Opinion ID: 209997
Heading Depth: 3
Heading Rank: 2

Heading: Caraco's Injury Is Traceable to Forest

Text: Caraco's injury is also fairly traceable [to] the complained-of conduct of the defendant, Steel Co., 523 U.S. at 102-03, 118 S.Ct. 1003. It is not the Hatch-Waxman Act or the FDA framework that prevents Caraco's ANDA from being approved by the FDA, but rather Forest's actions in the contexti.e. under all the circumstances, Medlmmune, 127 S.Ct. at 771of the Hatch-Waxman framework. Simply put, if Forest had not listed its '712 and '941 patents in the FDA's Orange Book as valid patents covering the drug described in its NDA for Lexapro®, then 21 U.S.C. § 355(j)(5)(B)(iv) (2000) would not independently delay Caraco's ANDA from being approved by the FDA. Such but-for causation is sufficient to satisfy the traceability requirement of Article III standing. See Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 74-78, 81 n. 26, 98 S.Ct. 2620, 57 L.Ed.2d 595 (1978). As discussed above, where the first Paragraph IV ANDA filer has failed to trigger its own 180-day exclusivity period, the NDA holder's listing of Orange-Book patents delays a subsequent Paragraph IV ANDA filer from entering the marketplace indefinitely. Moreover, this delay occurs even if the drug described in the subsequent Paragraph IV ANDA does not infringe the Orange-Book-listed patents. Here, Forest's listing of the '712 and '941 patents in the Orange-Book effectively denies Caraco an economic opportunity to enter the marketplace unless Caraco can obtain a judgment that both those patents are invalid or not infringed by its generic drug. Under these circumstances, Forest's listing of the '941 patent (the patent-in-suit) in the Orange-Book creates an independent barrier to the drug market that deprives Caraco of an economic opportunity to compete. It is well established that the creation of such barriers to compete satisfies the causation requirement of Article III standing. See, e.g., Ne. Fla. Chapter, Associated Gen. Contractors of Am. v. Jacksonville, 508 U.S. 656, 666, 113 S.Ct. 2297, 124 L.Ed.2d 586 (1993) (holding that the imposition of [a] barrier to bid for certain government contracts satisfied the injury-in-fact and causation requirements of Article III standing); Clements v. Fashing, 457 U.S. 957, 962, 102 S.Ct. 2836, 73 L.Ed.2d 508 (1982) (holding that the imposition of an obstacle to [plaintiff's] candidacy for higher judicial office satisfied the injury-in-fact and causation requirements of Article III standing); Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 124-25, 89 S.Ct. 1562, 23 L.Ed.2d 129 (1969) (holding that the plaintiff had standing to sue where it alleged that it had been denied a share of the market).