Caan saupi chung, mi nih halnak hna i an dirhmun nih patent kong ceihmainak ah biakhiahnak a tuah khawh i a caan ah biakhiahnak a tuah khawh tiah an zumh. Hi biatak tein chimnak hi Federal Circuit nih Par Pharmaceutical, Inc. v. Hospira, Inc. case ah District Pharmacopoeia biachahnak a donghnak bik ah generic sii sertu cungah peng biaceihnak zung nih biakhiahnak a tuahmi fehternak caah hrampi a si. Par's patented formula buarnak, palhnak a fiangmi phunglam zong nih a phichuak cungah hnahnawhnak a pek.
Hi buainak hna hi ANDA taza cuainak ah a chuakmi an si, cu ah cun tazacuaitu nih Hospira's US Patent No. 9,119,876 le 9,925,657 cu Par's Adrenalin® (adrenaline) le a pek ning (injection) he pehtlai in a hal. Hospira nih phungbuar lonak le hman khawh lonak kha i vennak ah a dirpi (ramkulh biaceihnak zung nih Hospira cungah i vennak a tuah i cucaah nawlnak a tuah lo). Par patent cu a hlan lio adrenaline sernak hna i an tlamtlinlonak a tei khomi sernak caah aa tinhmi a si. A rawkralnak lam phun thum (oxidation, racemization le sulfonation) ruangah, a chiah khawhnak caan cu a tawi deuh. '876 patent chung i Claim 1 cu aiawhtu a si:
A tthencheunak ah aa telmi: 0.5 in 1.5 mg/mL hrawng epinephrine le/asiloah a chiti, 6 in 8 mg/mL hrawng tonicity regulator, 2.8 in 3.8 mg/mL hrawng pH a kaitertu sii, le antioxidant 0.1 in 1.1 mg/mL hrawng, pH a niamtermi sii 0.10.000 tiang. mL/mL le 0.01 in 0.4 mg/mL mL hrawng thlennak thir aa cawhmi thilri, cu chungah cun antioxidant ah sodium bisulfite le/asiloah sodium metabisulfite aa tel.
(Hospira nawlnak he aa pehtlaimi khamnak pawl langhternak caah ruahnak ah cafang nganpi hmang). Hi khamnak hna fianter hnu ah, ruahnak nih khamnak pakhat cio caah peng biaceihnak zung nih a hmanmi “biakamnak” timi biafang fianternak a chuahpi. Party pawl nih fiang tein hnatlaknak an tuahmi cu biafang nih a tlangpi sullam a ngeih awk a si, cucu “kong” ti a si; Federal Circuit Biaceihnak Zung caah, Hospira nih a kalhmi fianternak a pek lo.
A cunglei khamnak pathum kongah party pahnih nih thiamsang tehte an khan. Parr thiamsang hna nih biaceihnak zung nih 9 mg/mL sodium chloride hmangin 6-8 mg/mL (Hospira tlawmtam, 8.55 mg/mL tluk tlawmmi zong hman a si ko nain) phungbuarnak hngalh khawhnak dingah a hman tiah tehte an khan, zeicahtiah a timhmi tinhmi tlinter awkah a za, cucu “a chung i a luhter hnu ah cells hna i an tthatnak kha kilven” kha a si thi." Hospira thiamsang hna nih a riantuan hawi hna sinah a thiammi thiamsang hna nih 9 mg/mL cu “a tlawmbik” 6-8 mg/mL karlak ah a tla tiah an zumh maw timi kongah dohnak an chuahpi.
Transition metal complexes hna i rikhiahnak kong he pehtlai in, peng biaceihnak zung nih tehte cung ah hram bunh in citric acid cu theihmi chelating agent a si ti kha a langhter. Hospira nih a ANDA ah a chimmi cu, thilri thurhnawmhnak (thir) chung i a ummi thilri hna cu vawleicung phunglam (a bik in ICH Q3D) Lamhruainak chung ah a um. Par thiamsang hna nih a tlarimi thilri le thir chelating agent tlawmtam karlak pehtlaihnak cu a herhmi chung ah a um ti kha an langhter. Hospira thiamsang hna nih a tlangpi in Par thiamsang hna he an i zuam ti lo, asinain ICH Q3D phunglam a cunglei ri cu peng biaceihnak zung caah aa tlak lomi phunglam a si ti kha a langhter. Cu nakin, Hospira hneksaknak phu chungin aa tlakmi zat chuah ding a si tiah a zumh, cu nih cun chelating agent caah citric acid tlawm deuh a herh lai tiah a zumh.
Party pahnih hna cu pH tlawmternak sii Hospira's ANDA hmangin citric acid kha buffer (le a sodium citrate) ah a tlawm le tam langhter awkah an i zuam. Riantuannak ah, citric acid hrimhrim nih pH a karhter tiah ruah a si (cun ​​citric acid hrimhrim cu pH a zortertu a si ti cu lunghrin awk a um lo). Par thiamsang hna nih an chim ning ahcun, Hospira formula chung i citric acid zat tlawmternak nih citric acid cu Par nih a chimmi pH tlawmternak sii chung ah a tlakter khawh. “Cu citric acid molecule hna hmanh kha buffer system ah aa tel ve lai (Citric acid le sodium citrate fonhmi cu pH a karhtertu thilri ah hman tti an si” (A fiangmi aa kalhmi a um ko nain, phungbuarnak cu a hmaanmi thil a si ti kha philh hlah. Federal Circuit nih biaceihnak ah pengtlang biaceihnak zung nih a hmaanmi biakhiahnak kha a zohfel lai i a fiangmi Hospira palhnak a chuah khawh nakhnga.) thiamsang hna nih Par thiamsang hna he an lung aa rual lo i (a ttha tein) sermi chung i citric acid molecule pawl cu pH-tlawmtertu le pH-karhtertu ah ruah awk a si lo ti kha an langhter. Sihmanhsehlaw, peng biaceihnak zung nih Par nih a tei i Hospira ruahnak cheuhnak nih Par patent covo a buar lai tiah bia a chah.
Biaceihtu Taranto nih Federal Circuit nih Biaceihtu Dyke le Biaceihtu Stoll zong tonnak ah an i tel ve tiah a fehter tiah a zumh. Hospira nih nawlnak a tuahmi ah hin khamnak pathum cio ah peng biaceihnak zung nih biachahnak a tuahmi aa tel. Federal Circuit nih District Biaceihnak Zung hmuhmi kha a ruahnak ah a fehter hmasa i Hospira sernak ah 9 mg/mL sodium chloride a tlawm le tam cu Par nih a chimmi “a tlawmbik” 6-8 mg/mL ri chung ah a tla taktak tiah a ti. Mithiam phu nih “a naih tein” timi biafang hman tikah, “a hleiin langhtermi parameters caah a fekmi nambar ri hman hrial,” tiah Cohesive Techs nih a langhter. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995) cung ah hram bunh in. Monsanto Tech chimmi bia lak in, “about” timi cu halnak ah remh a si tikah, halmi nambar tlukruannak cu thiamnak a ngeimi nih halnak nih a huapmi riantuannak kha “a ttha tein a ruah” khawh tiangin tlukruannak leng tiang sauh khawh a si. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Cu bantuk thil sining ah, party pakhat hmanh nih halnak a kauhnak tlawmter ding an dirpi lo ahcun, biakhiahnak cu lungrualnak phunglam cungah hram aa bunh. Hi phunglam chung i a ummi thil hna ah hin, a buar tiah ruahmi formula cu kilvennak chungin “a tlawm deuh” maw ti aa tel (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Cun amah le amah aa langhter lonak ding caah kilvennak hmunhma cu zeitluk in dah a biapit ti kha aa tel. Hi kong he pehtlai in biaceihnak zung biakhiahnak ah nawlnak nih bawmhnak a pek ti kha cohlan ko hmanh sehlaw, Federal Circuit nih hitin a langhter: “Sualphawtmi thilri nih thil sining cheukhat tangah aa tlakmi “biakamnak” sullam a tlinh le tlinh lo cu thiamnak lei thil sining kong a si,” v. US Int'l Trade Comm', 75 Federal Court 1555, 1445 (Federal Biaceihnak Zung. 1996). Hika ah, panel nih peng biaceihnak zung nih hika ah langhtermi phunglam kha aa tlak ning tein a cohlan tiah an zumh, cun a biakhiahnak cu thiamsang tehte khannak cungah hram aa bunh. Peng Biaceihnak Zung nih Par thiamsang hna cu Hospira thiamsang hna nakin zumh awk tlak deuh an si tiah a ti, a hleiin “thilri lei thil sining, khamnak a ruang a biapitnak le khamnak a biapit lonak” cungah aa hngatmi a si. Cu he aa dang in, peng biaceihnak zung nih Hospira thiamsang hna nih “an chimmi tonicity modifier thiamnak lei hnulei sining asiloah riantuannak kong ah sullam a ngeimi hlathlainak an tuah lo” tiah a ti. Hi thil sining hna cungah hram bunh in, thiamsang phu nih a fiangmi palhnak an hmu lo.
Transition metal complexing agents hna i rikhiahnak kong he pehtlai in, Federal Circuit nih Hospira chimmi cu peng biaceihnak zung nih a ANDA chung i a ummi phunglam nakin a chuahpimi a tlangpi phunglam kha a biapi deuh awk a si tiah a al. Panel nih cun District Biaceihnak Zung nih citric acid cu a dikthliar in a hmuh i, cu cu sualphawtnak ah a langhtermi thir thlennak thilri a si tiah a hmuh, cucu kaphnih lei thiamsang tehte khannak he aa tlak. Citric acid nih chelating agent rian a ttuan taktak timi tehte khannak cungah hram bunh in, hi hmuhning nih hin Hospira nih citric acid cu chelating agent ah hman ding in timhmi a si lo timi a alnak kha a al. USC§271(e)(2) ningin, ANDA taza cuainak ah phungbuarnak biakhiahnak caah phunglam cu ANDA ah langhtermi a si (biaceihnak zung nih a langhter bantukin, a ṭhami buarnak a si), Sunovion Pharm kha a langhter. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Hospira nih a ANDA aa bochannak cu ICH Q3D phunglam a si, cucu peng biaceihnak zung biachahnak kha a dirpi, a tlawmbik ah FDA nih hi hmun ah “a dang thawngpang” a herh hnu ah hi citation hi ANDA ah an chap caah a si lo. ANDA cu hi kongah dai tein a um lo. Federal Circuit nih peng biaceihnak zung nih Hospira chimmi nih khamnak he aa tlak dih ti langhternak caah tehte a za tawk a ngei tiah a hmuh.
A donghnak ah, citric acid le a buffer pawl i pH-thlen khawhnak kong he pehtlai in, Federal Circuit nih Hospira chimmi cungah hram bunh in hi kong he pehtlai in halnak nawl a ngei lo. Cun, Federal Circuit nih '876 le '657 patent hna i (aa khatmi) sining hna nih “a tlawmbik ah aa ralchanhmi kha fek tein a langhter” tiah panel nih a chimmi kha a hngalh. Federal Biaceihnak Zung nih hi (asiloah hmun dang) halnak hi a doh lo caah, Federal Biaceihnak Zung nih District Biaceihnak Zung nih Hospira sermi nih a fiantermi halnak (thil dangdang lakah, hi) a buar timi fiang tein biachahnak a tuah lo tiah a ti. Biaceihnak zung i mipi sinah a ummi cungah aa hngat). A sining) le fehter a si lai.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Circuit Biaceihtu Dyk, Taranto le Stoll, Circuit Biaceihtu Taranto ruahnak
Hngalhternak: Hi tharchuahnak a tlangpi a si caah, hika ah pekmi thawngpang cu thil sining vialte ah hman khawh a si lo, cun thil sining pakhatkhat cung ah hram bunh in upadi lei ruahnak cheuhnak tel loin hi thawngpang cungah zeihmanh tuah ding a si lo.
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