Kwa nthawi yayitali, anthu akhala akukhulupirira kuti kapangidwe ka zopempha kangakhale ndi gawo lofunika kwambiri pamilandu ya patent. Kulankhula zoona kumeneku ndiko maziko a Federal Circuit kutsimikizira chigamulo cha khothi lachigawo motsutsana ndi wopanga mankhwala opangidwa mwapadera pachigamulo chaposachedwa cha District Pharmacopoeia pa mlandu wa Par Pharmaceutical, Inc. v. Hospira, Inc.. Kuphwanya malamulo a Par patent, miyezo yomveka bwino ya zolakwika kunakhudzanso zotsatira zake.
Mavutowa adayambitsidwa mu mlandu wa ANDA, pomwe wodandaulayo adatenga Hospira's US Patent Nos. 9,119,876 ndi 9,925,657 yokhudza Par's Adrenalin® (adrenaline) ndi njira yake yoperekera mankhwala (jakisoni). Hospira idalimbikitsa kusaphwanya malamulo ndi kusavomerezeka ngati chitetezo (khothi lachigawo lidapereka chitetezo motsutsana ndi Hospira ndipo chifukwa chake silinachite apilo). Par patent ikufuna njira yomwe imathetsa zofooka za art adrenaline formulations zakale. Chifukwa cha njira zitatu zosiyana zowononga (oxidation, racemization ndi sulfonation), nthawi yake yosungira mankhwala ndi yochepa kwambiri. Chidziwitso 1 cha patent ya '876 ndi choyimira:
Kapangidwe kake kamakhala ndi: pafupifupi 0.5 mpaka 1.5 mg/mL ya epinephrine ndi/kapena mchere wake, pafupifupi 6 mpaka 8 mg/mL ya chowongolera mphamvu ya thupi, pafupifupi 2.8 mpaka 3.8 mg/mL ya chothandizira kukweza pH, ndi antioxidant ya pafupifupi 0.1 mpaka 1.1 mg/mL, chothandizira kutsitsa pH 0.001 mpaka 0.010 mL/mL ndi pafupifupi 0.01 mpaka 0.4 mg/mL mL ya chothandizira kusintha kwa zitsulo, pomwe antioxidant imaphatikizapo sodium bisulfite ndi/kapena sodium metabisulfite.
(Gwiritsani ntchito mawu okuluwika m'malingaliro kuti musonyeze zoletsa zokhudzana ndi apilo ya Hospira). Pambuyo pofotokoza zoletsa izi, lingalirolo linapereka tanthauzo la mawu oti "pangano" omwe amagwiritsidwa ntchito ndi khoti lachigawo pa choletsa chilichonse. Magulu onse adagwirizana momveka bwino kuti mawuwo ayenera kukhala ndi tanthauzo lake lachizolowezi, lomwe ndi "pafupifupi"; kwa Khoti Loona za Apilo la Federal Circuit, Hospira sanapereke kufotokozera kosiyana.
Magulu onse awiriwa adapereka umboni wa akatswiri pa zoletsa zitatu zomwe zili pamwambapa. Akatswiri a Parr adapereka umboni kuti khotilo linagwiritsa ntchito 9 mg/mL sodium chloride kuti lidziwe kuphwanya kwa 6-8 mg/mL (Hospira concentration, ngakhale kuti 8.55 mg/mL imagwiritsidwanso ntchito) chifukwa Ndikokwanira kukwaniritsa cholinga chomwe chinkafunidwa, chomwe ndi "kusunga umphumphu wa maselo amoyo atalowetsa adrenaline m'magazi." Akatswiri a Hospira adangopereka zotsutsa kwa anzake ngati akatswiri ake aluso ankakhulupirira kuti 9 mg/mL inali mkati mwa "pafupifupi" 6-8 mg/mL.
Ponena za zofooka za ma transition metal complexes, khoti lachigawo linatsimikizira kuti citric acid ndi mankhwala odziwika bwino a chelating kutengera umboni. Hospira inanena mu ANDA yake kuti kuchuluka kwa zinthu zodetsedwa (zitsulo) kuli mkati mwa miyezo yapadziko lonse lapansi (makamaka Malangizo a ICH Q3D). Akatswiri a Par adatsimikizira kuti ubale wofanana pakati pa chinthu chokhazikika ndi kuchuluka kwa mankhwala a chelating metal omwe atchulidwa muzonenazo uli mkati mwa kuchuluka kofunikira. Akatswiri a Hospira sanapikisanenso ndi akatswiri a Par, koma adatsimikizira kuti malire apamwamba a muyezo wa ICH Q3D anali muyezo wosayenera kukhoti lachigawo. M'malo mwake, akukhulupirira kuti kuchuluka koyenera kuyenera kuchotsedwa mu gulu loyesera la Hospira, lomwe akukhulupirira kuti lidzafunika milingo yotsika kwambiri ya citric acid ngati mankhwala a chelating.
Magulu awiriwa akupikisana kuti agwiritse ntchito mankhwala ochepetsa pH a Hospira's ANDA kuti afotokoze kuchuluka kwa citric acid ngati buffer (ndi sodium citrate yake). M'munda, citric acid yokha imaonedwa kuti imawonjezera pH (ndipo palibe kukayika kuti citric acid yokha ndi mankhwala ochepetsa pH A). Malinga ndi akatswiri a Par, kuchotsa kuchuluka kwa citric acid mu fomula ya Hospira ndikokwanira kuti citric acid ikhale mkati mwa kuchuluka kwa mankhwala ochepetsa pH omwe Par akunena. "Ngakhale mamolekyu a citric acid omwewo adzakhala gawo la buffer system (Citric acid yophatikizana ndi sodium citrate zimagwiritsidwa ntchito pamodzi ngati chowonjezera pH." (Ngakhale pali zotsutsana zoonekeratu, kumbukirani kuti kuphwanya malamulo ndi nkhani yeniyeni. Bungwe la Federal Circuit lidzawunikanso chigamulo chenicheni cha khothi lachigawo pamlandu. Kuti apeze cholakwika chodziwikiratu.) Akatswiri a Hospira sagwirizana ndi akatswiri a Par ndipo adatsimikizira (moyenera) kuti mamolekyu a citric acid omwe ali mu kapangidwe kake sayenera kuonedwa ngati ochepetsa pH komanso owonjezera pH. Komabe, khothi lachigawo linagamula kuti Par adapambana mlanduwo ndipo lingaliro la Hospira lingaphwanye ufulu wa patent wa Par. Apilo iyi idatsatira.
Woweruza Taranto anakhulupirira kuti Bungwe la Federal Circuit linatsimikiza kuti Woweruza Dyke ndi Woweruza Stoll nawonso adapezekapo pamsonkhanowo. Apilo ya Hospira idakhudza chigamulo cha khothi lachigawo pa chilichonse mwa ziletso zitatuzi. Bungwe la Federal Circuit poyamba linatsimikizira zomwe Khothi Lalikulu lidapeza poganiza kuti kuchuluka kwa 9 mg/mL sodium chloride mu Hospira formula kudagwera mkati mwa malire a "pafupifupi" 6-8 mg/mL omwe Par adatchula. Gulu la akatswiri linanena kuti mukagwiritsa ntchito mawu oti "pafupifupi", "pewani kugwiritsa ntchito malire okhwima a manambala pazinthu zinazake," Cohesive Techs adatchula. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), kutengera Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Pogwira mawu a Monsanto Tech, pamene “pafupifupi” yasinthidwa m'madandaulo, kuchuluka kwa manambala komwe kumanenedwako kumatha kupitilira malirewo mpaka kufika poti munthu waluso “adzaganizira moyenera” kuchuluka komwe kumakhudzidwa ndi zomwe akunenazo. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Pazochitika zotere, ngati palibe mbali iliyonse yomwe ikuvomereza kuchepetsa kuchuluka kwa zomwe akunenazo, kutsimikiza kumachokera pa muyezo wogwirizana. Zinthu za muyezo uwu zikuphatikizapo ngati njira yomwe ikunenedwa kuti ikuphwanya malamulo ndi “yocheperako” kuchokera ku malire a chitetezo (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Ndipo kuchuluka kwa chitetezo ndikofunikira bwanji pofuna kuchepetsa (osati zomwe zapangidwa pano) zokha. Ngakhale kuti anavomereza kuti pempholi likuthandizira chigamulo cha khoti pankhaniyi, Federal Circuit inanena kuti: “Kaya njira ya wotsutsidwayo ikukwaniritsa tanthauzo loyenera la “pangano” pazochitika zina ndi nkhani ya mfundo zaukadaulo,” v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Federal Court, 1996). Pano, gululi likukhulupirira kuti khoti lachigawo lavomereza moyenerera chitsanzo chomwe chafotokozedwa pano, ndipo chigamulo chake chikuchokera pa umboni wa akatswiri. Khoti Lachigawo linanena kuti akatswiri a Par anali okhutiritsa kwambiri kuposa akatswiri a Hospira, makamaka mpaka kufika podalira “mfundo zaukadaulo, kufunika kwa cholinga cha chiletsocho, komanso kusatsutsa chiletsocho.” Mosiyana ndi zimenezi, khoti lachigawo linanena kuti akatswiri a Hospira “sanachite kusanthula komveka bwino kwa maziko aukadaulo kapena ntchito ya wosintha tonicity yemwe akuti.” Kutengera mfundo izi, gulu la akatswiri silinapeze zolakwika zoonekeratu.
Ponena za zoletsa za zinthu zosinthira zitsulo, Bungwe la Federal Circuit linakana mfundo ya Hospira yakuti khoti lachigawo liyenera kuyang'ana kwambiri pa njira yake yodziwika bwino m'malo mwa zomwe zili mu ANDA yake. Gululo linapeza kuti Khoti Lalikulu linaona molondola citric acid ngati chinthu chosinthira zitsulo chofotokozera zomwe zanenedwa m'madandaulo, zomwe zikugwirizana ndi umboni wa akatswiri a mbali zonse ziwiri. Kutengera umboni wakuti citric acid imagwira ntchito ngati chinthu chosinthira zitsulo, lingaliro ili likukana mfundo ya Hospira yakuti citric acid si cholinga chogwiritsidwa ntchito ngati chinthu chosinthira zitsulo. Malinga ndi 35 USC§271(e)(2), muyezo woweruza kuphwanya malamulo a ANDA ndi zomwe zafotokozedwa mu ANDA (monga momwe khotilo linanenera, ndi kuphwanya malamulo komanga), ponena za Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Kudalira kwa Hospira pa ANDA yake ndi muyezo wa ICH Q3D, womwe umathandizira chigamulo cha khothi lachigawo, osati chifukwa chakuti mawuwa adawonjezedwa ku ANDA pambuyo poti FDA idafuna "chidziwitso china" pankhaniyi. ANDA sanangokhala chete pankhaniyi. Bungwe la Federal Circuit linapeza kuti khothi lachigawo linali ndi umboni wokwanira wotsimikizira kuti mawu a Hospira akutsatira kwathunthu lamuloli.
Pomaliza, ponena za mphamvu za asidi wa citric ndi zinthu zake zotetezera pH, Federal Circuit potengera zomwe Hospira adanena sizinasunge ufulu wonena pankhaniyi. Kuphatikiza apo, Federal Circuit idapeza kuti gululo lidanena kuti zomwe (zomwezo) za ma patent a '876 ndi '657 "zikuwonetsa zosiyana kwambiri." Popeza Khothi la Federal silinatsutse izi (kapena malo ena aliwonse), Khothi la Federal linanena kuti Khothi Lachigawo silinafike pamlingo womveka bwino kuti zomwe Hospira adalemba zidaphwanya zomwe zafotokozedwazo (pakati pa zinthu zina, izi) Zimadalira zomwe anthu ambiri ali nazo kukhothi). Mafotokozedwe) ndi kutsimikiziridwa.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Khoti Loyang'anira Boma 2020) Gulu: Malingaliro a Woweruza Boma Dyk, Taranto ndi Stoll, Woweruza Boma Taranto
Chodzikanira: Chifukwa cha mtundu wonse wa zosinthazi, zomwe zaperekedwa pano sizingagwire ntchito pazochitika zonse, ndipo palibe chomwe chiyenera kuchitidwa pa izi popanda upangiri walamulo kutengera zochitika zinazake.
©McDonnell Boehnen Hulbert & Berghoff LLP lero = Tsiku latsopano(); var yyyy = lero.getFullYear(); document.write(yyyy + “”); | Zotsatsa za Loya
Webusaitiyi imagwiritsa ntchito ma cookies kuti ikonze zomwe ogwiritsa ntchito akugwiritsa ntchito, kutsatira momwe mawebusayiti osadziwika amagwiritsidwira ntchito, ma tokeni ovomerezeka m'sitolo ndikulola kugawana pa malo ochezera a pa Intaneti. Mukapitiliza kusakatula tsamba lino, mukuvomereza kugwiritsa ntchito ma cookies. Dinani apa kuti mudziwe zambiri za momwe timagwiritsira ntchito ma cookies.
Copyright © var lero = Tsiku latsopano(); var yyyy = lero.getFullYear(); document.write(yyyy + “”); JD Supra, LLC