Amalungelo obunikazi embonini yezemithi
Ama-patenti angenye yezinsimbi zomthetho ezibaluleke kakhulu embonini yezemithi. Emkhakheni othembele kakhulu ocwaningweni nasekuthuthukisweni (R&D), ama-patenti asebenza njengesambulela sokuvikela izinto ezintsha kanye nendlela yokukhuthaza izinkampani, abacwaningi, kanye nezikhungo zezemfundo ukuthi zitshale imali eningi ekutholakaleni kwemithi emisha. Kodwa-ke, ama-patenti avame ukuba sembindini wempikiswano ngenxa yomthelela wawo emananini emithi , ukutholakala kwezindlela zokwelapha, kanye nokufinyelela komphakathi ekunakekelweni kwezempilo. Lesi sihloko sixoxa ngomqondo wama-patenti, indima yawo embonini yezemithi, izinhlobo zama-patenti, ukuguquguquka phakathi kwemithi yokuqala nemithi ejwayelekile, kanye nezinselele kanye neziqondiso zenqubomgomo zesikhathi esizayo.
Ukuqonda Amalungelo Obunikazi Nokubaluleka Kwawo Kwekhemisi
Ngokuvamile, ilungelo lobunikazi liyilungelo elikhethekile elinikezwa uhulumeni kumsunguli wento entsha yobuchwepheshe, isikhathi esithile esibekiwe. Leli lungelo elikhethekile livumela umnikazi welungelo lobunikazi ukuthi avimbele abanye ekwenzeni, ekusebenziseni, ekuthengiseni, ekungeniseni, noma ekusabalaliseni into entsha ngaphandle kwemvume. Esimweni semithi, izinto ezintsha zingafaka ama-molecule emithi amasha, izinqubo zokwenziwa, ukwakheka, izindlela zokusebenzisa (izinkomba), ngisho nezinhlelo zokulethwa kwemithi.
Imboni yezemithi inezici ezihlukile: izindleko zocwaningo eziphakeme kakhulu, isikhathi eside sokuthuthukiswa, kanye namazinga aphezulu okwehluleka. Ukuthuthukisa umuthi omusha kungathatha iminyaka, okubandakanya ukuhlolwa kwangaphambi kokwelashwa , izivivinyo zezokwelapha zezigaba eziningi, kanye nezinqubo zokubhalisa nokuqapha ngemuva kokumaketha. Ngaphandle kokuvikelwa kwelungelo lobunikazi, izinkampani zisengozini yokungakwazi ukubuyisa imali yazo ngoba izimbangi zingakopisha umkhiqizo uma usufakazelwe ukuthi uyasebenza futhi uphephile.
Amalungelo obunikazi njengesikhuthazo sokuqamba izinto ezintsha kanye nokubuyiselwa kwemali ekutshalweni kwezimali
Empeleni, amalungelo obunikazi anikeza isikhathi esilinganiselwe sokuphatha. Phakathi nalesi sikhathi, umnikazi welungelo lobunikazi anganquma amasu okuhweba, okuhlanganisa amanani, ukubambisana kwamalayisense, kanye nezinhlelo zokusabalalisa. Lesi sikhathi sokukhetha sibhekwa njengesinxephezelo sezingozi nezindleko ze-R&D.
Kodwa-ke, kubalulekile ukuqaphela ukuthi isikhathi esisemthethweni selungelo lobunikazi sivame ukubalwa kusukela ngosuku lokufaka ilungelo lobunikazi, hhayi kusukela ngosuku lokuthengiswa kwesidakamizwa. Ngenxa yokuthi izivivinyo zemitholampilo kanye nezinqubo zokuvunyelwa kokumaketha zinde, "isikhathi sokusebenza kwe-monopoly" emakethe sivame ukuba sifushane kunesikhathi esisemthethweni selungelo lobunikazi. Ukuze kuxazululwe lokhu, amanye amazwe asebenzise izindlela ezengeziwe ezifana nokwandiswa okuthile kokukhethekile noma izitifiketi ezengeziwe zokuvikela (kwezinye izindawo), yize lezi zinqubomgomo ziphinde zaphakamisa impikiswano mayelana nokufinyelela kwezidakamizwa.
Izinhlobo Zamalungelo Obunikazi Embonini Yezemithi
Amalungelo obunikazi emithi awavikeli njalo "isithako esisebenzayo" esiyinhloko. Ezinye izinhlobo ezivamile zamalungelo obunikazi embonini zifaka:
1. Ilungelo lobunikazi elihlanganisiwe
Kuvikela ama-molecule amasha noma izinto ezisebenzayo. Lezi ngokuvamile ziyizimvume zobunikazi eziqine kakhulu neziyigugu kakhulu ngoba zihlobene ngqo nomongo womuthi.
2. Ilungelo lobunikazi lenqubo
Ivikela izindlela zokukhiqiza noma zokuhlanganisa izithako ezisebenzayo. Lawa malungelo obunikazi abalulekile lapho inqubo ethile yenza ukukhiqizwa kube ngcono, kuphephe, noma kukhiqiza ubumsulwa obuphezulu.
3. Amalungelo obunikazi okwakha nokwakha
Ukuvikela isimo amalungiselelo emithi (isb., amaphilisi akhishwa njalo, ama-capsule, imijovo ye-depot), inhlanganisela yezithako ezisebenzayo nezinto ezithile ezisizayo, noma ukuqina kwefomula.
4. Ilungelo lobunikazi lokusetshenziswa noma indlela yokwelapha
Ihlanganisa izinkomba ezintsha zezokwelapha, njengomuthi owawusetshenziswa ekuqaleni kwe-hypertension kamuva owabonakala usebenza kwezinye izimo. Kwamanye amazwe, ukumbozwa "kokusetshenziswa kwezokwelapha kwesibili" kulawulwa amamodeli athile ezicelo.
5. Ifomu lekristalu elinelungelo lobunikazi, usawoti, noma i-polymorph
Ukwehluka kwe-physicochemical ku-molecule kungathinta ukuncibilika, ukuzinza, kanye nokutholakala kwezinto eziphilayo. Lolu hlobo lwelungelo lobunikazi luvame ukuvela esigabeni esithuthukile sentuthuko.
Lokhu kuhlukahluka kwe-patent kungadala "i-patent thicket," okusho ukuthi ama-patent amaningi avikela umkhiqizo owodwa ngezindlela eziningi. Ngokombono womsunguli, lokhu kuqinisa ukuvikelwa. Ngokombono wokufinyelela, kunganciphisa ukungena kwemithi ejwayelekile.
Izidakamizwa Zokuqala, Ezijwayelekile, kanye Nezokulingana Kwezinto Eziphilayo
Ngemva kokuphelelwa yisikhathi kwelungelo lobunikazi eliyinhloko, izinkampani ezijwayelekile zingakhiqiza izinhlobo eziqukethe isithako esisebenzayo esifanayo nomuthi wokuqala, uma nje zihlangabezana nezindinganiso zekhwalithi, ukuphepha, kanye nokusebenza kahle. Ngokuvamile, imithi ejwayelekile kumele ibonise ukulingana kwe-bio, okusho ukuthi iphrofayili yokumuncwa komuthi emzimbeni ilingana neyomkhiqizo obhekiselwe kuwo.
Ukungena kwemithi ejwayelekile kuvame ukwehlisa amanani kakhulu ngenxa yokuncintisana okwandayo. Lo mphumela ubalulekile ohlelweni lwezempilo lomphakathi kanye neziguli, ikakhulukazi ezifweni ezingamahlalakhona ezidinga ukwelashwa kwesikhathi eside. Ngakho-ke, amalungelo obunikazi avame ukubhekwa “njengesigaba sokuqala” (ukuvuselela okushukumisayo) esibe sesilinganiswa “yisigaba sesibili” (ukuncintisana kwemithi ejwayelekile) ukuqinisekisa ukufinyelela okubanzi.
Izinkinga Ezihlala Ziluhlaza kanye Nezimpikiswano Kumalungelo Obunikazi Ezemithi
Enye yezinkinga eziphikisana kakhulu ukuvikela imvelo, isu lokwandisa ukubusa kwemakethe ngokufaka amalungelo obunikazi engeziwe angabonisi ngempela ukuqamba okusha okukhulu. Izibonelo zifaka phakathi izinguquko ezincane ekwakhiweni, umthamo, noma ifomu lomthamo elibe selinelungelo lobunikazi ukuze kuvinjelwe ukuncintisana.
Abasekeli bamalungelo obunikazi akhuphukayo bathi ukuthuthuka okuqhubekayo nakho kungaba wusizo, njengokuthuthukisa ukuthobela imithetho yesiguli ngokusebenzisa izindlela zokukhululwa isikhathi eside noma ukunciphisa imiphumela emibi. Kodwa-ke, ukugxekwa kuvela lapho lawo malungelo obunikazi ebhekwa njengokwandisa nje ukukhethekile ngaphandle kokunikeza inzuzo enengqondo yezokwelapha.
Le mpikiswano idinga ibhalansi: uhlelo lwe-patent ludinga ukuvuza ukusungula izinto ezintsha kwangempela, kodwa kumele futhi luvimbele ukusetshenziswa kabi okuholela emananini aphakeme njalo.
Izindima Zelayisensi: Ezikhethekile, Ezingezona Ezikhethekile, Neziyimfuneko
Ngaphezu kokusetshenziswa kwelungelo lobunikazi, kunezindlela zokunikeza amalayisense ezithinta ukufinyelela kwezidakamizwa:
– Ilayisensi ekhethekile inikeza umuntu oyedwa ilungelo elilodwa lokukhiqiza/ukuthengisa into esunguliwe, ngokuvamile ngokushintshana nezinkokhelo zobukhosi.
– Ilayisensi engakhethi ivumela amaqembu amaningi ukuthi akhiqize, okungakhuthaza ukuncintisana okusheshayo.
– Ilayisensi ephoqelekile yinqubomgomo lapho uhulumeni evumela abanye ukuthi bakhiqize umuthi onelungelo lobunikazi ngaphandle kwemvume yomnikazi welungelo lobunikazi ngaphansi kwezimo ezithile, ngokuvamile ezihlobene nesithakazelo somphakathi, njengesimo esiphuthumayo sezempilo. Le ndlela isadinga isinxephezelo esifanele kumnikazi welungelo lobunikazi.
Ukuthola ilayisense ephoqelekile kuvame ukuba yindlela yokugcina, kodwa kungaba yinto ebalulekile lapho izinhlelo zezempilo zidinga ukufinyelela okusheshayo ekwelashweni okubalulekile ngamanani angabizi.
Amalungelo Obunikazi, Amanani Emithi, kanye Nokufinyelela Ekwelashweni Kwezempilo
Ubudlelwano phakathi kwamalungelo obunikazi namanani emithi akulula, kodwa ngokuvamile, amalungelo obunikazi avame ukuhlobana namanani aphezulu ngenxa yokuntuleka kokuncintisana okuqondile. Lokhu kuyiqiniso ikakhulukazi ngemithi emisha, okuhlanganisa ukwelashwa komdlavuza, izifo zokuzivikela komzimba, kanye ne-biologics. Kwezinye izimo, amanani aphezulu angavimbela ukutholakala emazweni anengeniso ephansi naphakathi.
Ukuze kuxazululwe le nkinga, kusetshenziswa izindlela ezahlukene, njengezingxoxo zamanani eziholwa nguhulumeni, izinhlelo zokuxhasa ngezimali zomshuwalense wezempilo, izinhlelo zokufinyelela iziguli, ukuthenga okuhlanganisiwe, kanye nokubambisana kwamalayisense okuzithandela. Inselele enkulu ukuklama izinqubomgomo ezikhuthaza ukusungula izinto ezintsha ngaphandle kokubeka engcupheni ilungelo lomphakathi lokwelashwa okwanele.
Izinselele Zesikhathi Esizayo: I-Biologics, i-Biosimilars, kanye nobuchwepheshe obusha
Imboni yezemithi manje isiqhubekela phambili kwezokwelapha ngebhayoloji, ukwelashwa ngezakhi zofuzo, ukwelashwa ngamaseli, kanye namapulatifomu asekelwe ku-mRNA. Lezi zinhlobo zezinto ezintsha zinezinkinga zokukhiqiza ezahlukene kanye nezidingo zelungelo lobunikazi kunemithi yamakhemikhali evamile. Ngakolunye uhlangothi, izidakamizwa ezifana ne-biosimilars, "izinguqulo eziseduze" ze-biologics, nazo ziyavela, zidinga ubufakazi bokulingana obuyinkimbinkimbi kakhulu kunezidakamizwa ezijwayelekile zendabuko.
Ngaphezu kwalokho, ubuchwepheshe bobuhlakani bokwenziwa bokutholakala kwemithi, ukuthuthukiswa kwemijovo emisha, kanye nokwelashwa okwenziwe ngezifiso kuphakamisa imibuzo emisha: ubani ongumnikazi walo mkhiqizo, yimiphi imingcele yobusha, nokuthi amalungelo obunikazi asetshenziswa kanjani ohlelweni locwaningo olubambisene.
Isiphetho
Amalungelo obunikazi embonini yezemithi ayinsika eyinhloko evumela ukusungulwa kwemithi ukuthi kuchume, okunikeza isivikelo esisemthethweni senzuzo ekutshalweni kwezimali ocwaningweni. Ngesikhathi esifanayo, amalungelo obunikazi nawo athinta amanani emithi kanye nokufinyelela, okudinga izinqubomgomo zokulinganisela ngokulinganayo. Izinselele ezifana nokwenqatshwa kwemithi ebalulekile, isidingo semithi ebalulekile, kanye nokuvela kwezindlela zokwelapha ezisezingeni eliphezulu zidinga uhlelo lwelungelo lobunikazi ukuthi luhlale luzivumelanisa nezimo. Okungcono kakhulu, uhlelo lwelungelo lobunikazi lwezemithi kufanele lukhuthaze ukutholakala kwezindlela zokwelapha ezintsha ngenkathi kuqinisekiswa ukuthi izinzuzo zokusungula izinto ezintsha zizwakala kabanzi emphakathini.
Uma ufisa, ngingavumelanisa lesi sihloko nomongo wase-Indonesia (isibonelo, ngithinta izimiso zoMthetho We-Patent, indima ye-BPOM, kanye nezibonelo zemithi ejwayelekile kanye nelayisensi ephoqelekile) noma ngengeze uhlu lwezincwadi kanye nezinkomba zesayensi.
