Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc.

This Hatch-Waxman litigation is a dispute between a brand-name pharmaceutical company and a generic drug manufacturer over a profitable immunosuppressant drug. The plaintiff, Veloxis Pharmaceuticals, Inc., is a specialty pharmaceutical company focused on the transplant market and is part of the Japanese Asahi Kasei group. The defendant, Glenmark Pharmaceuticals Inc., is the U.S. subsidiary of an India-based global pharmaceutical company that develops and markets a wide portfolio of generic and branded drugs. The case was triggered by Glenmark’s filing of an Abbreviated New Drug Application (ANDA) with the FDA (No. 217905) seeking approval to market a generic version of Veloxis's key product, ENVARSUS XR®. ENVARSUS XR® is an extended-release tablet formulation of the drug tacrolimus, which is widely used to prevent organ rejection in kidney transplant patients. Veloxis alleges that Glenmark's proposed generic product will infringe on its patent rights before they expire.

The primary patent identified in the case caption, U.S. Patent No. 9,549,918, is titled "Stabilized tacrolimus composition." It covers a stabilized, solid, sustained-release oral dosage form of tacrolimus that uses a stabilizing agent to prevent degradation of the active ingredient. While the '918 patent is central, court filings indicate that several other patents related to ENVARSUS XR® are also asserted in this litigation. The case is proceeding in the U.S. District Court for the District of Delaware and has been assigned to Judge Maryellen Noreika. This venue is highly significant; the District of Delaware is the leading jurisdiction for Hatch-Waxman patent cases, known for its experienced judiciary and well-developed case law in complex pharmaceutical disputes.

The case is notable as part of Veloxis's broader legal strategy to defend its ENVARSUS XR® franchise from multiple generic challengers. The drug represents a key asset for Veloxis, and the company has engaged in similar litigation against other generic manufacturers, including Sun Pharmaceutical Industries and Alkem Laboratories. A recent settlement with Sun Pharma blocked its generic competitor from the market until May 2028, highlighting the high stakes involved. This litigation against Glenmark is therefore a critical front in determining when a lower-cost generic alternative to this once-daily immunosuppressant will become available to transplant patients in the U.S. The outcome will have a direct impact on market competition and healthcare costs for this specific patient population.

Recent legal developments in Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc. have seen the case progress through initial pleadings and into discovery, alongside parallel challenges at the Patent Trial and Appeal Board (PTAB).

Key Legal Developments Chronologically

• Complaint Filed (2025-04-14): Veloxis Pharmaceuticals, Inc. initiated the lawsuit against Glenmark Pharmaceuticals Inc. following Glenmark's submission of Abbreviated New Drug Application (ANDA) No. 217905. The complaint alleged that Glenmark's proposed generic version of ENVARSUS XR® would infringe U.S. Patent No. 9,549,918. This action was filed under the Hatch-Waxman Act, triggering an automatic 30-month stay on the FDA's approval of Glenmark's ANDA. The case was assigned to Judge Maryellen Noreika in the District of Delaware.

• Answer and Counterclaims (2025-06-03): Glenmark filed its answer, denying infringement and asserting that the claims of the '918 patent are invalid. In its counterclaims, Glenmark sought a declaratory judgment of non-infringement and invalidity, arguing that the asserted patent claims are obvious in light of prior art and fail to meet other patentability requirements under 35 U.S.C. §§ 101, 102, 103, and/or 112.

• Scheduling Order Issued (2025-08-15): The court entered a scheduling order outlining the key deadlines for the case. Fact discovery was set to conclude by 2026-03-20, with expert discovery to follow. A claim construction (Markman) hearing was scheduled for mid-2026, and a 5-day bench trial was tentatively set for early 2027.

• Glenmark Files IPR Petitions (2025-10-22): In a significant strategic move, Glenmark Pharmaceuticals filed two petitions for inter partes review (IPR) with the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB). The petitions challenge the validity of numerous claims of the asserted U.S. Patent No. 9,549,918 on grounds of obviousness. The IPR case numbers are IPR2026-00112 and IPR2026-00113. Such proceedings often run in parallel with district court litigation and can significantly impact the case.

• Veloxis Files Preliminary Responses in IPRs (2026-01-28): Veloxis submitted its Patent Owner's Preliminary Responses to the PTAB for both of Glenmark's IPR petitions. In these filings, Veloxis argued that Glenmark had failed to establish a reasonable likelihood that it would prevail in invalidating the patent claims and urged the PTAB to deny institution of the reviews.

• Motion to Stay Litigation (2026-02-12): Citing its pending IPR petitions, Glenmark filed a motion to stay the district court litigation. Glenmark argued that a stay would conserve judicial and party resources, as a PTAB decision invalidating the patent claims would simplify or potentially moot the district court case. Glenmark pointed to the high institution rate for IPRs in the pharmaceutical sector as a factor weighing in favor of a stay.

• Veloxis Opposes Stay (2026-03-05): Veloxis filed its opposition to the motion to stay. The company contended that a stay would unduly prejudice it by delaying resolution of its infringement claims and disrupting the 30-month statutory window under the Hatch-Waxman Act. Veloxis argued that the case was not at an early stage, as significant discovery had already occurred, and that Glenmark's delay in filing the IPRs weighed against granting a stay.

• PTAB Institution Decision Pending (as of 2026-05-07): The PTAB is expected to issue its decisions on whether to institute Glenmark's IPR petitions in late April or early May 2026. The outcome of these decisions will be highly influential. If the PTAB institutes the reviews, it will significantly increase the likelihood that the district court will grant Glenmark's motion to stay the litigation pending the outcome of the IPRs.

• Current Posture (Ongoing): As of May 2026, the case remains active. The parties are awaiting Judge Noreika's ruling on the motion to stay, which is likely contingent on the imminent PTAB institution decisions. Fact discovery is nearing completion according to the current schedule, but the case's trajectory will be determined by the interplay between the district court and PTAB proceedings. No settlement has been reported.

Plaintiff's Counsel of Record

Veloxis Pharmaceuticals, Inc. has retained a combination of national lead counsel and Delaware-based local counsel, a common strategy in Hatch-Waxman litigation. The legal team is composed of attorneys from Patterson Belknap Webb & Tyler LLP and Morris, Nichols, Arsht & Tunnell LLP.

Based on a motion filed on August 21, 2025 (D.I. 24) and granted the following day (D.I. 26), the following attorneys have been admitted pro hac vice to represent the plaintiff.

Lead Counsel (Patterson Belknap Webb & Tyler LLP)

• Andrew M. Berdon (Partner, New York): As lead counsel, Berdon is an experienced trial lawyer focusing on patent and trade secret litigation, particularly for pharmaceutical and life sciences clients. He has a notable track record in Hatch-Waxman cases, having previously represented major pharmaceutical companies.
• James E. Baker (Counsel, New York): Baker's practice centers on intellectual property litigation with an emphasis on the pharmaceutical and biotechnology sectors.
• Laura Fairneny (Associate, New York): Fairneny focuses on patent litigation, including matters related to the Hatch-Waxman Act.
• Iyah Chen (Associate, New York): Chen is a patent litigator with experience in cases involving pharmaceuticals and medical devices.

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

• Jeremy A. Tigan (Partner, Wilmington, DE): Tigan serves as local counsel for Veloxis and is a seasoned Delaware litigator with extensive experience in the District of Delaware, which is a key venue for patent disputes. He is a partner in the firm's Intellectual Property Litigation group and has acted as lead or Delaware counsel in numerous patent infringement and trade secret cases.

An additional attorney, Brooke Kootman Dodson, was initially part of the legal team appearing pro hac vice but a notice was filed on October 9, 2025, requesting her removal as co-counsel as she was no longer with the firm.

Defendant's Counsel of Record

Based on a review of the court docket, Glenmark Pharmaceuticals Inc. is represented by a team of attorneys from three law firms: Heyman Enerio Gattuso & Hirzel LLP as Delaware local counsel, and Winston & Strawn LLP and Saul Ewing LLP as lead and supporting counsel.

Heyman Enerio Gattuso & Hirzel LLP (Local Counsel)

• Name: Dominick T. Gattuso
  • Role: Local Counsel
  • Firm: Heyman Enerio Gattuso & Hirzel LLP, Wilmington, DE
  • Note: Gattuso is a partner at his firm and frequently serves as Delaware counsel in complex intellectual property and corporate litigation in the District of Delaware.

Winston & Strawn LLP (Lead Counsel)

The docket shows a motion for pro hac vice admission for a group of attorneys from Winston & Strawn, a firm known for its patent litigation practice.

• Name: Maureen L. Rurka

  • Role: Lead Counsel (presumed)
  • Firm: Winston & Strawn LLP, Chicago, IL
  • Note: Rurka is a litigation partner who focuses her practice on patent infringement, particularly in pharmaceutical and Hatch-Waxman litigation.

• Name: Samantha Lerner

  • Role: Of Counsel / Supporting Counsel
  • Firm: Winston & Strawn LLP, Chicago, IL
  • Note: Lerner is a trial lawyer and co-chair of the firm's Complex Commercial Litigation Practice with experience in patent cases for pharmaceutical and medical device companies.

• Name: Sharon Lin McIntosh

  • Role: Of Counsel / Supporting Counsel
  • Firm: Winston & Strawn LLP, Washington, D.C.
  • Note: McIntosh is an of counsel attorney with a background in biochemistry who has significant experience in all phases of patent and PTAB litigation, including for generic pharmaceutical products.

• Name: Anna Sonju

  • Role: Associate
  • Firm: Winston & Strawn LLP, Chicago, IL (presumed based on co-filing)
  • Note: Publicly available information on this attorney's specific patent litigation experience is limited.

Saul Ewing LLP (Supporting Counsel)

A separate pro hac vice motion was filed for a group of attorneys from Saul Ewing (formerly Saul Ewing Arnstein & Lehr), another firm with a substantial Hatch-Waxman litigation practice.

• Name: Neal Seth

  • Role: Supporting Counsel
  • Firm: Saul Ewing LLP, Boston, MA
  • Note: Seth has experience in patent litigation, although specific high-profile case involvement is not detailed in readily available sources.

• Name: Wesley E. Weeks

  • Role: Supporting Counsel
  • Firm: Saul Ewing LLP, Washington, D.C.
  • Note: Weeks is a trial and appellate lawyer who frequently represents pharmaceutical companies in Hatch-Waxman patent litigation and IPR proceedings. His biography notes extensive experience representing ANDA filers.

• Name: Corey Weinstein

  • Role: Supporting Counsel
  • Firm: Saul Ewing LLP, Washington, D.C.
  • Note: Weinstein's practice focuses on IP and commercial litigation, including patents, and he has been involved in winning a high-profile drug patent case for a generic manufacturer.