INTELLECTUAL PROPERTY
AND
TECHNOLOGY TRANSFER IN
BIOTECHNOLOGY:
THE EXPERIENCE OF ICGEB
Decio Ripandelli - Yokohama, 24 August 2006
Structural and functional
genomics and related
biotechnologies are keys
for the development of
healthcare and agricultural
innovations over
the coming decades.
It is essential
for developing countries to
possess skills in the
basic and applied aspects of
recombinant DNA technology
and its control.
Each country must endeavour
to improve its scientific
education and governments
should learn to rely in
unbiased scientific opinion and
not color it politically.
Proper scientific education
means
not necessarily the
fashionable competitive science but to
learn and apply the scientific
method with logic and rigour.
The correct assessment
of the options for development
is only possible if there is an
educated scientific category.
ICGEB Signatory Countries (March 2006)
INSTRUMENTS OF ACTION
•RESEARCH PROJECTS
•LONG TERM
TRAINING
• RESEARCH
PROJECTS
• LONG TERM TRAINING
•SHORT• TERM
TRAINING
SHORT
TERM TRAINING
• COLLABORATIVE
RESEARCH
PROGRAMME
•COLLABORATIVE
RESEARCH
PROGRAMME
• COOPERATION WITH
INDUSTRIAL
SECTOR
•INTELLECTUAL
PROPERTY
AND TECHNOLOGY
• SCIENTIFIC SERVICES
TRANSFER
• INSTITUTIONAL SERVICES
•SCIENTIFIC SERVICES
•INSTITUTIONAL SERVICES
SUMMARY OF THE ACTIVITY
OF THE ICGEB (1988-2005)
• INTERNATIONAL PUBLICATIONS: >1,400
• LONG TERM FELLOWSHIPS:
500 awarded;
> 1,000 MTRAINEE/YEARS
• SHORT TERM TRAINING:
8,000 persons trained
• RESEARCH GRANTS:
285 awarded
(for a total of US$ 15,000,000)
• PATENTS:
40 filed
• TECHNOLOGY TRANSFER
AGREEMENTS:
71 signed
• C.B. is not defined through the instruments used, but through its goal to enhance the
capability of people and institutions to improve their competence and problemsolving capacities (GTZ 1999).
• C.B. refers to investment in people, institutions and practices that will, together,
enable countries in the region to achieve their development objectives (World Bank
1997)
• C.B. is the process by which individuals, groups, organizations, institutions and
societies increase their abilities to understand and deal with their development needs
in a broad context and in a sustainable manner (UNDP 1997).
• C.B. may be defined as the actions needed to create or enhance the capability of a
country or an institution (or an individual) to carry out its allotted functions and
achieve its objectives (UNDP 1993).
INSTRUMENTS OF ACTION
•RESEARCH PROJECTS
•LONG TERM
TRAINING
• RESEARCH
PROJECTS
• LONG TERM TRAINING
•SHORT• TERM
TRAINING
SHORT
TERM TRAINING
• COLLABORATIVE
RESEARCH
PROGRAMME
•COLLABORATIVE
RESEARCH
PROGRAMME
• COOPERATION WITH
INDUSTRIAL
SECTOR
•INTELLECTUAL
PROPERTY
AND TECHNOLOGY
• SCIENTIFIC SERVICES
TRANSFER
• INSTITUTIONAL SERVICES
•SCIENTIFIC SERVICES
•INSTITUTIONAL SERVICES
INSTRUMENTS OF ACTION
•
•
•
•
RESEARCH PROJECTS
LONG TERM TRAINING
SHORT TERM TRAINING
COLLABORATIVE
RESEARCH PROGRAMME
• COOPERATION WITH
INDUSTRIAL
SECTOR
•INTELLECTUAL
PROPERTY
AND TECHNOLOGY
• SCIENTIFIC SERVICES
TRANSFER
• INSTITUTIONAL SERVICES
INSTRUMENTS OF ACTION
•INTELLECTUAL PROPERTY AND TECHNOLOGY
TRANSFER
• RESEARCH PROJECTS
• LONG TERM TRAINING
• SHORT TERM TRAINING

patents
• ICGEB
COLLABORATIVE
RESEARCH PROGRAMME
• proprietary
COOPERATION
WITH

technologies
INDUSTRIAL SECTOR
• generic
SCIENTIFIC
SERVICES

products
• INSTITUTIONAL SERVICES
Technology Transfer
 flow of scientific knowledge and technical capacity
from originator/s to a larger public domain for acquisition
and utilization in order to generate goods and services
 process through which scientific invention, innovation
or discovery developed in a given sector is made
available to industry for possible commercial
exploitation
 Benefits of Technology Transfers
 technology acquisition without time and capital intensive R&D
 increased capacity building and skills development of technology
recipients
 increase the availability of generated products, increase
market opportunities and improve living conditions
 creation of employment opportunities and increase in
industrial sector productivity
 revenue generation and poverty alleviation
 Technology Transfer in Developing Countries
 essential/inevitable tool for industrial sector development,
productivity and economic growth
 circumvents the burden of R&D financial requirements as well as
time constraints for development of local capacity
 addresses
the scientific and digital
industrialized and developing countries
divides
between
The ICGEB Vision of Technology Transfer
 embraces both long-term measures aimed at capacity building and
skills development as well as short-term ones for the immediate
production of goods and services
Short-term Measures for Technology Transfer at the
ICGEB
 development of procedures for the production of recombinant
generic pharmaceuticals
 transfers to desiring institutions in ICGEB Member States and
pharmaceutical industries (in three stages)
• scientists from acquiring institutions are trained
at the facilities of the ICGEB
• trainees reproduce the production process under
close supervision by ICGEB staff
• trainees repeat production at the facility in home
country
 successful transfer upon success in stage 3
 supportive of relevant aspects of Doha Declaration of 2001
DECLARATION ON THE TRIPS AGREEMENT
AND PUBLIC HEALTH
Adopted on 14 November 2001
 We reaffirm the commitment of developed-country Members to
provide incentives to their enterprises and institutions to promote
and encourage technology transfer to least-developed country
Members pursuant to Article 66.2.
 We agree that the TRIPS Agreement does not and should not prevent
Members from taking measures to protect public health. Accordingly,
while reiterating our commitment to the TRIPS Agreement, we affirm
that the Agreement can and should be interpreted and implemented in
a manner supportive of WTO Members' right to protect public health
and, in particular, to promote access to medicines for all.
Recombinant Pharmaceuticals, Vaccines and
Diagnostics Developed at the ICGEB
• ERYTHROPOIETIN - EPO
• HUMAN INTERFERON (ALPHA - BETA - GAMMA) - IFN
• GRANULOCYTE COLONY STIMULATING FACTOR - GCSF
• HCV DIAGNISTIC KIT
• HIV DIAGNOSTIC KIT
• DENGUE DIAGNOSTIC KIT
•HEPATITIS B VACCINE
72 TECHNOLOGY TRANSFER AGREEMENTS
IN 18 COUNTRIES
HAVE GENERATED OVER 3 MILLION EURO (2003-2005)
 ICGEB-transferred technology is cost effective
Erythropoietin (EPO)
packaged in 4000 IU/vial/dose
global market for EPO is about USD 2.5 bn
public price in pharmacy is USD 70.0/dose
Production costs for 4000 IU
active ingredient USD 1.3
packaging
1.5
Total USD 2.8
total working days starting from cell culture to QC are about 21
Interferon alpha 2A (IFN)
packaging as 3MIU (11.1 g product/0.5mL)
global market for the product is USD 80 million
public price in pharmacy (3MIU) is USD 25.0/vial
ICGEB technology yields approx. 80mg pure product/litre of culture
Production costs for 3MIU
active ingredients USD 0.3
packaging
USD 1.5
Total
USD 1.8
Total of ten working days
Granulocyte colony stimulating factor (G-CSF)
packaging as 300 g/ml in 0.5 ml prefilled syringes
global market for the product is USD 1.5 billion
public price in pharmacy is USD 250.0/0.5 ml syringe
yields at ICGEB are above 100mg pure product/litre of culture
Production costs for 300 g
active ingredients
USD 0.3
packaging
USD 1.5
Total
USD 1.8
Total of ten working days
 Commerciability and Potential Sales
 the technology and procedures for the large-scale production
of EPO, IFN and G-CSF are optimized and standardized to the
requirements and specifications of both the
EU Pharmacopoeia and those of the US FDA.
 their properties will also satisfy the regulatory requirements
of any acquiring country
 advantage of greater affordability due to lower production costs
 technology transfer at the ICGEB costs a token fee which represents
a nominal contribution to R&D expenditure
ICGEB technologies stimulate industrial sector productivity and
economic growth, job creation and generates revenue
 Production Costs/Economic Returns
 Erythropoietin:
 total investment to set up plant (equipment, instruments and all
necessary reagents/chemicals) amounts to just over USD 1,000,000
 minimum potential sales would amount to at least USD 5,500,000
in the first year of production
 Interferon and G-CSF:
 total investment to set up plant (equipment, instruments and all
necessary reagents/chemicals) amounts to USD 1,200,000
 minimum potential sales would amount to USD 2,800,000. in
the first year of activity for interferon
 for G-CSF the minimum potential sales in the first year of
production is approximately USD 9,600,000
ICGEB AND IPRs
Objectives of ICGEB (as per its Statutes)…
• “ […] to assist developing countries in strengthening their scientific and technological
capabilities in the field of genetic engineering and biotechnology” [art.2(a),(d),(c)];
• “[…] to support in particular research development and application for the benefit of
developing countries and maintain close contacts with industry” [art. 3(a),(h),(j)];
… the MEANS for the practical achievement are twofold [art. 14(1),(5)]:
• publication of all results of its research activities is MANDATORY ”provided such
publication does not contravene the general policy of IPR as adopted by the Board”;
• “patent and other rights and any financial or other benefits associated herewith shall be
used”.
The effective utilisation of rights is secured through:
• the OWNERSHIP of ICGEB in all rights relating to any work produced or deve
the Centre [art.14.(2)];
• ICGEB rules regulating access to IPR is in “accordance to applicable international
conventions” [art. 14(4)].
===>
POLICY GUIDELINES ON PATENTS, LICENSING, COPYRIGHTS
AND OTHER RIGHTS TO IP OF THE ICGEB
(adopted by the ICGEB Board of Governors, November 2000)
LIFE OF AN ICGEB PATENT APPLICATION
NOTIFICATION OF THE APPLICATION TO ICGEB MEMBER STATES
•
FOLLOWING THE FILING OF A PATENT APPLICATION, ICGEB SHALL INFORM ITS
MEMBER STATES;
•
WITHIN 4 MONTHS (AND NOT LATER THAN 8 MONTHS FROM THE
PRIORITY
DATE), MEMBER STATES CAN INDICATE THEIR SPECIFIC INTEREST IN THE
INVENTION;
•
ICGEB WILL EXTEND THE PATENT ALSO IN THE(SE) MEMBER STATE(S) THAT SO
REQUIRE;
•
FILING AND MAINTENANCE COSTS IN THAT SPECIFIC MEMBER STATE WILL BE
BORNE BY THE RELEVANT GOVERNMENT;
•
THE CENTRE IS ALSO FREE TO FILE SUBSEQUENT PATENT APPLICATIONS IN OTHER
STATES, INFORMING THE RESPECTIVE MEMBER STATE ACCORDINGLY.
LIFE OF AN ICGEB PATENT APPLICATION
OWNERSHIP OF DATA
•
ICGEB STAFF MEMBERS (AND VISITING FELLOWS) HAVE TO VEST IN THE
CENTRE ALL RIGHTS, INCLUDING TITLE, COPYRIGHT AND PATENT RIGHTS,
IN ANY WORK PERFORMED AS PART OF THEIR OFFICIAL DUTIES;
•
RESULTS EMANATING FROM THE RESEARCH
IMPLEMENTED IN THE
FRAMEWORK OF THE COLLABORATIVE RESEARCH PROGRAMME BELONG
TO THE AFFILIATED CENTRE AND TO THE SCIENTISTS WHICH HAVE
CARRIED OUT THE RESEARCH;
•
IN CASE OF INVENTIONS PROTECTED AT THE EXPENSES OF A MEMBER
STATE, THE PATENT WILL BE CO-OWNED BY THE ICGEB AND BY THE
RESPECTIVE MEMBER STATE.
LIFE (AND DEATH) OF AN ICGEB
PATENT APPLICATION
COMMERCIAL DEVELOPMENT
•
•
IN CASE OF INVENTIONS OF POTENTIAL COMMERCIAL VALUE:
THE DIRECTOR-GENERAL WILL NEGOTIATE NON-EXCLUSIVE
EXCLUSIVE LICENSE AGREEMENTS WITH INDUSTRIAL PARTNERS;
OR
SUCH LICENSE AGREEMENT WILL CONTAIN A DOWN PAYMENT, PAYABLE IN
SEVERAL INSTALMENTS (e.g. 40%-40%-20%) AND ROYALTIES AS A
PERCENTAGE (e.g. 2-4%) OF THE NET SALES OF PRODUCTS SOLD);
ABANDONING A PATENT
•
•
AN ICGEB PATENT APPLICATION IS ABANDONED:
SHOULD THE PATENT OR THE PATENT APPLICATION PROVE NOT TO HAVE
ANY COMMERCIAL VALUE;
SHOULD NO SUITABLE INDUSTRIAL PARTNER BE IDENTIFIED WITHIN 30
MONTHS FROM THE PRIORITY DATE.
BENEFITS FROM AN ICGEB PATENT:
A CASE STUDY
THE PRODUCT: USING AN INSECT VIRUS AS A CARRIER FOR THE PRESENTATION OF
MULTIPLE EPITOPES SHOWING HIGH ANTIGENIC PROPERTIES (MOLECULAR
PRESENTING SYSTEM).
PROCEDURAL ITER
08/08/94
FIRST FILING IN AUSTRIA (PRIORITY DATE)
04/08/95
INTERNATIONAL EXTENSION VIA PCT
01/03/96
INTERNATIONAL PRELIMINARY EXAMINATION (IPE)
08/02/97
ENTERING THE REGIONAL (EUROPE) AND NATIONAL (USA) PHASES
28/08/98 LICENSING OF THE PRODUCT TO A US PHARMACEUTICAL
COMPANY
BENEFITS FROM AN ICGEB PATENT:
A CASE STUDY
MAIN CONTRACTUAL CONDITIONS
FINANCIAL IMPLICATIONS:
•
DOWN PAYMENT : -40%, UPON EXECUTION OF THE CONTRACT
-60%, 24 MONTHS AFTER THE SIGNATURE
•
ROYALTIES: ON A QUARTERLY BASIS, 1% OF THE NET SALES
OF PRODUCTS SOLD
CLAUSE OF EXCLUSIVITY:
•EXCLUSIVE RIGHTS FOR ALL OECD NATIONS, EXCEPT ITALY.
•NON EXCLUSIVE RIGHTS FOR ALL ICGEB MEMBER STATES (FULL
MEMBERS AT THE TIME OF THE SIGNATURE).
•LOSS OF NON EXCUSIVE RIGHTS: SHOULD A COMPANY IN ONE
ICGEB MEMBER STATE REQUEST THE LICENSING OF THE PATENT.
DEVELOPING COUNTRIES AND IPRs:
A NEW PARADIGM
• MANY DEVELOPING COUNTRIES ARE NOW
BECOMING POTENTIAL GENERATORS OF
INNOVATIVE TECHNOLOGIES;
• BUT THEY SOMETIME LACK THE ABILITY TO
PROTECT THEIR INNOVATIVE PRODUCTS OR
PROCESSES;
• INHERENT DIFFICULTIES RELATED TO THE
ADOPTION OF IPR REGIMES, AS STIPULATED BY
TRIPS;
===> DEVELOPMENT OF AN IPR CULTURE
Decio Ripandelli
Director, Administration and External
Relations
Padriciano 99,
34012 Trieste, ITALY
Tel: +39 040 3757345
Fax: +39 040 3757363
mailto: decio@icgeb.org
http://www.icgeb.org