Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd.

This patent infringement litigation, Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd., centers on a generic challenge to Veloxis's extended-release tacrolimus formulation. Veloxis Pharmaceuticals AS, a commercial-stage specialty pharmaceutical company headquartered in Denmark and operating as a subsidiary of Asahi Kasei, develops and commercializes medications for transplant patients, with its flagship product being Envarsus XR (tacrolimus extended-release tablets) used to prevent organ rejection. The defendant, Alkem Laboratories Ltd., is an Indian multinational pharmaceutical company specializing in generic and specialty pharmaceuticals, which sought to market its own generic version of tacrolimus extended-release tablets. The accused product is Alkem's tacrolimus drug product, as described in its Abbreviated New Drug Application (ANDA No. 219575).

The patents asserted by Veloxis in this case include U.S. Patent Nos. 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. These patents generally relate to solid dispersions of tacrolimus, pharmaceutical compositions comprising tacrolimus, and methods of using tacrolimus formulations for treating organ rejection, all pertinent to extended-release tacrolimus products. The case was filed in the District of Delaware, case number 1:24-cv-00784, and was assigned to Judge Maryellen Noreika. The District of Delaware is a particularly significant venue for Hatch-Waxman (ANDA) patent cases, consistently handling a large proportion of such disputes due to its experienced judiciary and the fact that many pharmaceutical companies are incorporated in Delaware.

This litigation is notable as it represents a typical Hatch-Waxman generic challenge in the substantial global market for tacrolimus, an immunosuppressant crucial for organ transplant recipients. Veloxis's Envarsus XR holds a premium position in this market, which is valued in the billions, with extended-release formulations like theirs comprising a significant share. The case concluded relatively quickly, with a Consent Judgment signed by Judge Noreika on January 13, 2026, indicating a settlement between the parties rather than proceeding to a full trial. The terms of the consent judgment included an injunction preventing Alkem from infringing the patents-in-suit by making, selling, or importing its ANDA product until patent expiration, unless otherwise authorized by Veloxis, while still allowing Alkem to maintain its Paragraph IV certification. No information regarding related IPRs for these specific patents in relation to this case was readily available through public search.

Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd.: Key Legal Developments and Outcome

The patent infringement litigation Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd., filed in the District of Delaware under case number 1:24-cv-00784, has concluded with a consent judgment. The case, initiated on July 3, 2024, centered on U.S. Patent 11,110,081, following Alkem Laboratories Ltd.'s Notice of Paragraph IV Certification regarding its ANDA for tacrolimus extended-release tablets.

Here's a chronological breakdown of the key legal developments:

• Filing & Initial Pleadings:

  • 2024-07-03: Veloxis Pharmaceuticals AS filed the patent infringement complaint against Alkem Laboratories Ltd.
  • (Details regarding the specific dates for Alkem's answer and any counterclaims were not immediately available in the search results but would have occurred in the months following the complaint filing).

• Pre-Trial Motions of Substance:

  • The provided search results do not explicitly detail any motions to dismiss, transfer, or stay pending IPR. However, extensions of time for scheduling order deadlines were granted. On October 28, 2025, an order reset deadlines for opening, rebuttal, and reply expert reports, and expert discovery. Another stipulation and order for extension of time, signed by Judge Maryellen Noreika on January 13, 2026, further adjusted these deadlines, with rebuttal expert reports due by January 20, 2026, reply expert reports by February 5, 2026, and expert discovery by February 27, 2026.

• Claim Construction (Markman) Outcomes:

  • 2025-10-20: A Markman Hearing was held before Judge Maryellen Noreika.
  • While the hearing date is confirmed, the specific outcome or opinion of the claim construction ruling was not provided in the search results. The official transcript of the hearing was set for release on January 22, 2026.

• Discovery Milestones:

  • 2025-12-05: Opening Expert Reports were due by this date.
  • 2026-01-20: Rebuttal Expert Reports were due by this date.
  • 2026-02-05: Reply Expert Reports were due by this date.
  • 2026-02-27: Expert Discovery was due by this date.
  • Notice of service for Defendants' Opening Expert Reports, including supporting appendices and exhibits, from Jason T. McConville, Ph.D., and Minnie Sarwal, M.D., Ph.D., was filed by Sun Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries, Inc., which appears to be a related party or another defendant in a consolidated case (1:24-cv-00726-MN) with shared deadlines.

• Trial Events, Verdict, and Post-Trial Motions:

  • The case did not proceed to trial.

• Final Disposition:

  • 2026-01-13: A Consent Judgment was signed by Judge Maryellen Noreika, terminating the civil case.

• Parallel PTAB IPR/PGR Proceedings:

  • A search for IPR or PGR proceedings related to U.S. Patent 11,110,0081 did not yield any directly relevant results indicating such proceedings were filed for this specific patent in relation to this case.The provided information indicates that the case Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd., 1:24-cv-00784, was filed on July 3, 2024, and concluded with a Consent Judgment on January 13, 2026. A Markman Hearing was held on October 20, 2025. While expert report deadlines were set and adjusted, no specific details about the initial pleadings (other than the complaint filing), substantive pre-trial motions to dismiss/transfer/stay, the outcome of the Markman hearing, specific discovery milestones beyond expert report deadlines, trial events, verdict, or post-trial motions were found. No parallel PTAB IPR/PGR proceedings related to U.S. Patent 11,110,081 were identified in the initial search.

To fully address the request, I need to:

1. Search for details on the filing of the answer and any counterclaims.
2. Search for any substantive pre-trial motions (e.g., motions to dismiss, transfer, or stay pending IPR) and their outcomes.
3. Attempt to find the outcome of the Markman hearing, if publicly available.
4. Confirm if there were any significant discovery disputes or rulings beyond the expert report deadlines.
5. Perform a more targeted search for PTAB IPR/PGR proceedings specifically for U.S. Patent 11,110,081, to confirm their absence or identify any if they exist.

Since the case terminated via a Consent Judgment, it is unlikely there were trial events, verdicts, or post-trial motions. The focus will be on the pre-judgment phase.

Updated plan:
Search for docket entries regarding:

1. Alkem Laboratories Ltd.'s answer and any counterclaims in 1:24-cv-00784.
2. Any motions to dismiss, transfer, or stay in 1:24-cv-00784.
3. The Markman Order or opinion in 1:24-cv-00784.
4. Significant discovery disputes or rulings in 1:24-cv-00784 beyond expert deadlines.
5. IPR/PGR proceedings for U.S. Patent 11,110,081 at the USPTO PTAB.## Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd.: Key Legal Developments and Outcome

The patent infringement litigation Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd., filed in the District of Delaware under case number 1:24-cv-00784, has concluded with a consent judgment. The case, initiated on July 3, 2024, centered on U.S. Patent 11,110,081, following Alkem Laboratories Ltd.'s Notice of Paragraph IV Certification regarding its ANDA for tacrolimus extended-release tablets.

Here's a chronological breakdown of the key legal developments:

• Filing & Initial Pleadings:

  • 2024-07-03: Veloxis Pharmaceuticals AS filed the patent infringement complaint against Alkem Laboratories Ltd.
  • Further details regarding the specific filing dates for Alkem's answer and any potential counterclaims are not readily available in the provided search results.

• Pre-Trial Motions of Substance:

  • The provided search results do not explicitly detail any substantive motions to dismiss, transfer, or stay pending IPR.
  • 2025-10-28: An order was issued setting or resetting scheduling order deadlines, including Opening Expert Reports due by December 5, 2025, Rebuttal Expert Reports due by January 14, 2026, Reply Expert Reports due by January 30, 2026, and Expert Discovery due by February 24, 2026.
  • 2026-01-13: A stipulation and order for an extension of time further adjusted expert report deadlines, with Rebuttal Expert Reports due by January 20, 2026, Reply Expert Reports due by February 5, 2026, and Expert Discovery due by February 27, 2026. This order also noted the service of Defendants' Opening Expert Reports by Sun Pharmaceutical Industries Ltd., which was likely a co-defendant in a related, consolidated action (1:24-cv-00726-MN) sharing discovery deadlines.

• Claim Construction (Markman) Outcomes:

  • 2025-10-20: A Markman Hearing was held before Judge Maryellen Noreika.
  • The specific outcome or a separate opinion detailing the claim construction ruling was not found in the provided search results. The official transcript of the Markman Hearing was scheduled for release on January 22, 2026.

• Discovery Milestones:

  • 2025-12-05: Deadline for Opening Expert Reports.
  • 2026-01-20: Deadline for Rebuttal Expert Reports.
  • 2026-02-05: Deadline for Reply Expert Reports.
  • 2026-02-27: Deadline for Expert Discovery.

• Trial Events, Verdict, and Post-Trial Motions:

  • The case was terminated by a consent judgment before reaching trial.

• Settlement, Dismissal, Judgment, or Appeal:

  • 2026-01-13: The case was terminated by a Consent Judgment signed by Judge Maryellen Noreika.

• Parallel PTAB IPR/PGR Proceedings on the Asserted Patents:

  • A search of the USPTO PTAB records for U.S. Patent 11,110,081 did not reveal any parallel Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings directly associated with this patent that would have affected this litigation.

Based on publicly available information, the counsel of record representing Veloxis Pharmaceuticals AS in Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd. (1:24-cv-00784) are likely attorneys from McAndrews, Held & Malloy, Ltd., who appear to have served as "Of Counsel" for Veloxis. It is also a requirement in the District of Delaware for out-of-state attorneys to associate with local Delaware counsel, who are typically responsible for filing all papers with the court.

While specific lead counsel and local Delaware counsel were not explicitly identified on the plaintiff's initial complaint or a formal notice of appearance through public web searches, the following attorneys from McAndrews, Held & Malloy, Ltd. were listed as "Of Counsel" for Veloxis Pharmaceuticals, Inc. in a document filed by the defendant (Alkem's Answer and Counterclaims, Document 12) on October 17, 2024:

• Bradley P. Loren (Role: Of Counsel, potentially lead patent litigation counsel)

  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, Illinois office).
  • Experience Note: Dr. Loren's practice focuses on chemistry, pharmaceuticals, and biotechnology, with experience in patent preparation, prosecution, due diligence, and litigation across all phases, including pre-suit analysis, discovery, and trial. He was previously an Associate at McAndrews, Held & Malloy, Ltd. from 2021-2025 and joined Casimir Jones, S.C. in 2025. He also explores patenting diagnostic inventions.

• Alejandro Menchaca (Role: Of Counsel, potentially lead patent litigation counsel)

  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, Illinois office).
  • Experience Note: Mr. Menchaca is a Shareholder at McAndrews with extensive experience in patent, trademark, and related law, focusing on litigation and prosecution. He specializes in ANDA litigation and counseling, as well as joint development disputes and trademark proceedings. He is recognized for his work in Litigation - Intellectual Property, Litigation - Patent, and Patent Law.

• Ben J. Mahon (Role: Of Counsel, potentially lead patent litigation counsel)

  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, Illinois office).
  • Experience Note: Mr. Mahon is a Partner at McAndrews specializing in patent litigation within the biological, chemical, and pharmaceutical arts. He has extensive experience in district court litigation, inter partes review (IPR) proceedings, and appeals before the Federal Circuit, including first-chair trial experience. He has secured favorable judgments, including invalidating patent claims in abuse-proof formulations cases.

• Rajendra A. Chiplunkar (Role: Of Counsel)

  • Firm: McAndrews, Held & Malloy, Ltd. (Chicago, Illinois office).
  • Experience Note: Mr. Chiplunkar is a Shareholder at McAndrews with a focus on patent litigation and post-grant proceedings. His experience spans various technologies including memory systems, wireless systems, computer hardware and software, and medical devices. Before joining the firm, he worked as an engineer at Motorola.

Local Counsel in Delaware:
The District of Delaware requires attorneys not admitted to practice by the Supreme Court of Delaware to associate with a local Delaware counsel who maintains an office in the district and is typically responsible for filing all papers. Although the specific local counsel for Veloxis Pharmaceuticals AS in this case could not be definitively identified from the available public search results, it is a mandatory requirement for litigation in this court.

Case Status Update: The case Veloxis Pharmaceuticals AS v. Alkem Laboratories Ltd., 1:24-cv-00784, originally filed on July 3, 2024, in the Delaware District Court, is now Closed. A Consent Judgment was signed by Judge Maryellen Noreika on January 13, 2026, terminating the civil case.

Counsel for Defendant Alkem Laboratories Ltd.:

Alkem Laboratories Ltd. was represented by attorneys from Richards, Layton & Finger, P.A. in Wilmington, Delaware.

• Kelly E. Farnan

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A., One Rodney Square, 920 North King Street, Wilmington, Delaware 19801
  • Experience Note: Kelly E. Farnan is an experienced litigator in intellectual property cases, frequently serving as Delaware counsel in patent infringement actions.

• Sara M. Metzler

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A., One Rodney Square, 920 North King Street, Wilmington, Delaware 19801
  • Experience Note: Sara M. Metzler is an attorney focusing on intellectual property litigation.