1. Nghin cu & Trin khai CNSH nng nghip: FTO & Qun l IP/TP L Th Thu Hin (VN) & Laurel Kilgour (USA) PIPRA-NOIP Workshop November 27-28, 2007 Hanoi, Vietnam

2. Ph n I.T do hnh ng trong nghin cu & trin khai CNSH nng nghip 3. N i dung

Gii thiu

Thut ng :

• T do hnh ng (FTO)

• Quyn sn xut sn phm (PC)

• Quy n s hu tr tu(IP)

• Quy n s hu ti sn(TP)

Phn tch FTO ca mt vi d n

• C s

• Ph ng php

Kt lun

4. Gii thiu

C c sn phm CNSH nng nghi p ,c bit l GMC s:

• Quan trng i vi an ninh lng thc & pht trin kinh t

• Cc thnh phn &/or quy trnh

• IP/TPRs km theo

1990s: c c t chc R&D

• Thc thi cc chnh sch IP/TP

• Hn ch chuyn giao min ph IP/TPRs

S huIP/TPRs trong CNSH n ng nghip :

• Ngy cng phc tp

• Ht sc quan trng

5. T nh hung

Cng ty AAA: Thnh cng trong to ging c chua bin i gen khng virus

• th trng trin vng

• Bn & phn phi

Mt ngy AAA nhn c th ca Vn phng Lut XXX:

• Gen khng virus: Sng ch US, chu u

• T chc ng k (i th): kin AAA

• AAA:

• • i mt vi cc th tc php l

• • Chi ph

6. T do hnh ng Freedom to operate - FTO

Ging c chua bin i gen ca AAA:

• IP & TPRs km theo

• Phc tp nhng c th gii quyt c

phn phi sn phm ng thi im->quy trnh phn tch quyn sn xut sn phm (PC), a ra kin v FTO

FTO l kh nng tin hnh cc ti nghin cu hoc pht trin sn phm vi ri ro thp nht v vi phm cc quyn s hu tr tu & ti sn ca bn th ba

kin v FTO c chun b bi lut s sng ch ( Duesing, 1997 )

7. PC

PC:

• Th no l PC?

• Ti sao cn PC?

• Cc bc lin quan l g?

• Cc thnh phn cn thit?

• Cc yu t cn xem xt?

PC xc nh ni dung k thut ca sn phm"

Tin hnh:

• Khi lut s yu cu nh l 1 phn ca nh gi tng th a ra kin FTO

• h tr cng ty ra quyt nh v pht trin & bn sn phm

8. PC

B nPC t ng hp bao gm

1) t t c cc thnh phn cn c to ra sn phm

2) t t c cc quy trnh s dng

3) m i s kt hp gia thnh phn & quy trnh s dng

M i kha cnh quan trng ca sn phm !IP & TP

9. S hu tr tu(IP) & S hu ti sn (TP)

tng

S hu tr tu

• V hnh

• Hu hnh

• • Bo h thng qua h thng php lut v quyn s hu tr tu

S hu ti sn

• Cc chng trnh my tnh

• Ngun gen

• Cc vt liu sinh hc

(Kryderet al ., 2000)

10. IP & TPRs

Xe t ca bn:

Ch s hu duy nht/ TP ca bn

Cho bn ca bn mn km theo giy cho mn, cho php lm g (hoc khng c lm g)

Bn khng s hu cc quyn s hu tr tu i km

• Bn ca bn khng th sn xut mt b phn no ca xe

• Vi phm quyn s hu sng ch

11. Tnh hung: IP # TPRs

AAA:

• Tm hiu mi sng ch

• ->a ging ra th trng

Th t Vn phng Lut XXX

• Plasmid: mn" (khng c gi tr php l) t Trng H BBB

• S hu TP: i th ca AAA/ cung cp cho BBB cng hp ng li-xng/ cho cc mc ch nghin cu & khng c chuyn giao cho bn th ba

12. IP & TPRs

T t c cc sng ch c tm kim

TP (cu trc gen/plasmid) cha c gim st & nh gi

Mi cng ty nn gim st cn thn cc vt liu nhn c t bn th ba, nhm m bo chng c c km theo hp ng thch hp v khng c cc hn ch trong vic thng mi chng ( Duesing, 1997)

13. Th i gian tin hnhph n tchPC

PC c th c thc hin khi sn phm :

• ang trong giai on xy dng k hoch,

• Khi ang tin hnh pht trin, hoc

• Khi sn phm ang sn sng a ra th trng

Cn tin hnh ng thi im, trc khi sn phm c pht trin (sm nht c th )

Cho php cng ty nh gi ton cnh IP & a ra quyt nh trc v thnh phn, quy trnh tt nht nn s dng & a vo pht trin sn phm, cng nh hn ch cc quyn s hu IP/TP nh km

14. FTO lun thay i

FTO: kh ng c nh

Ti n hnhPC & FTO: ch l bc u

Th ng xuyn gim st & cp nht PC

• 50-100 sng ch & h s ng k sng ch CNSH thc vt mi,

• Mt s sng ch ht hn bo h

15. Tnh hung: Ngun gen/ ging

Gi ng c chua bin i gen :

• Gieo trng nhiu ni

• Sn xut

Quy trnh PC: ng thi im, bao trm c IP & TP

Bc th mi: Quyn s hu ngun gen thuc i th khc ca AAA

-> Ngu n gen, ging cy trng, &/hoc cc quyn bo h ging cy trng i km cng l 1 yu t cn xem xt khi phn tch PC

16. Source: Stanleyet al.,2002 17. V d 1: Phn tch FTO caD n Khoai lang chuyn gen ASP1 18. C s

Khoai lang: ngun cung cp nng lng & dinh dng/ quan trng i vi nhiu nc ang pht trin

Protein ca khoai ty thiu 1 s aa, lysine & methionine -> NASA, USDA -> TU ->khoai lang GM: gen m ho cho protein d tr mi (ASP-1) (do Demegen nghin cu trc y)

i hc Tuskege (TU), USA

Trong D n hp tc nghin cu, gen m ho ASP1 c chuyn vo 4 ging khoai lang Vit Nam

19. Phng php

Tm hiu cc bi bo tng quan;

Tm hiu tt c cc ti liu lin quan trn cc c s d liu v khoa hc (CAB, BIOSIS, AGRICOLA)

Kim tra cc thng tin lin quan, cc bi bo, thuyt minh d n v cc hp ng ti tr kinh ph

Xem xt cc hp ng

Kim tra & theo di cc con ng chuyn giao TP

Tm kim cc sng ch trn cc c s d liu v sng ch & cc c s d liu khc

Kim tra cc sng ch (cc yu cu bo h)

Xy dng khung IP/TP

Kim tra ng thi tt c cc thnh phn/ nh gi ton cnh IP/TP

(Kryderet al ., 2000)

20. Tin hnh phn tch PC

Cc phng php & quy trnh s dng trong pht trin sn phm?

Cc thnh phn ca sn phm

IP & TPRs c th km theo cc thnh phn ny?

21. Tin hnh phn tch PC ngu n : Stanleyet al.,2002 22. Tin hnh phn tch PC

Ngun gen

Cc cu trc gen (cc vector chuyn gen)

• pBI121C2H

• pCGN1559-EG-ASP1

Phng php chuyn gen, nui cy m & ti sinh

Chn lc t bo/ m chuyn gen

Phn tch cc cy trng bin i gen

23. Cc c s d liu v khoa hc & sng ch

IBM Intellectual Property Network - http://www.patents.ibm.com/ibm.html

MicroPatent - http://www.micropat.com/

C quan Sng ch chu u - http://ep.espacenet.com/

C quan Sng ch & Nhn hiu hng ha Hoa K - http://www.uspto.gov/patft/index.html

24.

Vector(s) t o dng: chn cc on DNA

• Cc v tr to dng

• Cc ch th chn lc

• Nhn ln trongE. coli

Vector(s) bi u hin : s n sinhProtein(s)

• Nhn ln trongE. coli

• Gen khng khng sinh trong vi khun

• Promoter thc vt(CaMV35S); Terminator

• Ch th chn lc thc vt

Vectors 25. Agrobacterium tumefaciens: c ng c t nhin cho chuyn gen thc vt

do chuy n gen t vi khun sang genome thc vt

g y bnh khi u thc vt (ch yu l cy hai l mm)

Photographs supplied by Sharon von Broembsen, Oklahoma State University 26. A. tumefaciens: c ng c t nhin cho chuyn gen thc vt

Gen chuyn nm trnTi (tumor-inducing)plasmid.

Ti A. tumefaciens vir genes LB RB T-DNA Ti plasmid ~ 120 kbp ori 27. Phng php chuyn gen gin tip quan vi khunAgrobacterium T-DNA ci bin (cha gen chuyn) gen chuyn trn Ti-plasmid A. tumefaciens NST vi khun T bo thc vtc chuyn gen NST thc vt Ngun: Monsanto gen chuyn 28.

Phn lp gen quan tm(GOI)->vector t o dng

Thi t k vector biu hin mang"promoter-GOI-terminator"

Chuy n gen( aGOI v o trong m thc vt )

T i sinh cc m sau chuyn gen - to cy mi t cc t bo chuyn gen

Ch n lc cc th bin np

Phn tch s biu hin gen

Cc bc to GMC 29. B sung cc trnh t DNA kim sot s biu hin gen

Promoter khi u phin m ; kim sot v tr, thi gian & mc biu hin ca GOI

Terminator: kt thc gen

Promoter TerminatorGOI 30. Tm kim TP

Tm hiu ai c ci g t u, khi no & bng cch no

Cc c s d liu khng c sn

Cn mng li cc chuyn gia lm vic trong d n

Mc tiu l tm hiu, khm ph & thu thp cc bn sao ca mi hp ng chuyn giao, thuyt minh d n, hp ng ti tr, hp ng lao ng & cc hp ng bo mt

31. Ging cy trng 32. S chuyn giao TP ca vectorpBI121C2H 33. S chuyn giao TP ca vectorpCGN1559-EG-ASP1 34. S hu IP/TP Monsanto Company Nos Terminator Demegen, Inc. asp-1 Structural gene Monsanto Company CaMV35S Promoter Gene of interestMycogen Plant Science, Inc. 3 tml Monsanto Company Nos Terminator Cambia Biosystems LLC. GusA Monsanto Company NptII Structural gene Monsanto Company CaMV35S Monsanto Company (Original) Nos Promoter Marker genes Tuskegee; Demegen pCGN1559-EG-ASP1 Calgene pCGN1559 Demegen pBI121C 2 H Clonetech Lab, Palo Alto, CA. pBI121 Binary vector(s)C58 EHA105A.tumefaciens Provided by the Center for Plant Biotechnology Research, Tuskegee University.DH 5 E.coliBacterial strains Vietnam ChiemDau, TrangTuNhien, K51, NN31 Sweet potato varieties Ngu n gc s hu IP/TP Th nh phn sn phm 35. Bng tng hp PC 36. ASP1 gen 37. Hp ng/ giy php c th cn Hp ng/ giy php c th cn a sn phm ra th trng hoc xut khu 38. V d 2:Golden Rice TM 39. " Golden Rice TM "

GOI:

• Gt1 promoter - Phytoene synthase ( psy )

• 35S promoter- Phytoene desaturase ( crtI )

• Gt1 promoter - Lycopene -cyclase ( lcy )

• • Gt1 = Endosperm specific glutenin

Ch th chn lc

• Khng Hygromycin (35S promoter -aphIV )

40. Golden Rice TM- Vectors Figure 1.Structures of the T-DNA region of pB19hpc used in single transformations, & ofpZPsC and pZLcyH used in co-transformations. Representative Southern blots of independent transgenic T 0 -plants are given below the respectiveAgrobacteriumvectors. LB, left border; RB, right border; "!", polyadenylation signals; p, promoters;psy , phytoene synthase;crtI , bacterial phytoene desaturase;lcy , lycopene-cyclase;tp , transit peptide. 41. Ngu n : Stanleyet al.,2002 42. T bothc vt c chuyn gen Ngun: Monsanto DNA NST thc vt Gen chuyn Cc ht "Bn gen" - Phng php chuyn gen trc tip Sng ch ti Trng H Cornell, USA Cc quyn lq n cng ngh c bn cho DuPont nm 1990 http://www.nysaes.cornell.edu/pubs/press/1999/genegun.html 43. (daffodil) (bacteria) (daffodil) Introducedenzyme (source) 70 prietary technologies(40 US patents)

Uncertainty

High transaction costs

Golden Rice TM 44. FTO - Nhn xt chung

Cc sn phm CNSH nng nghip:

• Phc tp: cc thnh phn &/or quy trnh IP/TPRs nh km

Cn chi ph pht trin li sn phm, chi ph cho cc hp ng, cc th tc php l: khng hay & khng cn thit

Xc nh cc quyn ny:

• Ai s hu hoc kim sot?

• Cch thc c chng? C km MTAs? Mua? Khng bit?

nh gi:

• Sn phm s c sn xut u, a ra th trng no, s dng hay tiu th (ni a/ xut khu)?

• Lut no? (tu tng quc gia)

45. FTO - Nhn xt chung

Cn tin hnh phn tch PC->a ra kin FTO

FTO nn c tin hnh:

• sm->c th quyt nh trc v thnh phn, cng ngh, quy trnh s dng pht trin sn phm & qua gim thiu/ trnh cc vn v IP/TP

• Thng xuyn cp nht

• Theo di MTAs

• Bit bn c g

46. FTO - Nhn xt chung

• Chuyn giao quc t:

• • IPRs: lut quc gia

• • Hu ht sng ch CNSH nng nghip: c gi tr cc quc gia pht trin-> ch c mt vi tr ngi v IP trong chuyn giao cng ngh

• • Ph t sinh vn -> nh p khu sang cc quc gia khc ni c bo h

• • Chin lc ngn hn: s dng bt hp php

• • Di hn: gp kh khn

• • Bn giao & bn nhn: nn hiu bit v cc vn IP/TP lin quan

• • Quc gia: cn xy dng nng lc qun l IP/TP-> x y dng cc mi quan h bn vng !

47. Phn II. Qun l IP/TP Vit Nam 48. Hin trng

Nghi n cu & Trin khai CNSH Nng nghi p

• Mc ti tr & cc chng trnh

Mc ng k sng ch thp nhng ang c xu hng tng

• 1864 h s ng k nm 2005 nhng ch c 3.9% ca ngi Vit

Mc bo h thc vt cng thp nhng ang c xu hng tng

• Trong nhng nm gn y tng cc h s ng k bi cc trng i hc ca VN

Lut S hu tr tu mi (2006)

• Ph hp vi hip nh TRIPS

Hin i ha NOIP

• Th vin in t IP & h thng ng k qua mng

K hoch ci thin h thng php l

• X l vi phm tt hn

49. Hi n trng : C c hip c quc t

VN l thnh vin caWIPO t 1976 v k k t cc hip c chnh sau

• Cng c Berne, Cng c Paris, Hip c Hp tc Sng ch (PCT)

VN tr thnh thnh vin ca UPOV t 2006

• Hip nh song phng vi Hoa K: VN phi thc thi h thng bo h sng ch i vi tt c ng vt & thc vt khng phi l ging

VN tr thnh thnh vin ca WTO t 2006

• C hi mi: chuyn giao cng ngh, cc mi quan h mi vi cc cng ty quc t

• Kh khn: m phn hp ng, cn bo v cng ngh hoc thuc s hu cng ng

50. Hi n trng : C c vin nghin cu

Th ng mi ha cc kt qu nghin c u: mi i vi hu ht cc trng i hc

• Hu ht cc vin nghin cu ca CP phi t trang tri vo nm 2009

Hin c nhiu hp tc quc t

• Ti tr; cung cp vt liu

Quyn s hu IP: mi i vi cc nh khoa hc

Hu ht cc trng i hc ca VN khng cvn phng qun l IP

• Ngay c nhng ni c sng ch c bo h cng khng c quy ch IP hon thin

51. Xy dng nng lc Nhn xt chung

Hp tc & chia x thng tin

• Cc trng i hc cn trao i & chia x kinh nghim v qun l IP

• H tr t cc t chc quc t & cc t chc phi chnh ph

H tr t cp trn

• Cn ti tr & nng cao nhn thc v IP

Xy dng quy ch IP

• Thng qua quy ch sm to tnh nht qun

• Bao gm cc iu khon v IP trong cc hp ng lao ng

• Cn phn nh r trch nhim i vi cng ng & mc tiu thu li nhun

Di hn: Vn phng qun l IP. Nhng cn thc t!

• Hu ht cc d n s khng thu li nhun cho trng i hc

• Mt s li ch l v hnh; cn nhiu nm

• • o to sinh vin, ci thin kinh t a phng, tip cn cng ngh mi

52. Xin trn trng cm n !