{"id":6705,"date":"2026-03-20T15:10:10","date_gmt":"2026-03-20T08:10:10","guid":{"rendered":"https:\/\/wincolaw.com.vn\/?p=6705"},"modified":"2026-03-23T10:32:33","modified_gmt":"2026-03-23T03:32:33","slug":"toa-an-toi-cao-uc-se-quyet-dinh-tuong-lai-cua-viec-gia-han-thoi-han-bang-sang-che-doi-voi-cac-bang-sang-che-ve-cong-thuc-duoc-pham","status":"publish","type":"post","link":"https:\/\/wincolaw.com.vn\/vi\/toa-an-toi-cao-uc-se-quyet-dinh-tuong-lai-cua-viec-gia-han-thoi-han-bang-sang-che-doi-voi-cac-bang-sang-che-ve-cong-thuc-duoc-pham.html","title":{"rendered":"T\u00f2a \u00e1n T\u1ed1i cao \u00dac s\u1ebd quy\u1ebft \u0111\u1ecbnh t\u01b0\u01a1ng lai c\u1ee7a vi\u1ec7c gia h\u1ea1n th\u1eddi h\u1ea1n b\u1eb1ng s\u00e1ng ch\u1ebf \u0111\u1ed1i v\u1edbi c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf v\u1ec1 c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m"},"content":{"rendered":"

H\u00f4m nay, T\u00f2a \u00e1n T\u1ed1i cao \u00dac-t\u00f2a ph\u00fac th\u1ea9m cao nh\u1ea5t c\u1ee7a \u00dac- \u0111\u00e3 ch\u1ea5p thu\u1eadn \u0111\u01a1n xin kh\u00e1ng c\u00e1o \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi ph\u00e1n quy\u1ebft c\u1ee7a T\u00f2a \u00e1n Li\u00ean bang To\u00e0n th\u1ec3 trong v\u1ee5 Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd (Otsuka v Sun Pharma).<\/p>\n

Di\u1ec5n bi\u1ebfn n\u00e0y \u0111\u01b0\u1ee3c xem l\u00e0 t\u00edn hi\u1ec7u t\u00edch c\u1ef1c \u0111\u1ed1i v\u1edbi c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c, v\u00ec ph\u00e1n quy\u1ebft trong v\u1ee5 Otsuka v Sun Pharma \u0111\u00e3 thu h\u1eb9p \u0111\u00e1ng k\u1ec3 kh\u1ea3 n\u0103ng gia h\u1ea1n th\u1eddi h\u1ea1n b\u1eb1ng s\u00e1ng ch\u1ebf (Patent Term Extensions PTEs) \u0111\u1ed1i v\u1edbi c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf li\u00ean quan \u0111\u1ebfn c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m (pharmaceutical formulations).<\/p>\n

V\u1ea5n \u0111\u1ec1 m\u00e0 T\u00f2a \u00e1n T\u1ed1i cao s\u1ebd xem x\u00e9t l\u00e0 b\u1eb1ng s\u00e1ng ch\u1ebf c\u1ee7a Otsuka \u0111\u1ed1i v\u1edbi c\u00f4ng th\u1ee9c aripiprazole ti\u00eam gi\u1ea3i ph\u00f3ng k\u00e9o d\u00e0i (controlled-release injectable formulation) v\u00e0 vi\u1ec7c li\u1ec7u b\u1eb1ng s\u00e1ng ch\u1ebf n\u00e0y c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c gia h\u1ea1n th\u1eddi h\u1ea1n d\u1ef1a tr\u00ean s\u1ef1 ph\u00ea duy\u1ec7t qu\u1ea3n l\u00fd c\u1ee7a thu\u1ed1c Abilify Maintena hay kh\u00f4ng.<\/p>\n

Tuy nhi\u00ean, quy\u1ebft \u0111\u1ecbnh c\u1ee7a T\u00f2a \u00e1n T\u1ed1i cao c\u00f3 kh\u1ea3 n\u0103ng \u1ea3nh h\u01b0\u1edfng r\u1ed9ng h\u01a1n, kh\u00f4ng ch\u1ec9 \u0111\u1ed1i v\u1edbi v\u1ee5 vi\u1ec7c n\u00e0y m\u00e0 c\u00f2n \u0111\u1ed1i v\u1edbi c\u00e1c PTE hi\u1ec7n t\u1ea1i v\u00e0 t\u01b0\u01a1ng lai li\u00ean quan \u0111\u1ebfn b\u1eb1ng s\u00e1ng ch\u1ebf v\u1ec1 c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n

B\u1ed1i c\u1ea3nh: <\/strong>Theo \u0110\u1ea1o lu\u1eadt B\u1eb1ng s\u00e1ng ch\u1ebf c\u1ee7a \u00dac, b\u1eb1ng s\u00e1ng ch\u1ebf c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c gia h\u1ea1n t\u1ed1i \u0111a 5 n\u0103m ngo\u00e0i th\u1eddi h\u1ea1n ti\u00eau chu\u1ea9n 20 n\u0103m n\u1ebfu b\u1eb1ng s\u00e1ng ch\u1ebf \u0111\u00f3, v\u1ec1 b\u1ea3n ch\u1ea5t c\u00f4ng b\u1ed1 v\u00e0 y\u00eau c\u1ea7u b\u1ea3o h\u1ed9 m\u1ed9t ch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m t\u1ef1 th\u00e2n (pharmaceutical substance per se); ho\u1eb7c m\u1ed9t ch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t b\u1eb1ng quy tr\u00ecnh s\u1eed d\u1ee5ng c\u00f4ng ngh\u1ec7 DNA t\u00e1i t\u1ed5 h\u1ee3p v\u1edbi \u0111i\u1ec1u ki\u1ec7n s\u1ea3n ph\u1ea9m ch\u1ee9a ho\u1eb7c bao g\u1ed3m ch\u1ea5t \u0111\u00f3 \u0111\u01b0\u1ee3c ghi trong S\u1ed5 \u0111\u0103ng k\u00fd H\u00e0ng h\u00f3a \u0110i\u1ec1u tr\u1ecb c\u1ee7a \u00dac (Australian Register of Therapeutic Goods ARTG), t\u1ee9c l\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh t\u1ea1i \u00dac.<\/p>\n

\u0110\u1ea1o lu\u1eadt B\u1eb1ng s\u00e1ng ch\u1ebf \u0111\u1ecbnh ngh\u0129a \u201cch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m\u201d (pharmaceutical substance) l\u00e0 m\u1ed9t ch\u1ea5t (bao g\u1ed3m h\u1ed7n h\u1ee3p ho\u1eb7c h\u1ee3p ch\u1ea5t c\u1ee7a c\u00e1c ch\u1ea5t) d\u00f9ng cho m\u1ee5c \u0111\u00edch \u0111i\u1ec1u tr\u1ecb, m\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng c\u1ee7a n\u00f3 (ho\u1eb7c m\u1ed9t trong c\u00e1c c\u00e1ch s\u1eed d\u1ee5ng) li\u00ean quan \u0111\u1ebfn t\u01b0\u01a1ng t\u00e1c h\u00f3a h\u1ecdc ho\u1eb7c l\u00fd-h\u00f3a v\u1edbi h\u1ec7 sinh l\u00fd c\u1ee7a con ng\u01b0\u1eddi, ho\u1eb7c t\u00e1c \u0111\u1ed9ng l\u00ean t\u00e1c nh\u00e2n g\u00e2y nhi\u1ec5m, \u0111\u1ed9c t\u1ed1 ho\u1eb7c ch\u1ea5t \u0111\u1ed9c trong c\u01a1 th\u1ec3 ng\u01b0\u1eddi; nh\u01b0ng kh\u00f4ng bao g\u1ed3m c\u00e1c ch\u1ea5t ch\u1ec9 d\u00f9ng cho ch\u1ea9n \u0111o\u00e1n ho\u1eb7c x\u00e9t nghi\u1ec7m in vitro.<\/p>\n

Trong nhi\u1ec1u n\u0103m, C\u01a1 quan S\u00e1ng ch\u1ebf \u00dac (Australian Patent Office) cho r\u1eb1ng \u0111\u1ecbnh ngh\u0129a n\u00e0y bao g\u1ed3m c\u1ea3 c\u00e1c c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m g\u1ed3m ho\u1ea1t ch\u1ea5t v\u00e0 t\u00e1 d\u01b0\u1ee3c v\u00e0 v\u00ec v\u1eady c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf v\u1ec1 c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c gia h\u1ea1n PTE. Quan \u0111i\u1ec3m n\u00e0y c\u0169ng \u0111\u01b0\u1ee3c m\u1ed9t s\u1ed1 ph\u00e1n quy\u1ebft s\u01a1 th\u1ea9m c\u1ee7a T\u00f2a \u00e1n Li\u00ean bang \u1ee7ng h\u1ed9.<\/p>\n

Tuy nhi\u00ean trong v\u1ee5 Otsuka v\u00e0 Sun Pharma, T\u00f2a \u00e1n Li\u00ean bang To\u00e0n th\u1ec3 k\u1ebft lu\u1eadn r\u1eb1ng \u201cch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m\u201d theo \u0111\u1ecbnh ngh\u0129a c\u1ee7a \u0110\u1ea1o lu\u1eadt ch\u1ec9 bao g\u1ed3m c\u00e1c ho\u1ea1t ch\u1ea5t v\u00e0 kh\u00f4ng bao g\u1ed3m c\u00e1c c\u00f4ng th\u1ee9c b\u00e0o ch\u1ebf (formulations). Theo T\u00f2a \u00e1n<\/p>\n

ch\u1ec9 ho\u1ea1t ch\u1ea5t m\u1edbi c\u00f3 kh\u1ea3 n\u0103ng t\u01b0\u01a1ng t\u00e1c v\u1edbi h\u1ec7 sinh l\u00fd con ng\u01b0\u1eddi ho\u1eb7c t\u00e1c \u0111\u1ed9ng l\u00ean t\u00e1c nh\u00e2n g\u00e2y b\u1ec7nh, \u0111\u1ed9c t\u1ed1 ho\u1eb7c ch\u1ea5t \u0111\u1ed9c, theo c\u00e1ch m\u00e0 \u0111\u1ecbnh ngh\u0129a ph\u00e1p lu\u1eadt d\u1ef1 li\u1ec7u.Khi xem x\u00e9t l\u1ecbch s\u1eed l\u1eadp ph\u00e1p c\u1ee7a c\u01a1 ch\u1ebf PTE, T\u00f2a \u00e1n c\u0169ng cho r\u1eb1ng Qu\u1ed1c h\u1ed9i \u00dac c\u00f3 \u00fd \u0111\u1ecbnh gi\u1edbi h\u1ea1n kh\u00e1i ni\u1ec7m \u201cch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m\u201d \u1edf m\u1ee9c ho\u1ea1t ch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m (API).Theo quan \u0111i\u1ec3m c\u1ee7a T\u00f2a c\u00e1ch hi\u1ec3u n\u00e0y ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch c\u1ee7a c\u01a1 ch\u1ebf PTE, v\u1ed1n nh\u1eb1m b\u00f9 \u0111\u1eafp cho ch\u1ee7 s\u1edf h\u1eefu b\u1eb1ng s\u00e1ng ch\u1ebf nh\u1eefng ch\u1eadm tr\u1ec5 trong qu\u00e1 tr\u00ecnh xin ph\u00ea duy\u1ec7t qu\u1ea3n l\u00fd \u0111\u1ed1i v\u1edbi c\u00e1c ch\u1ea5t m\u1edbi v\u00e0 c\u00f3 t\u00ednh s\u00e1ng t\u1ea1o.<\/p>\n

T\u00f2a \u00e1n c\u0169ng cho r\u1eb1ng nh\u1eefng c\u1ea3i ti\u1ebfn v\u1ec1 h\u1ec7 th\u1ed1ng d\u1eabn thu\u1ed1c ho\u1eb7c d\u1ea1ng b\u00e0o ch\u1ebf (t\u1ee9c c\u00f4ng th\u1ee9c m\u1edbi) kh\u00f4ng ph\u1ea3i ch\u1ecbu c\u00e1c ch\u1eadm tr\u1ec5 qu\u1ea3n l\u00fd \u1edf m\u1ee9c \u0111\u1ed9 t\u01b0\u01a1ng t\u1ef1.<\/p>\n

Do \u0111\u00f3, PTE \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p cho b\u1eb1ng s\u00e1ng ch\u1ebf c\u00f4ng th\u1ee9c gi\u1ea3i ph\u00f3ng k\u00e9o d\u00e0i c\u1ee7a Otsuka \u0111\u00e3 b\u1ecb tuy\u00ean l\u00e0 kh\u00f4ng h\u1ee3p l\u1ec7. H\u1ec7 qu\u1ea3 c\u1ee7a vi\u1ec7c kh\u00e1ng c\u00e1o l\u00ean T\u00f2a \u00e1n T\u1ed1i cao.<\/p>\n

M\u1eb7c d\u00f9 v\u1ee5 Otsuka v\u00e0 Sun Pharma li\u00ean quan \u0111\u1ebfn m\u1ed9t c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m c\u1ee5 th\u1ec3, nh\u01b0ng v\u1ee5 \u00e1n n\u00e0y c\u00f3 th\u1ec3 t\u00e1c \u0111\u1ed9ng r\u1ed9ng \u0111\u1ebfn c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf v\u1ec1 c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m n\u00f3i chung.<\/p>\n

N\u1ebfu T\u00f2a \u00e1n T\u1ed1i cao gi\u1eef nguy\u00ean ph\u00e1n quy\u1ebft c\u1ee7a T\u00f2a \u00e1n Li\u00ean bang To\u00e0n th\u1ec3 ph\u1ea1m vi c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c gia h\u1ea1n PTE t\u1ea1i \u00dac s\u1ebd b\u1ecb thu h\u1eb9p \u0111\u00e1ng k\u1ec3 v\u00e0 nhi\u1ec1u PTE \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p d\u1ef1a tr\u00ean c\u00e1c c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m c\u00f3 th\u1ec3 b\u1ecb th\u00e1ch th\u1ee9c v\u1ec1 t\u00ednh h\u1ee3p l\u1ec7.<\/p>\n

Th\u1eddi \u0111i\u1ec3m ra ph\u00e1n quy\u1ebft s\u1ebd ph\u1ee5 thu\u1ed9c v\u00e0o l\u1ecbch x\u00e9t x\u1eed c\u1ee7a T\u00f2a \u00e1n v\u00e0 s\u1ef1 s\u1eb5n s\u00e0ng c\u1ee7a lu\u1eadt s\u01b0 c\u00e1c b\u00ean, nh\u01b0ng quy\u1ebft \u0111\u1ecbnh c\u1ee7a T\u00f2a \u00e1n T\u1ed1i cao c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u0111\u01b0a ra trong kho\u1ea3ng 12 th\u00e1ng t\u1edbi.<\/p>\n

Trong th\u1eddi gian \u0111\u00f3, t\u00ecnh tr\u1ea1ng ph\u00e1p l\u00fd v\u1ec1 kh\u1ea3 n\u0103ng \u0111\u01b0\u1ee3c PTE c\u1ee7a c\u00e1c b\u1eb1ng s\u00e1ng ch\u1ebf c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i \u00dac s\u1ebd v\u1eabn c\u00f2n kh\u00f4ng ch\u1eafc ch\u1eafn.<\/p>\n

IP Australia \u0111\u00e3 th\u00f4ng b\u00e1o r\u1eb1ng h\u1ecd s\u1ebd t\u1ea1m d\u1eebng x\u1eed l\u00fd c\u00e1c \u0111\u01a1n xin PTE c\u00f3 th\u1ec3 li\u00ean quan \u0111\u1ebfn c\u00f4ng th\u1ee9c d\u01b0\u1ee3c ph\u1ea9m v\u00e0 vi\u1ec7c t\u1ea1m d\u1eebng n\u00e0y c\u00f3 th\u1ec3 ti\u1ebfp t\u1ee5c cho \u0111\u1ebfn khi T\u00f2a \u00e1n T\u1ed1i cao \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh cu\u1ed1i c\u00f9ng.<\/p>\n

Ngu\u1ed3n https:\/\/www.spruson.com\/australias-high-court-to-decide-the-future-of-patent-term-extensions-for-pharmaceutical-formulation-patents\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

H\u00f4m nay, T\u00f2a \u00e1n T\u1ed1i cao \u00dac-t\u00f2a ph\u00fac th\u1ea9m cao nh\u1ea5t c\u1ee7a \u00dac- \u0111\u00e3 ch\u1ea5p thu\u1eadn \u0111\u01a1n xin kh\u00e1ng c\u00e1o \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi ph\u00e1n quy\u1ebft c\u1ee7a T\u00f2a \u00e1n Li\u00ean bang To\u00e0n th\u1ec3 trong v\u1ee5 Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd (Otsuka v Sun Pharma). Di\u1ec5n bi\u1ebfn n\u00e0y \u0111\u01b0\u1ee3c xem l\u00e0 […]<\/p>\n","protected":false},"author":1,"featured_media":6294,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[101,9],"tags":[],"yst_prominent_words":[],"class_list":["post-6705","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-so-huu-tri-tue","category-tin-tuc"],"_links":{"self":[{"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/posts\/6705","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/comments?post=6705"}],"version-history":[{"count":2,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/posts\/6705\/revisions"}],"predecessor-version":[{"id":6714,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/posts\/6705\/revisions\/6714"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/media\/6294"}],"wp:attachment":[{"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/media?parent=6705"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/categories?post=6705"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/tags?post=6705"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/wincolaw.com.vn\/vi\/wp-json\/wp\/v2\/yst_prominent_words?post=6705"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}