Takeda Pharmaceutical Company et. al. v. Hetero Drugs et. al.

8/3/2019 Takeda Pharmaceutical Company et. al. v. Hetero Drugs et. al.

1/28

U V S 1 ) ,C s S O D.CASHIERSCivil Action N oakeda Pharmaceut ical Company Limited andTakeda Ph armaceu ticals No rth America, Inc.,UNITED STATES DISTRICT COURTSOUTHERN DISTRICT OF NEW YORK --E O T ETTr'z n Plaintiffs,

v. C O M P L A I N THetero Drugs Limited,Hetero Labs Lim ited Unit V,Hetero USA Inc.,Cam ber Pharm aceuticals Inc., andInvagen Pharm aceuticals Inc.,

Defendants.

Anthony J. V iolaAndre K. CizmarikZachary W . SilvermanEDWARDS WILDMAN PALMER LLPAttorneys for PlaintiffsTakeda P harmaceut ical Company Limited, andTakeda Pharmaceuticals North America, Inc.750 Lexington Ave.New Y ork , NY 10022(212) 308-4411

C iV 8302

Plaintiffs, Takeda Pharmaceutical Company Limited (formerly known as TakedaChem ical Industries, Ltd.) ("TPC") and Takeda Ph armaceu ticals North Ame rica, Inc. ("TPN A")(collectively, "Takeda" or "Plaintiffs"), by their undersigned co unsel, for their Complaint againstdefendants Hetero Drugs Limited, Hetero Labs Lim ited Unit V, Hetero USA Inc., CamberPharm aceuticals Inc., and Invagen P harmac euticals Inc. (collectively "Hetero" or "Defendants"),allege as follows:


2/28

Jurisdiction and Venue1. This i s an act ion for patent inf r ingem ent ar is ing un der the patent laws of the

United Sta tes , Ti tle 35, United Sta tes Code an d ar is ing under 3 5 U.S.C. 271(e) (2) , 271(b) , and281-283 . Subjec t m a t te r ju ri sd ic tion i s p roper und er 28 U.S .C. 1331 and 1338 (a ) . Venue i sproper un der 28 U.S.C. 1391(b)- (c) and 1400 (b) . Personal jur isdic t ion over the defenda nt inNew York i s p roper under N .Y. C .P .L .R. 301 and 302(a ) , and because the de fendant i s do ingbusiness in this jur isdict ion.

Parties2. TPC is a Japanese corporat ion hav ing i ts corporate headquarters in Osaka, Japan

and p r inc ipa l p lace of bus iness in Osaka , Japan . TPN A is a wh ol ly own ed U.S . subs id ia ry ofTakeda A m er ican Hold ings , Inc . , wh ich i s a who l ly owned U.S . subs id ia ry of TPC. TPN A hasi ts corporate headquarters and pr inc ipal p lace of bu siness in Deerf ie ld , I ll inois and is orga nizedunder the l aws o f Delaware .

3. TPC i s engaged in the bu s iness o f r esearch , deve lop ing , ma nufac turing andm arke ting of a b road spec t rum of innova t ive pharmaceu t ica l p roduc ts , inc lud ing ACT OS whichcontains the act ive ingredient piogl i tazone.

4. Upon informat ion and be l ie f , de fendant He te ro Drugs L imi ted ( "He te ro Drugs")i s an Indian corporat ion hav ing a pr incipal place of bus iness at 7-2-A2, Hetero Corpo rateIndus t r ial Es tates , Sanath N agar , Hyde rabad - 500 018 , A.P. India.

5. Upon inform at ion an d be l i e f, He te ro Labs L im i ted Uni t V ( "Hete ro L abs") i s anInd ian corpora tion having a p r inc ipa l p lace of bus iness a t Survey N o. 439 , 440 , 44 1 & 458 ,APIIC Formula t ion SEZ, Polepa l ly Vi l l age , Jadcher la Manda l , Mahaboo b N agar Dis t-509 301 ,Andhra Pradesh , Ind ia .

2


3/28

6. Upon inform at ion and be l i e f , He te ro USA Inc . ( "He tero USA") i s a com panyorgan ized and exis t ing und er the laws of Delaware, having i t s pr incipal place of bus iness at 1035Centennia l Avenue , P i sca taway , N J 0885 4 . Upon informat ion and be l i e f , He te ro USA i s awho l ly-owne d subs id ia ry o f H etero Drugs .

7. Upon info rmation an d bel ief , Hetero USA is the "U.S. Regulatory Ag ent" withrespec t to A NDA No . 203467 ( the "He te ro AN DA") , wh ich i s the sub jec t o f th i s ac tion .

8. Upon info rmation an d bel ief , Hetero f i led the Hetero AN DA with respect top iog l it azone hydroch lor ide t ab let s , 15 mg , 30 m g , and 45 mg .

9. Upon inform ation and bel ief , Hetero se l ls generic drugs througho ut the UnitedStates , inc luding in a t leas t Ne w Y ork, through i ts U.S. m arket ing off ices , which inc lude Cam berPharm aceu t ica ls Inc . ("Cam ber") and Invagen P harmaceu t ica l s Inc . ( " Invagen ") . Camber i s aDelaware co rpora t ion w i th a pr inc ipa l p l ace o f b us ines s a t 1031 Cen tenn ia l Avenue , P i s ca taway,New Je rsey 08854 . Invagen i s a N ew Y ork corpora t ion w i th a p r inc ipa l p lace of bus iness a t 7Oser Avenue , Hauppauge , New Y ork 11788 . Upon inform at ion and b e l ie f , Camber and Invagenare w ho l ly -own ed subs id ia r ies o f H etero Drugs .

10. Upon info rm ation and bel ief , Hetero is current ly t ransac t ing business in theSouthern D istric t of New Yo rk, a t leas t by m aking an d shipping into th is Judic ia l Dis tric t , or byusing, offer ing to se l l or se l ling or by ca using others to use , offer to se l l or se l l, pharm aceut icalproduc ts . Upon info rma tion and bel ief , Hetero der ives substant ia l revenu e f rom inters ta te and/orin te rna t iona l comm erce , inc lud ing subs tan ti a l revenue f rom goods used or consum ed or se rv icesrendered in the Sta te of N ew Y ork and th is Judic ia l Dis tr ic t . By f il ing i ts ANDA , Hetero hascom m i tted , and unless enjo ined , w i l l cont inue to co mm i t a to r tious ac t w i thou t the S ta te of New

3


4/28

York , w h ich He te ro expec t s or shou ld reasonab ly expec t to have con sequences in the S ta te ofN e w Y o rk .

The N ew Drug A pplication11. TPN A se l l s p iog li tazone-conta in ing d rug p roduc t s under the t rade nam e ACT OS

New Drug Appl ica t ion ( "NDA") he ld by TPNA (N DA No. 21-073) .12. ACT OS i s approved for use as an adjunct to d ie t and exerc ise to impro ve

glycemic control in pat ients wi th Type 2 Diabetes (non-insul in-dependent diabetes mel l i tus ) .

ACT OS i s ind ica ted for mo nothe rapy . ACTOS i s a lso indicated for use in com binat ion w ith asulfonylurea , m etformin , or insul in wh en die t and exerc ise p lus the s ingle agent does not resul t inadequate glycem ic control.

13. The approval l e tt e r f o r ACTOS , wi th approved label ing, wa s issued by the FDAon Ju ly 15 , 1999 . The approva l w as for bo th mo nothe rapy and com bina t ion the rapy , based uponthe FDA's considerat ion of c l inical s tudies , presented in a s ingle N DA, for both types o ftherapies .

14. Cer ta in am endm ent s to the approved l abe l ing fo r ACT OS have subsequent lybeen approved .

The Patents in Suit15. United Sta tes Patent No. 5,965,584 ("the '584 patent") , ent i tled "Pharm aceut ical

Com pos i ti on , " a true and co r rec t copy o f w hich i s appended here to as Exhibit A, was du lyi ssued on October 12, 1999 to inventors Hitoshi Ikeda, Takashi Sohda and Hiroyu ki Odaka andass igned to p la in t i ff TP C. The '584 pa ten t c la im s , in te r a li a , a pharmaceu t ica l com pos i t ioncompris ing piogl i tazone [()-54[442-(5-ethyl-2-pyrid inyl)e thoxy]phenyl]methy1]-2,4-th iazol id inedione], or sa l ts thereof in comb inat ion with a b iguanidee t fo rm in) and

4


5/28

m ethods for t reating diabetes which com prise adminis ter ing a therapeut ical ly effec t ive amou nt ofpiogl i tazone or sal t s thereof in comb inat ion wi th a biguanide.

16. Plaint i f f TP C has been an d s t i ll i s the own er through ass ignm ent of the '584patent , which expires on June 19, 2016.

17. United Sta tes Patent No. 6 ,329,404 ("the '404 p atent") , ent it led "Pharm aceut icalcom pos i ti on , " a true and co r rec t copy o f w hich i s appended here to as ExhibitA3, was du ly i s suedon December 11 , 200 1 to inventors Hi tosh i Ikeda , Takash i Sohda and Hi royuk i Odaka , andass igned to p la in t i ff TPC . The '404 pa ten t c la im s , in te r a li a , a pharmaceu t ica l com pos i t ioncom pris ing piogl i tazone or sal t s thereof in comb inat ion wi th an insul in secret ion enhan cer (e.g. ,a sulfonylurea , such as g l im epir ide) and metho ds for treat ing diabetes which com priseadm inis tering a therapeut ical ly ef fect ive am ount of piogl i tazone or sal ts thereof in com binat ionwith an insul in secret ion enh ancer .

18. Plaint i f f TPC h as been and s t i l l is the own er through ass ignm ent of the '404patent , which expires on June 19, 2016.

19. United Sta tes Patent No . 6 ,166,043 ("the '043 patent") , ent i t led "Pharm aceut icalCom pos i ti on , " a true and co r rec t copy o f w hich i s appended here to as Exh ibit C, was du lyi s sued on December 26 , 2000 to inventors Hi tosh i Ikeda , Takash i Sohda and Hi royuk i Odaka ,and ass igned to p la in ti f f TPC. The ' 043 pa ten t c la im s , in te r al i a , m e thods for reduc ing theamo unt of ac t ive com ponents adm ini ste red to a d iabe ti c pa t ien t , wh ich com pr i se adm ini ste ring atherapeut ical ly effec t ive amo unt of p iogl i tazone or sa l ts thereof in comb inat ion with a b iguanide,e . g . , m etfounin.

20. Plaint i f f TPC h as been and s t i l l is the own er through ass ignm ent of the '043patent , which expires on June 19, 2016.

5


6/28

21. United States Patent No. 6,172,090 ("the '090 patent"), entit led "Pharm aceuticalCom position," a true and correct copy of which is append ed hereto as Exhibit D, was dulyissued on January 9, 2001 to inventors Hitoshi Ikeda, Takashi Sohd a and Hiroyuki Odaka, andassigned to plaintiff TPC. The '090 patent claims, in te r alia, methods for reducing the sideeffects of active com ponents adm inistered to a diabetic patient, which co mp rise administering atherapeutically effective amoun t of pioglitazone or salts thereof in comb ination with a biguanide,e. g., metformin, as the active componen ts.

22. Plaintiff TP C has been an d sti l l is the owner through assignm ent of the '090patent, which expires on Jun e 19, 2016.

23. United States Patent N o. 6,211,20 5 ("the '205 patent"), entit led "Pharma ceuticalCom position," a true and correct copy of which is append ed hereto as Exhibit E, was dulyissued on April 3, 2001 to inventors Hitoshi Ikeda, Takashi Sohda and Hiroyuki Odaka, andassigned to plaint iff TPC. T he '205 patent claims, inter al ia , methods for reducing the am ount ofactive compo nents adm inistered to a diabetic patient, which com prises administering atherapeutically effective am ount of pioglitazone or salts thereof in com bination with an insulinsecretion enhancer (e.g., a sulfonylurea).

24. Plaintiff TPC h as been and sti ll is the ow ner through assignm ent of the '205patent, which expires on June 19, 2016.

25. United States Patent N o. 6,271,24 3 ("the '243 patent"), entitled "Pharm aceuticalCom position," a true and correct copy of which is append ed hereto as Exhibit F, was duly issuedon Aug ust 7, 2001 to inventors Hitoshi Ikeda, Takashi Sohda and H iroyuki Odaka, and assignedto plaintiff TPC . The '243 patent claims, inter alia , m ethods for reducing the side effects ofactive compo nents adm inistered to a diabetic patient, which com prises administering a

6


7/28

therapeut ical ly effec t ive am oun t of p iogl i tazone o r sa l ts thereof in com binat ion w ith an insul inpreparat ion.

26. Plaint i f f TPC h as been and s t i l l is the own er through ass ignm ent of the '243paten t , which expi res on June 19 , 2016.

27. United Sta tes Patent No . 6 ,303 ,640 ("the '640 paten t") , ent i t led "Pharm aceut icalCom pos i ti on , " a true and co r rec t copy o f w hich i s appended here to as Exhibit G, was du lyissued on October 16, 2001 to inventors Hitoshi Ikeda, Takashi Sohda and Hiroy uki Odaka, andass igned to p la in t i ff TP C. The '640 pa ten t c la ims , in te r a l i a , me thods for reduc ing the s ideeffec ts of ac t ive com pon ents adm inis tered to a d iabet ic pat ient , wh ich com prises adminis ter ing atherapeut ical ly effec t ive am oun t of a p iogl i tazone o r sa l t thereof in com binat ion w ith an insul insecret ion enhan cer (e.g. , a sul fonylurea) .

28. Plaint i f f TPC has been an d s t i ll i s the own er through ass ignm ent of the '640patent , which expires on Aug ust 9 , 2016.

29. Plaint i f f TPC has granted an ex clusive l icense to p la int i f f TPN A und er the '584patent , the '404 paten t , the '043 pa tent , the '090 pa tent , the '205 patent , the '243 paten t , and the`640 patent (col lect ively, the "Taked a Patents") .

30. In accordan ce with i ts exc lusive l icense , p la int i f f TPN A sel ls p iogl i tazone -con ta in ing drug produc t s under the t rade nam e ACT OS , amo ng o thers , in the Uni ted States .Sales of TPNA's p iogl i tazone-conta ining drug products are made pursuant to approval by theFDA of , amo ng o the rs , NDA No . 21-073 .

31. Pla in ti f f TPC m anufac tures the AC TOS drug produc t s so ld by TPNA .32. Pla in ti f fs TP C and TPN A w i l l be both subs tan t ia l ly and i r repa rab ly ha rm ed by

inf r ingem ent of any of the Takeda Pa ten t s. There i s no adequa te remedy a t l aw.

7


8/28

C O U N T I( INFRINGEMEN T OF TH E ' 584 PATEN T UN DER 35 U.S .C . 271(E ) (2 ) (A) )

33. Pla in ti f fs TPC and T PN A repea t and incorpora te here in by r e f erence thea l lega t ions con ta ined in each o f the fo rego ing paragraphs .

34. Upon informat ion and be l ie f , He te ro f i l ed an A bbrevia ted N ew Drug Appl ica t ion( "ANDA") w i th the Food and Drug A dminis t ra t ion ( "FDA") under 21 U.S .C. 355( j ) (ANDANo . 203467) seek ing approva l to marke t 15 m g , 30 m g , and 45 m g tab le ts com pr i singpiogl i tazone as i ts hydroch lor ide ("HCl") sa l t .

35. By this AN DA fi l ing, Hetero has indicated that i t intends to eng age, and that thereis a substant ia l l ikel ihoo d that i t wi l l engage, in the com m ercia l manu fac ture , im porta t ion, use ,offer for sa le , and/or sa le , or inducem ent thereof , of p la int i f fs ' patented piog l i tazon e drugproduc t s imm edia te ly or imm inent ly upon rece iv ing FDA approva l to do so . Also by i ts AN DAfil ing, Hetero has ind icated that its drug produc ts conta ining piog l i tazon e are b ioequivalent toTakeda 's p iogl i tazone drug products .

36. By i t s AN DA f i l ing , He te ro seeks to o b ta in approv a l to com merc ia l lym anufac ture , use , im port , offer for sa le , and/or se l l , a l leged gen eric equivalents of p la int i f fs'A C T O S piogl i tazone drug pro ducts pr ior to the expira t ion date of the 584 patent .

37. By a le t ter ( the "Notice Let ter") dated October 24, 2011, Hetero inform ed TP Cand T PN A that Hetero ha d f i led a cer t i ficat ion to the FDA, pursuant to 21 U.S.C. 355 (j)(2) (A)(vi i ) (IV) . On or about October 25, 2011, NDA holder , TPN A, received the NoticeLet ter . On or about October 26, 2011, patent own er, TPC, received a dupl icate or ig inal of theNo t ice Let t e r.

8


9/28

38. The N otice Letter, purporting to be Hetero's Notice of Certification under 21U.S.C. 355 (j)(2)(B)(ii), indicates that Hetero intends to man ufacture, use or sell pioglitazonehydroc hloride tablets before the expiration of the '584 p atent. The N otice Letter states that"Hetero's ANDA Produ ct will not li terally infringe any claim s of the '584 patent" and that"[H]etero's AN DA Prod uct will not infringe the claim s of the '584 p atent under the doctrine ofequivalen ts. . . ."

39. Hetero's fi l ing of AN DA N o. 203467 for the purpose of obtaining FDA approvalto engage in the co mm ercial manufacture, use, importation, offer for sale and/or sale, orinducem ent thereof, of drug products containing pioglitazone or salts thereof before theexpiration of the '584 patent is an act of infringem ent under 35 U.S.C. 271(e)(2)(A).

40. Hetero's manufacture, use, importation, offer for sale, and/or sale, or inducem entthereof, of i ts proposed pioglitazone drug p roduct will induce infringem ent of at least one claimof the '584 patent under 3 5 U.S.C. 271(e)(2)(A).

41. Upon information and b elief, Hetero is aware or reasonably should be aware, ofthe widespread u se of pioglitazone in comb ination therapy, and that such use does n ot require aphysician to co-p rescribe pioglitazone with a biguan ide, e.g., me tformin. Further, patientsroutinely take pioglitazone in com bination with additional active com ponents, such asbiguanides. The intended use of piogl i tazone in combinat ion therapy to t reat diabetes would bereadily apparent to custom ers of Hetero (e.g., including, without l imitation, physicians,pharm acists, pharm acy benefits managem ent comp anies, health care providers who establishdrug form ularies for their insurers and/or patients).

42. Upon inform ation and belief, Hetero's propo sed label for i ts pioglitazone drugproducts does not rest r ic t the use of those products to only m onotherapy. As is wel l known to

9


10/28

Hetero and i t s cus tom ers , the m ajor i ty of pat ients treated wi th piogl i tazone take i t in comb inat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in t reatme nt with piogl i tazone incom bina t ion w i th a b iguanide such as me t formin , in com bina t ion w i th an insu l in sec re t ionenhan cer such as a sulfonylurea , and/or in comb inat ion with an insul in preparat ion. Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re we l l know n to H e te ro and cus tomers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce, a id and abet , infr ingem ent of the '584 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf ringement .

43. Addit ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, inform at ion for pat ients regarding the co-adm inis t rat ion of , and/or drug in teract ions between, piogl i tazone and bigu anides , e .g. ,m etformin , and such informat ion wi l l p romote the use o f p iog l it azone in com bina t ion wi thbiguanides , e .g . , metform in. The benef ic ia l ef fec ts of such co-adm inis t ra tion and /or interac t ionsare wel l know n to custom ers of Hetero. By inc luding th is inform ation in i ts label , Hetero w il l bem arket ing piogl i tazone w ith spec if ic intent , and/or with the desire to ac t ively induce, a id andabe t , in f r ingemen t of the '584 pa ten t . He te ro know s or reasonab ly shou ld kno w tha t i t s p roposedconduc t w i ll i nduce in f r ingem ent .

44. Upon informat ion and be l ie f , He te ro has p lanned and in tended to ac t ive ly induceo ther s to in f r inge the '584 pa ten t w hen i t s AINDA appl i ca tion i s approved and p lans and in t endsto do so on approval .

45. Upon inform at ion an d be l i e f, the ac t s of in f ringement a l l eged above a re and havebeen de l iberate and w il lfu l , and in fu l l know ledge of the exis tence of the '584 patent .


11/28

46. Unless Hetero is enjoined f rom infr inging and inducing the infr ingem ent of the`584 p atent , p la int i ffs wil l suffer substant ia l and i r reparable injury . P la int i f fs have no adequater emedy a t l aw.

COUNT I I( INFRINGEMEN T OF T HE ' 404 PAT ENT UNDER 3 5 U.S .C . 271(E )(2 ) (A) )


48. The H etero Not ice Let ter also indicates that Hetero in tends to m anufac ture, use,or se l l p iogl i tazone hy drochlor ide table ts before the expira t ion o f the '404 patent . The N oticeLet ter s ta tes that "Hetero ' s AND A Prod uct wil l not l i tera l ly infr inge an y of the c la ims o f the`404 paten t . . ." and that "Hetero ' s ANDA P roduct wil l not infr inge the c la ims of the '404 patentunde r the doctr ine of equivalen ts . . . ."

49. Hete ro 's f i ling of AN DA N o. 203467 for the purpose of ob ta in ing FDA approva lto engag e in the com m ercial manu facture, use, im por tat ion, of fer for sale and/or sale, orinduce m ent thereof , of drug produc ts containing piogl i tazone or salt s thereof before theexpira t ion of the '404 patent is an ac t of infr ingem ent under 35 U .S.C. 271(e) (2) (A) .

50. Hetero' s manu fac ture , use , imp orta t ion, offer for sa le , and/or sa le , or induce m entthereof , of i ts proposed p iogl i tazone drug prod uct wil l induce infr ingem ent of a t leas t one c la imof the '404 patent un der 35 U.S.C. 271(e) (2) (A) .

51. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iogl i tazone in com binat ion therapy, and that such use does not require aphys ic ian to co -p resc ribe p iog l i t azone w i th an insu l in sec re t ion enh ancer ( .g . , a su l fony lu rea ).Further , pat ients rout inely take piogl i tazone in com binat ion with addi t ional ac t ive com pon ents ,


12/28

such as insulin secretion enhancers. The intended use of pioglitazone in combination therapywould be readily apparent to customers of Hetero (e.g., including, without limitation, physicians,pharmacists, pharmacy benefits managem ent com panies, health care providers who establishdrug form ularies for their insurers and/or patients).

5 2 . Upon inform ation and belief, Hetero's proposed label for its pioglitazone drugproduc ts does not restrict the use of those products to only m onotherapy . As is well know n toHetero and its custom ers, the majority of patients treated with pioglitazone take it in com binationwith another antidiabetic drug, namely, such patients obtain treatment with pioglitazone incombination with a biguanide such as m etformin, in combination with an insulin secretionenhancer such as a sulfonylurea, and/or in combination with an insulin preparation. Thebeneficial effects of such com bination therapy are well know n to Hetero and cu stomers ofHetero. On information and belief, Hetero will be marketing pioglitazone with specific intent,and/or with the desire to actively induce, aid and abet, infringem ent of the '404 patent. Heteroknows or reasonably should know that its proposed conduct w ill induce infringement.

5 3 . Additionally, upon information and belief, Hetero's proposed label also provides,or will be required by the FDA to provide, inform ation for patients regarding the co -administration of, and/or drug interactions between, pioglitazone and insulin secretion enhancerssuch as a sulfonylurea and such information will promote the u se of pioglitazone in com binationwith insulin secretion enhancers such as a sulfonylurea. The beneficial effects of such co-administration and/or interactions are well known to customers of Hetero. By including thisinfon ation in its label, Hetero w ill be m arketing pioglitazone with specific intent, and/or withthe desire to actively induce, aid and abet, infringement of the '404 patent. Hetero knows o rreasonably should k now that its proposed conduct will induce infringement.


13/28

54. Upon in fo rmat ion and be l i e f, Hetero has p l anned and in tended to ac t ive ly induceothe rs to in f ringe the '404 pa ten t when i t s AN DA app l ica tion i s approved and p lans and in tendst o do so on approval .

55. Upon in fo rmat ion and be l ie f , the ac t s o f i n f r ingem ent a l leged ab ove are and havebeen de l iberate and w il lfu l , and in fu l l know ledge of the exis tence of the '404 patent .

56. Unless Hetero is enjoined f rom infr inging and inducing the infr ingem ent of the`404 p atent , p la int if fs wil l suffer substant ia l and i r reparable injury . P la int i f fs have no adequater emedy a t l aw.

COUNT III(INFRINGEMENT OF THE METHOD CLAIMS OF THE '584 PATENT

UNDER 35 U.S.C. 271(b))

57. Pla in ti ff s TPC and T PN A repea t and incorpora te here in by r e f erence thea l lega t ions con ta ined in each o f the fo rego ing paragraphs .

58. Upon inform at ion and be l i e f , approva l of AN DA N o. 203467 i s subs tan t i a llyl ikely to resul t in the com m ercia l manu fac ture , use , imp orta t ion, offer for sa le , and/or sa le , orinducement the reof , o f a d rug p roduc t wh ich i s marke ted and so ld for use in a me thod c la imed inone or m ore c la ims o f the '584 pa ten t , im media te ly or im minent ly upon approva l of the ANDA ,and prior to the exp ira t ion o f the '584 patent .

59. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iog l it azone in the me thods of on e or m ore c la ims of the '584 p a ten t andthat use in such metho ds does no t require a physic ian to co-prescr ibe piogl i tazone with ab iguanide , e .g ., m e t formin Fur the r , pa t ien t s rou t ine ly t ake p iog l i tazone in com bina t ion wi thadd i tiona l ac t ive com ponents , such as b iguanides for use in m e thods covered by the ' 584 pa ten t .The intende d use of p iogl i tazon e in comb inat ion therapy to t reat d iabetes would be readi ly

- 13 -


14/28

apparen t to a custom er of Hetero (e .g . , inc luding, without l imita t ion, physic ians , pharm acis ts ,pha rmacy benef i ts m anagem ent com panies , hea lth ca re p rovide rs who es tab l ish d rug formu la rie sfor thei r insurers and/or pat ients ) .

60 .pon info rma tion and bel ief , Hetero 's proposed label for i ts p iogl i tazone d rugproduc t s does no t re s t ri c t the use of those p roduc t s to o n ly m onothe rapy . As i s we l l know n toHetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in com binat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in treatmen t with piogl i tazon e incom bina t ion w i th a b iguanide such as m e t formin , in com bina t ion w i th an insu lin sec re tionenhan cer such as a sulfonylurea , and/or in comb inat ion with an insul in preparat ion. Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re w e l l known to He te ro and cus tom ers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce , a id and abet , infr ingem ent of the '584 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf r ingem ent .

58.ddi t ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wil l be required by the FDA to provide, infoim at ion for pat ients regarding the co-adm inis t ra tion of , and/or drug interac tions between , p iogl i tazon e and biguanides , and suchinformation wil l promote the use of p iogl i tazone in combinat ion with biguanides , e .g . ,m etformin . The benef ic ia l ef fec ts of such co-adm inis t ra tion and/or interac t ions are wel l know nto custom ers of Hetero. By inc luding th is inform ation in i ts label , Hetero wil l be m arket ingpiogl i tazone w ith spec if ic intent , and/or with the desire to ac t ively induce, a id and abet ,in f r ingem ent of the '584 pa ten t . He te ro know s or reasonab ly shou ld kno w tha t i t s p roposedconduc t w i ll i nduce in f r ingem ent .


15/28

59. Upon info l inat ion and bel ief , the ac ts of infr ingem ent a l leged above are and havebeen de l iberate and wi l l ful .

60. Unless Hetero is enjoined f rom infr inging and inducing infr ingem ent of the '584patent , p la int i f fs w il l suffer substant ia l and i r reparable injury . P la int i ffs have no adequater emedy a t l aw.

COUNT TV(INFRINGEMENT OF THE METHOD CLAIMS OF THE '404 PATENTUNDER 35 U.S.C. 271(b))


62. Upon inform at ion an d be l i e f, approva l of AN DA N o. 203467 i s subs tan t i al lyl ikely to resul t in the com m ercia l manu fac ture , use , im porta t ion, offer for sa le , and/or sa le , orinducement the reof , o f a d rug p roduc t wh ich i s marke ted and so ld for use in a me thod c la imed inthe '404 pa ten t, imm edia te ly or imm inent ly upon approva l of the ANDA , and p r ior to theexpira t ion of the '404 patent .

63. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iog li tazone in the m e thods of one or m ore c la im s of the '404 pa ten t andthat use in such metho d does no t require a physic ian to co-prescr ibe piogl i tazone with an insul insecret ion enh ancer (e .g . , a sulfonylurea) . Further , pat ients rout inely take piog l i tazone incom binat ion w ith addi tional ac t ive com pon ents , such as insul in secre t ion enh ancers for use inm ethods covered by the ' 404 pa ten t . The in tended use o f p iog l it azone in com bina t ion the rapy totreat d iabetes wo uld be readi ly apparent to a custom er of Hetero (e .g . , inc luding, withou tl imita t ion, physic ians , pharmacis ts , pharmacy benef i ts management companies , heal th careproviders w ho es tabl ish drug form ular ies for thei r insurers and/or pat ients ) .

-15-


16/28

64. Upon in form ation and bel ief , Hetero 's proposed label for i ts p iogl i tazone d rugproduc t s does no t re s t ri c t the use of those p roduc t s to on ly mo nothe rapy . As i s we l l known toHetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in com binat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in treatmen t with piogl i tazone incom bina t ion w i th a b iguanide such as me t formin , in com bina t ion w i th an insu lin sec re tionenhan cer such as a sulfonylurea , and/or in comb inat ion with an insul in preparat ion. Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re we l l know n to H e te ro and cus tomers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce , a id and abet , infr ingem ent of the '404 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf r ingem ent .

65. Addit ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, inform at ion for pat ients regarding the co-adm inis t rat ion of , and/or drug in teract ions between , piogl i tazone and insul in secret ion enhanc erssuch as a su l fony lu rea and such informat ion w i ll p romo te the use of p iog l i tazone in co mbina t ionwith an insul in secre t ion enhan cer , such as a sulfony lurea . The benef ic ia l ef fec ts of such co-adm inis t ra tion and/or interac t ions are wel l know n to custom ers of Hetero. By inc luding th isinform ation in i ts label , Hetero w il l be m arket ing piogl i tazone w ith spec if ic intent , and/or withthe des i re to ac t ive ly induce , a id and abe t , in f r ingem ent of the ' 404 pa ten t . He te ro know s orreasonab ly shou ld know tha t i ts p roposed conduc t w i l l induce inf r ingement .

66. Upon infouna t ion and be l ie f , the ac t s of in f r ingem ent a l leged above a re and havebeen de l iberate and wi l l ful .


17/28


CO U NT V(INFRINGEMENT OF THE METHOD CLAIMS OF THE '043 PATENTUNDER 3 5 U.S.C. 271(b))


69. Upon inform at ion an d be l i e f, approva l of AN DA N o. 203467 i s subs tan t i al lyl ikely to resul t in the com m ercia l man ufac ture , use , im porta t ion, offer for sa le and/or sa le , orinducement the reof , o f a d rug p roduc t wh ich i s marke ted and so ld for use in a me thod c la imed inone or m ore c la ims o f the '043 pa ten t , im media te ly or im minent ly upon approva l of the ANDA ,and prior to the ex pira t ion of the '043 patent .

70. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iog l it azone in the me thods of on e or m ore c la ims of the '043 p a ten t andthat use in such metho ds does no t require a physic ian to co-prescr ibe piogl i tazone with abiguanide, e .g . , metform in. Further , pat ients rout inely take piogl i tazon e in com binat ion w ithadd i tiona l ac t ive com ponents , such as b iguanides for use in m e thods covered by the ' 043 p a ten t.The in t ended use o f p iog l i tazone in com bina t ion therapy to r educe the am oun t o f ac t ivecom ponen t s used in such therapy wo uld be r ead i ly apparen t to a cus tom er o f Heteroinc luding, without l imita t ion, physic ians , pharmacis ts , pharmacy benef i ts managementcom panies , heal th care providers who es tabl ish drug form ular ies for thei r insurers and/orpat ients ) .


18/28

71. Upon in form ation and bel ief , Hetero 's proposed label for i ts p iogl i tazone d rugproduc t s does no t re s t ri c t the use of those p roduc t s to on ly mo nothe rapy . As i s we l l known toHetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in com binat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in treatmen t with piogl i tazone incom bina t ion w i th a b iguanide such as me t formin , in com bina t ion w i th an insu lin sec re tionenhan cer such as a sulfonylurea , and/or in comb inat ion with an insul in preparat ion. Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re w e l l known to He te ro and cus tom ers ofHetero. On inform ation and bel ief , Hetero W il l be m arket ing piogl i tazone with spec if ic intent ,and/or w ith the desire to ac t ively induce , a id and abet , infr ingem ent of the '043 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf ringement .

72. Addit ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, inform at ion for pat ients regarding the co-adm inis t ra tion of , and/or drug interac tions between , p iogl i tazon e and biguanides , e .g . , m etform inand such informat ion wi l l p romo te the use of p iog l it azone in com bina t ion wi th b iguanides , e .g . ,m etformin. The ben ef ic ia l ef fec ts of such co-adm inis t ra tion and/or interac t ions are wel l know nto custom ers of Hetero. By inc luding th is inform ation in i ts label , Hetero wil l be m arket ingpiogl i tazone w ith spec if ic intent , and/or with the desire to ac t ively induce, a id and abet ,in f r ingem ent of the '043 pa ten t . He te ro know s or reasonab ly shou ld kno w tha t i t s p roposedconduc t w i ll i nduce in f r ingem ent .

73. Upon inform at ion an d be l i e f, the ac t s of in f ringement a l l eged above a re and havebeen de l iberate and w il lfu l .


19/28

74. Unless Hetero is enjoined f rom infr inging and inducing infr ingem ent of the '043patent , p la int i f fs wil l suffer substant ia l and i r reparable injury . P la int i ffs have no adequater emedy a t l aw.

C O UN T V I(INFRINGEMENT OF THE METHOD CLAIMS OF THE '090 PATENTUNDER 3 5 U.S.C. 4 271(b))


76. Upon inform at ion an d be l i e f, approva l of AN DA N o. 203467 i s subs tan t i al lyl ikely to resul t in the com m ercia l manu fac ture , use , imp orta t ion, offer for sa le and/or sa le of ad rug p roduc t wh ich i s marke ted and so ld for use in a me thod c la imed in one or m ore c la im s ofthe '090 pa ten t , imm edia te ly or imm inent ly upon approva l of the AN DA, and p r ior to theexpirat ion of the '090 patent .

77. Upon infouna t ion and be l ie f , He te ro i s aw are or reasonab ly shou ld be aw are , o fthe widespread use of p iog l i tazone in the m e thods of one or m ore c la ims of the ' 090 pa ten t, andthat use in such metho ds does no t require a physic ian to co-prescr ibe piogl i tazone with ab iguanide , e .g . , me t formin . Fur the r , pa t ien t s rou t ine ly t ake p iog l i t azone in co m bina t ion w i thadd i tiona l ac t ive com ponents , such as b iguanides for use in m e thods covered by the ' 090 p a ten t.The intend ed use of p iogl i tazon e in com binat ion therapy to reduce s ide effec ts of such therapywo uld be readi ly apparent to a custom er of Hetero (e .g . , inc luding, without l imita t ion,phys ic ians , pha rmac is t s, pha rmacy benef i ts m anagemen t com panies , hea lth ca re p rovide rs whoes tabl ish drug form ular ies for thei r insurers and /or pat ients ) .

78. Upon in form ation and bel ief , Hetero 's proposed label for i ts p iogl i tazone drugproduc t s does no t re s t ri c t the use of those p roduc t s to o n ly m onothe rapy . As i s we l l know n to

-19-


20/28

Hetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in com binat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in treatmen t with piogl i tazone incom bina t ion w i th a b iguanide such as m e t formin , in com bina t ion w i th an insu lin sec re tionenhancer such as a su l fony lu rea , and /or in com bina t ion wi th an insu l in p repara t ion : Th ebenef ic ia l e f fec t s of such com bina t ion the rapy a re w e l l known to He te ro and cus tom ers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce, a id and a bet , infr ingem ent of the '090 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf r ingem ent .

79. Addit ional ly , upon i nfoinat ion and b el ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, inform at ion for pat ients regarding the co-adm inis t ra tion of , and/or drug interac tions between , p iogl i tazone and bigu anides , e .g . , m etforminand such informat ion wi l l p romote the u se of p iog l i t azone in com bina t ion wi th b iguanides , e .g . ,m etformin . The benef ic ia l ef fec ts of such co-adm inis t ra tion and/or interac t ions are wel l know nto custom ers of Hetero. By inc luding th is inform ation in i ts label , Hetero wil l be m arket ingpiogl i tazone w ith spec if ic intent , and/or with the desire to ac t ively induce, a id and abet ,in f r ingem ent of the '090 pa ten t . He te ro know s or reasonab ly shou ld kno w tha t i t s p roposedconduc t w i ll i nduce in f r ingem ent .

80. Upon in fo rmat ion and be l i e f, t he ac t s o f i n fr ingement a l l eged above are and h avebeen del iberate and w il lfu l .



21/28

C O U N T V II(INFRINGEMENT OF THE METHOD CLAIMS OF THE '205 PATENTUNDER 3 5 U.S .C. 4 271(b))

82. Plaintiffs TPC and T PN A repeat and incorporate herein by reference theallegations contained in each of the foregoing paragraphs.

83. Upon information and b elief, approval of AN DA No . 203467 is substantiallylikely to result in the com mercial m anufacture, use, importation, offer for sale and/or sale, orinducem ent thereof, of a drug product wh ich is marketed and sold for use in a method claim ed inone or mo re claims of the '205 patent, imm ediately or imm inently upon approval of the ANDA,and prior to the ex piration of the '205 patent.

84. Upon informat ion and bel ief , Hetero is aware or reasonably should be aware, ofthe widespread use of piogl i tazone in the m ethods of one or m ore c laims of the '205 patent andthat use in such m ethods does n ot require a physician to co-prescribe pioglitazone with an insulinsecretion enhan cer (e.g., a sulfonylurea). Further, patients routinely take pioglitazone incom bination with additional active com ponents, such as insulin secretion enhancers for use inmethods covered by the '205 patent . The intended use of piogl i tazone in com binat ion therapy toreduce the amou nt of active com ponents used in such therapy would be readily apparent to acustom er of Hetero (.g., including, withou t limitation, physicians, pharma cists, pharm acybenefits managem ent comp anies, health care providers who establish drug formu laries for theirinsurers and/or patients).

85. Upon inform ation and belief, Hetero's proposed lab el for its pioglitazone drugproducts does not rest r ic t the use of those products to only m onotherapy. As is wel l known toHetero and its custom ers, the majority of patients treated w ith pioglitazone take it in comb inationwith another antidiabetic drug, nam ely, such patients obtain treatment w ith pioglitazone in

-21 -


22/28

com bina t ion w i th a b iguanide such as m e t formin , in com bina t ion w i th an insu l in sec re t ionenhancer such as a su l fony lu rea, and /or in com bina t ion wi th an insu lin p repara tion . Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re w e l l known to He te ro and cus tom ers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce, a id and abet , infr ingem ent of the '205 patent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i l l induce inf r ingem ent .

86. Addit ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, informat ion for pat ients regarding the co-adm inis t rat ion of , and/or drug in teract ions between , piogl itazone and insul in secret ion enhan cerssuch as a su l fony lu rea and such informat ion w i l l p romo te the use of p iog l i tazone in com bina t ionwith insul in secre t ion enhan cers . The benef ic ia l ef fec ts of such co-adm inis t ra tion and/orinterac t ions are wel l know n to custom ers of Hetero. By inc luding th is inform ation in i ts label ,Hetero w il l be m arket ing piogl i tazone w ith spec if ic intent , and/or with the desire to ac t ivelyinduce , a id and abe t , in f r ingement of the ' 205 pa ten t . He te ro kno ws o r reasonab ly shou ld knowthat its proposed con duct wil l induc e infr ingem ent .

87. Upon in fo rmat ion and be l i e f, t he ac t s o f i n fr ingement a l l eged above are and h avebeen de l iberate and wi l l ful .



23/28

COUNT V I II(INFRINGEMENT OF THE METHOD CLAIMS OF THE '243 PATENTUNDER 3 5 U.S.C. 4 271(b))


90. Upon info ima t ion and be l ie f , approva l of A NDA No . 203467 i s subs tan t ia l lyl ikely to resul t in the com m ercia l manu fac ture , use , im porta t ion, offer for sa le and/or sa le , orinducement the reof , o f a d rug p roduc t wh ich i s marke ted and so ld for use in a me thods c la imedin one or m ore c la ims of the '243 pa ten t , immedia te ly or imm inent ly upon approva l of theAN DA, and pr ior to the expira t ion of the '243 p atent .

91. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iog l it azone in the me thods of on e or m ore c la ims of the '243 pa ten t andthat use in such metho ds does no t require a physic ian to co-prescr ibe piogl i tazone with an insul inpreparat ion. Further , pat ients rout inely take piogl i tazon e in com binat ion w ith addi t ional ac t ivecom ponen ts , such as insu l in p repara tions for 'u se in m e thods covered by the '243 p a ten t . Theintended use o f p iogl i tazone in com binat ion therapy to t reat a d iabet ic pat ient to reduce s idee f fec t s of ac t ive com ponents used in such the rapy wou ld be read ily apparent to a cus tomer ofHetero (e .g . , inc luding, without l imita t ion, physic ians , pharm acis ts , pharm acy benef i tsmanagement companies , heal th care providers who es tabl ish drug formular ies for their insurersand/or p at ients ).

92. Upon info rm ation and bel ief , Hetero 's proposed label for i ts p iogl i tazone drugproduc t s does no t re s t ri c t the use of those p roduc t s to on ly m onothe rapy . As i s we l l know n toHetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in comb inat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in treatmen t with piogl i tazon e in


24/28

com bina t ion w i th a b iguanide such as me t formin , in com bina t ion w i th an insu l in sec re t ionenhan cer such as a sulfonylurea , and/or in comb inat ion with an insul in preparat ion. Thebenef ic ia l e f fec t s of such com bina t ion the rapy a re we l l know n to H e te ro and cus tomers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce, a id and abet , infr ingem ent of the '243 patent . Heteroknow s o r r easonably should know tha t it s p roposed conduc t w i ll i nduce in f r ingem ent .

93. Addit ional ly , upon inform ation and bel ief , Hetero ' s proposed label a lso provides ,or wi l l be required by the FDA to prov ide, inform at ion for pat ients regarding the co-adm inis t rat ion of , and/or drug in teract ions betw een, piogl i tazone and insu l in preparat ions , andsuch inform at ion wi l l prom ote the use of piogl i tazone in com binat ion wi th insul in preparat ions .Th e benef ic ial ef fects of such co-a dm inis trat ion and/or in teract ions are wel l known to cus tom ersof Hetero. By inc luding th is information in i ts label , Hetero w il l be m arket ing piogl i tazone w ithspecif ic intent , and/or w ith the desire to ac t ively induce, a id and abet , infr ingem ent of the '243pa ten t . He te ro know s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induceinf r ingement .

94. Upon in fo rmat ion and be l i e f, t he ac t s o f i n fr ingement a l l eged above are and h avebeen d el iberate and wi l l ful.



25/28

COUNT IX(INFRINGEMENT OF THE METHOD CLAIMS OF THE '640 PATENTUNDER 3 5 U.S .C. 4 271(b))

96. Pla in ti ff s TPC and T PN A repea t and incorpora te here in by r e f erence thea l lega t ions con ta ined in each o f the fo rego ing paragraphs .

97. Upon inform at ion an d be l i e f, approva l of AN DA N o. 203467 i s subs tan t i al lyl ikely to resul t in the com m ercia l manu fac ture , use , imp orta t ion, offer for sa le and/or sa le , orinducement the reof , o f a d rug p roduc t wh ich i s marke ted and so ld for use in a me thods c la imedin one or m ore c la ims of the '640 pa ten t , imm edia te ly or imm inent ly upon approva l of theAN DA, and pr ior to the expira t ion of the '640 patent .

98. Upon inform at ion an d be l i e f, He te ro i s aware or reasonab ly shou ld be aw are , o fthe widespread use of p iog l i tazone in the m e thods of one or m ore c la ims of the '640 p a ten ts andthat use in such metho ds does no t require a physic ian to co-prescr ibe piogl i tazone with an insul insecret ion enh ancer (e .g . , a sulfonylurea) . Further , pat ients rout inely take p iogl i tazone incom bina t ion wi th add i t iona l ac t ive com ponents , such as insu l in sec re tion enhancers for u se inm ethods covered by the '640 pa ten t . The in tended use of p iog l i tazone in com bina t ion the rapy toreduce s ide effec ts of ac t ive com pon ents used in such therapy would be readi ly apparent to acustom er of Hetero (e .g . , inc luding, without l imita t ion, physic ians , pharm acis ts , pharm acybenef i ts man agem ent com panies , heal th care providers w ho es tabl ish drug fol inular ies for theirinsurers and/or pat ients ) .

99. Upon in form ation and bel ief , Hetero 's proposed label for i ts p iogl i tazone d rugproduc t s does no t re s t r ic t the use of those p roduc t s to on ly m onothe rapy . As i s we l l know n toHetero and i ts custom ers , the m ajori ty of pat ients t reated with piogl i tazone take i t in com binat ionwith ano ther ant id iabet ic drug, nam ely, such pat ients obta in t reatm ent with piogl i tazone in

- 25 -


26/28

com bina t ion w i th a b iguanide such as me t formin , in com bina t ion w i th an insu l in sec re t ionenha ncer such as a sul fonylurea, and/or treatm ent in comb inat ion wi th an insul in preparat ion.The ben ef ic ia l e ffec ts of such co mb ina t ion the rapy a re w e l l known to He te ro and cus tom ers ofHetero. On inform ation and bel ief , Hetero wil l be market ing piogl i tazone w ith spec if ic intent ,and/or w ith the desire to ac t ively induce, a id and abet , infr ingem ent of the '640 p atent . Heteroknow s or reasonab ly shou ld know tha t it s p roposed conduc t w i ll induce inf ringement .

100. Addit ional ly , upon inform ation and bel ief , Hetero ' s propo sed label a lso provides ,or wi l l be required by the FDA to prov ide, informat ion for pat ients regarding the co-adm inis trat ion of , and/or drug in teract ions between , piogl itazone and insul in secret ion enhan cerssuch as a sulfonylurea and that such inform ation wil l promo te the use of p iogl i tazone incom binat ion with an insul in secre t ion enhancer . The ben ef ic ia l ef fec ts of such co-adm inis t ra tionand/or interac t ions are wel l know n to custom ers of Hetero. By inc luding th is inform ation in i tslabel , Hetero wi l l be m arket ing piogl i tazone w i th speci f ic in tent , and/or wi th the des i re toac t ive ly induce , a id and ab e t , in f r ingemen t of the '640 pa ten t . He te ro kn ow s or reasonab lyshould know tha t it s p roposed conduc t w i ll i nduce in f r ingem ent .

101 . Upon inform at ion an d be l i e f, the ac t s of in f ringement a l l eged above a re and havebeen d el iberate and wi l l ful.

102 . Unless Hetero is enjoined f rom infr inging and inducing infr ingem ent of the '640patent , p la int i f fs wil l suffer substant ia l and i r reparable injury . P la int i ffs have no adequater emedy a t l aw.

W HER EFORE, Plaint i f f s reques t the following rel ief :(a )declara tory judgm ent pursuant to 28 U.S.C. 2201 e tsue. that mak ing, us ing,se l l ing, offer ing to se l l and/or imp ort ing Hetero ' s drug product for w hich i t seeks


27/28

FDA appro val or i ts ac t ive ingredient p iog l i tazone wil l infr inge a t leas t onec la im o f one o r m ore o f the Takeda Pa ten t s ;

(b ) a dec lara tory judgmen t pursuant to 28 U.S.C. 2201 ethat inducing them aking, us ing, offer ing for sa le , se l ling and/or im port ing of He tero 's drugprodu ct or i ts ac t ive ingredient p iogl i tazone, w il l infr inge a t leas t one c la im ofone o r m ore o f the Takeda Pa ten t s ;

(c ) a dec lara tory judgmen t pursuant to 28 U.S.C. 2201 et seq. and an o rderpursuan t to 35 U.S.C. 271(e) (4) (A) providing that the effec t ive date of anyFDA approv al for Hetero to comm ercia l ly m ake, use , se l l, offer to se l l or imp ortpiogl i tazone or any drug prod uct conta ining piogl i tazone be no ear l ier than thedate fol lowing the exp irat ion da te of the las t to expire of the Take da Pa tents (asextended, i f appl icable);

(d ) a permanent injunct ion res t ra ining and enjoining against any infr ingement bydefend ants , thei r of f icers , agen ts , at torneys , em ployee s , successors or ass igns , orthose ac t ing in pr ivi ty or concert with them, of the Taked a Patents , through thecom m ercia l manu fac ture , use , sa le , offer for sa le or imp orta t ion into the UnitedStates of p iogl i tazone or any drug prod uct conta ining piogl i tazone, and/or anyi nducemen t o f the s ame;

(e ) Attorneys ' fees in th is ac t ion und er 35 U.S.C. 285; and(f) Such fu r ther and other rel ief in favor of P laint if f s and agains t Defend ants as this

Cour t may d eem jus t and proper .


28/28

Dated: New York, New YorkNovem ber 16 , 2011 Takeda Pharmaceu t ica l Com pany L imi ted andTakeda P harmaceut i ca l s Nor th Amer ica , Inc .By thei r at torneys ,Anthony J . V 'o lAndre K. Ci arikZachary W . S ilve imanE DWARDS WIL DMAN P AL ME R L L P750 Lex ing ton AvenueNew Y o r k , NY 1 0 0 2 2(212) 308-4411David G. Conl in ( to be adm it ted pro hac vice)Barbara L . Moore ( to be adm i tt ed pro hac vice)Kath leen B. Can ( to be adm i t ted pro hac vice)Ad am P . S amansk yE DWARDS WIL DMAN P AL ME R L L P111 Hunt ing ton A venueBoston, MA 02199-7613(617) 239-0100

Takeda Pharmaceutical Company et. al. v. Hetero Drugs et. al.

Documents

Transcript of Takeda Pharmaceutical Company et. al. v. Hetero Drugs et. al.