World Intellectual Property Organization

Model Project on "Genetic Modification of hyaluronidase inhibitor glycoprotein (WSG) in the roots of Withania Somnifera (Hania plant) for Anti Venom Treatment" between Astra Zeneca, National Institute of Health and Local Government, Karimabad, Pakistan

Subject matter

Plant genetic resources

Summary of use(s)

The Hania plant (Withania Somnifera) material will be taken from natural habitat of Karimabad for R&D purposes for 5 years and commercial purposes for next 20 years with permission of the local government, if any. The local government will specify a 50 hectare land area where botanical garden for experimental work on Hania plant will be developed with technical support of NIH and financial support of Astra Zeneca. After expiration of 25 years the botanical garden will be sole property of local government along with all its moveable and immoveable property.

Purpose or background

(1) Development of medicine for anti-venom treatment of snake bite and other reptiles having venomous effect.

(2) Better medicinal use of Hania plant roots through R&D by using traditional knowledge of local community.

(3) Encouragement of R&D activities in Pakistan in the field of human treatment medicines.

(4) Welfare of local community in Karimabad (Hunza valley) for benefit sharing in the areas of education and health.

(5) Opening of horizons for future research on anti-venom drugs.

Contact details

Syed Khalid Mehmood Bukhari, Director General, Intellectual Property Organization of Pakistan (Ipo-Pakistan), Pakistan, H-23, St-87, G 6/3, Islamabad, Pakistan, Info@Ipo.Gov.Pk, 0092 51 920 8146, 0092 51 920 8157

 

REPLY TO WIPO/GRTKF/IC/Q.6

COPY OF THE CONTRACT

Please indicate whether a copy of an existing contract or model agreement is attached to this response:

Response: No.

Question 1: Please give the contract title.

Response:

Genetic Modification of hyaluronidase inhibitor glycoprotein (WSG) in the roots of Withania Somnifera (Hania plant) for Anti Venom Treatment

Question 2: Please identify the contract parties.

Response:

(1) Astra Zeneca (Medicine Company), UK

(2) National Institute of Health (NIH), Islamabad

(3) Local Government, Karimabad (Hunza Valley, Pakistan)

Question 4: Please state the overall contract's purpose

Commercial and Industrial Application                                                 X

Question 5: Please state the contract’s objective.

Response:

(1) Development of medicine for anti-venom treatment of snake bite and other reptiles having venomous effect.

(2) Better medicinal use of Hania plant roots through R&D by using traditional knowledge of local community.

(3) Encouragement of R&D activities in Pakistan in the field of human treatment medicines.

(4) Welfare of local community in Karimabad (Hunza valley) for benefit sharing in the areas of education and health.

(5) Opening of horizons for future research on anti-venom drugs.

Question 6:  Please identify the scope of the contract.

Response:

Plant Genetic Resources                                                                      X

Question 7: Please state whether the genetic resources are being supplied from in-situ conditions or from ex-situ conditions. "In-situ conditions" means conditions where genetic resources exist within ecosystems and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties. "Ex situ conditions" means conditions where genetic resources exist outside their natural habitats; for instance, a germplasm bank or microbial collection:

In-Situ Conditions         x

Question 8: Contract Activities: Please state the permitted uses of the genetic resources under the contract.

Response:

The Hania plant (Withania Somnifera) material will be taken from natural habitat of Karimabad for R&D purposes for 5 years and commercial purposes for next 20 years with permission of the local government, if any. The local government will specify a 50 hectare land area where botanical garden for experimental work on Hania plant will be developed with technical support of NIH and financial support of Astra Zeneca. After expiration of 25 years the botanical garden will be sole property of local government along with all its moveable and immoveable property.

Question 10: Please state the date that the contract came into force.

Response:

15th July, 2010

Question 11: Please state the contract’s duration.

Response:

25 years

Question 12: Please identify and record all intellectual property (IP) related clauses in the contract. For example:

Response:

Clause(s) relating to:

Please set out relevant clause(s) or summary of clause(s) including, if appropriate, explanation of the context of the clause(s) in relation to the contract and/or project as a whole

Industrial property incl. patents, trademarks, geographical indications and appellations of origin, etc.

(1) The development of anti-venom drug will be based on research carried out at NIH, Islamabad. Therefore a special clause for filing patent application in Pakistan, UK and other target countries/regions has been included. The patent application will be filed at the end of the 2nd year of research and it is expected that Patent for genetically modified hyaluronidase inhibitor glycoprotein (WSG) will be awarded from all relevant countries/regions up to the end of 5th year of the Contract.

(2) The medicine will be given a special commercial name "Astra-Hania" or "Hanio-Zeneca" and trade mark registration will be applied in Pakistan, UK and other target countries/regions at the end of the 2nd year of Contract.

Copyright and related rights

The artistic design of "Astra-Hania" or "Hanio-Zeneca" on the packing of medicine will be copyrighted. The manual of treatment for patient's guide will also be copyrighted at the time of commercialization.

Licensing

Lincencing arrangement for better commercialization of medicine will be the sole prerogative of Astra Zeneca. Separate rules and regulations of licencing will be developed by the company (Astra Zeneca) when product will be launched in the market.

Monetary Benefit-sharing as relates to IP: e.g. up-front payments, royalties, milestone payments, ethno-botanical premiums, trust funds, etc.

A separate chapter for Benefit Sharing has been included in the Contract. Following are the main points of this chapter regarding monetary benefit sharing:-

(1) A special Trust Fund for the local community of Karimabad will be established with initial amount of Rs. 100million with in 6 months of signing the Contract. Astra Zeneca will share 80%, NIH 15% and Local Government of Karimabad 5% in the initial amount of Trust Fund. A three member committee (one from each partner) will administer this Fund. The initial amount of Trust will be consumed within first 5 years of the Contract. During next 20 years 5% of total annual profits will be designated for Trust Fund as royalty. The Fund will be consumed for three purposes; (i) Increase in literacy rate and up gradation of education standard in Karimabad; (ii) Fully funded scholarships for higher education on competitive basis for residents of Karimabad; and (iii) Improvement of public health facilities in Karimabad

Non monetary Benefit-sharing as relates to IP: e.g. IP-related training, technology transfer, exchange of results, etc.

As mentioned earlier a separate chapter for Benefit Sharing has been included in the Contract. Following are the main points of this chapter regarding non-monetary benefit sharing:-

(1) The technical expertise of local people and farmer community will be preferred for development of 50 hectare Botanical Garden in Karimabad.

(2) The agricultural graduates and botanical experts of local area will be preferred for research work on Hania plant in the said Botanical Garden and they will be trained by experts of NIH and Astra Zeneca to develop their Negotiation capacity.

(3) Special IP training courses will be conducted for officials of Local Government to develop their capacities for royalty and other arrangements.

(4) The technology should be transferred automatically to the Local Government after the expiration of 25 years of the contract.

Question 13: Please state whether any IP rights have been obtained as a result of activities carried out pursuant to the contract. For instance, whether any patents have been granted (citing, where possible, a Patent Number); whether any trademarks have been registered, etc.

Response:

The contract is at initial stages. Patent and trademark applications will be filed on the completion of 2nd year of the project.

Question 14: Confidentiality: Please set out any Confidentiality clause(s) or a summary of such clause(s) in the contract including, if appropriate, an explanation of the context of the clause(s) in relation to the contract and/or project as a whole.

Response:

All the researchers and technical workers of Local Government, NIH and Astra Zeneca are bound to maintain secrecy until research work is going on and Patent applications are not accepted by the relevant offices of target countries. The people involved in research work are not allowed to leave without strong valid reason up to the end of 5th year of the contract.

In order to give a legal context to the IP clauses in question, please provide the following information:

Question 16: Please identify any laws and regulations applicable to the contract in question, in particular any relevant IP-related clauses in legislation regulating access to genetic resources and in any sui generis legislation to protect associated traditional knowledge:

Response:

Existing Laws and Regulations

Please state name and date of law and, if possible, relevant clause number(s)

National laws and regulations in provider country

1) Patent Ordinance, 2000 (Amended in 2006) Sections 7, 8, 13, 34.

2) Trade Mark Ordinance, 2001

3) Copyright Ordinance, 1962 (amended in 2000)

4) Contract Act, 1872 (Amended from time to time)

Regional laws and regulations

Pakistan Biodiversity Act

International laws and regulations

Convention on Biological Diversity

Question 18: Please state the Governing Law of the Contract.

Response:

Contract Act 1872 (Amended from time to time)

Question 19: Dispute Resolution: Please state how the parties have agreed to resolve any disputes that might arise under the contract (mediation, conciliation, arbitration, national jurisdiction etc) identifying, in particular, the agreed dispute resolution body (international, regional, national, or local).

Response:

Dispute resolution will be done by mutual conciliation among the parties and in case of further dispute court of national jurisdiction will be consulted.

Question 21: Please share any practical advice that you may have arising out of the drafting, negotiation and conclusion of the contract in question, in particular, any advice relating to the IP aspects of the contract.

Response:

1) Prior Informed Consent: The Local Government of Karimabad with the technical support of IPO-Pakistan, WTO wing of Ministry of Industries and Production, SMEDA and CBD focal point Ministry of Environment took steps to obtain prior informed consent of local community and seek advice of abovementioned institutes for negotiations on the Contract.

2) Benefit Sharing: A separate chapter for Benefit Sharing has been included in the Contract. Following are the main points of this chapter regarding monetary benefit sharing:-

(i) A special Trust Fund for the local community of Karimabad will be established with initial amount of Rs. 100million with in 6 months of signing the Contract. Astra Zeneca will share 80%, NIH 15% and Local Government of Karimabad 5% in the initial amount of Trust Fund. A three member committee (one from each partner) will administer this Fund. The initial amount of Trust will be consumed within first 5 years of the Contract. During next 20 years 5% of total annual profits will be designated for Trust Fund as royalty. The Fund will be consumed for three purposes; (i) Increase in literacy rate and up gradation of education standard in Karimabad; (ii) Fully funded scholarships for higher education on competitive basis for residents of Karimabad; and (iii) Improvement of public health facilities in Karimabad.

(ii) The technical expertise of local people and farmer community will be preferred for development of 50 hectare Botanical Garden in Karimabad.

(iii) The agricultural graduates and botanical experts of local area will be preferred for research work on Hania plant in the said Botanical Garden and they will be trained by experts of NIH and Astra Zeneca to develop their capacity.

(iv) Special IP training courses will be conducted for officials of Local Government to develop their negotiation capacities for royalty and other arrangements.

(v) The technology should be transferred automatically to the Local Government after the expiation of 25 years of the contract.

Question 22: Please share any “lessons learned” arising from your work in the field of contractual agreements for access to genetic resources and benefit-sharing.

Response:

The important point of the Contract is welfare of local community in the areas of basic education and public health. Although the alternative purpose of the project is development of anti-venom medicine, its commercialization and profit gain but the main objectives are social welfare of local community in Karimabad (Hunza valley) and R&D facilitation in NIH, Islamabad. If this project is successfully completed and the Contract is acted upon according to its letter and spirit it will be win-win situation for all the contracting parties. The medicine company Astra Zeneca will strengthen its roots for further investment in the field of plant genetic resources, the research institute, NIH will be able to conduct more and more R&D activities for development of life saving drugs and indigenous communities like Karimabad will be encouraged to share their knowledge for benefit of human beings.

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