UNITED STAT ES DIS TRICT COURT F OR THE DIS TRICT OF COLUM BIA

) AP OTEX, INC., et al . ) ) P laintif fs, )

) v. ) Civil Action No. 10-517 (R MC) ) KA THLE EN SEB ELIUS , Secre tary, Depart m ent of Health an d Hu m an Service s, et al. , ) ) ) ) Defendan ts. ) )

MEMORAN DUM OP INION The question prese nted is whether the U.S. Food and Drug Administration (“F DA”)

was arbitra

ry and capr icious when i t ap p l ied the rea soning of a rec ent D.C. Circuit opinion, with which the FDA disag ree s , t o t h e fa cts of the instant dispute when time is of the essenc e and the Solicitor Genera l has not y et dec ided whethe r to move for rehe aring

. Plaintiffs in this consolidated case , Apotex, I nc. (“A potex”), and Rox ane L abora tories, I nc. (“Roxane”) , are two manufa cture rs o f g ener ic drug s. They asser t that it is the heig ht of arbitra

riness for the FDA to explain its own rea ding of the “cle ar” lang uag e of the statute and then apply the contra

ry rea soning of the Circuit, with the eff ect of allowing a third g ener ic drug manufa cture r to g et 180 day s of marke ting exclusivi ty starting , perha ps, as ear ly as April 6, 2010. The Court disag ree s. On this rec ord and with these fac ts, the FDA rec og nized t h at i t i s b o u nd to follow the C ircuit opinion until an d u n less it g ets that opinion modified or reverse d. The parties’

rec ourse is to the Circuit.I. BACKG ROUND A quick sum m ary of a lot of litigation should suffice to prese nt the curr ent
controve rsy . Reade rs are direc ted to the Circuit’s decision, Teva Pharms. USA, Inc. v. Sebelius , 595 F. 3d 1303 ( D.C. Cir. 2010), for de tails.

Teva Pharmac euticals USA, I nc., is a gen eric drug manufa cture r. I t filed an abbre viated new drug application (“A NDA” ) with the FDA and claimed that its g ener ic versions of Coz aar and Hy

zaar (losarta

n) did not infr inge the ’075 patent held by Merc k, the brand name drug manufa cture r. Be cause Teva ’s ANDA contained a cer tification pursuant to 21 U.S.C. § 355(j)(2) (A)( vii)(I V), if the F DA approve d the ANDA, Teva would have 180 da y s of marke ting

ex clusivity for its g ener ic drug s immediately upon expiration of Merc k’s last rela ted p at en t

. S ee id. § 355(j)(5) (B )(iv)( I ). I n s t ead of suing Teva for patent infring ement, Merc k responde d by “delisting ” the patent with the FDA

. See id. § 355(j)(5) (D)( i)(I )(bb) (C C ). As interpre ted by the FDA , the Food, Drug , and Cosmetic Act, as amende d (codifie d in rele vant part at 21 U.S.C. § 355), provides for forf

eiture of exclusivi ty if the first ANDA filer (her e, Teva ) fails to marke t its product within a specifie d time afte r patent delisting. See Teva Pharms. USA, Inc., v. Sebelius , 638 F. Supp. 2d 42, 48 (D.D.C. 2009), rev’ d and remande d by 595 F. 3d 1303 (D.C. Cir. 2010). I t is undisputed that Teva did not g o to marke t within that time period afte r Merc k delisted the ’075 patent, since the FD A h ad n ot approve d Teva ’s ANDA and FDA did not publicize that Merc k had withdrawn the patent from FDA ’s list. The FDA deter mined that Teva had thus forf eited its rig ht to exclusivi ty and this Court agr eed. See ge nerally id.

The Circuit d i d n o t

. Holding that the structure of the Act does not permit the unilatera l action of a patent holder to deprive a first ANDA applicant of its s h o rt -t er m m arke ting

-2-exclusivi ty , the Circuit reve rsed and direc ted this Court to g ive relief to Teva

. Teva , 595 F.3 d at

1319 (“We therefor e reverse the j udg ment of t he dis trict court, but, as the c ourt has y et to addre ss the appropr iateness of eac h form of relief that Teva has soug ht, we rema nd for further proce eding s . . . .”). On rema n d , t h e FDA informed the Court that it had lear ned that the Merc k ’075 patent had actua lly expired prior the filing of Teva ’s law s u i t , due to Merc k’s failure to pay maintenanc e fee s to the U.S. Patent and Trade mark Offic e afte r it “delisted” the patent. FDA arg ued that patent expiration is another and separ ate basis on which, under the Act, it mig ht be found that Teva had forf

eited marke ting exclusivi ty

. See 21 U.S.C. § 355(j)(5) (D)( i)(VI ). FDA advised the Court that it had posted a notice at www.r eg ulations.gov in Docke t No. FDA -2010-N- 0134, and was

rec eiving comments on how it should interpre t § 355(j)(5) (D)( i)(VI ), under which exclusivi ty may be forfeited i f a p atent ex pires. FDA promised t o make its deter mination no later than Marc h 26, 2010. FDA urg ed the Court to withhold its reme dy order for Teva until afte r FDA d ec i d ed the question of statutory interpre tation. Howeve r, beca use Teva had persua ded the Circuit to expedite i t s appea l and the mandate, in light of the anticipated expiration of t he last Merc k patent on April 6, 2010 (except for

Merc k’s fa ilure to maintain the patent), this Court issued its order on relief on Marc h 16, 2010. See Dkt. # 28. On the FDA ’s motion to amend the order , the Court issued its final order on Marc h 26, 2010. See Dkt. # 33. On Marc h 26, 2010, as predic ted, FDA issued a letter to ANDA applican t s an d notified them that, while it disag ree d with the Circuit opinion, it had applied the Circuit’s rea soning
to answe r “no” to the question of whether a brand name drug manufa cture r could unilatera lly cause its patent to expire and, thus, forc e a forf ei ture of a first ANDA applicant’ s rig ht to marke ting

-3-exclusivi ty for 180 day s. See Dkt. # 34. There fore , the FD A announc ed, it would not preve nt the

first ANDA applicant, Teva , from enjoy ing its 180-day marke ting exclusivi ty for its g ener ic losartan drug s, and would not approve any other ANDA application d u ri n g t h at time period. Id. The consolidated petiti ons for a preliminary injunction immediately fo l l o wed in an attempt to preve nt FDA ’s appr oval of Te va’s AN DA.

Apotex and Rox ane a

re both g ener ic drug

manufa cture rs who compe te with Teva

. Eac h Plaintiff has a pe nding A NDA f or gene ric versions of C ozaar a nd Hy zaar a nd eac h has bee n prepa ring to beg in marke ting afte r April 6, 2010. Apotex participa ted as amicus curiae in the Teva suit; it was g rante d intervenor status on remand. A

potex fil ed the instant complaint on March 30, 2010, along with a proposed very short briefing schedule , with which the FDA ag ree d. Teva filed

a motion to intervene on the same day

. The Court a dopted the briefing schedule and g rante d Teva intervenor status. Rox ane filed its separ ate suit on Marc h 30; it ag ree d to the same briefing schedule and moved, without opposition, to consolid at e t h e cases. The Court g rante d both motions. This abbre viated opinion rec og nizes the parties’ ne ed for a quick de cision. II. LEGAL STANDARDS There are four familiar fac tors that g overn whether preli m i nary injunctive relief should be awa

rded and they are analy

zed on a sliding scale

. I n other words, the strong er the case on

one po i n t , t h e l es ser the evidenc e needs to be on another

. I n order to obtain a preliminary injunction, a party must demonstrate that: (1) it has a likelihood of succe ss on the merits; (2) it will suffe r irrepa

rable injury in the absenc e of preliminary relief ; (3) other interested parties will not be substantially injured i f t he requested r elief is g rante d; and (4) g ranting such re lief would ser ve the public interest. See Katz v. George town Univ. , 246 F.3d 685, 687-88 (D.C. Cir. 2001); Biovail Corp.

-4-v. FDA , 448 F. Supp. 2d 154, 155 (D.D.C. 2006). The likelihood of succe ss require ment is the most

important of these fac tors. Id. “Without any probability of preva iling on the merits, the Plaintiffs’ purported injuries, n o matter how compelling , do not justify preliminary injunctive relief .” Am. Banke rs Ass’n v. Nat’l Credit Union Admin. , 38 F. Supp. 2d 114, 140 (D.D.C. 1999). “[A] party seeking a preliminary injunction must demonstrate

. . . ‘a likelihood of succe ss on the merits,’” not

mere ly the exis tence of “questions ‘so serious, substantial, dif ficult and doubtful, as to make them fair g round for

litigation.’” Munaf v. Ge ren , 128 S. Ct . 2207, 2219 (2008). Review of final ag ency action is conducte d under the Administrative Procedur e Act, 5 U.S.C. § 551 et seq . FDA ’s Marc h 26, 2010 letter to ANDA applicants for g ener i c v er s i ons of Coz aar and Hy

zaar (losarta

n) drug products constituted final ag ency action as it rela tes to Plaintiffs and is , t h er ef

o re , subject t o court review. The FDA does not arg ue otherwise. Under the AP A, a
court will uphold ag ency action unless it is arbitra ry or capr icious or inconsistent with the law. See 5 U.S.C. § 706(2)(A) ; Tourus Records, Inc. v . DEA , 259 F.3d 731, 736 ( D.C. Cir. 2001). III. ANALYSIS The Court cannot find that the FDA was arbitra ry or capr icious when it politely expressed its disag ree ment with a D.C. Ci rc u i t decision that had ruled ag ainst the ag ency , but nonetheless applied the rea soning of the Circuit to a differ ent but, on t h es e fa cts , closely rela ted question. Given the fac ts and law in this rec ord, the Court fi n d s that Plaintiffs have a very slim chanc e of succe ss on the merits. This fac tor does not support issuance of a preliminary injunction.

The irrepa

rable harm predic ted by Plaintiffs is not to be ignor ed. Their drug products would be prec luded from competing with Teva ’s for 180 day s and, acc ording to Plaintiffs, that head start would have a m ulti-mil lion dollar consequence that could not be recove red. FDA points out

-5-that “[m] ere injuries, howeve r substantial, in terms of money , time and ener g y nece ssarily

expended,” do not constitute irrepa rable harm. W

is. Gas Co. v. FERC , 758 F.2d 669, 674 (D.C. Cir. 1985). “[F]inancial h ar m al o n e cannot constitute irrepa rable injury unless it threa tens the very exis tence of the movant’s business,” Sociedad Anonima Vina Santa Rita v. Dep’ t of Treasury , 193 F. Supp. 2d 6, 14 (D.D.C. 2001), a standard neither Plaintiff meets. Plaintiffs also arg ue, howeve r, that consumers will suffe r from signific antly highe r price s if Teva ’s g ener ics do not have immediate
g ener ic competition. This latter arg ument is fore stalled by the Circuit’s finding that the structure of the Act indica tes a c lear

pro-c onsumer cong ressional intent to rewa rd a f irst ANDA a

pplicant that challeng es a brand manufa cture r’s patent with short-term marke ting exclusivi ty , as a matter of law and public policy . This fac tor counsels a g ainst an injunction.

As to harm to others, an injunction as soug ht by Plaintiffs would cer tainly injure Teva and would preve nt public acc ess to any g ener ic of these drug s. This fac tor does not support issuance of an injunction.

The four th fac tor to consider is the public interest. Plaintiffs arg ue that consumers

are entitled to brisk competition among g ener ic drug manufa cture rs so that they will enj o y l ower price s. The arg ument is contra ry to the teac hing of Teva , wher e the Circuit de scribed the structure of the statute as pro-c onsumer b ec au s e t h e first ANDA filer is encour ag ed by the rew ard of exclusivi ty to hurry g ener ic drug s to marke t. Teva , 595 F.3d at 1318 (“The statute’s g rant of a 180- day delay in multipl e g ener ic competition for the first succe ssful para g raph I V file r is a pro-c onsumer device

. . . . The statute thus delibera tely sacr ifices the benef its of full g ener ic competition at the first chanc e allowed by the brand man u fa ct u rer’s patents, in favor of the benef its of ear lier g ener ic competition, broug ht about by the promise of a rew ard for g ener ics that stick their necks out

. . . .”).

-6-Thus, this factor a lso fails to support preliminary injunctive relief

. IV. CONCLUSION The Court will deny Plaintiffs’ motions for a preliminary injunction [Dkt. # 4 in No. 10-517; Dkt. # 4 in No. 10-521]. The Court ag ree s that FDA proper ly followed the logic of the D.C. Circuit’s decision i n Teva Pharms. USA, Inc. v. Sebeli u s , 5 9 5 F. 3 d 1303. A m emorializing order

acc ompanies this memorandum opinion.

Date: Apr il 2, 2010 /s/ ROSEMARY M. COL L YER United States District J udg e

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