MOORE, Circuit Judge.
Defendant-Appellant Apotex, Inc. (Apotex) appeals the order of the United States District Court for the District of New Jersey dismissing its declaratory judgment action for noninfringement against Plaintiffs-Appellees Janssen Pharmaceutica, N.V. and Janssen, L.P. (collectively Janssen). We affirm.
This case arises under the Hatch-Waxman Act (Act),
Under the Act, a pioneering or brand name drug company seeking to manufacture a new drug must prepare, file, and have approved 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 the new drug's safety and efficacy obtained from clinical trials. 21 U.S.C. § 355(b)(1). The applicant must also identify 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 "Orange 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
In order to bring about early resolution of patent disputes between generics and pioneering drug companies, the Act provides 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, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). The ANDA filer 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 have the option of suing on all, some, or none of the patents included 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 final 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 approve 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 pharmaceutical companies to challenge suspect Orange Book listed patents, the 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 entitled to the 180-day exclusivity period regardless of whether it establishes that the Orange Book patents are invalid or not infringed by the drug described in its ANDA. All that is required for the first 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).
On December 8, 2003, the Hatch-Waxman 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 early 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 applicant seeks approval ..." 21 U.S.C. § 355(j)(5)(C)(i)(II). Specifically, the MMA allows a Paragraph IV ANDA filer a right to bring a declaratory judgment action for noninfringement or invalidity of the relevant listed patents against the patentee and NDA holder, if the patentee has not brought an infringement action within the 45-day notice period. 21 U.S.C. § 355(j)(5)(C). Congress extended federal court jurisdiction over these 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).
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 the 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
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, 223 Fed.Appx. 999 (Fed.Cir.2007). While Apotex was not a party to that trial, Apotex stipulated to infringement, validity, and enforceability 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 the '663 patent by filing a Paragraph III Certification 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 the FDA will not approve a later-filed Paragraph IV ANDA based on the same NDA. Teva's 180-day exclusivity 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 infringed— whichever comes first. 21 U.S.C. § 355(j)(5)(B)(iv) (2000). As Teva filed a Paragraph III Certification with respect to the '663 patent, the FDA will not approve Teva's generic product before the expiration of the '663 patent. Because Janssen did not sue Teva for infringing the '425 and '587 patents, the FDA will be able to approve Teva's generic version of risperidone oral solution upon the expiration of the '663 patent. Teva will be able to commercially market its generic product immediately upon receiving FDA approval.
Apotex subsequently submitted an ANDA application to the FDA seeking approval to market its generic version of risperidone 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 Paragraph IV Certification directed to the '663 patent. On March 3, 2006, Janssen sued Apotex for infringing the '663 patent in the United States District Court for the District of New Jersey, but Janssen did not sue Apotex on the '425 and '587 patents (collectively, the unasserted patents). In its Answer to Janssen's Complaint on April 25, 2006, Apotex asserted four counterclaims, including claims for declaratory judgment of noninfringement of the two unasserted patents. Specifically, Apotex sought a declaratory judgment of noninfringement with respect to the two 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).
On December 8, 2006, Janssen provided Apotex with a covenant-not-to-sue with respect to the '425 and '587 patents. After
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 jurisdiction under the Declaratory Judgment Act, 28 U.S.C. § 2201, to ANDA Paragraph IV disputes, 21 U.S.C. § 355(j)(5)(C). Congress 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 relevant text of the Declaratory Judgment Act reads:
28 U.S.C. § 2201(a). The Declaratory Judgment Act's "actual controversy" requirement "refers to the type of `Cases' and `Controversies' that are justiciable under Article III." MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 S.Ct. 764, 771, 166 L.Ed.2d 604 (2007).
In MedImmune, the Supreme Court stated that a justiciable declaratory judgment action exists when:
Id. at 771 (citation omitted). The Court emphasized that the dispute must be:
Apotex argues that it is suffering three actual and continuing injuries which create a substantial controversy of sufficient immediacy to warrant the issuance of a declaratory judgment. Specifically, Apotex argues that (1) it is unable to promptly launch its generic risperidone product and compete in the market immediately upon the expiration of the '663 patent; (2) its approval of its noninfringing generic risperidone product is being indefinitely delayed; and (3) its affiliates, suppliers, and downstream customers face patent uncertainty because Janssen's covenant-not-to-sue does not cover them. We address each 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 sufficient immediacy to warrant the issuance of a declaratory judgment. Without a declaratory
Apotex 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 declaratory judgment action must be present "at all stages of review, not merely at the time the complaint is filed." Steffel v. Thompson, 415 U.S. 452, 459 n. 10, 94 S.Ct. 1209, 39 L.Ed.2d 505 (1974); see Benitec Austl., Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344 (Fed.Cir.2007) ("The burden is on the party claiming declaratory judgment jurisdiction to establish that such jurisdiction existed at the time the claim for declaratory relief was filed and that it has continued since."); Int'l Med. Prosthetics 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] existed 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, infringement, 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 filed 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 declaratory judgment claims in Caraco was no longer present on October 11, 2007—the date the district court dismissed the instant case. Further, we conclude that the harm that has continuously existed in the present case—Apotex's inability to launch its generic product immediately upon the 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
The key difference between Caraco and this case is that the harm that gave rise to the jurisdiction over the declaratory 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 patents, it cannot obtain FDA approval until the expiration of the '663 patent because of its stipulations with respect to that patent. Instead, the harm to Apotex that has continuously existed is its exclusion 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 Hatch-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 period is not a cognizable Article III controversy, but a result envisioned by the Hatch-Waxman Act. As noted above, the Hatch-Waxman Act struck a careful balance between encouraging the development of new drugs 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 suspect Orange Book listed patents. The 180-day exclusivity period is important to generic pharmaceutical companies as it promotes patent challenges by enabling a generic company a period to recover its investment in these challenges. See C. Scott Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L.Rev. 1553, 1605 (2006) (noting the importance of the 180-day exclusivity period for decreasing the free-rider problem and concomitantly incentivizing challenges of Orange Book listed patents); see also Purepac Pharm. Co. v. TorPharm, Inc., 354 F.3d 877, 879
B. Indefinite Delay
Second, Apotex argues that absent a declaratory judgment action, its approval of its noninfringing generic risperidone product will be indefinitely delayed until Teva's 180-day exclusivity period is triggered. Apotex contends that Teva does not have to commercially launch immediately after the expiration 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; stockpiling drug product; or concerns over brand patents).
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 generic product for at least another two years.
At no time between the filing of the counterclaims through 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 the future. In Caraco, this court considered the same harm that Apotex alleges and concluded that it was insufficient to create a justiciable Article III case or controversy. See Caraco, 527 F.3d at 1296 n. 14 (noting possible delay of the first Paragraph IV ANDA filer launching after the expiration 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 emphasized that the dispute must be "definite and concrete" and be "real and substantial" in order to give rise to justiciable Article III case or controversy. MedImmune, 127 S.Ct. at 771; see Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed.Cir.2008) (noting MedImmune "did not change the bedrock rule that a case or controversy 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 hold 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 judgment jurisdiction.
Finally, Apotex argues that Janssen's covenant-not-to-sue is deficient as it does not protect Apotex's affiliates, suppliers, and downstream customers. We disagree. The relevant portion of Janssen's covenant-not-to-sue states:
The covenant expressly gives Apotex protection from suit 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 Cyrix."). Similarly, the covenant protects all of Apotex's customers without any distinction between direct and downstream customers as it states "[s]imilarly, Janssen would not sue or otherwise seek to hold Apotex's customers and distributors liable. ..." Therefore, we hold Janssen's covenant-not-to-sue is not deficient, as it protects Apotex's affiliates, suppliers and downstream customers.
As we conclude no jurisdiction existed for Apotex's declaratory judgment action, we need not address the remainder of the parties' arguments. For the foregoing