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Budapest Notification No. 355
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 Poland Relating to the Acquisition of the Status of International Depositary Authority by the Collection of Plasmids and Microorganisms (KPD)

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 Poland, on December 20, 2022, of a communication, dated December 19, 2022, relating to the acquisition of the status of International Depositary Authority by the Collection of Plasmids and Microorganisms (KPD), which states that this Depositary Institution is located on the territory of Poland 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 ("Budapest Treaty").

Pursuant to Article 7(2)(b) of the Budapest Treaty, the Collection of Plasmids and Microorganisms (KPD) shall acquire the status of International Depositary Authority under the Budapest Treaty on January 26, 2023, that is, on the date of publication of the communication by the International Bureau.

January 19, 2023


Text of the information communicated by the Government of the Republic of Poland relating to the acquisition of the status of International Depositary Authority by the Collection of Plasmids and Microorganisms (KPD)

[Original: English]

INFORMATION COMMUNICATED

1. Name and address

    COLLECTION OF PLASMIDS AND MICROORGANISMS (KPD)
    University of Gdansk
    Wita Stwosza 59
    80-308 Gdansk Poland

    Tel. +48 58 523 60 70
    E-mail: kpd@ug.edu.pl; anna.kaczorowska@ug.edu.pl
    www:https://kpd.ug.edu.pl

2. Legal status

Collection of Plasmids and Microorganisms (KPD), located in Gdansk, Poland, is a microbial resource centre affiliated with the University of Gdansk.  The University of Gdansk (UG) has a legal personality and was established as a public university under the provisions of the Regulation of the Council of Ministers in 1970 (Journal of Laws No. 6 item. 49).  Since then, the University has developed into the largest institution of higher education in northern Poland and has gained recognition for its research in biology, biotechnology, biomedicine, oceanography and quantum physics.

In 2016, taking the opportunity provided by the funds of the Operational Programme Infrastructure and Environmental and the European Regional Development Fund 2014-2020, UG transformed its main campus into a modern, sophisticated research-educational centre with three new, fully equipped buildings housing the Faculty of Biology, Faculty of Chemistry, and Intercollegiate Faculty of Biotechnology, providing an impetus for interdisciplinary research.  The University of Gdansk has established links with some 120 university-level institutions across Europe and around the world.  It has created and runs two international research centres, including the International Centre for Cancer Vaccine Science under the International Research Agendas Programme of the Foundation for Polish Science and the European Union within the framework of the European Regional Development Fund.  UG is also a member of the 'European University of the Seas' (SEA-EU) alliance launched as part of the flagship 'European University Initiative' of the European Commission.  In 2020, to bolster scientific cooperation between three major academic institutions of Gdansk's city and to consolidate their research potential, UG, together with the Gdansk University of Technology and the Medical University of Gdansk established the Daniel Fahrenheit Association of Gdansk Universities.

KPD was formally established in 2014 as an independent unit at the Faculty of Biology of the University of Gdansk under the Rector's Ordinance No 16/R/14, with a mission to provide open access to high-quality microbial resources and associated data and promote scientific integrity by making published research material available to others.  KPD's operation is sustained by financial support from the University of Gdansk and the Polish Ministry of Education and Science.

KPD is registered at the World Date Centre of Microorganisms (WDCM) under the number 1084.  It has been a member of the European Culture Collections' Organisation (ECCO) since 2016.

3. Facilities and equipment

In accordance with Article 6(2)(ii) of the Treaty, KPD has the facilities necessary to perform its scientific and administrative tasks under the Treaty.

KPD is located at the new premises of the Faculty of Biology of the University of Gdansk, Baltic Campus, built under the Operational Programme Infrastructure and Environment, co-financed by The European Regional Development Fund (ERDF).  It possesses independent, fully equipped BSL-2 laboratories (with a total area of circa 100 square meters), including a laboratory for microbial identification and characterisation, samples repository, lyophilisation room, room for liquid nitrogen storage, and office space dedicated to the storage of data and documentation pertaining to the culture collection.

With the Department of Microbiology located on the same floor, KPD shares a media-preparation room, glassware washing room, sterilisation room with several autoclaves, cold storage rooms, incubation rooms, dark room and stockroom for safe chemical storage.  Also, it has full access to molecular biology laboratories located in the Department of Microbiology and all shared infrastructure within the Faculty of Biology.

Consistent with Rule 2.2 of the Regulations, KPD's advanced research infrastructure enables the long-term preservation of deposited microorganisms, maintaining their physical, genetic, and functional stability, as well as distribution of authenticated microbial strains and DNA samples (e.g. recombinant plasmids).

KPD's equipment encompasses orbital shakers and culture incubators, gradient thermocyclers, TapeStation system for DNA capillary electrophoresis, an automated system for digital PCR, an automated liquid handling system (epMotion station), MiSeq next-generation sequencer, MALDI TOF spectrometer for rapid microbial identification (MALDI Biotyper) and Omnilog Combo Plus ID system for automated and cell phenotyping.  KPD also possess a platform for complex biochemical and biophysical protein characterisation allowing for the determination of protein thermal and chemical stability as well as measuring biomolecular interactions (Monolith and Prometheus).

Equipment for long-term preservation includes an isothermal liquid nitrogen freezer with an auto-fill and monitor system, which controls the automatic filling of the liquid nitrogen jacket, deep freezers and lab refrigerators, enabling storage of samples at +4°C, -20°C, -80°C and -190°C.  Cultures received for deposit under the Budapest Treaty will be preserved as glycerol stock at -80°C, by freeze-drying and/or in liquid nitrogen vapour.

All storage spaces and laboratories are equipped with an alarm system and are continuously monitored for temperature.

Access to all laboratories is under electronic surveillance with CCTV cameras and restricted to the staff with digitally programmed key cards preventing unauthorised access to the facilities and ensuring that only the qualified personnel within the facilities can access the stored biological material.

4. Scientific level

KPD maintains a scientific collection of more than 1,300 publicly available microbial strains.  Established initially to preserve Escherichia coli laboratory strains deposited by the members of the scientific community working on molecular biology and microbial genetics at the University of Gdansk, the collection expanded to meet the biotech industry's needs and include environmental and clinical bacterial strains.  KPD houses plasmids, cloning vectors, expression systems, recombinant DNA constructs, bacterial strains with a potential application as tools in molecular biology, biotechnology and bioengineering, and natural bacterial strains isolated from diverse environments.  The collection is steadily growing through extensive collaboration with individual researchers and research teams in academia and the public health sector.

KPD supports open bioscience by facilitating access to published research material and providing authenticated strains for biotechnological applications and innovative solutions to the most pressing problems like growing antimicrobial resistance.  For example, several published studies on testing the efficiency of alternative antimicrobial agents used a panel of recent clinical multi-drug resistant clinical isolates deposited in KPD.

Since the very beginning, KPD has been networking with the scientific community within the country and abroad.  KPD was instrumental in placing microbial culture collections on the Polish Roadmap of Research Infrastructures, defining undertakings of strategic importance to the development of Polish science and its competitiveness, in 2014.  This success was followed by three consecutive investment grants from the Polish Ministry of Science and Higher Education for purchasing capital equipment.  The government funding enabled KPD to develop state-of-the-art research infrastructure and create an open and collaborative environment for conducting excellent research.  The cutting-edge technology implemented at KPD is used by several research teams in studies supported by the Polish National Science Centre and going beyond the areas of microbiology.

KPD's staff participated in several international research projects on exploiting the biotechnological potential of bioresources from extreme or marine environments, funded under the European Union 7th Framework Programme for Research and Technological Development, Horizon 2020, under the Norwegian Financial Mechanism, or cooperation activities under the lnterreg Baltic Sea Region Programme.

KPD has also been involved in activities to establish the European Consortium of Microbial Resource Research Infrastructure (MIRRI-ERIC), of which Poland is a prospective member.

The collection curator has been a member of the Forum of Interim National Coordinators of MIRRI.

KPD is active at a local level in the Pomerania region; it joined a partnership for regional smart specialisation "Long Healthy Life - Innovations in the prevention, diagnosis and therapy of civilization diseases and ageing society".

The collection operates in compliance with international guidelines, including World Federation for Culture Collection (WFCC) guidelines for culture collections, the Common Access to Biotechnology Resources Information (CABRI) Guidelines and Organisation for Economic Co-operation and Development (OECD) "Best Practice Guidelines for Biological Resource Centers".

5. Staff

In accordance with Article 6(2)(ii) of the Budapest Treaty, the KPD has competent staff to perform its scientific and administrative tasks under the Treaty.

KPD is headed by the collection curator with a doctoral degree with extensive professional experience in molecular biology and microbiology and international collaboration.  The curator acquired knowledge and practical skills in the methodology and principles of preservation of biological material and management of biological resource centres and core facilities through training organised by recognised European microbial collections.  All administrative tasks pertaining to the KPD are performed by an administration specialist working in the collection.  The technical staff responsible for basic media preparation, autoclaving, maintenance of essential microbiological equipment in operating condition, cleaning glassware, decontamination and utilisation of cultured materials according to the regulations is shared with the neighbouring Department of Microbiology.  KPD also has sustainable support from the microbiology and molecular research biology group at the Department of Microbiology in the area of human resources for scientific tasks.

The supplied biological material for patent purposes and administrative work related to deposits will be handled by the dedicated, permanent staff employed at the KPD on a full-time basis.  Given the increased need for laboratory work, additional staff scientists will be employed.

KPD staff have familiarised themselves with the Code of Practice for Institutions that are International Depositary Authorities (IDAs), published in December 2018, and are committed to providing quality service to future depositors.

6. Types of microorganisms accepted for deposit

KPD accepts pathogenic and non-pathogenic bacteria, archaea, genetically modified microorganisms, microbial consortia, and plasmids in a host and/or as isolated DNA preparations, which can be handled under containment levels 1 and 2.  Pathogens belonging to a hazard group higher than Risk group 2 according to the EU directive 2000/54/EC and its updates are excluded.  Class 2 genetically modified microorganisms may be accepted for deposit; however, the period for completion of a deposit will be longer to allow for the sufficient time needed to meet regulatory requirements.

Microorganisms should be submitted for deposit as lyophilised preparations.  The depositor must supply 25 ampoules of freeze-dried cells of the same batch.  The freeze-dried cells of one or more of these ampoules will be subjected to a viability test.

Plasmids need to be sent together with a suitable host if such a host is not available in the public KPD collection.  The non-publicly available host provided by the Depositor needs to be deposited separately in the public KPD collection or as a separate deposit under the Regulations of the Budapest Treaty.  Plasmids can be sent within a freeze-dried host or as isolated DNA preparations.  The minimum amount of isolated DNA that must be supplied by the depositor when making their deposit is 12 microtubes of 20 micrograms of ethanol-precipitated DNA.  The plasmid DNA must have a sufficient degree of purity and integrity to ensure a successful transformation.

In the case of microbial consortia or mixtures of microorganisms, KPD recommends that the Depositor separates the different components and deposits them individually.  In such cases, the Depositor is charged for each separate deposit.  Exceptionally, KPD may also accept deposits of defined mixtures of microorganisms on the conditions that (i) it is possible to ensure that the mixture can be preserved without losing one of the components, (ii) the individual components can easily be distinguished macroscopically, and (iii) it is possible to test the viability of each of the organisms in the mixture individually.  However, KPD is not responsible for changes in the characteristics of the properties of the consortium once it has been deposited.  The acceptance of mixtures of microorganisms is subject to the KPD curator's decision, and the fees related thereto must be fixed on an individual basis by prior negotiation with the prospective Depositor.

Contaminated cultures, undefined, unidentifiable microorganisms, strains with no scientific description and/or proposed taxonomic designation whose identity cannot be verified will not be accepted.

All deposits should be able to withstand preservation by either freeze-drying or freezing over liquid nitrogen, or by some other method of long-term preservation without any significant change to their properties.

The KPD reserves the right to refuse to accept for deposit material that is technically or legally too difficult to manage, or which in its view represents an unacceptable hazard, or it is not in a position to process.

7. Official languages

The official language of the KPD is English.  Communications are also accepted in Polish.

8. Technical requirements and procedures

In accordance with Rule 6.3(a) of the Regulations, KPD requires that:

    - that the microorganism be deposited in the form and quantity necessary for the purposes of the Treaty and the Regulations;

    - that the application and accession form used by the KPD for deposits under the Budapest Treaty, equivalent to model BP/1, is duly completed by the depositor;

    - that the written statement referred to in Rule 6.1(a) or 6.2(a) be drafted correctly in English;

    - that the fee for storage referred to in Rule 12.1(a)(i) be paid;

    - that necessary permission for transportation and deposit be obtained by the depositor, and

    - that, to the extent permitted by the applicable law, the depositor signs the "Patent Deposit" contract with KPD defining the respective liabilities of the parties.

In accordance with the Regulations, KPD will:

    - verify the viability of each deposit and will store it;

    - issue receipts, viability statements and other requisite official notices;

    - conform to the secrecy required by Rule 9.2; and

    - furnish the samples under the conditions and according to the procedures envisaged in Rule 11.

9. Schedule of Fees

    In PLN
Preservation
  Storage according to Rule 12.1(a)(i) (comprising the initial viability check, the preservation and storage of biological materian( � 1200
  Conversion of a deposit made outside the Budapest Treaty into a deposit according to the Budapest Treaty (comprising of the initial viability check, the preservation and storage of biological materian( � 1200
  Prolongation of the duration of the storage over the one provided by Rule 9 of the Regulations under the Budapest Treaty, per year 100
Issuance of a viability statementaccording to Rule 12.1(a)(iii) of the Regulations under the Budapest Treaty
  where a viability test is requested 150
  based on the most recent viability test 50
Furnishing of samples
  To the depositor, according to Rule 11.2 (i) of the Regulation under the Budapest Treaty 200
  To a third party according to Rule 11.2 (ii) and 11.3 of the Regulations under the Budapest Treaty 200
Communications and attestations
  Communication of information under Rule 7.6 of the Regulations under the Budapest Treaty 50
  Attestation referred to in Rule 8.2 of the Regulations under the Budapest Treaty 50

Fees (in Polish zloty) do not include shipping costs or bank fees, or Value-added tax (VAT).  (For customers outside Europe, no VAT will be added).