Hun rei tak chhung chu miten patent litigation-ah hian claims structure hian hmun pawimawh tak a chang thei a, a chang fo bawk tih an ring tawh a ni. He thu dik tak hi Federal Circuit-in Par Pharmaceutical, Inc. v. Hospira, Inc. case-a District Pharmacopoeia thutlukna hnuhnung berah chuan district court-in generic damdawi siamtu laka thutlukna a siam chu a nemnghet theihna chhan a ni. Par-a patented formula bawhchhiatna, clear error standard-te pawhin result-ah nghawng a nei a ni.
Heng harsatnate hi ANDA litigation-ah a awm a, chutah chuan plaintiff chuan Par-a Adrenalin® (adrenaline) leh a pek dan (injection) chungchangah Hospira-a US Patent No. 9,119,876 leh 9,925,657 a claim a ni. Hospira chuan non-infringement leh invalidity chu defense atan a rawt a (district court chuan Hospira lakah defense a file a, chuvang chuan a appeal lo). Par patent hian a hmaa adrenaline formulation-a a tlakchhamnate hneh thei tur formulation siam a tum a ni. Degradation pathway hrang hrang pathum (oxidation, racemization leh sulfonation) avang hian a shelf life hi a tawi ber a ni. '876 patent-a claim 1 chu a aiawhtu a ni:
Composition pakhatah hian: epinephrine leh/ emaw a chi 0.5 atanga 1.5 mg/mL vel, tonicity regulator 6 atanga 8 mg/mL vel, pH tisangtu agent 2.8 atanga 3.8 mg/mL vel, leh antioxidant 0.1 atanga 1.1 mg/mL vel, pH tihhniamtu agent 0.001 atanga 0.010 vel a awm mL/mL leh transition metal complexing agent 0.01 atanga 0.4 mg/mL mL vel, chutah chuan antioxidant-ah hian sodium bisulfite leh/ emaw sodium metabisulfite te a tel a ni.
(Hospira appeal nena inzawm khapna awmte tarlanna atan ngaihdanah hian boldface hmang rawh). Heng khapnate hi a sawifiah hnuah, ngaihdan chuan district court-in khapna tin atana a hman “thuthlung” tih thumal hrilhfiahna tur a rawt a ni. He thumal hian a awmzia pangngai, “about” tih hi a nei tur a ni tih hi party-te chuan chiang takin an inrem a; Federal Circuit Court of Appeals tan chuan Hospira chuan a kalh zawnga sawifiahna a pe lo.
A chunga khapna pathum chungchangah hian party pahnihte hian expert testimony an pe a ni. Parr-a mithiamte chuan court chuan 9 mg/mL sodium chloride hmangin dan bawhchhiatna chu 6-8 mg/mL inkar (Hospira concentration, 8.55 mg/mL aia hniam pawh hman ni mah se) a hmang tih an sawi a, a chhan chu it It is sufficient to meet the intended purpose, which is to meet “integrity of living cells after injecting adrenaline into the blood.”. Hospira-a mithiamte chuan a thawhpui te lakah dodalna an siam chauh a, a technician thiam tak takte chuan 9 mg/mL chu 6-8 mg/mL range “approximate”-ah a tla tih an ring em tih an sawi.
Transition metal complex-te tihkhawtlai chungchangah district court chuan citric acid hi chelating agent hriat lar tak a nih thu evidence aṭanga a finfiah a ni. Hospira chuan an ANDA-ah elemental impurities (metals) awm zat chu international standard (a bik takin ICH Q3D) Guidelines chhungah a awm tih a sawi. Par-a mithiamte chuan standard product leh claim-a tarlan metal chelating agent concentration inzawmna inmil chu a mamawh zat chhungah a awm tih an finfiah a ni. Hospira-a mithiamte hian vawi khat chu Par-a mithiamte a tlangpuiin an inel lo a, mahse ICH Q3D standard-a upper limit chu district court tan chuan standard dik lo a nih thu a tichiang leh ta a ni. Chu ai chuan Hospira test batch atang hian a zat tur dik tak lakchhuah a ngai niin a ngai a, hei hian chelating agent atan citric acid level hniam zawk a mamawh dawn niin a ngai.
Party pahnihte hian pH tihhniamtu agent Hospira’s ANDA hmangin citric acid concentration chu buffer atan (leh a sodium citrate) tarlan tumin an inel a ni. Field-ah chuan citric acid ngei pawh hi pH tisangtu anga ngaih a ni (chuan citric acid ngei pawh hi A pH tihhniamtu a ni tih pawh rinhlelh rual a ni lo). Par-a mithiamte sawi dan chuan Hospira formula-a citric acid awm zat chu paih chhuah chuan citric acid chu Par-in pH tihhniamna agent a sawi range chhungah a awm theih nan a tawk a ni. “Chutiang citric acid molecule vek pawh chu buffer system-ah a tel ve dawn a ni (Citric acid leh sodium citrate inzawmkhawm chu pH tisangtu atan hman dun a ni” (Inhnialna chiang tak awm mah se, dan bawhchhiatna hi thil dik tak a ni tih hre reng ang che. Federal Circuit chuan district court-in thutlukna dik tak a siam chu thubuai ngaihtuah hunah a enfiah leh ang. Thil dik lo chiang tak a thlen theih nan.) Hospira-a mithiamte chuan an pawm lo Par-a mithiamte chuan (a remchan dan angin) formulation-a citric acid molecule-te chu pH tihhniamtu leh pH tipungtu anga ngaih tur a ni lo tih an finfiah a, Mahse, district court chuan Par-a chuan he thubuai hi a hneh a, Hospira-a rawtna hian Par-a patent rights a bawhchhiat phah dawn niin a sawi.
Judge Taranto chuan Federal Circuit chuan Judge Dyke leh Judge Stoll te pawh meeting-ah hian an tel ve tih a nemnghet niin a ngai. Hospira-a appeal-ah hian district court-in khapna pathum zinga pakhat theuh chungchanga thutlukna a siam a ni. Federal Circuit chuan District Court-in Hospira formulation-a sodium chloride 9 mg/mL concentration chu Par. Expert group chuan “approximate” tih thumal hman hunah, “parameter tarlan tawhte tana numerical boundary khauh tak hman loh tur,” tiin Cohesive Techs chuan an tarlang. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), Pall Corp. leh Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995)-a innghat. Monsanto Tech thusawi tarlangin, claims-a “about” tihdanglam a nih chuan, claimed numerical range chu range aiin a tizau thei a, chu chu mi thiam chuan claim-in a huam chin chu “reasonably consider” theih a ni. LLC leh EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018)-ah thubuai siamsak a ni. Chutiang hunah chuan, party pahnih zingah chuan claim huam chin tihtlem an rawt loh chuan, thutlukna siam chu cohesion standard-ah a innghat a ni. He standard-a thil awmte chu, dan bawhchhia nia sawi formula chu humhalhna huam chhung a\angin “a tlem ber” em tih te (Conopco, Inc. v. May Dep’t Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Tin, amah ngei pawh tihtlem (tuna thil hmuhchhuah ni lo) tumna atana venhimna huam chin chu engtiang chiahin nge a pawimawh tih te a ni. Chu thubuai chu he thubuai chungchânga court thutlukna siamnaah hian thawhhlawk tak a ni tih pawm mah se, Federal Circuit chuan heti hian a târ lang a ni: “Thil engemaw takah chuan thubuai siamsaktu hmanrua chuan “thuthlung” awmzia dik tak a tlin leh tlin loh chu technical facts-a thil awm a ni,” v. US Int’l Trade Comm’, 75 F.3d 1545, 1554 (Federal Court, 1996 a ni). Hetah hian panel chuan hetia tarlan precedent hi district court chuan a remchan dan angin a pawm niin a ngai a, a thutlukna chu expert testimony atanga siam a ni. District Court chuan Par-a mithiamte chu Hospira-a mithiamte aiin an rintlak zawk niin a sawi a, a bik takin “technical facts, khapna siam chhan pawimawhna leh khapna hi sawiselna awm lo”-ah a innghat tlat a ni. Chumi nêna inkalh takin, district court chuan Hospira-a mithiamte chuan “a sawi chhuah tonicity modifier-a technical background emaw, a hnathawh dân emaw chu awmze nei takin an zirchiang lo,” tiin a sawi. Heng thilte a\ang hian expert panel chuan tihsual chiang tak an hmu lo.
Transition metal complexing agent-te tihkhawtlai chungchangah Federal Circuit chuan Hospira-in district court-in a ANDA-a thu awmte aiin a general formula ruahman chu a ngaihtuah zawk tur a ni, a ti chu a hnawl a ni. Panel chuan District Court chuan citric acid chu claims-a tarlan transition metal complexing agent angin dik takin a ngai tih a hmu a, hei hi party pahnih expert testimony nen a inmil hle. Citric acid hian chelating agent angin hna a thawk tak tak tih thusawi atanga chhut chuan, he ngaihdan hian Hospira-a’n citric acid hi chelating agent atana hman tum a ni lo tih a sawi chu a hnawl a ni. 35 USC§271(e)(2) ang chuan ANDA litigation-a infringement thutlukna siamna atana standard chu ANDA-a tarlan thupui (court-in a tarlan angin, constructive infringement a ni), Sunovion Pharm. , Inc. leh Teva Pharm te inkarah thubuai siamsak a ni. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013)-ah a tarlang bawk. Hospira-in a ANDA a rinchhanna hi ICH Q3D standard a ni a, hei hian district court thutlukna hi a thlawp a, a tlem berah chuan he citation hi FDA-in he lam hawia “alternative information” a mamawh hnua ANDA-a dah belh a nih vang a ni lo. Hemi chungchangah hian ANDA chu a ngawi reng lo. Federal Circuit chuan district court chuan Hospira thusawi hian khapna chu a zawm kim vek tih finfiahna tling tak a nei tih a hmuchhuak a ni.
A tawp berah chuan citric acid leh a buffer-te pH-influencing property chungchangah chuan Federal Circuit chuan Hospira-a thusawi chu a chhut a, he thubuai chungchangah hian claim theihna a nei lo. Chu bâkah, Federal Circuit chuan panel chuan ’876 leh ’657 patent-a (a inang) specification-te chuan “a tlem berah chuan a kalh zawngin a târ lang” tih a hre ta a ni. Federal Court chuan he (or hmun dangah pawh) claim hi a dodal loh avangin, Federal Court chuan District Court chuan Hospira-a formulation hian explained claim a bawhchhia tih thutlukna chiang tak a siam lo niin a sawi (thil dang dang zingah, hei hi) It depends on the public content of the court). Specifications) tih leh a dik tih finfiah a ni ang.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Circuit Judge Dyk, Taranto leh Stoll, Circuit Judge Taranto te ngaihdan
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