Litigation
Untitled case
active1:24-cv-00726
Patents at issue (1)
Summary
This is an active litigation case in the Delaware District Court involving US Patent 11,123,331.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
This active patent infringement litigation, case number 1:24-cv-00726, is unfolding in the Delaware District Court before Judge Maryellen Noreika. The plaintiff is Veloxis Pharmaceuticals, Inc., an operating pharmaceutical company specializing in treatments for transplant patients. The defendants are Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc., also operating pharmaceutical companies, which are alleged to be infringing. This is an Abbreviated New Drug Application (ANDA) case, meaning Veloxis Pharmaceuticals is asserting its patent rights against the defendants' efforts to market a generic version of one of its drugs. The accused product is a generic extended-release oral dosage form of tacrolimus, a drug used for immunosuppressive treatment, which is associated with Veloxis's ENVARSUS XR product.
The sole patent at issue is US Patent 11,123,331, titled "Tacrolimus for improved treatment of transplant patients." This patent describes an extended-release oral dosage form containing tacrolimus or a similar active substance, designed for once-daily immunosuppressive treatment of patients, particularly those undergoing kidney or liver transplants. The invention aims to provide a high bioavailability and an improved pharmacokinetic profile compared to existing dosage forms. The District of Delaware is a prominent venue for patent litigation, especially in the pharmaceutical sector, due to the high number of pharmaceutical companies incorporated there, its experienced judiciary, and a well-established body of patent-specific precedent.
The case, filed on June 19, 2024, is active, though PacerMonitor indicates a "terminated" date of April 6, 2026, which likely refers to a previous stage or a related aspect of the case, as docket entries from late March 2026 show ongoing activity, including a pretrial conference and stipulations. This litigation is notable as it is part of the ongoing landscape of ANDA cases in the pharmaceutical industry, where innovator companies like Veloxis Pharmaceuticals seek to protect their intellectual property against generic manufacturers. While the specific impact on the market for tacrolimus extended-release drugs remains to be seen, these cases are crucial for both innovator and generic companies in terms of market exclusivity and drug pricing. The case shares some procedural aspects, including shared stipulation orders, with a related case, Veloxis Pharma Inc v. Alkem Laboratories Ltd (1:24-cv-00784), also before Judge Noreika, further highlighting the ongoing efforts by Veloxis to enforce its patent portfolio.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
Key Legal Developments and Outcome in Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al. (1:24-cv-00726)
This patent infringement case, filed in the District of Delaware, concluded with a consent judgment on January 13, 2026, prior to its scheduled bench trial. The litigation involved Veloxis Pharmaceuticals, Inc. (Plaintiff) asserting US Patent 11,123,331 against generic drug manufacturers Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. (Defendants).
Below is a chronological overview of the key legal developments:
Filing & Initial Pleadings
- Complaint Filed: Veloxis Pharmaceuticals, Inc. initiated the lawsuit by filing its complaint on June 19, 2024.
- Amended Complaint Filed: An amended complaint was filed on May 16, 2025.
- Defendants' Notice Letter: The defendants issued a notice letter on September 10, 2024, though the specific content related to their answer or counterclaims is not detailed in the available information. Details regarding the defendants' formal answer and any counterclaims are not explicitly provided in the search results but would have occurred in the normal course of litigation.
Pre-trial Motions of Substance
No specific substantial pre-trial motions, such as motions to dismiss, transfer, or stay pending IPR, were highlighted in the provided search results. Given the case's termination via consent judgment, any such motions may have been resolved or mooted by the settlement.
Claim Construction (Markman)
- Markman Hearing: A Markman hearing, where the court construes the claims of the patent, was held on October 20, 2025, before Judge Maryellen Noreika.
- Transcript Availability: The transcript for the Markman hearing had a redaction request deadline of November 14, 2025, a redacted transcript deadline of November 24, 2025, and was set for release from restriction on January 22, 2026. The specific outcome or content of the claim construction order is not detailed in the available information.
Discovery Milestones
The parties engaged in expert discovery, with several scheduling order deadlines adjusted:
- Opening Expert Reports: Originally due, then reset, to December 5, 2025.
- Rebuttal Expert Reports: Initially due January 14, 2026, subsequently extended to January 20, 2026.
- Reply Expert Reports: Originally due January 30, 2026, later extended to February 5, 2026.
- Expert Discovery: Initially due February 24, 2026, then extended to February 27, 2026. These adjustments indicate active progression through the expert discovery phase leading up to the resolution.
Trial Events, Verdict, and Post-Trial Motions
- Bench Trial Scheduled: A bench trial was scheduled for April 6, 2026.
- Trial Not Held: The case was terminated before the scheduled trial date, indicating that a trial did not occur.
Settlement, Dismissal, Judgment, or Appeal
- Consent Judgment and Termination: The case was terminated by a Consent Judgment signed by Judge Maryellen Noreika on January 13, 2026. This date of termination contradicts the previously generated overview, which stated April 6, 2026. The January 13, 2026 date is sourced from specific docket information regarding the Consent Judgment. A consent judgment typically signifies a settlement agreement between the parties that is entered as a final judgment by the court. No information regarding an appeal is available, as the case was concluded by agreement.
Parallel PTAB IPR/PGR Proceedings
While the case involved US Patent 11,123,331, there is no direct information from the provided search results indicating any parallel Patent Trial and Appeal Board (PTAB) IPR (Inter Partes Review) or PGR (Post-Grant Review) proceedings specifically challenging this patent. Though other Veloxis patents have been involved in separate litigations, no IPR/PGR for US Patent 11,123,331 appeared in the search results.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Morris, Nichols, Arsht & Tunnell
- Jeremy A. Tigan · lead counsel
Here's an identification of the counsel of record representing Veloxis Pharmaceuticals, Inc., the plaintiff in 1:24-cv-00726 in the District of Delaware:
Attorneys for Veloxis Pharmaceuticals, Inc. (Plaintiff)
Jeremy A. Tigan
- Role: Attorney for Plaintiff (specific role like lead counsel is not explicitly stated in the provided snippet but he is listed as "Attorney(s) for Plaintiffs").
- Firm & Office Location: The firm is not explicitly stated in the provided snippet, but further investigation on PACER or firm websites would typically reveal this.
- Relevant Patent Litigation Experience: Not directly available from the provided search results. Further search would be needed to detail his specific patent litigation experience or notable past cases.
The document "SUPPLEMENTAL INFORMATION FOR PATENT CASES INVOLVING AN ABBREVIATED NEW DRUG APPLICATION (ANDA)" filed on June 19, 2024, in this case, lists Jeremy A. Tigan as "Attorney(s) for Plaintiffs."
As of the current search, additional counsel representing Veloxis Pharmaceuticals, Inc. have not been explicitly identified by name or firm in the provided snippets. A more direct search of the full PACER docket for this specific case, looking at all "notice of appearance" filings, would be necessary to identify all counsel and their specific roles (e.g., local counsel if Mr. Tigan is not based in Delaware). Filings do not appear to be sealed regarding counsel appearances.In the patent infringement case 1:24-cv-00726 in the District of Delaware, Veloxis Pharmaceuticals, Inc. (Plaintiff) is represented by the following counsel:
Counsel for Veloxis Pharmaceuticals, Inc. (Plaintiff)
- Jeremy A. Tigan
- Role: Partner, Intellectual Property Litigation (appearing as counsel for Plaintiff). He often acts as lead or Delaware counsel.
- Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware.
- Relevant Patent Litigation Experience: Jeremy Tigan is an IP litigation partner whose practice focuses on patent infringement and trade secret disputes before the U.S. District Court for the District of Delaware. He has experience in bench and jury trials in the District of Delaware and appeals before the Third and Federal Circuits. He is consistently ranked as a leading Delaware patent litigator by various publications, including Chambers USA, IAM Patent 1000, and Managing Intellectual Property's IP Stars. His work concentrates on technologies in pharmaceuticals, semiconductors, software, and consumer products.
Morris, Nichols, Arsht & Tunnell LLP is explicitly listed as "Plaintiff's Counsel" for Veloxis Pharmaceuticals, Inc. in this case. While Jeremy A. Tigan is identified on a court filing as "Attorney(s) for Plaintiffs," a full docket review, which would typically be required to identify all appearing attorneys, has not been fully performed by the web search tool beyond these direct mentions. However, based on the firm's profile and its recognition in IP litigation, it is highly probable that other attorneys from Morris, Nichols, Arsht & Tunnell LLP are also involved as counsel of record. No filings appear to be sealed regarding counsel appearances.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Kratz & Barry
- R. Touhey Myer · lead counsel, local counsel
Here is the identified counsel of record representing the defendant(s) in Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al (1:24-cv-00726) in the Delaware District Court:
R. Touhey Myer
- Role: Partner, likely serving as lead and/or local counsel.
- Firm: Kratz & Barry LLP, Wilmington, DE. He is also listed as Counsel for Bochner PLLC.
- Experience Note: Mr. Myer focuses his practice on complex patent matters, particularly Hatch-Waxman litigation, before the U.S. District Court for the District of Delaware. He has served as lead and local counsel in numerous such cases, obtaining favorable rulings and settlements for clients. He is also a licensed Patent Attorney and practices before the USPTO.
Based on available public information, R. Touhey Myer is consistently identified in connection with filings made on behalf of Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. in this specific case.
While other attorneys like Richard L. Horwitz, Bindu Ann George, and Richard C. Weinblatt have experience in patent litigation and connections to Delaware firms, the provided search results do not definitively confirm their representation as counsel of record for the defendants in this specific case, 1:24-cv-00726. Richard L. Horwitz is a retired partner with a background in intellectual property. Bindu Ann George Palapura is associated with Potter Anderson & Corroon, LLP, and has been identified as patent owner litigation counsel in other matters. Richard C. Weinblatt, with Stamoulis & Weinblatt LLC, engages in patent and ANDA litigation, often representing generic pharmaceutical defendants, but his specific appearance in this case for Sun Pharmaceutical is not explicitly detailed in the provided search snippets. Without specific docket entries confirming their appearances for the defendants in this particular case, their roles cannot be stated definitively.