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No Rubber Stamp: DNJ Scrutinizes Unopposed Sealing Motions in Hatch-Waxman Case

Reports on patent litigation in the District of New Jersey — an ongoing series
By Paul W. Kalish and Jonathan J. Madara
A judge with a gavel and litigants
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Key Points

  • Even when unopposed, a motion to seal will likely be closely reviewed by the Court and may not be granted in full.
  • Parties may get a do-over given the potentially sensitive information at stake, even if it denies a motion to seal, the Court may do so without prejudice and give a party another opportunity.
  • Expect a thorough analysis as the Court may conduct a detailed review, potentially resulting in denial of motions, such as refusing to seal information that has been publicly disclosed.

For patent litigants who assume that an unopposed sealing motion will quietly keep business information out of public view, the District of New Jersey’s message is a cautionary one: the justification for sealing must be proven document by document and redaction by redaction.

A recent decision by U.S. Magistrate Judge J. Brendan Day shows that the Court is inclined to reject boilerplate and inadequately supported justifications for sealing and will unseal material that is already public.

In a detailed order handed down on June 12, 2026, the Court addressing five unopposed motions to seal filed by defendants Alkem Laboratories Ltd. and Zydus Pharmaceuticals (USA) Inc. / Zydus Lifesciences Limited in consolidated Hatch-Waxman patent litigation brought by Intra-Cellular Therapies, Inc.

The order provides a useful illustration of how courts in the District of New Jersey apply Local Civil Rule 5.3(c) and are likely to scrutinize what information parties seek to seal, even when unopposed, in view of the presumptive right of public access to judicial records and proceedings.

As we discussed in a prior alert, sealing motions arise frequently in the context of patent litigation, where sensitive business and technical information is routinely at issue, but are not pro forma motions; they require strict compliance with the DNJ’s local rules for success.

Common Law Right of Public Access

The Court set forth the well-established standard that the common law right of public access to judicial records can be overcome only upon a showing of "good cause," which requires a "particularized showing that disclosure will cause a clearly defined and serious injury to the party seeking closure."

This standard, as codified in Local Civil Rule 5.3(c)(3), requires the movant to address the nature of the materials, the legitimate private or public interest supporting the request, the clearly defined and serious injury that would result absent sealing, the unavailability of a less restrictive alternative, and any prior sealing orders. The Court then analyzed each of the five motions in turn.

Motion 1 - Information already in the public domain cannot be sealed.
The Court denied in part Alkem's motion to seal “all references to certain management changes within its business,” which Alkem contended at the time of the motion had not been made public. The Court, however, noted one management change had been disclosed through a publicly filed declaration by the individual in the case as well as the individual's public LinkedIn profile. The Court granted Alkem’s motion with respect to the other management changes that were the subject of the motion because they had not been publicly disclosed.

Motion 2 - Confidential ANDA product and business strategy information warrants sealing, but boilerplate explanations will be rejected.
The Court granted motions to seal exhibits containing details concerning Zydus’s ANDA product and business strategies, finding a legitimate privacy interest, competitive harm from disclosure, and that narrowly tailored redactions or full sealing were the least restrictive alternatives available. Zydus had sought to seal additional categories of information that the Court found did not warrant sealing. In particular, the Court found that “Zydus has, at least not yet,” met the standard to seal the (1) identity of a Rule 30(b)(6) representative; (2) Drug Master File, report numbers, and API batch numbers; and (3) passages purportedly relating to Zydus’s product or business. Notably, with respect to item 3, the Court indicated that “Zydus provided the exact same basis for sealing all of the information included in its motion, regardless of the actual nature of the information at issue.” The Court further cautioned that “boilerplate explanations” and “similar deficiencies in future motions to seal may result in summary denial.” Here, although the Court was unwilling to grant Zydus’s motion, it merely denied it without prejudice and permitted Zydus to file a renewed motion to seal with “specific and particularized justification” for sealing.

Motion 3 – Overbroad redactions will not be permitted.
For this motion, the Court granted Alkem’s motion to seal in their entirety certain exhibits and redact certain exhibits pertaining to a February 3 letter, finding they contained confidential and sensitive business information concerning development and formulation of Alkem’s ANDA product. The Court denied the motion as to the February 3 letter itself, finding the proposed redactions were overbroad and “generically summariz[ed] the discovery dispute” and noting Alkem did not seek to seal the “bulk of the Letter, which discusses the dispute in more specific terms.” Thus, the Court unsealed the February 3 letter in its entirety.

Motion 4 – Potential ANDA launch information may be sealed.
The Court permitted Zydus to seal “information regarding factors affecting the potential launch timeline of its product,” agreeing its disclosure “would cause significant competitive and/or financial harm.”

Motion 5 – Sealing entire exhibit may be appropriate where redactions are not viable.
The Court granted Zydus’s motion seeking to redact portions of documents, as well as seal entire exhibits, which contained information regarding Zydus’s ANDA product. Here, the Court noted that sealing Exhibits 2 and 3 in their entirety was permissible, where any less restrictive alternative, such as redactions, “would reveal sensitive information about Zydus’s ANDA product and business strategies.”

Takeaway

This Order serves as a reminder to litigants in the District of New Jersey that motions to seal must be carefully tailored, supported by particularized justifications, and limited to information that is genuinely confidential and competitively sensitive. Even where motions to seal are unopposed, the Court is likely to closely consider the information that is the subject of the sealing motion.


Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.