Key Points

• Visiting judge denied a request to move claim-narrowing deadlines earlier in a Hatch-Waxman ANDA case involving hundreds of asserted patent claims.
• Parties must now conduct expert discovery on all asserted claims before making final elections of asserted claims and prior art.

A visiting judge in the District of New Jersey has declined to accelerate claim-narrowing deadlines in a Hatch-Waxman dispute, leaving the parties to conduct expert discovery on all 534 asserted patent claims.

The ruling in Amneal Pharmaceuticals LLC et al. v. Sandoz Inc. offers an early signal about how visiting Judge Jennifer Choe-Groves of the U.S. Court of International Trade may adapt her District of Delaware-style case-management preferences to cases already in progress.

DNJ Local Patent Rules

Patent cases — especially those involving numerous patents and hundreds of asserted claims — can be prohibitively complex and expensive through discovery. Because trying hundreds of claims is generally impracticable, some courts have standard practices for narrowing asserted claims as cases progress.

The DNJ's Local Patent Rules do not provide for such narrowing, which is instead addressed on a case-by-case basis through case management.

However, as we discussed in a recent alert, a new set of procedures applies to cases assigned to visiting Judge Choe-Groves. As we noted, many of Judge Choe-Groves' order preferences appear closely modeled on the practices of Chief Judge Colm F. Connolly of the District of Delaware (where she has also sat by designation since 2023), including procedures for claim narrowing for Hatch-Waxman cases. A recent decision from Judge Choe-Groves reinforces these preferences, except as to the timing of proposed claim narrowing.

Limits on Asserted Claims and Prior Art References

In Hatch-Waxman cases, Judge Choe-Groves’ preferences indicate that unless otherwise agreed to by the parties, plaintiffs may initially assert no more than 10 claims of any one patent and no more than 32 claims in total. Defendants may initially identify no more than 12 prior art references for any one patent and no more than 30 prior art references in total. No later than 28 days after the Court issues a claim construction order, these limits narrow further: defendants must reduce to no more than six prior art references per patent and 20 total references. Then, no later than 14 days after defendant’s narrowing disclosure, plaintiffs must reduce to no more than five claims per patent and 16 total asserted claims.

By contrast, the DNJ Local Patent Rules do not impose any comparable numerical limits in ANDA cases.

Background to Dispute

Judge Choe-Groves was assigned to two parallel cases between the parties on April 20, 2026. The parties were directed to submit a joint proposed amended scheduling order. The parties were unable to agree on several issues, including the number of claims that would be permitted in the final election of asserted claims.

Amneal argued that because there were two “coordinated” actions, involving 8 and 15 patents, respectively, it should be permitted to assert 16 and 30 claims, respectively, in its final election of asserted claims in each matter, a reduction from its initial assertion of 534 claims across all patents. Sandoz, on the other hand, argued Amneal should be limited to no more than 16 claims total for the final election of asserted claims.

In accordance with Judge Choe-Groves’ Scheduling Order Template, the parties agreed that the final election of asserted prior art should occur no more than 28 days after the Court issues a claim construction order, followed by the final election of asserted claims no more than 14 days later. Amneal also pointed out that it did not object to additional limits to asserted prior art and claims after the close of all discovery.

On June 23, Judge Choe-Groves entered a scheduling order, requiring the final election of asserted prior art by January 26, 2027 and the final election of asserted claims on February 19, 2027, which adopted Amneal’s position of 46 claims total (16 from one action and 30 from the other).

Departing from the parties' joint request, the June 23 Scheduling Order provides that these reductions are to take place after service of all three rounds of expert reports, which will be completed with the service of reply reports on December 9, 2026. The June 23 Scheduling Order contains no indication of why the parties’ joint request regarding the timing of the final elections, which adopted Judge Choe-Groves’ preference from the Scheduling Order Template, was not adopted. It is worth noting that the new schedule was adopted in the middle of the case and that the Markman briefing timeline was fairly compressed with only two terms at issue.

Court Declines to Adjust Schedule

Sandoz wrote to the Court seeking modification of the schedule to comport with the parties’ jointly requested deadlines for final election of asserted prior art and final election of asserted claims, which were tied to the proposed August 12, 2026 Markman hearing date.

These reductions were thus likely to occur before service of opening expert reports (due October 9, 2026), depending on the issuance of the Court’s Markman decision.

Several days later, the Court issued its Scheduling Order, denying Sandoz’s request to modify the scheduling order. Thus, absent further modification to the schedule, the parties will proceed to conduct expert discovery on all 534 presently asserted claims.

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.

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