Diad andukey a panaon, manisia iray totoo ya say istruktura na saray reklamo et nayarin tan mabetbet ya walay desididon betang to ed litigasyon na patent. Sayan inkaprangka so basiyan na Federal Circuit pian nakumpirma so desisyon na korte na distrito sumpad managgaway generic ya tambal diad sankabaloan ya desisyon na District Pharmacopoeia ed kaso na Par Pharmaceutical, Inc. v. Hospira, Inc. Say impakasumlang ed patented formula nen Par, saray malinew ya estandarte na lingo et walaan met na epekto ed saray resulta.
Sarayan problema et nanlapud ANDA litigation, ya ditan et inala na nanreklamo so Hospira's US Patent Nos. 9,119,876 tan 9,925,657 nipaakar ed Par's Adrenalin® (adrenaline) tan say paraan na pangiter to (injection). In-adbokasiya na Hospira so ag-inkasumlang tan ag-inkayadyari bilang depensa (say korte na distrito so angisegep na depensa sumpad Hospira kanian ag-inmapela). Say Par patent et parad sakey a pormulasyon ya makatalona ed saray kakulangan na saray akaunan pormulasyon na adrenaline. Lapud taloran nanduruman dalan na inkabulok (oxidation, racemization tan sulfonation), say shelf life to et antikey labat. Say Claim 1 na '876 patent et mangirerepresenta:
Sakey a komposisyon ya tugyopen na: manga 0.5 anggad 1.5 mg/mL na epinephrine tan/odino asin to, manga 6 anggad 8 mg/mL na tonicity regulator, manga 2.8 anggad 3.8 mg/mL na pH raising agent, tan sakey ya antioxidant ya manga 0.1 anggad 1.1 mg/mL, pH ya abeba anggad 1.00.00. mL/mL tan manga 0.01 anggad 0.4 mg/mL mL na transition metal complexing agent, ya say antioxidant et kaiba so sodium bisulfite tan/odino sodium metabisulfite.
(Mangigana na boldface ed opinyon pian nipanengneng iray panameget ya misiglaotan ed apela nen Hospira). Kayari na impangiter na kabaliksan ed sarayan panameget, say opinyon so angiproponi na kabaliksan na terminon “sipanan” ya inusar na korte na distrito parad kada panameget. Malinew ya inmabobon iray partido ya say termino et nepeg ya walaan na ordinaryon kabaliksan, salanti, “nipaakar ed”; parad Federal Circuit Court of Appeals, ag-angiter na eksplinasyon si Hospira ed kasunian to.
Parehon angiter na eksperton testimonya so duaran partido ed sarayan taloran panameget ed tagey. Intestigo na saray eksperto nen Parr ya say korte et angusar na 9 mg/mL sodium chloride pian naamtaan so infringement ed 6-8 mg/mL (hospira concentration, anggaman 8.55 mg/mL met so konsentrasyon ya inusar) lapud saya et magenap pian nasumpal so gagala, salanti, “mantinien so integridad na saray selula ed bilay kayari na pangi-inject ed sakey a linya dala." Saray eksperto nen Hospira et angitarya labat na saray kontra ed saray katrabaho to no kasin manisia iray marunong a teknisyan to ya say 9 mg/mL et walad loob na “ngalngalin” 6-8 mg/mL.
Nipaakar ed saray limitasyon na transition metal complexes, pinaneknekan na distriton korte ya say citric acid et kabkabat ya chelating agent base ed ebidensya. Inkuan na Hospira ed ANDA to ya say karga na saray elemental impurities (metal) et walad loob na saray internasyonal ya estandarte (lalo la ed ICH Q3D) Guidelines). Pinaneknekan na saray eksperto nen Par ya say mipetekan a siglaotan na estandarten produkto tan say konsentrasyon na metal chelating agent ya abitla ed saray claims et walad loob na nakaukolan a range. Saray eksperto na Hospira et ag lamet akikompetensia ed saray eksperto nen Par ed inkalapagan, balet ta apaneknekan ya say sankatageyan a limitasyon na ICH Q3D ya estandarte et agmanepeg ya estandarte parad korte na distrito. Imbes, manisia ya say manepeg ya karakel so nepeg ya alaen ed test batch nen Hospira, ya manisia ya mankaukolan na mas abeban lebel na citric acid bilang chelating agent.
Mankokompetensya so duaran partido ya usaren so pH lowering agent ya Hospira's ANDA pian nadetermina so konsentrasyon na citric acid bilang buffer (tan say sodium citrate to). Diad lawak, say citric acid a mismo so ipapasen ya mamaatagey ed pH (tan anggapoy panduaruwa ya say citric acid a mismo et sakey a pH lowering agent). Unong ed saray eksperto nen Par, say pangibawas ed karakel na citric acid ed pormula na Hospira et magenap la pian say citric acid et onloob ed pH lowering agent ya ibabaga nen Par. "Anggan saratan a parehon molekula na citric acid et magmaliw a kabiangan na buffer system (say nankakasakey a Citric acid tan sodium citrate et uusaren a saniiba bilang pH raising agent." (Anggaman walaray mapatnag a kontradiksyon, tandaan ya say panagsumlang et sakey a katuaan. Repasoen na Federal Circuit so katuaan a desisyon na district court diad sakey a bista Pian nasabi so mapatnag iran lingo nen Hospira.) saray eksperto et ag-onabobon ed saray eksperto nen Par tan apaneknekan (makatunongan) ya saray molekula na citric acid ed pormulasyon et ag nepeg ya ipasen ya parehon mamapaabeba tan mamapaatagey na pH Balet, indesisyonan na distriton korte ya analo si Par ed kaso tan say proposal nen Hospira et onsumlang ed saray kanepegan nen Par ed patent. Sayan apela so tinmumbok.
Manisia si Judge Taranto ya pinekderan na Federal Circuit ya inmatendi met ed miting si Judge Dyke tan Judge Stoll. Say apela nen Hospira et nipaakar ed desisyon na korte na distrito ed kada sakey ed taloran panameget. Inmunan kinompirma na Federal Circuit so adiskobre na District Court diad opinyon to ya say konsentrasyon na 9 mg/mL sodium chloride ed pormulasyon na Hospira et talagan onloob ed loob na “ngalngalin” 6-8 mg/mL ya limitasyon ya inkuan nen Par. Imbaga na grupo na eksperto ya no usaren so terminon “approximately”, “paliisan so pangusar na istrikton numerical boundaries parad saray espisipikon parametro,” so inkuan na Cohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), base ed Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Diad pangibalikas ed imbaga na Monsanto Tech, no say “about” et nauman ed saray claims, say ibabaga ran numerical range et nayarin napalaknab ed labas na range anggad laknab ya say marunong a too et “makatunongan ya ikonsidera” so sakop ya sakop na claims. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Diad ontan iran kaso, no anggapo ed saray partido so mangisusulong na pambawas ed sakop na reklamo, say determinasyon et nibase ed estandarte na pankakasakey. Kaiba ed saray elemento na sayan estandarte no kasin say ibabagan mansusumlang a pormula et “moderate” manlapud sakop na proteksion (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Tan no panon kaimportante so sakop na proteksion parad gagala na pangipresenta ed inkasikato () . Anggaman inaksobi ton say kerew et makatulong ed desisyon na korte ed sayan isyu, inkuan na Federal Circuit: “No kasin say kagawaan na akusado et makatunongan ed makatunongan a kabaliksan na “sipanan” diad silong na pigaran sirkumstansya et sakey a pamaakaran na teknikal iran katuaan,” v. US Int’l Trade Comm’, 75 Federal 33, 1455, 1455 (Federal Court. 1996). Dia, manisia so panel ya say district court et duga so inadapta to ed precedent ya adeskribe dia, tan say desisyon to et nibase ed testimonya na eksperto. Inkuan na District Court ya mas makapakombinse iray eksperto nen Par nen saray eksperto nen Hospira, lalo la ta nanmatalek itan ed “teknikal iran katuaan, say kaimportantian na gagala na panameget, tan say ag-inkakritiko na panameget.” Diad pidumaan, inkuan na district court ya saray eksperto nen Hospira et “ag-akagawa na makabaliksan ya analysis ed teknikal ya background odino function na ibabaga ran tonicity modifier.” Base ed sarayan katuaan, anggapoy aromog na saray eksperton grupo na mapatnag iran lingo.
Nipaakar ed saray limitasyon na transition metal complexing agents, impulisay na Federal Circuit so argumento nen Hospira ya say district court et nepeg komon ya manpokus ed iproproponin general formula to imbes ya saray probisyon ed ANDA to. Nalmoan na Panel ya duga so impangipasen na District Court ed citric acid bilang say transition metal complexing agent ya adeskribe ed saray claims, ya mitunosan ed eksperton testimonya na duaran partido. Base ed testimonya ya say citric acid et talagan onkikiwas bilang chelating agent, sayan panmoria et ag to labay so argumento nen Hospira ya say citric acid et ag-inisip ya usaren bilang chelating agent. Unong ed 35 USC§271(e)(2), say estandarte parad panagdesisyon na panagsumlang ed ANDA litigasyon et say karga na ANDA (unong ya impabitar na korte, sakey itan a makagunggunan panagsumlang), ya inaon toy Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Say panagmatalek na Hospira ed ANDA to et say ICH Q3D standard, ya onsusuporta ed desisyon na district court, anggan panon et aliwan lapud sayan citation et inyarum ed ANDA kayari na kinaukolan na FDA so “alternatibon impormasyon” ed sayan lawak. Ag-inmesel so ANDA ed sayan isyu. Nalmoan na Federal Circuit ya say korte na distrito et walaan na magenap ya ebidensya pian napaneknekan ya say balikas nen Hospira et sigpot ya ontutumbok ed panameget.
Kaunoran, nipaakar ed pH-influencing properties na citric acid tan saray buffer to, say Federal Circuit so angibase ed ibabaga nen Hospira tan agto inreserba so kanepegan ya mangibaga ed sayan isyu. Niarum ni, naamtaan na Federal Circuit ya inkuan na panel ya say (parehon) detalye na '876 tan '657 ya patente et "manpapanengneng na kabaliktaran." Lapud ag-inkontra na Federal Court iyan (odino antokaman nin pasen) ya reklamo, inkuan na Federal Court ya say District Court et ag-akasabi ed malinew ya konklusyon ya say pormulasyon nen Hospira et sumlang ed impaliwawa ya reklamo (kaiba ed arum niran bengatla, saya) Mandedepende itan ed publikon karga na korte). Saray detalye) tan nakumpirmaan.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Opinyon nen Circuit Judge Dyk, Taranto tan Stoll, Circuit Judge Taranto
Disclaimer: Lapud inkalapagan ya inkagawa na sayan update, say impormasyon ya inter dia et nayarin ag-onaplika ed amin a situasyon, tan anggapoy nepeg ya gawaen ed sayan impormasyon no anggapoy espisipikon legal ya simbawa base ed espisipikon sirkumstansya.
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