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Glenmark
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  IN THE UNITED ST TESDISTRICT COURTFOR THEE STERN DISTRICTOF VIRGINI Richmond Division GLENMARK GENERICSLTD., et. al Plaintiffs,   FERRING B.V., Defendant. MEMOR NDUMOPINION (DenyingDefendant sMotiontoDismiss) ThisisanactionseekingadeclaratoryjudgmentpursuanttotheFederalFood, Drug,andCosmeticAct( FFDCA ), 21 U.S.C.§§301-399,asamendedbytheDrugPriceCompetitionandPatentTermRestorationAct of 1984 ( Hatch-WaxmanAct or the Act ),arising from thelisting of apatentinanFDApromulgateddocumentcalled the  Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referredtoasthe OrangeBook. ThecaseispresentlybeforetheCourtonDefendantFerringB.V. s( Ferring )MotiontoDismiss( Motion ,ECFNo. 15) challengingsubjectmatterjurisdiction, filed on July 30, 2014. The parties have fully briefed the issue, andthe Court heard oral argumentonthemotiononSeptember 19, 2014. Forthereasonsstatedherein,theCourt findsthatithassubjectmatterjurisdictioninthismatter,asthecasepresentsajusticiableArticleIIIcontroversy.Moreover,theCourtfindsnopersuasivereasontoexerciseits discretionpursuanttotheDeclaratoryJudgmentActanddeclinejurisdictioninthis Civil Action No.3:14CV422-HEH Case 3:14-cv-00422-HEH Document 29 Filed 10/14/14 Page 1 of 13 PageID# 202  matter.Accordingly,theCourtdeniesFerring sMotiontoDismisspursuanttoRules12(b)(1)and12(b)(6) of theFederalRules of CivilProcedure. I B CKGROUND A StatutoryFramework Theapproval of prescriptiondrugsisgovernedbytheHatch-WaxmanandtheMedicarePrescriptionDrug,Improvement,andModernizationAct of 2003( MMAAmendments ).TheHatch-WaxmanActwascreatedto strikeabalancebetweentwo competingpolicyinterests:(1)inducingpioneeringresearchanddevelopment of newdrugsand(2)enablingcompetitorstobringlow-cost,genericcopies of thosedrugsto market. CaracoPharm.Labs.,Ltd. v. ForestLabs.,Ltd., 527 F.3d 1278,1282(Fed. Cir.2008)(internalcitationsomitted). TheActrequirespharmaceuticalcompaniesseekingtomarketnew,previouslyunapproveddrugs,tofileaNewDrugApplication( NDA )withthe FDA. 21 U.S.C. § 355(a), (b).Theinnovatingpharmaceutical company must providethe FDAwith informationincluding allpatentscoveringits drug orthe methods of using thedrug with respect to which a claim ofpatent infringement could reasonably be asserted ifa person notlicensedbytheownerengagedinthemanufacture,use,orsale of thedrug. Caraco, 527F.3dat 1282 (citing 21 U.S.C.§355(b)(1),(c)(2)).TheFDAthenpromulgatesthepatentsintheOrangeBook. 21 U.S.C.§355(j)(7)(A).DrugsapprovedbytheFDAare knownas listeddrugs. 21U.S.C.§355(j)(2)(A)(i). TheHatch-WaxmanActalsoprovidesalessarduousapprovalprocessfor companies seekingto market genericversionsof these patenteddrugs, known asthe Case 3:14-cv-00422-HEH Document 29 Filed 10/14/14 Page 2 of 13 PageID# 203   AbbreviatedNewDrugApplication ( ANDA ). Caraco, 527F.3dat1282.To successfullyfileanANDA,genericdrugmakersarenotrequiredtoconducttheirown independentclinicaltrialstoprovethesafetyandefficacy of theirdrugs.21U.S.C.§ 355(j)(2)(A)(iv).Instead,genericdrugcompaniescan,andusuallydo,utilizethe research of theinnovatingpharmaceuticalcompanysolongasthegenericdrugcompany establishesthatitsgenericdrugproductisthe bioequivalent toaNDAlisteddrug. Id. EachANDAapplicantmustsubmitone of fourcertificationsaddressingeach of thepatentsitseekstotakeadvantage of for therelevantdruglistedintheOrange Book. 21 U.S.C. §355G)(2)(A)(vii).Inparticular,theANDAfilermustcertifythateither:(I) nopatentinformationhasbeen filedwith the FDA; (II)thepatenthasexpired;(III)the patent will expire on a particular date and approval of the ANDA should be deferred until expiration; or (IV) inthe opinion ofthe ANDA applicant, the patent is invalid or willnot be infringed bythe manufacture, use, orsaleofthe generic drug. 21 U.S.C. § 355(b)(2)(A)(i)-(iv). Thelastcertification option, thatanOrange-Book-listedpatentis invalid ornot infringed, is commonly known asa ParagraphIV certification. WhereanANDAcontainsaParagraphIVcertification,thetiming of approval depends on two events:(i) whether the holder of the listed patent brings an infringement suit withinforty-five days of receiving notice of the ANDA filing, and(ii) whether the company seekingapproval was the first to file an ANDA witha Paragraph IV certificationtothelistedpatent. See 21 U.S.C. §355(j)(5)(B)(iii).Toencouragethe filing of ANDAs, the Act grants the first company to file an ANDA Paragraph IV Case 3:14-cv-00422-HEH Document 29 Filed 10/14/14 Page 3 of 13 PageID# 204  certification,a180-dayperiod of genericmarketingexclusivityfromthedate of its firstcommercialmarketing beforeothergenericcompanieswillbeapprovedbytheFDAto enterthemarket.21U.S.C.§355(j)(5)(B)(iv). Pursuanttothe MMA amendments,theexclusivityperiodistriggeredonlybythe first-filinggeneric sfirstcommercialmarketing,butcanbeforfeitedundercertain conditions,includingfailuretolaunchafterafinalcourtjudgment of noninfringementor invalidity. SeeDey Pharma, LP v. SunovionPharms., Inc., 611 F.3d1158,1160(Fed. Cir.2012)(citingMedicarePrescriptionDrug,Improvement,andModernizationAct of 2003,Pub.L.No.108-173,§1102,117Stat.2066,2457-60)).The MMA wasenacted  topreventNDAholdersfrom gaming theHatch-WaxmanActbyforestallingtheresolution of patentdisputeswithANDAfilers. Caraco, 527F.3dat 1285. Putanother way, ifasubsequent ANDA filerobtaineda final judgmentthatthepatentswereinvalid ornot infringed, then the first ANDAfilerwould forfeit its 180-day exclusivity period if itdidnotmarketthedrugwithin75days. See id. (citing 21 U.S.C.§355(j)(5)(D)). B FactualBackground ThiscaseinvolvesGlenmark seffortstoobtaintheFoodand Drug Administration s( FDA )approvaltomarketagenericversion of Ferring sU.S.Patent No. 7,002,340 ( 340 patent ) for desmopressin acetate.1 Sanofi holds the approved NDAforDDAVPTablets,whichcontaintheactiveingredientdesmopressinacetate. (Compl. H20,ECFNo. 1). DDAVP isthereference-listeddruguponwhichGlenmark s ANDArelies. (Id.) AlthoughFerringdoesnotholdtheNDA,itownedthe 340patent 1 Desmopressin acetate acts onthe kidneys to reduce the amount of urineproduced at night. WebMD, http://www.webmd.eom/drugs/2/drug-12128/desmopressin-oral/details (last visitedSeptember 19,2014). Case 3:14-cv-00422-HEH Document 29 Filed 10/14/14 Page 4 of 13 PageID# 205
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