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Judge Sleet grants leave to amend to add declaratory judgment counterclaims in ANDA litigation


In a recent Memorandum, Judge Gregory M. Sleet granted defendants’ motion for leave to amend to add declaratory judgment counterclaims for U.S. Patent Nos. 9,295,802 (“the ’802 patent”); 9,265,911 (“the ’911 patent”); and 9,279,794 (“the ’794 patent”) in this ANDA litigation regarding plaintiffs’ product INOmax®. Mallinckrodt Hospital Products IP Ltd., et al. v. Praxair Distribution, Inc., et al., C.A. No. 15-170-GMS (D. Del. Aug. 2, 2016). The ’802 patent, ’911 patent and ’794 patent each issued to plaintiffs after the filing of this action. Id. at 2. Shortly after the patents issued, they were added to the Orange Book listing for INOmax®. Id. Defendants sought to have the newly-issued patents added to the case by stipulation of the parties, but plaintiffs disagreed. Id. at 2-3. Soon after plaintiffs noted their disagreement, defendants filed expedited Paragraph IV Certifications regarding the newly-issued patents. Id. at 3.

Granting defendants’ motion, Judge Sleet first explained that “adding the new patents to this case will conserve judicial and party resources, because the alternative would require the parties to initiate a new lawsuit. The court does not find any inference of bad faith on the part of the Plaintiffs.” Id. at 4. Next, Judge Sleet found that Plaintiffs would not be prejudiced by the addition of the new patents. Specifically, Judge Sleet noted that two of the newly-added patents were continuations of a patent already being asserted in the case. Id. Judge Sleet also noted that “Plaintiffs cannot claim surprise or lack of notice, as the Defendants notified them of their intent to add the new patents to the suit nearly two weeks before filing an expedited Paragraph IV certification for the new patents and over two weeks before seeking leave to amend.” Id. at 5.

Finally, Judge Sleet considered whether such amendment would be futile. Plaintiffs argued that defendants’ amendment would be futile because the court lacks subject matter jurisdiction over the new patents. Id. Specifically, plaintiffs contended that “since the Defendants’ Motion to Amend was filed four days after the Defendants’ expedited Paragraph IV certification and lacked an offer of confidential access to the ANDA, it fails the provisions of§ 355(j)(5)(C)(i)(I) and must be denied.” Id. Rejecting plaintiffs’ argument, Judge Sleet “decline[ed] to follow a form-over-function approach”:

Here, the Defendants have satisfied the purpose of the Hatch-Waxman declaratory judgment provisions. The Plaintiffs had access to the Defendants’ ANDA for over a year before they added new patents to the INOmax Orange Book listing. The Plaintiffs chose to add the patents to the INOmax listing without adding them to their claims of infringement against the Defendants’ ANDA. The Defendants notified the Plaintiffs on April 22, 2016 that they intended to seek declaratory judgment to settle the question of whether these new patents conflicted with their ANDA. Over forty-five days have elapsed since the Plaintiffs were first made aware of the Defendants’ desire to seek declaratory judgment. As a result, the purpose of the statute is satisfied and subject matter jurisdiction is established over the new patents for this case under the first Paragraph IV certification.

Id. at 6 (citations omitted).

Mallinckrodt Hospital Products IP Ltd., et al. v. Praxair Distribution, Inc., et al., C.A. No. 15-170-GMS (D. Del. Aug. 2, 2016).

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