This is a declaratory judgment action arising under the Hatch-Waxman Act. We must decide whether the district court properly dismissed the case for lack of jurisdiction, specifically, lack of a justiciable controversy under Article III of the United States Constitution.
Teva Pharmaceuticals, Inc. (“Teva”) seeks to manufacture and market a generic version of the drug donepezil hydrochloride (“donepezil”), an approved treatment for Alzheimer’s disease. Eisai Co. and Eisai Medical Research, Inc. (collectively “Eisai”) hold the approved New Drug Application (“NDA”) for donepezil, which Eisai currently markets as Aricept®. Eisai also owns the five patents listed for Aricept® in the Orange Book. Teva requests a declaratory judgment that its generic version of donepezil does not infringe four of these Orange Book patents, Patent Nos. 5,985,864 (“’864 patent”); 6,140,321 (“’321 patent”); 6,245,911 (“’911 patent”); and 6,372,760 (“’760 patent”), (collectively the “DJ patents”).
Aside from the value of such a judgment in itself, a finding of noninfringement has special significance to generic drug manufacturers like Teva under the Hatch-Waxman Act. To market a generic version of a previously-approved drug, manufacturers must file and receive approval of an Abbreviated New Drug Application (“ANDA”). In conjunction with an ANDA, manufacturers must also submit a certification with respect to each of the drug’s Orange Book patents. The first manufacturer to file what is called a “Paragraph IV Certification” for a given Orange Book patent is entitled to 180 days of generic marketing exclusivity. Until the first-filer’s exclusivity period has run, the FDA may not approve ANDA applications by other manufacturers who have filed Paragraph IV certifications for that same patent. The first-filer’s exclusivity period can be triggered by either the (1) commercial marketing of the drug by the first Paragraph IV filer or (2) entry of a court judgment finding that patent invalid or not infringed, whichever happens first. A subsequent Paragraph IV filer can thus trigger the first-filer’s exclusivity period by obtaining a court judgment.
Teva is a subsequent Paragraph IV filer. This case turns on whether a subsequent Paragraph IV filer has a legally cognizable interest in when the first-filer’s exclusivity period begins, such that delay in triggering that period qualifies as “injury-in-fact” for the purposes of Article III.
In this case, the alleged injury-in-fact stems from a pending ANDA filed by Gate Pharmaceuticals (“Gate ANDA” or “second ANDA”), an unincorporated division of Teva. FDA approval of the Gate ANDA has been delayed indefinitely because the exclusivity period of the first-filer, a company called Ranbaxy Laboratories Ltd. (“Ranbaxy”), has not been triggered. Before the district court, patent owner Eisai argued that Teva failed to establish the existence of an Article III controversy. The district court agreed and dismissed the case for lack of jurisdiction. In finding that Teva failed to allege a controversy of sufficient immediacy and reality for Article III purposes, the district court relied in part on a preliminary injunction entered against Teva and Gate in a separate, still-pending patent infringement action regarding Patent No. 4,895,841 (“’841 patent”).
Teva appeals the dismissal of its declaratory judgment action and argues the case should proceed. We agree. Under this court’s decision in Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc., 527 F.3d 1278 (Fed. Cir. 2008), Teva has alleged a sufficiently concrete injury fairly traceable to Eisai’s actions. Further, the injury can be redressed by the requested relief: a declaratory judgment of noninfringement would trigger the first-filer’s exclusivity period, which currently blocks FDA approval of the Gate ANDA. The district court’s decision is reversed and the case remanded for further proceedings consistent with this opinion.
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