NGHIENCVV- TRAOBdl
NHdlNG DIEU KHOAN LINH HOAT CClA HIEP DjNH TRIPS LIEN QUAN DEN BAO HO SANG CHE DUOC PHAM VA SUVAN DUNG C O A V I E T NAM
LE THI BICH THUY*
TRAN THIHAIAN **
Tom tdt: Hiep dinh vi cdc khia cgnh lien quan din thuang mgi cua quyin s& hOu tri tue (TRIPS) vdi muc tieu cdn bdng Igi ich cua chu so hdu quyin va Igi ich ciia cgng ddng da tgo ra khdng it linh hogt ddnh cho cdc qudc gig dgc biet ddnh cho ddi tugng la sdng chi trong ITnh vgc dugc phdm. Bdi viit phdn tich nhiing linh hogt md Hiep djnh TRIPS xdy dung ddnh cho sdng chi dugc phdm; quy dinh phdp lugt vi so hOu tri tue cua Viet Nam trong viic sic diing nhicng linh hogt ndy; dua ra mgt so de xudt nham tan dung tdt han niia nhiing diiu khodn linh hogt cua Hiep dfnh TRIPS, ddp ung nhu cdu tiip cgn dugc phdm cho dgi bgphgn ngicai dm d Viet Nam.
Tic khod: Hiep dinh TRIPS; quyin sd hieu tri tue; sdng chi dugc phdm; diiu khodn linh hogt;
quyin tiip can thudc
Nhgn bdi: 31/5/2019 Hodn thdnh bien tgp: 12/3/2020 Duyet ddng: 02/4/2020 FLEXIBILITY PROVISIONS OF THE TRIPS AGREEMENT RELATING TO PROTECTION OF PHARMACEUTICAL PATENTS AND THE APPLICATION OF VIETNAM
Abstract: In order to balance the interests of rights owners and the community. Trade - related Aspects of Intellectual Property Rights Agreement (TRIPS) has created a number of flexibilities for the member states, especially for patents in the pharmaceutical sector. The paper analyses the flexibilities
• that the TRIPS Agreement has designed for pharmaceutical inventions and the intellectual property law of Vietnam on the use of those flexibilities. It also offers some proposals to make better use of the provisions of TRIPS Agreement on flexibilities.
Kevwords: TRIPS; intellectual property rights; pharmaceutical inventions; flexibility provision;
the right to access to medicines
Received: May 31". 2019; Editing completed: Mar 12^, 2020; Acceptedfor publication: Apr T^. 2O20
1. Khai q u a t ve Hipp djnh T R I P S va thuang mai cua quyen sd huu tri tup (Hiep n h u n g quy dinh lien quan deo bao hp sang djnh TRIPS) dugc ki k i t ngay 15/4/1994 va che d u y c p h a m cd hipu lye t u ngay 01/01/1995. Hidp djnh Ld phy lye cfta Hipp djnh Marakesh v i TRIPS quy djnh tdt ca cdc khia cgnh chinh thdnh lap Td chftc thuong mai thi gidi (WTO), cfta quyin sd hftu tri tup. Id dieu udc qudc ti Hipp djnh v i cdc khia canh lien quan d i n ddu tidn cho thay mdi lidn k i t giua quyin sd huu tri tup va thuang mgi, ddng thdi tao ra
* Th?c St, Trintng Dfi h ^ Lu?t Hi Npi CO c h i da phuong 6k phdng ngua va gidi E-mait: matryoshka [email protected] i , _ . , i „•-„ „ ' ^ „„/• .. . L
** Tl. - u - I r ^ - Quyet tranh chap giua cac quoc gia thanh
** Th?c 51, H9C vif n khoa hi^ quan su , . . E-mail: tranthihaian76@gmaiUom vien ve sd huu tri tup.
56 TAP CHI LUAT HQC SO 11/2019
NGHIEN CUV' TRAO Ddi Hiep djnh TRIPS ra ddi dgt ra ydu cdu
cho tat ca cdc qudc gia thiuih vidn phdi cung cap nhirng tidu chuin bdo hO tdi thiiu nhdt cho hp thdng phap ludt vi sd hO^ tri tud (SHTT). Budc tiin vugt bdc vd ddng gdp Idn nhat ciia Hipp djnh nay la xay dyng dugc he thong cac bipn phap thyc thi quyen SHTT md trudc dd chua cd bat ki dieu udc quoc te ndo dd cdp. Hipp djnh ydu cau cac qudc gia thanh vidn phdi bdo hg sdng chd cho tat cd ddi tugng thuOc mgi Imh vyc khoa hpc cdng nghO, trong dd duong nhidn bao gdm sdng che trong lihh vyc dugc phdm. Trong nhiing ngogi 1? va gidi han md Hipp djnh TRIPS de ra trong qua trhih xac l$p quyin, duy tri va thyc thi quyen SHTT doi vdi sdng che cd nhiing quy djnh ddc thft cho nhdm ddi tugng la sdng chi dugc phdm. Sy ra ddi cfta TRIPS ddi vdi vide bdo hO cdc sdng che trong luih vyc dugc phdm la budc nhay vgt vi trade khi TRIPS ra ddi, mgi cuOc dam phdn qudc te ve SHTT ludn diin ra gay gdt vd chua di din kit qua gifta yeu cau nang cao mftc dO bao hO vd quyin cfta chft sd hiiu sang chi dugc phdm vdi mong mudn bdo vp tdt hon sftc khoe cOng ddng qua vipc duy tri kha nang tiip cgn cfta cdng chiing vdi dugc phdm cd gid hgp li. Thgm chi, d cap dO phap lugt qudc gia, cd rat nhieu qudc gia tu chdi cung cdp che dO bdo hg ddi vdi sang che dugc pham vi eho rdng day Id hdnh dOng chdng Igi Igi ich cdng cOng. Ke ca d nhihig qudc gia phat trien, noi md quyen SHTT ndi chung, sang chi ndi rieng dugc bdo hO da hdng trdm ndm thi vipc bdo hg sdng che ddi vdi dugc phdm cung chi mdi bdt dau dugc
thyc hipn trong nhung ndm cudi cfta thd ki XX (vi dy nhu Phdp tft ndm 1960; Thuy Sy tft ndm 1977; Nhdt Ban tu ndm 1976; Italy, Thuy Diin tft ndm 1978; Tay Ban Nha, Bd Ddo Nha, Hy Lgp vaNa Uy tft nam 1992.. .)."^
Myc dich cfta Hipp djnh dugc quy djnh tai Didu 7 rdng Igi ich cua chft sd hiiu va ngudi sft dyng kidn thftc cdng nghp nen dugc tinh ddn trong sy hai hoa, "viec bdo hg vd thgc thi quyen s& hOu tri tui phdi gdp phdn thuc day viec cdi tiin, chuyin giao vd phd bien cdng nghi, gdp phdn dem Igi lai ich chung cho ngu&i tgo ra vd nguai sic dung lain thicc cdng ngh4, dem Igi Igi ich xd hgi vd Igi ich kinh te, tgo ra dugc su cdn bdng giUa quyin vd nghia vu"S^^ Didu 8 Hipp djnh quy djnh vi nguydn tdc tiep tyc cftng cd myc dich trdn: "Trong viec ban hdnh hogc sica ddi cdc ludt vd quy dinh phdp ludt ciia minh, cdc thdnh vien cd the thuc hiin cdc Men phdp cdn thiit di ddm bdo vdn di y ti vd dinh du&ng cho nhdn ddn, thiic day Igi ich cdng cgng trong nhicng ITnh vuc co tdm quan trgng sdng cdn ddi v&i suphdt trien kinh ti- xa hgi vd cong nghe cda minh".^^^ Nhu vdy, cd thd thdy rdt rd rdng viec ddm bao kha ndng tiip cgn thudc vd cac san pham dugc
(1). Fredrick M. Abbott, Edward Ball Eminent Scholar, Professor of Intematicmal Law, Florida State University, College of Law, WTO TRIPS Agreement and Its Implications for Access to Medicines in Developing Countries, http://ssm.com/abstract= 1924420, truy c|ip 07/3/2020.
(2). Dieu 7 Hifp djnh TRIPS, https://www.wto.org/
engUsh/tratop_e/trips_e/trips_e.htm, ttuy cap Qfll^l^lQ.
(3). Dieu 8 Hi?p dinh TRIPS, https://www.wto.org/
english/tratop_e/trips_e/trips_e.htm, truy cap 07/3/2020.
TAP CHI LUAT HQC SO 11/2019 57
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khdc la mOt trong- nhiing Igi- ich Idn cfta xd hgi cdn phdi dugc d i cdp trong sy can bdng ma Hipp djnh TRIPS nhdn manh. Hipp dinh TRIPS ra ddi va c u r ^ cap c h i dO bdo hd cao cho quyin SHTT, tuy nhien van dam bdo vi^c bao vp quyin SHTT khdng cdn trd d i n Igi ich cdng ddng, trong dd cd sftc khoe cOng ddng. Hidp djnh TRIPS dugc ki kit va thyc thi cd tam quan trgng ddi vdi vipc bdo hO sdng che lidn quan den dugc phdm ma trudc hit Id dua ra dugc tidu chudn thdng nhdt vd toi thidu cho phap lugt trong Imh vyc ndy.
MOt sd quan didm cdn cho rdng, TRIPS la chiin thing cfta eac qudc gia phdt trien vd cdc cdng ti dugc phdm Idn.^'^^ Tuy nhidn, can phdi nhin nhgn mgt each khach quan vd tdng the rdng, bdn cgnh nhung tidu chudn vd quy djnh tdi thidu trong vipc bdo hO dgc quyin sdng chd, Hipp dinh TRIPS cung cap nhieu diiu khodn Imh hogt cho cac qudc gia thdnh vidn vd didu khoan nay tryc tiep Hen quan din ddi tugng nhgy cam la sang che trong Imh vyc dugc phdm vdi vdn d i tiip cdn dugc pham thiit yeu va sue khoe cdng ddng, tieu biiu la quy djnh vd cap li xdng bdt budc, quy djnh v i thdi gian chuyin tiep cho cac qudc gia dang phat trien...
D i tidp tyc nhdn mgnh va cy thd hod nhftng quy djnh chua ro ve ngogi Ip, cung nhu gidi hgn quyen Hen quan d i n nhdm ddi tugng ndy vdi nhung ddc thu ridng, HOi nghi BO tradng lan thft IV ciia WTO da tiep tyc
dua ra Tuyen bd Doha ve TRIPS va sftc khoe cOng ddng vd Tuydn bd nay dugc xem nhu vdn ban phap li chuyen bipt ddnh ridng cho nhdm ddi tugng Id sdng chd dugc phdm.
Tuyen bd Doha Id budc tiin ddng k i trong vide k h d i ^ djnh chft quydn cfta qudc gia trong vipc su dyng cdc quy djnh cua Hipp dinh TRIPS de bao vd vdn de sftc khoe cOng ddng. Mac dft vim cdn nhutig vdn dd chua gidi quyit dugc nhung Tuydn bd Doha thyc sy la mgt trong nhung sy phat trien quan trgng cudi th^p ki trong vdn de thuang mgi vd sftc khoe. Nd bao hiOu sy thay ddi dang k i vd tich eye trong suy nghi v i bdng sang chi ddnh cho sdng che dugc pham vd la goc re cfta chuoi nhihig ddng thdi t i i p theo nhdm
"each tan" vipc bao vp quyen SHTT nhu cdng cu chinh sdch xa hOi vi Igi fch tdng thi chu khdng chi la c o c h i gidi han bdo vd Igi ich thuang mgi.*^*
Doi vdi nhdm ddi tugng sang che dugc phdm, trade khi Hipp dinh TRIPS ra ddi, chinh sdch, phdp ludt ciing nhu thyc tien bao hg d cdc quoc gia vd cimg khac bipt, dgc bipt la gifta cdc nude phat trien va cac nude dang phdt tridn. Vipc cap bdng sdng c h i ddi vdi cac m^t hang thiet yeu nhu thudc men vd thyc phdm trong thdi gian dai dugc xem nhu la hAnh dOng chong Igi Igi ich cdng cdng, vi the bdo hg ddi vdi sdng che dugc phdm cho
(4). Carlos M. Correa, Guide to Pharmaceutical Patents (n32), p. xiii, published by South Centre, Geneva, Switzerland, 2018, tr. 5.
(5). Ellen F.M.'t Hoen, LL.M, The Global Politics of Pharmaceutical monopoly power- Drug patent, access, innovation and tfie application of the WTO Doha Declaration on TRIPS and Public health. AMB Publisher, 2009, tr. 23, https://apps.who.int/medicine docs/documents/s20963en/s20963en.pdf truy cgp 07/3/2020.
58 TAP CHi LU^T HQC S 6 11/2019
NGHIENCUV- TRAOBdl ddn nay van la van di mdi ddi vdi khdi^ it
qudc gia tren thd gidi. Ngay tgi thdi didm Vdng ddm phan Urugoay dien ra vao nam 1986, cd 49/98 thdnh vidn cua Cdng udc Paris vi bao hO sd hiiu cdng nghipp logi trft vipc cap bdng ddc quyen sang chi cho sang chi Hen quan ddn lihh vyc dugc phdm.*^*
Ngay tai cac qudc gia phdt triin, noi md quyen SHTT ndi chung, sdng che ndi ridng dugc bdo hO da hang trdm ndm thi vipc bdo hO sdng chi ddi vdi dugc phdm cung chi mdi bat dau dugc thuc hiOn trong nhftng ndm cudi cfta the ki XX; vi dy nhu Phdp tu nam 1960, Thyy Sy tft nam 1977, Nhat Ban tft ndm 1976, Italy, Thyy Diin tft ndm 1978, Tay Ban Nha, Bd Ddo Nha, Hy Lap va Na Uy tft nam 1992... Li do thudng dugc dua ra dd tft chdi bdo hd ddi vdi sdng chi trong linh vyc dugc pham la xuat phat tft "tinh quan trgng vi mat xd hgi cua dugc phdm cUng nhu sg tin tu&ng rdng, viec bdo hg sdng chi dugc phdm se ddn den su lam dung dgc quyen ciia chit sa hOu",^^^ dieu ndy dnh hudng Idn din phftc Igi chung cfta xa hOi.
Thgm chi nhung qudc gia ghi nhan chd dO cdp bdng sang chi cho sang che dugc phdm cimg quy dinh nhidu hgn che ddi vdi quyen ciia chft sd huu trong thdi ban bdo hd. Ngay cd Dftc va Thyy Sy Id hai qudc gia di dau trong cdng nghiep dugc pham cftng khdng cung cap che dO bdng dgc quyen cho sdn phdm, ma chi cdp bdng dOc quyin cho quy trinh sdn xudt, dieu ,nay ddng nghTa vdi vide
cho phdp nhung chu thi khdc dugc sdn xudt san phim tren quy tritih mdi, tgo su cgnh tranh ve gia tdt hon.'^'
2. Nhihig dieu khoan tinh ho^t cua Hiep d|Dh TRIPS lien quan din b^o hp sdng che dirge pham va quyen tiep c^n durgc pham
Quyen SHTT ddi vdi sdng che dugc pham cho phep chft sd huu cd quyen ngan cam ngudi khac sft dyng vd khai thdc sang che dugc phdm da dugc bdo hO trong thdi gian nhat djnh. Tuy nhien, nhu da ndi, hon nhflng logi ddi tugng khdc cfta quyin sd hiiu cdng nghipp, sdng chi dugc phdm Id ddi tugng cd dnh hudng Idn din quyin Igi cfta cOng ddng, vi the nhirng gidi hgn dgt ra cho qua trinh xem xet cap bang dOe quydn hay hgn che quydn cua chft sd huu ddi tugng sd hiiu cdng nghipp ndi chung chft yeu dugc ap dyng cho sang che dugc pham.
Thic nhdt, vdi tdn chi myc tieu va nguydn tdc dugc de ra, ngay tft nhung quy djnh dau tidn vi djnh nghia sdng chd vd tidu chudn dd bdo hO sdng chd, Hipp djnh TRIPS da cd nhftng "khoang md" cho phdp ludt cdc qudc gia de cd thd can bdng dugc Igi fch cfta cdc nhdm chft thd lien quan. Theo dd, Hipp djnh cho phdp cac thanh vien ty quyet cdc bien phdp can thiit, phu hgp vdi hodn cdnh xa hdi cfta minh de "bao dam van dd y td vd dinh dudng cho nhdn dan" vd cdc bien phap di
"ngdn ngfta sy Igm dyng quyen sd hiiu tri tup bdi nhftng ngudi ndm quyen", mien rdng cac bipn phdp dd khdng trai vdi cdc quy ^inh tai Hiep dinh.
(6). Carlos M. Correa, tldd, tr. 5.
(7). Ellen F.M.'t Hoen, LLM, tldd, tr. 23. (8). Ellen F.M.'t Hoen, LL.M, tldd, tr. 24.
TAP CHi LUAT HQC SO 11/2019 59
NGHIEN CUV' TRA O BOI
Vdi ddi tugng" dugc bdo'hO Id sdng chi, Hiep djnh TRIPS khdng dua ra dinh nghia di gidi han md ddt ra tidu chudn dd mOt ddi tugng se dugc bdo hO vdi danh nghia la sang chd, do la khi nd cd tinh mdi, trinh dO sdng tao vd kha ndng dp dung cdng nghipp. Trdn thyc td, trong Imh vuc dugc pham, nhieu san phdm dugc dugc tgo ra dya trdn CK; nguydn lieu ty nhidn. Do Hidp djnh TRIPS khdng dinh nghia the ndo la "sdng chd" ndn moi qudc gia co quy djnh khac nhau ve mftc dO coi nhiing nguydn lieu nay la giai phap kT thuat dugc sang tao ra hay chi don thudn Id nhftng phat minh khdng thd cap bang sang ehi. Mdc du nhidu qudc gia thuOc Td chftc hgp tac va phdt trien kinh td (OECD) van coi cdc chdt ty nhien dugc phdn Igp tft mdi tradng ty nhien cfta chftng la nhiing sang che ed the dugc bdo hO song nhiing qudc gia dang phat trien d trinh dO cao hon nhu Argentuia vd Brazil lai logi trft cdc chat ty nhidn khdi ddi tugng dugc cap bai^ dOc quyen sang che - ke ea tradng hgp dugc phdn lap tft mdi tradng ty nhidn.^^^ Vdn di liOu cdc chdt ty nhien cd dugc coi la ddi tugng bao hd dudi danh nghia sdng chd hay khdng Id lya chgn ve mat chinh sach - nd phy thuOc nang lye cfta ngdnh sdn xuat dugc trong nude va chinh sdch y te qudc gia. Cdc bdng sang chd sdn phdm cd the tac dOng nghidm trgng ddn quyen cfta cdc doanh
(9). Xem chi tiet trong: UNCTAD, "Dau hr san xuat dupe pham a cac qudc gia dang phat trien: Tai li^u huong dan tham khao". New York & Geneva, 2011, tr. 48 - 49, https://unctad.org/en/Docs/diaepcb2011d5_
en.pdf, truy cap 07/3/2020.
nghipp sdn xuat thudc generic (thudc da het thdi hgn bdo hO) trong vi^c tiep c§n va sft dyng cac chdt ty nhien cho hogt dgng sdn xuat thuoc cfta hg.
Ben canh dd, sau nhftng dam phan cang thing, Hipp djnh dua ra dugc quy djnh cudi cftng Id cdc qudc gia thdnh vidn phdi cam kit cung cdp sy bdo hO cho sang chd trong mgi Imh vyc cdng nghp khi nd dap ftr^ dugc cdc tidu chudn chung. Tuy nhidn, nhu vgy khdng ed nghTa la mpi sang che dugc pham ddp ftng dugc yeu cau, tidu chuan ndi tren deu dugc cdp van bdng bao hO. Hidp dinh TRIPS quy djnh rdng, cac thdnh vidn cfta WTO co quydn ddt ra mOt sd gidi hgn trade khi cap bdng sdng che (pre-grant exceptions) qua vide quy djnh cdc ddi tugng khdng dugc bao hp, trong dd cd nhdm ddi tugng lien quan den lihh vyc dugc pham la cac phuang phdp ehdn doan, chfta benh, phau thuat cho ngudi va dOng v$t. Ben cgnh dd, Hipp djnh TRIPS ciing quy djnh tai Dieu 27.2 vd Dieu 27.3 rang cdc thanh vien cd the "logi trie khong cdp patent cho nhimg sdng che thugc tru&ng hgp cdn phdi bj cdm khai thdc nhdm muc dich thuang mgi trong Idnh thd ciia minh de bdo ve trgt tu cdng cgng hogc dgo dice xa hgi ke cd de bdo ve cugc sdng vd sice khoe cua con ngu&i vd dgng vgt hogc th^c vgt de trdnh gdy nguy hgi nghiem trgng cho mdi truong". Nhu vgy, vdi quy dinh nay, Hipp djnh TRIPS trao quyin rat ro cho cac qudc gia thanh vien trong viec dua ra nhung ban chd cap bdng ddi vdi ddi tugng cd anh hudng nhiiu den Igi ich cdng cOng, duong nhidn, trong do cd ddi tugng la dugc pham
60 TAP CHI LUAT HQC SO 11/2019
NGHIENCUV- TRAOBOI de phyc vy cho mye dich bdo vO sftc khod vd
cuOc sdng ciia ngudi dan.
Tha hai, khdng chi quy djnh cho c ^ thdnh vien cd quyen dua ra cdc gidi hgn trudc khi cdp bdng sang che (pre - grant exceptions), Hipp djnh cdn dua ra cdc gidi han doi vdi quyen cfta chft sd hiiu sau khi dugc cap bdr^
sdng chi (post-grant exceptions). Cd thi thdy, nhiing gidi han nay dugc ddt ra chft yeu Id di dp dyng trong luih vyc dugc phdm. Dd la cdc ngogi 10: ngogi Ip ddi vdi quyin sdng chi dugc bao hO (Q\s.u 30); bdt buOc chuyen giao quyen sft dyng sang che (Dieu 31); van de het quyen (exhaustion) va nhap khau song song dugc phdm (Diiu 6 va khoan 1 Dieu 28), cy thi:
- Diiu 30 Hipp dinh TRIPS quy dinh.-
"Cdc thdnh vien cd the quy dinh mgt sd ngogi le nhdt dinh doi v&i cdc dgc quyen dugc cap tren ca s& patent v&i dieu kien Id cdc ngogi le do khong mau thudn vdi viec khai thdc binh thu&ng patent do vd khong ldm tdn hgi mgt cdch bdt hgp U t&i Igi ich hgp phdp cua chit sd huu patent vd Igi ich hgp phdp ciia bin thu ba".
Nhu vay, cdc thanh vidn cd the quy djnh cdc hdnh vi sft dyng sdng chi neu dap ung dugc cd ba diiu kidn sau thi khdng bj coi la vi phgm quyen cfta chft sd huu sang che. Cy thi: hanh vi dd phdi "cd gidi hgn" (Hmited);
hdnh vi dd khdng dugc "xung dOt bdt hgp U vdi viec khai thdc binh thudng" (normal exploitation) cfta sang che; hdnh vi dd khdng dugc ldm "tdn hgi mOt cdch bdt hgp li tdi Igi ich hgp phap" (legitimate interests) cfta chft sd hun sang chi cung nhu Igi ich
hgp phap cfta bdn thft ba. Hipp djnh TRIPS khdng cd sy gidi thich rd rang cho tidu chudn
"cd gidi hgn", do cd the lit gidi hgn vd thdi gian, vi khdng gian, pham vi hay gidi ban khdc. Tuy nhien, cd thi hidu Id hdnh vi ndy chi cd anh hudng nhd den quyen cfta chu sd hiiu. Vipc khai thdc binh thudng d ddy dugc hiiu la vipc chft sd hftu thyc hiOn, nhung hoat dOng kmh ti nhdm tim kiem Igi nhugn, Igi ich kinh t i tft sang che, ciing nhu ngdn ehdn nhung hdnh vi cgnh tranh cd khd ndng ldm can trd, gidm sftt thu nhgp md chft sd bun cd thd cd dugc tft quydn dOc quyen ddi vdi sang che. Ba diiu kipn ma Hipp dinh TRIPS dua ra phai dugc xem xdt trong tung vy vide cy thd, cd the tdc dOng lan nhau vd phai dugc xem xdt tren co sd myc tidu, nguydn tdc dugc dua ra tgi Dieu 7 vd Dieu 8.1 Hipp djnh.
Vide cho phdp cdc thdnh vidn quy djnh ngogi le doi vdi cac quyen ddc quyen gdn liin vdi sang chi theo hudng khdng liet kd cdc tradng hgp cy the tgo sy linh hogt cho cdc thanh vidn dugc phep xdy dyng ngoai Ip phft hgp trong phdp lu|it qudc gia mhih. '
Vi dy dien hinh cho nhdm ngoai le nay dugc Co quan giai quyit tranh chdp cfta WTO (DSB) cdng nhgn trong vy viec
"Canada - Pharmaceutical Patents" la hanh vi sft dung sdng chi vi dugc phdm cdn trong thdi hgn bdo hO nhdm thu thap thdng tin di thyc hidn thft tuc xin phep co quan quan li dugc (regulatory review exception - ngoai le Bolar, ngogi 1? dugc d^t tdn theo vu vide dugc giai quyet tai tod an phuc tham Lien bang Hoa Ky) cho phep luu hanh dugc pham
TAP CHI LUAT HQC SO 11/2019 61
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generic.''^* Dugc phdm generic la. dugc phdm d mdt nude md sdng chd Hdn quan din dugc phdm do khdng dugc bdo hg hodc dd hit thdi han bdo hO hay dugc sdn xuat theo giay phep chuydn giao quyin sft dyng sang chi bdt buOc cua co quan nha nude cd thdm quyen. Vu vipc nay la tranh chdp giiia Cgng ddng chdu Au (EC) va Canada ve vipc giai thich vd dp dyng Diiu 30 Hipp djnh TRIPS trong phdp lugt vi sdng chi ciia Canada. Bdn chdt cfta vy vipc ehinh la quan diem khac nhau cfta EC va Canada Hen quan ddn thu thgp thdng tm dd thyc hidn thft tyc xin phep vd ngogi le san xuat - luu kho cd thuOc tradng hgp ngogi Ip dugc dua ra tai Dieu 30 hay khdng. Ngogi le nay cho phep cac cdng ti dugc khdng nam gift sdng chd sau dd cd the sdn xudt va dua dugc phdm generic ra thj tradng ngay sau khi sang che het thdi hgn bao hO de cgnh tranh vdi cdng ti dugc da timg ddc quydn sft dyng sang che dd.
Diiu ndy se giftp giam gid dugc pham, giftp ngudi bpnh tidp c$n nhanh chdng dugc phdm cdn thidt.
- Diiu 31 Hiep djnh TRIPS quy djnh vi bdt buOc chuyen giao quyen sft dyng sang chi ma khdng gidi ban co sd dd co quan cd tham quyin ciia cdc thdnh vidn WTO cdn eft ra quyit djnh bdt buOc chuyen giao nay.
Li do bdt buOc chuyin giao quydn sft dyng sang chi dugc quy djnh trong Hipp djnh TRIPS bao gdm: bdt bugc chuyen giao
(10). WTO, Repwt of panel, Ccmada - Patent Protection of Pharmaceutical Products, WT/DS114/R, 17/3/2000, https://www.wto.org/english/tratop_e/dispu_e/7428d, pdf. truy c$p 07/3/2020.
quyen sft dung sdi^ chi dya trdn quy djnh tgi Diiu 5(A) Cdng udc Paris; trudng hgp c6 tbh trgng khdn cdp qudc gia hodc tradi^
hgp ddc bipt cdp bdeh khdc; sft dyng sang che cho myc dich cdng cOng, phi thuemg mai, bao gdm sft dyng sang che nhan danh nhd nude; nhiing hogt (^ng bj co quan xdt xft hodc CO quan hanh chinh coi la chdng canh tranh; nhim sft dyng sang che phy thugc (sang che thft hai).
Di thuc hipn bdt buOc chuyin giao quyin sft dyng sang che, cac qudc gia thdnh vien cfta TRIPS can tuan thft cdc didu kipn sau: 1) viec bdt buOc chuyen giao quyin su dyng sang chd phai dugc xem xet theo timg tinh hudng cy thi; 2) chi dugc sft dyng bdt buOc chuyin giao quyin sft dung sdng che niu trade khi sft dyng, ngudi cd y djnh sft dyng dd cd gang de dugc ngudi nam quyen cap phep sft dung vdi gid vd cac diiu kien thuong mai hgp li nhung nhiing cd gdng do da khdng dat dugc ket qua; 3) pham vi vd thdi gian sft dyng ph^i dugc gidi han troi^
vipc thyc hien mye dich bdt huge chuyin giao quyen sft dyng sdng chd chft yeu de cung cap cho thi tradng ngi dja cua thdnh vien cap phep; 4) quyet djnh bdt buOc chuydn giao quyen sft dyng sang che phai c6 kha nang hi dmh chi khi cac dieu kipn dan din vipc cap phep chdm dut tdn tai vd khdng cd khd nSng tdi hipn nhung phai bao vp mOt each thoa dang Igi ich hgp phap cfta nhftng ngudi dugc cdp phep sft dyng; 5) ngudi ndm gift quyen phdi dugc trd tien den bft thod ddng tuy theo gid trj kinh ti cfta quyen sft dyng dugc cdp; 6) hipu lye phap li cfta quyit
62 TAP CHI LUAT HQC SO 11 /2019
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djnh trong bdt buOc chuyen giao quyen sft dyng sdng chd cd t h i bj xem xet lai theo thft tyc t u phdp hoac theo thft tyc dOc Igp khdc tgi CO quan cd thdm quyen cap cao hon.
v d n dd vd b i t bugc chuyen giao quyin sft dung sdng c h i hay cdn ggi Id li xdng bdt buOc dugc quy djnh trong Hipp djnh TRIPS, tuy nhien van de hang rao bien gidi ddi vdi giay phdp bat buOc ndy lai tgo ra cugc tranh lugn Idn t r o i ^ khuon khd cfta WTO, chft y i u la do anh hudng cfta nd ddi vdi viec tiep cgn thuoc d cdc qudc gia kem phdt triin vd dang phat tridn khdng cd nang lye san xuat dugc phdm d trong nude. Tranh lugn nay da trd thanh chft dd trung tam tai HOi nghi bO tradng WTO td chftc tgi Doha vdo ndm 2001 vd da dugc gidi quyit bdi Tuydn bd Doha.
Tuyen bd dd ehi ra dugc egt moc quan trgng trong cuOc tranh ludn giua quyin sd hiiu tri tup vd quydn tiep can dugc phdm. Quyen sd hiiu tri tup can dugc tdn trgng vd bdo vp, tuy nhidn ciing phdi nhin thay dugc nhftng anh hudng ciia nd ddi vdi gia cd, vi the Hipp dinh TRIPS cdn phdi dugc gidi thich va thyc thi theo hudng bao ve Igi ich cOng ddng, trong dd cd bdo V? sftc khoe va ddc bipt la quydn tiip cgn dugc phdm cho mgi ngudi ddn.'' '^
Tren co sd quy djnh cua Dogn 6 Tuyen bd Doha ndi tren, Quyet dinh vd thyc thi Dogn 6 Tuyen bd Doha v i Hipp djnh TRIPS (11). Do^in 6 TuySn bo Doha. Trich nguyen vSn: "We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement", hVcps'JIviwvj. who. int/medicines/areas/policy/tripshealt h.pdf?ua=l, fruy cap 07/3/2020.
va sftc khoe cOng ddng (Quyit djnh so 2003) dugc thdng qua ngay 30/8/2003 cy t h i hod quy djnh v i cdp li xdng bdt buOc nhu sau:
"NghTa vu cua cdc thdnh vien xudt khdu theo Diiu 31(f) cua Hiep djnh TRIPS se dugc mien trie doi v&i viec cap gidy phip bdt bugc b&i su cdn thiet cho muc dich sic d^ng ciia cdc sdn phdm dugc phdm vd xudt khdu chiing den cdc thdnh viin nhdp khdu du diiu kien". Quyit dinh nay d^t ra nhung quy tdc vd dieu kipn cho ca cac thanh vidn xudt khau vd thdnh vidn nhdp khdu de hp ed the sft dyng mdt cdch hidu qud he thdng cap phep bat buOc cung nhu su dyng tdt cdc quy tdc danh gia ndng lye sdn xuat trong ngdnh dugc phdm. Ben cgnh do, d i dam bao rang dugc phdm dugc sdn xuat theo giay phdp bat buOc khdng dugc tiip tyc xudt khdu vd ban ra d cac nude khac vdi gid thap hon, Quydt djnh quy djnh rdng thdnh vien nhap khdu can phdi thyc hien cac bien phdp hgp li vd can thiet d i ngdn chgn viec lam dung he thong ndy.*'^'
- Diiu 6 Hipp dinh TRIPS trao cho cdc thanh vien WTO quydn ty quyet djnh trong phdp lugt qudc gia vd che dO hdt quyen (exhaustion) ddi vdi quydn SHTT. Tuy thugc vdo cdch quy djnh trong phdp li4t, chu sd huu quyen SHTT se bet quyen khi sdn phdm chfta.dung quydn SHTT do dugc: ban lan dau tien vdi sy cho phep ciia chft sd hiiu ndy trdn thj tradng trong nude (hit quyen qudc gia), khu vyc (hit quyen khu vyc) hay qudc t i (het quyen qudc te). Mac dft khodn 1 Dieu (12) Quyet djnh 2003 ve th\rc thi dogn 6 Tuyen bd Doha, httpsV/www. wto.org/english/tratop_e/trips_e/imp !em _para6_e.htm, truy cdp 07/3/2020.
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28 Hipp djnh TRIPS quy djnh chft sd huu sdng chi ed quyen ngan cam vi^c nh|ip khdu san pham chfta dyng sang che song cd chft thich rdng, quydn nhap khdu nay phu thuOc vao quy djnh het quydn cfta phdp lugt quoc gia Ndu cac nude dang va kdm phat triin lya chgn vipc hit quyin qudc ti, dugc phdm ban vdi gid thdp d nude ngodi se dugc phep nhgp khdu &e gdp phan gidm gia dugc pham trong nude.
Nhu vay, HiOp djnh TRIP,S da cd cac quy djnh Imh hogt thuc ddy vipc tiep cdn dugc phdm, mac dft cdn nhiiu y kien cho rdng Hipp djnh TRIPS cd the hgn che quyin con ngudi ndi chung va quyen tidp cdn dugc phdm ndi ridng. Vdn de quan trgng hipn nay Id cdc thdnh vien WTO, nhdt la cac nude dang ho$c kem phat trien nhu Vipt Nam phdi van dyng cdc quy djnh linh hogt nay dd ddm bao quyin tidp cdn dugc phdm cho ngudi dan, cdn bdng hgp li quyen SHTT va quyen tiip cgn dugc phdm.
3. Su v^D diJing nhung dieu khoan linh hogt cua Hipp dmh TRIPS trong phdp lu|it s& hull tri tup Vif t Nam hipn hanh ve bao hO sdng che dirQ^c pham
Sang chi dugc phdm ludn dugc coi Id ddi tugng dugc bdo hO theo quy djnh ciia phap luat ve SHTT cfta Vipt Nam. Theo quy djnh tgi khoan 1 Dieu 58 Lugt sd huu tri tud hien hdnh, sdng chi dugc pham cung nhu sdng che trong mgi liiih vyc khoa hgc cdng nghe khdc se dugc cung cap chi dO bao hO dOc quyin neu thoa mdn cdc tieu chudn chung ve tmh mdi, trinh dg sang tgo vd kha ndng dp dung cdng nghipp. Trdn co sd quy
djnh cfta Hidp djnh TRIPS ciing nhu ndi dung cfta Tuyen bd Doha vi Hipp djnh TRIPS va sftc khoe cgng ddng vi cac tradng • hgp hgn che quyen cfta chft sd huu sdng chi, ddc bipt Id sdng che ddi vdi dugc phAm, phdp li4t Viet Nam dd cd nhung quy djnh ve cff bdn Id tuong thich, cy thd:
Thic nhdt, ddi vdi nhftng gidi hgn trong giai doan xem xet trudc khi cap bdng dOc quyin sang che
- Logi trft nhung ddi tugng khdng dugc bdo hO dudi danh nghia sang che:
Khoan 12 Diiu 4 Ludt SHTT djnh nghia
"sdng chi" la giai phdp kT thugt dudi dgng san phim hodc quy trinh nhdm gidi quyit van di xdc djnh bdng vipc ftng dung cdc quy lugt ty nhien. Tft dinh nghTa nAy cd thi phdn biOt gifta nhung tdc dOng ve mat kl thudt thyc hipn bdi con ngudi (cd the dugc cap bdng sang che) vd nhung phat hipn cdc sir vgt dd tdn tai sdn trong ty nhien (khong c6 khd ndng dugc cdp bdng s ^ g chd).
Tgi diem b khodn 3 Diiu 25 Thdng tu so 01/2007/TT-BKHCN ngay 14/2/2007 hudng dan thi hanh Nghj djnh sd 103/ND-CP/2006 hudng dan thi hMi Ludt SHTT vi sd hftu cdng nghidp H^t kd dugc phdm vdo doi tugng dugc coi Id giai phdp kl thudt theo nhu
^ nghia tai khoan 12 Didu 4 Luat SHTT. Mat khdc, didm c khoan 3 Diiu 25 Thdng tu neu rd cdc chat ty nhidn khdng phdi do con ngudi sang tgo ra se khdng dugc coi Id giai phap kl thuat. Nhu vgy, cdc can bO thdm djnh don xin cap bdng sdng che vd cdc thdm phdn se phdi ty xdc djnh xem cai gi cd thd dugc coi !a sdn phdm sdng tao cfta con
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ngudi. Diem de gay tranh cai d ddy Id mOt sdn phdm cua t y nhien dugc tach ra khdi mdi tradng t y nhidn cfta nd va sau dd dugc bien ddi thdng qua tac dOng cfta con ngudi di tgo ra nhung gia trj, ftng dyng mdi (vi dy, tinh sach hod sdn phdm dd) cd the dugc coi Id sdn pham sang tgo cfta con ngudi trong khuon kho -^ nghia ciia nhftng quy djnh trdn. Tuy nhidn, neu chi rieng qua trinh phan tach hay cd lap chdt dd khdi mdi trudng ty nhien cfta nd thi dudng nhu k h d i ^ dft dd coi la san phdm sdng tao cfta con ngudi nhu y nghia Id mOt gidi phap kl thudt.
- Tiep den, mgt sd ddi tugng dap ling dugc cac tieu chuan cua sang che van cd thi bj logi tru, tftc la. khdng dugc bdo hO dudi danh nghia sdng chd. Khoan 7 Diiu 59 Lugt SHTT x i p cac phuong phdp chan dodn vd chfta bpnh vao nhdm ddi tugng khdng dugc bdo vp dudi danh nghTa sang chi. Cac phuang phdp dd Id mOt phdn trong cdng vipc hang ngdy cfta cac bac sT, quy djnh nay hodn todn phft hgp vdi tinh thdn cfta Dieu 27.3(a) Hipp djnh TRIPS.f'3>
Thic hai, ddi vdi nhiing ban che quyen cfta chft sd hiiu cfta sang c h i da dugc cap bdng dOc quydn
Mgt Id ddi vdi quy djnh ve nhung hgn chi quyin cfta chft sd huu sdng chi, phdp luat Viet Nam cy thd hod tgi khodn 2 Diiu 125 Ludt SHTT v i nhftng tradng hgp chft sd hflu sdng chi khdng dugc quyen ngdn cam ngudi khdc sft dyng sdng c h i cfta minh nhu:
1) sft dyng sdng che nhdm phyc vy nhu cau (13). Dieu 27 Hi?p dinh TRIPS, hl^-7/www.wto.OTg/
aiglish/tratop_e/trips_e/h-ips_eJitm, truy cdp 07/3/2020.
cd nhan hodc myc dich phi thuang mgi ho^c nhim myc dich ddnh gid, phdn tich, nghien cftu, gidng dgy, thft nghiem, san xuat thft hodc thu thap thdng tin d i thuc hiOn thft tyc xin phep san xuat, nhap khau, luu hdnh san phdm; 2) luu thdng, nhgp khau, khai thdc cdng dung cfta san phdm dugc dua ra thj tradng, ke ca thj tradng nude ngodi mOt cdch hgp phap; 3) sft dyng sang che do ngudi cd quyen sft dyng t r a d e . . .
Ddi vdi nhirng tradng hgp tren, mOt mdt ngudi sft dyng sang chd khdng phdi xin phep, mgt khac, phap lugt ciing cd quy djnh chung rdng, neu viec su dyng sdng chi khdng nhdm myc dich kinh doanh thi khdng phai trd thft lao cho chft sd bun sang chi.
Trdn co sd quy dinh ve cac gidi hgn cho cdc tradng hgp sft dung ddi tugng dugc bao hg md khdng cdn xm phdp chft sd hiiu tai Diiu 30 Hipp djnh TRIPS, phap luat Vipt Nam da cu the hod nhung hanh vi ndy.
Trong do cd the thay, hanh vi tuong ddi d^e thu lien quan ddn ddi tugng sang chd dugc p h i m chinh la vide tien hanh nghidn cftu, gidng dgy, thft nghiem hogc thu thdp thdng tin dd thuc hidn thu tuc xin phep san xuat, nhap khau, luu hanh sdn pham. Diem a khoan 2 Dieu 125 dd cap ngoai le phyc vu cho quy trinh cap phep luu hanh thudc cfta CO quan quan li nha nude - cy the Id chft sd hflu bdng sang che khdng cd quyin ngdn cam ngudi khac su dung sdng che dd thyc hipn cac hdnh vi nhdm muc dich "thu nghiem, sdn xudt thic hodc thu thgp thdng tin di thuc hien thii tuc xin phep sdn xudt, nhdp khdu, lint hdnh sdn phdm ". Ngogi Ip ndy ddc
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bipt quan trgng ddi vdi cac doanh nghidp sdn xuat thudc generic, bdi ndu khdng cd quy djnh nhu vdy thi hg khdng thd tidn hanh vide nOp hd so xin cap phep luu hdnh thudc trong thdi han bdo hO cfta sang chd. Didu nay se keo ddi thdi gian dgc quyin thj tradng thyc td cua chu sd huia, lam cham Igi qua trinh gia nhdp thj tradng cfta cac ddi thft cgnh tranh generic va ngan can vipc hg gia thuoc mgc dft bdng sang c h i da h i t hgn. Cym tft "thft nghiem" sft dyng tai didm a khoan 2 Didu 125 tao diiu kidn cho vide dien giai rdng ddi vdi quy djnh ndy theo hudng khdng chi bao gdm nhiing hdnh vi Hen quan tryc tiip den thft tyc xin phep, ma ea nhftng hoat dgr^ tien hanh trong giai dogn thft nghiem tien lam sang, miin Id chung lien quan hgp li ddn viOc chudn bj hd so xin phep. Dieu nay bao gdm ca nhung tradng hgp bj tft chdi cap phep hogc ede trudng hgp khdng nop hd so xin phep do k i t qud. thft nghiem khdng thuydt phuc.*''*'
Hai Id ddi vdi quy djnh ve bat budc chuyin giao quyen sft dung sang c h i , n i u nhu trong Hipp djnh TRIPS, van dd nay dugc quy djnh la hinh thftc sft dung khac khdng can cd sy cho phep cfta ngudi nam gift quydn la chft sd hiiu, ngoai nhftng ngogi Ip dugc ddt ra dd gidi hgn quyen cfta chft sd hiiu quy dinh tai Didu 30 Hipp djnh thi phdp lugt Vipt Nam Igi quy dinh chung tgi Diiu 125 Luat SHTT vd cac tradng hgp chu sd hftu sang chd khdng cd quydn ngan cam ngudi khac sft dung. Tuy cd sy khac nhdu v i
(14). UNCTAD, tidd, tr. 111,112.
vide ghi nhan thdnh diiu khodn rieng biet hay la mOt tradng hgp hgn che quyen cfta chft sd hOu thi v i eo bdn, bdt budc cliuydn giao quyen sft dyng sdng che theo quy djnh cfta phap ludt Vipt N a m tuong thich vdi quy djnh ndn tdng cfta Hipp djnh TRIPS.
Theo quy djnh tgi D i i u 145 Lugt SHTT thi vipc bdt buOc chuyen giao quydn sft dyng sang chd dugc thyc hidn khi chft sang c h i khdng thyc hidn nghia vu sft dyng sang c h i theo quy djnh cfta phdp luat nham phyc vy nhu cdu qudc phdng, an nmh, phdng benh, chfta benh, dinh duong cho nMn dan hoac cac nhu cau cap thiet khac cfta xa hOi.
Vide thyc hipn BBCGQSDSC cung phdi dap ftng cac d i i u kipn nhu: 1) ngudi cd nhu cdu sft dyng sang chd khdng dat dugc thoa thuan vdi ngudi nam ddc quydn sft dung sang e h i v i viOc ki ket hgp ddng sft dung sang c h i mdc dft trong khoang thdi gian hgp li dd cd gdng thuong lugng vdi mftc gia vd cac diiu kien thuong mgi thod dang; 2) ngudi ndm dOc quydn sft dung sang che hi coi la thyc hipn hdnh vi hgn che cgnh tranh bj cdm theo quy dinh cua phap ludt vd cgnh tranh;
3) ngudi nam dgc quydn su dyng sang che cd quyen yeu cau cham dut quyen sft dyng khi can eft chuyen giao khdng cdn tdn tai va khong cd khd ndng tdi xudt hiOn vdi didu kipn vide cham dftt quyen sft dyng dd kh6ng gay thidt hai cho ngudi dugc chuyen giao quydn sft dung sang che. D u a n g nhidn trong thdi gian chuydn giao quydn sft dyng sang che thi chft sd hiru van dugc thanh toan thft lao va chi phi nhu trudng hgp chuydn giao ty nguydn.
,66 TAP CHI LUAT HOC SO 11/2019
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phep sft dung sdng che nhdn danh Nha nude cho myc dich cdng cOng, thuang mai, an ninh, qudc phdng, phdng benh, chfta bdnh, djnh duat^ va dap ftng cac nhu cau cap thiit khac cfta xd hOi. Nhu v^y, doi vdi tradng hgp lien quan den van de sftc khoe eOng ddng dnh hudng trdn dipn rgng, lien quan ddn vipc sft dyng mOt ddi tugng la sang che dugc pham dang trong thdi hgn bdo hg thi Nha nude hoan toan cd thd dya vdo dieu khoan ndy dd su dyng sang chd nhdm phyc vy cho vipc bao vp sftc khoe cOng ddng, d§c bipt ddi vdi cdc trudng hgp djch bdnh, cac bpnh truyen nhiem dien rOng.
Ba Id ve vin di hit quyin, didm b khoan 2 Diiu 125 Lugt SHTT quy djnh, vipe luu thdng, nhgp khau, khai thdc cdng dyng cfta sdn phdm (dugc bdo hg sd hun cdng nghipp) dugc dua ra thj trudng mdt each hgp phap, ki cd thj tradng nude ngoai, bdi "chinh chft sd hftu nhdn hipu hodc ngudi dugc phdp ciia chft sd hiiu nhdn hipu" la khdng vi pham phap lugt. Xem xet quy djnh nay trong mdi tuong quan vdi quy djnh tuong tu vd tuih trgng hit quyin ddi vdi gidng cdy trdng dugc thfta nhdn tgi khodn 2 Diiu 190 Lugt SHTT,- cd the cho phep gidi thich ring, chd dg het quyin ddi vdi sdng chi md Viet Nam dang dp dyng Id chi dg hit quyen quoc te. Hien nay, vide nhap khdu song song dugc phim dang dugc cho phep theo Quyet djnh cfta Bp y te sd 1906/2004/QD-BYT ngdy 28/5/2004.
Vide quy djnh hit quyin qudc te nhu vdy se tang khd ndng tiip can dugc pham cfta ngudi bpnh d Vipt Nam.
4. Mpt so de xuat nbSm v^n dung toi da cdc diiu khoan linh ho^t cua Hipp dinh TRIPS trong bao h§ sang che dirg-c pham Trdn co sd cdc quy djnh Imh hogt cfta Hipp djnh TRIPS va can nhdc den quyen SHTT cftng nhu quyen tiip cgn dugc phim, Vipt Nam dd cd nhung quy dinh phdp luat tuong ddi phft hgp, tuy nhidn van cdn mdt sd ban chi cin khdc phye nhu:
Thu nhdt, nhu da phdn tich, phap ludt Vipt Nam lya chgn hinh thftc lipt kd cac tradng hgp chft sd hiiu sdng chd khdng dugc phep i^an cim ngudi khdc sft dyng sang chd tgi khoan 2 Diiu 125 Lugt SHTT, trong dd cho phdp sft dung sang chi "nhdm phuc vu nhu cau cd nhdn hogc muc dich phi thuang mgi hogc nhdm muc dich ddnh gid, phdn tich, nghiin cuu, gidng dgy, tha nghiem, sdn xudt thic hogc thu thdp thdng tin de thgc hien thu tgc xin phep sdn xudt, nhdp khdu, lieu hdnh sdn phdm". Cdch quy dinh nay mang tmh lipt ke co hgc, khdng the bao qudt hdt dugc nhftng tmh hudng sft dyng sang chi trdn thyc ti dugc xem la ehinh ddng cd thd phdt sinh. Mat khac, vipe Upt ke nhu vay chua lam rd ba ydu cdu ve gidi hgn quyen ddi vdi sang chi theo Dieu 30 Hipp dinh TRIPS la hdnh vi dd phai "cd gidi hgn";
hanh vi dd khdng dugc "xung dgt bdt hgp H vdi vipc khai thac binh thudng" cfta sang chi; vd hdnh vi do khdng dugc lam "tdn hai mgt cdch bat hgp li tdi Igi ich hgp phdp" ciia chft sd hiiu sang chi cung nhu igi ich hgp phdp cua ben thft ba. Gid su xdy ra tranh chdp ve quyen sft dyng ddi vdi sdng che
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khdng thuOc cac trudng hgp -dugc liet kd thi se rat khd de phan dinh va giai quydt, mdc du vipc sft dyng la chinh dang vd khdng lam tdn hai ddng ke den quyen cfta chft sd hiiu trong thdi hgn bdo hO- Do vgy, phdp lugt ndn quy djnh theo hudng dua ra ba tidu chudn, yeu cau ddi vdi cac hdnh vi gidi ban quyin cfta chft sd hiiu bdng sang che de tuong thich vdi quy dinh ciia Hipp djnh TRIPS va se de dang cho vide xac djnh vide sft dyng sang che la cd sy vi phgm hay khdng.
Bdn canh do, trong nhftng tradng hgp sft dyng sdng che khdng can cd sy dong y cfta chft sd huTa sang c h i md van khdng bi coi la vi phgm quydn SHTT cd tradng hgp sft dyng sang che cho myc dich nghien cftu. Tuy nhidn, tradng hgp ngogi Ip nay chua thyc sy thod ddng va ro rang, vipe ap dyng trdn thyc td khdng de dang va chua cd co sd phdp U vung ehdc. Can cd quy dinh cy thi hon vd khich Ip hon nua vipc sft dyng vdi tradng hgp nay trade khi sang chd trong Imh vyc dugc pham het thdi hgn bao hO, nhdm tao didu kidn thugn Igi cho vipc tiep can sdm hon nhung loai thudc thiet yiu hoac day mgnh vipc sft dung nhftng sdn p h i m thay thi tuong ty ke ca khi sang che chua hit thdi han bao hg.
Thu hai, dieu khodn ve bdt buOc chuyin giao quyin sft dung sang chi Id diiu khodn Imh hogt dugc Hiep dinh TRIPS dua ra trong cac trudng hgp ban chd quydn cfta chu sd hiiu sang chi, la diiu khodn nhan dugc sy quan tam ddc biet va dugc dp dung chft yeu cho Hnh vyc dugc phdm C) Vipt Nam, bdt
buOc chuyen giao quyin sft dyng sdng che cung da dugc ghi nhdn tft trong Phap l?nh vi bdo hg sd bun cdng nghidp ndm 1989, hien dugc quy dinh trong Lu|it SHTT va cdc vdn ban hudng d i n thi hdnh. Mdc dft dd cd sy phat trien manh me trong phdp luat vd SHTT hipn hdnh so vdi trade ddy tuy nhidn cdc quy dinh ve bdt huge chuydn giao quydn su dyng sang che van cdn kha nhieu bat cdp, cd the hgn che kha ndng sft dyng cd hidu qud tren thyc t i nhiing quy djnh nay. Cho d i n nay, Viet Nam chua lan ndo cap quydt djnh bat buOc chuyen giao quyen sft dyng sang chi, mac dft nhu cau sft dyng bdt buOc chuyen giao quydn su dyng sdng c h i nhdm myc dich cdng cOng phi thuong mgi Id nhu cau thyc tien cfta Vipt Nam. Cho d i n nay, BO y t i mdi chi mOt lan cd dOng thai "de dga" sft dyng chd djnh ve bdt bugc chuyin giao quydn sft dung sdng che. Cy thd, vipc BO y t i (Cyc quan li dugc) cudi nam 2005 "de dga" sft dung quyin ma c h i djnh phap ludt v i bdt buOc chuyen giao quydn sft dyng sdng che ddi vdi sdng che quy dinh, vdi li do bdo ve sue khoe cOng ddng trong djch cftm gia cam (H5N1) da buOc Cdng ti dugc phim Hoffman La Roche phai ddng y chuyin giao quydn sft dyng sang che sdn xu^t thudc Tamiflu cho cac cdng ti dugc phdm Vipt Nam.^'^* Dieu nay cho phep khdng djnh vide quy dinh cy t h i che djnh phdp ludt v i BBCGQSD ddi vdi quydn SHTT khi chu thi quyin SHTT vi phgm phdp luat cgnh tranh la (15).Xem them: Thong bdo sd 8186/QLD-DK ngay 09/11/2005 cua C^c quan li dir^c.
68 TAP CHI LUAT HQC SO 11/2019
NGHIEN CUV-TRAO Bdi het sftc can thiet, it nhdt ciing cd tac dyng rdn
de cdc doanh nghipp, nhdt Id cdc cdng ti da qudc gia hogt dOng d Vipt Nam khdng thd qud Igm dyng quyin SHTT dugc phap lugt Vipt Nam bao hO.
Hoan thien phap lugt trong van di ndy se tao CO sd phdp li cho vipc sft dyng cd hidu qud bdt buOc chuyen giao quyen sft dyng sang chd theo hudng khai thdc hgp li cac Igi ich ciia hp thdng bdng dOc quydn sang chi vd hgn che cac tdc dOng tieu cyc cfta hp thdng nay, phft hgp vdi quy djnh ciia Hipp djnh TRIPS ndi rieng va ciia cdc dieu udc qudc te khdc ma Viet Nam la thanh vien ndi chung.
Thd ba, hipn nay phap lugt Viet Nam ehi mdi cd nhiing quy dinh cho vipc xem xet va cdp bdng dOc quyin ddi vdi sang chi ndi chung. Lien quan den nhdm sang che Hen quan ddn dugc phdm chi mdi cd quy djnh vd yeu cdu them ddi vdi hd so xm cap vdn bdng bdo hO. Tuy nhidn, nhu dd de cap, vdi dac thu Id nhdm ddi tugng cd anh hudng Idn den Igi ich CLia cOng dong, phap luat cin phai cd thdm nhflng quy djnh ridng va d^c thu danh cho loai ddi tugng nay nhdm dam bao can bang dugc Igi ich cfta cOng ddng, hudng tdi myc dich thyc sy vd cudi cftng ciia hO thdng bdng ddc quyen sang che la vi myc dich cdng cgng. Cd thd thiy rdng, vipc dua ra eac tidu chuin dugc dp dyng di kidm tra va cdp bdng sang che ddi vdi sdn phim dugc phdm khdng chi mang y nghTa bao hg sy sdng tao tri tu? ma nd lien quan mat thiet den cac chuih sach cdng nghiOp va y td cOng ddng.
Cdc nhd hogch djnh chinh sach trong khu
vyc y ti ciing nhu nhflng ngudi lam cdng vipc thim tra sdng che can phdi nhdn thftc dugc rang, cdc quyet djnh Hen quan den vipc cap bdng sang chi cd thi tryc tiep dnh hudng den sue khod vd ddi sdng cfta ngudi dan d dat nude noi bdng sdng che dugc cap vd dugc thyc thi.
Theo dd, phdp lugt can quy djnh dieu kipn, yeu cau cao ban doi vdi vipc cap van bdng bao hO ddi vdi nhdm sdng chd dugc phim; thu hpp pham vi bdo hO ddi vdi nhdm sdng che dugc phim; trao quydn cho nhung chu thi thft ba dugc phan ddi vipc cdp bang dOc quyin trong thdi ban nhdt djnh. Bdn than yeu cau nay ciing lam tdng thdm trinh dO kl thugt thyc sy cua cdc doanh nghipp sdn xudt dugc pham trong nude di tgo ra dugc nhftng san pham dugc pham thyc sy cd tinh mdi va sang tgo so vdi nhung sdng che trade dd.
Thu tu. Dieu 7 HiOp djnh TRIPS di ra myc tidu chung ciia Hipp dinh la vipc bdo hd quyen SHTT phai phft hgp vdi Igi ich xd hOi ndi chung, tinh thdn nay cflng dugc phdp lugt Vipt Nam quy djnh tai Didu 7 va Dieu 8 Lugt SHTT. Nhu vay, vipc chu sd hftu bdng dOc quyen sang che sft dyng sai myc dich cfta bdng sdng chi cd nghia Id sft dyng khdng phu hgp vdi myc dich ciia hp thdng bao hg sang che. Trong Hnh vyc dugc pham, cdc hanh vi nhu djnh gia thudc qui cao, djnh gia nhdm thdn tuih ddi thu, tu chdi chuydn quydn sft dyng sdng chi tren co sd ty nguypn trong nhimg tmh hudng cu the cd the cau thdnh hdnh vi su dyng bdng dOc quydn sang
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chi sai myc dich.'"*' 6 mOt sd nude, hanh vi sft dyng bdng sdng che sai myc dich cd thi bj triing phgt bdi^ vipe toa an quydt djnh khdng buOc ddi thft canh tranh phai chdm dftt hanh vi xam phgm khi chft sd hflu bdi^
sang che khdi kipn hanh vi xam pham ra tod (tftc la trung phgt bdng each khdng thuc thi su bdo hg).f^^> Luat SHTT cfta Viet Nam khdng dd cgp cy thi van de sft dyng cdc quydn SHTT sai myc dich.
Trong liiih vyc sd hflru tri tup, khi chft sd huu bang dgc quyen sang chd nam trong tay dOc quydn va cd quyen cam ngudi khdc sft dung sdng chd, hg de dang d vj tri thdng lirih thi tradng hon so vdi cac ddi thft canh tranh.
Hanh vi Igm dyng vj tri thdng lihh la thugt ngft quan trgng trong phdp luat cgnh tranh va hdnh vi nay khdng nhat thiet Uen quan den bdo hO sdng chi vd phdp ludt vi SHTT ciing khdng dd cap van de ndy. Tuy nhidn, cd the thiy ring, chu sd hun bdng dOc quydn sang chd trong phgm vi quyen ma phap luat ve SHTT trao cho, hodn toan cd the thyc hidn hdnh vi hgn che san xuat, cai tidn tiep theo ddi vdi sang che, can trd sy phat tridn kl thugt, cdng nghp vd ngdn cdn vipc tham gia thj tradng ciia ddi thft cgnh tranh mdi; chft the quydn SHTT Igi ngdn can viec gia nhgp thj tradng cfta ddi thft canh tranh vdi y do chiem cac thj tradng thft cap vdn khdng ndm cdc quyen dOc quyin cfta minh thi hdnh vi dd cd the bj coi Id Igm dyng vj tri thdng ITnh thi tradng.
(16). UNCTAD, tldd, M. 152 - 1 5 8 . (17). UNCTAD, tldd. IT. 152.
Vipc thyc biOn cac quyen dOc quyen n cdch thdng thudng khdng phdi duang nhi' sd dan ddn cac hanh vi ve Igm dyng vi _.
thdng Imh thj trudng, bdi neu khdng thi su tdn tgi ciia cac quyen SHTT se trd thanh v6 nghia. Tuy nhidn, neu trong tradng hgp chii sd hiiu bdng dOc quyen qud lam dyng dpc quyen cfta minh dd tien hdnh cdc hanh vi cgnh tranh khdng lanh mgnh thi ndn cd cdc quy djnh cfta phap lugt lam co sd di xdc dinh gidi ban tuong ddi va xft li cdc hdnh vi ndy./.
TAI LIEU THAM KHAO 1. Carlos M. (Torrea, (juide to Pharmaceutical
Patents (n32), p. xui, published by South Centre, Geneva, Switzerland, 2018.
2. Ellen F.M.'t Hoen, LL.M, The Global Politics of Pharmaceutical monopoly power- Drug patent, access, innovation
and the application of the WTO Doha Declaration on TRIPS and Public health, AMB Publisher, 2009, https://apps. who.
int/medicmedocs/documents/s20963 en/s2 0963en.pdf
3. Frederick M. Abbott, Edward Ball Eminent Scholar, Professor of International Law, Florida State University, College of Law, WTO TRIPS Agreement and Its Implications for Access to Medicines in Developing Countries, http://ssm.coni/
abstract= 1924420
4. UNCTAD, "Ddu tu sdn xudt dugc phim d cdc qudc gia ^ n g phat trien: Tai Upu hudi^
dan tham khdo". New York & Geneva, 2011, https://unctad.org/en/Docs/diaepcb 201Id5_en.pdf
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