Teva Pharmaceuticals Usa, Inc. v. Pfizer Inc.
405 F.3d 990
Fed. Cir.
2005
Check Treatment
Docket

*1 ent Drivas, the actual error and historical error Dimitrios T. LLP, White & Case York, compared York, are after the thrusters have of New New filed an opposi- correction; prebias been fired in the it is petition tion to the for defendant-appellee. only comparison this that the after second With on opposition him the Jeffrey were J. modulating step employed. This does Oelke and Adam Gahtan. descriptive dimmish the content of the T. Moriarty, Brian filed an amicus curiae specification. established, The evidence on brief for the Generic Pharmaceutical Asso- facts, undisputed specification de- ciation. scribes the modulating two steps of the holding claim. The invalidity Mentlik, Lerner, David, William L. Lit- reversed, ground is and the case is re- Mentlik, LLP, Krumholz tenberg, & manded for proceedings. Westfield, further New Jersey, filed an amicus Pharmaceuticals, curiae brief for IVAX AND

REVERSED REMANDED him on the Roy With brief was H. Wepner.

Lawrence DeMille-Wagman, Attorney, Commission, Federal Trade of Washing- ton, DC, filed an amicus curiae brief for the Federal Trade Commission. himWith Graubert, brief were John D. Act- TEVA USA, PHARMACEUTICALS ing Counsel; General Susan A. Creighton,

INC., Plaintiff-Appellant, Director, Bureau of Competition; John F. Daly, Deputy General Counsel for Litiga- tion; Unt, and Lore A. for Counsel Intel- INC., PFIZER Defendant-Appellee. lectual Property. No. 04-1186. Whitehouse, Theodore Case Willkie LLP, Farr Gallagher & Washington, United States Court of Appeals, DC, filed an amici curiae brief for United Federal Circuit. States Senators Kennedy, M. Edward McCain, John April S. E. Charles Schumer. MICHEL, Before Chief Judge, NEWMAN, MAYER, LOURIE, CLEVENGER, RADER, SCHALL, BRYSON, GAJARSA, LINN, DYK, and PROST, Judges. Henry Dinger, C. Goodwin Procter ORDER

LLP, Boston, Massachusetts, filed a petition combined panel rehearing and petition combined rehearing rehearing en banc plaintiff-appellant. rehearing en banc by was filed Of counsel on petition was Thomas Appellant, J. response and a thereto Meloro, Jr., Kenyon Kenyon, & of New vited the court Appel- filed York, New York. petition lee.1 The for rehearing was re- 1. Amicus by: curiae briefs were filed 1-The Federal Trade Commission. *2 manipulated by to statutory procedures be heard panel that to the merits ferred first fore- Thereafter, to the clear and petition holders the appeal. banc, the amici generic drug and of the response, detriment rehearing en seeable to circuit referred were curiae briefs dustry. request to authorized who are

judges apprehen- Teva court’s reasonable The banc. appeal en to rehear whether poll for a con- wrong is the test sion taken, failed. requested, and poll actual, crete, or imminent in thereof, Upon consideration problem generic considering when THAT: IT ORDERED IS ANDA certification.2 with a second-filed rehearing is (1) petition for The it, and the compel III does not denied. rejected the doctrinal has Supreme Court (2) banc is rehearing en petition for that Teva introduces. Our cases rigidity denied. apprehension, in the recognize reasonable issue the court will mandate of as but typical patent 11, 2005. on April operational attempt give pragmatic DYK, GAJARSA, MAYER, Circuit patentees can which guidance against appeal en banc. rehear Judges, conduct, and control their their structure costs, fact-specific in a area litigation GAJARSA, with whom Judge, Circuit correspond facts law. The ANDA in a joins, DYK, Judge, dissents Circuit only, in name infringement case typical opinion. separate duty to it is court’s constitutional DYK, whom Judge, with Circuit in their context. facts look those GAJARSA, joins, dissents Judge, Circuit misguided Article The Teva court’s opinion. in a separate Congress’s clear thwarts analysis further foster, provi- through the detailed intent GAJARSA, Judge, with whom Circuit Hateh-Waxman, greater competi- sions dissenting from DYK, Judge, joins,, in generic pharmaceuticals. tion banc. declining rehearing en the order petition has denied The Court respect- I this case en banc. must

review I. denial. This is from that

fully dissent Teva has shown is whether question the Hateh-Waxman critical issue within justiciable case by en banc failure of this court Act.1 The swept unambiguously Congress decision, Article court’s correct the Teva action to jurisdic- limitation (Fed.Cir.2005), aside additional allows 108-173, Stat. 2066 Pub. L. No. Generic Pharmaceutical Association. 2-The Pharmaceuticals, (codified at 21 U.S.C.A. amended Inc. as 3-Ivax (West M. Ken- Supp.2004) Edward 355(j)(5)(C)(i) 4-United States Senators McCain, Schum- nedy, (West E. John S. Charles Supp.2004)). U.S.C.A. er. Hateh-Waxman scheme of the The overall Competi- Drug Price Patent Laws detail in our decisions Act described Term Restoration Act tion Patent Pharms., Thompson, 268 F.3d Mylan (codified at 98 Stat. 1585 Pub.L. No. Pharms., (Fed.Cir.2001) and Andrx (2000), 360(cc) §§ 35 U.S.C. 21 U.S.C. (Fed.Cir. Corp., 276 F.3d (2000)), v. Biovail as §§ 271 and 282 amended Drug, Prescription of the Medicare Title XI 2002). Act of Improvement, and Modernization potentially tion introduced the Declara- the constitutional provision opera- and is Act, tory Judgment 28 U.S.C. 2201. tive only respect to controversies which sense[.]”). are such in shall, courts of the [T]he United constitutional States Supreme to the extent As the consistent with recognizes, the Consti- Court *3 tution, § subject jurisdiction have 2201 controversy requirement matter highly is in any brought by action fact specific. person under section 2201 of title 28 for de- The difference between an abstract claratory judgment that such is question and a “controversy” contem- invalid or not infringed. plated by the Declaratory Judgment Act 271(e)(5) (West necessarily § 35 one of degree, U.S.C.A. and it Supp.2004), difficult, would be if by 108-173, as added possible, Pub. L. would be 117 Stat. (Dec. 2003). 8, precise to fashion a 2457 test for determining The law is clear that in every case justiciability this whether issue has there is such a three elements: (1) concrete, controversy. Basically, question actual or imminent injury in (2) fact; fairly each case is whether the alleged, traceable causation facts between under all injury circumstances, and conduct; defendant’s show that and (3) there is a redressability. See substantial Steel Co. v. Citi- be- parties tween Env’t, having zens 83, Better adverse legal 523 U.S. 103- inter- for ests, 04, 1003, of 118 sufficient (1998); immediacy S.Ct. 140 and reality L.Ed.2d 210 Valley Forge warrant the Christian issuance a declaratory Coll. v. of Ams. Unit- judgment. ed Separation State, Church and for Inc., 464, 472, 454 U.S. 752, 102 S.Ct. 70 Md. Co., Cas. Co. v. Pac. &Coal Oil 312 (1982). L.Ed.2d 700 Only the concrete 270, 273, U.S. 510, 61 S.Ct. 85 L.Ed. 826 injury in disputed. fact is (1941). Court,3 Supreme court,4 this The cases controversy treat our sister require- circuits5 consistently apply ments of holding Article III 2201 together to all looking the circum- approach their stances surrounding instructive a controversy. here. Ju- risdiction under 2201 can be no broader A. jurisdiction than under yet cases show that very 2201 is broad The Teva majority not, opinion does deed. Article III is no narrower. See its reasons for failing to do so are not Aetna Ins. Hartford, Co. v. Conn. convincing. In far more difficult Life factual Haworth, 227, 240, 300 461, U.S. 57 S.Ct. contexts the courts have nonetheless found (1937) (§ 81 L.Ed. 617 2201 regard concrete, “has “a actual or injury imminent Co., 3. See Steel 523 U.S. at 118 S.Ct. rule that addresses all shades relationships 1003; Duke Co. v. Study Power Carolina Envtl. disputants."); Arrowhead Indus. Wa- Inc., 59, 81, Group, 2620, 438 U.S. 98 S.Ct. ter, Ecolochem, Inc., 731, 846 F.2d 57 L.Ed.2d (finding 595 actual case (Fed.Cir.1988) (observing 735-36 "there is no plaintiffs where would sus- specific, all-purpose test” for an actual con- injury tain operation planned nuclear troversy). power plant, injury was redressable constitutionality challenge to Price-Anderson 5.See, Mass., e.g., 1003, Riva v. 61 F.3d 1009- Act). (1st Cir.1995); Kidder, Co., Peabody & Corp. Energy 556, 4. See v. Corp., EMC Maxus Corp., v. F.2d Norand 89 F.3d 562-63 807, (2d (Fed.Cir.1996) Cir.1991); Cas.); (quoting Oneida Md. Tribe Indians of Wis. BP Chems. Ltd. v. of Wis., Union Corp., (7th Carbide State Cir. (Fed.Cir.1993) ("There simple 1991). is no Article III. injury Pow In Duke satisfying fact” in this Group, 693. Teva’s Study 120 S.Ct. Envtl. v. Carolina er Co. more immediate. 57 L.Ed.2d is far by comparison, 438 U.S. chal appellees (1978), example, the “concrete, ac- showing The facts Price- constitutionality of the lenged far easier to injury” are imminent tual limit Act, Congress By Act. Anderson the first ANDA identify. Ivax filed of nuclear liability tort aggregate ed the Zoloft; Teva filed ingredient active nuclear single operators plant power Teva certi- ANDA. or second subsequent utility was a appellant “incident.” formulation proposed fied power nuclear constructing that was Patent U.S. No. infringe Pfizer’s including persons appellees, plants. *4 was invalid. patent 5,248,699, or that the the of proximity close live within “who for this days to sue Teva 45 Pfizer had facilities,” the statute challenged planned infringement, 35 patent 67, 98 Id. at Amendment. the Fifth under Although 271(e)(2)(A), did not. and added). theory Their 2620 (emphasis S.Ct. Ivax, of they out settled acci sued nuclear Pfizer had a event that “in the of royalty a with Ivax bear- granted ‘taken’ he Pfizer court. property their dent compensation.” preserved just patent, the ’699 of any ing assurance license out added). (emphasis exclusivity, statutory day S.Ct. Id. at Ivax’s 180 theory stat that this court concluded set to be- duopoly comfortable designed a controversy. III justiciable ed a last potentially gin June (“[A]ppellees See id. in expiration patent days past the ’699 op the injury from immediate will sustain ap- not therefore could FDA 2010. The plants.”). power disputed eration the days drug until 180 generic prove Teva’s ei- exclusivity expired in standing Ivax’s of Article after The breadth —when with was invali- expired or sharply patent contrasts ’699 cases ther the environmental in construction FDA approval Teva court’s narrow without the dated —and Supreme Court context. product. this ANDA not market its could fact, concrete that a has held Ivax, leveraged Pfizer settling with By non-profit’s III, a where is shown exclusivity to insulate the Hatch-Waxman discharg polluter’s that a allege members challenge. validity any from patent the ’699 reasonable es, members’ “and the affiant judi- from itself insulated Pfizer also those dis the about concerns effects and bounds the-metes determination of cial affiants’ those directly affected charges, in relation scope claim patent of its ’699 aesthetic, inter recreational, economic central determination design-around, Earth, Laid Friends ests.” sys- patent our function of (TOC), 528 U.S. Envtl. Servs. law effect, Pfizer insular of this Because tem. 693, 145 L.Ed.2d 167, 183-84, 120 S.Ct. all but against extended —ás effectively added). ex The Court (emphasis underlying U.S. Pat- term of its Ivax—the statements— conditional ruled that pressly expires on June 4,356,518, which ent No. for recre a river would use members patent’s the ’699 2006, to, coincide pollu discharging stopped if ation Laidlaw in 2010.6 expiration later concrete to show into it—sufficed tants invali- thought found it had is, the '518-—or the active patent claims '518 6. That patent need dating art patent is an .'699 '699 Zoloft. The ingredient —would market, to enter the '518 license generic, like improvement. Once action. infringement an face not '699 but design around could This up ties investment its an actual controversy). The purpose of proposed generic until at pre- least reasonable analysis “is to cludes it testing potentially weak determine whether the judicial need for patent, precludes it from triggering attention is real and immediate.” BP statutory Chems., exclusivity period with a success- F.3d at 978. The Teva court validity ful challenge, ignores precludes precedent general reads from introducing infringement policy effective design- considerations into Ar- around, III, as ticle they do belong. as the where law encourages. The live The contextual differences found on the face of this bottleneck under second ANDA filer typical and the Any statute.7 defines a con- this. infringement case make the ap- reasonable crete, actual or imminent injury in fact prehension test inappropriate for this ac- within the meaning of Article and on By guiding patentee’s conduct in that basis justiciable Teva states a contro- typical apprehen- versy sion patentee allows the to avoid litigation. Identifying justiciable contro-

B. versy in terms of a threat *5 litigation, the doctrine establishes the cir- None of problems these can be found in in cumstances which the uncertainty of typical the patent infringement context, in legal rights materially a potential harm which this regularly court has tested im infringer in the marketplace. The injury mediate injury in the reasonable facing Teva in kind, this case is different in apprehension test. Consistent with Mary but no less actionable. land Casualty, this court has never held that Article III required that analysis. injury does not depend threats Quite to the contrary, this court has re from the incumbent. In view of the stat- peatedly that observed ute, reasonable appre the exists independent any hension simply a functional approach threat, and the policy motivation for apply- typical to patent infringement problems ing the apprehension test is under 2201. See EMC Corp. v. Norand completely lacking. There is no in sense Corp., (Fed.Cir.1996) 89 F.3d the court demanding the incumbent to (quoting Cas.); Md. BP Chems. Ltd. v. brandish the threat of infringement ac- Union Carbide Corp., 4 tions, beyond even the of listing act (“There (Fed.Cir.1993) simple no rule patent in Book, Orange the given a statu- that all addresses shades of relationships tory system encourages that the incum- between disputants.”); Arrowhead Indus. bent to do everything possible prevent to Water, Ecolochem, v. 846 F.2d patents from being put in play. No (Fed.Cir.1988) 735-36 (observing incumbent threat, will ever make the if it specific, “there is no all-purpose test” for can simply ride out the term in the listed patent expired, '518 Teva could Shalala, confident- Corp. Mova Pharm. Cf. ly enter the compound (D.C.Cir.1998) market with a ("It that did possi- n. infringe patent. bottleneck, ble that statutorily-created '699 But because of coupled express with statute’s Hatch-Waxman exclusivity, reference to Pfizer insulat- declaratory judgment ed as a the '699 actions means of any from litigation. test in bottleneck, relieving that might suffice practice to al- this extends the '518 term plaintiff low a to show the existence of a 'case until the ’699 expires. controversy’ demonstrating without an im- sued.”). mediate being risk of judicial declaring when in role court’s spe- a fact principles, first From patent.8 this III to extend under powers the reasonable shows that analysis cific It bear action. does not for this designed is not test of Article scope case. a Com- also focuses on Teva court The II. the modified accompanying Report mittee 271(e)(5) Arti- grants §of language Report in can- language 2003 Act. maximum extent to the jurisdiction III cle language plain not contradict that provides The statute

possible. can- 271(e)(5). enactment legislative jurisdic- matter subject have shall courts judicial power not limit in Teva majority’s language a Commit- III, and, fortiori, 2003 Act9 to the history legislative our Article misstates that Report tee its rea- but point, addressed this seems bind this court. cannot jurisprudence unconvincing. soning is Ultimately, the .idea provides specifically The statute mis- standing is limitation on suggests “shall, consistent the extent courts of Hatch- language plain placed, given Constitution, subject matter have with the express provides The statute Waxman. court, action.” jurisdiction challenge, generics mechanism directive therefore, Congressional has actions, or va- scope claim declaratory any jurisdictional applying refrain this statu- patents. Under lidity of listed or found by the courts crafted limitation court,challenges ge- scheme, it is tory overlooks Teva court § 2201. The limit incumbent drug companies neric point. basic submitting over-inclusive overreaching by *6 focuses court further The Teva any given patents applicable lists of introduced originally language intent to Congress’s formulation. branded an incum- 271(e)(5), provided which § entry pre- market early generic foster days “shall within to sue failure bent’s any limita- argument any real cludes controversy between actual an establish the circumstances Certainly under owner.” applicant declaratory action case, Teva’s conference at 1336. 395 F.3d strategic Pfizer’s police method ideal provision changed to language was exclu- Hatch-Waxman manipulation “shall, extent consistent to the the courts Delayed resolution sivity provisions. subject Constitution, matter have pur- no Teva serves facing the bottleneck actions. over these jurisdiction” will issue patents at by then the as pose, 271(e)(5) “not was § court concludes pre- is no basis expired. There have district automatically bestow meant grounds. Article III cluding this suit on as such actions over jurisdiction court contrary This conclusion Teva’s.” Id. 271(e)(5). The §of language plain (cid:127) analysis Article III Teva court’s full Article language bestowed change juris- Supreme Court longstanding distorts recognizes the simply jurisdiction 2003, Stat. Labs., L. No. Pub. Mfg. Mining Barr Co. 8. See Minn. (West 355(j)(5)(C)(i) (codified (Fed.Cir.2002). at 21 U.S.C.A. (West 35 U.S.C.A. Supp.2004) Drug, ,9. Prescription the Medicare Title XI of Act”]. “2003 Supp.2004)) [hereinafter Act Improvement, Modernization prudence misapplies (Fed.Cir.2005). decisions of F.3d I dissent this court. presented justicia- Teva has from the denial of rehearing en banc. ble and the courts should de- all,

cide it. Worst I. court’s Article III legislative forestalls plain language of the 2003 Medicare correction. The court should have correct- Amendments requires that in the Hatch- ed this error en banc. I respectfully dis- Waxman context the federal courts allow sent from the refusal to do so. declaratory judgment actions to the full extent allowed by Article III. 35 U.S.C.A. DYK, Judge, with whom 271(e)(5) (“[CJourts of the United States GAJARSA, Circuit joins, Judge, dissenting shall, to the extent consistent with the from the order denying rehearing en banc. Constitution, subject have jurisdic- matter This presents case an important ques- tion in any brought action ... under sec- tion under the Hatch-Waxman Amend- tion 2201 of title 28 for a declaratory judg- ments, which were part enacted as of the ment that is invalid or not Drug Competition Price and Patent Term infringed.”). if legislative Even histo- Restoration Act of Pub. 98- ry L./No. could be read as our approving reason- (codified 98 Stat. 1585 at 21 U.S.C. apprehension test, able that history cannot §§ 360cc §§ and U.S.C. overcome the plain language of the statute. (2000)) 271, 282 holder —whether So we must decide whether Article III is can delay Food and Drug Administration satisfied. (“FDA”) approval of application for a There are relatively few Supreme Court competing generic drug by simple ex- dealing cases with Article III and declara-

pedient of refusing to sue for infringement. tory judgments, but the few cases that do Here there is a present controversy over provide exist no support for a reasonable to secure approval of its Ab- apprehension of imminent suit require- breviated New Drug Application ment. The declaratory judgment statute (“ANDA”), plainly adequate to satisfy the designed to deal with a situation requirements of Article III. which the declaratory judgment defendant Declaratory Judgment Act, suit, bring i.e., declined to in which there *7 (2000), 2201 and the 2003 Medi- was no reasonable apprehension of immi- Amendments, care Medicare Prescription nent suit. The Supreme up- Court case Drug, Improvement, and Modernization holding the just statute involved such a 2003, XI, Act of Title Access to Affordable situation —one in which there nowas immi- Pharmaceuticals, 108-173, Pub. L. No. 117 nent risk of suit because potential the 2066, (codified Stat. 2448-69 in pertinent plaintiff declined to sue. Aetna Ins. Life part at 21 355(j)(5)(C)(i) (West U.S.C.A. Haworth, Co. v. U.S. S.Ct. Supp.2004) and 35 U.S.C.A. (1937). 81 L.Ed. 617 In that the (West Supp.2004)), designed were to cre- insured on policies several stopped making ate a declaratory judgment remedy in cir- premium payments and repeated made permitted cumstances by Article III. The claims for benefits account of total and panel’s holding, relying on earlier permanent decisions disability. Id. at court, of our that Article III bars such a S.Ct. 461. Aetna refused to pay benefits remedy unless “a reasonable apprehension because it contended that the insured was of imminent suit” exists is incorrect. not disabled that the policies had USA, Teva Pharm. Pfizer, Inc., 395 lapsed due to nonpayment. Id. Id. States law. suit, under United to sue Sallen bring failed The insured S.Ct. rejected CL’s First Circuit declaratory judgment appeal, On the for a filed Aetna so that apprehension a reasonable argument was disabled that the insured that 239, 57 Id. at Article III: lapsed. satisfy required policies had of suit is these that found Court 461. The S.Ct. appre- a claims that reasonable CL controversy within to a rise gave facts Arti- to meet required of suit is hension “[tjhere is stating meaning of Article require- controversy Ill’s case cle face who parties dispute a here only way this is not ment. But adversary proceeding.... in an other each pur- a case existence establish concrete, not defined dispute is ap- III. The reasonable poses Article calls, not It abstract.... hypothetical or cab- exists to suit doctrine prehension hypothetical upon advisory opinion ivhere declaratory judgment actions present adjudication basis, for an but controversy poten- surrounds a only Id. at facts.” upon established tial, is not lawsuit. That future case. Circuit, in a case Likewise, Ninth liability (internal omitted faced a citations risk at 25 plaintiff Id. which “[ajn added). action suit, that has held that court found than emphasis rather a case or ... declaratory judgment registrant “provides for a law States United a real and plaintiff if the has ... controversy domain name has lost a who he will be that returning injunction for an of action cause de not suit. Societe liability,” subject to can registrant if the the domain name Hunt en Aluminium Conditionnement compliance with” Unit- is in that she show (9th Co., Eng’g Thus, er court Id. at 26. law. ed States added).1 Cir.1981) First (emphasis controversy issue found that directly addressed more has even Circuit “a certain and that certain Licenciamentos v. Corinthians in Sallen the issue apprehension’ ‘reasonable renders (1st .2001), F.3d 14 Cir D LT question irrelevant.” conflicts with adopted view is correct: view, the First my There, a in this case. decision panel III wheth- under Article test Property Organization Intellectual World concrete is a present er there cy- to be (“WIPO”) panel found Sallen an incorrect applied here panel and the name ordered his domain bersquatter reached here also test. Licenciamentos to Corinthians transferred relying on this case wrong result in (“CL”). filed 21-22. Sallen Id. at LTDA test. erroneous dec seeking a court district suit in federal law under United States laration *8 the WIPO

(which challenge to allowed II. decision) to the domain entitled he was three are to me that there' it seems Here court dis The district at 22. name. Id. controversies: potential intent no CL had the case because missed purchased 941,- party The third at 944-45. that filed a manufacturer case involved 1. That harmless at 941. A hold equipment. Id. invalidity of the judgment of declaratory the third contract between provision in the potentially unautho- patent after defendant's plaintiff in placed the plaintiff party and the working defendant person rized liability. at Id. third party with if the suit third threatened 945. equipment. plaintiff’s purchased the party potential There is a controversy over The Hatch-Waxman provide Amendments whether the ANDA filing itself was an for right to secure resolution of the infringement. I doubt this, whether controversy through a declaratory judg- alone, standing satisfies Article III be- ment. cause Pfizer seems not to care whether Ivax earlier filed paragraph certifi- IV infringement occurred. Textron cation regarding the ’699 and then Lycoming Reciprocating Div., Engine settled Thus, with Pfizer. Ivax enjoy will UAW, Corp. AVCO 653, 661, 523 U.S. a 180-day exclusivity period beginning (1998) 140 L.Ed.2d 863 (1) with the earlier of day the first (finding no constitutional controversy (which markets generic its drug cannot be where the declaratory judgment defendant 2006) earlier than June or the date had no “interest in defending the binding that the ’699 is held or invalid not contract”). nature of the infringed in the decision of a court.2 Be- 2. There potential is also a cause of the paragraph certification, IV over whether Teva should be allowed to Teva’s application be approved cannot manufacture and market drug without the FDA until after 180-day Ivax’s exclu- incurring damages for infringement. The sivity period ends. F.3d at problem here is that Teva has not alleged 1330. In words, other running that it intends to market or sell drug exclusivity period could be triggered be- at time the near future or that it is fore Ivax’s first marketing date if Teva being prevented doing so the risk could secure a declaratory judgment of of infringement damages. Instead, Teva non-infringement or invalidity. Approval alleges only that the filing of its ANDA of Teva’s ANDA would follow days constituted technical infringement; thereafter.

Pfizer did file suit within the 45-day period; that Pfizer included ’699 pat Normally, one expect ent in Orange Book; and that Pfizer approval issue would litigated be between tends enforce patents through litiga Teva FDA, but, and the as we recognized (J.A. 52.) Unless actually in Minnesota Mining and Manufacturing about to manufacture or drug, sell the Co. v. Laboratories, Barr Inc., 289 F.3d there would seem to be no case or contro (Fed.Cir.2002), Congress provided versy under theory. Societe de Con approval would depend on the out- ditionnement, 655 F.2d at 944. come of litigation private parties (the The third potential controversy is owner and potential over whether Teva’s ANDA should be ap- fringer) over questions of infringement proved earlier days than 180 after Ivax and validity.3 There is certainly a con- commences marketing. my view, there crete controversy (and between Pfizer is present Ivax) concrete controversy over and Teva over when Teva’s ANDA to such an approval, which should be approved. Both Pfizer and Ivax satisfies requirements of Article III. want the approval of Teva’s application sure, 2. To be Pfizer’s bring failure to drug suit unless there is an earlier holding of non- 45-day within the period specified in section invalidity. 355(j)(5)(B)(iii) means that the *9 approval of the ANDA will delayed be not 3. Apotex, See also Thompson, section, despite that but Pfizer's failure (Fed.Cir.2003); Mylan Pharm., Inc. v. sue, to 355(j)(5)(B)(iv) will bar Thompson, (Fed.Cir.2001). 268 F.3d 1323 approval days until 180 after Ivax markets the delay. The avoid to wants Teva delayed. infringement turns delay

question circumstances, Under these validity.4 a case there

I think that of Article meaning

within validity infringement questions appears addressed. be

should aof existence recognize insuffi- controversy is that holds

but I re- III.5 purposes

cient de- panel’s Under disagree.

spectfully contest remedy Teva lacks

cision agree I approval. ANDA delay in its that Gajarsa Judge Mayer Judge unfair- such require III does

ness. HORNBACK, Plaintiff- B.

Alton

Appellant, Defendant-Appellee. STATES,

UNITED

No. 04-5149. Appeals, Court States

United Circuit.

Federal 19, 2005.

April Banc Denied En

Rehearing 19, 2005.

May Teva fact ”[t]he panel states imposes an additional '518 4. While standpoint a business disadvantaged from ANDA approval of Teva’s limitation exclusivity period and the 180-day Ivax's approved until not be could creates Teva not to sue decision that Pfizer’s 30, 2006), (June it is expires ’518 disad- removing that impediment date approval litigate the hardly premature distinct separate and matters vantage are invalid- litigation over since controversy exists an Article from whether consume patent could itself ity the '699 and Pfizer.” time. significant