in re rosuvastatin calcium patent litig., c.a. no. 08-1949-jjf-lps (d. del. june 29, 2010) (farnan,...

8/9/2019 In re Rosuvastatin Calcium Patent Litig., C.A. No. 08-1949-JJF-LPS (D. Del. June 29, 2010) (Farnan, J.).

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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE

IN RE: ROSUVASTATIN CALCIUMPATENT LITIGATION,ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,

Pla in t i f f s ,v.

MYLAN PHARMACEUTICALS INC.,Defendant .

ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,

Pla in t i f f s ,v.

SUN PHARMACEUTICAL INDUSTRIESLTD. ,

Defendant .ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,

Pla in t i f f s ,v .

SANDOZ INC.,Defendant .

MDL No. 08-1949-JJF

Civ i l Action No. 07-805-JJF-LPS




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P l a i n t i f f s ,v .

PAR PHARMACEUTICALS INC.,Defendant .



APOTEX CORP.,Defendants .



AUROBINDO PHARMA LTD. ANDAUROBINDO PHARMA USA INC.,

Defendants .

Civ i l Act ion No. 07-808-JJF-LPS




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COBALT PHARMACEUTICALS INC.AND COBALT LABORATORIES INC.,

Defendants .ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,


AUROBINDO PHARMA LTD. ANDAUROBINDO PHARMA USA INC.,

Defendants .ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,


TEVA PHARMACEUTICALS USA,Defendant .




Ford F. Farabow, Esquire; Char les E. Lipsey, Esqui re ; Kenneth M.Frankel , Esquire and York M. Faulkner , Esquire of FINNEGAN,HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P . , Washington, D.C.


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Richard D. Kirk, Esquire and Stephen B. Brauerman, Esquire ofBAYARD, P.A. , Wilmington, Delaware.Attorneys fo r Defendant Aurobindo Pharma Ltd.Richard A. Kaplan, Esquire; Ralph J . Gabric , Esquire; Je f f ry M.Nic ho ls, E sq uire and Jason W. Schigelone, Esquie of BRINKS HOFERGILSON & LIONE, Chicago, I l l i no i s .Joseph H. Huston, J r . , Esquire o f STEVENS & LEE, APC, Wilmington,Delaware.Attorneys fo r Defendant Teva Pharmaceut ials USA, Inc .William A. Rakoczy, Esquire; Paul J . Molino, Esqui re ; Deanne M.Mazzochi, Esqui re ; Joseph T. Ja ros , Esqui re ; Tara M. Raghavan,Esquire and Eric R. Hunt, E squire of RAKOCZY MOLINO MAZZOCHISIWIK LLP, Chicago, I l l i no i s .Mary B. Mat terer , E squire of MORRIS JAMES LLP, Wilmington,Delaware.Attorneys fo r Defendant Mylan Pha rmaceut ic al s, I nc .

MEMORANDUM OPINION

June ~ c r , 2010Wilming ton, Del aware


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Henry J . Renk, Esquire of FITZPATRICK, CELLA, HARPER & SCINTO,New York, New York.Mary W. Bourke, E squire of CONNOLLY BOVE LODGE & HUTZ LLP,Wilmington, Delaware.Attorneys f o r P l a i n t i f f s .Thomas A. Stevens, Esquire o f ASTRAZENECA PHARMACEUTICALS LP,Wilming ton, De laware.Attorney f o r P l a i n t i f f s , AstraZeneca Pharmaceut icals LP,AstraZeneca UK Limited, and IPR Pharmaceu t ica l s .William R. Zimmerman, Esquire and Steven A. Maddox, Esqui re o fKNOBBE, MARTENS, OLSON & BEAR, LLP, Washington, D.C.Payson Le M e i l l e u r , Esquire of KNOBBE, MARTENS, OLSON & BEAR,LLP, I r v i n e , C a l i f o r n i a .Attorneys f o r Defendants, Cobal t Pha rmaceut ic al s, I nc . and Cobal tL a b o r a t o r i e s , I n c .Charles B. Klein, Esqui re ; John K. Hsu, Esqui re ; Adam S.Nade lh af t, E sq uire and Mark A. Smith, E squire of WINSTON & STRAWNLLP, Washinton, D.C.Kevin G. Abrams, Esquire and John M. Seaman, Esquire o f ABRAMS &BAYLISS LLP, Wilming ton, Del aware.Attorneys f o r Defendant Sun Pharmaceut ica l I n d u s t r i e s , Ltd.Danie l G. Brown, Esquire o f WILSON, SONSINI, GOODRICH & ROSATI,New York, New York.Dutch D. Chung, Esquire o f WILSON, SONSINI, GOODRICH & ROSATI,Washington, D.C.F r e d e r i c k L. C o t t r e l l , I I I , Esquire and Steven J . Fineman,Esquire o f RICHARDS, LAYTON & FINGER, P.A. , Wilmington, Delaware.Attorneys f o r Defendant Par Pharmaceut icals , I n c .Robert B. B r e i s b l a t t , Esquire; Craig M. Kuchii , E s q u i r e ; JeremyC. Daniel , E s q u i r e ; Stephen P. Benson, Esquire and B r i a n J .Sod ik of f, E sq uir e o f KATTEN MUCHIN ROSEMAN LLP, Chicago,I l l i n o i s .Richard L. Horwitz, Esquire and D avid E. Moore, E squire of POTTERANDERSON & CORROON LLP, Wilmington, Delaware.Attorneys f o r Defendant Apo tex Corp .Thomas P. Heneghan, Esqui re ; J e f f r e y S. Ward, E s q u i r e ; Edward J .Pardon, Esquire and Shane A. Brunner , Esquire of MERCHANT &GOULD, Madison, Wisconsin.


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AstraZeneca Pharmaceut icals LP, AstraZeneca UK Limited , IPRPharmaceut icals Inc. and Shio nogi S eiy ak u Kabushiki Kaisha( co l lec t ive ly , "P l a i n t i f f s " ) brought t h i s ac t ion a ga in st se vera ld i f f e ren t generer ic drug manufacturers , Mylan Pharmaceu t ica l sI nc . , Sun Pharmaceut ical Indus t r i es , Ltd . , Par Pharmaceutica l ,I nc . , Apotex Corp., Aurobindo Pharma Ltd . , Coba lt Ph a rmaceut ic a lsI nc . , Cobal t Labora to r ies Inc . , Teva Pharmaceu t ica l s USA, Inc .( co l lec t ive ly , "Defendants") l a l leg ing in f r ingement of U.S.Patent No. RE 37,314 (the " '314 pa t en t " ) , cover ing rosuvas ta t inand i t s s a l t s , based on De fe nd an ts ' s ubm is sio n of an AbbreviatedNew Drug Appl ica t ion ("ANDA") to th e Food and Drug Admin is t ra t ion("FDA") fo r approval to engage in th e commercial manufacture ,use , o r sa le in th e U n ~ t e d Sta te s of rosuvas ta t in calc iumt ab l e t s . With the excep t ion of Apotex Corp. , Defendants admitt h a t they have i n f r inged cla ims 6 and 8 of th e '314 pa ten t bysubmi t t ing i t s ANDA under 35 U.S.C. 271 (e) (2) (A). However,Defendants contend t ha t c la ims 6 and 8 of th e '314 pa ten t are

Unless otherwise noted, a l l docket i tem ( "D. I . " )re fe rences are to MDL. 08-1949. An ac t ion was a lso broughtaga ins t Apotex, Inc . , Aurobindo Pharma USA Inc . , and Sandoz Inc.The a ctio n a ga in st Apotex, Inc . was t rans fe r red by th e Cour t toth e Southern Dis r i c t of Flor ida (D.I . 456.) The ac t ion aga ins tAurobindo Pharma USA Inc . was dismissed by s t i pu l a t i on of th epa r t i e s . (D.I . 359 in Civ. Act . No. 07-810; D.I . 218 in Civ.Act. No. 08-359.) The a ct io n a ga in st Sandoz, Inc. has beenstayed, and the pa r t i e s have agreed to be bound by th e Cour t ' sdec i s ion in t h i s l i t i g a t i on . (D.I . 217, 218 in Civ. Act . No. 07807. )

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inva l id and unenforceable . In addi t ion , Defendants havechal lenged th e standing of Pla in t i f f AstraZeneca Pharmaceut icalsLP to sue fo r infr ingement and have f i l ed motions to dismissbased on t h i s i s sue . As fo r Defendant Apotex Corp. , Apote x Corp.contends t h a t it d id not engage in an in fr ing ing ac t in th e f i r s tins tance , because it d id not "submit" the ANDA with in the meaningof Sect ion 271(e) (2) (A)

With th e e xc ep tio n of Defendant Apotex Corp. , no Defendantcon tes t s t h a t th e Court has subjec t mat te r j u r i sd i c t i on over t h i sac t ion pursuant to 28 U.S.C. 1331 and 1338, as a r i s i ng underthe pa ten t laws of the United Sta tes , Ti t l e 35 of the UnitedSta tes Code and th e Abbreviated New Drug Appl ica t ion provis ionsof the Hatch-Waxman Amendments to th e Federa l Food, Drug andCosmetic Act, 21 U.S.C. 355(j)venue a re also uncontested .

Personal j u r i sd i c t i on and

The Cour t held a Bench Tr ia l on th e i s sues of i nva l id i t y andunenforceab i l i ty from February 22, 2010, through March 3, 2010,and reserved dec is ion on th e s ta nd in g i s sue fo r r eso lu t ion pos t -t r i a l . Brie f ing on th e v ar io us pos t - t r i a l i s sues was notcompleted un t i l June 4, 2010. 2 This Memorandum Opinion

Following Defendants ' f ina l pos t - t r i a l submission,P la in t i f fs f ile d a Motion For Leave To Fi le A Sur-Reply . (D.I .546.) P l a i n t i f f s contend t ha t they are en t i t l ed to a su r - rep lyto address i s sues r a i s ed fo r th e f i r s t t ime in Defendants ' f i n a lsubmission, spec i f ica l ly the Japanese tes t imony of Mr. MasamichiWatanabe, th e c ase S ch erin g Corp. v. Glenmark Pharms. Inc. USA,07-1334(JLL), 2010 U.S. Dis t . LEXIS 38382 (D.N.J. Apr. 19, 2010) ,

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c o n s t i t u t e s t h e C o u r t ' s f i n di n g s o f f a c t and c on c l u si o ns o f lawon t h e i s s u e s o f s ta n d in g, i n v a l i d i t y and u n e n f o r c e a b i l i t y .

BACKGROUND

I . The Part ies

P l a i n t i f f AstraZeneca Pharmaceut icals LP i s a Delawarec o r p o r a t i o n with i t s p r i n c i p a l p l a c e o f b u s i n e s s i n Wilmington,Delaware. P l a i n t i f f AstraZeneca UK Limited i s a c o r p o r a t i o ne x i s t i n g under t h e laws of t h e United Kingdom with i t s p r i n c i p a lp l a c e o f b u s i n e s s i n London, England. P l a i n t i f f IPRPharmaceut icals I n c . i s a wholly owned s u b s i d i a r y o f AstraZenecaUK, e x i s t i n g under t h e laws of t h e Commonwealth of Puerto Ricowith a p r i n c i p a l p l a c e of b u s i n e s s i n Canovanas, Puerto Rico.P l a i n t i f f Shionogi Seiyaku Kabushiki Kaisha i s a Japanesec o r p o r a t i o n with a p r i n c i p a l p l a c e o f b u s i n e s s i n Osaka Japan.P l a i n t i f f s a r e engaged i n t h e b u s i n es s of r e s e a r c h , development,manufacturing a n d / o r s e l l i n g pharmaceut ical p r o d u c t s world-wide.

Defendant Aptoex Corp. i s a Delaware c o r p o r a t i o n with i t sp r i n c i p a l p l a c e o f b u s i n e s s i n Weston, F l o r i d a . DefendantAurobindo Pharma Limited i s a c o r p o r a t i o n e x i s t i n g under t h e lawso f I n d i a with i t s p r i n c i p a l p l a c e o f b u s i n e s s i n Andhra Pradesh,I n d i a . Defendant Cobalt Pharmaceut icals I n c . i s a Canadian

and a l l e g e d miss ta tements made by Defendants . Defendants opposet h e Motion. (D.I . 550.) In t h e C o u r t ' s view, much of t h ed i s p u t e d m a t e r i a l i s newly r a i s e d , and P l a i n t i f f s d i d no t have ano p p o r t u n i t y t o address it. Accordingly , t h e Court w i l l g r a n tP l a i n t i f f s ' Motion and t h e Sur-Reply w i l l be deemed f i l e d .

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corpora t ion with i t s p r inc ipa l place of business in Ontar io ,Canada. Defendant Cobal t Labora to r ies Inc . i s a Delawarecorpora t ion with i t s p r inc ipa l place of business in BonitaSprings , Flor ida . Defendant Mylan Pharmaceut icals Inc . i s a WestVi rg in ia c o rpo ra ti on with i t s p r inc ipa l place of business inMorgantown, West Virg in ia . Defendant Par Pharmaceut ical , Inc . i sa Delaware corpora t ion with i t s p r inc ipa l place of business inWoodcliff Lake, New Je rsey . Defendant Sun Pharmaceut icalIndus t r i es Ltd. i s a corpora t ion ex i s t i ng under th e laws of Ind iawith i t s p r inc ipa l place of business in Maharasht ra , India .Defendant Teva Pharmaceut icals USA, Inc . i s a Delawarecorpora t ion with i t s pr inc ipa l place of business in North Wales,Pennsylvania . Defendants a re engaged in the bu sin ess of making,s e l l i ng and /or d i s t r i bu t ing gener ic drugs in the United Sta tes .I I . The Pat en t Genera lly

The '314 pa ten t i s a re issue of U.S. Paten t No. 5,260,440( the ' ' '440 pa t en t " ) , which per ta ins to rosuvas ta t in and i t ss a l t s , which are compounds useful in th e tre atm e nt ofhypercholesterolemia, hyper l ipopro te inemia and a the rosc le ros i s .(PTX-682 a t 1:26-28; PTX-1054 a t 1:32-34 . ) The inven t ion securedin th e '440 pa ten t was made by co- inven to rs Kentaro Hira i ,Teruyuki Ish iba , Haruo Koike and Masamichi Watanabe. P l a i n t i f fShio nogi S eiy ak u Kabush ik i Kaisha i s the owner of the '440pa ten t , and a f t e r consummation of a l i cense agreement with the

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Ast raZeneca -a f f i l i a t ed P la in t i f f s , an app l ica t ion was made tore i s sue th e '440 pa t en t . The drug covered by the re i s sued '314pa ten t i s known as ro suvas ta t in calcium and marketed and sold bythe Ast raZeneca -a f f i l i a t ed P la in t i f f s under the name CRESTOR asa r e su l t of a l i cens ing agre emen t b etween Shionogi and theAst raZeneca -a f f i l i a t ed P la in t i f f s .

Claims 6 and 8 of th e '314 pa ten t a re a t i s sue in t h i sl i t i ga t i on . Claim 6 i s an independent cla im d ire cte d to

the compound 7- (4- (4- f luorophenyl) -6- isopropyl -2- (Nmethyl-N-methylsulfonylamino)pyrimidin-5-yl)-(3R,5S)dihydroxy-(E) -6-heptenoic acid ( rosuvas ta t in) in theform of a non -t oxi c pha rmaceu t ic a ll y acceptable s a l tthe reo f .

(PTX-1054 a t 16:30-33.) Claim 8 i s a dependent claim d ire cte d tothe compound of claim 6 in the form of a calcium s a l t , which i sro suvas ta t in calcium, the ac t ive i ng red ien t in CRESTOR.1054 a t 16:35.)

(PTX-

The cla ims a t i s sue were cons t rued by Magis t ra te JudgeSta rk , and h is recommendations concerning claim cons t ruc t ion wereadopted by th e Court. (D .I. 348 in 08-md-1949.) C la im 6 i scons t rued as "[a] non- to x ic ph armac eu ti ca ll y a c ce p ta b le s a l t ofthe compound 7- (4 - (4 - f luo ropheny l ) -6 - i sop ropy l -2 - (n-methyl-N-methylsu lfonylamino)pyrimidin-5-yl) -(3R,5S) -d ihydroxy-(E) -6 -hep teno ic ac id . " ( Id. ) Claim 8 i s cons t rued so as to encompassthe monocalcium b is s a l t , reading the c la im as " [ t ]he compound ofClaim 6 in th e form o f a calcium s a l t . " ( Id. )

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By t h i s a c t i o n , P l a i n t i f f s seek an o r d e r p r o h i b i t i n g t h e FDAfrom approving Defendants ' ANDAs p r i o r t o t h e e x p i r a t i o n o f t h e'314 p a t e n t on February 12, 2011, and e n j o i n i n g Defendants fromt h e commercial manufacture, use, o f f e r t o s e l l , s a l e o ri m p o r t a t i o n o f t h e i r r o s u v a s t a t i n calcium t a b l e t s p r i o r t o t h ee x p i r a t i o n o f P l a i n t i f f ' s e x c l u s i v i t y . Defendants contend t h a tcla ims 6 and 8 a r e i n v a l i d as obvious under 35 U.S.C. 103 andas improper ly r e i s s u e d cla ims under 35 U.S.C. 251. Defendantsa l s o contend t h a t t h e '314 p a t e n t i s u n e n f o r c e a b l e based upon t h ea l l e g a t i o n t h a t t h e o r i g i n a l '440 p a t e n t was procured throughi n e q u i t a b l e conduct . Defendants a l s o seek an o r d e r t h a tP l a i n t i f f AstraZeneca Pharmaceut ica l LP l a c k s s ta nd in g t o s u e .The Court w i l l a d d r e s s t h e i s s u e s r a i s e d by t h e p a r t i e s i n t u r n .

DISCUSSION

I . InfringementA. The P a r t i e s ' Content ionsInfr ingement i s only a t i s s u e i n t h i s c a s e with r e s p e c t t o

Defendant Apotex Corp. ("Apotex") , and o nly co nc ern s t h e q u e st i o no f whether Apotex "submit ted" ANDA No. 79-145, such t h a t it maybe l i a b l e f o r infr ingement under S e c t i o n 271 (e) (2) (A) .P l a i n t i f f s contend t h a t t h i s Court , both i n t h i s a c t i o n ando t h e r s , as wel l a s numerous o t h e r c o u r t s , have r e c o g n i z e d t h a t anagent f o r a f o r e i g n ANDA a p p l i c a n t who s i g n s t h e ANDA a p p l i c a t i o nand i n t e n d s t o b e n e f i t d i r e c t l y i f t h e ANDA i s approved may be

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l i ab l e fo r in f r ingement under Sect ion 271 (e ) (2) (A) . (D.I . 499 a t4-6 . ) Pla in t i f f s contend t h a t under t h i s s tandard , Apotex i sl i ab l e fo r in f r ingement , because it s igned the ANDA, as th e U.S.agent of its re l a t ed company, Apotex, Inc . , and f u r the r t h a tApotex in tends to d i r e c t ly benef i t i f th e FDA approves th eapp l i ca t ion . (Id. a t 6-8. ) Thus, P l a i n t i f f s contend t h a t Apotexi s proper ly cons idered to be an en t i t y t h a t submit ted th e ANDA.

In response, Apotex contends t h a t it d id not "submit" theANDA w ith in the meaning of Sect ion 271(e) (2) (A). According toApotex, th e FDA regu la t ions make it c lea r th at only the"appl icant" submits an ANDA. (D. I . 521 a t 3-6 . ) Apotex contendst h a t it has not sought approval to commercia l ly manufacture, use,or s e l l th e claimed invent ion and t h a t every ce r t i f i c a t i on madein th e ANDA was made by Apotex Inc . , not Apotex. (Id. a t 7-8 . )Thus, Apotex contends t h a t it i s not the app l i can t of th e ANDA.Although Apot ex acknowledges t h a t it ac ted as th e a uth oriz ed U.S.agent fo r the ANDA on behal f o f Apotex, I nc . , Apotex main ta inst h a t author ized U.S. agen ts cannot be l i ab l e fo r in f r ingementunder Sect ion 271(e) (2) , even though they have s igned an ANDAapp l i ca t ion . Apotex contends t h a t the ac t of s ign ing the ANDA i sa min i s t e r i a l ac t t h a t i s i n su f f i c i en t to crea te "submi t te r"l i a b i l i t y . According to Apotex, the cases re l i ed upon byPla in t i f f s fo r a cont ra ry pos i t ion a re incons i s ten t with th es t a t u t o ry and regula tory framework governing ANDA submissions ,

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inc luding 21 U.S.C. 355( j ) , 21 C.F.R. 314.3(b) , 21 C.F.R. 314, 94(a) (1) , and FDA Form 356h, and are d is t ingu i shab le bothprocedura l ly and fac tua l ly from t h i s ac t ion . ( Id . a t 8-14. )Apotex fu r the r contends t ha t Section 271(e) (2) (A) does notr equ i re an inqui ry in to whether one in tends to bene f i t from ANDAapproval , and t ha t such an inqui ry i s specu la t i ve and does notmeet the s pe ci f ie d a cts of seek ing approval to make, use, o r s e l lthe claimed invent ion as requi red by Sec t ion 271(e) (2 ) (A).

Alte rna t ive ly , Apotex contends t ha t P la in t i f f s have no tdemonst ra ted by a preponderance of the evidence t ha t Apotex Corpin tends to d i r ec t l y bene f i t i f the FDA approves ANDA No. 79-145.In t h i s regard , Apotex contends t ha t it i s a d i s t i n c t companyfrom Apotex I n c . , and t ha t the decis ions of Apotex, Inc . shouldno t be imputed to Apotex. Apotex fu r the r contends t ha t its e l e c t s which Apotex produc ts it wi l l market , and t ha t it doesno t market every gener ic manufactured by Apotex, Inc . (Id . a t14-15. ) Thus, Apotex contends t ha t the evidence does no t supporta f inding t ha t Apotex in tends to d i r ec t l y bene f i t from the FDA'sapproval o f ANDA No. 79-145.

B. Whether Apotex Corp. Mav Be Liable For Infr ingement AsThe "Submit te r" Of An ANDAIn prev ious decis ions i s sued by the Court , th e Court has

he ld t ha ta wholly-owned subs id iary of a fore ign ANDAapp l i can t , which s igns an ANDA as the agento f i t s paren t -app l i can t , and which in tends to

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bene f i t d i r ec t ly i f the ANDA i s approvedby pa r t i c i pa t i ng in the manufacture,importat ion , d i s t r i bu t ion and /or sa le of thegener ic drug - - [ is] subjec t to s u i t under 271(e) as one who has "submit ted" an ANDA.

In re Rosuvastat in Calcium Paten t Li t i g . , 2008 WL 5046424, a t *10(D. Del. Nov. 24, 2008) (Stark , J . ) ("Rosuvasta t in I"), adoptedby AstraZeneca Pharms. LP v. Aurobindo Pharma Ltd . , 2009 WL483131 a t *3 (D. Del. Feb. 25, 2009) (Farnan, J . ) ("Rosuvas ta t in~ " ) . Regardless of whether t h i s standard may be c on sid ere d th elaw of the case as Pla in t i f f s contend, the Cour t i s n ot p ersu ade dt ha t t h i s r e c i t a t i on of the l ega l standard fo r determining whomay be l i ab l e fo r submission of an ANDA app l ica t ion i s erroneoussuch t h a t it should be reconsidered by the Cour t as urged byApotex. The Cour t ' s conclus ion t h a t l i a b i l i t y fo r inf r ingementmay extend to an agent of the appl icant who s igns the ANDA andin tends to b en ef i t d i r ec t ly i f the ANDA i s approved i s cons i s ten twith th e dec is ion of othe r cour t s consider ing t h i s i s sue . Wyethv. Lupin Ltd . , 505 F. Supp. 2d 303, 306-307 (D. Md. 2007) ;Avent is Pharma Deutschland GmbH v. Lupin Ltd . , 403 F. Supp. 2d484, 492-494 (E.D. Va. 2005) . Recent dec is ions of t h i s Cour t a rea ls o c o ns is te nt . See Cephal on , Inc . v. Watson Pharmaceutica ls ,I nc . , 629 F. Supp. 2d 338, 349 (D. Del. 2009) (Robinson, J . ) ; seea lso In re Cyclobenzpr ine Hydrochlor ide Ex tended -Re le ase CapsulePaten t Li t iga t ion , MDL, No. 09-2118, 2010 WL 902552 a t * 6 (D.Del. Mar. 12, 2010) (Robinson, J . ) . As J udge Rob in son explained

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in Cephalon, " [p ] ar ti es 'a c ti v el y invo lved ' in prepar ing the ANDAa re deemed to have ' submi t ted ' the ANDA, rega rd le s s of whetherthey are the named app l i can t ; th is i s espec ia l ly t rue where thepa r t i e s involved are in th e same corpora te fami ly . 'Act iveinvolvement ' includes 'market ing and d i s t r i bu t ing the approvedgener ic drugs in the United S t a t e s . ' " 629 F. Supp. 2d a t 349(c i t a t ions omit ted) .

Apotex contends t h a t the aforement ioned cases a red is t ingu ishab le on t h e i r f ac t s in t ha t the companies involved hada d i f f e ren t corpora te r e la t ionsh ip and/or were more involved inthe ANDA prepa ra t ion than Apotex was in t h i s case . While theCour t a cknowledge s di f fe rences among the cases , the Court i s notpersuaded t h a t these di f fe rences j u s t i f y a d i f f e ren t r e s u l ti n so f a r as the a pp ro p ri ate l eg a l s tandard fo r a "s ubm itte r" o f anANDA app l ica t ion i s cons idered . In th e Cour t ' s view, the FDAregu la t ions c i ted by Apotex do not c on str ue S ec tio n 271(e) (2) (A),and do not preclude an au thor ized agent who s igns an app l i can tfrom being cons idered a "su bm itte r" o f the ANDA. See 21 C.F.R. 314.3(b) (descr ib ing th e "appl icant" as any person who "submits"an ANDA) In add i t ion , the Court f inds nothing in the t ex t ofSect ion 271 (e) (2 ) (A) to l im i t th e s ub m itte r of th e ANDA to onewho s igns the Paragraph IV ce r t i f i c a t i on . Moreover, th e Court i spersuaded t h a t th i s i n t e rp re t a t i on of Sec tion 271 (e ) (2) (A) i scons i s ten t with Congressional i n t en t as explained by Magis t ra te

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Judge S t a r k i n R o s u v a s t a t i n I , 2008 WL 5046424 a t *10-11, andsubsequently adopted by t h e Court .

Applying t h i s l e g a l s t a n d a r d t o t h e f a c t s of t h i s c a s e , t h eCour t concludes t h a t Apotex submit ted t h e ANDA a p p l i c a t i o n sucht h a t it may be l i a b l e f o r in frin gement o f t h e '314 p a t e n t .Apotex i s i d e n t i f i e d i n t h e ANDA and i t s amendment as t h ea u t h o r i z e d U.S. agent f o r Apotex, I n c . , and t h e s e documents weres i g n e d by Mr. Kir an Kris hnan , Manager o f R eg ula to ry A f f a i r s f o rApotex, using t h e address and phone number of Apotex. (PTX-1343;PTX-1410 a t 2; Tao Dep. 73:13-19.) Although Apotex i s not awholly owned s u b s i d i a r y of Apotex, I n c . / t h e two companies a r ec l o s e l y r e l a t e d . Apotex i s a wholly-owned s u b s i d i a r y ofAposherm, I n c . , which i n t u r n , i s a wholly-owned s u b s i d i a r y ofApotex Holdings I n c . (PTX-1255.) Apotex I n c . i s a wholly-owneds u b s i d i a r y of Apotex Pharmaceut ica l Holdings I n c . / which i n t u r n ,i s 94 percent-owned by Apotex Holdings I n c . ( I d . ) Aposherm,I n c . , Apotex Pharmaceut ical Holdings, I n c . , and Apotex Holdings,I n c . , a r e shel l -companies t h a t e x i s t on paper, but have no formalmeet ings . (Sherman Dep. 9:22-12:11 .) Apotex I n c . and Apotexhold themselves out p u b l i c a l l y and i n t e r n a l l y a s p a r t of t h eApotex Group of companies. (PTX-1624; PTX-1625; PTX-1630; FahnerDep. 14:21-15:6; McInt i re Dep. 134 :16-139: 8; 140: 5-11 .)

In a d d i t i o n , t h e Court i s persuaded t h a t Apotex a c t i v e l yp a r t i c i p a t e d i n a c t i v i t i e s r e l a t e d t o t h e ANDA submission. The

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FDA d ir ec te d i nq u ir ie s to Apotex reg ard in g th e ANDA app l ica t ion(PTX-1779 a t AC461j PTX-1780 a t AC473), and Mr. Krishnan s tayeda t the headquar te rs o f Apotex Inc . in Canada to a s s i s t in thep repara t ion of the ANDA and answer ques t ions while th e D ire cto rof Regula tory Affa i r s fo r Apotex Inc . , Ms. Bernice Atao, was ou tof the of f i c e . (Krishnan Dep. 64:2-65:5 j Tao Dep. 60:1-13, 83:5-19, 98:7-99:4 . ) Mr. Kr is hnan r ev iewed the dra f t ANDA p r i o r tosubmission to th e FDA and consul ted with and answered subs t an t iveques t ions posed by the regula tory s t a f f of Apotex Inc . , inc on ne ct io n w ith the submission. (PTX-1315j PTX-1329j PTX-1337jPTX-1340j PTX-1342 j PTX-1357 j PTX-1358j PTX-1360j Krishnan Dep.56:2 0- 57 :1 8, 5 9:1 2- 60 :1 4, 6 1:1 6-6 2:1 4, 64:2-66:5 , 67:11-69:20,70:1-20, 76:1-78:8 , 85:13-86:10, 86:21-91:15 j Tao Dep. 83:13-19,86 :21 -91 :15 , 107 :10- 108:15, 123:6-22.)

In a dd it io n to the foregoing, the Court i s also persuadedt ha t P la in t i f f s have es tab l i shed by a preponderance of theevidence t ha t Apotex in tends to d i r ec t l y bene f i t from theapproval of the ANDA. Apotex i s the market ing arm of Apotex Inc .Ms. Tammy McIn t i re , the Pres ident of Apotex, t e s t i f i e d t ha tApotex Inc . made the decis ion " to develop [ r ]o suvas ta t in calciumas a gener ic product fo r the United Sta tes , fo r Apotex Corp. tos e l l in the United Sta t e s . " (McInt ire Dep. 204 :5 -9 . )Apotex 's in te n t io n to market and s e l l Apotex I n c . ' s gener icro suvas ta t in calcium produc ts in the United Sta t e s , coupled with

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its a c t i o n s i n connect ion with t h e ANDA submission and i t sd e s i g n a t i o n as t h e U.S. agent f o r Apotex I n c . , s a t i s f y t h e l e g a ls ta n d ar d f o r l i a b i l i t y as an ANDA " s u b m i t t e r " under S e c t i o n271(e) (2) (A). Accordingly, t h e Court concludes t h a t Apotex maybe h e l d l i a b l e f o r in f r ingement o f cla ims 6 and 8 o f t h e '314p a t e n t under S e c t i o n 271(e) (2) (A) as a s u b m i t t e r o f an ANDA.I I . STANDING

A. The P a r t i e s ' Content ionsDefendants have a l s o moved t o d i s m i s s P l a i n t i f f AstraZeneca

Pharmaceut ica ls LP ("AstraZeneca) from t h i s l i t i g a t i o n f o r l a c ko f s t a n d i n g . (D.I . 422.) Defendants contend t h a t AstraZeneca LPdoes not own t h e '314 p a t e n t , does not p o s s e s s an e x c l u s i v el i c e n s e t o t h e '314 p a t e n t , and i s not an e x c l u s i v e marketer o fCRESTOR. Defendants f u r t h e r p o i n t out t h a t P l a i n t i f f s nevers p e c i f i c a l l y p l e d t h a t each p a r t y had s t a n d i n g , but g e n e r a l l ya v e r r e d t h a t a l l P l a i n t i f f s h e l d s u b s t a n t i a l r i g h t s i n t h e '314p a t e n t . Because AstraZeneca LP l a c k s any p r o p r i e t a r y r i g h t s t ot h e p a t e n t i n s u i t , Def endant s con tend t h a t it has no s t a n d i n g t opursue a c l a i m o f infr ingement under t h e Hatch-Waxman Act .

I n response , AstraZeneca LP contends t h a t it has s t a n d i n gbecause (1) it s e r v e s as t h e e x c l u s i v e agent o f P l a i n t i f f , IPRPharmaceut ica ls I n c . ("IPR"), who i s t h e owner o f t h e New DrugA p p l i c a t i o n ("NDA") f o r CRESTORi (2) it submit ted IPR's NDA t ot h e FDAi and (3) it i s IPR's l i c e n s e d marketer o f CRESTOR i n t h e

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United S ta t e s . (D.I . 443.) AstraZeneca LP acknowledges t h a t ina typ ica l pa ten t case , it would not have standing, but contendst ha t a d i f f e ren t conclusion i s wa rr an te d h er e because the t ex t ,s t ruc tu re , and l eg i s l a t i ve h i s to ry of the Hatch-Waxman Actsuppor t s standing fo r an NDA holder in th e f i r s t ins tance and fo rthe agent of an NDA holder under agency pr inc ip les .13 . )

(Id . a t 4-

B. Legal Pr inc ip les Rela ted To StandingThe par ty br ing ing an ac t ion fo r p aten t infr ingement bears

the burden of es tab l i sh ing t ha t it has s tand ing . Sitcom Sys . ,Ltd. v. Agilent Techs . , Inc . , 427 F.3d 971, 976 (Fed. Cir . 2005)For p urp oses o f d emon str atin g standing under Art i c l e I I I of theCons t i tu t ion , th e p l a i n t i f f must show (1) an in ju ry in f ac t , (2)with a f a i r l y t r aceab le connect ion to th e chal lenged ac t ion , and(3) th e re qu ested r e l i e f wil l redress the a l l eged in ju ry . Stee lCo. v. C itiz en s fo r a Bet t e r Env ' t , 523 U.S. 83, 103 (1998) .Courts a lso recognize th re e p ru de nt ia l p rin cip le s th at must becons idered in th e s ta nd in g ana lys i s : (1) a par ty gene ra l ly mustl i t i g a t e i t s own r igh t s and not the r igh t s of a t h i rd par ty ; (2)th e q ue stio n must not be an abs t rac t , genera l ized gr ievance ; and(3) th e harm must be in the zone of i n t e r e s t s pro tec t ed by th es t a tu t e o r cons t i tu t iona l prov i s ion a t i s sue . Val ley ForgeChr i s t i an Col lege v. Americans United fo r Separat ion of Church &Sta te , 454 U.S. 464, 474-475 (1982).

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The Federa l Circu i t has recognized t h ree po t en t i a lca tegor i e s of p l a i n t i f f s fo r purposes of c on sid er in g th e q ue stio nof standing: " those t h a t can sue in t h e i r own name a lone; thoset ha t can sue as long as the pa ten t owner i s jo ined in the su i t ;and those who cannot even pa r t i c i pa t e as a par ty to aninfr ingement su i t . " Morrow v. Mic ro so ft Cor p. , 499 F.3d 1332,1339 (Fed. Cir . 2007) . The f i r s t c ate go ry o f p l a i n t i f f s hold a l ll ega l r igh t s to th e pa ten t as the p aten tee o r assignee of a l lpa ten t r i gh t s . Id . a t 1339-1340. The second c at eg or y in c lu d esp l a i n t i f f s who hold exclusionary r i gh t s and i n t e r e s t s , bu t nota l l subs t an t i a l r i gh t s to th e patent such as exc lus ive l i censees .Id . a t 1340. The t h i rd ca tegory of p l a i n t i f f s are those who holdl e ss than a l l subs t an t i a l r i gh t s to the pa ten t , and l ackexc lus ionary r i gh t s such a s n on -e xc lu si ve l i censees . Id . a t1340-1341. Pla in t i f f s in th e t h i rd ca tegory lack s tand ing andcannot br ing su i t . Id .

C. Whether AstraZeneca LP Lacks Standing To B rin g T hisActionIn t h i s case , AstraZeneca LP urges the Cour t to expand the

second category of recognized p l a i n t i f f s to include NDA holdersand t h e i r au th o ri ze d agents . However, the Court i s n ot p ersua dedt ha t a va l id l ega l bas i s ex i s t s fo r t h i s expansion. Pla in t i f f sarguments and c i t a t i ons notwi ths tand ing , th e Court does notunders tand th e Hatch-Waxman Act o r i t s amendments to haveexpanded th e t r ad i t i ona l ca tegor ies o f re co gn iz ed standing in

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pa ten t infr ingement ac t ions , except to crea te a case o rcontroversy by a def ined ac t of inf r ingement . See Glaxo,Inc . v. Novopharm Ltd. , 110 F.3d 1562, 1569 (Fed. Cir . 1997)Indeed, t h i s Court has prev ious ly u t i l i z ed the t r ad i t i ona ls tand ing an aly sis in eva lua t ing standing ques t ions under theHatch-Waxman Act. See Purdue Pharma Prods. L.P. v. Par Pharms,Inc . , 2008 U.S. Dis t . LEXIS 98178 a t *6-7 (D. Del . Dec. 3, 2008)( s ta t ing t h a t \ \ 'only a pa ten t owner o r an exc lus ive l i censee canhave cons t i tu t iona l standing to br ing an in f r ingement su i t ; anon-exclusive l i censee does no t ' " ) . Although AstraZeneca LPpremises i t s argument on IPR's s t a t u s as the NDA holder , IPR i sac tua l ly the exc lus ive sub- l icensee of th e pa ten t , al lowing IPRto f a l l in to one of the a l ready recognized ca tegor i e s ofp l a i n t i f f s with s tand ing . AstraZeneca LP i s not an exc lus ivel i censee of th e pa ten t , Grtho Pharm. Corp. v. Genet ics I n s t . , 52F.3d 1026, 1031 (Fed Cir . 1995) , and IPR's presence in t h i sac t ion cannot cure AstraZeneca LP's standing def ic iency.Fai rch i ld Semiconductor Corp. v. Power In te gra tio ns , In c . , 630 F.Supp. 2d 365, 370 (D. Del. 2007). Moreover, AstraZeneca LP i seven fu r ther removed from IPR's s t a t u s , because even i f IPR'ss t a t u s as an NDA holder i s considered re l evan t , AstraZeneca LP i sonly the au thor ized agent fo r IPR. AstraZeneca makes much of thefac t t ha t , as au thor ized agent fo r IPR, it re ce iv ed th e HatchWaxman Act Notice Let te r s from Defendants. However, th e mai l ing

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of Notice L e t t e r s i s a requirement o f t h e Hatch-Waxman Act and i snot an a c t i o n t h a t i n and of i t s e l f c r e a t e s s t a n d i n g , absen t acognizable c o n s t i t u t i o n a l o r s t a t u t o r y b a si s.

In sum, AstraZeneca Pharmaceut ica ls LP holds no i n t e r e s t i nand does not have any e x c l u s i o n a r y r i g h t s i n t h e '314 p a t e n t , andt h e r e f o r e , t h e Court concludes t h a t AstraZeneca LP has nos t a n d i n g t o b r i n g o r j o i n i n t h i s infr ingement a c t i o n .Accordingly, t h e Court w i l l g r a n t Defendants ' Motion and dismissAstraZeneca LP from t h i s a c t i o n based upon l a c k of s t a n d i n g .I I I . INEQUITABLE CONDUCT

A. The P a r t i e s ' Content ionsDefendants contend t h a t t h e '314 p a t e n t i s unenforceable as

a r e s u l t o f i n e q u i t a b l e conduct i n t h e p r o s e c u ti o n of t h eo r i g i n a l '440 p a t e n t from which t h e '314 p a t e n t was r e i s s u e d .(D . l . 501 . ) S p e c i f i c a l l y , Defendants contend t h a t t h r e e membersof t h e P a t e n t Department a t P l a i n t i f f Shionog i S ei yaku KabushikiKaisha ("Shionogi") , Ms. Kitamura 3 , Mr. S h i b a t a and Mr. Tamaki,f a i l e d t o d i s c l o s e t o t h e PTO two h i g h l y m a t e r i a l p r i o r a r tp a te n t a p p l ic a t io n s by Bayer and S andoz, as wel l as a EuropeanS ea rc h Report. Defendants have no d i r e c t evidence o f an i n t e n tt o deceive t h e PTa, but urge t h e Court t o i n f e r such i n t e n t based

Ms. Kitamura i s a l s o r e f e r r e d t o i n t h e r e c o r d by h e rmarried name, Ms. Ozawa. However, f o r ease o f unders tanding andc o n s i s t e n c y , she i s r e f e r r e d t o as Ms. Kitamura f o r both t h epurposes of d i s c u s s i o n and f o r purposes o f c i t a t i o n t o t h et r a n s c r i p t s .

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on var ious ac t ions taken by each of th e aforement ionedi nd iv idua l s dur ing t h e i r tenure a t Shionogi and t h e i r work inp ro se cu tin g th e '440 pa ten t .

In r esp on se , Pla in t i f f s contend t h a t Def endants c anno te sta bl i s h in te nt to deceive by c l ea r and convi nc ing ev id ence,because the re are othe r reasonable in fe rences t h a t can be drawnfrom th e ac t ions of Ms. Kitamura, Mr. Shibata and Mr. Tamaki.(D. l . 540.) In pa r t i cu l a r , Pla in t i f f s contend t h a t Ms. Kitamural e f t Shionogi before any Informat ion Disclosure Statement ("IDS")was due, and in any even t , d id not recognize a pa ten t ab i l i t yproblem t h a t would p romp t her to make a di sc losure p r i o r to herdepar ture . (Id . a t 13-16. ) Pla in t i f f s a lso contend t h a t ne i the rMr. Shibata nor Mr. Tamaki were subs tan t ive ly involved in th epa ten t app l ica t ion a t i s sue , and t h a t to th e extent they wereinvolved , n e it he r r ea liz e d t h a t th e p r i o r a r t had no t beendisc losed because th e Shionogi Paten t Department was in a s t a t eof confus ion and chaos due to th e d ep artu re of ce r t a i n employeesand a s ign i f i c an t ly increased workload on the remainingemployees. (Id. a t 22-38. )

B. Legal Pr inc ip les Related To Inequi table ConductIndividua ls assoc ia ted with th e f i l i ng and prosecu t ion of a

pa ten t app l i ca t ion , in c lu d in g in v en to rs named in the app l ica t ion ,a tto rn ey s o r agen ts p ro se cu tin g th e app l ica t ion , and thoseinvolved in th e p re pa ra tio n o r prosecu t ion of th e app l ica t ion who

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are as soc i a t ed with the inventor , have a duty of candor , goodf a i th and honesty in t h e i r deal ings with the PTO. 37 C.F.R. 1.56(a) , (c) . The duty of candor , good f a i th and honestyin clu de s th e duty to submit t r u th fu l in format ion to the PTO, aswell as information which i s mater ia l to the examinat ion of thep at en t a p pl ic a ti on . Elk Corp. of Dal las v. GAF Bldg. Mater ia l sCorp. , 168 F.3d 28, 30 (Fed. Cir . 1999).

UInequi table conduct occurs when a patentee breaches h is orher duty to the PTO of ' candor , good f a i th , and honesty. ' f fWarner-Lambert Co. v. Teva Pharms. USA, Inc . , 418 F.3d 1326, 1342(Fed. Cir . 2005). A pa ten t procu red as a r e s u l t of inequ i t ab leconduct i s unenforceable , and i f inequi tab le conduct occurred inr e l a t i on to one pa ten t cla im, the en t i r e pa ten t i s renderedunenforceable . Kingsdown Medical Consul tan ts v. Hol l i s t e rIncorpora ted , 863 F.2d 867, 877 (Fed. Cir . 1988).

To es t ab l i s h inequi tab le conduct due to the f a i l u r e tod isc lose mater i a l information or the submission of fa l seinformation, th e par ty ra i s ing the i s sue must prove by c l e a r andconvinc ing evidence t ha t (1) t he in fo rm a tio n i s mate r ia l ; (2) theknowledge of t h i s information and i t s mate r i a l i t y i s chargeab leto th e p at en t a p pl ic an t; and (3) the app l i can t ' s submission offa l se information o r i t s fa i lu re to d isc lo se t h i s in format ionre su l t ed from an i n t en t to mislead the PTO. Warner-Lambert , 418F.3d a t 1342-1343 (c i t a t ions omit ted) . UInformation i s

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c o n s i d e r e d m a t e r i a l when t h e r e i s a s u b s t a n t i a l l i k e l i h o o d t h a t ar e a s o n a b l e examiner would h av e c o n s i d e r e d t h e i n f o r m a t i o nimportant i n d e c i d i n g whether t o al low t h e a p p l i c a t i o n t o i s s u eas a p a t e n t . " TAP Pharm. Prods. v. OWL Pharm., L.L.C. , 419 F.3d1346, 1351 (Fed. C i r . 2005). However, a r e f e r e n c e t h a t i sm a t e r i a l need not be d i s c l o s e d i f it i s cumulat ive t o o r l e s sm a t e r i a l than o t h e r r e f e r e n c e s t h a t have a l r e a d y been d i s c l o s e d .Elk C orp., 168 F.3d a t 31. A r e f e r e n c e i s cumula t ive i f it" t e a c h e s no more than what a reasonable examiner would c o n s i d e rt o be t a u g h t by t h e p r i o r a r t a lr ea d y b e f or e t h e PTO." Regentsof t h e Univ. of Cal. v. E l i L i l l y & Co., 119 F.3d 1559, 1575(Fed. C i r . 1997).

In a d d i t i o n t o m a t e r i a l i t y , t h e p a r t y seeking t o e s t a b l i s hi n e q u i t a b l e conduct must demonst ra te t h a t t h e p a t e n t a p p l i c a n ta c t e d with t h e i n t e n t t o deceive t h e PTO. I n t e n t t o dece ive t h ePTO may be e s t a b l i s h e d by d i r e c t evidence o r i n f e r r e d from t h ef a c t s and c i rcums tances su rround ing t h e a p p l i c a n t ' s o v e r a l lconduct . Impax Labs. v. Avent is Pharms. , 468 F.3d 1366, 1375(Fed. C i r . 2006) i Molins PLC v. Textron, I n c . , 48 F.3d 1172, 1180(Fed. C i r . 1995) . In determining whether t h e a p p l i c a n t ' s o v e r a l lconduct evidences an i n t e n t t o deceive t h e PTO, t h e Federa lC i r c u i t has emphasized t h a t t h e c h a l l e n g e d "conduct must bes u f f i c i e n t t o r e q u i r e a f i n d i n g of d e c e i t f u l i n t e n t i n t h e l i g h tof a l l t h e c i r c u m s t a n c e s . " Kingsdown Medical C o n s u l t a n t s , 863

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F.2d a t 873. " ' In a case involving nondisclosure of in fo rmat ion ,c l ea r and conv in ci ng evi denc e must show t h a t th e app l i can t made ade l ibera te deci s ion to withhold a known mater ia l r e f e rence . ' "Star Sc i en t i f i c , Inc . v. R.J . Reynolds Tobacco Co. , 537 F.3d 1357(Fed. Cir . 2008) (quoting Molins PLC v. Textron, Inc . , 48 F.3d1172, 1181 (Fed. Cir . 1995) (emphasis in o r i g i na l ) ) . In ten t todeceive may not be in fe r red from the mate r i a l i t y of theundisclosed reference a lone , but an in fe re nce of i n t en t todeceive i s gene ra l ly appropr ia te where t he re i s (1) a high degreeof mater i a l i ty of th e re fe rence ; (2) evidence t h a t the app l i can tknew o r should have known of i t s mater i a l i ty , and (3) th eappl icant has not pro vide d a c red ib le exp lana t ion fo r withhold ingthe re fe rence . Carg i l l , Inc . v. Canbra Foods, Ltd . , 476 F.3d1359, 1368 (Fed. Cir . 2007); Cancer Research Tech. v. B arr L abs .,Inc . , 2010 WL 286639, *18 (D. Del. Jan . 26, 2010) (Robinson, J . )(quoting Praxa i r , Inc . v. ATMI, Inc . , 543 F.3d 1306, 1314 (Fed.Cir . 2008) ( in te rna l quota t ions and c i t a t i ons omitted) .Genera l ly , th e more mater ia l the omission, th e l e s s th e degree ofin ten t th at must be shown to reach a conclus ion of i nequ i t ab leconduct . Dig i ta l Contro l Inc . v. Charles Machine Works, 437 F.3d1309, 1313 (Fed. Cir . 2006) (d iscussing th e b ala ncin g ofmate r i a l i t y and i n t en t and s ta tin g th at "a g rea t e r showing of onef ac to r al low[s] a l e s s e r showing of the o ther" ) ; Elk Corp. , 168F.3d a t 32. In add i t ion , an in fe rence of i n t en t to deceive must

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be " the s ing le most reasonable in ference able to be drawn fromthe evidence to meet the c l ea r and convincing s tandard ," and acour t e r r s when it overlooks one reasonab le infe rence in favor ofan equa l ly p laus ib le in fe rence where th e evidence i s suscep t ib leto m ultip le reasonab le infe rences . Id . ( c i t ing Scanner Techs.Corp. v. ICOS Vision Sys. Corp. , 528 F.3d 1365, 1376 (Fed. Cir .2008) (emphasis added)) .

Once mater i a l i ty and i n t en t have been es tab l i shed , th e courtmust conduct a balancing t e s t to determine "whether th e sca lestilt to a conclusion t h a t ' i nequ i tab le conduct ' occur red ."Cri t ikon, Inc . v . Becton Dickinson Vascular Access , Inc . , 120F.3d 1253, 1256 (Fed. Cir . 1997) . The ques t ion of whetheri nequ i t ab le conduct occurred i s equ i t ab le in nature , and thus , i scommitted to th e sound d isc re t ion of th e t r i a l cour t . Elk Corp. ,168 F.3d a t 30-31; Kingsdown Medical Consul tants , 863 F.2d a t876.

Reissue proceedings cannot cure a pa ten t held to beunenforceable due to i nequ i t ab le conduct . Avent is Pharma S.A. v.Amphastar Pharms. , Inc . , 525 F.3d 1334, 1341 n .6 (Fed. Cir . 2008)( c i t ing Hoffman-LaRoche Inc . v. Lemmon Co., 906 F.2d 684 (Fed.Cir . 1990)) . As th e Federal Circu i t has exp la ined , " [ i ] t i s wellse t t l ed t h a t , in th e re ve rse case of i nequ i t ab le conduct duringprosecu t ion of the o r ig ina l app l i ca t ion , r e i s sue i s not ava i lab leto obta in new cla ims and thereby r ehab i l i t a t e th e pa t en t . "

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Hewlet t -Packard Co. v. Bausch & Lomb, Inc . , 882 F.2d 1556, 1563n .7 (Fed. Cir . 1989) .

C. Whether The '440 Paten t Was Procured ThroughInequi table Conduct

After reviewing th e evidence adduced by the pa r t i e s a tt r i a l , the Cour t concludes t ha t Defendants have not es tab l i shedtha t the '440 pa ten t was procured through inequ i tab le conduct .Pla in t i f f s have not chal lenged th e mater i a l i ty of the Sandozre fe rence , bu t have chal lenged th e mater i a l i ty of the EuropeanSearch Repor t and the Bayer re fe rence . Based on the evidencesubmit ted by the pa r t i e s , the Court c an no t c on clu de t ha t thesere fe rences are immater ia l ; however, the Cour t i s not inc l ined tof ind them to be high ly mater ia l such t h a t th e degree ofmater i a l i ty of th es e r ef er en ce s should permit Defendants to makea l e s s e r ev iden t ia ry showing on th e i n t en t element . Rather , theCourt view s the evidence of in ten t in t h i s case on i t s owns t r eng th and concludes tha t Defendants have not es tab l i shed , byc l ea r and conv inc ing ev idence , t h a t Ms. Kitamura, Mr. Shibata andMr. Tamaki in tended to deceive the PTO by f a i l i ng to disc losethese re fe rence . Although th e Court ce r t a i n l y unders tands howthe circumstances r a i s ed by Defendants could be sugges t ive ofnefar ious conduct on the pa r t of the aforement ioned i nd iv idua l sin the Shionogi Paten t Department, th e Court c an no t co nclu de t h a tthese c ir cumst an ce s t ak en ind iv idua l ly o r co l l e c t i v e ly r i s e to

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th e l eve l of c l ea r and convinc ing evidence of inequ i tab leconduct .

In reaching t h i s conclusion, th e Court i s simply notpersuaded t h a t the s ing le most reasonable infe rence to be drawnfrom these circumstances i s decept ive i n t en t . For example,Defendants make much of the fac t t h a t Mr. Shib ata h eld on to theEuropean Search Report fo r fo r ty days before sending it fo rf i l i ng , ca l l ing t h i s an "unprecedented period of s tudy" comparedwith Mr. Shiba ta ' s t rea tment of othe r correspondence dur ing t h i st ime frame. (D.I . 501 a t 14.) However, t he re i s no evidencet h a t Mr. Shibata was "s tudying" o r otherwise even eva lua t ing t h i sdocument. Rather , the evidence produced by Pla in t i f f sco l l e c t i v e ly sugges t s a t ime of confusion , personne l change, andoverwork in the Shionogi Paten t Department such t h a t it would notbe unreasonable to i n f e r from t h i s 40 day per iod t h a t th edocument had merely b een ca ug ht in a s tack of papers . (DTX-508-Ta t 79; Shibata T r. 682:1-19 .) Indeed, Mr. Shibata had noreco l l ec t ion of having reviewed t h i s r epor t , which requ i red noresponse, and Mr. Shibata t e s t i f i ed t ha t he d id not make anyconnect ions between th e European Search Report t ha t he sentunreviewed to th e f i l e and th e correspondence t h a t he checked fo rMs. Shimizu concerning th e t iming of a response to th e U.S.r e j e c t i on of th e pending app l i ca t ion and mat te rs of formassoc ia ted with th e U.S. c la ims . (S hib ata T r. 682:1-19; 798:15-

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801:14, 803:19-804:16.) As Mr. S h i ba ta c a n d i dl y e x p la in e d , "It h i n k I was i n a v e r y n e a r s i g h t e d myopic s t a t e o f mind" because

t h e r e was v e r y much a l i m i t a t i o n i n t ime andmuch workload. And t h a t meant t h a t t h eamount of t ime t h a t could be spent f o ri n d i v i d u a l m a t t e r s had been reducedd r a m a t i c a l l y . And I t h i n k t h e r e s u l t of iti s t h a t t h e c a r e t h a t could be a l l o c a t e d t oe ach a ss ignment , each t a s k and t h e manner i nwhich t h e job was being done j u s t was no t upt o p a r .

(Shibata Tr. 800:6-15.)Defendants a l s o p o i n t t o t h e s p l i t t i n g of t h e '440

a p p l i c a t i o n between Ms. Shim izu and Mr. Tamaki contending t h a t"Mr. S h i b a t a v i o l a t e d t h e longstanding Shionogi r u l e r e q u i r i n gt h a t t h e same person be r e s p o n s i b l e f o r handl ing a l lcorresponding a p p l i c a t i o n s " so t h a t he cou ld manipu la te andp r e v e n t t h e d i s c l o s u r e of t h e European Search r e p o r t and t h eSandoz r e f e r e n c e . (D.I . 501 a t 16.) However, t h e c o u n t e r v a i l i n gevidence produced by P l a i n t i f f s and view ed as a whole, p a i n t s amore innocent e x p l a n a t i o n of Mr. S h i b a t a a s a new andinexper ienced manager a t t e m p t i n g t o handle an u n d e r s t a f f e d andoverworked P a t e n t Department. (S hib ata T r. 798 :15- 801: 14 , 803 :4 -804:16. ) Mr. S h i b a t a a dm itted a s much on t h e w i t n e s s s t a n dt e s t i f y i n g , t h a t :

[B]ack then , I was - I was doing t h e b e s t Icould do, and I thought I was doing what Ihad t o do and ought t o do. But through t h i sl a w s u i t , I have been shown v a r i o u s documentsand I have come t o be ashamed as t o mymanagement. I t h i n k t h e management was v e r y

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poor. And on t h a t s c o r e , I do r e g r e t andI ' v e done a l o t o f s e l f r e t r o s p e c t i o n .(Shibata Tr. 803:10-16. )

In a d d i t i o n , Defendants emphasize Mr. S h i b a t a ' s r o l e i ncomparat ive t e s t i n g o f t h e compound claimed i n t h e S-4522a p p l i c a t i o n with t h e compounds from t h e Bayer , Nissan and Sandozr e f e r e n c e s t o suggest t h a t he was a t t e m p t i n g t o conceal t h e s er e f e r e n c e s . However, an e q u a l l y p l a u s i b l e i n f e r e n c e i s t h a t t h i scomparat ive t e s t i n g could have been used t o c o n f r o n t t h e p r i o ra r t and overcome c h a l l e n g e s t o p a t e n t a b i l i t y , p a r t i c u l a r l y givenMr. S h i b a t a ' s tes t imony, which t h e Cour t f i n d s c r e d i b l e , t h a t hehad l i k e l y thought , a t t h e r e l e v a n t t ime, t h a t t h e Bayer andSandoz r e f e r e n c e s had a l r e a d y been d i s c l o s e d .751:12-752:18; DTX-68-T a t 1 . )

(S hib ata T r.

Defendants p o i n t t o s e v e r a l a c t i o n s by Mr. Tamaki t o suggestt h a t he i n t e n d e d t o concea l m a t e r i a l p r i o r a r t from t h e PTO;however, Mr. Tamaki 's conduct i s a l s o e x p l a i n e d by t h e a t l e a s te q u a l l y p l a u s i b l e e x p l a n a t i o n of t h e work l o a d and confus ion a tt h e Shionogi P a t e n t Department. (Tamaki T r. 5 66 :2 0- 56 8:2 1; PTX-624-SUM.) Moreover, t h e evidence i n d i c a t e s t h a t Mr. Tamaki 'swork on t h e '440 p a t e n t was much l e s s e x t e n s i v e than what hasbeen suggested by Defendants . (Tamaki T r. 4 20 :1 1-2 0, 431:22-432:4, 523:6-525:5; DTX-500-T a t 159.) A lthough Mr. S h i b a t ai n t e n d e d t o a s s i g n t h e u . S . a p p l i c a t i o n t o Mr. Tamaki, t h a ti n t e n t i o n was u l t i m a t e l y not c a r r i e d out because o f Mr. Tamaki 's

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a l ready s t ra ined workload. (Shibata 686: 12 -687 :4 , 709 :7 -18,802:5-803:3; DTX-500-T a t 138.)

Defendants also at tempt to undermine Mr. Tamaki 'sc red ib i l i t y by point ing to h is conduct with the AstraZenecaa f f i l i a t ed Pla in t i f f s during l i cens ing nego t i a t ions . In theCour t ' s view, however, t h i s evidence has l imi ted re levancebecause it pe r t a in s to a per iod of t ime occur r ing wel l - a f t e r theissuance of the '440 pa ten t . Sta r Sc i en t i f i c , 537 F.3d a t 1370,n .10 . Fur ther , it i s equal ly reasonable fo r t h i s evidence to becons t rued as ind ica t ive of Mr. Tamaki 's good f a i t h andc red ib i l i t y in t ha t he conceded t h a t Shionogi knew about theSandoz and Bayer re fe rences , b ut p ro vid ed reasonab le exp lana t ionsto the Ast raZeneca -a f f i l i a t ed P l a i n t i f f s fo r why th e re fe renceswere not di sc losed . (Tamaki T r. 48 2:22-48 4:9 , 48 6:6-20 , 542:12-545 :3 , 549 :23- 550: 22 ; DTX-32-T; DTX-33 a t 2-3; DTX22-T a t 5-6;DTX - 36 a t 1 .)

Defendants make much of Ms. Ki tamura's t es timony dur ingt r i a l t ha t she knew of the duty of di sc losure in c on ne ct io n w i thu .S . pa ten t app l ica t ions , but t ha t she d id not d isc lose the Bayerapp l ica t ion , even though she knew t h a t it "encompassed" a t l e a s tsome of the compounds being claimed in the app l ica t ion t h a ti ssued as the '440 pa ten t . As Pla in t i f f s poin t out , however, theduty to di sc lose does not pe r t a in to p r i o r a r t t h a t "encompasses"the inven t ion , but only to p r i o r a r t t h a t es t ab l i s he s a prima

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fac ie case of unpa ten tab i l i ty . See In re Bai rd , 16 F.3d380, 382 (Fed. Cir . 1994) ("The fa c t th a t a c la imed compound maybe encompa ss ed by a di sc losed gener ic fo rm ula does not by i t s e l frender t ha t compound obvious ." ) (c i t a t ions omit ted) . Indeed, th efac t th a t a l a t e r invent ion may in f r inge an ea r l i e r pa ten t doesnot a f f ec t the pa ten t ab i l i t y of the l a t e r inven t ion , and it i snot u nr ea so nabl e to view the June 1991 search r epo r t with re spec tto the Bayer app l ica t ion as ra i s ing a po ten t i a l inf r ingementproblem, bu t not an i nva l id i t y o r pa ten t ab i l i t y problem. Ms.Kitamura t e s t i f i ed t h a t she did not perce ive a pa ten t ab i l i t yproblem based on the Bayer app l ica t ion p r i o r to h er d ep ar tu refrom Shionogi , and t h a t she d id not subs tan t ive ly consider whatp r i o r a r t , beyond t h a t c i ted a l ready in the spec i f i ca t ion , shouldbe c i t ed to th e PTO in the IDS. (Kitamura Tr. 1533:13-23,1535:6-14; PTX-1676-T; DTX-500 a t 131.) Mr. Ki tamur a's t es timonyi s not implausib le as Defendants contend, given t h a t Ms. Kitamurahad given not ice around the t ime the u .S . app l ica t ion was f i l ed ,t h a t she would be leaving Shionogi a t th e end of Ju ly 1992.(Kitamura Tr. 1536:3-9 .) Indeed, a t the t ime Ms. Kitamura l e f tShionogi , the IDS was not due, and he r tes t imony re ga rd in g th elack of a pa ten t ab i l i t y i s sue i s not incons i s ten t with thedocumentary evidence which judged th e compounds to be novel .(PTX-1676-T a t SH95938; DTX-500 a t 131; DTX-508 a t 79-82; DTX-22-T a t 5-6; Kitamura Tr. 1459:10-13; Tamaki Tr. 5 44 :1 6- 54 5: 3.)

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Defendants a lso po in t to a Ju ly 20, 1992 memorandum by Mr. Yasumisugges t ing a po t en t i a l pa t en t ab i l i t y problem und er J ap an es e lawbased on the Bayer re fe rence to suggest t ha t Ms. Kitamura wasaware of a pa t en t ab i l i t y problem. However, the memo i s da ted twodays before Ms. Kitamura 's depar ture , and the re fo re , it i s no tunreasonable to bel ieve t ha t Ms. Kitamura would not have beeninformed of t h i s memorandum. (DTX-57-T; PTX-1676-T a t SH95938.)Indeed, Ms. Kitamura had no reco l l ec t ion of receiv ing t h i smemorandum, and there i s no evidence in the record to thecon t ra ry . (Kitamura Tr. 1450:11-1451:1, 1536:3-9 .)

In sum, the Cour t i s n ot p ersu ad ed t ha t the evidencepresented by Defendants r i s e s to the l eve l of the c l e a r andconvinc ing evidence requi red to e s t ab l i sh i nequ i t ab l e conduct .In reach ing t h i s conclus ion , the Court c red i t s the te st im on y o fMs. Kitamura, Mr. Shiba ta and Mr. Tamaki and f inds the ra t iona leconcerning th e in ex pe rie nce , in cre as ed workload, and r e su l t i ngconfus ion in the Shionogi Paten t Department to be an equal lyp laus ib le explana t ion fo r the f a i l u r e of Shionogi to c i t e theEuropean Search Repor t , the Bayer re fe rence and the Sandozreference to the USPTO during th e app l ica t ion process t ha t led tothe i s suance of the '440 pa ten t . Indeed, none of theaforement ioned i nd iv idua l s was a Japanese pa ten t a tto rn ey o ragen t , and in fac t , th e Shionogi Patent Department as a wholeemployed no one with l ega l experience in the f i e l d of pa t en t s .

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While in h inds igh t it may be a t t r a c t i ve to co ns tru ct a de l ibe r a t escheme of d ece ptive i n t en t from th e ac t ions of these i nd iv idua l sgiven the success of CRESTOR@ in the marketp lace, it i s a t l e a s tequal ly p laus ib le from t h e i r tes t imony and the contemporaneousdocumentary evidence , t h a t a scheme to defraud was th e f u r the s tth ing from th e minds of these i nd iv idua l s a t the re l evan t t imeand t h a t t h e i r v is ion was l im ited to th e overwhelming demandsthey faced da i ly in t h e i r s e ve re ly u nd er st af fe d depar tment .Viewed in t h i s con tex t , which the Cour t i s persuaded i s th eappropr ia te con tex t given the tes t imony and evidence, ac t ionssugges t ive of malfeasance become no more than a s t r i ng ofmishaps, mistakes , misapprehensions and mi sj udgment s on th e pa r to f in ex pe rie nc ed and overworked i nd iv idua l s . Accordingly , theCourt w il l e n te r judgment in favor of P l a i n t i f f s and aga ins tDefendants ' on th e i s sue o f i nequ i t ab le conduct .IV. OBVIOUSNESS

A. The Pa r t i e s ' Content ionsDefendants contend t h a t th e as se r ted c la ims o f the '314

pa ten t would have been obvious as o f Ju ly 1, 1991, th e da te ofthe claimed invent ion, and thus , a re inva l id . (D.I . 501 a t 35.)In present ing t h i s argument , Defendants contend t h a t th etes t imony and evidence a t t r i a l crea tes a pr ima fac i e showing ofobv io us ne ss b as ed on th e p r i o r a r t and t h a t the secondary

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cons idera t ions re l a t ed to obviousness are i n su f f i c i en t toovercome the pa ten t ' s i nva l i d i t y .Defendan t ' s argument i s f i r s t premised on th e c on te ntio n

t h a t a person of ord inary sk i l l in the a r t would l i ke ly haves t a r t ed th e process of developing rosuvas ta t in with Compound lb .( ld . a t 42.) Defendants note t h a t Compound 1b i s the c lo se s tp r i o r a r t re fe ren ce to the claimed invent ion and i s der ived fromthe Sandoz re fe rence . ( ld . a t 37 ( c i t ing D. l . 517 a t DFF 422) . )Defendants f u r the r contend t h a t Compound 1b was a pa r t i cu l a r lyobvious choice from which to i n i t i a t e development ofrosuvas ta t in , because it was notably important w ith in the Sandozre fe rence as high l igh ted by Sandoz 's p re fe ren t i a l t rea tment ofCompound 1b in the re fe rence . (ld. a t 47.) According toDefendants, Compound 1b does no t need to be shown to be the onlyposs ib l e s t a r t i ng po in t o r the " lead compound" in th e developmentof rosuvas ta t in , bu t r a the r , t ha t Compound 1b would have been anobvious and su i t ab le s t a r t i ng po in t from which to begin th edevelopment of rosuvas ta t in . ( ld . a t 37-42.)

From t h i s s t a r t i ng poin t , Defendants fu r the r contend t ha tthe development of rosuvas ta t in would have been obv io us b ec au sethe p yrim id in e c or e s t ruc tu res with in rosuvas ta t in would alsohave been an obvious development a t the t ime rosuvas ta t in wasc rea ted , based upon contemporaneous exper imenta t ion with andpubl i ca t ions concerning such s t ruc tu re s . ( ld . a t 45.)

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Defendants a l so contend t h a t a person o f ord inary s k i l l in th ea r t would have been motivated to develop a more hydroph i l i cs t a t in , such as rosuvas t a t in , so as to pos i t i on a new produc t inth e m arketp lace . ( Id . a t 49. ) Last ly , Def enda nt s c on te nd t h a tth e di f fe rences between rosuvas t a t in and th e p r i o r a r t would havebeen obvious to a person o f s k i l l in th e a r t , b oth c on ce rn in g th emethod of modify ing th e p r i o r a r t and in th e expected r e s u l t s ofrosuvas t a t in . ( Id . a t 52-59. )

In add i t ion to Defendants ' d i r e c t arguments on obviousness ,De fe nd an ts c on te nd t h a t th e secondary cons ide ra t i ons re lev an t toobviousness do not overcome i n v a l i d i t y . ( Id . a t 59. )Spec i f i c a l l y , Def enda nt s c on te nd t h a t : (1 ) P l a i n t i f f ' s c l i n i c a lexper t , Dr. Jones , was not c red ib le and should not be cons idered(id . a t 60-61) i (2 ) rosuvas t a t in i s not a commercial success ( id .a t 61 ) i (3) rosuvas t a t in d id not s a t i s f y any long f e l t , bu t unmetneed ( id . a t 61-62) i (4) r o suvas t a t i n ' s p rope r t i e s were no tunexpected ( id . a t 62-63) i (5) P l a i n t i f f s d id no t e s t ab l i sh t h a to the r s t r i ed and fa i l ed to develop a s t a t in comparable torosuvas t a t in ( id . a t 64) i (6) t h e re was no skep t ic i sm concerningrosuvas t a t in ( id . a t 65) i and (7) th e evidence o f copyingrosuvas t a t in i s l im ited to Defendants ' a t tempts to produce agener ic vers ion which i s not ev idence o f n on -o bv io us ne ss .a t 65-66. )

( r d .

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In re sp on se , P l a i n t i f f s contend t h a t Defendants have notes t ab l i shed by c l ea r and convin ci ng evid ence t h a t the '314 pa ten ti s obvious. (D .I . 540 a t 53.) Spec i f i ca l ly , P l a i n t i f f s contendt h a t the scope and con ten t o f the re levant p r i o r a r t does notprovide evidence o f obviousness , because seve ra l en t i t i e sabandoned t h e i r research e f fo r t s r e l a t ed to pyrimidine cores t a t in s based upon the preva i l ing be l i e f tha t pyrimidine coreswere i n f e r io r to then ex is t ing techno logy . (Id . a t 61-62. )Addi t iona l ly , P l a i n t i f f s contend t h a t th e cla im s of th e '314pa ten t t h a t a re spec i f i c to r os uv as ta tin p resen t unique andinseparab le fea tu re s and prope r t i e s t h a t were discovered anddeveloped by the inven to rs of the pa t en t - i n - su i t .64.)

(Id . a t 63-

According to P l a i n t i f f s , De fendan ts ' a ss ump tions andas se r t ions about th e development of rosuvas t a t in a re based on ahinds igh t ana lys i s of a successfu l product and ignore thejudgments , dec is ions , and experimentat ion t h a t was requ i red toreach th e end product . (Id. a t 65-66.) In t h i s regard ,P l a i n t i f f s contend t ha t Defendants have not shown any reason whyit would have been obvious to s t a r t with Compound 1b as opposedto one of the many othe r su i tab le s t a r t i ng po in t s . (Id . a t 67.)However, even i f a person sk i l l ed in the a r t happened to s t a r twith Compound 1b, P l a i n t i f f s contend t h a t t he re was no obvious

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motivat ion to make th e modi fi ca tio ns to Compound Ib t h a tul t ima te ly led to the crea t ion of rosuvas t a t in . (Id . a t 68.)

In add i t ion , P l a i n t i f f s contend t h a t th e secondaryconsidera t ions demonst ra te t h a t th e in ve ntio n c la imed in the '314pa ten t was no t o bv iou s. Spec i f i ca l ly , P l a i n t i f f s contend t ha t(1) rosuvas t a t in had unexpected proper t i es ; (2) othe rs wereskep t i ca l o f th e sa fe ty of rosuvas t a t in ; (3) rosuvas ta t in met al ong - fe l t , but unmet need; and (4) othe r companies fa i l ed todevelop a pyrimidine based s t a t i n a t the t ime of th e in ve ntio n o frosuvas t a t in and Defendants now seek to copy th e product t h a tP l a i n t i f f s succeeded in bringing to the market . (Id . a t 72-76. )

B. Legal Pr inc ip l e s Related To ObviousnessIn pe r t i nen t pa r t , 35 U.S.C. 103 prov ides t h a t a pa ten t

may not be obta ined " i f the di f fe rences between th e sub jec tmat te r sought to be paten ted and the p r i o r a r t a re such t h a t th es ub je ct m atte r as a whole would have been obvious to a personhaving ord inary s k i l l in th e a r t . " 35 U.S.C. 103. Obviousnessi s a ques t ion of law t h a t i s pred ica ted upon seve ra l fac tua li nqu i r i e s . See Richardson-Vicks v. Upjohn Co., 122 F.3d 1476,1479 (Fed. Cir . 1997) . Spec i f i ca l ly , the t r i e r of fac t mustconsider four i s sues : (1) th e scope and con ten t o f th e p r i o r a r t ;(2) the l eve l of ord inary s k i l l in the a r t ; (3) the di f fe rencesbetween th e claimed sub jec t mat te r and the p r i o r a r t ; and (4)secondary considera t ions of non-obviousness , such as commercial

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success , long f e l t bu t unsolved need, f a i l u re of o ther s ,a cq ui es ce nc e o f othe rs in the indus t ry t h a t the pa ten t i s va l id ,and unexpected r e su l t s . Graham v. John Deere Co. , 383 U.S. 1,17-18 (1966) (the "Graham f ac to r s " ) . In KSR In te rn . Co. v.Telef lex I nc . , the Supreme Court reaf f i rmed t h a t the Grahamf ac to r s "cont inue to define the inqu iry t h a t con t ro l s " anobviousness ana lys i s . 550 U.S. 398, 407 (2007) .

Because an i ssued patent i s presumed va l id , the par ty -seeking to c ha lle ng e th e va l id i t y of a pa ten t based onobviousness must demonst ra te by c l ea r and convi nc ing evi dencet h a t th e inven t ion descr ibed in th e pa ten t would have beenobvious to a person of ord inary s k i l l in th e a r t a t the t ime th einven t ion was made. Pf ize r , Inc . v. Apotex, Inc . , 480 F.3d 1348,1359-60 (Fed. Cir . 2007) . Clear and convi nc ing evi dence i sevidence t h a t places in the fac t f inde r "an abi din g conv ic ti ont ha t the t r u th of [ the] fac tua l con ten t ions are ' h igh lyprobab le . ' " Colorado v. New Mexico, 467 U.S. 310, 316 (1984)

C. Whether The '314 Patent I s Inva l id As ObviousAf te r e va lu atin g th e e xte ns iv e arguments of the pa r t i e s and

the evidence adduced a t t r i a l , the Cour t concludes t h a tDefendants have not demonst ra ted by c lea r and convi nc ing evi dencet h a t the '314 pa ten t i s inva l id as obvious. In the Cour t ' s view,Defendants ' arguments are driven by hinds igh t and based onnumerous assumpt ions , the va l id i t y of which w ere coun te red by

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P l a i n t i f f s ' equal ly compell in g evi denc e t h a t s i gn i f i c an t work wasneeded to develop rosuvas t a t in . (See Heathcock Tr. 2 63 :2 -2 70 :2 1;Roush T r. 1 74 3:2 4- 17 45 :2 , 1 76 9:2 0- 17 73 :1 5.) In add i t ion , theCour t i s persuaded t h a t the f i r s t and t h i rd Graham f ac to r s ,concerning the scope and content of th e p r i o r a r t and thed i f fe rences between the p r i o r a r t and th e claimed sub jec t mat te r ,re spec t ive ly , weigh in favor of a conclus ion t ha t th e c la imedinven t ion was not obvious. For example, while Compound 1b wasre l evan t p r i o r a r t to the '314 pa ten t , th e Cour t i s no t convincedt h a t it would have been obvious to a person sk i l l ed in the a r tt h a t rosuvas ta t in was merely seve ra l , obvious modi f ica t ions awayfrom Compound lb . That rosuvas ta t in was not obvious from th escope and content of th e p r i o r a r t i s demonstra ted by the f ac tt h a t o ther pharmaceut ical en t i t i e s working on p yrim id in e c ores t a t in s d id not c r ea t e a s t a t in comparable to r os uv as ta ti n and,in fac t , abandoned t h e i r e f fo r t s . Furthermore, mult ip lemodi f ica t ions to th e bas ic pyr im id in e c or e s t ruc tu re wererequ i red to c rea te rosuvas t a t in , and the Cour t i s n ot p ersu ad edt h a t these modi f i ca t ions would have been obvious to one sk i l l edin th e a r t .Addi t iona l ly , the Court concludes t ha t the secondary f ac to r s

of non-obviousness weigh in favor o f a conclus ion t h a t th e '314pa ten t i s n ot o bv io us. The evi dence d emon st ra te s t h a t t he re wasmuch skept ic ism in th e in du stry concerning the sa fe ty of

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rosuvas ta t in (P ears T r. 1 30 7:1 2- 13 10 :2 2), and the Cour t f inds itt e l l i ng t h a t no othe r pharmaceut ical companies at tempted toc rea te a comparable product d e sp it e r es ea rc h in the area and theeconomic incent ives of en te r ing an add i t iona l p lay e r in th es t a t in market . (Heathcock T r. 290:6-18; Roush Tr. 1728:13-1729:19.) A ccordingly , based on th e foregoing , the Courtconcludes t ha t Defendants have not shown by c l ea r and convincingevidence t h a t the '314 pa ten t i s inva l id as obvious, andt he re fo re , judgment wi l l be en tered in favor of P l a i n t i f f s andaga ins t Defendants on the i s sue of i nva l id i t y due to obviousness .v. REISSUE

A. The Pa r t i e s ' Content ionsDef endants c on te nd t h a t Pla in t i f f s cannot e s t ab l i sh

in fr in gement o f th e '314 pa ten t because it i s inva l id asimproperly re i s sued . (D. l . 501 a t 66.) According to Defendants ,t he re were no e r ro rs in the o r ig ina l '440 pa ten t t h a t warran tedre issue under th e governing s t a tu t e . ( ld . ) Defendants contendt h a t Shionogi de l ibe ra te ly chose not to cla im rosuvas ta t in in th e'440 pa ten t as pa r t of a company dec i s ion to concea l th edevelopment of th e product from competi to rs . ( ld . a t 78-80. )Defendants also contend t h a t Shionogi d e li be r a te ly c r af te d abroad claim in th e '440 pa ten t t h a t overlapped the Sandozre fe rence in an a t tempt to g ar ne r e xte ns iv e p ro te ctio n, d es pitet imely knowledge of the Sandoz re fe rence . (ld. a t 80-83. )

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Defendants mainta in t h a t Shio nogi to ok f u l l advantage o f t h eb r e a d t h of t h e claimed i n v e n t i o n and only sought t o narrow thep a t e n t t o claim r o s u v a s t a t i n s p e c i f i c a l l y , when it becameadvantageous t o l i c e n se t h e compound. (Id. a t 83.)

In resp onse, P l a i n t i f f s contend t h a t t h e r e i s s u e of t h e '440p a t e n t was e n t i r e l y proper and based upon v a l i d grounds f o rr e i s s u e . (D.I. 540 a t 42.) S p e c i f i c a l l y , P l a i n t i f f s contendt h a t t h e d e l i b e r a t e p r e s e n t a t i o n of cla ims t h a t a r e l a t e rrecognized t o be too broad i s a c o r r e c t a b l e e r r o r j u s t i f y i n gr e i s s u e . According t o P l a i n t i f f s , t h e over b r e a d t h of t h e '440p a t e n t and t h e f a i l u r e t o claim r o s u v a s t a t i n s p e c i f i c a l l y was notbased on an i n t e n t t o deceive , but on the misunders tandings andmisapprehensions of i n d i v i d u a l s who were not w e l l - t r a i n e d ands u f f i c i e n t l y exper ienced. (See I d . g e n e r a l l y . ) P l a i n t i f f sf u r t h e r contend t h a t t h e r e i s no l e g a l support f o r Defendants 'c o n t e n t i o n t h a t e q u i t a b l e p r i n c i p l e s demand a conclusion t h a tt h e r e i s s u e was improper. (Id . a t 50.)

B. Legal P r i n c i p l e s Related To The Reissue of P a t e n t sA p a t e n t may be r e i s s u e d t o c o r r e c t an e r r o r under 35 u.s.c.

251, which, i n p e r t i n e n t p a r t s t a t e s :Whenever any p a t e n t i s , through e r r o r withou t anyd e c e p t i v e i n t e n t i o n , deemed wholly o r p a r t l yi n o p e r a t i v e o r i n v a l i d , by reason o f a d e f e c t i v es p e c i f i c a t i o n o r drawing, o r by reason of thep a t e n t e e cla iming more o r l e s s than he had a r i g h tt o claim i n t h e p a t e n t , t h e D i r e c t o r s h a l l , on t h es u r r e n d e r o f such p a t e n t and t h e paYment of t h e feer e q u i r e d by law, r e i s s u e t h e p a t e n t f o r t h e

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invent ion disc losed in the o r ig ina l pa ten t , and inaccordance with a new amended app l ica t ion , fo r th eunexpired pa r t of the term of th e or ig ina l pa ten t .No new mat te r sha l l be in t roduced in to th eapp l ica t ion fo r r e i s sue .

35 U.S.C. 251. Under t h i s sec t ion , r e i s sue i s permi t t ed tocor rec t the f ol low in g t yp es of defec ts : (1) an e r ro r in th espec i f i c a t i on , (2) a de fec t ive drawing, (3) th e o r ig ina l claimwas too broad, and (4) the o r ig ina l claim was too narrow. Fores tLabs . , Inc. v. Ivax Pharms. , Inc . , 438 F. Supp. 2d 479, 497 (D.D el. 2006). " [T ]h e p urp os e of the re issue s t a tu t e i s to avoidfo r f e i t u re of subs tant ive r igh t s due to e r r o r made without i n t en tto dece ive . " Id . (c i t a t ions omi t t ed) . The s t a t u t e i s remedia lin natu re and based upon fundamental pr inc ip les of equ i ty andf a i rnes s , and thus, should be l i be ra l l y cons t rued so as to permitr e i s sue . See In re Wilder , 736 F.2d 1516, 1519 (Fed Cir . 1984)

Not every event o r circumstance t h a t might be l abe led an"er ro r" i s cor rec t ab le by re i s sue proceedings . In re Weiler , 790F.2d 1576, 1579 (Fed. Cir . 1986) (c i t a t ion omi t t ed) ; see a lso MBOLabs. Inc . v . Becton, Dickinson & Co. , 602 F.3d 1306, 1313 (Fed.Cir . 2010) (confirming s tandard) . Genera l ly , those e r ro rs th atare cor rec t ab le by re issue a re er ro r s of "inadvertence, acc ident ,o r mistake." Weiler , 790 F.2d a t 1582. A "de l ibe ra te ac t ion ofan inven to r o r a t to rney during prosecu t ion gene ra l ly f a i l s toqua l i fy as cor rec t ab le e r ro r , " where the r e i s sue would contraveneth e o pe ra tio n of appl icable s t a tu t e s o r USPTO ru les . In re

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Serenkin , 479 F.3d 1359, 1362, 1364 (Fed. C i r . 2007). Thus, t h emere f a c t t h a t an a c t i o n was taken i n " f u l l consciousness" doesnot n e c e s s a r i l y p r e c l u d e t h e f i n d i n g o f a c o r r e c t a b l e e r r o r ,where t h e a c t i o n was not tak en w ith d e c e p t i v e i n t e n t , and t h er e i s s u e would n ot c on tra ve ne t h e law.1200, 1207 (C.C.P.A. 1974).

I n r e Wadlinger , 496 F.2d

When a p a r t y c h a l l e n g e s a p a t e n t ' s v a l i d i ty based onr e i s s u e , t h e presumpt ion t h a t t h e p a t e n t i s v a l i d remains . Thus,t h e p a r t y c h a l l e n g i n g t h e a p p r o p r i a t e n e s s o f t h e r e i s s u e mustprove t h e i n v a l i d i t y of t h e r e i s s u e by c l e a r and convincingevidence. See Kau fman Co. v. Lantech, I n c . , 807 F.2d 970, 973-74(Fed. C i r . 1986).

C. Whether t h e '314 P a t e n t I s I n v a l i d As Improper lyReissuedA f t e r reviewing t h e p a r t i e s ' arguments i n l i g h t of t h e

evidence adduced a t t r i a l , t h e Court concludes t h a t Defendantshave not e s t a b l i s h e d , by c l e a r and convi nc ing ev id ence, t h a t t h e'314 p a t e n t i s i n v a l i d as an improper r e i s s u e of t h e '440 p a t e n t .While t h e t r o u b l e s i n t h e Shionogi P a t e n t Department r a i s e t h es p e c t e r of malfeasance i n h i n d s i g h t , t h e Cour t i s u l t i m a t e l y notconvinced t h a t t h e cla im s of t h e '440 p a t e n t t h a t ove rla pp ed w it ht h e Sandoz r e f e r e n c e were the r e s u l t of some planned s t r a t e g y o rs i n i s t e r m o ti v a t i o n a s opposed t o mere mistake o r o v e r s i g h t byoverworked i n d i v i d u a l s with l i m i t e d t r a i n i n g and e x p e r t i s e . Toreach a c o n t r a r y conclusion i n t h i s case would r e q u i r e t h e Cour t

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to c red i t a number of infe rences , which the Cour t f indsunsuppor ted by the r eq u is ite c le ar and convincing s tandard .Rather , the t o t a l i t y of the evidence demonstra tes to th e Courtt h a t it was equa l ly p laus ib le t ha t t h i s e r ro r was dr iven bychaos, confus ion , and inexper ience r a t he r than any de l ibe ra teplan of ac t ion . The lack o f l ega l t ra in ing with in the ShionogiPaten t Department, the changing and l imi ted personnel within t h a tdepar tment , and the ongoing confus ion l eve l ind ica te t h a tconfus ion i s a t le a s t as l i ke ly a cause of the over lap withSandoz, as any cause t ha t would have made r e i s sue improper. (SeeShibata 799: 9- 800 :19 , 803 :4 -804 :16; Kitamura 1536:3-9; DTX-500 a t214; Takayama Dep. 231:3-25.) As Ms. Kitamura cred ib lyt e s t i f i ed , th e i n t e rna l Shionogi search repor t of which she wasaware, did not r a i s e a pa ten t ab i l i t y problem with re spec t toSandoz, and a fu l l copy of the Sandoz re fe rence was no t sen t toher . (Kitamura T r. 1 41 4:1 4-1 422:3 , 1 42 3:2 0-1 424:4 , 1 48 1:3 -1 4,1458:17-22; DTX-33; DTX-22-T.) Thus, Ms. Kitamura d id notapprec ia te any overlap with the Sandoz re fe rence p r i o r to herdepar tu re from Shionogi , and those who prosecuted the '440 pa ten ta f t e r h er d ep ar tu re were l ikewise unaware of the Sandoz re fe rencedue to the unin ten t iona l miscommunications t h a t ensued dur ing thevar ious t r a ns it io n s a t Shionogi . (Kitamura 1504:10-1505:14; DTX-515-T a t 22-23; DTX-5.)

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Defendants a lso suggest t h a t the overbreadth of th e cla imswas a de l ibera te i n t en t to concea l Shionogi ' s development ofrosuvas t a t a in from i t s compet i to rs , and t ha t th i s dece i t fu lin t en t precludes r e i s sue . Although Defendants provided someevidence t ha t th e Shionogi pa ten t app l ica t ion process may havebeen driven by s t r a t eg i c dec i s ions to delay compet i t iors froml ea rning of t h e i r development of rosuvas ta t in , the Cour t i su l t imate ly no t persuaded t h a t Defendants have es tab l i shed , byc l ea r and conv inc ing ev idence , t ha t th e r e i s sue was improper.As a threshold mat te r , th e Court f inds no evidence t h a t Shionogide l ibe ra te ly and decept ive ly decided to fo rg o n arrowly cla imingrosuvas ta t in . Rather , th e '440 pa ten t both covered and descr ibedrosuvas ta t in in the examples l i s t ed w ith in the spec i f i ca t ion andin the bread th o f the o r ig ina l c la ims . (PTX-495 a t SH89082-86jSH89090j PTX-590 a t C57140-44, C57149-50j PTX-609 a t SH88362,SH88369-71, SH88374j Tamaki 459:7-460:-13 .) The a p pli ca ti on a ls opresen ted data showing t h a t rosuvas ta t in had ac t i v i t y 4 .5 t imeshigher than mevinol in , and t he re fo re , rosuvas ta t in c lea r ly hadthe bes t ac t i v i t y of any of the compounds di sc losed in the pa ten tapp l ica t ion . (PTX-495 a t SH89092j PTX-590 a t C57150j PTX-609 a tSH88375.) Thus, Shionogi ' s i n t e r e s t i n r os uv as ta tin would havebeen evident from the app l i ca t ion , and the Cour t i s no t persuadedt h a t the fa i lu re to spec i f i c a l l y cla im rosuvas ta t in was ther e su l t of any decept ive i n t en t by Shionogi o r any purposefu l

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d e s i r e t o avoid such a narrow cla im. Based on t h i s d i s c l o s u r e ,it i s t h e C o u rt ' s view, t h a t t h e e r r o r i n t h e '440 p a t e n t was noti n f a i l i n g t o cla im r o s u v a s t a t i n but i n unknowingly cla imings u b j e c t m a t t e r broader t h a n r o s u v a s t a t i n t h a t ove rl ap ped w ith t h eSandoz r e f e r e n c e , an e r r o r which t h e Court concludes i s p r o p e r l yremedied by r e i s s u e . See I n r e H a r i t a , 847 F.2d 801, 804-805(Fed. C i r . 1988) i Wilder , 736 F.2d a t 1519.

In a d d i t i o n , t h e Cour t f i n d s t h e circumstances here t o bed i s t i n g u i s h a b l e from c a s e s l i k e In r e Serenkin , 479 F.3d 1359,1363 (Fed. C i r . 2007) . I n Serenkin , r e i s s u e was denied f o r l a c kof e r r o r because t h e a t t o r n e y p r o se c u ti n g t h e p a t e n t knowinglys u r r e n d e r e d a p r i o r i t y d a t e f o r t h e p a t e n t i n o r d e r t o achieve as p e c i f i c and d ef i n ed g a i n i n t h e form o f being a b l e t o submit newdrawings and o t h e r m a t e ri a ls t h a t had been miss ing i n t h e e a r l i e ra p p l i c a t i o n . In c o n t r a s t , t h e evidence adduced i n t h i s caseshows no such d e l i b e r a t e choices and no v i o l a t i o n s o f r u l e s o rs t a t u t e s t h a t would r e n d e r t h e r e i s s u e of t h e '440 p a t e n timproper. Accordingly , t h e Court concludes t h a t Defendants havenot e s t a b l i s h e d by c l e a r and conv in ci ng evi denc e t h a t t h er e i s s u e d '314 p a t e n t , with i t s r o s u v a s t a t i n s p e c i f i c c l a i m s , i si n v a l i d , and t h e r e f o r e , t h e Court w i l l g r a n t judgment i n f a v o r o fP l a i n t i f f s and a g a i n s t Defendants on t h e i s s u e of improperr e i s s u e .

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CONCLUSION

For the reasons d iscussed , the Court concludes t h a t Apotexmay be held l i ab l e fo r in f r ingement o f cla ims 6 and 8 o f the '314pa ten t under Sect ion 271(e) (2) (A) as a submi t t e r o f an ANDA. Inadd i t ion , the Court wi l l g ran t Defendants ' Motion To DismissAstraZeneca Pharmaceut i ca l s LP For Lack o f Standing . Judgmentwi l l be en tered in favor of P l a i n t i f f s and aga ins t Defendants onthe i s sues o f i nva l i d i t y and unenforceab i l i t y o f th e '314 pa ten t .P l a i n t i f f s sha l l submit , with not ice to Defendants a proposedFina l Judgment Order , ou t l in ing th e Cour t ' s ru l ings onin f r ingement , i nva l i d i t y and unenforceab i l i t y con ta ined he re in .

An appropr ia te Order wi l l be en tered .

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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE

IN RE: ROSUVASTATIN CALCIUMPATENT LITIGATION,ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,

P l a i n t i f f s ,v.

MYLAN PHARMACEUTICALS INC.,Defendant .



SUN PHARMACEUTICAL INDUSTRIESLTD. ,

Defendant .ASTRAZENECA PHARMACEUTICALSLP, ASTRAZENECA UK LIMITED,IPR PHARMACEUTICALS INC., ANDSHIONOGI SEIYAKU KABUSHIKIKAISHA,

P l a i n t i f f s ,v.

SANDOZ INC.,Defendant.

in re rosuvastatin calcium patent litig., c.a. no. 08-1949-jjf-lps (d. del. june 29, 2010) (farnan,...

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