Caraco Pharm Labs v. Forest Labs (Lexapro) CAFC Decision

The following guest post is provided by H. Keeto Sabharwal, IP Litigation Practice Group Leader for Blank Rome LLP, based in Washington, DC:

In its 2-1 decision in Caraco Pharm. Labs. v. Forest Labs. yesterday, the CAFC further refined its 180-day exclusivity jurisprudence and its position regarding the sufficiency Declaratory Judgments under the FDCA and the Supreme Court's new standard articulated in MedImmune v. Genentech.  In so doing, it appears to have offered a solution to the so-called "bottleneck" problem, where subsequent ANDA applicants are barred from approval when a first ANDA applicant settles litigation and the innovator refuses to sue subsequent filers.

The case centers around Forest Lab's blockbuster antidepressant drug escitalopram oxalate (LEXAPRO).  Forest has listed 2 patents - U.S. Patent Nos. RE 34,712 and 6,916,941 - in the FDA's orange book as covering escitalopram.  Ivax pharmaceuticals was the first to file ANDA applications containing Paragraph IV certifications that the '712 (exp: 2012) and '941 (exp: 2023) patents were either not infringed by its generic version, or the patents were invalid and/or unenforceable.  Forest sued Ivax on the '712 patent, but not on the '941 patent.  Ultimately, the Ivax's generic version was found to infringe the '712 patent and, thus, Ivax was enjoined from marketing its generic version until 2012.

Consequently, all subsequent ANDA filers were precluded from approval until 181 days after the expiration of the '712 patent, because Ivax has procured 180-day exclusivity (a.k.a. generic exclusivity) by virtue of its first-to-file status.  Subsequent filers may circumvent Ivax's exclusivity, however, by obtaining a court-judgment that both the '712 and '941 patents are invalid or not infringed.

Caraco Pharm. Labs. filed an ANDA application against both the '712 and '941 Patents.  In response, Forest sued Caraco within the 45-day period only on the '712 patent, but not on the '941 patent.  Because Caraco must obtain a court-judgment on both '712 and '941 patents to immediately trigger Ivax's exclusivity and expedite the approval of its own ANDA, Caraco filed a Declaratory Judgment action seeking a ruling of noninfringement or invalidity of the '941 patent.  In response, engaging in a clever example of "Hatch-Waxman Gamesmanship," Forest freely and unilaterally granted Caraco an irrevocable covenant not to sue for infringement of the '941 patent, knowing that a "covenant not to sue" would not qualify as a triggering event under the Hatch-Waxman amendments.  The court dismissed Caraco's complaint for not meeting the "actual case or controversy" requirement for DJ actions.

In reversing the district court, the CAFC panel concluded that Caraco had satisfied the Supreme Court's MedImmune standard for Declaratory Judgment actions.  The Court advanced three primary reasons for finding Caraco had standing: (1) it had a cognizable injury-in-fact; (2) Forrest's listing of the '712 and '941 is the source of that injury; and (3) its alleged injury is redressible by the court.  For more information, please click here for the Court's full opinion, or see the attached pdf file.[Download 07-1404.pdf]

Lastly, it is important to note that the center piece of this case is Ivax's ANDA, which was filed before the Medicare Modernization Act Amendments to the FDCA.  Therefore, the forfeiture provisions that now would typically apply to Ivax had its ANDA been filed after 2003 do not.  To that end, this decisions effect in finding injury in the post-MMA context remains unclear.