Cephalon v. Sandoz, No. 11-821-SLR (D. Del.)
In January 2010, Sandoz sent a Paragraph IV notice letter to Cephalon in connection with its ANDA for a generic version of Cephalon's FENTORA (fentanyl citrate) buccal tablets. Cephalon responded by filing suit against Sandoz under 35 USC § 271(e)(2), alleging infringement of U.S. Patent Nos. 6,200,604 and 6,974,590 based on Sandoz's Paragraph IV certifications on the two patents.
On January 4, 2011, U.S. Patent Nos. 7,862,832 and 7,862,833 were issued. On April 25, 2011, Cephalon submitted the '832 and '833 patents for listing in the Orange Book with respect to FENTORA. But because Cephalon did not submit the '832 and '833 patents for listing within 30 days of issuance, Sandoz was not required to (and did not) file an amended patent certification with respect to the two patents in its ANDA. See 21 CFR § 314.94(a)(12)(vi):
(vi)Late submission of patent information. If a patent on the listed drug is issued and the holder of the approved application for the listed drug does not submit the required information on the patent within 30 days of issuance of the patent, an applicant who submitted an abbreviated new drug application for that drug that contained an appropriate patent certification before the submission of the patent information is not required to submit an amended certification.
Notwithstanding that Sandoz did not file a Paragraph IV (or any) certification with respect to the '832 and '833 patents, on September 15, 2011, Cephalon filed suit against Sandoz alleging infringement of the patents under § 271(e)(2). Cephalon also included claims under the Declaratory Judgment Act in its complaint. Sandoz responded by filing a motion to dismiss the complaint for lack of subject matter jursidiction and failure to state a claim.
In an Order today, the district court denied Sandoz's motion. According to the court, "Sandoz, relying primarily on the opinion issued in Eisai v. Mutual (D.N.J. 2007), argues that the court's authority to exert subject matter jurisdiction over the instant dispute is narrowly limited . . . put more simply, no Paragraph IV certification, no jurisdiction." The Delaware court distinguished Eisai, stating that in that case, "the patent holder's conduct was so egregious that its ability to take advantage of § 271(e)(2) was forfeited." Further, the Eisai court "went on to hold that the patentee could not maintain an infringement action pursuant to the Declaratory Judgment Act because '§ 271(e)(2) provides the jurisdictional peg for infringement actions brought prior to ANDA approval and, in the absence of the jurisdictional hook, jurisdiction is lacking.'"
The Delaware court stated:
I respectfully disagree with the sweeping conclusion that the absence of a Paragraph IV certification limits, as a matter of law, the court's subject matter jurisdiction under both 35 USC § 271(e)(2) and [the Declaratory Judgment Act]. With respect to § 271(e)(2), the sole purpose of the Paragraph IV certification in the artificial world of the Hatch-Waxman Act is to provide notice of what patents may be implicated by the ANDA, in order to trigger suit. In reality, however, the inquiry truly begins because the ANDA filer seeks approval to market a patented drug prior to the expiration of the relevant patent.
The court held:
Where, as here, the jurisdictional trigger was properly pulled by the filing of an ANDA and the initial Paragraph IV certification by Sandoz, the court's jurisdiction should not be confined simply because Sandoz was not required to file an amended Paragraph IV certification. Clearly, Sandoz was put on notice of the '832 and '833 patents. It would be ironic, indeed, if the absence of an amended Paragraph IV certification precluded suit, when the certification provisions exist for the benefit of the patentee.
Finally, the court concluded that there is no connection between § 271(e)(2) and the Declaratory Judgment Act: "so long as there is an actual controversy, that is, there is a 'sufficient allegation of immediacy and reality,' 'the exercise of jurisdiction over such an action is within the discretion of the district court.'"