Ma Patent mu Makampani Opanga Mankhwala
Ma patent ndi chimodzi mwa zida zofunika kwambiri zalamulo mumakampani opanga mankhwala. Mu gawo lomwe limadalira kwambiri kafukufuku ndi chitukuko (R&D), ma patent amagwira ntchito ngati chitetezo cha zatsopano komanso njira yolimbikitsira makampani, ofufuza, ndi mabungwe ophunzira kuti azigwiritsa ntchito ndalama zambiri pakupeza mankhwala atsopano. Komabe, ma patent nthawi zambiri amakhala pakati pa mkangano chifukwa cha momwe amakhudzira mitengo ya mankhwala , kupezeka kwa njira zochiritsira, komanso mwayi wopeza chithandizo chamankhwala kwa anthu onse. Nkhaniyi ikufotokoza za lingaliro la ma patent, udindo wawo mumakampani opanga mankhwala, mitundu ya ma patent, momwe mankhwala oyamba ndi omwe amapangidwa, komanso zovuta ndi malangizo amtsogolo.
Kumvetsetsa Ufulu wa Patent ndi Kufunika Kwake pa Pharmacy
Kawirikawiri, patent ndi ufulu wapadera womwe boma limapatsa wopanga zinthu zatsopano zaukadaulo, kwa nthawi inayake. Ufulu wapaderawu umalola mwini patent kuletsa ena kupanga, kugwiritsa ntchito, kugulitsa, kulowetsa, kapena kugawa zinthu zatsopano popanda chilolezo. Pankhani ya mankhwala, zinthu zatsopano zitha kuphatikizapo mamolekyu atsopano a mankhwala, njira zopangira, mapangidwe, njira zogwiritsira ntchito (zizindikiro), komanso njira zoperekera mankhwala.
Makampani opanga mankhwala ali ndi makhalidwe apadera: ndalama zambiri zofufuzira, nthawi yayitali yopangira, komanso kuchuluka kwa kulephera kwakukulu. Kupanga mankhwala atsopano kungatenge zaka zambiri, kuphatikizapo kuyesa koyambirira kwa mankhwala , kuyesa kwachipatala kwa magawo angapo, komanso njira zolembetsa ndi kuyang'anira pambuyo pa malonda. Popanda chitetezo cha patent, makampani ali pachiwopsezo chosatha kubweza ndalama zawo chifukwa opikisana nawo amatha kukopera mankhwalawa akangotsimikizika kuti ndi othandiza komanso otetezeka.
Ma Patent monga Cholimbikitsira Kupanga Zinthu Zatsopano ndi Kubweza Ndalama
Mwachidule, ma patent amapereka nthawi yochepa yogwiritsira ntchito. Munthawi imeneyi, mwini patent amatha kusankha njira zogulitsira, kuphatikiza mitengo, mgwirizano wa zilolezo, ndi njira zogawa. Nthawi yapaderayi imaonedwa ngati chipukuta misozi cha zoopsa ndi ndalama za kafukufuku ndi chitukuko.
Komabe, ndikofunikira kudziwa kuti nthawi yovomerezeka ya patent nthawi zambiri imawerengedwa kuyambira tsiku lopereka patent, osati kuyambira tsiku lomwe mankhwalawo agulitsidwa. Popeza mayeso azachipatala ndi njira zovomerezeka zogulitsira zimakhala zazitali, "nthawi yogwira ntchito yodziyimira payokha" pamsika nthawi zambiri imakhala yochepa kuposa nthawi yovomerezeka ya patent. Pofuna kuthana ndi izi, mayiko ena akhazikitsa njira zina monga kuwonjezera zina za kudzipereka kapena ziphaso zina zodzitetezera (m'madera ena), ngakhale kuti mfundozi zayambitsanso mkangano wokhudza kupeza mankhwala.
Mitundu ya Ma Patent mu Makampani Opanga Mankhwala
Ma patent a mankhwala nthawi zonse samangoteteza "chogwiritsidwa ntchito" chachikulu. Mitundu ina yodziwika bwino ya ma patent mumakampani ndi awa:
1. Patent yophatikizana
Amateteza mamolekyu atsopano kapena zinthu zogwira ntchito. Izi nthawi zambiri zimakhala ma patent amphamvu komanso amtengo wapatali chifukwa zimagwirizana mwachindunji ndi maziko a mankhwala.
2. Patent ya njira
Amateteza njira zopangira kapena kupanga zosakaniza zogwira ntchito. Ma patent awa ndi ofunikira pamene njira inayake imapangitsa kupanga kukhala kogwira mtima, kotetezeka, kapena koyera kwambiri.
3. Ma patent opangira ndi kupanga
Kuteteza mawonekedwe kukonzekera mankhwala (monga mapiritsi otulutsidwa nthawi zonse, makapisozi, jakisoni wosungiramo mankhwala), kuphatikiza zosakaniza zogwira ntchito ndi zinthu zina zowonjezerera, kapena kukhazikika kwa mankhwalawo.
4. Patent yogwiritsira ntchito kapena njira yochiritsira
Ikufotokoza zizindikiro zatsopano zachipatala, monga mankhwala omwe poyamba ankagwiritsidwa ntchito pochiza kuthamanga kwa magazi omwe pambuyo pake amakhala othandiza pa matenda ena. M'mayiko ena, chithandizo cha "kugwiritsa ntchito mankhwala ena" chimayendetsedwa ndi mitundu ina ya mankhwala.
5. Mtundu wa kristalo, mchere, kapena polymorph
Kusintha kwa kapangidwe ka thupi mu molekyulu kungakhudze kusungunuka, kukhazikika, ndi kupezeka kwa bioavailability. Mtundu uwu wa patent nthawi zambiri umachitika pamlingo wapamwamba wa chitukuko.
Kusiyanasiyana kwa ma patent kumeneku kungapangitse "chidebe cha patent," kutanthauza ma patent angapo omwe amateteza chinthu chimodzi kuchokera mbali zosiyanasiyana. Kuchokera ku malingaliro a wopanga zatsopano, izi zimalimbitsa chitetezo. Kuchokera ku malingaliro opezera, zimatha kuchepetsa kulowa kwa mankhwala wamba.
Mankhwala Oyambitsa, Omwe Amagwiritsidwa Ntchito Pamodzi, ndi Ofanana ndi a Bioequivalence
Pambuyo poti patent yoyamba itatha, makampani opanga mankhwala opangidwa ndi generic amatha kupanga mitundu yokhala ndi mankhwala omwewo monga mankhwala oyamba, bola ngati akwaniritsa miyezo yabwino, chitetezo, komanso kugwira ntchito bwino. Kawirikawiri, mankhwala opangidwa ndi generic ayenera kusonyeza kufanana kwa bioequivalence, zomwe zikutanthauza kuti kuyamwa kwa mankhwala m'thupi ndi kofanana ndi kwa mankhwala ofunikira.
Kulowa m'masitolo nthawi zambiri kumatsitsa mitengo kwambiri chifukwa cha mpikisano wokwera. Izi ndizofunikira kwambiri pazaumoyo wa anthu onse komanso odwala, makamaka matenda osatha omwe amafunika chithandizo cha nthawi yayitali. Chifukwa chake, ma patent nthawi zambiri amawonedwa ngati "gawo loyamba" (kulimbikitsa zatsopano) lomwe limayendetsedwa ndi "gawo lachiwiri" (mpikisano wamba) kuti zitsimikizire kuti anthu ambiri akupeza mwayi wopeza.
Nkhani Zobiriwira Nthawi Zonse ndi Mikangano mu Ma Patent a Zamankhwala
Chimodzi mwa nkhani zomwe zimakangana kwambiri ndi evergreening, njira yowonjezerera ulamuliro pamsika mwa kulemba ma patent ena omwe sasonyeza luso lapadera. Zitsanzo zikuphatikizapo kusintha pang'ono kwa kapangidwe kake, mlingo, kapena mawonekedwe a mlingo omwe kenako amakhala ndi patent kuti aletse mpikisano.
Othandizira ma patent owonjezera amanena kuti kusintha kowonjezera kungakhalenso kofunika, monga kukonza kutsatira kwa wodwala kudzera mu njira zowonjezerera kapena kuchepetsa zotsatirapo zoyipa. Komabe, kutsutsidwa kumachitika pamene ma patent oterewa amaonedwa ngati kungowonjezera kupatula popanda kupereka phindu lofunikira kuchipatala.
Mkangano uwu ukufuna mgwirizano: dongosolo la patent liyenera kupereka mphotho ku luso lenileni, komanso liyeneranso kupewa kugwiritsa ntchito molakwika zomwe zimapangitsa kuti mitengo ikhale yokwera nthawi zonse.
Maudindo a Chilolezo: Okhaokha, Osapatula, ndi Ofunikira
Kuwonjezera pa kukakamiza patent, palinso njira zina zopezera chilolezo zomwe zimakhudza kupezeka kwa mankhwala osokoneza bongo:
- Chilolezo chapadera chimapatsa munthu mmodzi ufulu wokhawo wopanga/kugulitsa chinthu chatsopano, nthawi zambiri posinthana ndi ndalama zachifumu.
- Zilolezo zopanda chilolezo zokha zimathandiza magulu angapo kupanga zinthu, zomwe zingathandize kuti mpikisano ukhale wofulumira.
– Chilolezo chokakamiza ndi mfundo yomwe boma limalola ena kupanga mankhwala okhala ndi patent popanda chilolezo cha mwini patent pansi pa zifukwa zina, zomwe nthawi zambiri zimakhudzana ndi zofuna za anthu onse, monga ngozi yazaumoyo. Njirayi imafunabe kulipidwa koyenera kwa mwini patent.
Kupereka chilolezo chokakamiza nthawi zambiri kumakhala njira yomaliza, koma kungakhale kofunikira kwambiri pamene mabungwe azaumoyo akufunika kupeza chithandizo chofunikira mwachangu pamitengo yotsika mtengo.
Ma Patent, Mitengo ya Mankhwala, ndi Kupeza Chisamaliro cha Zaumoyo
Ubale pakati pa ma patent ndi mitengo ya mankhwala si wophweka, koma kawirikawiri, ma patent nthawi zambiri amakhudzana ndi mitengo yokwera chifukwa chosowa mpikisano wachindunji. Izi ndi zoona makamaka pa mankhwala atsopano, kuphatikizapo mankhwala a khansa, matenda odziteteza ku matenda a autoimmune, ndi biologics. Nthawi zina, mitengo yokwera imatha kulepheretsa kupezeka m'maiko osauka komanso apakati.
Pofuna kuthetsa vutoli, njira zosiyanasiyana zikugwiritsidwa ntchito, monga kukambirana za mitengo motsogozedwa ndi boma, njira zopezera ndalama zothandizira inshuwaransi yazaumoyo, mapulogalamu opezera odwala, kugula zinthu pamodzi, ndi mgwirizano wodzipereka wa ziphaso. Vuto lalikulu ndikupanga mfundo zomwe zimalimbikitsa kupanga zinthu zatsopano popanda kusokoneza ufulu wa anthu wopeza chithandizo chokwanira.
Mavuto Amtsogolo: Biologics, Biosimilars, ndi Matekinoloje Atsopano
Makampani opanga mankhwala tsopano akupita ku biologics, machiritso a majini, machiritso a maselo, ndi nsanja zochokera ku mRNA. Mitundu iyi ya zinthu zatsopano ili ndi zovuta zosiyanasiyana zopangira komanso zofunikira patent kuposa mankhwala wamba. Kumbali ina, biosimilars, "mabaibulo oyandikira" a biologics, nawonso akubwera, omwe amafunikira umboni wofanana kwambiri kuposa mankhwala wamba.
Kuphatikiza apo, ukadaulo wanzeru zopanga kuti mupeze mankhwala, kupanga katemera watsopano, ndi njira zochiritsira zomwe munthu aliyense payekha zimadzutsa mafunso atsopano: ndani mwini wake wa chipangizochi, kodi malire a zinthu zatsopano ndi ati, ndi momwe ma patent amagwiritsidwira ntchito mu kafukufuku wogwirizana.
Mapeto
Ma patent mu makampani opanga mankhwala ndi chinsinsi chofunikira chomwe chimalola kuti zatsopano za mankhwala zipite patsogolo, zomwe zimapereka chitetezo chalamulo pa phindu la ndalama zomwe zayikidwa mu kafukufuku. Nthawi yomweyo, ma patent amakhudzanso mitengo ya mankhwala ndi mwayi wopeza, zomwe zimapangitsa kuti pakhale mfundo zoyenera zogwirizanitsa. Mavuto monga kuletsa kugwiritsa ntchito mankhwala ofunikira, kufunikira kwa mankhwala ofunikira, komanso kubuka kwa njira zamakono zochiritsira amafuna kuti njira ya patent isinthe nthawi zonse. Mwanjira yabwino, njira yopezera ma patent ya mankhwala iyenera kulimbikitsa kupezeka kwa njira zatsopano zochiritsira pamene ikuwonetsetsa kuti ubwino wa zatsopano ukumvedwa ndi anthu ambiri.
Ngati mukufuna, nditha kusintha nkhaniyi kuti igwirizane ndi nkhani ya ku Indonesia (mwachitsanzo, kukhudza zomwe zili mu Lamulo la Patent, udindo wa BPOM, ndi zitsanzo za mankhwala opangidwa ndi anthu wamba komanso chilolezo chokakamiza) kapena kuwonjezera zolemba zamabuku ndi maumboni asayansi.
