Kwenguva yakareba, vanhu vave vachitenda kuti chimiro chezvikumbiro chinogona uye chinowanzoita basa guru mumatare edzimhosva. Kutaura chokwadi uku ndiko kwakava hwaro hweFederal Circuit kusimbisa mutongo wedare redunhu uchipesana nemugadziri wemishonga inogadzirwa nemagetsi mumutongo wekupedzisira weDistrict Pharmacopoeia munyaya yePar Pharmaceutical, Inc. v. Hospira, Inc.. Kutyorwa kwemitemo yePar patented, mitemo yekukanganisa yakajeka kwakakanganisawo mhedzisiro.
Matambudziko aya akakonzerwa mumatare eANDA, umo mupomeri akati Hospira's US Patent Nos. 9,119,876 uye 9,925,657 maererano nePar's Adrenalin® (adrenaline) uye nzira yayo yekuisirwa (jekiseni). Hospira yaitsigira kusatyorwa kwemutemo uye kusashanda senzira yekudzivirira (dare redunhu rakaisa dziviriro kuna Hospira saka harina kukwidza nyaya yacho). Par patent yakanangana nefomula inokunda kusakwana kwemafomula ekare eadrenaline. Nekuda kwenzira nhatu dzakasiyana dzekuora (oxidation, racemization uye sulfonation), hupenyu hwayo hwesherufu hupfupi. Chirevo 1 chepatenti ya '876 chinomiririra:
Musanganiswa une: inenge 0.5 kusvika 1.5 mg/mL ye epinephrine uye/kana munyu wayo, inenge 6 kusvika 8 mg/mL ye tonicity regulator, inenge 2.8 kusvika 3.8 mg/mL ye pH raising agent, uye antioxidant inosvika 0.1 kusvika 1.1 mg/mL, pH reduction agent 0.001 kusvika 0.010 mL/mL uye inenge 0.01 kusvika 0.4 mg/mL mL ye transition metal complexing agent, apo antioxidant inosanganisira sodium bisulfite uye/kana sodium metabisulfite.
(Shandisa mavara matema mumaonero kuratidza zvirambidzo zvine chekuita nekukwidza nyaya kwaHospira). Mushure mekutsanangura zvirambidzo izvi, pfungwa yacho yakakurudzira kududzirwa kweshoko rekuti "sungano" rinoshandiswa nedare redunhu parambidzo yega yega. Mapato akabvumirana zvakajeka kuti izwi iri rinofanira kunge riine zvarinoreva, izvo zvinoreva "nezve"; kuDare Repamusoro reFederal Circuit, Hospira haana kupa tsananguro yezvakasiyana.
Mapato ese ari maviri akapa humbowo hwenyanzvi pamusoro pezvirambidzo zvitatu zviri pamusoro apa. Nyanzvi dzaParr dzakapupura kuti dare rakashandisa 9 mg/mL sodium chloride kuona kukanganiswa kuri pakati pe6-8 mg/mL (Hospira concentration, kunyange zvazvo concentrations dziri pasi pe8.55 mg/mL dzichishandiswawo) nekuti zvakakwana kuzadzisa chinangwa chaive chakanangana, icho chiri "kuchengetedza kusimba kwemasero mapenyu mushure mekupinza adrenaline muropa." Nyanzvi dzaHospira dzakangoramba vaaishanda navo pamusoro pekuti nyanzvi dzake dzaitenda here kuti 9 mg/mL yaiwira mukati me "inenge" 6-8 mg/mL.
Nezvemiganhu ye transition metal complexes, dare redunhu rakaratidza kuti citric acid inozivikanwa se chelating agent zvichibva pauchapupu. Hospira yakataura mu ANDA yayo kuti zviri mukati mezvinhu zvisina kuchena (simbi) zviri mukati memitemo yepasi rose (kunyanya ICH Q3D) Guidelines). Nyanzvi dzaPar dzakaratidza kuti hukama hwakaenzana pakati pechigadzirwa chakajairwa nehuwandu hwesimbi chelating agent hwakataurwa muzvikumbiro huri mukati mehuwandu hunodiwa. Nyanzvi dzaHospira hadzina kukwikwidzana zvakare nenyanzvi dzaPar, asi zvakaratidza kuti muganho wepamusoro we ICH Q3D standard waive mwero usina kukodzera kudare redunhu. Pane kudaro, anotenda kuti huwandu hwakakodzera hunofanira kubviswa kubva muHospira's test batch, iyo yaanotenda kuti inoda mazinga akaderera e citric acid se chelating agent.
Mapato maviri aya ari kukwikwidzana kushandisa mushonga unoderedza pH weHospira's ANDA kuti vatsanangure huwandu hwecitric acid sebuffer (uye sodium citrate yayo). Mumunda, citric acid pachayo inoonekwa seinowedzera pH (uye hapana mubvunzo kuti citric acid pachayo iA pH inoderedza agent). Sekureva kwenyanzvi dzePar, kubvisa huwandu hwecitric acid muHospira formula kwakakwana kuita kuti citric acid ive mukati mehuwandu hwemushonga unoderedza pH unotaurwa nePar. "Kunyangwe mamorekuru ecitric acid iwayo achava chikamu chebuffer system (Citric acid yakabatanidzwa nesodium citrate zvinoshandiswa pamwe chete semushonga wekuwedzera pH." (Kunyangwe paine kupokana kuri pachena, yeuka kuti kutyora mutemo inyaya yechokwadi. Federal Circuit ichaongorora sarudzo yechokwadi yedare redunhu mukutongwa. Kuti isvike pakukanganisa kuri pachena.) Nyanzvi dzeHospira hadzibvumirani nenyanzvi dzePar uye dzakaratidza (zvine musoro) kuti mamorekuru ecitric acid ari muchimiro haafanirwe kuonekwa seanodzikisa pH uye anokwidza pH. Zvisinei, dare redunhu rakatonga kuti Par akakunda nyaya yacho uye chikumbiro chaHospira chaizotyora kodzero dzePar dzepatent. Kukwidza nyaya uku kwakatevera.
Mutongi Taranto akatenda kuti Federal Circuit yakasimbisa kuti Mutongi Dyke naMutongi Stoll vakapindawo musangano. Kukwidza nyaya kwaHospira kwaisanganisira chisarudzo chedare redunhu pane chimwe nechimwe chezvirambidzo zvitatu. Federal Circuit yakatanga kusimbisa zvakawanikwa neDare reDunhu mumaonero ayo kuti huwandu hwe9 mg/mL sodium chloride muHospira formula hwakaderera mukati me "inenge" 6-8 mg/mL muganho wakataurwa nePar. Boka renyanzvi rakaratidza kuti pakushandisa izwi rekuti "inenge", "dzivisa kushandisa miganhu yenhamba yakasimba pamatanho akatarwa," akadaro Cohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), zvichibva paPall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Tichitora mashoko aMonsanto Tech, kana "pamwe chete" pakashandurwa muzvikumbiro, nhamba dzinotaurwa dzinogona kuwedzerwa kupfuura huwandu hwacho kusvika pakuti munhu ane hunyanzvi "achafunga zvine musoro" nezvepfungwa dzakafukidzwa nechikumbiro. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Muzviitiko zvakadaro, kana pasina bato rinotsigira kuderedza huwandu hwechikumbiro, chisarudzo chacho chakavakirwa pachiyero chekubatana. Zvinhu zviri muchiyero ichi zvinosanganisira kana fomura inopomerwa yekutyora mutemo iri "pakati nepakati" kubva pachiyero chekudzivirira (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Uye kukosha kwekudzivirira kwakakosha sei nechinangwa chekuganhurira (kwete chigadzirwa ichi) pachacho. Kunyangwe vachibvuma kuti chikumbiro ichi chine mupiro kumutongo wedare panyaya iyi, Federal Circuit yakati: “Kuti zano remupomerwi rinosangana nerevo ye“chibvumirano” ine musoro pasi pemamwe mamiriro ezvinhu inyaya yechokwadi chehunyanzvi,” v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Federal Court, 1996). Pano, dare rinotenda kuti dare redunhu rakagamuchira zvakakodzera muenzaniso watsanangurwa pano, uye chisarudzo charo chakavakirwa pauchapupu hwenyanzvi. Dare reDunhu rakati nyanzvi dzePar dzaive dzinogutsa kupfuura nyanzvi dzeHospira, kunyanya kusvika pakuti dzakavimba ne“chokwadi chehunyanzvi, kukosha kwechinangwa chekurambidzwa, uye kusatsoropodzwa kwekurambidzwa.” Kusiyana neizvi, dare redunhu rakati nyanzvi dzeHospira “hadzina kuita ongororo ine musoro yeruzivo rwehunyanzvi kana basa remugadziri wetonicity anonzi.” Zvichibva pachokwadi ichi, dare renyanzvi harina kuwana zvikanganiso zviri pachena.
Nezvemiganhu yezvinogadzirisa simbi zvinochinja, Federal Circuit yakaramba nharo yaHospira yekuti dare redunhu raifanira kunge rakatarisa pane fomura yaro yakarongeka pane zviri muANDA yaro. Panel inoona kuti Dare reDunhu rakaona nemazvo citric acid semushonga unogadzirisa simbi unotsanangurwa muzvikumbiro, izvo zvinoenderana neuchapupu hwenyanzvi hwemapato ese ari maviri. Zvichibva pauchapupu hwekuti citric acid inoshanda semushonga unochinja, maonero aya anoramba nharo yaHospira yekuti citric acid haina kuitirwa kushandiswa semushonga unochinja. Sekureva kwe35 USC§271(e)(2), mwero wekutonga kutyorwa kwemutemo mumatare eANDA ndezviri muANDA (sezvakataurwa nedare, kutyorwa kwemutemo kunovaka), tichitarisa Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Kuvimba kweHospira neANDA yayo ndiyo chiyero cheICH Q3D, chinotsigira mutongo wedare redunhu, kwete nekuti chirevo ichi chakawedzerwa kuANDA mushure mekunge FDA yada "rumwe ruzivo" panyaya iyi. ANDA haina kuramba yakanyarara panyaya iyi. Federal Circuit yakawana kuti dare redunhu raive nehumbowo hwakakwana hwekuratidza kuti zvakataurwa naHospira zvaienderana zvizere nemutemo uyu.
Pakupedzisira, maererano nehunhu hwecitric acid nezvinoumba pH zvinokanganisa pH, Federal Circuit yakavakirwa pane zvataurwa naHospira uye haina kuchengetedza kodzero yekutaura panyaya iyi. Pamusoro pezvo, Federal Circuit yakadzidza kuti dare rakati zvirevo (zvakafanana) zvemapatent a'876 na'657 "zvinoratidza zvakapesana." Sezvo Federal Court isina kupikisa chikumbiro ichi (kana chero imwe nzvimbo), Federal Court yakatonga kuti Dare reDunhu harina kusvika pamhedziso yakajeka yekuti chirevo chaHospira chakatyora chikumbiro chakatsanangurwa (pakati pezvimwe zvinhu, izvi) Zvinoenderana nezviri mudare reveruzhinji). Matsananguro) uye zvinosimbiswa.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Dare re ...
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