LtATSOtHtrUTRiTUt . —
QUY DEVH VE SANG CHE DlTOC PHAM CUA HIEP DINH D 6 I T A C XUYEN THAI BINH DUONG (TPP) VA
ANH in/OfNG DEN CHIEN LlTOC PHAT TRIEN
Di/oc PHAM VTET NAM
NGL~\ EN XUAN QUANG*
\ G U \ ' E N XUAN LY**
Tdm tit
TPP dugc cho Id mgt trong nhung hiip dinh TRIPs cpng vai nhung tiiu chudn bdo hp sa hdu tri tug khdt khe.
dgc biit trong linh vuc duac phdm. Hiip ^I'^h nay dugc cho Id se trao qud nhieu quyen cho chu sd hiiu sdng che, vi the CO the se gdy khd khdn cho viec sdn xudt thudc generic. Trong qud trinh TPP dugc dam phdn, cd rdt nhieu phdn tich dy bdo thudc generic se gap khd khdn vd bi tri hoan luu hdnh, cdc cong ty mai sebfcan tra do hiin tugng "bgi rgm sdng che " (paten thicket), vd chiin luge keo ddi ihdi gian bdo hp sdng che (evergreening). vt vgy nguai ddn co the bi hgn chi tiip cgn thudc do thudc generic bi cdn tra gia nhgp thi truang. Bdi viet gom ba phan: so sdnh quy djnh bdo hp sdng chi dugc phdm cua TPP vd lugi hign hdnh cua Vigt Nam; dnh huong cua TPP ddi vai chien luge phdt triin dupe phdm Viet Nam vd kien nghi xdy dung ludt Viit Nam.
Tir khda: sdng che dugc phdm. TPP. thudc generic, thudcgdc, chu sd hiiu sdng chi Abstract
TPP is considered as a TRIPs Plus Agreement with stricter standards of inlelleciual property rights, especially for f^tarmaceutical products. The agreement would grant power to patent owners and cause difficulities for generic manufacturers. During negotiation for the TPP. many analysts predicted generics would encounter difficulties and be delayed to access market: new manufacturers could be hampered by patent thickets and evergreening; therefore, the public access to generics may be limited. The paper consists of three parts: TPP requirements versus Vietnam s law on pharmaceutical patent: ^ecls of TPP on Vietnam s pharmaceutical strategy until 2020, and recomendations.
Keywords: pharmaceutical patent. TPP, generics, original drug, patent owners
1. So sanh quy djnh bao hp sang che I.L Boi tirgng dirge bdo hp sdng chi diryc pham trong Hifp d|nhTPP va phip Ddi tugng bio hd sang che dugc quy dinh luat hi^n hinh ciia Viet Nam tgi Dieu 18.37 cua TPP. Theo khoan 1 diiu Trong Hiep dinh Ddi tic thuong mai xuyen niy, thi mdi Bin phdi quy dinh bdng dpc Thii Bmh Duong (Trans-Pacific Partnership quyin sdng chi cd thi dugc cdp cho bdt ky Agreement - TPP)^ quy dinh rieng cho dugc mpt sdng chi ndo, dii Id sdn phdm hay Id quy pham dugc ghi nhan tgi Tieu myc C - Cdc trinh, thupc mpi Unh vuc cdng ngh4, v&i dieu gidi phdp Uin quan den duge phdm, thugc ki4n sdng chi do m&i, co trinh dp sdng tgo vd Myc F - Sdng chi vd du li4u thu nghi4m vd cd khd ndng dp dung cdng nghi4p. Quy dinh cdc cdc da li4u bdo mat khde, cua Chuong nay the hien lai mdt phin Diiu 27 Hipp dinh 18 - S&huu tri tu4 ciia TPP. Biy dieu khoan TRIPs, nen se khdng ddi hdi cac nude thinh trong lieu muc C chi quy dinh ve thdi han bio vien TPP phai thay ddi phap Iuat lien quan hp va bio hg dii lieu thir nghipm, cho nen cic ciia mmh.Tuy nhien, nhiing khic bipt trong lieu chuan cap bang sing chi dugc phim se cac diiu kien de dugc cip bing sang chi giira gidng nhu cic nginh cdng nghiep khic theo cic nude thanh vien TPP cd the se dan tdi quy djnh chung ve sing chi trong Tilu muc vipc mgt sd nude trong dd cd Viet Nam se A cua Chuong nay. can phii thay ddi phap Iuat hrong iing khi
• TS. Lugt hpc. Giang vien Khoa luat Dan sy, ^ ^ ^"^C thdng qua.
Truong DH Lugt TP. Ho Chi Mmh. ' Dilu 18.37.1 cua TPP gidng nhu TRIPs
" ThS Lugt hpc. C^jO p j ^ ^ ^^^. ^^^ ^^^ ^•^^^ ^^^ ^^^ q^y
70 T ^ CHi KHOA HQC PHAP L V S 6 0 2 ( l 0 g / 2 ^ dinh dieu kien cap sang che la "cd khi nang
ap dyng cdng nghipp" vi "cd trinh dp sang tao" tuong ling vdi "hihi ich" va "khdng hien nhien". Tuc, theo TRIPs vi TPP, cac nude cd the coi hai thugt ngfr niy la tuong ducmg, nhung khdng bi bat bupc phii lim nhu vay.
Tuy nhien, do npi ham cua thuat ngu cd the dugc hieu khic nhau nen vipc lya chgn thugt ngu nao cho dieu kien cap sang che trong lugt Yitt Nam la van de quan Irgng can dugc xem xet'. Trong pham vi bii phin lich niy, nhdm tic gii xin dua mdt sd luan giii khic nhau trong ap dyng "cd kha nang ap dyng cdng nghipp" va "hiru ich".
Tinh "hiiu ich" bat nguon tii lu^t Hoa Ky,^
thyc tien ap dyng tai nude nay nude niy cho thay "hiru ich" dugc hieu vdi nghia rit r0ng, bao gdm tat ci cic hinh thiic su dyng, cdng nang hay cii tien nio ddi vdi cac sin pham hay quy trinh da cd.^ "Cd kha nang ip dyng cdng nghipp" li thuat ngii vdn xu4l phit tir Lien minh chau Au,"* li mgt khai nipm chat che hon, ddi hdi cac dieu kipn cao hon vl chat lugng ciia sang chi nhim dim bio sang
' Lugt Vipt Nam hipn tgi dang i p dyng khii nipm
"CO k h i nang dp dyng cong nghipp". Tham k h i o Di^u 5 Lugt Sd hfln tri tup n i m 2005
- Sivaramjani Thambisetty, Legal Transplants in Patent Law: iVhy Utility is the New Industrial Applicability, London School of Economics and Political Science, 6/2008
* O Hoa Ky cd ba logi bSng sing che: sang che hiiu dyng (utility patents), sing che v^ thiet k^ {design patent); v i sdng che cho cay tsong (plantpatents). Phgm vi bii phan tich nay ve dupe phim cho nen logi sang che dupe phan tich l i sing ch6 him dyng. Sang che huu dyng CO the dupe cap cho guy trhih/phuong each sin xuat (process/ method), thifit bj/ hp thdng diing trong san .\uai (machine), sin phim dupe san xuit (article of manufactiire), hogc sy ket hpp thinh phin hda hpc (composition of matter) mdi v i huu dyng bit ky, hay mpi cii tien mdi v i hflu dyng cua chung. <ht^://www.
uspto.gov/patents-getting-started/general-information- conceming-patents#heading-4> truy c ^ ngiy 14/5/2016 va <httpV/www.webpatentcom/knowbase/evaluate/law/
lawlllO0.htm> truy qip ngiy 14/5/2016.
^ •• Dieu 57 cua Cong udc sing che Chau Au vh i p dyng cdng nghipp; Mgt sdng che se dugc xem xel cd khd nang dp dgng cdng nghiip neu cd the dugc tgo ra hay dupe sii dgng trong ngdnh cdng nghiip bat ky. ke cd ndng nghigp
<https://www.epo.org/law-practice/legal-texts/html/
epc/2016/e/ar57Jitml> tmy c ^ n g a y 24/9/2016.
che cd mgt ung dyng thyc tien, tiic li chac chic hihi ich nen cd th6 dugc dung.*
Sy lya chgn ihugt ngii li rat quan trgng va phiic tgp vi moi thugt ngiJ phiri inh sy khic nhau trong y nghia vi tieu chuin. Chiing toi cho rang quy djnh cho phep thinh vien tuy chgn thu^t ngii trong TRIPS vi TPP vdi ngM y hy vpng cac thinh vien se sii dung chung tieu chuin nhu cic nude phit triin trong vipc giii thich vi ip dyng.^ Tuy nhien, tren thyc tl mpi s6 sing chi cd the dugc cap bing bio hp Irong khu vyc phap ly niy nhung cd the khdng dugc cap d noi khic. Dilu niy cd th6 inh hudng din tuong lai cua mpt nganh cdng nghipp va ldc dp phii triin cdng ngh? o mpt quoc gia.
vin de nay cd thi dl ding nhgn thay trong ITnh vyc cdng nghp sinh hpc.'Vi dy, mpt nhi sing chi cdng nghp smh hgc can cdng bo trinh ty DNA sin xuit ra mpt logi protein vi dgc diim hiiu ich cda logi protein long hgp da thda yeu cau tinh hihi ich. De thda yeu ciu khi nang ip dyng cdng nghipp ciia Lidn minh chau Au, nha sing che nay can phii chiing minh them la sing che ve tdng htpp DNA niy cd tiem nang vl mat thuong mgi, bdi vi khii ni^m "cong nghiep" trong Dilu 57 Cdng udc sang che Chau Au dugc hieu vdi nghia ril rpng bao gdm cac hogt dgng dugc thyc hipn cd gii tri thuong mgi. Vi thi ciing cin thi hipn Igi ich tii chinh nay (cy thi, ngay lgp tiic) trong don yeu ciu sing chi. Vi dy tren cho thay, ca hai lieu chuin "hiru ich" vi "cd kha nang ap dyng cdng nghipp" diu y§u cau
' Emily Peters, Utility or Not Utility? - Indusbial Applicability in the UK. 2012<http://www.aipla.
org/committees/conmiittee_pages/BiotechnoIogy/
Committee%20Documents/Comparative%20Law%20 Symposium,%20Ottavra,%20Apr2012/Utility%20or%20 Not%20Utility%20-%20hidustrial%20AppIicability%20 in%20the%20UK%20FINAL.DOC.>.
' N h g n d i n h n i y d y a t r g n b i i "The practical application of industrial applicability/utiiity requirements under national and regional laws", 04-2001 '-wwwwiuo int/edocs/mdocs/scp/en/scp_9/scp_9_5.pdP> truy cari *
14/5/2016. ^P ' Vi dy ve cong nghp sinh hpc d u ^ c chpn bdi vl
cdng nghi sinh hpc l i m$t m i n g quan trpng trong s i n xuit dupe p h i m (vie xin, thu6c tri ung thu. )
LI AT SO HUtr TRf TU|: ^ chii scr huu sing che phii chiing minh viec dip ling cac yeu cau ve tinh hihi ich. Ca hai tieu chuan deu yeu cau cac sang che phii cd chiic nang cy the, va tinh hiiu ich tren thyc te cho cgng ddng. Tuy nhien, "kha nang ap dyng cdng nghipp" cd khii nipm va phgm vi luong doi hep hon "hiru ich", dieu nay thay rd trong cdng nghe sinh hgc, bdi vi sin pham tdng hgp tu cdng nghe sinh hpc (cdc polypeptite) vdn di xay ra trong co the ngudi, sinh vat khac va cd the se cd dugc tdng hgp theo nhiing cich khic nhau cho nen vipc chung minh gii bi Ipi nhuan cd the dugc xem Ii co sd ciia gia tri thyc tien.*
Ngoai ra, vipc lya chpn thuat ngii ("hihi ich" hay "cd khi nang ap dung cdng nghipp") trong quy dinh tieu chuan bio hp sing che cd the din den vipc loai tru bio hg mpt sd sing che. Chang han d Nhit Bin vi Chiu Au, "cd khi nang ap dung cdng nghiep dugc chpn", vi dieu nay hin nhien da logi nhihig sing che ve phau thuat, chin doin, hay dieu tri y khoa (vi phau thuat, chin doin, hay dieu tri y khoa dugc cac qudc gia niy xem li khdng cd kha nang ap dyng cdng nghiep).'-"' Chac chan la nhimg phuong phap phdu thuat,
' Quyet djnh T 0870/04 (BDPl Phosphatase MAX-PLANCK) H,05a005 <http://www.epo.org/
law-practice/case-law-appeals/recent/t040870eul.
html> truy cgp ngay 24 '9/2016.
Luu y tgi Vipt Nam, van de l^i nhugn thuong mgi klwng phii li mpt yeu td de danh gia "co kha nang ap dyng cong nghipp" theo Quy che tham djnh don dang ky sang che (Ban hinh kem theo Quyet djnh sd 487/
QD-SHTT ngay 31/3a010 ciia Cue Tnrdng Cyc Sd hflu tri tu^. Tuy nhien, nhom tic gii muon dua ra mpt cich ucp cgn dang dupe ap dyng tren the gidi (cy the li Li£n minh chau Au).
* Cung cin phii hieu nhiing chinh sich khong bio bp sang che cho phucmg phip dieu trj li de bao ve cic y bic si va khuyen khich hp diing nhirng phuong phip dicu tri t6t nhat cho tit ca b?nh nhan. N^u bio hp sang che cho phuong phap di^u trj. thi bpnh vien hay bic si se phai chi tra chi phi sing chg trudc khi dieu trj, neu khdng se vi pham lugt sang chi.
'• Sunum ^'bseySm^,PaieniinginPharmaceuticals:
India and Japan. Study cum Research Report, WIPO- JPO Ltmg Term Fellowship-2010 <http:,/www.wipo.
int export/sites/www/about-wipo/en/ofTices/japan/
rcsearch/pdPindia 2010.pdf>tiuyc|p 14/57016.
chan doin hay dieu tri y khoa viia ke tren la hiiu ich, vi vay cd the cap bang sing che d nhung khu vyc phap Iy quy dinh "hiru ich"
(nhu Hoa Ky).
Tuy nhien, lieu chuan "cd khi nang ip dyng cdng nghiep" se cd the se tgo rio cin cho nhung nhi sang che trong linh vyc cdng nghe sinh hpc. Nhirng nhi sing che trong nude cd the khdng cd uu the ve chuyen mdn, khi nang \ i cdng nghp cilng nhu co sd ha tang so vdi cic cdng ty da qudc gia. Ngay ci ddi vdi nhiing nhi sang che cua cac cdng ty ldn thi viec chiing minh mdt dugc pham sinh hpc li hieu qua vi an loan da Ii mpt thich thiic.
Do dgc tinh cua dugc pham sinh hgc, viec xac dinh tinh hihi ich ciia che pham smh hpc can phai cd thdi gian. Tuy nhien, neu khdng cd CO che bio ve sing che nay, cic nha sang che trong nude se gap khd khan de tiep tye nghien cihi cdng dyng cua san pham. Nhung Viet Nam gia nhgp TPP vdi mong mudn phit trien thudc sinh hpc ky thuat cao, theo nhu phit bieu ciia trudng doin dim phin TPP."
\'i viy, md rgng bio hp cho sin phim cdng nghe sinh hpc cd the tgo co hpi di tat ddn diu trong sin xuit vac xin vi nhiing thudc sinh hgc hien dai tai Yiet Nam..
Dilu 18.37.2 cua TPP quy dinh "Cdc Bin khdng dinh rdng bdng dpc quyen sdng che cd thi dugc cdp cho cdc sdng che co yiu cdu bdo ho cho it nhdt mpt trong cdc doi tugng sau:
cdc cdng dung m&i cua mpt sdn phdm da biet, cdc phuang phdp sic dung m&i cua mpt sdn phdm dd biet, hogc edc quy trinh su dung m&i cua mpt sdn phdm da biet. Mpt Bin cd thi gi&i hgn cdc quy trinh m&i ndy & nhirng quy trinh khdng yeu cdu bdo hp don thudn vi4c sir dung sdn phdm ". Day la diem khic bipt quan trgng giua Dilu 18.37.2 ciia TPP va Dilu 27 cua TRIPS. Theo do, vdi mdt san phim da biet cd the se dugc cap sing che neu cd cdng dung mdi hay cic cich thiic mdi (bao gdm phuong ''Doanh nhdn Sdi Gdn online, 'TPP tic dpng the nao din nganh dupe Vipt Nam," 2/10/2015, <http://www.
doanhnhansaigon.vn/thoi-su-trong-nuoc/tpp-tac- dong-the-nao-dennganh-duoc-viel-nain/1092243/>
truy cap 14/5/2016.
72 TAP CHi KHOA HQC PHAP L V S 6 02 (l05)g»^
phip sii dyng hogc quy trinh sir dyng mdi).
Lugt Vipt Nam hien khdng cd quy dinh ve viec bao hg cho cac phucmg thiic sii dyng hay hinh thiic mdi ciia dugc pham Dieu 4 khoan 12 Lugt Sd hiru tri tup nam 2005 dinh nghia:
"sdng che Id gidi phdp ky thugt du&i dgng sdn phdm hogc quy tnnh nhdm gidi quyit mpt van di xdc dfnh bdng vi4c ung dung cdc quy ludt tu nhien ". Nhu viy, luit Viet Nam yeu can mpt sing che phii li mpt sin pham hogc mgt quy trinh de cd the dugc dang ky bio hp. Mpt each thirc hay phucmg phip sd dyng khdng the dugc xem li mpt sin pham hay mpt quy trinh vi vi vgy khdng dip iing dieu kipn de dugc cip bang sing che. Day cd the li iy do Cyc sd hiiu tri tup Vipt Nam hipn chua cip van bang bio hp cho nhiing don yeu cau lien quan den cich thuc hay phuong phap sii dyng mdi cho dugc pham cii. '^
Tuy nhien, vdi cdng dyng mdi, \^pt Nam da cip bang sing che cho nhirng nhirng dugc chat da biet dugc thay ddi dang bio chi ho^c lieu de cai thipn tie dyng dieu tri hogc giim tic dyng gay hgi. '^
Vipc bio hp cdng dyng mdi cho dugc phim hipn van la mpt van de gay ra nhieu tranh luin '- Theo ket qua tim kiim tai IP LIB ngiy 18/05/2016. Cfing thdng tin Cue sd huu tri tup Vipt Nam, <http://iplib.noip.gov.vn/WebUI/
WDetailPAT.php?intRecNum-3&HitListViewMod e=Compact&reF=>.
'^ Mpt so vf dy vc bing sing ch5 dupe cip nhu:
- So bing 1-0013536. ngay cong bi: 26/01/2015 ten sing ch^ Ii dupe pham dgng nude fin djnh chua axetylxystein va vat chira de chira dupe phim nay;
- So bing 1-0007683 ngay cip 25/06/2009, ten sing che la dupe phim dgng lieu chua azithromyxin cd tie dyng dupe giim thieu va sd dyng chung di bio chi thuoc;
- Sd bing 1-0007212 cip ngiy 25/09/2008, ten sing cha li "Sii dyng dupe phim chiia axit lactic hogc lactat de bao chi thufic di di£u trj chiing phii nao hay cic thircmg ton d nao vi diiu tn hgu phau cho bpnh nhin sau phau thugt tim;
- So bing 1-0007764 cip ngay 27/07/2009 cho sing che "Dupe pham giai phong cd kiim soit cd tac dyng khang retrovirut, quy trinh bao che dupe pham nay va img dyng ciia chung".
trong gidi hgc gii tren the gidi.'' Nhieu quoc gia nhu Nhgt Ban,'^ An Dp"^ quy djnh cac t i ^ chuin cap bing sang chi cho cdrig dyng tndi cho dugc phim rit nghiem ngat bing cich dgt ra lieu chuin vl trinh dg sing tgo/thih 1^^"S hiin nhien cy thi. Chinh vi viy, sang che chi cap cho nhimg cdng dyng mdi thyc sy mang Igi hipu qua dilu tri ro rang va ngydi cd tiinh dp trung binh &ong Iinh vyc khdng the dy doin hay nghi ra. Bon sing chi dugc pham trong ttich dan hipn dang dugc cip bang tgi Vipt Nam se khdng dugc chap nhgn tai An D0 vi Nhgt Ban bdi vi cai tiin dd khdng mang Igi hipu qua dang kl hogc la mpt ngudi cd trinh dp trung binh trong ITnh vyc dugc pham cd Ihl dy doin nghi ra each thiic cai lien bio che dl cii thipn tic dyng. Cho ndn, cd the ndi vipc cip sing chi cho cdng dyng mdi ciia Vipt Nam hipn nay khi de ding.
Vl vgy, niu Viet Nam khdng cd nhirng quy d;nh cy the cho lieu chi vl trinh dp sing tgo/tinh khdng hiin nhien trong dugc phim, vi niu hipp dinh TPP dugc thyc thi, thi cd thiphii cip nhiiu bing sang chi cho nhirng cich thiic, phuong thiic sii dyng mtffi cho mpt dugc pham da cd chi vdi thay ddi rat nhd ve cic thanh phin trong dugc pham da cd.
Nhdm tic gia cho rang, vi Dilu 18.37 ciia hipp djnh TPP khdng quy djnh sy thay doi dd phii tgo ra hipu qua dieu tri lam sing nhu the nio, dp dd se khien cho vipc dang ky bio hp sing chi dl ding. Quy djnh nay gay quan ngai se xay ra hipn tugtig byi rgm sing che (patent thicket) vi chien luge kdo dii thdi
'•• WIPO Online, Drug Patents Under the Spotlight. Sharing practical knowledge about pharmaceutical patents, 2004 '^http;//apps,who.int/
medicinedocs/en/d/Js4913e/3.3.html#Js4913e.3.3>
truy cgp 14/5/2016.
'' Suman Shrey Singh, Palentingin Pharmaceuticals • India and Japan <http://www.wipo.int/export/sites/
www/about-wipo/en/offices/japan/research/pdf/
india_2010.pdP> truy dip 14/5/2016. , '* The high court of Judicature at Madrac
(06Aug2007), Novartis AG v. Union of lnHi7 Nos. 24759-24760 of 2006, (Madras H.C AUB 6 2007). tgi http://iudis.nic.in/judis_chennai/qrvdi<;n aspx?filenaroe= 11 i 21 truy c$p 24/9/2016. ^'
LUAT s o HptJ TRI TUE
gian bao hp ciia sing che (evergreening), "
cho nen Vipt Nam can du lieu va xay dyng cy the cic tieu chi ve ve trinh dp sing tao/ tinh khdng hien nhien trong dugc phim.
Nhung ngogi Ip cd the khdng dugc t ^ bing saiig che dugc quy dinh tgi khoan 3 vi 4 cua Ehlu 18.37 Hipp dinh TPP khong khic so vdi Hipp dinh TRIPs. Nghia li, ciing gidng nhu TRIPs, Hiep dinh TPP cho phep cd thi loai trii khdng cap bing dgc quyen sing chi cho nhiing sing che can phii bi cam khai thic nhim muc dich thuong mgi trong phgm vi lanh thd ciia minh de bao vp trat ty cdng cpng hoac dao diic xa hpi, ke ca de bio vp cupc sdng hoac siic khde ciia con ngudi, dpng vgt hoac thuc vit hogc de trinh gay nguy hai nghiem trpng tdi ty nhien hogc mdi trudng. Theo quy djnh niy, inpt Ben trong Hiep dinh cd quyin tir choi cap bang sing che cho cac phuong phip chin doin, cic phuong phip npi va phuong phap ngogi khoa de chira bpnh cho ngudi hoac ddng vgt dpng vat ma khdng phii la cac chiing vi sinh, cac quy trinh sin xuat thyc vat vi dgng vgt chu yeu mang tinh chat sinh hpc mi khdng phii la cic quy trinh phi smh hgc hogc vi sinh.
Tdm Igi, quy djnh vl dii tugng sang chi tgi Dieu 18.37 hau nhu giong vdi quy dinh ciia TRIPs; chi khac d chd TPP bit bugc them cac nude thanh vien cd co chi bio hg them cho cic cdng dyng mdi ciia mpt sin phim da biet, cic phuong phap sii dyng mdi cua mgt san pham da biit, hoac cac quy trinh sii dyng mdi cua mpt sin pham da biit. Vi vgy, cd thi ndi doi tugng bio hd sing chi ciia Hiep dinh TPP md rpng so vdi Hi?p djnh TRIPs.
7.2. Diiu chinh th&i hgn bdng sdng chi do sy chgm tre eua eg quan qudn ly
Quy djnh ve vipc dilu chinh thdi han sang che chung cho cic nginh cdng nghipp dugc ghi nhan tgi Dilu 18.46 cua TPP. Theo do
" Tmng tam WTO, Khuyen nghi chinh sack cda cpng dong doanh nghiip Viit Nam vi phuang dn ddm phdn hiip ^i"h doi Idc .xuyen Thdi Binh Duong (TPP) Chuang sd hOn tri tue (Ma INTA- TPP4). Phong thuong mgi vi cdng nghipp Vif t Nam, 2012, http://wtocenter.vn/sites/wtocenter.vn/files/
tpp/attachments/INTA-2012-2-TPP4- Khuyen%20 n^i%20Chuong%20IP.pdf, truy cgp 14/5/2016.
moi Ben phii nd lyc hit siic dl xu Iy don sing chi mgt cich cd hipu qua yi kjp thdi, vdi myc tidu tranh nhimg chgm tre khdng can thiit va bit hgp ly; mgt Ben cd the quy dinh cac thii tuc cho phep ngudi ngp don sing che dl nghj thim dinh nhanh don sing che ciia minh; niu cd sy cham tri bit hgp ly trong viec cip bing sang che ciia mgt Ben, Ben dd phii quy dinh cac bien phi;^ de dieu chinh tiidi hgn bing sang che nham bii dap cho nhiing chgm tre nhu vgy theo dl nghj cua chii sd huu bing sang che; su cham trd bat hgp ly it nhit phii bao gom sy chgm tre trong viec cip bing sang chi keo dii hon nam nam ke tir ngiy nop don trong lanh thd cua ben do, hogc ba nam sau khi cd dl nghi thim dinh don, tuy thdi diem nao mudn hon.
Rieng ddi vai dugc pham, thdi gian den bii do su chgm tri cua co quan quin Iy dac biet dugc quy djnh tgi Dieu 18.48 cua Hipp djnh TPP. Theo dd, chu sd hihi sang che cac nginh khic thi phii yen cau den bu cho sy cham tre, nhung chu sd hihi sang che dugc se tu dugc dieu chinh thoi han bio hp sing chi de bii dap theo quy djnh.
O gdc dp bio vp quyen Igi cua nhi sin xuat thudc generic va ngudi sir dyng thulc, Dilu 18.48 giiip keo dai thdi gian bao hg cua bing sang che vi vgy tri hoan viec gia nhgp thi trudng ciia thudc generic rit ldn, cho ngn se ban che kha nang tiep can cac thudc vdi gii phii chang. Tuy nhien, d gdc dp khac, quy djnh tgi Dilu 18.48.1 lai Ii mpt dilu khoin tien bp, vi se khuyen khich cic nude xuc tiin cip bang sing che vi cip phep luu hinh dugc phain mgt cich hipu qui vi kip thdi.
Ddi chieu quy dinh tuong duong ciia Viet Nam tai Dilu 93 Luat Sd hiiu tri tue (19/
VBHN-VPQH ngay 18/12/2013), cho thiy tuit hien hinh chi quy dinh bing dgc quyen sirig che cd hipu luc ttr ngay cip bing sang che va keo dii den het hai muoi nam ke tir ngay npp don. Lugt Viet Nam hien khdng cd quy djnh ve viec dilu chinh thdi gian bio hp bang sing chi. Tiic li, co quan quan ly khdng cd nghia vy phii gia hgn bang sang che ddi vdi trudng hgp cham tre trong viec xem xet
74 TAP c m KHOA HQC P H A T L i a w j ^ * ^ cap bang sing che. Cho nen, quy djnh tai
Dieu 18.48 ve dieu chinh thdi hgn bio hg sing che se giiip keo dai thdi gian bao hp dpc quyen cho khoing thdi gian chgm tri de bu dip cho chii sd huu sang che. Viec dieu chinh thdi hgn bio hd sing che se cho phep chii sd hihi dugc tri hoan thai diem het dpc quyen ddi vdi sin phim. Nhu vay, vipc tiep cgn thj trudng thudc generic cd the se bi cham trd tgi Vipt Nam khi TPP cd hieu lyc.
Dilu 18.48 TPP khdng quy djnh nhihig gidi han ve dieu chinh thdi hgn bio hp sang che do bj nit ngin bat hgp ly. Khoin 3 dilu niy cho phep cic ben quy djnh dieu kipn va hgn che trong hp thdng phip ly vi thyc thi rieng cua nude minh va khuyen khich cic ben thira nhgn hay duy tri cac quy trinh xiic tien vide kiem tra cic don xin luu hinh sin pham. Nhdm tic gii cho ring diy li mgt dieu khoin md giup Vipt Nam can nhac quy djnh bd sung nhiing dieu kipn vi gidi hgn trong vipc ip dyng co chi bii dip dya tren tinh chat phiic tgp trong tham dinh sing che dugc pham.
1.3. Quy djnh ve lien kit sdng che Quy djnh ve lien ket sang che dugc ghi nhgn tgi Dilu 18.53 TPP. Lien kit sang chi dugc hieu Ii vipc thiet lap mdi quan hp giiia qua trinh phe duypt iuu hinh thudc generic vi tinh trgng sing che cua sin pham gdc.'"
He thong niy khdng cho cap phep luu hanh nhirng thuoc generic trudc khi het thdi han bio hp sang che hoac co quan cd tham quyen chi cd the ra quyet dinh ve vipc sing che khdng bj vi pham hoac khdng cd hi?u lyc khi cd sy ddng thuan ciia chii sd huu sing che.
Nhu vay, hp thdng niy dat trich nhipm chimg minh thudc generic khdng dugc bio hp sing che/ sang che het han cho nhi sin xuit thudc generic. Hp thdng ciing dat trich nhipm phai ngan chan vipc dang ky va luu hanh thudc generic dang dugc bao hg sang che len co quan quin ly cua mpt qudc gia.
'* LawTeacher Online, Analysis of the concept of Patent linkage, <http://www.lawteacher.net/free-law- essays/constitutional-law/analysis-of-the-concept-of- patent-linkage-constitutional-law-essay.php#ftn6>
truy cgp 24/9/2016.
Hipp djnh TRIPS khdng cd quV^**'"^. ^ lien kit bing sang chi ma chi quy ^ ' f ."^T hgn bio hg khdng dugc ket thuc ^ ^ ^ " 1 ° ^ 20 nam tinh tir ngiy npp dgn (Dieu 33- hgn bao hp), vi ^ gy cac sing che co the dugc keo dai hon 20 nam theo quy dinh cua Moa Ky cd thi bi bd ngd." Hp thdng lien kej sang chi khdi ngudn tgi Hoa Ky visau do mo hinh niy dugc tiip nhgn tgi cic qudc gia khac. L-gi ich mi hp thdng niy mang lai do !a cung cap thdng tin vl tinh trgng sing che cua mgt san phim. Thdng tin niy gidp cho nha sin xuat thudc generic biit nhihig sing che nao dang bao hp mpt dugc phim va cd co sd de quydt djnh sit dyng sing chi sau khi het han bao hp; giup giim bdt nhung vy vipc kipii tyng vi pham sing chi lang phi va khdn| can thiet;
tang cudng hieu qui vi nang suat cho hogt dpng nghien cuti vi phit triin thudc cho ci nhi sin xuit thudc goc vi generic vi hp thong niy giup dinh hudng va dy li^u hogt dgng diu tu nghien curu vi sin xuat.
Theo quy djnh tgi Dilu 18.53.1 Hipp djnh TPP, mpt Ben se cd mOt co chi thdng bio, • cung cip quyen cho chu sd hiiu sing che de ngan chan vipc gia nhgp thj trudng ciia thudc generic. Bdi vi, vdi quy djnh niy, mgt Ben phii hoac la tgo ra mgt hp thdng de thdng bio cho ngudi nam bang dpc quyen sing che (thyc te la ngudi cd quyen luu hanh sin pham) hogc thdng bio trudc khi san pham cgnh tranh luu hinh, hay mpt sin pham cd cdng dyng dugc phe duypt, dugc ghi nhan trong yeu cau bio hp. Mpt ben ciing can cho ngudi nam bang dpc quyen sang che dii tlidi gian va co hOi de tim chien luge bao gdm quy trinh tu phap vi hanh chinh, Ipnh cam so bg hay cic bipn phip tgm thdi cd hipu qui tuong duong.
Hoac la, cic Ben se lya chgn giii phap thii hai nhu quy djnh tgi khoin 2 Dilu 18.51. Theo dd, mpt Ben se thdng qua hogc duy tri mpt hd thdng tu phip tang cudng ngan cin, dya
" Hoa Ky cd quy djnh cic trudc hpp k^o dii sing ' che tgi 35.U.S Code § 156-Extension of patent term
<htlps://www.law,comell.edu/uj,code/tcxt/35/i569g[_
us_code_temp_noupdates=0#qt-us_code temo noupdatcs>miy cgp 24/9/2016. ^ - P-
T.,-.-_(n_ulLLl, I''
LUAT scr HUtJ TRI TUE
tren thdng tin sang che lien quan den thdng tin ngp cho co quan cip giay phep luu hanh ciia mgt ngudi nim giu bang sing che hogc ngudi ngp don xin cap giay phep luu hinh, hogc dya tren sy phdi hgp tryc tiep giua cac CO quan cap giay phep luu hinh vi cic van phdng cip bang sing che, viec cap giay phep luu hanh cho bit ky ben thii ba mua bin sin phim dugc phim yeu cau cd bang sang che toiyen bd sin phim dd, trir khi cd su cho phep hogc ddng y ciia chu sd hiiu bing sing che.
Nhu viy, mpt Ben cd the tgo ra mdt he thdng tu phip bd sung de ngan chan ngudi npp don khdng dugc luu hanh mpt sin phim, hay mpt sin phim cd each sii dung dugc phe duypt da dugc yeu cau bio hd sing che. He thdng nay yeu cau sy phdi hgp true tiep giiia ea quan phe duy?t cip phep luu hinh vi co quan cap bing dpc quyen sing che. Quy dinh nay md rpng nghTa vu ciia cic co quan quan ly trong toan bg thdi gian sing che dugc bao hp, trir khi chii sd hiiu bang dpc quyen sing che ddng y, hay cho phep sir dung thdng tin dd.
Hipn nay, Viet Nam chua cd cic quy dinh Uen ket giiia he thdng bao hd sang che va quy trinh cip phep gia nhgp thj trudng.
Trudc day Vipt Nam da timg phan ddi yeu cau tuong ty ctia Phdng Thuong mai chiu Au.-° He thdng lien ket bang sing che cd the bj Igm dyng, tgo ra ip lyc cho co quan cip phep va nii ro tri hoan gia nhgp thj trudng ciia thudc generic. Cac Igi ich tii chinh ciia ngudi dugc cip van bang sing che trong viec lam cham Igi khi nang tiep can thj trudng cua thudc generic cd the ldn hon nhieu so vdi cac khoan phat hp cd the phai chju. Vi vay, cd the xay ra vin de khai bao khdng tnmg thyc sang che hogc gui don kien nham tri hoan
^'Vipt Nam cho ring se l i khdng phii hpp niu dira qu> trinh bio hp sing c h i v i o ihii tye hinh chinh, bdi se khong the dua ra mpt mpnh Ipnh hanh chinh hay thu tye hinh chinh de thyc thi vipc b i o hp dd." Xem Faunce. Thomas Alured and Townsend. Ruth, Trans Pacific Partnership Agreement - Public Health and Medicines Policies (November 7. 2010). \o ordinary deal - Unmasking the transpacific partnership free trade flgreemt'n«http://ssm.com/abstract=1704834>
truy cgp 14(5 2016.
75 qua trinh phe duypt luu hinh thudc generic.
Vdi moi don yen ciu cap phep luu hanh cho mdt dugc phim generic, thi co quan cd tham quyen phai ra soit tit ca cac bang sang che lien quan dang cd hieu luc, phii thdng bio cho chu sd hiru cic bang sing che dd biet ve yeu cau nay vi trudng hgp cd khieu ngi thi phii dimg viec cap phep luu hinh cho den khi nio khieu nai dugc giii quyet xong. Lien ket sang che dgt len vai co quan cd thim quyen cap phep luu hanh nhung ganh nang trach nhipm rit ldn vi bio ve cic chii sd huu sang che dang cd hieu lyc mdt each qui miic. Hon niia, he thdng niy cdn chuyen toin bp nii ro sang ngudi cd yeu cau dang k>' luu hinh thudc generic bdi CO quan cd tham quyen se hoan vipc cap phep lim hanh tron^ trudng hgp cd khilu ngi tir cac chii sd hiiu bang sang che dang cd hieu lyc.
Va \ iec hoan cip phep se keo dii cho den khi nio khieu ngi dugc giii quyet xong. Vi vgy, vipc cho phep thudc generic dugc luu hanh se gap khd khan hon nhieu do h? thong lien ket sing che tao dieu ki?n cho chii sd hiiu van bang sing che vj Ui ip dao ddi thu cgnh tranh tiem nang ctia minh.
De can bang bai muc tieu khuyen khich nghien ctiu phat trien thudc mdi vi kha nang tiep can thudc generic gii re, Hoa Ky cd co che 180 ngiy dgc quyen cho nhi sin xuat generic nao ngp don xin cip phep luu hanh diu tien thing kipn cao bupc vi phgm sing che hogc sang che khdng hipu lyc ciia nhi sin xuat gdc.^' Khi dd, trong 180 ngiy dgc quyen nhi sin xuat generic se la don vi san xuat thudc generic duy nhat dugc cap phep luu hinh. Day li "phan thudng" nham khuyen khich vi bii dap cho nil ro bj kien vi pham sing che. Nhdm tac gia cho rang, day cd the
!a mgt giii phip ma Vi?t Nam cd the hgc hdi de xay dung co che can bang Igi ich trong hp thdng lien ket sing che.
2. Anh hudng cua TPP doi vdi chien tirgc phat trien dugc pham Viet Nam
Nhu phin tich tgi phin 1, Hiep djnh TPP md rpng kha nang dugc cap sing che, tao ra
" The Hatch-Waxman Amendments Myc 505(j) cua Dgo luat (21 U.S.C. 3550))-
76 TvU* CHf KHOA HQC PHAP LY SO OZ (i^^
mgt CO chi bao hg ngudi sd hihi bing sing Theo Td chuc Y tl Thi gidi (WHO), cong chi (co che lien kit) va quy djnh mgt khoing nghipp dugc Viet Nam chi d miic dang P _
triln.^^ Vipt Nam da cd cdng nghipp dugc npi thdi gian bu dap cho nhimg chgm tre ciia qui
trinh cap phep luu hanh. Lipu nhirng vin de niy se inh hudng nhu the nio ddi vdi chiin luge phat trien dugc phim Vipt Nam?
Chien luge qudc gia phat trien nganh dugc Vipt Nam den ndm 2020 vd tam nhin den ndm 2030 dugc Thu tu&ng Chinh phu phi duy4t tgi Quyet dinh sd 68/QD-TTg vio ngiy
10/01/2014. Myc tieu ctia chien luge niy Ii nham cung iing du thudc cho nhu ciu phdng benh, chixa bpnh ciia nhan dan vdi chat lugng bio dim, gii hgp ly; phu hgp vdi co cau benh tat, dip iing kjp thdi yeu cau an ninh, qudc phdng, thien tai, djch bpnh vi cic nhu cau khin cap khac. Chien luge cung nham dim bao vipc cung ling thudc cho ddi tugng thupc dipn chinh sich xa hpi, dong bao dan tpc thieu sd, ngudt ngheo, vdng sau, viing xa. Theo dd, den nam 2020, thudc sin xuit yong nude chiim 80% tong gia tri thuoc tieu thy yong nam, sin xuit dugc 20% nhu ciu nguyen li?u cho san xuat thuoc trong nude.
Vi vgy, cin phii xiy dyng nen cdng nghipp dugc, trong dd tap trung dau tu phat trien sin xuat thuoc generic bio dim chat lugng, gii hgp ly, tung budc thay the thudc nhgp khiu;
phit trien cdng nghipp hda dugc, phit huy the mgnh, tiem nang ciia Vipt Nam dl phit trien sin xuit vac xin, thudc tir dugc lieu.
De chiin luge vl thudc Vi?t Nam thinh cdng, thi CO quan quin Iy can hoin thipn chinh sach thiic diy vipc nghien ciiu, sin xuit, xuit khiu, nhgp khau, cung img thudc thiit yiu, bao dam cho ngudi din cd dieu kien tiep can, lya chpn, sii dung thudc an toin, hipu qua vdi gii hgp Iy; ban hinh chinh sach uu dai ddi vdi vipc sin xuat, cung iing va sii dung thudc generic, thudc chuyen khoa dac trj, thudc cd dang bao che die bipt, vie xin, sinh phim;
hgn chi iihgp khau cic logi nguyen lipu thudc, thudc generic mi Vi?t Nam cd thi sin xuat dugc. Ben canh dd, Nha nude ciing cin cd chinh sach uu tien sii dung thudc sin xuit tgi Vi?t Nam hi ngudn ngan sach nhi nude, va bao hiem y tl.
dia, nhung da sd phii nhgp khiu nguyen vgt lipu, do dd cd thi ndi ring cdrig nghipp du^c Vipt Nam vin d muc phit triin ming binh - thip. Theo muc phin logi cua To chiic Phit triin Cdng nghipp Lien hgp qudc (LTNIDO United Nations Industrial Development Organization), nginh cdng nghiep d^^pc Vipt Nam hien dang dihig d khoang nhdm 3-4," die cd cdng nghipp dugc ngi dia sin xuit dugc da sd thinh phin tu nguyen li^u nhgp vi sin xuit dugc mpt sd nguyen lipu trung gian. NIU theo WHO va Hpi nghj thuong mgi va phit triin cua Lien hgp qudc (UNCTAD - United Nations Conference on Trade and Development) phan logi m^fc W phit triin cdng nghipp dugc cua cac (p^Bs gia, thi nginh cdng nghipp dugc Vipt Nam giai dogn hipn nay mdi d gan cap dp 3,^'* titc li cd cdng nghipp dugc ngi dja, cd sin xuat thuoc generic, xuit khau dugc mgt sd dugc
" Cao Minh Quang, "T6ng quan ve cdng nghipp dupe Vipt Nam: co hdi, thich thdc vi chien lupc phit trien giai dogn 2011-2020, tdm nhin 2030", Tgp chi dupe hgc, 8/2011 <http://www.lrc.tnu.edu.vn/upload/
collectionAriefyi3966_3032012835351.pdf^ truy cgp 14/5/2016.
^Theo phan logi ciia T6 chdc phit triin c6ng nghi^
Lien hpp qu6c (UNIDO), trinh dO phit bien cdng nghipp dupe cua cfc quoc gia dupe chia theo 5 mdc phit triin:
Muc 1: khong cd cdng nghi^ dupe, hoin toin nhgp khau.
Mlic 2: Ddng goi bin thinh phim nh|p khiu, gja cong.
Mlic 3: Cdng nghi^ dupe npi dja san xuit dupe da si thanh pham tii n^jyen lipu nh^p.
Mdc 4: Sin xuat dupe nguySn lipu vi nguyen li§u trung gian
Mdc 5: Cd khi ning phit minh thuic mdi
" To chdc Y ti thi gidi (WHO) vi Hpi nghj thuong mgi vi phit trien cua Lifin hpp quic (UNCTAD) phan logi muc dpjjhit triin cdng nghi§p dupe cua eic q u ^ gia theo 4 cap dp:
Cap dp 1: hoan toin phai nhgp khiu thuoc.
cip dO 2: sin xuat dirpc m^t so thu6c tfin g6c«
(generic); da so thuoc phii nhgp khau.
cip dp 3: cd cdng nghi^ dupe npi dja. c6 sin xuit thuoc generic; xuat khau dupfc mpi so du^rc phim
cip dp 4: sin xuit dupe nguyen lipu vi phii niinh thuoc mdi.
LUAT SO HttJTRI r u t
pham. Dinh gii nay dugc cdng bd nam 2011, tuy nhien hipn nay vin phin inh chinh xic tinh hinh sin xuit vi xuit nhap khiu ciia nganh dugc theo bio cio nganh 2015.^ Vi vay, dl \^pt Nam hoin thanh chiin luge niy, ddi hdi nd lye dang ke de vugt len phit dien chii dpng cdng nghiep hda dugc.
Trong khi dd, tiem nang phit trien vie xin khi gia nhgp Hipp dinh TPP li rat Idn. Hien Vi?t Nam da sin xuat dugc 12 loai vac xin, trong dd 10 loai vac xin dugc sir dyng trong Chuong trinh Tiem chung qudc gia. Hien bdn nhi miy sin xuat vac xin ciia Viet Nam dang dugc xay dyng du cung cip cho nhu ciu trong nude vi dap iing nhu cau xuit khiu ra qudc tl. Hien 4 loai vac xin cua Viet Nam dang tham gia tiin thim djnh ciia WHO dl cic td chirc qudc te cd the mua sd lugng ldn cung cap cho toin cau.^^
Cho nen, khi gia nhgp vao Hipp djnh TPP, Vi?t Nam se cd them co hpi ciing nhu thich thiic de hoin thinh chiin luge niy.
Ve CO hpi, Hipp djnh TPP cd the lim cic nhi diu tu yen tam ring sin phim tn tup cua hp se dugc bao hd, va khi nang thu Igi tren khoing diu tu Idn cho dugc phim, nen trong dai han:
- Vipt Nam cd the thu hut dugc diu tu tir nhCrng tgp doin dugc pham Idn de cii tien cdng ngh? bao che bang cic hgp ddng hgp tic licensing, gia cdng
- Vipt Nam cimg cd the thu hiit diu tu dl phit trien nghien ciiu vi sin xuat thudc mdi, dgc bipt li sin pham sinh hpc, vie xin. Kha nang phat trien di tat ddn diu se nang cao vj the nginh dugc Vipt Nam tren quoc te.
Vl khd khan, Hipp djnh TPP md rpng doi tugng dugc bio hp va keo dii thdi gian bao hp, nen trong ngan hgn, cd the cd tie dgng
^' Sacombank-SBS Online, Vietnam/Stock markei- Bdo cdo cgp nhgt ngan/i-Thing 12.2015-Nganh dupe,
<www sbsc.com.vn/Handlers/DownloadReport.
ashx?ReportID=1150> tray cgp 14'5/2016.
" Tiem chiing md rpng Online, Vdc .xin oia VN co ca hgi cung cap cho td chiic y te the gidi, 2015
<http://www.tiemchungmorong.vn/vi/content/vac- xin-cua-vn-co-co-hoi-cung-cap-cho-chuc-y-te-gioi hmil-0> tray c§p 14/5/2016.
77 xiu din doanh nghipp trong nude va sy tiep can thudc cua ngudi dan Vipt Nam. Bdi vi
\^et Nam la nude dang phit trien, va dang d budc so khai trong tien trinh ba cap dp phat trien ve khoa hgc cdng nghp cua the gidi,^'-^^
nhu cau cua cdng chung, cua nen kinh te ciing nhu cua su nghiep phit dien khoa hgc trong viec tiep can di feuc, khoa hpc va cdng nghe da cd san cua the gidi vdi chi phi thap hoac khdng mat phi la rat Idn. Quy dinh SHTT cang chat che, khi nang tiip cgn cua cdng chiing ddi vdi cic tri thiic, cdng nghe can thiet cing giim, vi co hpi de phit trien ciing bj hgn che tuong irng. Day chinh la Iy do mi viec tang cudng bao hg SHTT d mirc dp cao nhat cd the hau nhu chi thich hgp vdi cie nude phit trien den cip dp 3, cip dp sing tgo - nhirng nude da chuyen tir nhgp khiu cdng nghe sang xuit khiu cdng nghp.
Hau nhu cac doanh nghiep dugc Vipt Nam chi phi rat it cho vipc nghien cihi vi phat trien dugc pham mdi vi chii yiu sin xuit thudc generic^. Cac quy djnh TRIPs cpng cin trd vipc sin xuat thudc generic ciia cic doanh nghiep niy. Trong khudn khd WTO, bin than cic nude cung thira nhgn rang Hipp djnh TRIPS dua ra tieu chuin qui cao neu xet tir gdc
•'' Bao gdm cap dp 1 - lim theo, cap dp 2 - cii tien;
cip dp 3 - sing tgo.
-* Trung tam WTO Online, Khuyen nghi chinh sdch cua cpng dong doanh nghiip yiet Nam vi phuang dn ddm phdn hiip dinh ddi tdc xuyen Thdi Binh Duang (TPP) Chuang sd hiiu tri tu? (Md INTA-TPP4), Phdng thuong mgi va cong nghipp Vipt Nam, 2012.
<hnp://www.trangtamwlo.vn/sites/default/files/
publications/inta-2012-2-tpp4-khuyen_nghi_chuong ip.pdf> truy cgp 14/5/2016.
" Mang thong tin khoa hpc & cdng nghp TP.HCM, Cfing nghipp dirpc dang phit trien d Vipt Nam, theo STINFO So 12/2014, tgi http://vww.cesti.gov.vn/
the-gioi-du-lieu/cong-nghiep-duoc-dang-phat-trien- o-viet-nam,htmI tray cap ngay 14/4/2016 vi Tuoi tre online, Nginh dupe Vipt Nam "di khap khicng vdi mpt chan chfing ngng!" ding 18/11/2015 tgi http://
tuoitre.vn/lin/cbinh-tri-xa-hoi/20151118/nganh- duoc-viet-nam-di-khap-khieng-voi-mot-chan-chong- nang/1004980.html truy cap 14/4/2016.
78 T ^ C H i KHOA HQC PHAPLV SO 0 2 ^ H n j ^ ^ dp dugc phim". Day la Iy do cic nude ddng
thugn trong viec dua ra tuyen bd Doha 2001 ve viec ip dyng linh hoat Hipp djnh TRIPs ddi vdi cic trudng hgp hen quan den quyen tiep can dugc phim cua cdng chiing. Nen day ciing Ii can cii quan trpng de cic nude, die biet Ii cic nude dang phat trien, ip dyng cung nhu ddi hdi nhiing tieu chuan SHTT linh hogt va phii hgp yong vin de nay yong ci WTO lan cic dim phan thuong mgi khac.
3. Mgt so kiln ngh|
Hipn tgi, cd hai bai hpc ldn vl phit trien cdng nghipp dugc pham tir An Dp vi Nhgt Bin. Ci hai qudc gia niy deu rit thinh cdng trong vipc diy mgnh sin xuat dugc phim trong nude, vi ding budc chu dpng ngudn cung thuoc generic cho thj trudng ngi dja.
Ci Nhat Bin, chinh sich y te dpc lap hoin toin vdi chinh sach phat trien cdng nghipp dugc. Giai doan sau chien tranh, nha nude xiet chat nhap khiu de tgo co hgi cho nhi san xuat trong nude chiim giir thj trudng npi dja.
Khi sin xuit trong nude phit trien du manh, nhi nude khuyen khich hogt dpng sang tgo bang chinh sach bao hp sin phim thay vi bao hg quy trinh sin xuat. Sau dd, Nhgt Ban gia nhgp WTO ciing li luc cac cdng ty duge phim trong nude cd dugc thj trudng ngi dja Cling vdi hinh dp phit trien cao vi khi nang xuat khau dugc pham ra nude ngoii.
O An Dp, nhi nude phat triin dugc phim npi dja bang cich xiet chat vipc cip bing sang che duge pham cho cic cdng ty da qudc gia. Ci giai dogn dau. An Dp cam cip bing sing chi cho dugc phim. Khi gia nhap to chirc WTO, An Dp phii dilu chinh Igi luit SHTT vi eip sang chi cho dugc phim nhung vdi quy djnh 3d^' An Dp da tu chdi cip bing sang chi cho
" Trung tam WTO Online, Khuyen nghi chinh sdch cua cpng dong doanh nghiep ^ii' Nam vi phuang dn ddm phdn hiip dinh doi tdc xuyen Thdi Binh Duang (TPP) Chuangsdhuu tri lue (Ma INTA-TPP4), Ph6ng thuong mgi vi cong nghipp Vipt Nam, 2012. <http://
www.trungtamwto.vn/sites/default/fiIes/publications/
inta-2012-2-tpp4-khuyen_nghi_chuong_ip.pdf> truy cap 14/5/2016.
" Section 3 - What are not inventions of The Patents Act, 1970.
nhiiu dugc phim cii tien. Tuy nli'^"'/*'/i"J[
djnh thiiu rd rang ciia dilu lugt niy, rat nhie danh chip giira nhi nude vi cdng ty da quoc gia xiy ra, vipc nay ciing inh hudng den uy ciia An Dp vdi cac nha dau tu.
Trong hoan cinh hgi nhap vdi djnh huong thu hut diu tu cho nghien cuu va phit tnen, a Vipt Nam viec lya chpn chinh sach bao hp so huu di tup Ii tit yiu. Ben cgnh do, de tranh nhirng franh chip vl bing sing che, Vipt Nam cin xiy dyng khung phap Iy hoin chinh hon cho sing che dugc phim.
Vdi nhirng phan tich d-ong myc_ 1 va 2, chung tdi dl nghj x^y dyng hudn^ din cy the vl tieu chuin cip bing sing ehl cho dugc pham nhu sau:
1 - Viet Nam cin xiy dyng ngi him cua khii nipm ma Hipp djnh TPP cdn bd ngd nhu
"cd khi nang ip dyng cdng nghiep" hay "him ich". Nhu da phan tich sy khic bi^t cua hai tieu chuin tgi muc I, niu chpn "cd khi nang ip dyng cdng nghipp" cd the tao thuin Igi yong phit dien thudc generic; tuy nhien "hiiu ich" Igi tgo thugn Igi cho dem vi trong nude phit trien vie xin, vi dugc pham sinh hgc.
2 - Vidt Nam can xay dyng tieu chuan "cd trinh dp sing tgo/ tinh khdng hien nhien" cho dugc pham. Khdng nen bio hg cho nhihig sing che dugc pham don thuan chi la mpt dgng mdi ciia mgt hoat chit da biit ma khdng tgo ra cii thipn ding ke trong hipu qui dilu (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machineorapparatusunless such known process results in a new product or employs at least one new reactant.
Explanation .- For die purposes of this clause salts, esters, ediers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly In properties with regard to efficacy.
Office of the Controller General of Patents • Designs & Trade Marks (Misnistry of Commerce &
Industry of India) online. Section 3(d) - Indian Pate Act 1970-Sections. <http://ipindia.nic.in/IpAcis'' Rules/updated_Version/sections/ps3.html> in,v -~
14/5/2016. ^ '^^P
LUAT sofHtruTRj r u t
di. Dang mdi nhu kit tinh vd dinh hinh ket tinh (amorphous to crystalline) hay tinh the vd dinh hinh (crystalline to amorphous) hoac hiit im dl siy khd (hygroscopic to dried), ddng phin, chit chuyin hda, phuc, kit hgp da dang, mudi, hydrate, da hinh, este (ester), ete (ether) hoic kieh thudc phan hi mdi, se dugc coi la cimg hogt chit trii khi dang diing mdi tao ra dugc nhung tac dyng dieu tri ding ke.
3 - Viet Nam cin cd tieu chi vi hudng dan ro ring de danh gii nhu the nao la "ed tic dung dilu trj ding ke" khi so sinh hipu qui giiia dang di tdn tgi va dgng mdi (mpt sd dang (mudi, ddng phan, chat chuyen hda...) cua mpt hoat chat nhu phan tich d phan 2).
Ciing can quy djnh cgt mdc xic djnh trinh dp cdng nghp cd the tgi thdi diem nop don hogc ngiy uu tien. Do khdng the cd mpt tri sd gii di chuan de danh gia hipu qua cho tit ca cic sin phim, ke ci dugc pham, nen hipu qui ciia mpt thudc khdng nhat thiet phii dugc dinh lugng theo gia trj cd djnh.
4 - Vi^t Nam cin nghien ciiu them kinh nghipm ap dyng phip luit ciia cic nude de tgo CO che can bang khi xay dyng he thdng lien ket sing che nham han che kha nang lam d^ng cua ngudi nam dpc quyen sing che. Nhu phan tich tai muc c. Quy dinh vi liin ket sang che, Vipt Nam cd the nghien ciru quy djnh ciia Hoa Ky cd co che 180 ngiy dpc quyen cho nha san xuat generic nao npp don xin cip phep luu hinh diu tien thing kien cio budc vi pham sing che hogc sing che khdng hieu iuc cua nha sin xuat gdc. Day cd the la mdt ca che hay de cin bang hai myc tieu khuyen khich n ^ e n ciiu phat trien thudc mdi va kha ning tiep cgn thudc generic gii re. •
Tii li^D tham khao
i n 35.U.SCode§ 156-Extension ofpalent term <https://
www.law.eomell.edu/useode/text/35/1567qt- us_^code_temp_noupdates=0#qt-us_code_temp_
noupd^cs>
(21 Access Campaign Onhne, TRIPS. TRIPS Plus and Doha, 2011, <http7/wwwjnsfiiccess.org/eonlent trips-trip&plus-BndHloha>
[3] Alexandria, USPTO Online (United States Patent and Trademark Office, General information
concerning patents. 2015 <htIpy/www.uspto.
gov/palents-getting-started/general-information- conceming-patents^eading-4>
[4] Bp Luat Dan su nam 2005 (So 33/2005/QHll n g ^ 14/06/2005), [trans: Civil code of 2005 (No 33/2005/QHIl dated 14 Jun 2005)1 [5] Cao Minh Quang, "Tdng quan ve cong nghiep
dupe Vipt Nam: co hpi, thich thuc va chien lupc phat triin giai dogn 2011-2020, tam nhin 2030", Tgp chi Dugc hpc, 8/2011 <ht^://www. lrc.mu.edu.
%'nAipload/coUection/briefi' 13966_3032012835351.
pd£>; [Cao Minh CJuang, Deputy Minister of Health,
"General about Vietnam's pharmaceutical industry:
opportimities, challenges and development strategy of 2011-2010, vision to 2030", Pharmacology Journal 8/2011]
[6] Chi&i lupc quoc gia phat trien nganh dupe V\^l Nam giai dogn d ^ nam 2020 va tim nhin den nam 2030 theo Quydt dinh s6 68/QD-TTg phe duy§t ngay 10/01/2014; [trans: The national strategy on development of the Vietnam pharmaceutical industiy up to 2020, with a vision toward 2030 acconding to Decision 68/QD-TTG dated 10Jan2014]
[7] c i n g thong tin Cpc so huu tri tup Vipi Nam, Theo ket qua tim \atm tai IP LIB ngay 18/05/2016, [trans: National Office of Intellectual Property of Vietnam, searching result of IP LIB of 18May2016], http://iplib.noip.gov.vn/WebUI/WDetailPAT.
p h p ? i n t R e c N u m = 3 & H i t L i s t V i e w M o d e=Compact&ref=>
[8] Doanh nhan Sii Gon online, TPP tdc dpng the ndo den ngdnh dupe Viit Nam, 2/10/2015, [trans:
Saigonbusinessmen online. How TPP will affect Vietnam's pharmaceutical industiy, 02Oct2015],
<http://www.doanhnhansaigon.vn/thoi-sii-trong- nuoc/tpp-lac-dong-the-nao-dennganh-duoc-viei- nam/1092243/>, accessed on 14 May 2016.
[9] Emily Peters, Utility or Not Utility? - Industrial Applicability in the UK, 2012, <http://www.aipla.
org/committees/committee_pages/Biotechnology/
Committee%20Documents/Comparative%20 Law%20Symposium,%20Ottawa,%20Apr2012/
U t i l i t y % 2 0 o r % 2 0 N o t % 2 0 U t i l i t y % 2 0 - % 2 0 lndustriai%20Applicability%20in%20the%20 UK%20FINAL.DOC.>
[10] Eunqwan Patent Office, The European Patent Convention, Article 57-Patentability. <httpsi//
www.epo.org/law-practice/legal-texts/html/
epc/2016/e/ar57.html>, truy cap n ^ y 24/9/2016.
[11] Europepean Patent Office, T 0870/04 (BDPl Phosphautse/MAX-PUNCK) 11/05/2005. <hapJi www.epo.org/law-practice/case-Iaw-appeals' recenl/tO4O870eul .htral>
T A P C H i K H O A H O C P H A P LV S 6 0 2 ( l O S y Z O H [12] FauDce, Thomas Ahired and Townsend Ruth,
Trans Pac^ Partnership Agreement - PiMic Health and Medicines Policies /\ovember 7,2010).
No ordinary deal - Unmasking the Oxmspacific partnership free trade agreement, <littp://ssm.C0Tll/
abstract-1704834>
[13] H i ^ dinh TRIPS [trans. TRIPS A^eement]
[14] Karin L. Ferriter (USPTO/ Linkages Between Generic Aj^raval and the Patent System in the United States, 2007
[15] LawTeacher Online, Analysis of the concept of Patent linkage, <http://www.lawteacberjiet/
free-law-essays/constitutional-law/analysis-of- the-concept-of-patent-linkage-constitutional-law- essay.php#ftn6>
[!6] Lugt so huu tri mp nam 2005 (S6 50/2005/QHll n ^ y 29/11/2005) [trans: Intellectual property Law of 2005 (No 50/2005/QHl 1 dated 29Nov2005)]
[17] National Institute ofEconomic and Social Research Online, A study of Patent thickets, 2012, <iittp-J/
e m l . b e r k e l e y e d u / / - - b h h a l l / p a p e r s / H H v G R _ Patent_Thickets_FIN_290cl! 2.pdfl>
[18] Nghidinhsol03/2006/ND-CPngay22/9/2006eua Chinh phu q i ^ djnh chi tiet v i hudng dan thi hanh m$t s6 dieu ciia Lugt So hihi tri tup ve so hihi cong n ^ p p [trans: Decree number 103/2006/NI>-CP dated 22Sep20061^ Govwnraent toin:5)lement some articles regarding inteUecbial industrial prt^ierty]
[19] Office of the CwitroUer General of Patents, Designs
& Trade Marks (Misnistry of Commoce & Industry of India) online. Section 3(d) - Indian Patent Act 1970-Seclions. <http://ipindia.nic.in/IPActs_RuIes/
updated_Version/sections^)s3.html>
[20] Quy che thim dinh don ding ky sing ch^ (Ban hanh kem theo Quyet d|nh 487/QD-SHTT) ngiy 31/3/2010 cua Cyc Truong Cpc So huu tri tup) [trans: Regulation on patent evaluation (attached to Decision 487/QD-SHTT) dated 31 Mar2010by National Office of hitellectual Property of Vietnam]
[21] Sacombank-SBS Onhne, VietNam/Stock maricet - Bdo cdo cgp nhgt ngdnh - Thdng 12/2015 - Ngdnh dupe, <www.sbsc.eom.vn/Handlers/
D o w n I o a d R e p o r t . a s h x ? R e p o r t I D = l 150>
[trans: Sacombank-SBS Online, Vietnam/
Stock market-Jieport for industrial update-Dec 2015-Pharmacutical industry]
[22] Sivaramjani Thambisetty, Legal Transplants in Patent Law: Why Utility is the New Industiial Applicability, London School of Economics and Political Science, 6/2008
[23] Suman Shrey Singh, Po/enftng in/'AoTOjacew/icfl/s;
India and Japan, Stiidy cum Research Report, WtPO-JPO U n g Temi Fellowship-2010 <hnp://
www.wipo.int/export/sites/www/about-wipo/en/
officcs/iapan/researchpdPindia_2010.pdt>
[24] The Halch-Waxman Amendments. Section 505(])
ofAct21U.S.C.3550) . [25] The high court of Judicature at Madras
(06Aug2007). Novaitis AG v. Union of India.
Nos. 24759-24760 of 2006. (Madras H.C, Aug. 6, 2007), <httpy/Judis.rac.in/judis_chennai'qiydisp.
aspx?filenaine= 11121 >
[26] Th6ng tu so OI/2007/TT-BKHCN ngiy 14 thing 02 nfim 2007 oia Bp Khoa hpe va Cong nghp huong din thi hanh Nghi djnh s6 103/2006/NE)- CP ngay 22 thing 9 nfim 2006 cua Chinh phu quy djnh chi tiet v i huong dan thi hinh mpt s6 dilu oia Lu§t So h&u tri tu? vg sd hihi cong nghipp [trans:
Circular number OI/2007/IT-BKHCN dated 14 Feb 2007 by Ministty of Science and Technology to implement Decree 103/2006/ND-CP dated 22 Sep 2006 by Government regarding guidance for some articles of Intellectual industrial property]
[27] Tiem chiing md rpng Online, Vac xin ciia VN co CO hpi cung cap cho to chirc y te the gidi, 2015 [trans: Expanded ftogram on Immunizatiwionl'ne, Vietnam's vaccine with opportunities to supply for iVTO, 2015], <htq)://www.tiemchungmorong.vn/
vi/content/vac-xin-cua-vn-co-co-hoi-cung-cap- cho-chuc-y-te-gioiiitml-0>
[28] Trung tarn WTO Online, Khuyen nghi chinh sdch cua cpng dong doanh nghiep Viit Nam ve phucmg dn ddm phdn hiip 'If'^h doi tdc xuyen Thdi Binh Duang (TPP) Chuang so hiiu tii nig (Md INTA-TPP4), Phdng thuong mgi va cong nghipp Vi^t Nam, 2012 [trans: WTO Centre online, Recomendations of Vietnam's enterprise community on plans for TPP negotiation for Chapter of Intellectual property (Code INTA-TPP4), Department of Commercel and bidustiy of Vietnam, 2012], <http://wtocenter.
vn/sites/wtocenter.vn/files/tpp/attachments/INTA- 2012-2-TPP4- Khuyen%20nghi%20Chuong%20 IRpdf>
[29] ^^etnamnet online, Chinh thuc ky hiep djnh TPP, 2016 [\^etnamet online, TPP signed, 2016],
<http://vietnamnet.vn/vn/kinh-doanh/288252/
chinh-thuc-ky-ket-hiep-dinh-tpp.html>;
[30] Webpatent online. Law-Statutory Class. 2009
<http://www, webpatent.com/knowbase/evaluate/
law/lawlllOO.htm>
[31] WIPO Online, Drug Patents Under the Spotlight.
Sharing practical knowledge about pharmaceutical patents. 2004 <httpy/apps.who.int/medicinedocs/
en/d/Js4913e0.3iitml#Js4913e.3.3>
[32] WIPO, The practical application of industrial applicability/utility requirements under national and regional laws, 04-2001. <www.wipo.int/edocs/
mdocs/sciyeti/scp_9/scp_9_5.pdr>
