Untitled case

This patent infringement litigation, case number 1:25-cv-00458, is currently pending in the Delaware District Court before Judge Maryellen Noreika. The plaintiff is Veloxis Pharmaceuticals, Inc., a Delaware corporation and the holder of NDA No. 206406 for ENVARSUS XR®, which are tacrolimus extended-release tablets. Veloxis is an operating company in the pharmaceutical industry, focusing on organ transplant therapies. The defendant is Glenmark Pharmaceuticals Inc., USA, also a Delaware corporation, which filed ANDA No. 217905 seeking approval from the FDA to market and sell generic 0.75 mg, 1 mg, and 4 mg extended-release tablets of tacrolimus. This constitutes the accused product in this Hatch-Waxman litigation.

The core dispute revolves around Glenmark's Paragraph IV Certification that its ANDA products do not infringe, or that the asserted patents are invalid or unenforceable. The patents-in-suit include U.S. Patent No. 10,166,190 (the '190 patent), among others. The '190 patent is directed to stabilized pharmaceutical compositions comprising tacrolimus, or an analogue, dissolved or dispersed in a vehicle and a stabilizing agent. Specifically, it aims to prevent or reduce the formation of degradation products of tacrolimus, particularly 8-epitacrolimus, by maintaining a pH below 7 in the composition, often through the use of an organic acid like tartaric acid. The choice of the District of Delaware is common for ANDA cases due to its established patent law expertise and the fact that both parties are Delaware corporations.

This case is part of broader ANDA litigation initiated by Veloxis Pharmaceuticals to protect its tacrolimus extended-release product, ENVARSUS XR®. Veloxis has been involved in similar litigation against other generic manufacturers, such as Sun Pharmaceutical Industries Ltd. and Alkem Laboratories Ltd., also in the District of Delaware. A Markman hearing in this case with Glenmark was held on October 20, 2025, before Judge Noreika, indicating the case is progressing through the claim construction phase. A stay was previously in effect, and the parties provided a status update regarding the litigation in May 2026. The prevalence of such ANDA suits highlights the significant market value of tacrolimus extended-release formulations and the ongoing efforts by brand-name pharmaceutical companies to defend their intellectual property against generic competition. No direct linkage to PTAB IPRs specifically for the '190 patent in this case was readily found in the search results.

This summary details the key legal developments and current posture of the patent infringement litigation Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc., USA, Case No. 1:25-cv-00458-MN, in the District of Delaware.

Key Legal Developments and Outcome:

1. Filing & Initial Pleadings:

• Complaint: Veloxis Pharmaceuticals, Inc. filed the complaint on April 14, 2025. The complaint alleges infringement of U.S. Patent Nos. 8,664,239, 8,685,998, 9,549,918, 10,166,190, 10,864,199, 11,110,081, 11,123,331, 11,419,823, and 12,083,103, relating to Glenmark's ANDA No. 217905 for extended-release tacrolimus tablets.
• Answer & Counterclaims: Glenmark Pharmaceuticals Inc., USA filed its answer, affirmative defenses, and counterclaims on June 5, 2025. Glenmark denied the allegations of infringement and challenged the validity of Veloxis's patents.

2. Pre-trial Motions of Substance:

• Motion to Stay: The case was stayed. On February 2, 2026, Veloxis and Glenmark filed a stipulation and order regarding a stay of the litigation. This stay was in effect as of May 2026, with the parties having agreed to an extension. The stipulation allows either party to request that the court lift the stay at any time.

3. Claim Construction (Markman) Outcomes:

• A Claim Construction Hearing is scheduled for July 1, 2026.

4. Discovery Milestones with Strategic Significance:

• No specific strategically significant discovery milestones were identified in the available information beyond the general progression of a Hatch-Waxman case that includes the filing of initial disclosures and responses to interrogatories and requests for production by Glenmark's counsel.

5. Trial Events, Verdict, and Post-trial Motions:

• A bench trial is currently scheduled for February 8, 2027.

6. Settlement, Dismissal, Judgment, or Appeal:

• The case is currently in a stayed status. No settlement, dismissal, or judgment has been reached.

7. Parallel PTAB IPR/PGR Proceedings:

• No parallel PTAB IPR/PGR proceedings on the asserted patents for this specific case (1:25-cv-00458-MN) were found in the available information. However, Veloxis Pharmaceuticals Inc. has been involved in other patent litigation cases, including some that have settled.

In Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc., USA, Case No. 1:25-cv-00458 in the District of Delaware, the plaintiff, Veloxis Pharmaceuticals, Inc., is represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Here's a breakdown of the identified counsel:

Morris, Nichols, Arsht & Tunnell LLP (Delaware Local Counsel)

• Jeremy A. Tigan
  • Role: Likely local counsel and a key member of the litigation team. He has filed several documents on behalf of Veloxis, including proposed orders, answers to counterclaims, and status reports.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Morris Nichols is a prominent Delaware law firm known for its intellectual property litigation, particularly in the pharmaceutical and biotechnology sectors. Mr. Tigan is an associate with the Intellectual Property Litigation group and focuses on patent litigation in pharmaceuticals, biotechnology, and medical devices. He has represented Veloxis in other related cases.
• Jack B. Blumenfeld
  • Role: Likely local counsel. He has signed court documents on behalf of Veloxis in related cases.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Mr. Blumenfeld is a well-known attorney at Morris Nichols, a firm recognized for handling high-stakes, complex matters in intellectual property litigation.
• Travis J. Murray
  • Role: Associate with the Intellectual Property Litigation group.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Mr. Murray's practice focuses on patent litigation encompassing pharmaceuticals, biotechnology, and medical devices. He is also a registered pharmacist.

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Lead Counsel)

• Andrew M. Berdon
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (office location not specified in direct search results for this case, but Finnegan has multiple offices, including Washington, D.C., and New York).
  • Note: Finnegan is a leading full-service intellectual property firm with extensive experience in pharmaceutical patent litigation, including Hatch-Waxman cases.
• James E. Baker
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan attorneys are known for their expertise in managing patent portfolios and handling complex patent infringement and Hatch-Waxman litigation in the life sciences sector.
• Laura Fairneny
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan frequently represents pharmaceutical clients in all aspects of patent law.
• Iyah Chen
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan has a team of IP specialists regularly engaged in patent portfolio management and litigation for pharmaceutical and biotechnology companies.

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thought
The user is asking to identify the counsel of record for the defendant, Glenmark Pharmaceuticals Inc., USA, in case 1:25-cv-00458. I need to find their names, roles, firms, office locations, and relevant experience. I will use web search with various keywords related to the case number, defendant name, and types of litigation (Hatch-Waxman, ANDA, patent infringement) to find docket entries, firm announcements, or legal news that list the attorneys. I will specifically look for mentions of "counsel for Glenmark" or attorney appearances.Here is the identified counsel of record representing Glenmark Pharmaceuticals Inc., USA in Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc., USA, Case No. 1:25-cv-00458:

Current Counsel of Record for Glenmark Pharmaceuticals Inc., USA:

• Dominick T. Gattuso
  • Role: Lead Counsel (indicated by filing various notices and substantive responses on behalf of Glenmark).
  • Firm: Saul Ewing LLP
  • Office Location: Wilmington, Delaware.
  • Note on Experience: Dominick Gattuso is a Partner at Saul Ewing LLP and is known for his experience in intellectual property litigation, particularly in the pharmaceutical and Hatch-Waxman areas, often serving as lead counsel or Delaware counsel in the District of Delaware. He frequently represents generic pharmaceutical companies in ANDA litigation.

Previously Listed Co-Counsel (Removed):

• Wesley E. Weeks
  • Role: Former Co-Counsel. He was removed as co-counsel via a notice filed on May 11, 2026.
  • Firm: Not specified in the removal notice, but likely affiliated with previous representation before the change of firm affiliation by Glenmark.
  • Note on Experience: Information on specific patent litigation experience for Wesley E. Weeks in relation to Glenmark in publicly available search results is not readily found.
• Corey Weinstein
  • Role: Former Co-Counsel. He was removed as co-counsel via a notice filed on May 11, 2026.
  • Firm: Not specified in the removal notice, but likely affiliated with previous representation before the change of firm affiliation by Glenmark.
  • Note on Experience: Information on specific patent litigation experience for Corey Weinstein in relation to Glenmark in publicly available search results is not readily found.

It is noted that a "NOTICE of Change of Firm Affiliation by Glenmark Pharmaceuticals Inc., USA" was filed by Dominick Gattuso on May 11, 2026, the same day the notice to remove Wesley E. Weeks and Corey Weinstein was filed. This suggests a change in the primary legal team representing Glenmark, with Dominick Gattuso continuing to represent them under his current firm.

While a "Lead Counsel" role is indicated for Dominick Gattuso based on the filings, in District of Delaware patent cases, out-of-state firms often partner with local Delaware counsel. Firms like Morris, Nichols, Arsht & Tunnell LLP and Bayard, P.A. are frequently engaged as Delaware counsel in complex intellectual property and Hatch-Waxman litigation. However, the search results for this specific case directly list Dominick Gattuso and his current affiliation with Saul Ewing, indicating he may be serving in a lead capacity with his firm also having a Delaware office. No other specific Delaware local counsel has been explicitly identified in the provided docket snippets for Glenmark at this time.