INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER IN BIOTECHNOLOGY: THE EXPERIENCE OF ICGEB Decio Ripandelli - Yokohama, 24 August 2006.

INTELLECTUAL PROPERTY AND

TECHNOLOGY TRANSFER INBIOTECHNOLOGY:

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 educationmeans

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• SHORT TERM TRAINING• COLLABORATIVE RESEARCH

PROGRAMME• COOPERATION WITH

INDUSTRIAL SECTOR• SCIENTIFIC SERVICES• INSTITUTIONAL SERVICES

•RESEARCH PROJECTS

•LONG TERM TRAINING

•SHORT TERM TRAINING

•COLLABORATIVE RESEARCH PROGRAMME

•INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER

•SCIENTIFIC SERVICES

•INSTITUTIONAL SERVICES

SUMMARY OF THE ACTIVITYOF 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 TRANSFERAGREEMENTS: 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 problem-solving 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• SHORT TERM TRAINING• COLLABORATIVE RESEARCH

PROGRAMME• COOPERATION WITH

INDUSTRIAL SECTOR• SCIENTIFIC SERVICES• INSTITUTIONAL SERVICES

•RESEARCH PROJECTS

•LONG TERM TRAINING

•SHORT TERM TRAINING

•COLLABORATIVE RESEARCH PROGRAMME

•INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER

•SCIENTIFIC SERVICES

•INSTITUTIONAL SERVICES

INSTRUMENTS OF ACTION

• RESEARCH PROJECTS• LONG TERM TRAINING• SHORT TERM TRAINING• COLLABORATIVE RESEARCH

PROGRAMME• COOPERATION WITH

INDUSTRIAL SECTOR• SCIENTIFIC SERVICES• INSTITUTIONAL SERVICES

•INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER

INSTRUMENTS OF ACTION

• RESEARCH PROJECTS• LONG TERM TRAINING• SHORT TERM TRAINING• COLLABORATIVE RESEARCH

PROGRAMME• COOPERATION WITH

INDUSTRIAL SECTOR• SCIENTIFIC SERVICES• INSTITUTIONAL SERVICES

•INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER

ICGEB patents

proprietary technologies

generic products

process through which scientific invention, innovation or discovery developed in a given sector is made available to industry for possible commercial exploitation

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

Benefits of Technology Transfers

increased capacity building and skills development of technology recipients

revenue generation and poverty alleviation

increase the availability of generated products, increase market opportunities and

improve living conditions

technology acquisition without time and capital intensive R&D

creation of employment opportunities and increase in industrial sector

productivity

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 divides between industrialized and developing countries

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 immediateproduction of goods and services

Short-term Measures for Technology Short-term Measures for Technology Transfer at the ICGEBTransfer 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

successful transfer upon success in stage 3

supportive of relevant aspects of Doha Declaration of 2001

• trainees reproduce the production process under close supervision by ICGEB staff

• trainees repeat production at the facility in home country

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.

DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

Adopted on 14 November 2001

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)

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 1.3packaging 1.5

Total USD 2.8

total working days starting from cell culture to QC are about 21

ICGEB-transferred technology is cost effective

Interferon alpha 2A (IFN)

ICGEB technology yields approx. 80mg pure product/litre of culture

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

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)

yields at ICGEB are above 100mg pure product/litre of culture

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

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 representsa 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:

minimum potential sales would amount to at least USD 5,500,000 in the first year of production

total investment to set up plant (equipment, instruments and allnecessary reagents/chemicals) amounts to just over USD 1,000,000

Interferon and G-CSF:

total investment to set up plant (equipment, instruments and allnecessary reagents/chemicals) amounts to USD 1,200,000

minimum potential sales would amount to USD 2,800,000. inthe 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

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 developed by the Centre [art.14.(2)];• ICGEB rules regulating access to IPR is in “accordance to applicable international conventions” [art. 14(4)].

ICGEB AND IPRs

===> POLICY GUIDELINES ON PATENTS, LICENSING, COPYRIGHTS AND OTHER RIGHTS TO IP OF THE ICGEB(adopted by the ICGEB Board of Governors, November 2000)

• 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

NOTIFICATION OF THE APPLICATION TO ICGEB MEMBER STATES

• 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 OF AN ICGEB PATENT APPLICATION

OWNERSHIP OF DATA

COMMERCIAL DEVELOPMENT

IN CASE OF INVENTIONS OF POTENTIAL COMMERCIAL VALUE:• THE DIRECTOR-GENERAL WILL NEGOTIATE NON-EXCLUSIVE OR EXCLUSIVE

LICENSE AGREEMENTS WITH INDUSTRIAL PARTNERS;

• 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);

LIFE (AND DEATH) OF AN ICGEB PATENT APPLICATION

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.

THE PRODUCT: USING AN INSECT VIRUS AS A CARRIER FOR THE PRESENTATION OF MULTIPLE EPITOPES SHOWING HIGH ANTIGENIC PROPERTIES (MOLECULAR PRESENTING SYSTEM).

PROCEDURAL ITER

08/08/94FIRST FILING IN AUSTRIA (PRIORITY DATE)

04/08/95INTERNATIONAL EXTENSION VIA PCT

01/03/96INTERNATIONAL PRELIMINARY EXAMINATION (IPE)

08/02/97ENTERING THE REGIONAL (EUROPE) AND NATIONAL (USA) PHASES

28/08/98LICENSING OF THE PRODUCT TO A US PHARMACEUTICAL COMPANY

BENEFITS FROM AN ICGEB PATENT:A CASE STUDY

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

BENEFITS FROM AN ICGEB PATENT:A CASE STUDY

MAIN CONTRACTUAL CONDITIONS

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 RipandelliDecio RipandelliDirector, Administration and Director, Administration and External RelationsExternal Relations

Padriciano 99, 34012 Trieste, ITALY

Tel: +39 040 3757345Fax: +39 040 3757363

mailto: [email protected]://www.icgeb.org