UNITED STAT ES DIS TRICT COURT F OR THE D ISTRIC T OF CO LU M BIA SAN OF I -A VENT I S e t al

. , : : Plaintiffs, : Civil Action No.: 09-1495 (RMU)

: v. : Re Docume nt No.: 5

: FOO D AND D RUG : ADMI NI STRATI ON et al., : : De fe nd ants . :

M EM OR

AN DU M OP IN ION D ENY I N G TH E P LA INT IF FS ’ M OT I ON F OR A T E M P ORARY RE S T RAI NI NG O RDE R AND P RE L I M I NARY I NJ UNCT I ON I. IN TR OD UC TIO N This case is before the cour t on the plaintiffs’ motion for a te mporary restra ining or der (“ TRO ” ) a

nd pr e lim ina

ry inj un c tio n. Pla int if

f D e bio ph arm

S.A . ( “ De bio ph arm ” ) i s a Swi ss company that holds the patent for

the anti-c ance r drug

ox aliplatin. Plainti ff Sanof i-Aventis is the pio ne e r m anu fa c tur e r o f t he dr ugand pla int if f S ano fi -A ve nti s U .S. L L C ( c oll e c tiv e ly “ Sano fi
Av e nti s” ) h old s th e e xclu siv e lic e ns e fo r t he dr ugin t he Un ite d St ate s. Sano fi -A ve nti s ma rk e ts and sells oxalipl atin under the brand na me Elox atin®. The plaintiffs a sk the court to orde r the Food a nd DrugAdministration (“F DA”) to rescind a pproval it has g iven to third-par ty drug manufa cture rs to manufa cture and mar ket g ener ic ver sions of ox aliplatin. Be cause the plaintiffs have f ailed to demonstrate that they are substantially

likely to succe ed on the mer its of their ca se, the cour t denies their r equest for

a TRO and pr eliminary

injunction.2 II. F ACTUAL & P ROCEDURAL BACK GR OUND

A. The Hatch-Waxm an Act The re levant portions of the H atch- Wax man Act, 21 U.S.C. § 355 (“the Hatch- Wax man Act”) amende d the Food, D rugand Cosmetic Act, 21 U.S.C. § 351 et seq. , and dictate the proce ss by

which g ener ic drug s are approve d by the FD A and mar

keted by the drugcompanies. Am on goth e r t

hin g s, the Hatc h- Waxma

n A c t r e qu ir e s a

dr ugmanu fa c tur e r s e e kin ga pp ro va l to produce a g ener ic ver sion of a drugto cer tify that the patent f

or the c orre sponding br and-na med drug“is invalid or will not be infring ed by the manufa cture , use or sa le of the ne w drugfor whic h the application is subm itted.” 21 U.S.C. § 355(b)(2) (A)( iv), (j)(2) (A)( vii)(IV). The patent holder has for ty -five da y s after rec eivingnotification of the c ertification to bring a patent infring ement action ag ainst the drugmanufa cture r that filed the c ertification. 21 U.S.C . § 355(c) (3)( C), (j)(5) (B )(iii). Onc e such a n action is filed, the F DA must withhold approval of the drug
manu fa c tur e r’ s a

pp lic atio n to pr od

uc e a g e ne ri c dr

ug(“ g e ne ri c a

pp lic atio n” ) f

or a thi rt y -m on th period (“ thirty -month stay ”). Id. The thirty -month stay may be shortene d, howeve r, if “the dis tr ic t c ourt

[in whic h th e pate nt i nf

ri ng e me nt a c tio n is br ou g ht] d e c ide s th at th e pate nt i s invalid or not infring ed,” 21 U .S.C. § 355(c)(3) (C)(i), at which point the FDA ’s appr oval shall be eff ective the “date on which the c ourt enter s judgme nt,” 21 U.S.C. § 355(c)( 3)(C)( i)(I ) (“ the entry of judg ment provision”).A s expl ai ne d be lo w , th e co urt h el d an e m er g en cy

h eari ngo n th e pl ai nt if

fs ’ m ot io ns . Th e co urt 1 de ni ed

th e m ot io ns f

ro m th e be nc h, n ot in g th at

th is m em or an dum

o pi ni on w ou ld f ol lo w . H r’ g Tr. 19:17
- 18. B ecause the defend ants d id no t file a written brief in oppo sition, and becau se the defend ants d id no t disp ute th e factu al and pro cedura l pos ture o f the case as p osited by the plaintiffs, se e ge ne ra ll

y H r’ g Tr. , th e co urt a cc ep ts th e pl ai nt if fs ’ ac co un t o f th e fa ct s as s et f orth in the ir m otion. The defen dants in this action are n ot parties to the N ew J ersey suit. See Pls .’ M ot. , Exs. C & D. 2 3

B. Th e Ne w Jersey Suit and Sub sequent F DA Ac tion 1 The plaintiffs in this action ar e the patent holder, manuf actur er a nd licensee of Eloxatin, the name br and

fo r o xali platin . Co mpl . ¶ 2. Af te r a numbe r o f d

ru gmanu fa c tur e rs se e kin gto produce g ener ic ver sions of ox aliplatin filed the re quired patent cer tification, the plaintiffs broug ht a patent infr inge ment suit ag ainst them in the United States District Court for the District of Ne w J erse y

(“the New Jersey

suit”). Pls.’ Mot. at 7. On J une 18, 2009, the Ne w J erse y court 2 ruled that the pla intiffs’ patent ha d not been infr inge d and, on June 30, 2009, that court enter ed judgme nt. Id. The plaintiffs f iled an eme rg ency

motion to s tay

the district court’s judg ment pendingappea l with the Fede ral Circuit, which the court g rante d on J uly 1, 2009. Id., Ex. C. On J uly 10, 2009 the Fe dera l Circuit ex tended the sta y to include the entire period up to the dispositi on of the a

ppeal. Id ., Ex . D. The F eder al Circuit has y et to rule on the me rits of the
a pp e a l. On August 7, 2009, the FDAapprove d the application of Teva Par enter al Medicine s, Inc. (“Te va”) to produce a g ener ic ver sion of ox aliplatin. Id. at 1. On August 10, 2009, the plaintiffs filed a c omplaint with thi s court, see king a TRO and pre liminary

injunction that would require4

the FD A to resc ind its approval of Te va’s a pplication. See ge nerally Compl.; Pls.’ Mot. At an
emer g ency

hear ing he ld that same day the cour t denied the plaintiffs’ motions from the bench f or the re asons set for

th below.

III . A NA LY SIS A. Legal Standard f

or Injunctive Re lief This court may

issue interim injunctive relief only when the mova

nt demonstrates “ [1] that he is likely

to succe ed on the mer its, [ 2] t hat he is likely to suffer irrepa rable harm in the absenc e of pr eliminary

relief , [3] that the balanc e of e quities tips i n his favor, a nd [4] that an injunction is i n the public intere st.” W inter v. Natural Res. Def. Council, Inc. , 129 S. Ct . 365, 3 7 4 (2 0 0 8 ) ( ci t i n g Munaf v. Ge ren , 128 S. Ct . 2207, 2218-19 (2008) ). It is particularly important for the mova

nt to demonstrate a likelihood of suc cess on the me rits. Cf
. Benten v . Kessler , 505 U. S. 1 08 4, 10 85 (1 99 2) (p e r c ur iam) . Ind e e d, a bs e nt a “ su bs tanti a l in dic atio n” of

lik e ly su c c e ss on the merits, “ther e would be no justification for the cour t’s intrusion into t he ordina ry proce sses of administration and judicial r eview.” Am. Banke rs Ass’n v. Nat’l Credit Union Admin. , 38 F. Supp. 2d 114, 140 (D.D .C. 1999) (interna l quotation omit ted). B e c a us e int e ri m in

jun c tiv e re lie f i s a

n e xtra or din ary

fo rm of jud ic ia l r e lie f, c ourt s sh ou ld g rant such r elief spa

ring ly
. Mazurek

v. Armstrong , 5 20 U. S. 9 68 , 9 72 (1 99 7) . T he Sup re me Court has observe d “that a pr eliminary injunction is an ex traordina ry and dra stic remedy , one that should not be g rante d unless the movant, by a cle ar showing , car ries the bur den of pe rsuasion.” Id. There fore , althoug h the trial cour t has the discre tion to is sue or de ny a pre liminary i n j un c t i o n , i ti s n o ta

f o r mo f r e l i e f g r an t e d l i g h t l y. In addition, any

injunction that the court5

issues must be car efully

circ umscribed a

nd “tailore d to remedy

the har m shown.” Nat ’l

Tre as ur y Employe es Union v. Yeutter , 918 F.2d 968, 977 ( D.C. Cir. 1990). B. Th e CourtDenies the P laintif fs’ Motions f

or a TRO and a Pre lim inary Injun ction 1. The Plaintiff

s Have F ailed to Dem onstrate a Sub stantial Lik elihood of Success on the Me rits The plaintiffs a

rgue that, bec ause the Fe dera l Circuit entere d an orde r staying the New Jer se y dis tr ic t c ourt ’s jud g me nt, the thi rt y -m on th p e ri od

wa s st ill in e ff

e c t and the F DAsh ou ld not have a

pproved a ny pendingg ener ic applications reg ardingox aliplatin. Pls .’ Mot. at 2. The de fe nd ants re tor

t th at th e F DAwa s b ound by the Hatc h- Waxma

n A c t to a pp ro ve the g e ne ri c applications once the New J erse y district court ente red its judg ment, reg ardle ss of the stay
e nte re d b y

the F e de ra l Cir c uit . H r’ gTr . 1 2:2 1- 13 :4. Th e pa rt ie s a g re e that th is i s a

c a se of fi rs t impression in which this court is called to dete rmine whe ther a stay enter ed by

an appe llate cour

t
ov e rr ide s th e te rm inatin ge ff e c t th at th e e ntr

y of a dis tr ic t c ourt

jud g me nt h a s o n th e thi rt y -m on th period unde r the Hatch-Waxm an Ac t. Hr’gTr. 11:10-12. The plaintiffs a

rgue that the Nken v . Holder , 129 S. Ct . 1749 (2009) r ationale g overns the issue and outcome. Pls.’ Mot. at 8-9. In Nken , the Supreme Court a rticulated the differ ence s betwee n an injunction and a sta y . See ge nerally Nken , 129 S. Ct . 1749

. The pe titioner, an alien subject to a de portation order from the B oard of

I mmigration Appeals (“ BIA”) , soug ht a stay of the B I A’s orde r pendinghis appea l. Id. at 1754-55. The g overnme nt objected, a rguing that the I lleg al Immigration Reform and Immigra nt Responsibil ity

Act (“ I I RI RA”) pr ohibited such ac tion unless the petitioner c ould show by “cle ar a nd convincingevidenc e that the e ntry or execution of
su c h o rd e r w a s p ro hib ite d a s a matte r o f l aw, ” a s o pp os e d to the mor e le nie nt s tand ard a pp lic a ble6

to motions to stay . Id. at 1756 (quoting8 U.S.C. § 1252(f)). H olding that a stay and an injunction “serve differ ent purposes,” the Court noted that an injunction “dire ct[s] the conduc t of a par ticular a ctor [while] a stay operates upon the judicial proc eeding .” Nken , 129 S. Ct . at 1757- 58. The plaintiffs he re ma intain that, beca use the Nken Court held that a stay divests a district court’s or der of

its enforc eability , the FD A had no a uthority to approve the applications filed by the def endants in the Ne w J erse y suit. P ls.’ Mot. at 9; Hr’gTr. 6:15-7:1. The de fenda nts, on the oth e r h and , ave r t

hat th e statut or

y langua g e is c le a

r: the F DAmus t a

pp ro ve the g e ne ri c applications base d on the date of the e ntr yof a judg ment from the district cour t, not the date on wh ic h th at ju dg me nt b e c ome s e nfo rc e ab le . Hr’gTr. 12:24-13:7. The Nken decision does not addre ss the centr al issue in the instant case : the differ ence , if any , betwee n the date of the entry of judgme nt and the date of enf orce ability

of that judg ment. See ge nerally Nken , 129 S. Ct . 1749. Although the plaintiffs rely on the Fe dera l Circuit’s ruling in In re Av entis Pharma S.A. , 20 08 WL56 91 01 2 ( C.A . F e d. (C a l) July 23 , 2 00 8) , Pl s. ’ M ot. at 9, the de c isi on , in fa c t, undermines the pla intiffs’ position. Av e nti s dealt with a similar situation in which a pharma ceutica l company

appea led a district cour

t’s ruling that its patent was unenf orce able. Av e nti s , 3 1 4 F e d
. Ap p x. at 292. Ther e is, howeve r, a c rucia l disti nction betwee n Av e nti s and the instant case: the F eder al Circuit in Av e nti s did not sim ply

stay the district court’s or der, but i n s t e a d “ o r d e r [ e d ] th e d i s tr i c tc o urtt o t e mp o r ar i l y defer e ntry of judgment , pending
. . . resolution of the manda

mus petition.” Id. (empha sis added). Thus, the district court wa s expressly order ed not to enter

judgme nt, the entry

of judg ment provision by its terms could not apply . Her e, in contra st, the New Jersey court did ente r a judg ment, Pls.’ Mot. at 7, and that judgme nt was stay ed, id. , Ex . D. The pla in lang uag e of the entry of judg ment provision of theThe defen dants do not a ddress the b alance of eq uities fac tor, see H r’ g Tr. 1 6: 13
- 16 , and th e co urt 3 ack

now ledg es that this factor fav ors th e plain tiffs. Pursu ant to the court’s sealingord er, Orde r (Aug . 1 0, 2009 ) and the subseq

uent order un- sealing 4 th e ca se b ut

m ai nt ai ni ngc erta ind oc um en ts und er s ea l, O rd er

( A ug . 1 4, 2 00 9) , c erta in in fo rm at io n co nt ai ne d inth is m em or an dum o pi ni on is p ro te ct ed

f ro m p ub li c di sc lo sure and

is only av ailable to the parties at this tim e. 7 Hatch- Wax man Act is cle ar that the FDA ’s appr oval of a g ener ic application “shall be made
e ff e c tiv e on the [] date on

wh ic h th e c ourt e nte rs j u d g m e n t . ” 2 1 U
. S
. C
. § 3 5 5 ( c ) ( 3 ) ( C ) ( i ) ( I) (empha sis added). B eca

use the Ne w J erse y

court a ctually

enter ed judg ment, trig g eringthe entry of judg ment provision in the Hatch- Wax man Act r equiringthe FD A to approve the pending applications, the plaintiffs ha ve fa iled to demonstrate a likelihood of succe ss on the merits of their cla im. Although the f oreg oing a lone provides a sufficie nt basis for deny

ing the plaintiffs the re lief they

seek, Am. Banke rs Ass’n , 38 F. Supp. 2d at 140, ther e ar e other fac tors that
m i l i t at e a g a i n s ti n

j un c t i v e r e l i e f

, w h i c hth e c o urtt o u c h e s u p o nb r i e f l y. 2 . T h e Pl a i n ti f

f s H a v e Fa i l ed to De mon s tr a te I rr ep a ra b l e H a rm and th at the P ubl ic Intere st F avors Injunctive Relief 3 [R EDACTED] The de fenda nts counter that, if the plaintiffs preva il in the New Jersey 4 suit they will be able to obtain dama g es to compensate for a ny financ ial injury

cause d by

the g ener ic drugmanufa cture rs’ violation of the F eder al Circuit’s orde r. Hr’ gTr. 14:7-11. In the D.C. Circuit, “ec onomic loss does not, in and of itself, constitute irre para ble har m.” W is. Gas Co. v. Fed. Ene rgy Regulatory Comm’n , 758 F.2d 669, 674 ( D.C. Cir. 1985) (stating that “[m] ere injuries, howeve r substantial, in terms of money , time and ene rg y . . . are not enoug h. The possibility

that adequa

te compensatory

or other c orre ctive re lief will be ava ilable at
a late r d ate , in

the or din ary

c ours e of lit ig atio n w e ig hs he avil y a g a ins t a c la im o f i rr e pa

ra ble8

harm” ). Ne verthe less, a TRO may be the a ppropriate equitable r emedy “whe re the loss threatens the ver y exis tence of the movant’s business.” W ash. Metro. Area Transit Comm’n v. Holiday Tours, Inc. , 559 F.2d 841, 843 n.2 ( D.C. Cir. 1977). In this case, howe ver, the plaintiffs do not need the “extraordinar y and dra stic remedy” of injunctive relief

to protect them fr om the prospec t of ec onomic harm. Mazurek, 520 U.S. at 972. Rather, the pla intiffs can pr otect their e conomic intere sts by seekingenfor ceme nt of the F eder al Circuit’s order

staying the New Jersey

suit and potentially

collect damag es fr om any manufa cture r who violates that or der. Wit h respe ct to the public intere st involved in thi s case , the plaintiffs alleg e that the public is served by

adher ence to the applicable law – the Hatch-Waxm an Ac t, Pls .’ Mot. at 15- 16; Hr’gTr. 9:8-17. F or the same rea sons that the court de termined that the pla intiffs are
un lik e ly to s uc c e e d o n th e me ri ts o f t he ir c la im, the c ourt

re je c ts this argume nt. Th e de fe nd ants submit t hat the public intere st lies in acce ss to ge neric drug s that have be en F DA appr oved, Hr ’g Tr . 1 6:1 6- 25 . B e c a

us e the pla int if

fs have no t de mon str ate d th at th e y are su bs tanti a lly

lik e ly to
succe ed on the mer its of their claim, kee ping g ener ic oxalipl atin products off the marke t will not benef it the public interest. See Se ro no Lab orato rie s, In c . v . S

ha lal a , 1 58 F .3 d 1 31 3, 13 26 (D .C. Cir. 1998) (explaining that “ if . . . [the movant] is not li kely to establish that [ the g ener ic drug applications we re] wrong ly approve d, then the public intere st considerations weig h ag ainst an injunction”), Br istol-

My e rs S qu ibb Co. v . S

ha lal a , 923 F. Supp. 212, 222 (D.D .C. 1996) (holding that the “public will . . . bene fit from incre ased c ompetition . . . . A delay in the approva l [ of the g ener ic drugapplication], without a showing of a substantial likelihood on the merits[,] would not further the public intere st”).9 IV . C ON CL USI ON For the fore g oing r easons, the c ourt denies the pla intiffs’ motion for a TRO a nd preliminary

injunction. An Order

consistent with this Memorandum Opinion was issued on August 11, 2009.

RI CARDO M. URBI NA Un i t edS t at es Di s tri ctJ u d ge