Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc.

however, Recently, violence. Id. at 749. that the district court did not err in deter- mining that a Supreme violating the Florida Court held that conviction for bat- Flori- 784.085, da Statute “Battery aof Child tery of a law enforcement officer is not a by Throwing, Tossing, Projecting, or Ex- felony, necessarily forcible does not pelling Materials,” Certain Fluids or is a threat physical involve the use or force crime of purposes violence for of the ca- Hearns, or State v. violence. See reer offender enhancement. The use of (Fla.2007) 211, (discussing So.2d 218-20 physical against force another is an ele- 784.07). Fla. Stat. issue, ment of the statute. The statute at nominally while battery, requires entitled a IV. the violator to cause the child to come into interpret We the sentencing bodily fluids, contact with by “throwing, guidelines according plain to their mean tossing, projecting, expelling” or the fluids. ing. See United States v. Shenberg, 89 Fla. Stat. 784.085. These actions re- (11th Cir.1996). 1461, “The quire physical act and are directed plain meaning physical [p]ower, force is Thus, against a person. remain- violence, pressure or against directed ing requirement physical force is that it person physical in a consisting act.” Unit violence, “power, involve pressure.” 1339, ed Griffith, States v. 455 F.3d 1342 Griffith, 455 F.3d impact at 1342. The — (11th Cir.2006), denied, U.S. -, cert. against fluids pres- the child creates 2028, 127 S.Ct. 167 L.Ed.2d 771 sure and this minimal contact satisfies the omitted); (quotation & citation see also requirement physical Therefore, force. Ivory, United v. States 475 F.3d we conclude that the offense is a crime of (11th Cir.2007). person 1234-35 “A cannot violence. make physical particularly anof contact— reasons, For the above-stated we affirm insulting provoking nature —with anoth Young’s sentence. er exerting without some level of physical AFFIRMED. Griffith, force.” 455 F.3d at 1342. statute,

interpreting a similar we have re

jected argument physical force re (inter

quires violent force. See id. at 1343

preting § 922(g)(9) requirement CARACO PHARMACEUTICAL prior offense conviction have as LABORATORIES, LTD., “element, the use or attempted use of Plaintiff-Appellant, force, physical or the threatened use of a deadly weapon”). disagreed We in with

terpretations physical force that re LABORATORIES, INC., FOREST For “ quired more than ‘Newtonian mechanics’ Holdings, Ltd., est Laboratories ... ‘de minimis’ touching,” stating [or] A/S, H. Lundbeck Defendants-Appel “ Congress could have inserted ‘violent’be- lees. ” fore the ‘physical words force’ but did not No. 2007-1404. do so. Id. at (disagreeing 1343-45 with United States Appeals, Court of Belless, United States v. 338 F.3d 1063 Federal Circuit. (9th Cir.2003), Ashcroft, Flores v. April 2008. (7th Cir.2003)). Rehearing and Rehearing En Banc

V. Denied June reviewing After the record and

reading parties’ briefs, we conclude Hurst, Strawn,

James F. Winston & LLP, IL, plaintiff- Chicago, argued for him appellant. on the brief were With Derek and Samuel S. Park. Of J. Sarafa were N. John- counsel on the brief Steffen Goodrich, Washington, son Luke W. DC. Flattmann, Jr., Kirkland &

Gerald J. NY, LLP, York, argued for Ellis of New him on defendants-appellees. With Desmarais, M. Christine brief were John Benjamin Lasky. Willgoos, A. Of Peter J. Armenio. counsel was GAJARSA, Judge, Circuit Before FRIEDMAN, Judge, and Senior Circuit PROST, Judge. Circuit by court Opinion for the filed Circuit opinion filed Judge Dissenting GAJARSA. Judge Circuit FRIEDMAN. GAJARSA, Judge. Circuit the De- brought This action under is an Act, claratory Judgment provision §§ and the ac- establishing civil Act Hatch-Waxman certainty, 21 U.S.C. tions for 355(j)(5)(C). Plaintiff-Appellant Caraco (“Cara- Laboratories, Ltd. Pharmaceutical co”) a decision of the United appeals District Court for the Eastern Dis- “with respect States which a claim of dismissing Michigan reasonably trict could asserted be noninfringement if person action licensed owner by the Forest Defendants-Appellees manufacture, Lab- against engaged use, in the sale (“Forest”). oratories, Inc., al., 355(b)(1), et drug.” See 21 U.S.C. (c)(2). was dismissed for lack of Article III action lists all in a such jurisdiction grounds on the had publication titled the “Approved Drug been rendered moot when Forest unilater- Therapeutic Products With Equivalence ally granted Caraco a covenant not to sue publication Evaluations.” This is common- infringement of the patent-in-suit, ly as the “Orange Drugs known Book.” 6,916,941. However, Patent No. in the approved the FDA are known as “listed framework, context of the Hatch-Waxman drugs.” 355(j)(2)(A)(i). See U.S.C. covenant not not elimi- to sue did Second, to facilitate development parties. nate the between drugs, versions of listed Accordingly, we hold that Caraco’s declar- provides Hatch-Waxman Act an Abbrevi atory judgment presents action continu- (“ANDA”) Drug Application ated New III ing controversy, Article and reverse process generic for drug manufacturers. for proceedings. and remand further § 355(j). 21 pro See U.S.C. The ANDA approval generic cess streamlines FDA of I. BACKGROUND drugs by allowing applicants rely on the case arises under the This Hatch-Wax- safety the efficacy results of studies Act,1 governs man which Food and that supported the FDA’s of a approval (“FDA”) Drug approval Administration’s id.; drug. listed See Lilly Eli Co. v. & goal generic drugs. of new and The Medtronic, 661, 676, 496 U.S. 110 Act is a balance between two “[strike] 2683, 110 (1990). S.Ct. L.Ed.2d 605 Under (1) policy competing inducing interests: process, generic drug compa ANDA pioneering development research and of show, ny must submit information inter (2) drugs competitors enabling new alia, generic drug that its and the relevant low-cost, generic of bring copies those drug ingredi listed share the same active Pharms., drugs to market.” Inc. v. Andrx are bioequivalent. ents and 21 U.S.C. (Fed. 1368, Corp., Biovail 276 F.3d 1371 (iv). § 355(j)(2)(A)(ii), addition, generic Cir.2002). aspects following five of drug companies must submit one of four are Hatch-Waxman framework rele addressing Orange- certifications each vant to this case. patent Book-listed covering the listed First, a pioneering drug company must drug. Specifically, the must ANDA filer FDA approval drug by obtain sub- certify— (“NDA”). mitting Drug Application New (I) required] that [the informa- patent (b). 355(a), § part See 21 U.S.C. of As has tion not been filed [with process, NDA in- drug company must FDA], form the FDA of patents covering all (II) drug, or the methods of using patent that such expired, 156, 271, (2000)), 1. §§ The Hatch-Waxman Act name com- is the 35 U.S.C. 282 amend- as monly Drug Compe- used to refer Price Prescription Drug, ed Medicare Im- tition and Patent Act Term Restoration of 2003, provement, and Modernization Act of 1984, 98-417, Pub.L. No. 1585 98 Stat. 355, 360(cc) (2000), 108-173, Pub.L. No. 117 Stat.2066 (codified §§ at 21 U.S.C.

1283 Ltd. v. Group Apo courts.” (III) federal Glaxo which such the date on of (Fed.Cir. tex, Inc., expire, or will 2004) original); see Eli (emphasis in also (IV) or patent is invalid will that such Lilly, U.S. at 110 S.Ct. 2683 manufac- infringed not be (“Quite obviously, purpose subsec use, new ture, or of the' sale 3(e)(2) judicial .. submit- is to enable application which the tion! ... adjudication upon which the ANDA ted. dependfs].”) ] scheme! 355(j)(2)(A)(vii). generic If a § 21 U.S.C. generic seeks to market drug company Fourth, to incentivize ANDA filers to expira drug before the a listed

version of validity patents challenge listed patents cover Orange-Book-listed tion early as design around those file a certification ing drug, must provides Act the Hatch-Waxman possible, 355(j)(2)(A)(vii)(IV), i.e. under U.S.C. applicant first ANDA file a See Eli IV certification.” “Paragraph (“first Para- Paragraph IV certification All Lilly, S.Ct. 496 U.S. filer”) enjoy a graph ANDA shall 180- IV provide filers must Paragraph IV marketing day period exclusivi- Paragraph TV certification notice of their 355(j)(5)(B)(iv). ty. Until See U.S.C. the NDA patent owner and to both the ANDA filer’s exclu- first 355(j)(2)(B). This no holder. may sivity the FDA period expires, forth a “detailed statement tice must set Paragraph IV ANDA approve a later-filed opinion basis for the legal the factual and (hereinafter NDA on the based same is invalid applicant ANDA”). Id. “subsequent Paragraph IV infringed.” will not be Paragraph first Importantly, the IV 355(j)(2)(B)(iv)(II). § 180-day ex- ANDA filer is entitled the Act Third, facili the Hatch-Waxman it clusivity period whether or not estab- dis early tates the resolution Orange- holder’s lishes that the NDA pioneering generic and putes between are or not in- patents Book-listed invalid that by providing drug companies in its fringed by drug described ANDA filing IV Paragraph mere act of a ANDA; required is that the first all is infringement. act constitutes ANDA filer submit a sub- Paragraph IV 271(e)(2); 496 Lilly, § Eli 35 U.S.C. a complete ANDA that contains stantially 678, 110 The Act states that S.Ct. 2683. 21 IV certification. U.S.C. Paragraph infringement” “it shall an act of be § 355(j)(5)(B)(iv)(II)(bb). purpose ANDA “if the of such submit provides Act The Hatch-Waxman ... approval is to submission obtain exclusivity 180-day period begins manufacture, engage in commercial Paragraph that the first either on the date use, a ... in a claimed sale begins marketing ge ANDA filer its TV use claimed in a of which is patent or a final court the date of drug, neric or on pat such expiration patent before Orange- the relevant 271(e)(2). finding decision § As this court ent.” 35 U.S.C. “ infring 271(e)(2) patents invalid or Book-listed designed § explained, is has 21 ed, comes first. See U.S.C. infringement act of whichever create an artificial (2000)2; also Teva 355(j)(5)(B)(iv) § see jurisdiction establishing purposes Paragraph can IV ANDAfiler Congress replaced provisions which the first In exclusivity period fails mar- if it 180-day forfeit its governing the commencement a certain time. See regime ket within exclusivity period a new under with USA, v. Pfizer, event, Inc. to prevent triggering 395 incentive Pharms. (Fed.Cir.2005) {“Pfizer”). subsequent Paragraph because F.3d ANDAs IV words, applicable statutory approved other cannot be until exclusivity period Moreover, two methods of provisions provide trig expires. because subse- Paragraph ANDA fil quent Paragraph the first IV ANDA can gering IV filers (1) 180-day exclusivity period: er’s com activate the Paragraph first IV ANDA fil- mercial-marketing trigger pursuant 180-day exclusivity to 21 er’s period through the (2) § 355(j)(5)(B)(iv)(I) court-judgment trigger, subsequent U.S.C. Para- trigger court-judgment pursuant graph to 21 ANDA strong IV filers have a in- 355(j)(5)(B)(iv)(II) Only U.S.C. centive to challenge NDA holder’s the first IV ANDA filer Paragraph Orange-Book-listed can in court. period Conversely, trigger 180-day exclusivity via strong NDA holders have a commercial-marketing trigger. See 21 litigation incentive to avoid that would § 355(j)(5)(B)(iv)(I). However, trigger Paragraph the first IV ANDA fil- subsequent Paragraph exclusivity IV ANDA filers can period er’s allow Paragraph trigger first IV ANDA fil to approve subsequent Paragraph IV AN- 180-day exclusivity period days er’s via the DAs triggering after the event. court-judgment trigger. Mining Minn. & example, For if a first Paragraph IV Labs., Inc., Mfg. v. Barr Co. 271(e)(2) ANDA filer is found liable in a (Fed.Cir.2002) (“3M ”) (holding simply action or to mar fails Paragraph the first IV ANDA filer’s 180- ket its then drug, trig day exclusivity triggered can period be gered exclusivity its own period through court obtained subse court-judgment trigger or the commer filer). quent Paragraph ANDA IV case, cial-marketing trigger. approve

Since the FDA cannot subsequent subse- Paragraph IV ANDA filer quent Paragraph IV until generate ANDAs the first must a court-judgment triggering 180-day IV ANDA filer’s exclu- event in order to activate first Para sivity expires, the date which period graph 180-day filer’s exclusivity exclusivity period triggered period. is critical 355(j)(5)(B)(iv)(II) (2000); 3M, subsequent NDA holders and Paragraph at pre 780. More hand, IV ANDA filers. cisely, On the one subse- the subsequent Paragraph IV quent Paragraph ANDA filers IV have a ANDA filer judgment must obtain a strong generate incentive triggering to a the NDA Orange-Book-listed holder’s pat event allowing approve the FDA to their ents are invalid infringed by or not the subsequent ANDAs Paragraph drug IV 181 described in its subsequent Para days after the triggering event. On the graph IV ANDA. 21 U.S.C. hand, other § NDA holders have a strong 355(j)(5)(B)(iv)(II) However, if § 355(j)(5)(D); Pfizer, 1102(b). § U.S.C. see also 395 ap- The amendments also do not part F.3d at 1329. The amendment was ply generic drug company if another had filed Prescription Drug, Improve- the Medicare ment, Paragraph a IV ANDA for the same listed and Modernization Act of Pub.L. drug the before date of enactment the 108-173, (2003) ("Medi- No. 117 Stat.2066 case, generic drug MMA. In compa- Id. a "MMA”), care Act” or Modernization which Pharmaceuticals, Inc., ny, namely Ivax filed a Pfizer, was enacted on December 2003. Paragraph August IV ANDA in before 395 at Despite changes, F.3d 1328-29. these the December 2003 enactment of the MMA. grandfather provision the MMA contained Thus, the MMA provisions amendments to the specifying that the apply amendments do not governing the 180-day commencement of ex- Paragraph to IV ANDAs filed the before date clusivity period inapplicable are to this case. of enactment of the See MMA. MMA addition, Congress extended prevent the subse- holder can the NDA jurisdiction ANDA filer’s court federal over CAPCs “to the Paragraph IV quent delay approval FDA it can extent consistent with Constitution.” challenge, 271(e)(5). ANDA and subsequent Paragraph Accordingly, § IV feder subsequent Paragraph jurisdiction IV courts to delay thus al have over CAPCs into market. See entry they present ANDA filer’s the extent that an Article III 355(a) Novartis, (providing controversy. or “[n]o U.S.C. case F.3d for intro- person Congress explained shall introduce deliver the need for any new jurisdiction into interstate commerce over duction broad federal CAPCs approval [NDA of an drug, unless follows: to respect is effective with such

ANDA] are generic applicants [W]hen blocked Indeed, an NDA could thus drug”) holder by generic applicant’s 180-day first delay any subsequent Paragraph exclusivity, company brand entering until from the market ANDA filer ge could choose not to sue those other Orange-Book-listed pat- the NDA holder’s delay as to a final applicants neric so expire.3 ents trigger court decision that could provision “failure to market” force aspect of the Hatch- The fifth final market.[4] to first Act relevant this case is Waxman circumstances, ge- ... these ... patent certainty” “civil action obtain neric must be applicants able seek (“CAPC”). 355(j)(5)(C). See 21 U.S.C. involving all disputes pat- resolution of designed prevent NDA The CAPC Orange ents Book with listed the Hatch-Wax- “gaming” holders from immediately respect upon to the by forestalling resolution of man Act 45-day period. expiration We Teva disputes with ANDA filers. believe there can be case or controver- USA, Inc. v. Novartis Pharms. Pharms. sy courts to hear these (Fed.Cir.2007) 1330, 1342 Corp., sufficient merely cases because at is- (“Novartis ”). provi Under the CAPC Orange sue have been listed sions, if the NDA holder fails sue Book, statutory scheme and because days, IV ANDA filer within Act relies on ear- Hatchr-Waxman filer can sue the NDA holder ly patent disputes. The resolution obtain a provisions in this declaratory judgment Orange-Book-listed patents are relevant encourage early such infringed. are intended to invalid or not bill disputes. 355(j)(5)(C). resolution (dis- trigger. supra drug companies court-judgment See note 2 3. Generic can obtain imme- 1102(b), 2460). approval drugs cussing diate of their when 117 Stat. MMA Orange-Book-listed expire patents relevant Although legislative here discussion refers submitting Paragraph certify- by III ANDA provisions, 180-day this dis- to the amended ing patents expire will on date. inconsequential tinction is because under § 355(j)(2)(A)(vii)(III). See 21 U.S.C. 180-day original provi- both the and amended sions, ability subsequent Paragraph IV of to 4. The here refers to the “failure discussion approval depends ANDA to obtain FDA filers Act, provision of the market” Hatch-Waxman holding on the date of final court decision 355(j)(5)(D), first under which the Orange-Book-listed patents in- the relevant Paragraph IV ANDAfiler can forfeit its 180- Thus, infringed. valid or not Senator Kenne- day exclusivity by failing period to its market concerning dy’s the brand name remarks generic drug. 355(j)(5)(D) replaced Section delay company's such court incentive period triggering pro- 180-day exclusivity equally applicable to this case. are decisions case, applicable are this i.e. 21 visions that (2000), 355(j)(5)(B)(iv) including U.S.C. (Nov. 2003) patents Pharmaceuticals, Rec. S15885 '941 was Cong. Ivax (remarks (“Ivax”). Kennedy, ranking Sen. of mem- Accordingly, Inc. is entitled Ivax Health, ber of Senate Committee on U.S. generic days exclusivity, of market Pensions) Labor, Education, (empha- and begin day which will either it begins on the added). sis marketing generic drug, its or the date a court '712 determines that the and '941

II. FACTS patents infringed— are invalid or not whichever comes first. See Lexapro® A. NDA Forest’s for § 355(j)(5)(B)(iv) approved NDA for Forest holds its drug Lexapro®, which is used to treat responded Paragraph Forest to Ivax’s depression generalized anxiety and disor- by suing infringement IV ANDA Ivax for currently generic der. Forest faces no of patent, the '712 earlier the two Labs., competition Lexapro®. for Forest patents expire. Ivax counterclaimed Pharms., Inc., Inc. F.Supp.2d v. Ivax patent that the '712 Despite was invalid. (D.Del.2006). 479, 494 suing Ivax on the '712 patent, Forest did part process filing

As for Lexa- not sue Ivax for of the '941 NDA, pro® Forest listed two in patent. By holding patent in '941 Book, Orange namely: the FDA’s reserve, Forest insulated from an itself (“the 34,712 patent”) Patent Re. '712 Nos. invalidity noninfringement challenge by (“the 6,916,941 patent”). and '941 The Ultimately, Ivax.5 Forest defeated Ivax’s '712 patent covering includes claims sub- counterclaim invalidity pat on the '712 stantially escitalopram, forms of pure ent a judgment and obtained that the drug ingredient Lexapro®. active The '941 in infringed described Ivax’s ANDA patent generally crystalline parti- covers '712 which was affirmed this escitalopram particular cles of oxate Labs., court in Forest Inc. Ivax dosage well range, size as forms con- Pharms., (Fed.Cir. 501 F.3d 1263 taining particles range, of this size and 2007). manufacturing methods in particles range. sum,

size The '712 expires filing in Paragraph after IV cer- 2012; patent expires '941 tification for both the '712 '941 pat- ANDA, ents in Ivax failed obtain a Challenge B. The First court judgment that '712 either the or the Orange-Book-Listed to Forest’s infringed is invalid or Lexapro® Patents for and the Con- described its ANDA. Because sequences Subsequent for Para- Ivax has not obtained a graph IV ANDA Filers both of Orange-Book-listed pat- Forest’s applicant ents are infringed by first file a Para- invalid graph IV ANDA, certification drug described in its Ivax later, However, 5. As discussed in detail will be more that NDA. F.2d at 1346. Novartis this court held that where an NDA Novartis had not been decided at the time of brings against holder suit case, dispute, any Forest and Ivax's in and Paragraph only ANDA IV filer on one of sev- sought declaratory judgment Ivax never Orange-Book-listed patents covering eral its patent Forest's '941 was invalid or not in- NDA, standing filer the ANDA to seek a Pharms., fringed generic by drug, its see Ivax judgment any on of the NDA Inc., 1265. remaining OrangeBook-listed patents holder’s exclusivity begins of when Ivax 180-day ately regardless trigger its failed to — court-judgment trigger, drug court-judg- its period marketing via —via 355(j)(5)(B)(iv)(II) § trigger, U.S.C. ment U.S.C. (2000). However, 355(j)(5)(B)(iv)(II) § be- addition, generic drug because Paragraph first cause Ivax was the TV to ANDA was found in Ivax’s described with to both the '712 respect ANDA filer trig infringe patent, the '712 Ivax cannot subsequent patents, Paragraph and '941 180-day exclusivity period its via ger commercial-marketing trigger, only U.S.C. ANDA filer can activate Ivax’s IV (2000), until the '712 355(j)(5)(B)(iv)(I) court-judgment exclusivity period via Indeed, dis in 2012. patent expires judgment that trigger by obtaining a both enjoined Ivax from specifically trict court patents '712 '941 are invalid or not and using, offering selling to “making, sell infringed. States, into importing

within the United subsequent If a IV ANDA Paragraph in any products that the United States to pursue filer is not able either these patent, including [drug] '712 fringe the pathways triggering exclusiv- two Ivax’s un products [Ivax’s ANDA] referred to period ity period, exclusivity then Ivax’s patent the '712 ex til such time as ” patent expires until the '712 begin cannot Labs., Inc. v. Ivax pires .... Forest Moreover, Pharms., (D.Del. assuming 2012. there has No. 03-891-JJF 2006) Order). (Judgment triggering As no Nov. been other event result, exclusivity Ivax cannot activate its time, exclusivity period will not be Ivax’s commercial-marketing trig period via on the date the '712 ex- triggered patent expires. the '712 ger until actually begins Ivax market- pires unless generic if ing its date. Even no its longer trigger With Ivax able so, Ivax does the FDA will still be restrict- exclusivity period, pathways two re- approving subsequent ed from Para- subsequent Paragraph main IV open trigger filers who seek to Ivax’s ANDA until 181 after the graph days ANDA IV the '712 exclusivity period before patent expires.6 date '712 See First, a Para- expires subsequent in 2012. 355(j)(5)(B)(iv). U.S.C. ANDA filer could obtain a court graph IV short, triggering absent an event invalidating '712 exclusivity, Para- subsequent Ivax’s all the FDA to approve which would allow filers, Caraco, including graph IV ANDA approval, Ivax drug. Ivax’s With entry will be denied market legally generic would free sell be subsequent significant time. These exclusivity drug, period be would be Paragraph pre- IV ANDA filers will triggered day on the of its first commercial regardless cluded from market

marketing. See drugs described whether (2000) (the § 355(j)(5)(B)(iv)(I) “commer- infringe Orange- their ANDAs Forest’s Second, cial-marketing trigger”). a subse- patents regardless Book-listed quent Paragraph IV ANDA filer could exclusivity are valid. trigger period Ivax’s immedi- whether subsequent option be an until Forest's other patent expires, tion will not When covering filers will not Orange-Book-listed patent be able Lexa- approval filing a immediate FDA obtain patent, expires pro®, in 2023. See certification; obtaining FDA Paragraph III 355(j)(2)(A)(vii)(III). approval by filing Paragraph III certifica- 1288 Subsequent Challenge Shortly

C. Caraco’s after Caraco sued Forest for a Orange-Book-Listed declaratory judgment patent, on '941 Pat- Forest filed a motion to dismiss Caraco’s Lexapro® ents for 12(b)(1) pursuant action to Fed.R.Civ.P. on 2006, Plaintiff-Appellant May In Caraco grounds not present action did generic eseitalopram filed an ANDA for a “case” “controversy” required by a Paragraph included IV certification Article III of the In its Constitution. mo '712 for Forest’s and '941 for patents Lex- tion, argued that was Forest there no con 271(e)(2), § 35 apro®. Under U.S.C. this troversy because Caraco did not have a of infringement constituted technical act apprehension reasonable of suit on the patents. of both Forest Caraco sued At patent. the time Forest filed its infringement motion, of the '712 in a patent law precedent court’s most recent suit in the governing justiciability filed Eastern District of Michi Labs., Inc., judgment gan, applied suits reasonable-ap Forest v. Caraco Pharm. prehension-of-suit Labs., Ltd., test determine Case No. 2:06-EV-13143-B justiciable controversy whether a existed. As of AF-MKM.7 the time this writ See, e.g., Pfizer, 395 F.3d at Howev 1332. ing, parties’ litigation respect with er, below, as is discussed more detail the '712 patent ongoing. is motion, even before Forest filed its suing Despite infringement Caraco for Supreme reasonable-ap Court found the patent, of the '712 did not Forest sue prehension-of-suit test inconsistent with its Caraco the '941 patent. on However as MedImmune, precedent. Inc. Genen above, discussed under the Hatch-Wax- tech, Inc., 127 549 n. S.Ct. man framework Caraco has economic 764, 774 n. L.Ed.2d in determining interest whether the '941 The explained Court in Medlmmune that patent infringed by is invalid or not the whether a declaratory judgment action ANDA, in its described because presents an Article III must judgment invalidity or noninfringe- be based determined on “all the circum respect ment the '712 with both stances,” merely on whether the de can trigger Ivax’s exclusivity claratory judgment plaintiff is under a rea period. 355(j)(5)(B)(iv)(II) § See U.S.C. apprehension sonable Id. suit. at 771. (2000). Accordingly, sepa- Caraco filed a addition, after Forest filed its motion rate under Declaratory action Judg- to dismiss but before the district court Act, 2201, 2202, §§ ment and the ruling, made its this court issued deci- provision establishing Hatch-Waxman Novartis, sion in F.3d 1330. As CAPC, 355(j)(5)(C), seeking U.S.C. case, present the issue in Novartis was declaratory judgment de- whether a IV ANDA filer’s de- scribed in its ANDA infringe does claratory judgment against action an NDA patent. Forest’s '941 Caraco’s declaratory holder presented justiciable Article III respect action with to the '941 controversy. case or Id. at 1335. No- vartis, presently the case appeal. USA, is Teva Pharmaceuticals Inc. by suing It should be noted forty-five days receiving Caraco within after notice of infringement certification, trig- of the '712 paragraph Forest an automatic gered effect, stay automatic thirty-month "stay” 30-month goes during into approval provided which approve the FDA cannot the ANDA 355(j)(5)(B)(iii). 355(j)(5)(B)(iii), Under unless the suit resolved or the ex- patentee pires.” Pfizer, "[i]f the files an action 395 F.3d at 1328. ents, (“Teva”) patentee whether the has sued on applicant ANDA was first only paragraph all some of IV on all certification five file patents. certified covering an Orange-Booklisted patents by owned Novartis approved drug Id. at 1344. (“Novartis”). Corp. Id. Pharmaceuticals applying the all-the-eireum- thus a Para- Although Teva had filed at 1334. declaratory judgment test to a ac- stances all of Novar- certification for five graph IV phar- and a tion an ANDA filer between patents, Novartis Orange-Book-listed tis’ patentee, maceutical the Novartis decision only brought suit under U.S.C. argument eliminates Forest’s Caraco’s 271(e)(2)(A) infringement of one of for be declaratory judgment action dis- should those Id. patents.8 no missed because Caraco had reasonable suit, brought Novartis filed Teva patent. After of on the '941 apprehension suit issued, Novartis on the separate against action After decision Forest the Novartis pat remaining Orange-Book-listed granted four unilaterally Caraco an irrevocable However, district Id. at 1335. ents. not to for of the covenant sue declaratory judg grant- court dismissed Teva’s in goal '941 Forest’s stated patent. justiciable contro ment action for lack of was “to ing the covenant to Caraco con- grounds that had no versy on the Teva there no or controver- firm” that was case of on apprehension sy regarding suit the '941 parties reasonable between in remaining Orange-Book-listed pat provides, covenant rel- patent. four subject part: This was the evant ents. Id. dismissal appeal, in Id. Novartis. On appeal all hereby covenants itself and [Forest] Court’s Supreme court observed patent successors interest abrogated had MedImmune decision any alleged in- not to sue Caraco test, (whether indirect) reasonable-apprehension-of-suit No direct or fringement vartis, applying F.3d at or violation of the based Supreme all-the-circumstances any Court’s ANDA 78-219 or filing test, manufacture, use, sale, court there was a found offer commercial justiciable controversy par importation between for sale or decision, ties, 78-219. reaching products 1346. In this ANDA id. at described the court held that— this despite Caraco cove- Notably, giving justiciable

A con- sue, nant Forest refused to concede not filer troversy for an ANDA when arises was invalid or not the '941 Orange in the patentee patents lists drug described Cara- infringed Book, applicant files its fact, the ANDA hinged Forest its en- co’s ANDA. un- certifying the listed dismissal on cove- argument tire IV, patentee sue, stating: der “There no paragraph nant is against gave the submitted a covenant brings controversy action because we patents. agreed, more court ANDA on one or not to sue.” The district these three circum- from bench that stating “[t]here’s The combination of establishing '941 so there’s covenant not sue on the dispositive stances loss, no threat to be there’s declaratory judgment going actual Hearing on Mu- Transcript lawsuit.” paragraph pat- as to all the IV certified approval under 21 though ring ANDA from Teva on Teva’s 8. Even Novartis sued Novartis, 355(j)(5)(B)(iii). Orange-Book-listed patents, one stay n. 5. trigger bar- was sufficient 30-month 1290 2007) (em 30, subject 31 (May jurisdiction Dismiss at

tion to matter over such ac- added). basis, this phasis they On the district tions to the extent that present an III controversy. court ruled that there was no Article III Article case or See No- vartis, granted at controversy and Forest’s motion 482 F.3d 1337. Notably, is no

to dismiss. there indication MedImmune, In Supreme Court re that the district court the record consid proper affirmed the standard for deter Supreme ered either Court’s MedIm mining declaratory whether a judgment this court’s mune decision or Novartis de action satisfies the Article III case con making ruling. cision this when troversy requirement. 127 at S.Ct. Specifically, justicia the Court framed the III. ANALYSIS bility as inquiry alleged, “whether the facts A district court’s de dismissal of a circumstances, under all the show that claratory lack juris action for is a controversy, there substantial between presents question diction of law that this parties having interests, legal adverse Novartis, novo. court reviews de immediacy sufficient reality to warrant at 1335. of a declaratory judgment.” the issuance (quoting Id. Md. Cas. v.Co. Pac. Coal & starting point Our in analyzing Co., 270, 273, 312 Oil U.S. 61 S.Ct. 85 appeal is the Declaratory Judg (1941)). addition, L.Ed. 826 the Su Act, 2201(a), § ment 28 U.S.C. under preme emphasized Court that Article III which this Caraco filed suit. The relevant “ requires that the dispute be ‘definite and text the Act provides: concrete, touching legal relations of In case of actual within its parties having interests’; legal adverse jurisdiction any ... court the United that it be ‘real and substantial’ and States, upon filing appropriate specific ‘admi[t] of through relief a decree pleading, may declare the rights and character, of a distinguished conclusive legal other relations of interested an opinion advising from what the law declaration, party seeking such whether upon would be a hypothetical state of or not further relief be could ” Ins., Id. (quoting facts.’ Aetna 300 Life sought. 240-41, 461). 57 S.Ct. 2201(a). It is well established phrase “actual controversy” In Novartis court held we 2201(a) any controversy includes over must “follow teaching MedImmune’s jurisdiction. which there is Article III look at ‘all the circumstances’ to determine Haworth, Aetna v. Ins. Co. 300 U.S. whether action declaratory [an for a judg Life 227, 239-40, 57 S.Ct. noninfringement L.Ed. ment of or patent invalid (1937) (noting that “the ‘actual’ ity justiciable word is one presents] a Article III con definition”). of emphasis rather than of troversy.” 482 F.3d at 1339. Accordingly, addition, with respect declaratory judg acknowledged Novartis this court’s ment brought by actions Paragraph IV reasonable-apprehension-of-suit test was against ANDA filers NDA es Id.; holders to overruled MedImmune. see also noninfringement STMicroelectronics, tablish or invalidity Corp. SanDisk Orange-Book-listed patents, (Fed.Cir.2007). Congress specifically granted federal subject courts reasonable-apprehension-of-suit test re jurisdiction (1) matter “to the extent quired consis “both an explicit threat or other tent with the patentee, Constitution.” action which creates a 271(e)(5). Thus, federal courts have reasonable apprehension part fairly traceable connection between will face an plaintiff injury and the com- activity plaintiffs present suit and plained conduct of the defendant. infringement or constitute which could —of third, must And there be redressabili- with the intent steps taken concrete Novartis, ty requested relief 482 likelihood activity.” such an conduct —a MedImmune, alleged injury. will redress the Following at 1339. F.3d apprehension a of suit proving reasonable Env't, v. a Better 523 Steel Co. Citizens for ways patentee a can only many is one of 83, 102-03, 1003, 140 118 S.Ct. general more satisfy Supreme Court’s (1998) (internal omit 210 citations L.Ed.2d establish that test to all-the-eircumstances ted). Article III presents justiciable an a action Judicially Cogni- Alleges Caraco controversy. Injury-in-Fact zable all-the-circum applying In case, judg In as in most declaratory judg to Caraco’s stances test context, in the Cara- ment actions action, by the Su guided we are ment injury-in-fact is a “restraint on alleged co’s for three-part framework preme Court’s exploitation non-infringing the free presents an action determining whether Co., Inc. Hock goods,” Wing Shoe v. Red controversy. par justiciable Article III erson-Halberstadt, 1355, ticular, Arti justiciable an under action is (Fed.Cir.1998). Here, alleges 1360 Caraco (1) plaintiff has cle III where being selling from a non- it is excluded Wildlife, Lujan v. standing, Defenders product Forest has tak infringing because 555, 560, 112 S.Ct. 119 504 U.S. ap delay en that FDA from actions (2) (1992), present issues L.Ed.2d Novartis, 482 Caraco’s ANDA. See proving review, Abbott ripe judicial ed are (observing at 1340 that an Gardner, 136, 149, 87 387 U.S. Labs. requisite injury-in-fact filer suffers (1967), S.Ct. 18 L.Ed.2d ability approval of where its to secure stage any is moot at case not rendered by an NDA prevented ANDA has been States Parole litigation, United holder). 388, 397, Geraghty, Comm’n. v. 445 U.S. 100 S.Ct. 63 L.Ed.2d Novartis, explained As this court reasons, we following hold For a dif- presents framework Hatch-Waxman declaratory judgment action sat circumstances than those ferent set of requirements presents isfies these ordinary infringement an which underlie controversy. justiciable Article III “Ordinarily, potential competitor action: legally is free to market its other fields Standing A. adversely-held product in the face of Supreme explained Court contrast, the Hatch- patent. under mini the “irreducible constitutional an ANDA filer ... is not Waxman Act standing” following mum of contains the market legally [without free to enter requirements: three In- approval].” 482 F.3d at 1345. 355(a) foremost, deed, provides al- there must be First and (and or proved) person shall introduce deliver ultimately “injury leged “[n]o into interstate commerce plain- harm introduction in fact”—a suffered approval of an drug, [NDA unless an and actual or im- new tiff is “concrete” respect to such minent, effective with ANDA] is “conjectural” “hypotheti- not Thus, the FDA Second, drug.” by preventing be causation— cal.” there must generic the ANDAs approving from It S.Ct. 1003. the Hatch-Wax- manufacturers, drug pharmaceutical pat- man Act or pre the FDA framework that can potentially entees like Forest exclude ap vents Caraco’s ANDA from being non-infringing generic drugs from the FDA, proved by the but rather Forest’s market. If is correct ge- Caraco that its actions the context —i.e. “under all infringe drug neric does Forest’s '941 circumstances,” MedImmune, 127 S.Ct. then it has a right to enter the 771 — of the Hatch-Waxman framework. market, and its exclusion Simply put, if Forest had not listed its generic drug from the market and ’941 in the Orange FDA’s injury-in- actions is sufficient III Article patents covering Book as valid Moreover, fact. the fact that Forest’s ac- in its Lexapro®, described NDA for then only can tions exclude from the Caraco (2000) 355(j)(5)(B)(iv) would drug market the context of Hatch- independently delay Caraco’s Waxman framework does not Cara- render from being approved the FDA. Such “concrete, injury any co’s less actual or but-for causation is sufficient satisfy Co., 102-03, imminent.” Steel 523 U.S. at traceability requirement of III Article 118 S.Ct. 1003. standing. See Duke Power v.Co. Carolina sum, alleges In Caraco that it has been Study 59, Envtl. Group, 438 U.S. 74- exploitation “restrain[ed free of from] 78, 26, n. 98 S.Ct. 57 L.Ed.2d 595 Shoe, non-infringing goods,” Red Wing 148 (1978). exactly F.3d at 1360. This is type of above, As discussed where first injury-in-fact that is sufficient to establish Paragraph IV ANDA filer has failed to standing Article III under our caselaw. trigger 180-day exclusivity own period, id.; Novartis, See see also 482 F.3d at listing the NDA Orange-Book holder’s of (explaining that NDA holder’s use patents delays subsequent a Paragraph IV OrangeBook-listed of an patent to exclude entering ANDA filer from marketplace a drug maker from the market Moreover, indefinitely. delay this occurs type uncertainty creates “the exact of even drug if the described in legal the subse rights the ANDA quent judgment CAPC, Paragraph IV ANDA in action does not [i.e. § 355(j)(5)(C)] fringe Orange-Book-listed prevent”).9 patents. was enacted to Here, listing Forest’s of the '712 and '941 Injury

2. Caraco’s Is Traceable to patents in Orange-Book effectively de Forest nies Caraco an economic opportunity to injury enter the “fairly marketplace Caraco’s is also can trace unless Caraco able a complained-of [to] conduct of obtain judgment that both those patents Co., defendant,” 102-03, Steel 523 U.S. at are invalid not infringed by or its generic 9. Even before the MedImmune 355(j)(5)(B) bring and Novartis prod- tion in order to decisions, the District of Columbia Circuit possible uct to market. It is that such a came to a similar conclusion. Mova See bottleneck, statutorily-created coupled with Shalala, Corp. Pharm. v. express the statute's reference to declarato- (D.C.Cir.1998). Mova, n. 18 the court ry judgment relieving actions as means of following made the observation: bottleneck, might suffice to allow [T]he Federal Circuit has had no occasion plaintiff to show the existence of a "case decide whether there "a controversy” demonstrating without im- immediacy reality” sufficient sup- and being mediate risk sued. action, port declaratory judgment when (internal omitted). Id. citation plaintiff requires judgment under sec- circumstances, judgment drug For obtains favorable these drug. Under (the infringe patent patent- described in its ANDA does listing of est’s in-suit) an in Orange-Book creates then it will need invalidity noninfringe- to the market dependent barrier opportuni of an economic deprives Caraco order to ment on Forest’s '712 compete. It is well established ty exclusivity ob- period activate Ivax’s compete of such barriers possible. the creation swiftly tain FDA as approval requirement of Arti causation satisfies the Thus, judgment in action a favorable See, Chap e.g., Ne. Fla. standing. cle III for the '941 potential would eliminate the ter, Contractors Am. Associated Gen. from to exclude Caraco Jacksonville, 656, 666, 113 S.Ct. 508 U.S. market.11 (holding that 124 L.Ed.2d 586 “imposition of barrier” to bid [a] government contracts satisfied certain sum, declaratory judgment requirements injury-in-fact and causation injury-in-fact, causa satisfies the action standing); Clements v. Fash of Article III tion, redressibility requirements 2836, 957, 962, 102 ing, S.Ct. 73 457 U.S. Moreover, beyond satisfy standing. even (1982) (holding impo 508 L.Ed.2d ing requirements the of Article III stand candi [plaintiffs] an sition of “obstacle ing, action is consistent with the Caraco’s judicial the office” satisfied dacy higher Judg Declaratory of the purpose basic requirements injury-in-fact and causation previously Act. court has ment As this standing); Zenith Radio of Article III Declaratory explained, of the purpose “the Research, 395 U.S. Corp. v. Hazeltine patent ... in is to Judgment Act cases 124-25, 1562, 100, 89 23 L.Ed.2d 129 S.Ct. party re provide allegedly infringing the (1969) plaintiff the had stand (holding that delay uncertainty regarding lief from it ing alleged it had been to sue where rights.” Goodyear Tire & Rubber legal market). a of denied share the Releasomers, Inc., 956 Co. v. Novartis, (Fed.Cir.1987); also 482 see by Injury Is Redressible 3. Caraco’s (“The Declaratory Judg 2 n. F.3d 1336 Judgment Favorable 271(e)(5) Act ment and 35 U.S.C. injury-in-fact Finally, is Caraco’s underlying patent policies ‘serve[ ] judgment that by declaratory redressible enabling validity of the by test laws A favor patent infringed.10 '941 is not being are ... clear the judgment this case would able ” (quoting ... used scarecrows.’ that Forest’s actions path approval Water, Ecolo Indus. Inc. v. Arrowhead namely, deny us would otherwise Caraco— (Fed.Cir.1988))). chem, trigger of 21 ing court-judgment denied the claiming that it been 355(j)(5)(B)(iv)(II) to acti drugs, right non-infringing to sell exclusivity period. If Caraco vate Ivax’s alleged inju- injury-in-fact redress Caraco's 10. would be re- decree would Caraco’s also judgment patent judg- by ry-in-fact just that the '941 is dressed as well as other court invalid, sought Thus, has not objective granting but Caraco if Forest’s ment. invalidity in this case. patent sue on '941 the covenant Caraco, costly litigation with was to avoid decide, appears Although we so it 11. do not approach to might best resolve be the to a de- that if Forest would submit consent parties. controversy between the in Caraco's described cree infringe such ANDAdoes not the '941 alleged precisely type Finally, Caraco has Declaratory Judgment Act injury that the judgment action is also consistent with the Goodyear See Tire remedy. designed is Act, goal basic of the Hatch-Waxman Co., 956; Wing & Rubber Red F.2d at which is to for pharma balance need Shoe, 1360; generally see F.3d at E. with ge ceutical innovation the need for Borchard, Declaratory Judgments 803-04 Pharms., Andrx drug competition. neric (2d ed.1941) (discussing history Inc., 276 F.3d at previously 1371. As not Act). Declaratory Judgment particular, ed, a significant part carefully of this alleges that Forest’s actions ex- Caraco crafted dialectic balance encouraging is it clude from the market without ever sub- early disputes of patent resolution jecting patent Forest’s to a court subsequent Paragraph when IV ANDA fil scope.12 determination of its es- Caraco generic appli ers are “blocked a first sentially argues may that Forest’s actions See 180-day exclusivity.” cant’s Cong. narrowly it allow to “use a restricted [i.e. (Nov. 2003) (remarks Rec. S15885 justify much wider drafted] Kennedy).13 Sen. su- Borchard, infringement,” claims of E. pra, at 803-04. Indeed, Caraco claims Ripeness B. being is excluded from the “ripe” market Whether re even action though generic drug quires described in its evaluation “both the fitness of may infringe '941 patent. judicial issues decision and the earlier, present As Despite arguments noted Car- action dissent and judgment Forest, aco does not seek a that the '941 Kennedy’s regarding Senator remarks patent is invalid. the of a effect covenant not sue made to were "reasonable-appre applied when this court a 13. Both the dissent and Forest contend that hension-of-suit” as the test sole test for wheth legislative history of the the Hatch-Waxman seeking declaratory judgment er an action a supports argument Act the that the covenant invalidity noninfringement presented of or a to controversy not sue moots and all with See, justiciable controversy. e.g., Article III legislative history Caraco. which the Pfizer, 395 at 1332. Under the reason following dissent are and Forest cite the re- test, able-apprehension-of-suit a covenant not by Kennedy: marks Edward Senator controversy to sue would eliminate the be that, expect fullyWe all almost situations parties generic tween drug because the generic applicant challenged where a applicant longer would no have reasonable patent [by filing an ANDAwith a apprehension by patentee. of suit Howev pat- and not sued certification] been for er, earlier, singular ap as discussed infringement, ent this generic a claim proach applicant seeking justiciability declaratory judgment on give justiciable judgment will rise actions was struck down controversy" MedImmune, "case Supreme or under the Constitu- Court in 127 S.Ct. at tion. only We believe that the circumstance background, 774 n. 11. Given this Senator might in which case or not Kennedy’s only emphasize comments Con exist arise would in the rare circumstance gress’s jurisdiction intent that the of federal drug which the owner and brand com- courts to resolve CAPCswould extend to the pany given generic applicant have a cove- limits of the Constitution. sue, formally nant not to ac- otherwise Moreover, 271(e)(5). ultimately it is knowledge drug applicant’s province duty judicial department, and infringe. does Cong. not Rec. S15885 Congress, not to discern the limits of Article (Nov. 25, 2003) (remarks Kennedy, of Sen. Madison, jurisdiction. Marbury III See v. ranking member of U.S. Senate Committee (1 137, 177, Cranch) (1803). U.S. 2 L.Ed. 60 Health, Education, Labor, Pensions) on added). (emphasis nonmfringement. a com Caraco has withholding parties to the hardship Labs., drug product that has plete generic Abbott been court consideration.” 149, the first 1507. As to and no approval, 87 S.Ct. submitted to the judicial fit review prong, an action required facts are determine additional development would further factual where drug product infringes this whether ability court’s] advance “significantly [a not Second, patent. '941 if claims of Forest’s presented.” legal issues to deal with infringe does not Caraco’s Dep’t Hospitality Nat'l Park Ass’n withholding court then consid patent, 2026, Interior, 803, 812, 123 538 U.S. S.Ct. declaratory judgment of Caraco’s eration (2003). toAs the second 155 L.Ed.2d 1017 action has “immediate and substantial withholding court consideration of prong, forestalling ability impact” of Caraco’s hardship plaintiff to the an action causes exclusivity through period activate Ivax’s conduct has an complained-of where of 21 court-judgment trigger impact” substantial “immediate and (2000).14 As 355(j)(5)(B)(iv)(II) noted Ass’n, v. Toilet Goods plaintiff. Gardner earlier, invalidity 87 S.Ct. 387 U.S. noninfringement respect with to both the L.Ed.2d Ivax’s trigger and '941 can exclusivity period pursuant to 21 U.S.C. case, prongs In this both (2000). Thus, if 355(j)(5)(B)(iv)(II) Car First, inquiry are addi ripeness satisfied. infringe not Forest’s '941 aco’s does development factual would ad tional delaying then court consideration ability to decide vance the district court’s declaratory judgment action on declaratory judgment of Caraco’s action for right exclusivity. The lose dis- delaying resolu- cannot 14. The dissent concludes Our conclusion that the sent is incorrect. will have no immediate and tion of this suit case, Ivax, Indeed, forfeit first filer i.e. cannot impact on Caraco. substantial exclusivity period based on an as- is not majority opinion dissent states that "is sumption, but the texts of the Hatch- rather speculative conjectural, and in- highly Act and the MMA. See discussion Waxman yet legal uncertain issues have volves discussed, supra the amend- note 2. As MMA respect, With all due we been resolved.” include a to the Hatch-Waxman Act ments disagree. dissent offers three main rea- The specifically grandfather provision that ex- conclusion, support we its will sons to empts class IV ANDA a certain address each in turn. Ivax, filers, subject including being to from First, is the dissent states that there "no exclusivity pro- 180-day the MMA’s forfeiture first-filing generic that to conclude basis Accordingly, plausibly cannot be visions. it to, will, likely delay bring- or is manufacturer may argued forfeit its that Ivax nevertheless patent ing the '712 product to market after its exclusivity period. expires.” agree. We fails to What dissent Third, analysis that the dissent states our however, upon injury recognize, is that the prevail in its non- [Caraco] that will “assumes delay premised is which Caraco’s suit is assumption infringement claim—an uncertain (in exclusivity period) triggering Ivax's be- assumption, nor at We make no such best.” patent expires '712 now and when the tween prove A not it will plaintiff we. need need 2012, (in delay triggering Ivax’s in not prevail case in order to on the merits of its exclusivity period) patent after the '712 ex- standing bring prove it to the case. that has Thus, pires. when Co., 89, (“It the dissent is in error it at S.Ct. 1003 Steel 523 U.S. speculating analysis requires that our declaratory judgment ac- renders Caraco’s ANDA filer trigger IV fails to own moot. tion exclusivity period, subsequent a sure, beTo Forest’s covenant not to sue can only filer obtain FDA ap- apprehension eliminates proval reasonable of Orange-Book- before relevant suit on the '941 If a suit patent. patents expire threat of listed by obtaining judg- a only by was the action allegedly patents taken ment that those are or not invalid effectively Forest infringed. excluded Caraco a judgment required Such is to marketplace, from the trigger the covenant not to the first Paragraph IV ANDA fil- sue would moot case exclusivity period Caraco’s and divest er’s and thus allow the jurisdiction. the district court of III approve Article FDA to subsequent Para- See, e.g., Super Corp. Sack Mfg. v. Chase IV ANDA 181 graph days trig- after the Packaging Corp., circumstances, gering 1058-59 event. Under these to drug Forest’s covenant not sue to has been market. a sue covenant even after controversy with or not eliminate infringement to does dispute granted, Caraco, controversy can Orange-Book- because invalidity of the relevant by judgment a that determines substantial be resolved constitutes “a patents listed infringed is ad Forest’s '941 controversy, parties having whether between interests, drug described in Caraco’s ANDA. sufficient immedia legal verse pres- we hold that this action Accordingly, the issuance of cy reality to warrant MedImmune, an Article III case and con- ongoing 127 ents declaratory judgment.” troversy. S.Ct. at Here, not to sue Forest’s covenant Cara- IV. CONCLUSION to enter the

co not allow Caraco does Only obtaining a drug market. generic reasons, foregoing For the we reverse noninfringement on both judgment dismissing district court’s decision trigger '941 can Caraco '712 and declaratory judgment action and Caraco’s exclusivity 180-day period, which Ivax’s further consideration. remand for currently approv- FDA from prevents the AND REMANDED REVERSED ing judgment ANDA. Without Caraco’s patent, '941 noninfringement FRIEDMAN, Judge, Senior Circuit prevailed against Forest even if Caraco dissenting. action on separate infringement I would affirm. be able '712 would not Caraco exclusivity period via the Ivax’s activate I court-judgment trigger alleged in- Moreover, A. In most instances § 355(j)(5)(B)(iv)(II) fringer judgment seeks expires, exclusivity period until Ivax’s invalidity non-infringement ANDA. See approve FDA cannot Caraco’s subsequent judicial (2000). Thus, from a protect itself 355(j)(5)(B)(iv) significant ad- determination terminating this action without infringer. impact upon verse financial respect infringement on the with danger no present involves such case delay approval of patent could Cara- not to sue since the covenant possibility, thereby exclude co’s ANDA and Caraco (the manu- proprietary Forest market, precludes even if its from the (the facturer) subjecting ge- from Caraco patent. infringe the drug does not manufacturer) damages for in- neric circumstances, covenant Forest’s these patent. fringement of the '941 eliminate the con- Caraco does not sue troversy parties. between the seeking de- Here reason for Caraco’s non-infringement sum, claratory judgment declaratory judgment that it Its concern is not different. quite III presents Article action if it markets may be sued Cara- as whether the described patented drug, generic version Orange- infringes co’s ANDA present it can obtain a controversy that unless patent. but Booklisted '941 This issue, that its judicial an determination only upon a threat of premised is not may be de- ability enter the market ex- to A also infringement suit. based from and is effectively layed. This claim stems ists Forest’s actions because of the particular provisions upon the approving the Caraco’s prevent FDA from Act. from the Hatch-Waxman and thus exclude Caraco ANDA seeking non-infringement invalidity by that Act someone to mar- Under main- — generic patented drug taining declaratory-judgment ket a version of its litigation. Application Drug files an Abbreviated New argument This is highly speculative and “ANDA”). (known an filing as an The conjectural, legal and involves uncertain of infringement. ANDA constitutes act issues that not yet have been resolved. If, days forty-five within receiving I concluding have no basis that the filing alleges notice of such that the generic will, first-filing manufacturer isor the patent on the is invalid or that to, likely delay bringing product its to proposed generic infringe does not expires. market after In- the proprietary the the manufacturer deed, delay such seem would inconsistent generic sues the manufacturer for in- being with that the manufacturer’s first to fringement, Drug the Food and Adminis- file ANDA—a its situation it presumably approve tration cannot the ANDA for thir- sought give competitive advantage to it the Act ty provides months. The also having right the exclusive to its sell generic first manufacturer file generic products 180-days for the first covering patented drug has the product after that went on the market. right generic product to sell such exclusive argument The also days assumes that following for 180 sale first of the exclusivity 180-day period not begin would generic product or a holding court decision run until the generic manufacturer actu- infringed. invalid or not This ally begins product, marketing its and provision, 180-day under which period delay in such will marketing simply exclusivity judicial defer triggered by beginning 180-day period. of the It decision holding patent invalid or not plausibly however, could argued, be infringed, is the basis for Caraco’s conten- despite seemingly tion absolute nature of that there was an actual case or con- statutory 180-day exclusivity, gener- troversy before the district court despite unreasonably delays ic manufacturer that Forest’s covenant not infringe- to sue for the commencement of marketing ment. after the thirty period month the patent and term theory, Ias it understand and as expired, right exclusivity. have loses its it, apparently court views is that the Indeed, although the issue has been generic other manufacturers filed first who appeal, raised it could argued be might begin generic prod- sell their thirty period month itself termi- uct upon either expiration thirty of the if, nates after triggering that period stay month period or patents, suing generic for in- manufacturer generic because the manufacturers cannot fringement ANDA, it after files its begin selling products days their until 180 proprietary manufacturer effect vitiates after first-filing generic manufacturer by executing such action a covenant not to begins sales, its the result of such earlier sue for infringement dismissing filing by may manufacturer be infringement suit. delay ability to begin Caraco’s market- Finally, argument assumes that ing its product period, for a substantial will prevail it non-infringement even contends, indefinitely. Caraco thus assumption claim—an uncertain at best. holds, and the court should be able MedImmune, statutory Genentech, Inc., invoke the trigger- alternative Inc. v. ing exclusivity mechanism the 180-day 764, 771, S.Ct. period judicial (2007), of patent determination Supreme L.Ed.2d 604 Court —a in which the owner in each circumstance question that “the recently stated given all alleged, drug company under and brand have facts case is whether sue, circumstances, is a applicant that there a covenant not to generic show parties that controversy, formally acknowledge between otherwise substantial interests, of infringe.” sufficient does not having legal generic applicant’s drug adverse the issu- reality agree and to warrant court that this immediacy I do not with the ” Consid- declaratory judgment.’ emphasize[s] Congress’s “only ance of a statement here, I answer the circumstances ering jurisdiction all that of federal intent that question negatively. that would extend to to resolve CAPCs courts the limits of the Constitution.” legislative The court twice cites B. Act. The

history of the Hatch-Waxman that its C. The court contends decision cites, however, consists “history” that it necessary to and avoid appropriate the de- exclusively during of statements Congress sought to objectives defeat of the made Senator legislation on the bate that, Act it in the Hatch-Waxman achieve as “rank- whom it describes Kennedy, concludes, from permitting result would committee. of the Senate ing member” proprietary manufacturer use covenants however, not a Kennedy, was Senator manufactur- preclude to sue There is no legislation. of the sponsor obtaining declaratory judgments ers from his statements reflected that indication validity. and To on majority of committee the views of the may conclude Congress the extent that Senate, sponsors of the or of the or the judicial interpretations of particular view, Kenne- my Senator legislation. legisla- of the purposes the Act thwart the appro- provide do not dy’s statements tion, court, Congress, not for this it is for determining basis for priate adequate it changes in the Act to make whatever meaning legislation. and scope appropriate. deems States, See Garcia United 83 L.Ed.2d 105 S.Ct. II (“In history we have surveying legislative Although disagree with the court’s I repeatedly stated authoritative rulings, agree I with the substantive intent finding Legislature’s source for rejection of Forest’s con- apparent court’s bill, Reports on lies the Committee frivolous appeal tention that was and col- ‘represent] the considered

which seeking of therefor. The and sanctions understanding Congress- those lective questions appeal important under presents studying drafting men involved Act that this court has the Hatch-Waxman have eschewed proposed legislation.’ We no circum- decided. Under previously comments of one passing on the reliance fairly be charac- appeal stances could the Member, statements from casual Indeed, is difficult terized frivolous. omitted)). (citations floor debates.” appeal appel- in which the how an see If, however, Kennedy’s com- Senator appellate court lant and the prevails for deter- appropriate ments source are be so de- could adopts contentions statute, I would meaning mining scribed. weight his statement give considerable frivolity con- Perhaps made opin- the court’s Forest quoted in footnote ion, misguided under the belief cir- tention that: “We believe enhancing prospects so it was doing a case or cumstance which If was its merits. in the rare success might not would arise exist (as view, sadly Corporation mistaken. making was HSBC Finance succes frivolity argument, occupied which International, five sor to Household brief, Inc.), pages of its Forest’s counsel was Plaintiff-Appellee, helping neither his case nor aiding client’s and performing appellate court func- Services, Inc., HSBC Card HSBC Retail view, lawyer my tion. who makes Services, Inc., Nevada, Bank HSBC frivolity such a contention —and n.a., USA, N.A., HSBC Bank and argument, close of his oral Forest’s coun- Technology HSBC sel he and Services stated continued to characterize this (USA), Inc., Party Third appeal engages Defendants- sanctiona- frivolous— Appellees, ble conduct.

v. Decisioning.Com, Inc., Defendant/Third Party Plaintiff-Appellant. 2007-1277, 2007-1278, Nos. 2007-1308. Appeals, United States Court of Federal Circuit. 7,May 2008. Rehearing and En Rehearing Banc Denied June DECISIONING.COM, INC., Plaintiff-Appellant,

v.

FEDERATED DEPARTMENT

STORES, INC., Macys.Com, Inc.,

Bloomingdale’s, Inc., Bon, Inc.

(doing Marche), business as The Bon

Burdines, Inc., Department Rich’s

Stores, (doing Inc. business as Rich’s-

Macy’s, Goldsmith’s), Lazarus Bank, Department

FDS Stores Na- Bank, Group, Inc.,

tional FACS Systems Group, Inc.,

Federated Defen-

dants-Appellees.

Decisioning.Com, Inc., Plaintiff-

Appellant,

TD Holding Corporation, Ameritrade Ameritrade, Inc., TD and TD Wa Group, Inc., Defendants-Ap

terhouse

pellees. notes firmly our that is established in cases drug (as arguable) Ivax to market after opposed to when decides valid to absence of a expires. subject- patent implicate the '712 does cause of action not Second, i.e., statutory jurisdiction, the dissent states that we assume courts’ matter power adjudicate to Paragraph IV ANDA filer who that a first constitutional case.”). unreasonably delays marketing its (Fed.Cir.1995). delays '941 the date on which patent Corp. But see Fort James Co., approve 1340, Cup FDA is authorized to v. Solo 1347-49 (Fed.Cir.2005) that Specifically, (holding patentee’s ANDA. Caraco would be de- a to days alleged infringer until after the '712 covenant not sue an layed at least jury in 2012. after a patent expires noninfringement Because Caraco verdict did generic drug alleged infringer’s not moot market without counter- cannot However, being unenforceability). claim for approval, delayed from resolv- not ing noninfringement only allege its claim to of the '941 Caraco does a that has potential a for patent profits. apprehension creates lost reasonable of suit on the patent. '941 Accordingly, ripe alleges action is for Caraco also Caraeo’s judicial listing of patent Orange review. effectively prevents Book Caraco from en- C. Mootness tering Essentially, market. Car- is alleging aco it has been denied The mootness doctrine re entry to the market in manner is requisite personal quires that stake unique to the Hatch-Waxman context. is for a required party have stand of an ing at the outset action must contin Clearly, ordinary infringement in the throughout stages ue to exist all context, patentee even when a maintains Geraghty, action. 445 U.S. that its are infringed by valid and Supreme 1202. The Court artic S.Ct. defendant, potential a covenant not to ulated the mootness standard as follows: recipient sue allows the mar- enter the stated, Simply moot case is when the Indeed, ketplace. a covenant not sue on presented longer issues are no “live” or ensures that recipi- the covenant’s parties in legally cognizable lack ent will not be liable damages sub- terest the outcome. Where one of the ject to an injunction moot, presented several issues becomes patent. However, in the Hatch-Wax- live remaining supply issues the con context, regardless man of a covenant not requirement stitutional case or con sue, a generic,drug manufacturer can- troversy. approv- not enter the market without FDA McCormack, Powell 395 U.S. 496- Moreover, an al. NDA holder’s covenant 97, 89 S.Ct. 23 L.Ed.2d 491 subsequent sue a Paragraph IV (internal omitted). question citations ANDA filer does not affect the FDA’s here whether Forest’s unilateral cove- authority approve the ANDA. As dis- nant to sue Caraco on above, cussed where first Paragraph

Case Details

Case Name: Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Apr 1, 2008

Citation: 527 F.3d 1278

Docket Number: 2007-1404

Court Abbreviation: Fed. Cir.