Muddo dheer, dadku waxay aaminsanaayeen in qaab-dhismeedka sheegashooyinka uu door muhiim ah ka ciyaari karo dacwadaha shatiga. Daacadnimadani waa aasaaska Wareegga Federaalka si uu u xaqiijiyo go'aanka maxkamadda degmada ee ka dhanka ah soo saaraha daawada guud ee xukunka ugu dambeeyay ee Degmada Pharmacopoeia ee kiiska Par Pharmaceutical, Inc. v. Hospira, Inc.. Ku xadgudubka qaacidada shatiga leh ee Par, heerarka khaladaadka cad ayaa sidoo kale saameyn ku yeeshay natiijooyinka.
Dhibaatooyinkan waxaa sababay dacwadda ANDA, taas oo dacwooduhu uu ku andacoonayo in Hospira's US Patent Nos. 9,119,876 iyo 9,925,657 ay ku saabsan tahay Par's Adrenalin® (adrenaline) iyo habka maamulka (duritaanka). Hospira waxay ku doodaysay in aan la jebin iyo in aan waxba laga beddelin sidii difaac (maxkamadda degmadu waxay dacwad ka gudbisay Hospira sidaas darteedna ma aysan racfaan qaadan). Patent-ka Par waxaa loogu talagalay qaab-dhismeed ka gudbaya cilladaha qaacidooyinka adrenaline ee hore. Sababtoo ah saddex waddo oo kala duwan oo burbur ah (oksaydhaynta, racemization iyo sulfonation), cimrigiisa kaydka badanaa waa gaaban yahay. Sheegashada 1aad ee patent-ka '876 waa mid matalaad ah:
Halabuurka oo ka kooban: qiyaastii 0.5 ilaa 1.5 mg/mL oo epinephrine ah iyo/ama milixdiisa, qiyaastii 6 ilaa 8 mg/mL oo ah nidaamiyaha tonicity-ga, qiyaastii 2.8 ilaa 3.8 mg/mL oo ah wakiilka kor u qaada pH-ka, iyo antioxidant qiyaastii 0.1 ilaa 1.1 mg/mL, wakiilka hoos u dhigaya pH 0.001 ilaa 0.010 mL/mL iyo qiyaastii 0.01 ilaa 0.4 mg/mL oo ah wakiilka isku-dhafka birta ee kala-guurka, halkaas oo antioxidant-ku uu ku jiro sodium bisulfite iyo/ama sodium metabisulfite.
(Isticmaal farta geesinimada leh ra'yiga si aad u muujiso xayiraadaha la xiriira racfaanka Hospira). Ka dib markii la qeexay xayiraadahaan, ra'yigu wuxuu soo jeediyay fasiraad ku saabsan ereyga "axdiga" ee ay maxkamadda degmadu u isticmaasho xayiraad kasta. Dhinacyadu waxay si cad u ogolaadeen in ereygu uu lahaado macnihiisa caadiga ah, kaas oo ah "ku saabsan"; Maxkamadda Rafcaanka ee Federaalka, Hospira ma bixin sharraxaad ka soo horjeeda.
Labada dhinacba waxay bixiyeen marag-fur khabiir ah oo ku saabsan saddexda xayiraad ee kor ku xusan. Khubarada Parr waxay markhaati-fureen in maxkamaddu ay isticmaashay 9 mg/mL sodium chloride si loo go'aamiyo jebinta xadka 6-8 mg/mL (Fiirsashada Hospira, inkastoo heerarka hooseeya sida 8.55 mg/mL sidoo kale la isticmaalo) sababtoo ah waa ku filan tahay in la gaaro ujeeddada loogu talagalay, taas oo ah "ilaalinta sharafta unugyada nool ka dib marka lagu duro adrenaline dhiigga." Khubarada Hospira waxay kaliya ka soo horjeesteen asxaabtiisa in farsamoyaqaannadiisa xirfadlayaasha ah ay aaminsan yihiin in 9 mg/mL uu ku dhacay heerka "qiyaastii" 6-8 mg/mL.
Marka laga hadlayo xaddidaadaha isku-dhafka birta kala-guurka ah, maxkamadda degmadu waxay caddeysay in asiidhka citric uu yahay wakiil chelating ah oo la yaqaan iyadoo lagu saleynayo caddayn. Hospira waxay ku sheegtay ANDA-deeda in waxa ku jira wasakhda asaasiga ah (biraha) ay ku jiraan heerarka caalamiga ah (gaar ahaan Tilmaamaha ICH Q3D). Khubarada Par waxay caddeeyeen in xiriirka u dhigma ee u dhexeeya badeecada caadiga ah iyo fiirsashada wakiilka chelating-ka ee lagu sheegay sheegashooyinka uu ku jiro xadka loo baahan yahay. Khubarada Hospira mar kale ma aysan la tartamin khubarada Par guud ahaan, laakiin waxay caddeysay in xadka sare ee heerka ICH Q3D uu ahaa heer aan ku habboonayn maxkamadda degmada. Taa beddelkeeda, wuxuu aaminsan yahay in qaddarka ku habboon laga soo saaro dufcadda tijaabada Hospira, kaas oo uu aaminsan yahay inuu u baahan doono heerar aad u hooseeya oo ah asiidhka citric ah oo ah wakiilka chelating.
Labada dhinac waxay ku tartamayaan inay isticmaalaan wakiilka hoos u dhiga pH-ga ee Hospira's ANDA si loo qeexo isku-darka acid-ka citric sida kaydka (iyo sodium citrate-kiisa). Goobta, acid-ka citric-ga laftiisa waxaa loo arkaa inuu kordhiyo pH-ga (shaki kuma jiro in acid-ka citric-ga laftiisa uu yahay wakiilka hoos u dhiga pH-ga A). Sida laga soo xigtay khubarada Par, ka jarista qadarka acid-ka citric ee qaacidada Hospira waxay ku filan tahay in acid-ka citric-ga uu ku dhaco heerka wakiilka hoos u dhiga pH-ga ee uu sheegay Par. "Xitaa isla molikuyuulladaas citric acid waxay noqon doonaan qayb ka mid ah nidaamka kaydka (Citric acid iyo sodium citrate ee isku dhafan ayaa loo isticmaalaa sidii wakiil kor u qaada pH." (In kasta oo ay jiraan iska hor imaadyo muuqda, xusuusnow in jebinta ay tahay arrin xaqiiqo ah. Wareegga Federaalka ayaa dib u eegi doona go'aanka dhabta ah ee maxkamadda degmada maxkamad. Si loo gaaro qalad cad.) Khubarada Hospira way ka soo horjeedaan khubarada Par waxayna caddeeyeen (si macquul ah) in molikuyuullada citric acid ee ku jira qaacidada aan loo arkin inay yihiin hoos u dhigista pH iyo kordhinta pH. Si kastaba ha ahaatee, maxkamadda degmadu waxay xukuntay in Par ay ku guuleysatay kiiska soo jeedinta Hospira-na ay jebin doonto xuquuqda patent-ka ee Par. Racfaankan ayaa ku xigay.
Garsoore Taranto wuxuu aaminsanaa in Wareegga Federaalka uu xaqiijiyay in Garsoore Dyke iyo Garsoore Stoll ay sidoo kale ka soo qeybgaleen kulanka. Racfaanka Hospira wuxuu ku lug lahaa go'aanka maxkamadda degmada ee mid kasta oo ka mid ah saddexda xayiraadood. Wareegga Federaalka ayaa markii ugu horreysay xaqiijiyay natiijooyinka Maxkamadda Degmada iyadoo ra'yigeeda ku saleyneysa in fiirsashada 9 mg/mL sodium chloride ee qaacidada Hospira ay dhab ahaantii ku dhacday xadka "qiyaastii" 6-8 mg/mL ee ay sheegtay Par. Kooxda khubarada ayaa tilmaamtay marka la isticmaalayo ereyga "qiyaastii", "iska ilaali inaad isticmaasho xuduudo tirooyin oo adag oo loogu talagalay xuduudaha la cayimay," Cohesive Techs ayaa soo xigtay. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), oo ku salaysan Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Marka la soo xiganayo hadalka Monsanto Tech, marka "ku saabsan" wax laga beddelo sheegashooyinka, tirada la sheegay waxaa laga dheereyn karaa xadka ilaa heerka qofka xirfadda leh uu "si macquul ah u tixgelin doono" baaxadda ay daboolayso sheegashooyinka. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Maxkamadda Federaalka 2018). Xaaladaha noocaas ah, haddii labada dhinac midkoodna uusan u doodin yareynta baaxadda sheegashada, go'aanku wuxuu ku salaysan yahay heerka isku-xidhka. Qaybaha heerkan waxaa ka mid ah in qaacidada la sheegay inay xadgudub tahay ay "dhexdhexaad tahay" marka loo eego baaxadda ilaalinta (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Maxkamadda Federaalka, 1994). )), Iyo sida ay muhiim u tahay baaxadda ilaalinta ujeeddada xaddidaadda (ma aha ikhtiraaca hadda jira) lafteeda. Inkasta oo ay qiratay in sheegashadu ay ka dhigan tahay qayb ka mid ah go'aanka maxkamadda ee arrintan, Wareegga Federaalka ayaa tilmaamay: "Haddii qalabka eedaysanuhu uu buuxiyo macnaha "axdiga" macquulka ah xaalado gaar ah waa arrin xaqiiqooyin farsamo," v. US International Trade Comm', 75 F.3d 1545, 1554 (Maxkamadda Federaalka, 1996). Halkan, guddigu wuxuu aaminsan yahay in maxkamadda degmadu ay si habboon u qaadatay tusaalaha halkan lagu sharraxay, go'aankeeduna wuxuu ku salaysan yahay markhaatiyaal khabiir ah. Maxkamadda Degmadu waxay xukuntay in khubarada Par ay ka qanciyeen khubarada Hospira, gaar ahaan ilaa heerka ay ku tiirsanayd "xaqiiqooyinka farsamada, muhiimadda ujeeddada xaddidaadda, iyo dhaleecaynta xaddidaadda." Taas bedelkeeda, maxkamadda degmadu waxay xukuntay in khubarada Hospira "aysan samayn falanqayn macno leh oo ku saabsan asalka farsamo ama shaqada wax ka beddelka tonicity-ga ee la sheegay." Iyada oo lagu salaynayo xaqiiqooyinkan, guddiga khubarada ma helin wax khaladaad ah oo muuqda.
Marka laga hadlayo xaddidaadaha wakiilada isku-dhafka biraha ee kala-guurka, Wareegga Federaalka ayaa diiday doodda Hospira ee ah in maxkamadda degmadu ay ahayd inay diiradda saarto qaacidada guud ee la soo jeediyay halkii ay ka ahaan lahayd qodobbada ku jira ANDA. Guddigu wuxuu ogaaday in Maxkamadda Degmadu si sax ah u tixgelisay citric acid inay tahay wakiilka isku-dhafka biraha ee kala-guurka ee lagu sharraxay sheegashooyinka, taas oo la jaanqaadaysa markhaatiga khabiirka ah ee labada dhinac. Iyada oo lagu salaynayo markhaatiga ah in citric acid dhab ahaantii u dhaqmo sidii wakiil chelating ah, aragtidan waxay diidaysaa doodda Hospira ee ah in citric acid aan loogu talagelin in loo isticmaalo wakiil chelating ah. Sida ku xusan 35 USC§271(e)(2), heerka xukunka jebinta dacwadda ANDA waa nuxurka lagu sharraxay ANDA (sida maxkamaddu tilmaantay, waa xadgudub wax dhisaya), iyadoo soo xiganaysa Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Maxkamadda Federaalka, 2013). Ku tiirsanaanta Hospira ee ANDA waa heerka ICH Q3D, kaas oo taageeraya xukunka maxkamadda degmada, ugu yaraan ma aha sababtoo ah xigashadan waxaa lagu daray ANDA ka dib markii FDA ay u baahnayd "macluumaad kale" oo ku saabsan aaggan. ANDA kama aamusin arrintan. Wareegga Federaalka ayaa ogaaday in maxkamadda degmadu ay haysato caddayn ku filan oo caddaynaysa in hadalka Hospira uu si buuxda u waafaqsan yahay xayiraadda.
Ugu dambeyntii, marka laga hadlayo sifooyinka saameeya pH-ka ee citric acid iyo kaydkeeda, Wareegga Federaalka oo ku salaysan sheegashada Hospira mana uusan haysan xuquuqda uu ku sheeganayo arrintan. Intaa waxaa dheer, Wareegga Federaalka wuxuu ogaaday in guddigu uu sheegay in (isla) qeexitaannada shatiyada '876 iyo '657 "ugu yaraan si xooggan u tilmaamayaan liddi ku ah." Maadaama Maxkamadda Federaalka aysan ka hor imaan sheegashadan (ama meel kale), Maxkamadda Federaalka waxay xukuntay in Maxkamadda Degmadu aysan gaarin go'aan cad oo ah in qaacidada Hospira ay jebisay sheegashada la sharraxay (iyo waxyaabo kale, tan) Waxay ku xiran tahay nuxurka dadweynaha ee maxkamadda). Tilmaamaha) iyo in la xaqiijiyo.
Guddiga Par Pharmaceutical, Inc. v. Hospira, Inc. (Maxkamadda Wareegga Federaalka 2020): Ra'yiga Garsooraha Wareegga Dyk, Taranto iyo Stoll, Garsooraha Wareegga Taranto
Afeef: Sababtoo ah dabeecadda guud ee cusbooneysiintan, macluumaadka halkan lagu bixiyay waxaa laga yaabaa inaanu khuseyn dhammaan xaaladaha, mana jirto wax tallaabo ah oo laga qaadayo macluumaadkan iyada oo aan la helin talo sharci oo gaar ah oo ku salaysan xaalado gaar ah.
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