Opinion ID: 209997
Heading Depth: 3
Heading Rank: 1

Heading: Caraco Alleges a Judicially Cognizable Injury-in-Fact

Text: In this case, as in most declaratory judgment actions in the patent context, Caraco's alleged injury-in-fact is a restraint on the free exploitation of non-infringing goods, Red Wing Shoe Co., Inc. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355, 1360 (Fed.Cir.1998). Here, Caraco alleges it is being excluded from selling a non-infringing product because Forest has taken actions that delay the FDA from approving Caraco's ANDA. See Novartis, 482 F.3d at 1340 (observing that an ANDA filer suffers the requisite injury-in-fact where its ability to secure approval of its ANDA has been prevented by an NDA holder). As this court explained in Novartis, the Hatch-Waxman framework presents a different set of circumstances than those which underlie an ordinary infringement action: Ordinarily, a potential competitor in other fields is legally free to market its product in the face of an adversely-held patent. In contrast, under the Hatch-Waxman Act an ANDA filer . . . is not legally free to enter the market [without FDA approval]. 482 F.3d at 1345. Indeed, 21 U.S.C. § 355(a) provides that [n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an [NDA or ANDA] is effective with respect to such a drug. Thus, by preventing the FDA from approving the ANDAs of generic drug manufacturers, pharmaceutical patentees like Forest can potentially exclude non-infringing generic drugs from the market. If Caraco is correct that its generic drug does not infringe Forest's '941 patent, then it has a right to enter the generic drug market, and its exclusion from the generic drug market by Forest's actions is a sufficient Article III injury-in-fact. Moreover, the fact that Forest's actions can only exclude Caraco from the drug market in the context of the Hatch-Waxman framework does not render Caraco's injury any less concrete, actual or imminent. Steel Co., 523 U.S. at 102-03, 118 S.Ct. 1003. In sum, Caraco alleges that it has been restrain[ed from] the free exploitation of non-infringing goods, Red Wing Shoe, 148 F.3d at 1360. This is exactly the type of injury-in-fact that is sufficient to establish Article III standing under our caselaw. See id.; see also Novartis, 482 F.3d at 1345 (explaining that an NDA holder's use of an OrangeBook-listed patent to exclude a generic drug maker from the market creates the exact type of uncertainty of legal rights that the ANDA declaratory judgment action [i.e. the CAPC, 21 U.S.C. § 355(j)(5)(C)] was enacted to prevent). [9]