Be kakadaŋŋ nɛ ni mɛi heɔ amɛyeɔ akɛ bɔ ni atoɔ nibii ni abiɔ lɛ ahe gbɛjianɔ aha lɛ baanyɛ atsu gbɛfaŋnɔ ko ni he hiaa waa he nii yɛ hegbɛi ahe saji amli, ni bei pii lɛ, etsuɔ ​​he nii. Nɛkɛ anɔkwale nɛɛ ji nɔ ni Federal Kpokpaa lɛ damɔ nɔ ema kpokpaa nɔ kojomɔ he lɛ yiŋkpɛɛ ni ekɛteɔ shi ewoɔ tsofai ni akɛtsuɔ nii yɛ gbɛ ni ejaaa nɔ lɛ he lɛ nɔ mi yɛ kojomɔ hee ni Kpokpaa Tsofafeemɔ He lɛ kojo yɛ Par Pharmaceutical, Inc. kɛ Hospira, Inc. sane lɛ mli lɛ mli. Par mla ni yɔɔ hegbɛ lɛ mlikuu, tɔmɔi ni yɔɔ faŋŋ lɛ hu ná nɔ ni jɛ mli ba lɛ nɔ hewalɛ.
Naagbai nɛɛ ba yɛ ANDA saneyeli lɛ mli, ni mɔ ni kɛ sane lɛ ba lɛ bi Hospira U.S. Patent No. Hospira wo mla ni aku mli kɛ nɔ ni bɛ mli lɛ he hewalɛ akɛ nɔ ni akɛbuɔ mɔ he (kpokpaa nɔ kojomɔ he lɛ kɛ sane ko ni akɛbuɔ Hospira he lɛ tee kojomɔhe lɛ, no hewɔ lɛ ekɛ sane lɛ teeee kojomɔhe lɛ). Par patent lɛ yiŋtoo ji tsofa ko ni yeɔ tsutsu art adrenaline tsofai lɛ amli naagbai lɛ anɔ kunim. Yɛ gbɛi srɔtoi etɛ ni fiteɔ nii lɛ ahewɔ (oksidashin, racemization kɛ sulfonation) lɛ, eshihilɛ be lɛ faaa titri. Nɔ ni akɛɛ '876 hegbɛ lɛ ji najiaŋdamɔlɔ:
Nɔ ni yɔɔ mli ji: aaafee 0.5 kɛyashi 1.5 mg/mL ni ji epinephrine kɛ/loo eŋoo, aaafee 6 kɛyashi 8 mg/mL ni haa mɔ tsui nyɔɔ emli, aaafee 2.8 kɛyashi 3.8 mg/mL ni haa pH yaa hiɛ, kɛ nɔ ni haa mɔ he waaa aaafee 0.1 kɛyashi 1.1. mL/mL kɛ aaafee 0.01 kɛyashi 0.4 mg/mL mL ni ji tsakemɔ dade ni haa mɔ he feɔ shoo lɛ, ni nɔ ni fata he ji sodium bisulfite kɛ/loo sodium metabisulfite.
(Okɛ niŋmaa okadii ni yɔɔ ŋmɔlɔ atsu nii yɛ susumɔ lɛ mli ni okɛtsɔɔ naatsii ni kɔɔ Hospira shɛɛ sane lɛ he). Beni atsɔɔ naatsii nɛɛ amli sɛɛ lɛ, susumɔ lɛ wo wiemɔ ni ji “kpaŋmɔ” ni kpokpaa nɔ kojomɔhe lɛ kɛtsuɔ nii kɛhaa naatsii lɛ eko fɛɛ eko lɛ shishitsɔɔmɔ he ŋaa. Mɛi ni kɛ amɛhe woɔ mli lɛ kpɛlɛ nɔ yɛ faŋŋ mli akɛ esa akɛ wiemɔ lɛ aná eshishinumɔ ni ji “akɛ”; kɛha Federal Kpokpaa Nɔ Kojomɔ He ni Kwɛɔ Saji Anɔ lɛ, Hospira kɛ shishitsɔɔmɔ ni teɔ shi woɔ enɛ lɛ haaa.
Kuu enyɔ lɛ fɛɛ kɛ odaseyeli ni he esa ha yɛ naatsii etɛ ni awie he yɛ ŋwɛi nɛɛ he. Parr he nilelɔi lɛ ye odase akɛ kojomɔ he lɛ kɛ 9 mg/mL sodium chloride tsu nii ni ekɛtsɔɔ mla ni aku mli yɛ 6-8 mg/mL (Hospira mli nibii ni yɔɔ mli lɛ, eyɛ mli akɛ nibii ni yɔɔ mli lɛ amli nibii ni baa shi tamɔ 8.55 mg/mL lɛ hu ji nɔ ni akɛtsuɔ nii) ejaakɛ eshɛɔ he ni ekɛbaatsu nii koni ekɛ yiŋtoo ni ato he gbɛjianɔ lɛ atsu nii yɛ limainta in . adrenalin lɛ kɛboteɔ lá lɛ mli.” Hospira he nilelɔi lɛ teɔ shi amɛwoɔ enanemɛi nitsulɔi lɛ pɛ yɛ kɛji etsɔne he nilelɔi lɛ heɔ amɛyeɔ akɛ 9 mg/mL lɛ baagbee “aaafee” 6-8 mg/mL lɛ mli.
Yɛ nɔ ni kɔɔ husui ni yɔɔ dade ni akɛtsakeɔ nii lɛ ahe lɛ he lɛ, kpokpaa nɔ kojomɔ he lɛ ma nɔ mi akɛ citric acid ji nɔ ko ni ale akɛ ehaa dade ni haa mɔ he jɔ̃ɔ ehe lɛ damɔ odaseyeli nɔ. Hospira kɛɛ yɛ e-ANDA lɛ mli akɛ, nɔ ni yɔɔ shishijee muji (dade) mli lɛ yɛ majimaji ateŋ mlai (titri lɛ ICH Q3D) Gbɛtsɔɔmɔi lɛ amli. Par he nilelɔi lɛ ma nɔ mi akɛ wekukpaa ni kã nibii ni akɛtsuɔ nii lɛ kɛ dade ni haa mɔ he jɔɔ lɛ mli nibii ni awie he yɛ nɔ ni awieɔ lɛ mli lɛ teŋ lɛ yɛ nɔ ni ataoɔ lɛ mli. Hospira he nilelɔi lɛ kɛ Par he nilelɔi lɛ fɛɛ ebɔko akaŋ shikome ekoŋŋ, shi etsɔɔ akɛ ICH Q3D shishitoo mla lɛ ŋwɛi husu lɛ ji shishitoo mla ni esaaa kɛha kpokpaa nɔ kojomɔ he lɛ. Yɛ no najiaŋ lɛ, eheɔ eyeɔ akɛ esa akɛ ajie yibɔ ni sa lɛ kɛjɛ Hospira kaa lɛ mli, ni eheɔ eyeɔ akɛ ebaabi citric acid ni baa shi kwraa akɛ nɔ ni haa mɔ he jɔɔ lɛ.
Mɛi enyɔ lɛ miitswa amɛhe adafi koni amɛkɛ tsofa ni haa pH baa shi ni ji Hospira ANDA lɛ atsu nii ni amɛkɛtsɔɔ bɔ ni citric acid lɛ fa ha akɛ buffer (kɛ e-sodium citrate lɛ). Yɛ ŋmɔ mli lɛ, abuɔ citric acid diɛŋtsɛ akɛ ehaa pH yaa hiɛ (ni ŋwanejee ko bɛ he akɛ citric acid diɛŋtsɛ ji A pH shibaa nii). Taakɛ Par he nilelɔi lɛ tsɔɔ lɛ, kɛ́ ajie citric acid ni yɔɔ Hospira fɔmla lɛ mli lɛ, no fa bɔ ni sa ni baaha citric acid lɛ aba pH ni baa shi ni Par kɛɔ lɛ mli. “Nakai citric acid molecules lɛ nɔŋŋ po baafee buffer system lɛ fã (akɛ Citric acid kɛ sodium citrate ni akɛfee ekome lɛ tsuɔ nii akɛ nɔ ni haa pH lɛ yaa hiɛ.” Hospira he nilelɔi lɛ kɛ Par he nilelɔi lɛ kpãaa gbee ni amɛtsɔɔ (yɛ jwɛŋmɔ mli) akɛ esaaa akɛ abuɔ citric acid molecules ni yɔɔ tsofa lɛ mli lɛ akɛ nɔ ni haa pH baa shi kɛ nɔ ni haa pH yaa hiɛ lɛ fɛɛ Shi kɛlɛ, kpokpaa nɔ kojomɔhe lɛ kojo akɛ Par ye kunim yɛ sane lɛ mli ni Hospira susumɔ lɛ baaku Par hegbɛ ni akɛhaa lɛ mli.
Kojolɔ Taranto heɔ eyeɔ akɛ Federal Circuit lɛ ma nɔ mi akɛ Kojolɔ Dyke kɛ Kojolɔ Stoll hu tee kpee lɛ. Hospira sane ni ekɛtee lɛ kɔɔ kpokpaa nɔ kojomɔ he lɛ yiŋkpɛɛ yɛ naatsii etɛ lɛ eko fɛɛ eko he lɛ he. Federal Circuit lɛ ma nɔ ni Kpokpaa Nɔ Kojomɔ He lɛ na lɛ nɔ mi klɛŋklɛŋ yɛ esusumɔ mli akɛ, 9 mg/mL sodium chloride ni yɔɔ Hospira tsofa lɛ mli lɛ gbee shi diɛŋtsɛ yɛ “aaafee” 6-8 mg/mL husu ni Par kɛɔ lɛ mli. Kuu ni le nii jogbaŋŋ lɛ tsɔɔ mli akɛ, kɛ́ akɛ wiemɔ ni ji “aaafee” lɛ tsu nii lɛ, “tsi ohe kɛjɛ yibɔi ahe husui ni mli wa ni akɛtsuɔ nii kɛhaa nibii pɔtɛɛ komɛi ahe lɛ he,” Cohesive Techs lɛ tsɛ yisɛɛ. 1351 (Fed. Cir. 2008), ni damɔ Pall Corp kɛ Micron Separations, Inc., 66 F. Kɛ atsɛ Monsanto Tech wiemɔ lɛ sɛɛ lɛ, kɛ́ atsake “about” yɛ nɔ ni awieɔ lɛ mli lɛ, abaanyɛ atsake yibɔi ni awieɔ lɛ mli kɛyashɛ he ni mɔ ni he esa lɛ “baasusu” nɔ ni nɔ ni awieɔ lɛ kɔɔ he lɛ he yɛ gbɛ ni ja nɔ. 1336, 1342 (Maŋkwramɔŋ Kojomɔ He 2018). Yɛ shihilɛi ni tamɔ nɛkɛ mli lɛ, kɛji akɛ kui lɛ ateŋ mɔ ko mɔ ko fĩii sɛɛ akɛ abaatsi nɔ ni abiɔ lɛ nɔ lɛ, yiŋkpɛɛ lɛ damɔ ekomefeemɔ he mla lɛ nɔ. Nɔ ni fata nɛkɛ mla nɛɛ he ji kɛji akɛ nɔ ni akɛɛ eku mla mli lɛ ji “mlɛo” kɛjɛ hebuu lɛ mli (Conopco, Inc. v. May Dep’t Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , kɛ bɔ ni hebuu lɛ he husu ni yɔɔ ŋmɛnɛŋmɛnɛ beaŋ lɛ he hiaa ha . lɛ diɛŋtsɛ. Eyɛ mli akɛ Federal Circuit lɛ kpɛlɛ nɔ akɛ nɔ ni akɛɛ lɛ ji nɔ ko ni yeɔ ebuaa kojomɔ he lɛ yiŋkpɛɛ yɛ sane nɛɛ he moŋ, shi etsɔɔ mli akɛ: “Kɛ́ mɔ ni awieɔ ashiɔ lɛ lɛ tsɔne lɛ kɛ “kpaŋmɔ” shishinumɔ ni sa kpãa gbee yɛ shihilɛi komɛi amli lɛ, eji ŋaa gbɛ nɔ saji ahe sane,” v. US Int’l,53d F53 . 1554 (Maŋkwramɔŋ Kojomɔ He, 1996). Yɛ biɛ lɛ, kuu lɛ heɔ eyeɔ akɛ kpokpaa nɔ kojomɔ he lɛ ekpɛlɛ nɔkwɛmɔnɔ ni atsɔɔ mli yɛ biɛ lɛ nɔ yɛ gbɛ ni sa nɔ, ni eyiŋkpɛɛ lɛ damɔ ŋaalɔi odaseyeli nɔ. Kpokpaa nɔ Kojomɔ He lɛ wie akɛ Par ŋaalɔi lɛ haa mɔ naa nɔmimaa fe Hospira ŋaalɔi lɛ, titri lɛ kɛyashɛ he ni ekɛ ehe fɔ̃ɔ “tsɔne he saji, bɔ ni yiŋtoo ni yɔɔ naatsii lɛ he lɛ he hiaa ha, kɛ bɔ ni naatsii lɛ jeee nɔ ni awieɔ ashiɔ mɔ lɛ nɔ.” Nɔ ni tamɔɔɔ enɛ lɛ, kpokpaa nɔ kojomɔ he lɛ wie akɛ Hospira he nilelɔi lɛ “efeee tsɔne ni akɛɛ eji tonicity modifier lɛ he ŋaa gbɛ loo nitsumɔ lɛ mlipɛimɔ ni shishinumɔ yɔɔ he.” Kɛjɛ anɔkwalei nɛɛ anɔ lɛ, ŋaalɔi akuu lɛ enaaa tɔmɔ ko ni yɔɔ faŋŋ.
Yɛ nɔ ni kɔɔ husui ni yɔɔ dade ni akɛtsuɔ nii ni haa mɔ tsui nyɔɔ emli lɛ he lɛ, Federal Circuit lɛ kpoo Hospira wiemɔ ni ji akɛ kulɛ esa akɛ kpokpaa nɔ kojomɔhe lɛ kɛ ejwɛŋmɔ ama egbɛjianɔtoo ni ekɛha lɛ nɔ moŋ fe nibii ni yɔɔ e-ANDA lɛ mli lɛ. Kuu lɛ na akɛ Kpokpaa nɔ Kojomɔ He lɛ bu citric acid lɛ akɛ eji dade ni haa dade tsakeɔ ni atsɔɔ mli yɛ saji ni abiɔ lɛ amli lɛ jogbaŋŋ, ni enɛ kɛ odaseyeli ni he esa ni mɛi enyɔ lɛ fɛɛ ye lɛ kpãa gbee. Nɛkɛ susumɔ nɛɛ damɔ odaseyeli ni tsɔɔ akɛ citric acid tsuɔ nii diɛŋtsɛ akɛ nɔ ni haa mɔ he jɔɔ lɛ nɔ, ni ekpooɔ Hospira wiemɔ ni ji akɛ jeee akɛ akɛ citric acid tsuɔ nii akɛ nɔ ni haa mɔ he jɔɔ lɛ. Taakɛ 35 USC§271(e)(2) lɛ tsɔɔ lɛ, shishitoo mla ni akɛkojoɔ mlatɔmɔ yɛ ANDA saneyeli mli ji nɔ ni atsɔɔ mli yɛ ANDA lɛ mli (tamɔ bɔ ni kojomɔ he lɛ tsɔɔ mli lɛ, eji mlatɔmɔ ni tsɔɔ mɔ yiŋ), ni ekɛ Sunovion Pharm tsɛɔ. , Inc. kɛ Teva tsofafeemɔ he. , U.S.A., Inc., 731 F.3d 1271, 1279 (Maŋkwramɔŋ Kojomɔ He, 2013). Hospira he ni ekɛfɔ̃ɔ e-ANDA lɛ nɔ lɛ ji ICH Q3D mla lɛ, ni fiɔ kpokpaa nɔ kojomɔ he lɛ kojomɔ lɛ sɛɛ, kɛ hoo lɛ, jeee akɛni akɛ nɛkɛ citation nɛɛ fata ANDA lɛ he beni FDA lɛ bi “saji krokomɛi” yɛ nɛkɛ he nɛɛ sɛɛ. ANDA efeee dioo yɛ sane nɛɛ he. Federal Circuit lɛ na akɛ kpokpaa nɔ kojomɔ he lɛ yɛ odaseyeli ni fa bɔ ni sa ni baatsɔɔ akɛ Hospira wiemɔ lɛ kɛ naatsii lɛ kpãa gbee kwraa.
Yɛ naagbee lɛ, yɛ nɔ ni kɔɔ pH-hewalɛ ni yɔɔ citric acid kɛ e-buffers lɛ mli lɛ he lɛ, Federal Circuit lɛ damɔ Hospira nɔ ni ekɛɛ lɛ nɔ ni ekɛ hegbɛ ni ekɛbaatsu nii yɛ sane nɛɛ he lɛ haaa. Kɛfata he lɛ, Federal Circuit lɛ le akɛ kuu lɛ susu akɛ (nɔ kome too lɛ nɔŋŋ) ni kɔɔ ’876 kɛ ’657 hegbɛi lɛ ahe lɛ “kɛ hoo lɛ, etsɔɔ nɔ ni tamɔɔɔ nakai lɛ waa.” Akɛni Federal Kojomɔ He lɛ teee shi ewooo nɛkɛ (loo he kroko) sane nɛɛ hewɔ lɛ, Federal Kojomɔ He lɛ wie akɛ Kpokpaa nɔ Kojomɔ He lɛ eyashɛɛɛ mumɔŋ sane ko ni yɔɔ faŋŋ he akɛ Hospira wiemɔi lɛ teɔ shi ewoɔ sane ni atsɔɔ mli lɛ (kɛfata nibii krokomɛi ahe lɛ, enɛ) Edamɔ maŋ saji ni yɔɔ kojomɔhe lɛ mli lɛ anɔ). Nɔ ni kɔɔ he) ni ama nɔ mi.
Par Tsofafeemɔ, Inc. kɛ Hospira, Inc. (Maŋkwramɔŋ Kojomɔ He 2020) Kuu: Kpokpaa nɔ Kojolɔ Dyk, Taranto kɛ Stoll, Kpokpaa nɔ Kojolɔ Taranto susumɔi
Nɔ ni awieɔ: Akɛni saji ni akɛha yɛ biɛ lɛ kɔɔɔ shihilɛi fɛɛ ahe hewɔ lɛ, esaaa akɛ afeɔ nɔ ko yɛ saji nɛɛ ahe kɛji mla he ŋaawoo pɔtɛɛ ko ni damɔ shihilɛi pɔtɛɛ komɛi anɔ lɛ bɛ.
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