Plant Biotechnology Intellectual Property Rights

and the Bt cotton case in China

Qin Fang Wang

Associate professor

Biotechnology Research Institute

Chinese Academy of Agricultural Sciences

Ying Liang Liu

Associate Professor

China University of Political Science & Law

WIPO-UPOV symposium ON

INTELLECTUAL PROPERTY RIGHTS

IN PLANT BIOTECHNOLOGY

Geneva, October 24, 2003

Outline of presentation

◆ General review of IPR protection

◆ Current biotech IPRs in China

◆ Problems and challenges in plant IPRs

◆ The Bt cotton case study

◆ Concluding remarks

IPR protection in China:A general review

Administrative system of IPR in China 1

◆ The modern IPR system was developed in 1980s

economic reform and opening-up of China

◆ Chinese Patent Office founded in 1980

sole patent administration at state level

◆ Reconstructed as the State Intellectual Property Office,

SIPO in 1998

Administrative system of IPR in China 2

State Intellectual Property Office(SIPO)

◆ Under State Council

◆ Responsible for patent work and comprehensively coordination of the foreign related affairs in the field of

IPR ◆ Receiving office of International Searching Authority and

International Preliminary Examining Authority

State Intellectual Property Office(SIPO)

3 main administrations under the guidance of SIPO

◆ Chinese Patent Office ◆ Chinese Trademark Office

◆ Chinese Copyright Office

◆ under the guidance of SIPO

◆ receiving, examination and granting patent applications, examining request for reexamination, invalidation and other administrative functions given by SIPO.

Chinese Patent Office

Regulations of PRC on Patent

Patent Law◆ Adopted on March 12,1984; effective on April 1, 1985

◆ Amended in accordance with the Decision of the Standing Committee of the Seventh National People's Congress on September 4,1999

◆ Amended again on August 25, 2000, become effective on July 1, 2001

Plant varieties can not be granted as patent ( article 25)

Implementing Regulations of the Patent Law of PRC

◆ Issued on September 21, 1992

◆ Newly Promulgated on June 15, 2001, and effective on July 1, 2001

Seed Law of PRC

◆ Issued on July 8, 2000

◆ Related regulations issued by MOA:

a. Examine and approval regulation for major agricultural crops, Feb. 26, 2001

b. Labeling regulation of agricultural crops

c. Processing and packing regulation on agricultural crops seeds, Feb. 26, 2001

d. Major agricultural crops: rice, corn, cotton, soybean, oil rape, potato.

Current Biotechnology IPRs in China

Patent on genetic engineering

◆ A Division for Biotechnological Inventions was set up within the CPO

the application and examination of genetic engineering patents

◆ An IPR Affair Center(MOST) set up in 1995

governmental consulting agency for IPR issues

Patent on genetic engineering

◆ Applications filed in Chinese patent office increased year by year

◆ Dramatically increase in recent years

◆ 90% applications from foreign companies, domestic application increased recently

◆ Most Patents on genetic engineering are pharmaceutical

◆ Patents on agriculture only occupy about 10% in overall

Applications increased year by year, Dramatically increase in recent years (1985-2000)

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1985 1987 1990 1992 1994 1996 1998 2000

Over 90% are foreign applications in 1985-1998

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400domesti cforei gn

About 90% are foreign applications (1985-1998)

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100%domesti cforei gn

Top 10 foreign countries in applying gene patent in China

1. USA2. Japan3. Germany4. UK5. Switzerland

6. Denmark

7. France

8. the Netherlands

9. Canada

10. Australia

United States is the top country

Account for 39.7% of total foreign applications in the period of 1985 to 1998

Domestic application increased recently (1991-2001)

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Percentage of domestic/foreign application (1991-2001)

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United Gene Holding LTD

◆ A pharmaceutical company established by 2 professors from FuDan Univ. in 1997

◆ Filed 240, 2940 and 188 applications in 1999, 2000 and 2001, respectively

◆ Accounted for 25.6%, 85.3% and 34.3% of total annual application

Most patents on genetic engineering are pharmaceutical (1985-2001)

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1985 1987 1989 1991 1993 1995 1997 1999 2001

pharmaceuti calothers

Agriculture related patent application increased (1985-2001)

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1985 1987 1989 1991 1993 1995 1997 1999 2001

agri cul turepharmaceuti calothers

Agricultural patent occupy about 10% in overall (1985-2001)

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80.00%

pharmaceuti cal agri cul tural i ndustry

Protection of New Varieties of Plants in China

Regulations on the Protection of New Varieties of Plants

◆ Issued on March 20, 1997; effective on October 1, 1997, 1978 version

◆ 23 April, 1999, 39th member country of UPOV

◆ Detailed regulations on the implementation of regulation, effective on 23 April, 1999

Examining and approving authorities

Jointly responsible by MOA and SFA

◆ The Ministry of Agriculture(MOA):

∎grains, cotton, oil crop, hemp, mulberries, tea, sugar, vegetable, edible fungi, tobacco, fruit trees(juicy), herbaceous medicinal materials, herbaceous ornamental plants, grass, rubber tree, green manure.

◆ The State Forestry Administration(SFA):

∎ forest trees, bamboo, xyloid vine, ornamental woody plants, fruit trees(dry), woody oil-bearing, beverage plants, condiment plants, woody medicinal materials.

Protected botanical genera and species of plants (MOA)

◆ The first batch issued on June 16, 1999

rice, maize, Chinese cabbage, potato, spring orchids, chrysanthemum, Pink, clover, grass

◆ The second batch issued on March 3, 2000

wheat, soybean, oil rape, peanut, tomato, cucumber, chili, pear, dock

Protected botanical genera and species of plants (MOA)

◆ The third batch issued on Feb. 26, 2001

orchids, lily, bird of paradise, sealavender

◆ The fourth batch issued on Jan. 4, 2002

sweet potato, millet, peach, Litchi, water melon, cabbage, radish

◆ The fifth batch issued on July 14, 2003

broomcorn, barley, ramie, apple, citrus, banana, kiwifruit, grape, plum, eggplant

Progress of plant variety right application (MOA)

Office of Plant New Variety Protection, MOA

◆ 1061 applications received from April, 1999 to Aug., 2003

◆ 412 variety rights have been granted (39%)

◆ No transgenic plants variety granted by PVP

◆ Rice and corn are 2 major crops:

77% in total applications and 80% in total rights granted

20% and 60% over total variety rights granted, respectively

50% of rice and 95% of corn are hybrids (planting area)

Progress of plant variety right application (MOA)

To strengthen the management, MOA◆ Established a Propagation Material Preservation

Center for agricultural plant new varietiesquality and quantity detection & preservation

◆ Established one center and 14 branch centers for DUS test

Problems and Challenges in Plant Biotechnology IPRs

Public awareness

◆ Both government and scholars concerned with IPRs

◆ Less public awareness compared with developed countries

◆ Core funding provided by the government

◆ Research budget mostly given by the government

◆ Weak incentive mechanism for IPR protection

Capacity building on IPR protection

◆ General weak on capacity building

at research institute or university level

◆ Emphasis on educational and training programs on IPR protection

◆ Fiscal aids for education and training

Implementation on IPR protection

◆ Great progress in the legislation on IPR laws

◆ The implementation of IPR laws not yet fully completed

IPR administration and judical practice

Monitoring implementation is also a difficult task

Emerging mechanism for technology trasfer

◆ Mechanisms of technology transfer developing (agriculture)

◆ Emerging market and venture capital activity

◆ Human resources, capacity building, IPR managing

◆ Encouraging private funds

◆ Public/private relationship in TT

◆ Ideal model for TT

Enforcement of Laws and regulations

◆ Unauthorized use of IPRs, infringe patent right or plant breeder’s right

Small seed companies ; farmer sale seeds; infringement of right

◆ Regional concerns(local government): affect the settlement of legal disputes

◆ Supervise the infringement and balance the farmer’s right, a challenge in China

Case study of Chinese Bt cotton

Development of Bt Cotton

Research initiated in BRI, CAAS, 1990

Bt gene synthesized

pollen tube pathway transformation

Patent granted in 1998

Bt+CpTI patent granted in 2001

Bt+CpTI, double gene cotton

delay the development of bollworm’s resistance to Bt

Commercialization of Bt cotton

approved for commercialization in 1997

18 new transgenic cotton var. and hybrids

10,000 ha in 1998

153, 000 ha in 1999

207, 000 ha in 2000

600,000 ha in 2001

1.1 million ha in 2002

1.4 million ha in 2003

the only GMC with the largest sown area in China

Fig 1. Bioassay of transgenic cotton

CK transgenic

Bt/CpTI 双价转基因抗虫棉

Field performance of Bt cotton

Good Harvesting

XinJiangHeBei

Jiangsu

Biocentury

ShanDong

HuBei

Biocentury transgene technology Co. Ltd

Promote the commercialization of Bt cotton in China

Established in 1999

Headquarter located in ShenZhen

Company limited by shares

Five branch companies located in 5 provinces 33% share to the patent right owner (BRI, CAAS)

through licensing for patent exploitation

Impact of Bt cotton in China

Cotton yields (000kg/ha) by variety in Hebei and Shandong

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1.5

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3.5

Bt Non-Bt

Numbers of pesticide applicationsby variety in Hebei and Shandong

02468

101214161820

Bt Non-Bt

Pesticide use (kg/ha) by variety in Hebei and Shandong

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Bt Non-Bt

Labor input in pesticide application(day/ha)by variety in Hebei and Shandong

519

610

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Bt Non-Bt

Production cost per kg cotton output (yuan/kg) by variety in Hebei and Shandong

3.122

4.28

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Bt Non-Bt

`

Problems in the commercialization of Bt cotton

18 varieties or hybrids officially registered

more than 100 “Bt cotton” varieties available in the seed market:

real seeds with different name; fake seeds with real name.

cotton farmers are suffered from fake seeds

Concluding remarks I

The legal system for IPR protection is established in China, but need to be improved

Plant biotech IPR protection mainly through patent

Patent application on genetic engineering is dominated by foreign companies, but domestic application surpassed in recent years

Agriculture related patent application is increasing, but still dominated by pharmaceuticals

Concluding remarks 2

Great progress in non-transgenic plants for PVP: hybrid rice and corn

Many problems faced in the implementation of IPR protection, the system need to be improved or justified

Bt cotton has significant social/economic impact, is a good example of plant biotech benefits to the society and people

Thank you for your attention!

Thanks for your attention!

Further information on IPRs

Agriculture: Agri., forestry, livestock, breed aquatics; products and method.

Methodology: (1)searching from CPO data base (2) key words: recombination; gene; DNA; RNA; plasmids etc.

PVP

New variety: novelty; distinctness; uniformity; stability.

Protected botanical genera and species of plants (MOA)

◆ The first batch issued on June 16, 1999

rice, maize, Chinese cabbage, potato, spring orchids, chrysanthemum, Pink( 石竹） , clover, grass（早熟禾）

◆ The second batch issued on March 3, 2000

wheat, soybean, oil rape, peanut, tomato, cucumber, chili, pear, dock( 酸模）

Protected botanical genera and species of plants (MOA)

◆ The third batch issued on Feb. 26, 2001

orchids, lily, bird of paradise, sealavender （补血草）

◆ The fourth batch issued on Jan. 4, 2002

sweet potato, millet, peach, Litchi, water melon, cabbage, radish

◆ The fifth batch issued on July 14, 2003

broomcorn, barley, ramie （苎麻） , apple, citrus, banana, kiwifruit, grape, plum, eggplant

Total planting areas of major crops (2002)

◆ rice: 28.8 million ha

◆ wheat: 24.7 million ha

◆ corn: 24.3 million ha

◆ soybean: 9.5 million ha

◆ potato/sweet potato: 10.2 million ha

◆ cotton: 4.8 million ha

Seed Law

License policyHybrid seeds and parent seeds examined by Agri. /f

orestry administration at county level, and approved by provincial administrations

Article 27: farmer can sale or exchange extra seeds on free market w/o license