Apotex v. Forest Labs

Apotex filed suit against Forest Labs on Monday, January 10, seeking declaratory judgment of non-infringement based on Apotex’s ANDA and accompanying Paragraph IV certification for escitalopram oxalate (Lexapro®), an antidepressant.

For this drug, Forest Labs listed three patents in the Orange Book, including the two patents at issue. Apotex filed an ANDA with a Paragraph IV certification as to these two patents. Apotex was not the first filer of an ANDA for this drug. Apotex does not mention in its complaint that the Orange Book’s listing for the drug includes a third patent, RE34712, which the Orange Book states expires on September 14, 2011, with pediatric exclusivity until March 14, 2012. Forest Labs did not bring suit under 35 U.S.C. § 271(e)(2)(A), a statute that makes ANDA submission an act of infringement. Under the Hatch-Waxman Act, a suit within 45 days of receiving notification of Apotex’s Paragraph IV certification would have delayed FDA approval for Apotex’s ANDA by up to 30 months, but a lack of such a suit allowed Apotex to file a declaratory judgment action.

Apotex accordingly filed for declaratory judgment, alleging injury due to the uncertainty of facing an infringement suit from Forest Labs. Additionally, Apotex repeatedly cited the Federal Circuit ruling in Teva v. Eisai (on which we previously reported), which held that subsequent ANDA filers can bring suit against patent holders to trigger a first ANDA filer’s 180-day exclusivity period. However, the Federal Circuit ruling in Teva v. Eisai distinguished that case from another decision,Janssen Pharmaceutica v. Apotex, in which the subsequent ANDA filer admitted to validity, infringement, and enforceability of one of the Orange Book-listed patents for the drug at issue. In Janssen, the Federal Circuit affirmed dismissal of the case because, even with a favorable judgment, the subsequent ANDA filer would not yet have approval to market its drug. Apotex may face similar issues in its case against Forest Labs, depending on how Apotex certified its ANDA in relation to the patent that it does not mention in its complaint. Nonetheless, Apotex may have a case solely on its risk of suit under 35 U.S.C. § 271(e)(5) and 21 U.S.C. § 355(j)(5)(C)(i).

If the ruling in the present suit addresses the alleged injury from the first ANDA filer’s yet-to-begin 180-day exclusivity period, the ruling may speak to the breadth of the ruling in Teva v. Eisai. If courts apply Teva v. Eisai to a wide variety of subsequent ANDA filers, patentees may face more declaratory judgment suits from these parties, requiring the patentees to potentially defend patent validity challenges. Thus, a ruling for Apotex on this issue might produce increased certainty with increased occurrence of costly litigation. Conversely, if courts find more cases like this to be analogous to Janssen, fewer subsequent ANDA filers will be able to file for declaratory judgment, resulting in some uncertainty about the potentially infringing nature of ANDAs with Paragraph IV certifications.