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Plant Biotechnology Intellectual Property Rights and the Bt cotton case in China Qin Fang Wang Associate professor Biotechnology Research Institute Chinese.

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Presentation on theme: "Plant Biotechnology Intellectual Property Rights and the Bt cotton case in China Qin Fang Wang Associate professor Biotechnology Research Institute Chinese."— Presentation transcript:

1 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

2 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

3 IPR protection in China: A general review

4 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

5 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

6 State Intellectual Property Office(SIPO ) 3 main administrations under the guidance of SIPO Chinese Patent Office Chinese Trademark Office Chinese Copyright Office

7 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

8 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)

9 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

10 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.

11 Current Biotechnology IPRs in China

12 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

13 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

14 Applications increased year by year, Dramatically increase in recent years ( )

15 Over 90% are foreign applications in

16 About 90% are foreign applications ( )

17 Top 10 foreign countries in applying gene patent in China 1. USA 2. Japan 3. Germany 4. UK 5. Switzerland 6. Denmark 7. France 8. the Netherlands 9. Canada 10. Australia

18 United States is the top country Account for 39.7% of total foreign applications in the period of 1985 to 1998

19 Domestic application increased recently ( )

20 Percentage of domestic/foreign application ( )

21 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

22 Most patents on genetic engineering are pharmaceutical ( )

23 Agriculture related patent application increased ( )

24 Agricultural patent occupy about 10% in overall ( )

25 Protection of New Varieties of Plants in China

26 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

27 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.

28 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

29 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

30 Progress of plant variety right application (MOA) Office of Plant New Variety Protection, MOA 1061 applications received from April, 1999 to Aug., 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)

31 Progress of plant variety right application (MOA) To strengthen the management, MOA Established a Propagation Material Preservation Center for agricultural plant new varieties quality and quantity detection & preservation Established one center and 14 branch centers for DUS test

32 Problems and Challenges in Plant Biotechnology IPRs

33 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

34 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

35 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

36 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

37 Enforcement of Laws and regulations Unauthorized use of IPRs, infringe patent right or plant breeders right Small seed companies ; farmer sale seeds; i nfringement of right Regional concerns(local government): affect the settlement of legal disputes Supervise the infringement and balance the farmers right, a challenge in China

38 Case study of Chinese Bt cotton

39 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 bollworms resistance to Bt

40

41 Commercialization of Bt cotton approved for commercialization in new transgenic cotton var. and hybrids 10,000 ha in , 000 ha in , 000 ha in ,000 ha in million ha in million ha in 2003 the only GMC with the largest sown area in China

42 Fig 1. Bioassay of transgenic cotton CKtransgenic

43 Bt/CpTI Field performance of Bt cotton

44 Good Harvesting

45 XinJiang HeBei Jiangsu Biocentury ShanDong HuBei

46 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

47 Impact of Bt cotton in China

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

49 Numbers of pesticide applications by variety in Hebei and Shandong

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

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

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

53 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

54 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

55 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

56 Thank you for your attention! Thanks for your attention!

57 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.

58 PVP New variety: novelty; distinctness; uniformity; stability.

59 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(

60 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

61 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

62 Seed Law License policy Hybrid seeds and parent seeds examined by Agri. /forestry administration at county level, and approved by provincial administrations Article 27: farmer can sale or exchange extra seeds on free market w/o license


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