Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al.

This patent infringement litigation, Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al., case number 1:22-cv-00909, was filed on July 7, 2022, in the Delaware District Court and terminated on January 24, 2024.

The plaintiff, Veloxis Pharmaceuticals AS, is a commercial-stage specialty pharmaceutical company based in Denmark, with a U.S. subsidiary, Veloxis Pharmaceuticals, Inc., headquartered in Cary, North Carolina. Veloxis focuses on developing improved versions of difficult-to-formulate drugs, particularly for transplant patients, utilizing its proprietary MeltDose® technology. Its lead product is ENVARSUS XR® (tacrolimus extended-release tablets), an immunosuppressant used to prevent organ rejection in kidney transplant patients. The defendants are Intas Pharmaceuticals Ltd., an Indian multinational pharmaceutical company that produces generic therapeutic drugs, and its wholly-owned subsidiary, Accord Healthcare Inc., a large-scale provider of generic pharmaceuticals in the United States.

The dispute centered on Accord Healthcare's Abbreviated New Drug Application (ANDA) No. 217255, which sought FDA approval to market generic 0.75 mg, 1 mg, and 4 mg extended-release tacrolimus tablets, directly competing with Veloxis's ENVARSUS XR®. Veloxis asserted seven U.S. patents covering the formulation and clinical use of its extended-release tacrolimus product. While the initial metadata listed only Patent No. 11,110,081, court documents indicate that Veloxis asserted U.S. Patent Nos. 8,685,998; 9,549,918; 10,166,190; 10,864,199; 11,110,081; 11,123,331; and 11,419,823. Patent No. 11,110,081, titled "Tacrolimus for improved treatment of transplant patients," generally describes an extended-release oral dosage form of tacrolimus for once-daily immunosuppressive treatment of transplant patients. Patent No. 10,166,190 describes a stable pharmaceutical composition comprising a solid dispersion of tacrolimus in a vehicle with a stabilizing agent, preventing degradation. Patent No. 10,864,199, also titled "Tacrolimus for improved treatment of transplant patients," covers an extended-release oral dosage form of tacrolimus for once-daily immunosuppressive treatment. The case, a Hatch-Waxman (ANDA) patent infringement action, was heard in the District of Delaware, a popular venue for such disputes, particularly because many pharmaceutical companies are incorporated there and the court has an experienced patent bench. The case concluded with a stipulated consent judgment, resulting in a permanent injunction against Accord and Intas from commercializing their ANDA product until the expiration of all seven patents-in-suit. This outcome is notable as it successfully blocked the generic entry for Veloxis's branded drug.

Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al.: Key Legal Developments and Outcome

The patent infringement litigation, Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al., Case No. 1:22-cv-00909, filed in the District Court of Delaware, concluded with a consent judgment and permanent injunction in favor of Veloxis. The case, initiated on July 7, 2022, was terminated on January 24, 2024, after a duration of 566 days.

Filing & Initial Pleadings

Veloxis Pharmaceuticals, Inc. (the plaintiff, referred to as Veloxis Pharmaceuticals AS in the caption) filed a Hatch-Waxman patent infringement action on July 7, 2022, against Accord Healthcare, Inc. and its parent company, Intas Pharmaceuticals, Ltd. (the defendants). The dispute centered on Accord's Abbreviated New Drug Application (ANDA) No. 217255, which sought FDA approval to market generic 0.75 mg, 1 mg, and 4 mg extended-release tacrolimus tablets, a generic version of Veloxis’s branded immunosuppressant, ENVARSUS XR®.

Veloxis asserted seven U.S. patents covering the formulation and clinical use of ENVARSUS XR®. These patents included U.S. Patent Nos. 8,685,998; 9,549,918; 10,166,190; 10,864,199; 11,110,081; 11,123,331; and 11,419,823. All patents-in-suit are listed in the FDA's Orange Book. The defendants provided Veloxis with a Paragraph IV notice letter on May 23, 2022, asserting non-infringement and/or invalidity of the asserted patents. Defendants subsequently raised invalidity and non-infringement counterclaims, which were later dismissed with prejudice as part of the consent judgment.

Pre-trial Motions, Claim Construction, and Discovery

The available records do not detail any significant, fully litigated pre-trial motions such as motions to dismiss, transfer, stay pending IPR, or summary judgment. Similarly, there is no public record indicating that the case reached a formal claim construction (Markman) hearing or order, or any strategically significant discovery milestones. The relatively quick resolution via a stipulated consent judgment suggests that extensive pre-trial litigation, including these specific stages, may not have been fully pursued.

Trial Events and Post-Trial Motions

The case did not proceed to trial. Instead, it was resolved through a stipulated consent judgment. Therefore, no verdict or post-trial motions occurred.

Settlement, Dismissal, Judgment, and Appeal

The case concluded on January 24, 2024, when the parties entered a stipulated consent judgment. Under the terms of the consent judgment, Accord and Intas were permanently enjoined from making, using, selling, offering to sell, importing, or distributing their ANDA product (No. 217255) until the expiry of all seven patents-in-suit. All claims and counterclaims in the action were dismissed with prejudice, with each party agreeing to bear its own costs, disbursements, and attorneys' fees. The consent judgment specifically preserved Accord's Paragraph IV certification, meaning that while FDA approval for the ANDA product may proceed, its commercialization remains blocked until patent expiry. There was no appeal of this consent judgment.

Parallel PTAB IPR/PGR Proceedings

As of the latest available information, there is no indication of any inter partes review (IPR) or post-grant review (PGR) proceedings before the Patent Trial and Appeal Board (PTAB) that directly impacted the outcome of this specific district court litigation (1:22-cv-00909) by invalidating any of the seven asserted patents. While Accord Healthcare and Intas Pharmaceuticals have been petitioners in other IPR proceedings, such as IPR2026-00256 against U.S. Patent No. 11,014,982 (filed March 20, 2026), this patent was not among the seven asserted in the Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al. case. The resolution of this district court case via a consent judgment and permanent injunction occurred prior to any publicly confirmed IPR challenges on the specific patents-in-suit.

In the patent infringement case Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al., case number 1:22-cv-00909, the plaintiff, Veloxis Pharmaceuticals, Inc., was represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP.

The following counsel of record represented Veloxis Pharmaceuticals, Inc.:

• Jack B. Blumenfeld

  • Role: Lead Counsel
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware.
  • Experience Note: Jack Blumenfeld is a highly experienced patent litigator, frequently appearing in the District of Delaware. He is known for handling complex intellectual property disputes, particularly in the pharmaceutical and biotechnology sectors.

• Jeremy A. Tigan

  • Role: Lead Counsel
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware.
  • Experience Note: Jeremy Tigan is a partner at Morris Nichols, focusing on intellectual property litigation. He regularly represents clients in Hatch-Waxman patent infringement actions and other complex technology disputes in the District of Delaware. He signed the Consent Judgment in this case.

Here is the counsel of record representing the defendants, Intas Pharmaceuticals Ltd. and Accord Healthcare Inc., in Veloxis Pharmaceuticals AS v. Intas Pharmaceuticals Ltd. et al. (1:22-cv-00909 D. Del.):

Counsel for Defendants Intas Pharmaceuticals Ltd. and Accord Healthcare Inc.

• Name: Kelly E. Farnan

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A.
  • Office Location: Wilmington, DE
  • Notable Experience: Kelly E. Farnan is a director at Richards, Layton & Finger, focusing her practice on intellectual property litigation, particularly in the U.S. District Court for the District of Delaware. Her experience includes Hatch-Waxman patent litigation, as well as other complex commercial and intellectual property disputes.

• Name: Sara M. Metzler

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A.
  • Office Location: Wilmington, DE
  • Notable Experience: Sara M. Metzler is an associate at Richards, Layton & Finger, concentrating her practice on intellectual property litigation in the Delaware federal and state courts. She has experience representing clients in patent disputes, including those arising under the Hatch-Waxman Act.