartagena Protocol on Biosafety

[● EC Directive 93/88/EEC on Biological Agents]

[● Accord Européen Relatif au Transport International desMerchandises Dangereuses par Routes (ADR)]

● IATA Dangerous Goods Regulations (DGR)

● UPU Regulations for Postal Services

[● EU Council Regulation 3381/94/EEC on the Control of Exports of Dual-Use Goods from the Community]

● Emerging legislation on biosecurity

● various kinds of prescribed handling permits

• CBD does respect existing patents but suggestsaccess and benefit sharing (e.g. technology transfer)

• however, most patent offices do not require that theinformation on country of origin is given and an IDA may have no measures to ask for this kind of information

e.g. the European Patent Law does not require the information on the country of origin to be included in the patent documentation

whereas e.g. the Norwegian Patent Law does require this information or information on the providing country and on the obtained prior consent

Patent depositaries and CBD

THE BUDAPEST TREATY CLEARLY REGULATES THE OBLIGATIONS AND RIGHTS OF PATENT OFFICES, PATENT HOLDERS, DEPOSITARIESAND THIRD PARTIES WITH RESPECT TO THE BIOLOGICAL MATERIAL

The provisions of the Budapest Treaty offer regulations withregard to

● the setting up and themaintenance of an IDA

● the daily work of an IDA

● advice to the depositor

Art. 6 (1) Qualifying for the Status of IDAtogether with

Rule2.1 Legal Status

It is described what kind of institution may qualify for an IDA, and whatrequirements it needs to comply with.

".. must benefit from the assurances furnished by that state to the effectthat the said institution complies and will continue to comply with therequirements specified ..„

Art.6 (2) Requirements to become or to remain an IDAtogether with

Rule2.2 Staff and FacilitiesRule2.3 Furnishing of Samples ('expeditious and proper manner')

Details on abilities are given which the IDA must be ready to comply withto obtain and keep this status.

PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE SETTING UP AND MAINTENANCE OF AN IDA (1)

Art.7 Acquisition of Status: Communication of Technical Facilities of theprospective IDA

together withRule 3 Acquisition of StatusRule3.1Communication to the Director GeneralRule3.3 Extension of the List of Microorganisms Accepted

The administrative procedure of how to acquire the status of IDA, e.g. through diplomatic channels, to the Director general of WIPO is described.

Art. 8 (1) Termination of FunctionArt. 8 (2) Withdrawal of Declaration of Contracting State

together withRule 4.1 Processing of RequestRule 4.2 Communication of TerminationRule 4.3 Consequences for DepositsRule 5.1 Processing of DiscontinuanceRule 5.2 Processing of Refusal

The administrative process is described of how to proceed whenterminating or limiting the status of IDA according to external request or on own decision.

PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE SETTING UP AND MAINTENANCE OF AN IDA (2)

Rule 6.1 Making the Original Deposit

It is described what information needs to be given by the depositor

Rule 6.2 Making the New Deposit

It is described how to proceed when a new deposit of the same material needs to be made

Rule 6.3 Requirements by IDA

The requirements that may be set by the IDA are described. These need to be communicated to WIPO and published.

Rule 6.4 Acceptance Procedure

It is described under which circumstances to accept or not to acceptbiological material and which date is considered to be the deposition date.

PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE DAILY WORK OF AN IDA (1)

Rule 7 Receipt

Form, contents and processing of the official statement of receipt and acceptance to be issued by the IDA is described for the cases of original or new deposit or transfer of biological material.

Rule 8 Later Indications of Scientific Descriptions/Taxonomic Designations

Amendments of scientific descriptions and taxonomic designationsmay be made at any time.

Rule 9.1 Duration of Storage

Rule 9.2 Secrecy

Duration of storage is at least 30 years (plus 5 years after the most recentrequest for a sample)

Information on the fact of a deposit as well as on the nature of thedeposited material may be given only to authorized third parties .

PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE DAILY WORK OF AN IDA (2)

Rule 10 Viability Test and Statement

The processing of viability tests and the issuing of the officialstatement of viability by the IDA, as well as the contents of thisstatement are described.

Rule 11 Furnishing of Samplestogether with

Rule 2.3 Furnishing of Samples ('expeditious and proper manner')

It is explained who is entitled and when to obtain a sample, thecontents of the forms to be used, the languages to be used and the information that should accompany the sample when shipped.

Rule 12 Fees

Fees may be levied for the following services: storage (one fee forthe whole duration), attestation under rule 8.2, issuance of viabilitystatements (rule 10.2 (e)), furnishing of samples (rule 11.4 (h)), communication of information under rule 7.6.

PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE DAILY WORK OF AN IDA (3)

Article 3: Recognition and Effect of the Deposit of Microorganisms

Contracting states shall recognize ... the deposit of a microorganismwith any IDA ..

Article 4: New Deposit

(..) when the biological material is no longer viable at IDA, thedepositor may make a new deposit

(..) when e.g. export restrictions imposed by home country of the IDA prevent a foreign authorized third party from receiving a sample, thedepositor may deposit with another IDA

(.. ) when the IDA cannot furnish samples for any other reason

in connection with

Rule 6: Making the Original Deposit or New Deposit

ARTICLES AND RULES OF THE BT OF SPECIAL IMPORTANCE TO THE DEPOSITOR

● access to building as restricted as possible

● handling of deposits as separate as possible (preferably separate department)

● access to patent cultures and documentation for specific personnell only

● signature of involved staff requested under declaration of confidentiality

● locking away of working cultures and papers (separate laboratory and office, or, e.g., separate lockable incubators and drawers )

● long term storage of cultures separately in a locked room, in lockedrefrigerators or freezers , access for specific personnell only

● storage of documentation in lockable cabinets and/or on computers whichare not connected to a network and are not online accessible

● information about deposited strains to be given only to persons entitledto receive a sample of a deposited strain; even then only the informationspecified in Rule 9.2 resp. Rule 11.4 (f) (copy of the statement of receipt, cultivation conditions, indications whether the organism is dangerous) or as specified under Rule 7.6 (most recent scientific description/taxonomicdesignation.

COMPLIANCE WITH CONFIDENTIALITY

• Issuance of accession number

• Release of samples

• Release of information

PROBLEM

----- pressure ------ pity ------ accusations -----

Three central points of responsibilities and attentiveness for an IDA

The part of an IDA in the process of patent procedures

filing of patent documents

deposit at IDA; latestsame date

publicationof documentsand firstavailabilityof samplesand infochecking of

viability, purity and probability

formal checking

acceptanceand provisionof accessionnumber

potential competitorcan readdocumentsand obtainsamplesforcheckinginvention

parties

patent office

depositary

inventorpatenteedepositor

checking of novelty, etc

third

deposit date becomes valid

THANK YOU !

STORAGE OF FREEZE-DRIED AMPOULES

LIQUID NITROGEN STORAGE

Measures that should be taken at service collectionwith respect to CBD

• Information on CBD in catalogue and internet fordepositors and recipients of strains that regulations of CBD must be observed

additionally

• For depositors: on open catalogue collection accessionform it is asked for information on country of origin

• For recipients: on delivery slip ‘do not pass on to thirdparties‘

WHAT IS COVERED IN THE BT?

• PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE SETTING UP AND MAINTENANCE OF AN IDA

• PROVISIONS OF THE BUDAPEST TREATY WITH REGARD TO THE DAILY WORK OF AN IDA

• ARTICLES AND RULES OF THE BT OF SPECIAL IMPORTANCE TO THE DEPOSITOR