Tun da daɗewa, mutane sun yi imanin cewa tsarin da'awar na iya kuma sau da yawa yana taka muhimmiyar rawa a shari'ar haƙƙin mallaka. Wannan gaskiya shi ne tushen da Hukumar Tarayya ta tabbatar da hukuncin kotun gundumar a kan kamfanin kera magunguna na yau da kullun a cikin sabon hukuncin da District Pharmacopoeia ta yanke a shari'ar Par Pharmaceutical, Inc. da Hospira, Inc.. Keta tsarin mallakar fasaha na Par, ƙa'idodin kuskure bayyanannu suma sun yi tasiri ga sakamakon.
An haifar da waɗannan matsalolin ne a shari'ar ANDA, inda mai ƙara ya yi iƙirarin mallakar Hospira ta Amurka mai lamba 9,119,876 da 9,925,657 game da Adrenalin® (adrenaline) na Par da hanyar gudanar da shi (allura). Hospira ya ba da shawarar rashin keta doka da rashin inganci a matsayin kariya (kotun gundumar ta shigar da ƙara a kan Hospira don haka ba ta ɗaukaka ƙara ba). Patent ɗin Par yana da nufin wani tsari wanda ya shawo kan ƙarancin tsarin adrenaline na baya. Saboda hanyoyi uku daban-daban na lalatawa (oxydation, racemization da sulfonation), tsawon lokacin da zai ɗauka bai yi yawa ba. Da'awar 1 na patent ɗin '876 wakilci ne:
Wani abu da ya ƙunshi: kimanin 0.5 zuwa 1.5 mg/mL na epinephrine da/ko gishirinsa, kimanin 6 zuwa 8 mg/mL na mai daidaita tonicity, kimanin 2.8 zuwa 3.8 mg/mL na mai haɓaka pH, da kuma maganin hana kumburi na kimanin 0.1 zuwa 1.1 mg/mL, maganin rage pH 0.001 zuwa 0.010 mL/mL da kuma kimanin 0.01 zuwa 0.4 mg/mL na maganin haɗa ƙarfe, inda maganin hana kumburi ya haɗa da sodium bisulfite da/ko sodium metabisulfite.
(Yi amfani da fuskar da ke da ƙarfi a cikin ra'ayin don nuna ƙuntatawa da suka shafi ɗaukaka ƙarar Hospira). Bayan bayyana waɗannan ƙuntatawa, ra'ayin ya gabatar da fassarar kalmar "alkawari" da kotun gundumar ta yi amfani da ita ga kowace ƙuntatawa. Bangarorin sun amince a fili cewa kalmar ya kamata ta kasance da ma'anarta ta yau da kullun, wacce take "kusan"; ga Kotun Daukaka Kara ta Tarayya, Hospira bai bayar da wani bayani ga akasin haka ba.
Bangarorin biyu sun bayar da shaidar ƙwararru kan waɗannan ƙa'idodi guda uku da ke sama. Masana Parr sun shaida cewa kotun ta yi amfani da sodium chloride 9 mg/mL don tantance keta haddin da ke tsakanin 6-8 mg/mL (yawan sinadarin Hospira, kodayake ana amfani da shi ƙasa da 8.55 mg/mL) domin ya isa a cika manufar da aka nufa, wato "kiyaye mutuncin ƙwayoyin halitta masu rai bayan an saka adrenaline a cikin jini." Masana Hospira sun nuna rashin amincewa ga abokan aikinsa kawai kan ko ƙwararrun masu fasaha sun yi imanin cewa 9 mg/mL ya faɗi cikin kewayon "kusan" 6-8 mg/mL.
Dangane da iyakokin hadaddun ƙarfe na canzawa, kotun gundumar ta tabbatar da cewa citric acid sanannen wakili ne na chelating bisa ga shaida. Hospira ya bayyana a cikin ANDA cewa abubuwan da ke cikin ƙazanta na abubuwa (ƙarfe) yana cikin ƙa'idodin ƙasa da ƙasa (musamman ICH Q3D). Masana Par sun tabbatar da cewa alaƙar da ke tsakanin samfurin da aka saba da yawan sinadarin chelating da aka bayyana a cikin da'awar tana cikin iyakokin da ake buƙata. Masana Hospira ba su sake yin gogayya da ƙwararrun Par gabaɗaya ba, amma ta tabbatar da cewa iyakar sama ta ma'aunin ICH Q3D ba ta dace da kotun gundumar ba. Madadin haka, ya yi imanin cewa ya kamata a cire adadin da ya dace daga gwajin Hospira, wanda ya yi imanin zai buƙaci ƙarancin matakan citric acid a matsayin maganin chelating.
Bangarorin biyu suna fafatawa don amfani da sinadarin rage pH na Hospira's ANDA don ƙayyade yawan sinadarin citric acid a matsayin ma'aunin kariya (da kuma sinadarin sodium citrate). A fannin, ana ɗaukar sinadarin citric acid da kansa a matsayin mai ƙara pH (kuma babu shakka cewa sinadarin citric acid da kansa wakili ne mai rage pH). A cewar ƙwararrun Par, cire adadin sinadarin citric acid a cikin tsarin Hospira ya isa ya sa sinadarin citric acid ya faɗi cikin kewayon sinadarin rage pH da Par ta yi iƙirarin yi. "Ko da waɗannan ƙwayoyin citric acid ɗin za su zama wani ɓangare na tsarin buffer (haɗen Citric acid da sodium citrate ana amfani da su tare a matsayin wakilin haɓaka pH." (Kodayake akwai sabani a bayyane, ku tuna cewa keta doka gaskiya ne. Hukumar Tarayya za ta sake duba hukuncin kotun gundumar a cikin shari'a. Domin a cimma wata kuskure bayyananne.) Masana Hospira sun yi rashin jituwa da ƙwararrun Par kuma sun tabbatar (da hankali) cewa bai kamata a ɗauki ƙwayoyin citric acid a cikin tsarin a matsayin rage pH da ƙara pH ba. Duk da haka, kotun gundumar ta yanke hukuncin cewa Par ta lashe shari'ar kuma shawarar Hospira za ta keta haƙƙin mallakar Par. Wannan ƙarar ta biyo baya.
Alkali Taranto ya yi imanin cewa Kotun Tarayya ta tabbatar da cewa Alkali Dyke da Alkali Stoll suma sun halarci taron. Ɗaukaka ƙarar da Hospira ta yi ya shafi hukuncin kotun gundumar kan kowanne daga cikin ƙa'idodi uku. Kotun Tarayya ta fara tabbatar da sakamakon Kotun Gundumar a ra'ayinta cewa yawan sinadarin sodium chloride na 9 mg/mL a cikin maganin Hospira ya faɗi cikin iyakar "kusan" 6-8 mg/mL da Par ta yi iƙirari. Ƙungiyar ƙwararru ta nuna cewa lokacin amfani da kalmar "kusan", "ku guji amfani da iyakokin lambobi masu tsauri don takamaiman sigogi," in ji Cohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), bisa ga Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Da yake ambaton bayanin Monsanto Tech, lokacin da aka gyara "kusan" a cikin da'awar, ana iya tsawaita kewayon lambobi da aka yi iƙirari fiye da iyaka har sai ƙwararren mai da'awar zai "yi la'akari da" iyaka da aka rufe da'awar. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Kotun Tarayya 2018). A irin waɗannan yanayi, idan babu ɗayan ɓangarorin da ke goyon bayan rage iyaka na da'awar, ƙudurin ya dogara ne akan ma'aunin haɗin kai. Abubuwan da ke cikin wannan ma'aunin sun haɗa da ko tsarin da ake zargin ya keta "matsakaici" ne daga iyaka na kariya (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Kotun Tarayya, 1994). )), Kuma yadda mahimmancin iyaka na kariya don manufar iyakance (ba wannan ƙirƙira ba) kanta. Duk da cewa ta amince cewa ikirarin ya zama gudummawa ga hukuncin kotun kan wannan batu, Hukumar Kula da Shari'a ta Tarayya ta nuna cewa: "Ko na'urar da ake tuhuma ta cika ma'anar "alkawari" mai ma'ana a wasu yanayi batun gaskiya ne na fasaha," v. Hukumar Ciniki ta Duniya ta Amurka, 75 F.3d 1545, 1554 (Kotun Tarayya, 1996). A nan, kwamitin ya yi imanin cewa kotun gundumar ta amince da abin da aka bayyana a nan yadda ya kamata, kuma shawarar ta dogara ne akan shaidar ƙwararru. Kotun Gundumar ta yanke hukuncin cewa ƙwararrun Par sun fi ƙwararrun Hospira gamsarwa, musamman gwargwadon yadda ta dogara da "bayanan fasaha, mahimmancin manufar ƙuntatawa, da rashin sukar ƙuntatawa." Akasin haka, kotun gundumar ta yanke hukuncin cewa ƙwararrun Hospira "ba su yi bincike mai ma'ana game da asalin fasaha ko aikin mai gyaran tonicity da ake da'awar ba." Dangane da waɗannan hujjoji, kwamitin ƙwararru bai sami kurakurai a bayyane ba.
Dangane da iyakokin sinadaran hada ƙarfe na canzawa, Hukumar Kula da Haɗakar Ƙasa ta yi watsi da hujjar Hospira cewa ya kamata kotun gundumar ta mayar da hankali kan dabarar da ta gabatar maimakon tanade-tanaden da ke cikin ANDA. Kwamitin ya gano cewa Kotun Gundumar ta ɗauki citric acid daidai a matsayin maganin hada ƙarfe na sauyawa da aka bayyana a cikin da'awar, wanda ya yi daidai da shaidar ƙwararru ta ɓangarorin biyu. Dangane da shaidar cewa citric acid a zahiri yana aiki a matsayin maganin cire ƙarfe, wannan ra'ayi ya ƙi hujjar Hospira cewa ba a yi nufin amfani da citric acid a matsayin maganin cire ƙarfe ba. A cewar 35 USC§271(e)(2), ƙa'idar yanke hukunci a shari'ar ANDA ita ce abubuwan da aka bayyana a cikin ANDA (kamar yadda kotun ta nuna, keta doka ce mai gina jiki), tana ambaton Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Kotun Tarayya, 2013). Dogara da Hospira ta yi wa ANDA ita ce ƙa'idar ICH Q3D, wadda ke goyon bayan hukuncin kotun gundumar, aƙalla ba wai saboda an ƙara wannan ambato a cikin ANDA ba bayan da FDA ta buƙaci "wani bayani" a wannan fanni. ANDA ba ta yi shiru kan wannan batu ba. Hukumar Kula da Yankin Tarayya ta gano cewa kotun gundumar tana da isassun shaidu don tabbatar da cewa sanarwar Hospira ta cika ƙa'idar.
A ƙarshe, game da halayen da ke tasiri ga pH na citric acid da abubuwan da ke riƙe da shi, Hukumar Kula da Da'ira ta Tarayya bisa ga iƙirarin Hospira kuma ba ta da haƙƙin yin iƙirari kan wannan batu. Bugu da ƙari, Hukumar Kula da Da'ira ta Tarayya ta gano cewa kwamitin ya yanke hukuncin cewa (irin wannan) ƙayyadaddun bayanai na haƙƙin mallaka na '876 da '657 "aƙalla suna nuna akasin haka." Tunda Kotun Tarayya ba ta ƙalubalanci wannan (ko wani wuri ba), Kotun Tarayya ta yanke hukuncin cewa Kotun Gundumar ba ta cimma wani ƙarshe a fili ba cewa tsarin Hospira ya karya da'awar da aka bayyana (daga cikin wasu abubuwa, wannan) Ya dogara da abubuwan da kotun ke ƙunsa). Bayani dalla-dalla) kuma a tabbatar da su.
Par Pharmaceutical, Inc. da Hospira, Inc. (Kotun Da'ira ta Tarayya 2020) Kwamitin: Ra'ayoyin Alkalin Da'ira Dyk, Taranto da Stoll, Alkalin Da'ira Taranto
Bayanin Gargaɗi: Saboda yanayin wannan sabuntawa gabaɗaya, bayanin da aka bayar a nan bazai dace da dukkan yanayi ba, kuma bai kamata a ɗauki wani mataki akan wannan bayanin ba tare da takamaiman shawarar shari'a bisa ga takamaiman yanayi ba.
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