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Court rejects argument that, under the circumstances, lack of Paragraph IV certification means no act of infringement and no jurisdiction.

In a recent memorandum order, Judge Robinson rejected an ANDA defendant’s argument that the Court lacked subject matter jurisdiction over the parties’ dispute because the defendant’s ANDA did not include a Paragraph IV certification relating to the patents-at-issue. Cephalon, Inc. v. Sandoz, Inc., Civ. No. 11-821-SLR (D. Del. Mar. 1, 2012). The plaintiff originally listed two patents in the Orange Book in connection with its approved NDA for FENTORA®. The defendant then filed an ANDA, which included a Paragraph IV certification addressing those two patents. Id. at 1-2. Litigation followed, but was stayed pending the resolution of an appeal of a related case involving the validity of the same patents. Id. at 2.

Meanwhile, on January 4, 2011, the plaintiff was issued two new patents, which the plaintiff waited almost three months to list in the Orange Book in connection with FENTORA®. The Court noted that the defendant did not, and under 21 C.F.R. § 314.94(a)(12)(vi)(1995) was not required to, file an amended Paragraph IV certification because the plaintiff did not list the two new patents within 30 days of their issuance. Id. at 2. The plaintiff then sought to amend the pleadings in the stayed action to assert the two new patents, but the defendant declined to stipulate to such an amendment. Id. As a result, the plaintiff filed a new complaint against the defendant alleging infringement of the two new patents. Id. at 2-3.

In this second action, the defendant argued that the Court lacked subject matter jurisdiction because its ANDA did not include a Paragraph IV certification with respect to the two new patents, and there was, therefore, no artificial act of infringement under § 271(e)(2) creating jurisdiction. Id. at 3. Judge Robinson disagreed, explaining “Where, as here, the jurisdictional trigger was properly pulled by the filing of an ANDA and the initial Paragraph IV certification . . ., the court’s jurisdiction should not be confined simply because [the defendant] was not required to file[] an amended Paragraph IV certification. Clearly, [the defendant] was put on notice of the ‘832 and ‘833 patents.” Id. at 10. The Court “decline[d] to elevate form over substance where the purpose of the administrative process has been served and conclude[d] that jurisdiction under § 271(e)(2) [was] established.” Id. at 10-11. Moreover, the Court explained that it could still exercise jurisdiction over the dispute under the Declaratory Judgment Act if the defendant’s argument relating to § 271(e)(2) were accepted, finding that nothing in the Hatch-Waxman Act precludes a court from exercising jurisdiction based solely on the Declaratory Judgment Act. Id. at 11.


Cephalon, Inc. v. Sandoz, Inc., C.A. No. 11-821-SLR (D. Del. Mar. 1, 2012).

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