## United States Court of Appeals for the Federal Circuit

2008-1062 JANSSEN PHARMACEUTICA, N.V. and JANSSEN, L.P., Plaintiffs-Appellees,

v. APOTEX, INC., Defendant-Appellant.

Scott B. Howard , Patterson Belknap Webb & Tyler LL P, of New York, New York, argued for plaintiffs-appellees. With hi m on the brief were Gregory L. Diskant and Irena Royzman

. Amy D. Brody , Rakoczy Molino Mazzochi Siwik LL P, of Chicago, Illinois, argued for defendant-appellant. With her on the brief were William A. Rakoczy , Christine J. Siwik , and Robert M. Teigen . Of counsel on the br ief was Shashank Upadhye , Apotex, Inc., of Weston, Ontario, Canada. Appealed from: United States District Court for the District of New Jersey Judge Dennis M. Cavanaugh

## United States Court of Appeals for the Federal Circuit

2008-1062

JANSSEN PHARMACEUTICA, N.V. and JANSSEN, L.P., Plaintiffs-Appellees,

v.

APOTEX, INC., Defendant-Appellant. Appeal from the United States District Court for the District of New Jersey in case no. 06-CV-1020, Judge Dennis M. Cavanaugh.

_________ __________________ DECIDED: September 4, 2008

_________ __________________ Before MICHEL, Chief Judge , RADER and MOORE, Circuit Judges

. MOORE, Circuit Judge

. Defendant-Appellant Apotex, Inc. (Apotex) appeals the or der of the United States District Court for the District of New Jersey dismissing its declaratory judgment action for noninfringement against Plaintiffs-Appell ees Janssen Pharmaceutica, N.V. and Janssen, L.P. (collectively Janssen). We affirm.BACKGROUND
I. This case arises under the Hatch-Waxman Act (Act), 1 which governs the Food and Drug Administration’s (FDA) approval of new and generic drugs. The goal of the Act is to better balance two competing inte rests in the pharmaceut ical industry: “(1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.” Andrx Pharms., Inc. v. Biovail Corp. , 276 F.3d 1368, 1371 (Fed. Cir. 2002). Under the Act, a pioneering or brand name drug company seeking to manufacture a new drug must prepare, file, and have appr oved a new drug application (NDA) with the FDA. 21 U.S.C. § 355(a), (b). As part of its NDA, the applicant must submit information regarding t he new drug’s safety and effica cy obtained from clinical trials. 21 U.S.C. § 355(b)(1). The applicant must also i dentify all patents that “could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug,” 21 U.S.C. § 355(b)(1), (c)(2). The FDA publishes a list of those patents in the “Or ange Book.” Drugs approved by the FDA are known as “listed drugs.” 21 U.S. C. § 355(j)(2)(A)(i). To encourage the development of generic versions of listed drugs, the Act created an expedited approval process known as an Abbrev iated New Drug Application (ANDA). 21 U.S.C. § 355(j). Generic drug companies are not required to conduct their

1 The Hatch-Waxman Act is the name commonly used to re fer to the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355, 360(cc) (2 000), 35 U.S.C. §§ 156, 271, 282 (2000)), as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No . 108-173, 117 Stat. 2066 (2003).

2008-1062 2own independent clinical trials to prove safe ty and efficacy, but can instead rely on the research of the pioneer pharmaceutical companies. 21 U.S.C. § 355(j)(2)(A)(iv), (j)(8)(B). However, in order to rely on the research of the pioneer pharmaceutical companies, an ANDA applicant is required to show bioequiva lence of its generic drug to the NDA drug. 21 U.S.C. § 355 (j)(2)(A)(iv), (j)(8)(B). The ANDA applicant must also include a certification to eac h patent listed in the Orange B ook covering the listed drug that either (I) no patent info rmation has been filed with the FDA; (II) the patent has expired; (III) the patent will expire on a parti cular date and approval of the ANDA should be deferred until expiration; or (IV) in the opinion of the ANDA applicant, the patent is invalid or will not be infringed by the manufacture , use, or sale of the generic drug. 21 U.S.C. § 355(j)(2)(A)(v ii). These options are respectively referred to as Paragraph I, II, III, and IV Certifications. The timing of ANDA approval is tied to the type of certification contained in the ANDA. For Paragraph IV AN DAs, the timing of approval depends upon two events: (1) whether the pioneer drug co mpany brings an infr ingement action within 45 days of learning of the Paragraph IV ANDA filing, and (2) whether the company seeking approval was the first one to file an ANDA contai ning a Paragraph IV Certification to a listed pat ent (hereinafter first Par agraph IV ANDA filer). In order to bring about early resolu tion of patent disputes between generics and pioneering drug companies, the Act provi des that the filing of a Paragraph IV Certification is an act of patent infringement. 35 U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc. , 496 U.S 661, 678 (1990). The ANDA f iler must provide notice to the patentee and NDA holder of the factual and legal bases for the Paragraph IV Certification. 21 U.S.C. § 355(j)(2)(B). Upon such notice , the patentee and NDA holder

2008-1062 3have the option of suing on all, some, or none of the patents inclu ded in the Paragraph IV Certification. If the patentee or NDA holder does not bring suit within 45 days of receiving notice, the FDA may issue fina l approval of the ANDA once its approval requirements have been satisfied. 21 U.S.C. § 355(j)(5)(B)(iii). If, however, the brand name company brings suit within 45 days, the FDA may not approve the ANDA for 30 months. 21 U.S.C. § 355(j)(5 )(B)(iii). The FDA may appr ove the ANDA after that period, or earlier if a court has decided the patent(s)-in-suit are invalid or not infringed. 21 U.S.C. § 355(j)(5 )(B)(iii). As an incentive for generic pharmaceut ical companies to challenge suspect Orange Book listed patents, t he Hatch-Waxman Act grants the first company to submit a Paragraph IV ANDA a 180-day period of generic marketing exclusivity during which time FDA will not approve a later-filed Paragraph IV ANDA based on the same NDA (hereinafter subsequent Paragraph IV ANDA). 21 U.S.C. § 355 (j)(5)(B)(iv); see Minn. Mining & Mfg. Co. v. Barr Labs., Inc. , 289 F.3d 775, 778 (Fed. Cir. 2002). Significantly, the first Paragraph IV ANDA filer is entitl ed to the 180-day exclusivity period regardless of whether it establishes t hat the Orange Book pat ents are invalid or not infringed by the drug described in its ANDA. All that is required for the firs t Paragraph IV ANDA filer to receive the 180-day exclusivity period is that it submits a substantially complete ANDA that contains a Paragraph IV Certification. 21 U.S.C. § 355 (j)(5)(B)(iv)(II)(bb). The start of the 180-day ex clusivity period is trigge red by the earlier of two events: (1) the first Paragraph IV ANDA file r’s commercial marketing of a drug product;

2008-1062 4or (2) a court decision of non infringement or invalidity. 2 21 U.S.C. § 355(j)(5)(B)(iv) (2000). Only the first Paragraph IV ANDA f iler can trigger its 180-day exclusivity period via the commercial-marketing trigger. 21 U.S. C. § 355(j)(5)(B)(iv )(I) (2000). However, the subsequent Paragraph IV ANDA filers can trigger the first Paragraph IV ANDA filer’s 180-day exclusivity period via a succe ssful court judgment. Minn. Mining , 289 F.3d at
780. On December 8, 2003, the Hatch-Waxm an Act was amended by Title XI of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), Pub. L. No. 108-173, § 1102(a), 117 Stat. 2066, 2457-60. Prior to the MMA, NDA holders employed several methods of delaying the ear ly resolution of patent disputes. See Teva Pharms. USA, Inc. v. Novartis Pharms. Corp. , 482 F.3d 1330, 1342 & n.7 (Fed. Cir. 2007). The MMA ameliorates these situations by authorizing a “a civil action” under 28 U.S.C. § 2201 “for a declaratory judgment that the [listed] patent is invalid or will not be infringed by the drug for which the app licant seeks approval . . .” 21 U.S.C. § 355(j)(5)(C)(i)(II). Specifically, the MMA a llows a Paragraph IV ANDA filer a right to bring a declaratory judgment ac tion for noninfringement or invalidity of the relevant

2 In 2003, Congress replaced the provis ions governing the triggering of the 180-day exclusivity period with a regime in which the 180-day exclusivity period could be forfeited for various reasons, including the failure of the first Pa ragraph IV ANDA filer to launch its generic product within a certain time period. 21 U.S.C. § 355(j)(5)(D). This amendment was part of th e Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. No. 108-173, 117 Stat. 2066 (2003). However, the MMA contained a grandfather provision specifying that the amendments do not apply to Paragraph IV ANDAs filed befo re the date of the enactment of the MMA or to subsequent Paragraph IV ANDAs filed after the enactment of the MMA if the first Paragraph IV ANDA was filed prior to enactment of the MMA. See MMA § 1102(b). Here, a generic pharmaceutical company, Teva Pharmaceuticals USA, Inc., filed the first Paragraph IV ANDA in 2002, before the December 2003 enactment of the MMA. Thus, the MMA amendments governing the co mmencement and forfeiture of the 180- day exclusivity period are inapplicable to this case.

2008-1062 5listed patents against the patentee and NDA holder, if the patentee has not brought an infringement action within the 45-day not ice period. 21 U.S. C. § 355(j)(5)(C). Congress extended federal court jurisdiction over t hese declaratory judgment actions “to the extent consistent with the Constitution.” 35 U.S.C. § 271(e)(5). Therefore, federal courts have jurisdiction over these declaratory judgment actions to the extent that they present an Article III case or controversy. Caraco Pharm. Labs. v. Forest Labs. , 527 F.3d 1278, 1285 (Fed. Cir. 2008) (citation omitted).
II. Janssen holds an approved NDA for its drug Risperdal® Oral Solution. The Orange Book originally listed U.S. Patent Nos. 4,804,663 (’663 patent ), 5,453,425 (’425 patent) and 5,616,587 (’587 patent) in connection with this NDA. The ’663 patent covers the compound risperidone, which is t he active compound in the drug Risperdal® Oral Solution. The ’425 and ’587 patents cover specific aqueous solutions of risperidone and methods for preparing these solutions. The ’663 patent expired on December 29, 2007. However, the FDA granted Janssen an additional six months of pediatric exclusivity pursuant to 21 U.S.C. § 355a, making J une 29, 2008 the effective expiration date of the ’663 patent. 3 The ’425 and ’587 patents expire in 2014. The ’663 patent has been the subject of prior litigation. Following a bench trial, it was found to be infringed, valid , and enforceable. On May 11, 2007, this court affirmed the judgment of the district court. Janssen Pharmaceutica, N.V. v. Mylan Pharm., Inc. , 456 F. Supp. 2d 644, 671 (D.N.J. 2006), aff’d , 233 Fed. Appx. 999 (Fed. Cir. 2007). While Apotex was not a party to that trial, Apotex stipulat ed to infringement, validity, and

3 Hereinafter this opinion refers to the expiration of the ’663 patent’s pediatric exclusivity period as the expiration of the ’663 patent.

2008-1062 6enforceability of the ’663 patent based on the Federal Circuit opinion. Therefore, this stipulation took effect on May 11, 2007. Prior to September 2002, Teva Pharmaceuticals USA, Inc. (Teva) filed an ANDA to make a generic version of risperidone oral solution. In filing its ANDA, Teva respected the validity of t he ’663 patent by f iling a Paragraph III Cert ification on that patent. Teva was the first ANDA applicant to file a Paragraph IV Certification on the ’425 and ’587 patents. As such, Teva is entitled to 180 days of generic market exclusivity, during which t he FDA will not approve a late r-filed Paragraph IV ANDA based on the same NDA. Teva’s 180-day excl usivity period will begin either the day it begins marketing its drug, or on the date a court determines that the ’425 and ’587 patents are invalid or not infr inged—whichever comes first. 21 U.S.C. § 355(j)(5)(B)(iv) (2000). As Teva filed a Par agraph III Certification with res pect to the ’663 patent, the FDA will not approve Teva’s generic product bef ore the expiration of the ’663 patent. Because Janssen did not sue Teva for infri nging the ’425 and ’587 pat ents, the FDA will be able to approve Teva’s generic versi on of risperidone oral solution upon the expiration of the ’663 patent. Teva will be able to comme rcially market its generic product immediately upon receiving FDA approval. Apotex subsequently submitted an AN DA application to the FDA seeking approval to market its generic version of risper idone oral solution, in which Apotex also filed Paragraph IV Certifications on the ’425 and ’587 patents. In January 2006, Apotex amended its ANDA and provided Janssen with an additional Pa ragraph IV Certification directed to the ’663 patent. On March 3, 2006, Janssen sued Apotex for infringing the ’663 patent in the United Stat es District Court for the District of New Jersey, but

2008-1062 7Janssen did not sue Apotex on the ’425 and ’587 patents (c ollectively, the unasserted patents). In its Answer to Janssen’s Compla int on April 25, 2006, Apotex asserted four counterclaims, including claims for declarato ry judgment of noninfringement of the two unasserted patents. Specifically, Apot ex sought a declara tory judgment of noninfringement with respect to the tw o unasserted patents under the Declaratory Judgment Act, 28 U.S.C. § 2201, and the MMA to the Hatch-Waxman Act, 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5). 4 On June 28, 2006, Janssen moved to dismiss these two counterclaims on the ground that the action did not present a case or controversy as required by Articl e III of the Constitution. On December 8, 2006, Janssen provided Apotex with a covenant-not-to-sue with respect to the ’425 and ’587 patents. Afte r granting the covenant, Janssen requested that Apotex withdraw its counterclaims. Apotex refus ed. On October 11, 2007, the district court granted Janssen’ s motion to dismiss Apotex’s counterclaims for lack of subject matter jurisdiction. The district court found “no ca se or controversy” regarding the ’425 and ’527 patents. This appeal followed. DISCUSSION Whether an “actual controversy” exists that is sufficient to sustain federal subject matter jurisdiction is a question of law this court reviews de novo . Teva Pharms. USA, Inc. v. Novartis Pharms. Corp. , 482 F.3d 1330, 1335-36 (Fed. Cir . 2007). In the ANDA context, Congress extended federal court ju risdiction under the De claratory Judgment Act, 28 U.S.C. § 2201, to ANDA Paragraph IV disputes, 21 U.S.C. § 355(j)(5)(C).

4 Because Apotex’s counterclaims on the ’425 and ’587 patents were pending “on or after” the enactment of the MMA (December 8, 2003), Apotex can rely upon the declaratory judgment provisio n of that legislation. See MMA § 1101(c)(1).

2008-1062 8Congress also directed federal courts to exercise jurisdiction over these ANDA Paragraph IV declaratory judgment actions “to the extent consistent with the Constitution,” 35 U.S.C. § 271(e)(5). The re levant text of the De claratory Judgment Act reads: In a case of actual controversy within its jurisdiction . . . any court of the United States, upon the fili ng of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought. 28 U.S.C. § 2201(a). T he Declaratory Judgment Act’s “act ual controversy” requirement “refers to the type of ‘Cases’ and ‘Controversie s’ that are justiciable under Article III.” MedImmune, Inc. v. Genetech, Inc. , 127 S. Ct. 764, 771 (2007). In MedImmune , the Supreme Court stat ed that a justiciable declaratory judgment action exists when: the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adver se legal interests, of sufficient immediacy and reality to warr ant the issuance of a declaratory judgment. Id. at 771 (citation omitted). The Cour t emphasized that the dispute must be: “definite and concrete, touching t he legal relations of parties having adverse legal interests;” and that it be “real and subs tantial” and “admi[t] of specific relief through a decree of a c onclusive character, as distinguished from an opinion advising wh at the law woul d be upon a hypothetical state of facts.” Id. Apotex argues that it is suffering three actual and continuing in juries which create a substantial controversy of sufficient immediacy to warrant the issuance of a declaratory judgment. Specific ally, Apotex argues that (1 ) it is unable to promptly launch its generic risperidone product and com pete in the market immediately upon the expiration of the ’663 patent; (2) its approval of its noninfringing generic risperidone

2008-1062 9product is being indefinitely delayed; and (3) its affiliates, suppliers, and downstream customers face patent uncertainty becaus e Janssen’s covenant-not-to-sue does not cover them. We address eac h alleged injury in turn. A. Prompt Launch Apotex argues that absent a declaratory judgment with respect to the ’425 and ’587 patents and regardless of Janssen’s grant of a covenant-not-to-sue, it continues to suffer a cognizable harm of being unable to launch its generic risperidone product immediately upon the expiration of the ’663 patent. Apotex contends that this injury creates a substantial controversy of suffici ent immediacy to warr ant the issuance of a declaratory judgment. Without a declarato ry judgment, Teva’s 180-day exclusivity period will commence when it commercially launches its generic risperidone product after the expiration of the ’663 patent. Theref ore, the earliest Apot ex will be able to enter the market is 181 days after the expirati on of the ’663 patent. However, if Apotex is successful on its declaratory judgment acti on, Teva’s 180-day ex clusivity period will be triggered at a time that Te va will be unable to launch it s generic product. If Teva’s 180-day exclusivity period is ex hausted prior to the expirati on of the ’663 patent, Apotex will be able to enter the market immediat ely upon the expiration of the ’663 patent. 5

5 As Teva was the first Paragraph IV AN DA filer with respect to the ’425 and ’587 patents, it is entitled to a 180-day exclusivity period. Teva’s 180-day exclusivity period can be triggered by one of two events: (1) Teva’s commercial launch of its product; or (2) a favorable court judgment with respect to both the ’425 and ’587 patents. Because Teva fil ed a Paragraph III Certification for the ’663 patent, the FDA cannot approve Teva’s ANDA until the ’663 pat ent expires. As Teva cannot launch prior to FDA approval, the earliest Teva can market its generic product is at the expiration of the ’663 patent. Moreover, because Teva fa iled to obtain a favorable court judgment with respect to the ’425 and ’587 patents, Teva will only be able to trigger its 180-day exclusivity period by commercially laun ching its generic product. A subsequent Paragraph IV ANDA filer can trigger Teva’s 180-day exclusivity period by obtaining a

2008-1062 10Apotex contends that Caraco Pharm. Labs. v. Forest Labs. , 527 F.3d 1278 (Fed. Cir. 2008), in which this court held that despite the existence of a covenant-not-to-sue, a declaratory judgment claim brought under the Hatch-Waxman Act presents a justiciable Article III controversy, is controlling. We disagree. Jurisdiction over a declarat ory judgment action must be present “at all stages of review, not merely at the time the comp laint is filed." Steffel v. Thompson , 415 U.S. 452, 459 n.10 (1974); see Benitec Austl., Ltd. v. Nucleonics, Inc. , 495 F.3d 1340, 1344 (Fed. Cir. 2007) (“The burden is on the party clai ming declaratory judgment jurisdiction to establish that such jurisdiction existed at the time the claim fo r declaratory relief was filed and that it has continued si nce.”); Int’l Med. Prostheti cs Research Assocs., Inc. v. Gore Enter. Holdings, Inc. , 787 F.2d 572, 575 (Fed. Cir. 1986) (“[J]urisdiction over [] a declaratory judgment action [must have] exis ted at, and has continued since, the time the complaint was filed.”). We agree with the parties that if Apotex had not stipulated to the validity of the ’663 patent, then Caraco would have been controlling. However, Apotex stipulated to the validity, infringem ent, and enforceability of the ’663 patent on May 11, 2007. Therefore, while the harm that created a justiciable Article III controversy in Caraco was present when Apotex fi led its counterclaims on April 25, 2006, that harm ceased to exist upon Apotex’s stipulation. As such, the harm that gave rise to jurisdiction over the declarato ry judgment claims in Caraco was no longer present on October 11, 2007—the date the dist rict court dismissed the instant case. Further, we

court judgment that both the ’425 and ’587 patents are invalid or noninfringed. Therefore, if Apotex obtain s a favorable court judgment on the ’425 and ’587 patents, Teva’s 180-day exclusivity period will begin immediatel y—regardless of whether the ’663 patent has expired. This would result in Teva’s 180-day exclusivity period beginning during a time when it cannot se cure FDA approval and therefore cannot launch its product.

2008-1062 11conclude that the harm that has continuously existed in the present case—Apotex’s inability to launch its gener ic product immediately upon th e expiration of the ’663 patent—is not sufficient to give rise to declaratory judgment jurisdiction. In Caraco , Forest Laboratories Inc., et al. (Forest) was the pioneer pharmaceutical company, Ivax Pharmaceuticals, Inc. (Ivax) was the first Paragraph IV ANDA filer, and Caraco Pharma ceutical Laboratorie s, Ltd. (Caraco) was the subsequent Paragraph IV ANDA filer. 527 F.3d at 1286, 1288. Forest listed two patents in the Orange Book in relation to its NDA. Id. at 1286. Both Ivax and Caraco filed Paragraph IV ANDAs with respect to both of the listed patents. Id. at 1286, 1288. Forest chose to sue Ivax on only one of t he two listed patents. Id. at 1286. Forest’s patent was found valid, infringed, and enforceable. Id. (citing Forest Labs., Inc. v. Ivax Pharms., Inc. , 501 F.3d 1263 (Fed. Cir. 2007)). After Caraco f iled its Paragraph IV ANDA, Forest sued Caraco on only the previously litigated pat ent and granted a covenant-not-to-sue on the unlitigated, unasserted patent. Id. at 1288. Caraco brought a declaratory judgment action for noninfringement of the unlitigated, unasserted patent. Id. Caraco wanted to be able to challenge both patent s and if successful, this would trigger Ivax’s 180-day exclusivity period at a time when Ivax c ould obtain FDA approval and then launch its product . Hence, if Caraco was successful, Ivax would get its 180-day exclusivity period sooner and Caraco would be able to obtain FDA approval earlier—resulting in greater competition at an earlier time. Without a declaratory judgment, Caraco could be excluded from selling a noninfri nging product even if the a sserted patent was proven to be invalid. See id. at 1287, 1296 n.14. Therefore, Caraco could have been blocked from entering the market by an invalid patent. Id.

2008-1062 12The key difference between Caraco and this case is that the harm that gave rise to the jurisdiction over the dec laratory judgment claim in Caraco ceased to exist once Apotex stipulated to the validity, infringement, and enforceability of the ’663 patent. Therefore, unlike Caraco, Apotex cannot claim that at the time of the district court’s dismissal it was being excluded from selling a noninfringing product by an invalid patent—it stipulated to the validity of the ’663 patent. Even if Apotex successfully invalidates the ‘425 and ‘527 pa tents, it cannot obtain FDA approval until the expiration of the ‘663 patent because of it s stipulations with respect to that patent. Instead, the harm to Apotex that has cont inuously existed is its exclus ion from selling its alleged noninfringing product during Teva’s statutorily entitled 180-day exclusivity period. Apotex is being excluded from the market by Teva’s 180-day exclusivity period—a period which Teva is entitled to under the Hatc h-Waxman Act. This is a different injury than that alleged in Caraco

. Apotex’s inability to promptly launch its generic risperidone product because of Teva’s 180-day exclusivity perio d is not a cognizable Article III controversy, but a result envisioned by the Hatch-Waxman Act. As noted above, the Hatc h-Waxman Act struck a careful balance between encouraging the dev elopment of new dr ugs and enabling the marketing of low-cost generic drugs. See Andrx Pharms. , 276 F.3d at 1371. To this end, Congress decided to give generic pharmaceutical companies a 180-day exclusivity period as an incentive to challenge sus pect Orange Book listed patents. The 180-day exclusivity period is import ant to generic pharmaceutical companies as it promotes patent challenges by enabling a generic company a period to re cover its investment in these challenges. See C. Scott Hemphill, Paying for De lay: Pharmaceutical Patent

2008-1062 13Settlement as a Regulatory Design Problem , 81 N.Y.U. L. Rev. 1553, 1605 (2006) (noting the importance of t he 180-day exclusivity period for decreasing the free-rider problem and concomitantly in centivizing challenges of Or ange Book listed patents); see also Purepac Pharm. Co. v. TorPharm, Inc. , 354 F.3d 877, 879 (D.C. Cir. 2004) (“In order to encourage paragraph IV challenges, thereby increasing the availability of lowcost generic drugs . . . [the firs t Paragraph IV ANDA filer] has the right to sell its drug without competition [from other generic entrants] for 180 days.”). As the import of the 180-day exclusivity period is clear, we hold that Apotex’s exclus ion from the market because of Teva’s entitlement to this statutory exclusionar y period does not present a justiciable Article III controversy. B. Indefinite Delay Second, Apotex argues that absent a declaratory j udgment action, its approval of its noninfringing ge neric risperidone prod uct will be indefinitely delayed until Teva’s 180-day exclusivity period is tr iggered. Apotex contends th at Teva does not have to commercially launch immediately after the ex piration of the ’663 patent, and that Teva may indefinitely delay launching for various reasons (i.e., substantive problems with its applications which may prevent FDA approval; stock-piling drug product; or concerns over brand patents). 6 Apotex filed its counterclaims seeking declaratory judgment of noninfringement of the ’425 and ’587 patents on April 25, 2006. At this time, Teva could not launch its

6 In 2003, Congress eliminated the possi bility that the first Paragraph IV ANDA filer may indefinitely delay launching its generic product. See supra note 2.

2008-1062 14generic product for at least another two years. 7 The district court dismissed the counterclaims on October 11, 2007 more than six months before Teva could have launched. Final judgm ent was entered on Nove mber 2, 2007. At t he time of the final judgment dismissing the counter claims, the harm alleged by Apotex was too speculative because Teva could not yet have launched. We heard oral arguments in this case on July 7, 2008, approximately a week after Teva could have launched its generic product. 8 However, we are not deciding whet her the facts alleged on July 7, 2008—the date we heard oral arguments—giv e rise to a justiciable Arti cle III case or controversy. 9
We hold that at the time w hen the district court entered final judgment in this case, Apotex’s alleged harm of indefinite delay of approval was too speculative to create an actual controversy to warrant the issuance of a declaratory judgm ent.

7 The earliest Teva could have laun ched its generic product was on June 29, 2008—the expiration of the ’663 pat ent pediatric exclusivity period. 8 At the time we heard oral argument, both parties agreed that Teva had not yet launched its generic risperidone oral solution. 9 Jurisdiction over a declaratory judgment action must be present “at all stages of review, not merely at the ti me the complaint is filed." Steffel , 415 U.S. at 459 n.10. As noted above, the court was divested of jurisdiction on Ma y 11, 2007 the date that Apotex’s stipulated to the validity, enforc eability, and infringement of the ’663 patent. In limited circumstances, temporary jurisdictional defects—defects that arise after the filing date of the complaint—may be cured before the district court enters final judgment. See Mars, Inc. v. Coin Acceptors, Inc. , 527 F.3d 1359, 1370 (Fed. Cir. 2008) (holding that patentee must reacquire title to a patent prior to final judgment to correct the jurisdictional defect that arises when the plaintiff loses title to the patent during litigation); Schreiber Foods, In c. v. Beatrice Cheese, Inc. , 402 F.3d 1198, 1203 (Fed. Cir. 2005) (“In circumstances where dismissal fo r lack of initial standing is not required, the Supreme Court held in Caterpillar Inc. v. Lewis , 519 U.S. 61 (1996),] that jurisdictional defects can be cured before j udgment.”); Insituform Tech., Inc. v. Cat Contracting, Inc. , 385 F.3d 1360, 1371-72 (Fed. Cir. 2004) (holding that temporary loss of jurisdiction during patent lit igation can be cured before fi nal judgment). As Apotex failed to cure the jurisdictional defect by the time the district court entered final judgment, we need not reach the issue of w hether this case constitutes one of the limited circumstances in whic h temporary jurisdictional defects can be cured.

2008-1062 15At no time between the fili ng of the counterclaims th rough the final judgment was there any basis to conclude that Teva will, or is likely to , delay in bringing its generic product to market in t he future. In Caraco , this court considered the same harm that Apotex alleges and concluded t hat it was insufficient to cr eate a justiciable Article III case or controversy. See Caraco , 527 F.3d 1296 n.14 (noting possi ble delay of the first Paragraph IV ANDA filer launchi ng after the expirati on of a patent is too speculative to create a justiciable Article III case or controversy). Our decision in Caraco is supported by Supreme Court precedent which has emphasiz ed that the dispute must be “definite and concrete” and be “real and subst antial” in order to give ri se to justiciable Article III case or controversy. MedImmune , 127 S. Ct. at 771; see Prasco, LLC v. Medicis Pharm. Corp. , No. 2007-1523, slip op. at ___ (F ed. Cir. ___ 2008) (noting MedImmune “did not change the bedrock ru le that a case or contro versy must be based on a real and immediate injury . . . an objective standard that cannot be met by a purely subjective or speculative fear of future harm ”). Therefore, we hol d that a possible delay in the future of a first Paragraph IV ANDA filer in launching its generic product does not give rise to declaratory j udgment jurisdiction. C. Covenant-Not-to-Sue Finally, Apotex argues that Janssen’s covenant-not-to-sue is deficient as it does not protect Apotex’s affiliates, suppliers, a nd downstream customers. We disagree. The relevant portion of Janss en’s covenant-not-to-sue states: Janssen unconditionally covenants not to sue or otherwise seek to hold Apotex liable based on its manufacture , having manufactured, importation, distribution, use, sale and/or offering fo r sale of the risperdal oral solution, 1 mg/ml that are described in and t he subject of Abbreviated New Drug Application No. 77-719, as filed and as prov ided to counsel for Janssen on or about July 13 and 25, 2006 (“the A NDA”), for infringement of United

2008-1062 162008-1062 17 States Patents Nos. 5,453,425 (“the ’425 patent ”) [and] 5,616,587 (“the ’587 patent”) . . . . Similarly, Janss en would not sue or otherwise seek to hold Apotex’s customers or distributors liabl e based upon the importation, distribution, use, sale and/or offering fo r sale of the risperdal oral solution, 1 mg/ml that are described in and the subject of the ANDA for infringement of the ’425 patent [and] the ’587 patent . . . . The covenant expressly give s Apotex protection from su it for “manufacture [and/or] having manufactured” the claimed product. The “having manufactured” language expressly covers all suppliers and affiliates involved in the manufacturing process. See Cyrix Corp. v. Intel Corp. , 77 F.3d 1381, 1388 (Fed. Cir . 1996) (“ST acted within the scope of its ‘have made’ right under the ST-Intel agreement when it had ST-Italy make the microprocessors and then sold them to Cyri x.”). Similarly, the covenant protects all of Apotex’s customers without any di stinction between direct and downstream customers as it states “[s] imilarly, Janssen would not s ue or otherwise seek to hold Apotex’s customers and distributors liable . . . .” Therefore, we hold Janssen’s covenant-not-to-sue is not defic ient, as it protects Apotex ’s affiliates, suppliers and downstream customers. CONCLUSION As we conclude no jurisdiction existed fo r Apotex’s declaratory judgment action, we need not address the remainder of the parties’ arguments. For the foregoing reasons, we affirm the district court’s dismissal of Apotex’s declaratory judgment action.
AFFIRMED