IDAs - 30 YEARS OF EXPERIENCES WORLD-WIDELeibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen...

Leibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH

IDAs - 30 YEARS OF EXPERIENCES

WORLD-WIDE

119

145

240

127

150

119

145

240

127

150

16

54

2128

6

16

54

2128

61

39 4348

57

1

39 4348

57

27

46

93

8

2027

46

93

8

2020

0 3 0

20

0 3 04

0 2 3 240 2 3 2

72

112

149

54 54

72

112

149

54 54

Year of deposit1990 1995 2000 2005 2007

0

50

100

150

200

250

bacteria fungi/yeasts

human/animal cell cultures plasmid DNAs

bacteriophages others

GMOs

Kinds of biological material deposited per year at the DSMZ

Dr. Vera WeihsLeibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbHInhoffenstr. 7 BD-38124 Braunschweig [email protected] ICCC 12, Florianópolis, September 30, 2010


ICCC 12, Florianópolis, September 30,

2010

Budapest Treaty on the International Recognition of the Deposit

of Microorganisms for the Purposes of Patent Procedure

Certain culture collections are recognized as

„International Depositary Authorities“

Any contracting state must recognize a deposit made

in any IDA

done in 1977, in force since 1980


ICCC 12, Florianópolis, September 30, 2010

583

84

39

0

100

200

300

400

500

600

registered with WDCM patent depositary IDA (Budapest Treaty)

Qualification of culture collections


ICCC 12, Florianópolis, September 30, 201039 as of 09/2010

IDAs World-Wide

09/2010

DSMZ

7



The DSMZ – a Biological Resource Center

www.dsmz.de



BRC‘s According to OECD



5

4

2 2

1

4

1 1

2

4

1

2

1

2

1

2

1

2

1

2

1 1

1981 1982 19831984 1985 198619871988 19891990 1991 19921993 1994 19951996 19971998 1999 2000 20012002 20032004 2005 20062007 2008 2009 20100

1

2

3

4

5

acquisition of IDA status

termination of IDA status

Increase in numbers of IDAs

1981: ATCC, NRRL, FRI, CBS, DSM 2010: CBA, VTTCC



1134

0

883

1127

050

944

0

558

1594

0 18

North America

South America

Europe

Asia

Africa

Australia

0

200

400

600

800

1000

1200

1400

1600

2001

2009

per continent in 2001 und 2009

Deposits according to the Budapest Treaty

Total: 70.000



Kinds of Microorganisms Accepted for Deposit/Continent

1

2

4

3

19

7

1

3

15

7

1

2

7

4

11

2

4

1

13

3

1

5

6

1

2 2

3

18

7

1

America Europe Asia Australia0

5

10

15

20

algae

bacteria

fungi

human & animal cells

plant viruses

plant cell cultures

plasmid DNA

protozoa

yeasts


1-2Bacteria, fungi, yeastsNCAIM

1Animal, human and plant cell culturesKCLRF

1Bacteria, fungi, yeastsVKM

1-2Fungi, yeasts, bacteria, plasmid DNA, animal cell cultures, embryos, protozoa, plant cell cultures, seeds, algae

IPOD

2Fungi, bacteria, nematodesIMI

2Bacteria, fungi, yeasts, bacteriophages, plasmid DNA, plant viruses, plant cell cultures, animal and human cell cultures, murine embryos

DSMZ

1Algae, free-living protozoa, microorganismsCCAP

3; 2 for GEMsBacteria, fungi, yeasts, bacteriophages, plasmid DNACBS

1Microalgae, cyanobacteria and macroalgaeBNA

2 * 3Bacteria, fungi, yeasts, plasmid DNA, RNA, animal and human cell lines*BCCM

4

3 for GEMs

Algae, bacteria, fungi, yeasts, embryos, human, animal and plant cell cultures, bacteriophages, animal and plant viruses, seeds, DNA, RNA, protozoa

ATCC

2Animal and human cell linesABC

Containment level

Kinds of Biological Material Material AcceptedIDA (12 out

of 39)



2010

Group 1

Unlikely to cause human disease

Risk Group 2

Risk Group 3

Risk Group 4

Can cause human disease; low risk for the employees; unlikely

to spread to the community; effective prophylaxis and treatment

Can cause severe human disease; serious hazard for the employee;

risk to spread to the community; effective prophylaxis and treatment

Definition of Risk Groups - WHO

Causes severe human disease; serious hazard to the employee; high

risk to spread to the community; no effective prophylaxis or treatment



Classification of Microorganisms – Legal Background

International WHO Laboratory Biosafety Manual (2004)

national

Canada Laboratory Biosafety Guidelines, Health Canada

(Laboratory Center for Disease Control) (2004)

Germany Classification of fungi/bacteria, TRBA 460/466,

Federal Ministry for Labour and Social Order

USA Biosafety in Microbiological and Biomedical Laboratories, U.S.

Department of Health and Human Services Public Health Service,

CDC and NIH (2007)

Europe Directive 2000/54/EC on the protection of workers from risks related

to exposure to biological agents at work (European Parliament) (2000)

China General Biosafety Standards for Microbiological and Biomedical Laboratories

Ministry of Health (2003)



Tasks of an IDA

test the viability of the biological material

promptly after its receipt

store the biological material in a

genetically unchanged way

release samples for trials and

examinations to authorized parties

comply with the demand of secrecy

about deposited strains

be impartial and objective

The IDA has to



Microorganisms are genetically instable and can change

their properties by subsequent cultivation

Microorganisms have to be available on a long-term basis

with known, specific and stable properties

Industry needs genetically stable production strains

Important isolates/mutants resulting from scientific efforts need

to be maintained to prevent renewed enrichment/isolation

It must be guaranteed within a project that all the research

has been performed with the same organisms from the

very beginning until its end

Why is it Advisable to Preserve Microorganisms?



Reasons für the Preservation of Biological Material

Maintenance of the material

Without contaminations

Without genetical changes



Principles of Preservation

Reduction of the microbial metabolism, ideally to nil

Yet preserving the viability of the cells

Lowering the temperature

Depriving the cells of water


Survey: Different

Preservation Methods

METHOD SUCCESSFULLY PRESERVED

ORGANISMS

SHELF-LIFE GENETIC

STABILITY

storage under parrafin oil yeasts, fungi, some bacteria fungi: 5-20 y

bacteria: 2-5 y

low

storage in distilled water yeasts, filamentous fungi,

actinomycetes; not:

enterobacteria

1-5 y low

drying in gelatin discs enterobacteria, staphylococci,

pseudomonads; spore-forming

fungi

1/2-7 y medium

storage in sterile soil, sand

etc.

spore-forming bacteria and

fungi

non-sporeformers

10-15 y

1-5 y

good

L-drying bacteria, fungi, yeasts, animal

viruses, protozoa

2-5 y good

drying on glass beads or

porcelain rings

fungi, bacteria, mycoplasms 5-10 y

sporeformers:

10-15 y

good

freeze-drying bacteria, some yeasts > 40 y good

storage at domestic

refrigerator temperature

bacteria several

weeks/months

low

storage at -20C in glycerol bacteria several months -

2 y

medium

storage at -60 - -80C in

glycerol

bacteria 5 y good

storage in liquid nitrogen at

-196C

bacteria, fungi, yeasts, plant cell

cultures, animal cell cultures> 30 y good

maintenance on glassbeads

at -60 - -80C

bacteria > 10 y good



Storage in Liquid Nitrogen I



Storage in Liquid Nitrogen II



Storage in Liquid Nitrogen III



Storage in Liquid Nitrogen

IV



Drying of Microorganisms



Storage of Dried Cultures



Tasks of an IDA

test the viability of the biological

material promptly after its receipt

store the biological material in a

genetically unchanged way

release samples for trials and

examinations to authorized parties

comply with the demand of

secrecy about deposited strains

be impartial and objective

The IDA has to



11.1 To Interested Industrial Property Offices

When? --> At any Time on Request to the IDA

When?

11.2 To the Depositor or with the Authorization ofthe Depositor to Third Parties

--> At any Time on Request to the IDA

When?

11.3 To Parties Legally Entitled

--> By Confirmation of the Request by the Responsible Patent Office

Furnishing of Samples

acc. to the Budapest

Treaty



Furnishing of Samples - When ? To Whom ?

Patent Office

Depositor

Authorized Third Party

Certified Third Parties+

Patent Office

Depositor

Authorized Third Party

Filing Publication Grant20 years

Available for:


Release of a

Patent

Strain to Parties

Legally Entitled

REQUESTING PARTYIDA

Requests for the release of a st rain

Examines for informationwhether the strain maybe released

If no information available: IDAasks for copies of the patentdocuments

Sends information

If information is available or copiesare sent, a special form to be usedwith the relevant patent office is mailed

The form must be filled inand sent to the relevant patent office

PATENTOFFICE

Examines the entitlement of therequestor and (if positive) sends a letterof confirmation to the IDA and therequesting party



Registrations/Allowances which Might be Necessary

Act dealing with the prevention and

control of infectious diseases in man

Infectious diseases of animals enactment

Plant inspection act

Law regulating genetic engineering

Registration of the working area for the handling of

►human pathogens

►animal pathogens

►plant pathogens

►genetically engineered organisms

Personal allowances according to



Restrictions for the Shipment – Import/Export

EEC Directive restricting

ex-/import of plant pathogens

Import or

quarantine

restrictions

EEC Regulations for

the control of exports

of dual-use goods

Act on the control

of war weapons

EEC Directive restricting ex-/import

of epidemics of animals


Criteria for the Dispatch of Biological Material

Risk Group Destination Take notice of ... action/proof dispatch by

1

2

3

4

Home

Country

Foreign

country

Home

Country

Foreign

country

Genetic engineering act

Plant protection act

Infectious diseases of animals act

EU: Plant Protection Act

Air mail might not be admitted!

Act on the Control of War Weapons

Total embargo ?

Infectious Diseases Act

Infectious Diseases of Animals Act

Plant Protection Act

Genetic Engineering Act


EEC Regulation for the Control of

Exports of Dual-Use Goods


Import/quarantine restrictions

EU: Plant Protection Act

Embargo ?

Registered Laboratory

Permission

Permission

Permission

Only for civil use!

No dispatch!

Permission

Permission

Permission

Registered laboratory

Only for civil use!

Authorization

Only for civil use!

Import permit

Permission

No dispatch!

mail

mail/air mail

or

air freight

Courier

service



Transport of Biological Material

Pathogenic material - a menace or danger

during transportation for:

Postal employees,

airport personnel,

secretaries and others

who could be exposed hazardously

national and international laws and regulations

to reduce the possibility of an inadvertent release of

microorganisms



Transport by Mail I

Regulated by:UN Letter Post Compendium

Only possible exception: Infectious substances

Applicable for risk

group 1 organisms

Dangerous Goods are not to be transported

Triple packaging acc. to UPU Letter Post Manual Articles 16 and RL 129

And following PI 650 DGR Applicable for biological

substances, category B



Triple Packaging for Non-Infectious

SubstancesPrimary container Outer packaging

Secondary container

Absorbent material



Transport of Dangerous Goods as Freight

on the road

ADR – Accord Européen Relatif au

Transport International des Marchandises

Dangereuses par Routes

Transport in specified containers !!

by air IATA – International Air Transport Association

Dangerous Goods Regulations

by rail COTIF/RID – Regulations concerning the

international carriage of dangerous goods by rail

by sea IMDG – International Maritime

Dangerous Goods Code

Regulated by:



Classification of Infectious Substances

Category A:

Causing permanent

disability, life-threatening

or fatal disease

Category B

UN 2814 UN 2900 UN 3373

PI 602 PI 650

Triple Packaging

For Infectious

Substances

Primary

container

Outer packaging

Secondary

container

Absorbent

material



No. of Releases of Patent Strains at the DSMZ

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 20090

20

40

60

80

100

120

140

160

plant viruses bacteriophages plant cell cultures/seeds

hum./anim. cell cultures plasmid DNA fungi/yeasts

bacteria



Releases of Patent Strains – to Whom? (at the

DSMZ)

66

33

45

6160

76

63

2624

61

27

2221

22

33

30

3840

35 35

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

0

10

20

30

40

50

60

70

80

Industry

Research



113

239312

334307

390 411

329

467

13431285

1414

1311

8439 29 46 60 60 65 93 66 93 101

59

1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008

0

200

400

600

800

1000

1200

1400

1600

all IDAs DSMZ

- all IDAs (from 2002 with ATCC data) -

Release of Samples of Patent Deposits

> 13.000 samples



Guide to the Deposit of Microorganisms under the Budapest Treaty

Outline of general requirements for a deposit and

the furnishing of samples

Detailed description of specific requirements of

individual IDAs and Industrial Property Offices

Checklists

Model forms



Complications

Which

Might Arise

Refusal to accept the biological material

New deposit

Transfer of a deposited organism

Conversion of deposits made outside the

Budapest Treaty

Type strains as patent deposits



Complications Which

Might Arise Refusal to accept the biological material

The organism is not of the kind of organisms the IDA furnished

assurances

The cultivation are so exceptional that the IDA is technically not in a

position to handle the organism

The organism is received in a condition that indicates that it is

impossible to handle it

The organism proves to be non-viable at the first viability check

Note: No valid deposit, no deposition number !



Complications

Which

Might Arise


New deposit

The organism proves to be non-viable at a later viability check

Ex- or import restrictions give the depositor the right to newly

deposit with another IDA

Note: The original deposition date remains valid !



Complications

Which

Might Arise


New deposit


The IDA temporarily, partly or permanently ceases to carry out its

functions

Note: The original deposition date remains valid !



Complications

Which

Might Arise


New deposit


Conversion of deposits made outside the Budapest Treaty

● from a non-Budapest patent deposit to a deposit acc. to the BT

● from a non-Budapest, non-patent deposit to a deposit acc. to the BT

● from a safe deposit to a deposit acc. to the BT

Note:The original deposition date does not necessarily remain valid !



Complications

Which

Might Arise


New deposit


Conversion of deposits made outside the

Budapest Treaty




Patent protection or scientific merits?

readily available for the

scientific community

covered by patent

protection

Two parallel deposits with two different

deposition numbers

Budapest

deposit

Public

deposit




2010

Code of Practise

for IDA‘s

Aim:

- Harmonization of the procedure of patent deposits acc. to

the Treaty

- Help for existing and future depositaries to comply with the

Treaty, dealing with problems during a deposition procedure

Obligations of the depositor Obligations of the IDA

- information to be given by the depositor

- Deposit of mixed cultures

- unofficial notifications

- payment for a deposit

- withdrawal of a deposit

- conversion of a deposit

- co-deposit by more than one depositor

- selling the rights on a deposit

- depositor versus applicant of a patent

- acceptance of a deposit, deposition procedure

- test methods and criteria for viability testing

- contamination of deposited cultures

- responsibility for authenticity and purity of

deposited cultures

- request for information about a deposited culture

or related deposit documents

- end of the period of storage



Future

Influenced by the deposit of DNA sequences instead of patent

deposits of the replicable biological material

Increasing or decreasing deposit numbers?

Influenced by increasing number of IDAs



5

14

18

28

33

3739

5

14

18

28

33

3739

12

19

24

38

51

62

73

12

19

24

38

51

62

73

1981 1986 1991 1996 2001 2006 2010

0

10

20

30

40

50

60

70

80

IDAs

Budapest Union

Increase of IDAs/members of the Budapest Union



1.607

2.4812.621

3.279

2.818

3.114

1.607

2.4812.621

3.279

2.818

3.114

240 291411

1654

1415

1628

240 291411

1654

1415

1628

1986 1991 1996 2001 2006 2009

0

500

1.000

1.500

2.000

2.500

3.000

3.500

deposits per year/all IDAs

releases per year/all IDAs

Deposits/releases per year from all IDAs



119

145

240

127

150141

119

145

240

127

150141

16

54

2128

6

1716

54

2128

6

17

1

3943

48

5749

1

3943

48

5749

27

46

93

8

20

9

27

46

93

8

20

9

20

0 3 0 0 0

20

0 3 0 0 04 0 2 3 2 14 0 2 3 2 1

72

112

149

54 54

7072

112

149

54 54

70

Year of deposit

1990 1995 2000 2005 2007 2009

0

50

100

150

200

250

bacteria fungi/yeasts

human/animal cell cultures plasmid DNAs

bacteriophages others

GMOs

Kinds of biological material deposited per year at the DSMZ

Development of

Patent Deposit Numbers



115

138

9499

76 74

82 84

115

138

9499

76 74

82 84

17 16 15

50

38 36 35

44

17 16 15

50

38 36 35

44

1986 1991 1996 2001 2006 2007 2008 2009

0

20

40

60

80

100

120

140

average deposits per IDA

average release per IDA

Average deposits/releases per year and IDA



Thank you for your Attention!

Questions?

Dr. Vera Weihs

DSMZ-Deutsche Sammlung von

Mikro-

organismen und Zellkulturen GmbH

Inhoffenstr. 7 B

38124 Braunschweig

[email protected]

mailto:[email protected]

IDAs - 30 YEARS OF EXPERIENCES WORLD-WIDELeibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen...

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Transcript of IDAs - 30 YEARS OF EXPERIENCES WORLD-WIDELeibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen...