Senju Pharm. Co., Ltd. v. Metrics, Inc.

Consent to jurisdiction occurs when complying with registered-agent statute; filing an ANDA is not an initiation of a civil suit precluding the filing of an IPR.

Spring 2015

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) 

Drug Product and Patents-in-Suit: Prolensa® (bromfenac); U.S. Patents Nos. 8,129,431 (“the ’431 patent”), 8,669,290 (“the ’290 patent”), and 8,754,131 (“the ’131 patent”)

Nature of the Case and Issue(s) Presented: This case presented two issues: (i) whether general or specific jurisdiction is present over a foreign parent corporation; and (ii) whether the filing of an ANDA precludes the generic manufacturer from initiating an IPR before the Patent Trial and Appeal Board. Here, Metrics, Inc., a subsidiary of Mayne Pharma Group, was registered to conduct business in New Jersey and had a registered agent to accept service of process in New Jersey for all causes of action. Mayne Pharma Group is an Australian company with no offices or activities in New Jersey, nor is it registered to conduct business in New Jersey. Several days after the lawsuit was initiated, Mayne and Metrics filed petitions for IPR of the asserted patents.

As to jurisdiction, Metric argued that it was not subject to general or specific jurisdiction in New Jersey because—in view of the Supreme Court’s decision in Daimler—its actions did not give rise to jurisdiction. Metric asserted that compliance with the registered-agent statute was not consent to jurisdiction for a patent-infringement case. Mayne argued that the Court lacked jurisdiction over it because it was a foreign corporation with no connections to New Jersey. In particular, it did not have a registered agent in New Jersey. In addition, any activities it conducted that may be connected to New Jersey could not serve as the basis for general jurisdiction under Daimler.

Senju moved for the Court to enjoin Metric and Mayne from continuing the IPRs against the patents-in-suit because such IPRs were precluded as Metric and Mayne had initiated a civil action challenging the validity of the patents-in-suit when Metric and Mayne filed the ANDA. Metric and Mayne opposed stating that the filing of an ANDA was not initiating a lawsuit in district court, which is the pertinent procedure described in the statute.

Why Senju Prevailed: The court found that it had jurisdiction over Metric because Metric had consented to jurisdiction in New Jersey by complying with the registered-agent statute. The court rejected Metric’s argument that Daimler changed or overruled the principle that a party could consent to jurisdiction. Moreover, Metric did not provide any New Jersey authority for the proposition that its registered-agent statute was limited to only certain causes of action. On the other hand, the court found that it did not have jurisdiction over Mayne because Mayne lacked sufficient connection to New Jersey. The court stated that general jurisdiction was not present because the actions in New Jersey do not support general jurisdiction under Daimler as they did not rise to the high level set forth by the Supreme Court. As to specific jurisdiction, the Court rejected Senju’s argument that prior lawsuits in New Jersey involving Mayne were related to the issue in the present suit. The court allowed for jurisdictional discovery to see if Mayne entered into a contract with a New Jersey company to provide the active ingredient in the accused product.

As for Senju’s motion to enjoin Metric and Mayne, the court rejected this argument because the filing of an ANDA was not a civil action as contemplated by the statute. The court stated that an ANDA is not a filing with a judicial body or administrative body that could adjudicate or resolve disputes between parties. The court noted that other courts and the PTAB had rejected this same argument because the statute applies only to civil actions in district court, and an ANDA is not a filing in district court.

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