PPT - International Union for the Protection of New Varieties of Plants

mutebabiesΒιοτεχνολογία

6 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

304 εμφανίσεις

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



䍨楮敳攠䍯e祲楧桴 佦晩捥







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



䅭敮摥搠慧慩渠潮a䅵杵獴g㈵Ⱐ㈰〰Ⱐ扥捯浥 敦e散e楶攠潮o
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



乥N汹 偲潭o汧慴敤e潮⁊ 湥nㄵⰠ㈰,ㄬ1慮搠
effective on July 1, 2001



Seed Law of PRC




Issued on July 8, 2000



剥污R敤er敧畬慴楯湳i楳i略搠批⁍佁u




䕸慭楮攠慮搠慰灲潶慬⁲敧畬慴楯渠景f 浡m潲 慧物a畬u畲慬u
捲潰猬⁆敢⸠㈶Ⱐ㈰〱


b
⸠䱡.敬e湧⁲敧畬慴楯渠潦⁡杲楣畬瑵牡t 捲潰o





偲潣敳o楮朠慮搠灡捫楮朠r敧畬慴楯渠潮⁡杲楣畬u畲慬u捲潰猠
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



䅮A䥐删䅦晡楲⁃ 湴敲⡍体吩(獥琠異 楮‱㤹5



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



㤰┠慰灬p捡瑩c湳 晲潭⁦or敩杮⁣潭o慮楥猬i
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)

0
500
1000
1500
2000
2500
3000
3500
1985
1987
1990
1992
1994
1996
1998
2000
Over 90% are foreign applications in 1985
-
1998

0
50
100
150
200
250
300
350
400
domestic
foreign
About 90% are foreign applications (1985
-
1998)

0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
domestic
foreign
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

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)

0
500
1000
1500
2000
2500
3000
3500
domestic
foreign
Percentage of domestic/foreign application

(1991
-
2001)

0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
domestic
foreign
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



䅣A潵湴敤e景r′ ⸶┬‸.⸳┠慮搠㌴⸳┠潦⁴潴慬
annual application







Most patents on genetic engineering are
pharmaceutical

(1985
-
2001)

0
500
1000
1500
2000
2500
3000
3500
1985
1987
1989
1991
1993
1995
1997
1999
2001
pharmaceutical
others
Agriculture related patent application increased

(1985
-
2001)

0
50
100
150
200
250
300
350
400
1985
1987
1989
1991
1993
1995
1997
1999
2001
agriculture
pharmaceutical
others
Agricultural patent occupy about 10% in overall

(1985
-
2001)

0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
pharmaceutical
agricultural
industry
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



周攠䵩湩獴特r潦⁁杲o捵汴畲攨䵏M⤺


杲慩湳Ⱐ捯c瑯測t氠捲潰Ⱐ桥浰Ⱐc畬扥牲楥iⰠ瑥tⰠ獵条爬s
癥来v慢汥Ⱐ敤楢e攠晵湧椬⁴潢慣捯Ⱐ晲畩琠瑲t敳e橵楣礩Ⱐ
桥牢慣敯畳敤楣e湡氠浡m敲e慬猬a桥牢慣敯畳h
潲湡浥湴慬 灬慮瑳Ⱐ杲慳gⰠ牵扢敲⁴牥攬e杲敥渠浡湵牥m



周攠却慴攠䙯牥e瑲t 䅤浩湩獴牡r楯渨卆S⤺



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



周攠T散潮搠扡瑣栠楳i略搠潮⁍慲捨″Ⱐ㈰,0


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 varieties


quality 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



剥獥慲捨c扵摧整e浯m瑬t⁧楶敮e批⁴桥 杯癥牮浥湴



Weak incentive mechanism for IPR protection


Capacity building on IPR protection



General weak on capacity building



at research institute or university level




䕭灨E獩s 潮⁥摵捡瑩c湡氠慮搠瑲慩t楮i 灲潧牡浳†
潮⁉偒 灲潴散瑩tn



Fiscal aids for education and training





Implementation on IPR protection



Great progress in the legislation on IPR laws



周攠業灬敭敮瑡e楯渠潦⁉偒 污l猠湯琠祥n 晵汬礠捯c灬整敤


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, c
apacity 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;
i
nfringement 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,
199
0



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

XinJiang

HeBei

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

0
0.5
1
1.5
2
2.5
3
3.5
Bt
Non-Bt
Numbers of pesticide applications

by variety in Hebei and Shandong

0
2
4
6
8
10
12
14
16
18
20
Bt
Non-Bt
Pesticide use (kg/ha) by variety

in Hebei and Shandong

0
10
20
30
40
50
60
70
Bt
Non-Bt
Labor input in pesticide application(day/ha)

by variety in Hebei and Shandong

519
610
0
100
200
300
400
500
600
700
Bt
Non-Bt
Production cost per kg cotton output (yuan/kg)

by variety in Hebei and Shandong

3.122
4.28
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
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)
Ⱐ捬潶敲Ⱐ
杲慳s
(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)



周攠T潵牴栠扡瑣栠楳i略搠u渠n慮⸠㐬′〰2


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



周攠T楦i栠扡瑣栠楳i略搠潮⁊ 汹‱ Ⱐ㈰,3


broomcorn, barley, ramie
(苎麻)
Ⱐ慰灬攬⁣楴牵猬i
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



獯祢敡渺 㤮9楬汩 渠桡



potato/sweet potato: 10.2 million ha



cotton: 4.8 million ha



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