Opinion ID: 209997
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Heading: The First Paragraph IV Challenge to Forest's Orange-Book-Listed Patents for Lexapro® and the Consequences for Subsequent Paragraph IV ANDA Filers

Text: The first ANDA applicant to file a Paragraph IV certification for Forest's '712 and '941 patents was Ivax Pharmaceuticals, Inc. (Ivax). Accordingly, Ivax is entitled to 180 days of generic market exclusivity, which will begin either on the day it begins marketing its generic drug, or on the date a court determines that the '712 and '941 patents are invalid or not infringed whichever comes first. See 21 U.S.C. § 355(j)(5)(B)(iv) (2000). Forest responded to Ivax's Paragraph IV ANDA by suing Ivax for infringement of the '712 patent, the earlier of the two patents to expire. Ivax counterclaimed that the '712 patent was invalid. Despite suing Ivax on the '712 patent, Forest did not sue Ivax for infringement of the '941 patent. By holding the '941 patent in reserve, Forest insulated itself from an invalidity or noninfringement challenge by Ivax. [5] Ultimately, Forest defeated Ivax's counterclaim of invalidity on the '712 patent and obtained a judgment that the drug described in Ivax's ANDA infringed the '712 patent, which was affirmed by this court in Forest Labs., Inc. v. Ivax Pharms., Inc., 501 F.3d 1263 (Fed.Cir. 2007). In sum, after filing a Paragraph IV certification for both the '712 and '941 patents in its ANDA, Ivax failed to obtain a court judgment that either the '712 or the '941 patent is invalid or not infringed by the drug described in its ANDA. Because Ivax has not obtained a judgment that both of Forest's Orange-Book-listed patents are invalid or not infringed by the generic drug described in its ANDA, Ivax failed to trigger its 180-day exclusivity period via the court-judgment trigger, 21 U.S.C. § 355(j)(5)(B)(iv)(II) (2000). In addition, because the generic drug described in Ivax's ANDA was found to infringe the '712 patent, Ivax cannot trigger its 180-day exclusivity period via the commercial-marketing trigger, 21 U.S.C. § 355(j)(5)(B)(iv)(I) (2000), until the '712 patent expires in 2012. Indeed, the district court specifically enjoined Ivax from making, using, offering to sell or selling within the United States, or importing into the United States any products that infringe the '712 patent, including the [drug] products referred to in [Ivax's ANDA] until such time as the '712 patent expires. . . . Forest Labs., Inc. v. Ivax Pharms., Inc., No. 03-891-JJF (D.Del. Nov. 3, 2006) (Judgment Order). As a result, Ivax cannot activate its exclusivity period via the commercial-marketing trigger until the '712 patent expires. With Ivax no longer able to trigger its exclusivity period, only two pathways remain open to subsequent Paragraph IV ANDA filers who seek to trigger Ivax's exclusivity period before the '712 patent expires in 2012. First, a subsequent Paragraph IV ANDA filer could obtain a court judgment invalidating the '712 patent, which would allow the FDA to approve Ivax's drug. With FDA approval, Ivax would be legally free to sell its generic drug, and its exclusivity period would be triggered on the day of its first commercial marketing. See 21 U.S.C. § 355(j)(5)(B)(iv)(I) (2000) (the commercial-marketing trigger). Second, a subsequent Paragraph IV ANDA filer could trigger Ivax's exclusivity period immediately  regardless of when Ivax begins marketing its drugvia the court-judgment trigger, 21 U.S.C. § 355(j)(5)(B)(iv)(II) (2000). However, because Ivax was the first Paragraph IV ANDA filer with respect to both the '712 and '941 patents, a subsequent Paragraph IV ANDA filer can only activate Ivax's exclusivity period via the court-judgment trigger by obtaining a judgment that both the '712 and '941 patents are invalid or not infringed. If a subsequent Paragraph IV ANDA filer is not able to pursue either of these two pathways to triggering Ivax's exclusivity period, then Ivax's exclusivity period cannot begin until the '712 patent expires in 2012. Moreover, assuming there has been no other triggering event by that time, Ivax's exclusivity period will not be triggered on the date the '712 patent expires unless Ivax actually begins marketing its generic drug on that date. Even if Ivax does so, the FDA will still be restricted from approving any subsequent Paragraph IV ANDA until 181 days after the date the '712 patent expires. [6] See 21 U.S.C. § 355(j)(5)(B)(iv). In short, absent an event triggering Ivax's exclusivity, all subsequent Paragraph IV ANDA filers, including Caraco, will be denied entry to the drug market for a significant time. These subsequent Paragraph IV ANDA filers will be precluded from the market regardless of whether the generic drugs described in their ANDAs infringe Forest's Orange-Book-listed patents and regardless of whether Forest's patents are valid.