Litigation

Untitled case

Filed

2:26-cv-04939

Patents at issue (1)

Summary

This case, involving US patent 12527771, was filed in the New Jersey District Court under case number 2:26-cv-04939.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

This patent infringement litigation, Case No. 2:26-cv-04939, was filed in the New Jersey District Court on May 1, 2026, and is currently open. The plaintiff is Takeda Pharmaceutical Company Limited, a global biopharmaceutical company, while the defendant is Sun Pharmaceutical Industries Ltd., a multinational pharmaceutical company specializing in generic drugs. Both parties operate as pharmaceutical companies.

The dispute centers on U.S. Patent No. 12,527,771, which generally relates to "Viral inhibitors, the synthesis thereof, and intermediates thereto." More specifically, the patent covers a composition of maribavir—an antiviral medication used to treat post-transplant cytomegalovirus (CMV) infection—and one or more specified impurities (Compounds 9, 10, 11, and 12), wherein each impurity is present in an amount of 0.1% w/w or less relative to maribavir. The accused product is Sun Pharmaceutical's generic maribavir tablets, 200 mg, for which Sun seeks FDA approval through Abbreviated New Drug Application (ANDA) No. 219690. This generic product is intended to be a lower-cost version of Takeda's LIVTENCITY® drug.

This case is a typical Hatch-Waxman Act litigation, which arises when a generic drug manufacturer files an ANDA seeking to market a generic version of a brand-name drug before the expiration of the brand drug's patents. Such lawsuits are crucial for determining market exclusivity for innovator drugs and facilitating the entry of generic competition. While the specific judge assigned to this case is not yet publicly known, the District of New Jersey is a common forum for pharmaceutical patent cases due to its significant volume of such litigation. This case is notable within the pharmaceutical industry as it involves major players contesting the market entry of a generic version of a drug for a serious medical condition.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

The patent infringement lawsuit, Takeda Pharmaceutical Co. Ltd. v. Sun Pharmaceutical Industries Ltd., case number 2:26-cv-04939, was filed on May 1, 2026, in the District of New Jersey. As of June 1, 2026, the case is in its very early stages.

Given the recent filing date, specific legal developments such as detailed pleadings, substantive pre-trial motions, claim construction outcomes, discovery milestones, or trial events are not yet available in public records. The case is currently listed as "Open".

Key Legal Developments (Chronological Order):

  • 2026-05-01: Filing of Complaint
    Takeda Pharmaceutical Co. Ltd. filed a patent infringement complaint against Sun Pharmaceutical Industries Ltd. in the U.S. District Court for the District of New Jersey, initiating case 2:26-cv-04939. The complaint asserts infringement of US Patent 12527771. The specific product or service accused of infringement is not detailed in the available snippets but is likely a pharmaceutical product, potentially related to an Abbreviated New Drug Application (ANDA).

Expected Next Steps (Not yet occurred as of 2026-06-01):

  • Initial Pleadings: Following the complaint, Sun Pharmaceutical Industries Ltd. would typically file an answer, which may include counterclaims such as non-infringement, invalidity of the asserted patent, or unenforceability.
  • Pre-Trial Motions: Early motions could include motions to dismiss, motions to transfer venue, or motions to stay proceedings if parallel PTAB reviews are initiated. Given the early stage, no such motions have been recorded.
  • Claim Construction (Markman): This crucial stage, where the court interprets the meaning and scope of the patent claims, typically occurs later in the litigation process.
  • Discovery: The parties would engage in fact and expert discovery.
  • Trial and Post-Trial Motions: These events would occur much later if the case proceeds to trial.
  • Settlement, Dismissal, Judgment, or Appeal: The final disposition would arise from a settlement, a court judgment, or an appeal following a trial or dispositive motions.

Parallel PTAB IPR/PGR Proceedings:
As of the current date, no information is available in the provided search results regarding any parallel Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings filed with the Patent Trial and Appeal Board (PTAB) specifically challenging US Patent 12527771. Such proceedings often occur in pharmaceutical patent litigation but would need to be identified through direct searches of the USPTO's P-TACTS system for the specific patent number, which was not executed by the search tool.The patent infringement lawsuit, Takeda Pharmaceutical Co. Ltd. v. Sun Pharmaceutical Industries Ltd., case number 2:26-cv-04939, was filed on May 1, 2026, in the District of New Jersey. As of June 1, 2026, the case is in its very early stages.

Given the recent filing date, specific legal developments such as detailed pleadings, substantive pre-trial motions, claim construction outcomes, discovery milestones, or trial events are not yet available in public records. The case is currently listed as "Open".

Key Legal Developments (Chronological Order):

  • 2026-05-01: Filing of Complaint
    Takeda Pharmaceutical Co. Ltd. filed a patent infringement complaint against Sun Pharmaceutical Industries Ltd. in the U.S. District Court for the District of New Jersey, initiating case 2:26-cv-04939. The complaint asserts infringement of US Patent 12527771. The specific product or service accused of infringement is not detailed in the available snippets but is likely a pharmaceutical product, potentially related to an Abbreviated New Drug Application (ANDA).

Expected Next Steps (Not yet occurred as of 2026-06-01):

  • Initial Pleadings: Following the complaint, Sun Pharmaceutical Industries Ltd. would typically file an answer, which may include counterclaims such as non-infringement, invalidity of the asserted patent, or unenforceability.
  • Pre-Trial Motions: Early motions could include motions to dismiss, motions to transfer venue, or motions to stay proceedings if parallel PTAB reviews are initiated. Given the early stage, no such motions have been recorded.
  • Claim Construction (Markman): This crucial stage, where the court interprets the meaning and scope of the patent claims, typically occurs later in the litigation process.
  • Discovery: The parties would engage in fact and expert discovery.
  • Trial and Post-Trial Motions: These events would occur much later if the case proceeds to trial.
  • Settlement, Dismissal, Judgment, or Appeal: The final disposition would arise from a settlement, a court judgment, or an appeal following a trial or dispositive motions.

Parallel PTAB IPR/PGR Proceedings:
As of the current date, no information is available in the provided search results regarding any parallel Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings filed with the Patent Trial and Appeal Board (PTAB) specifically challenging US Patent 12527771. Such proceedings often occur in pharmaceutical patent litigation but would need to be identified through direct searches of the USPTO's P-TACTS system for the specific patent number, which was not executed by the search tool.

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

Based on the initial court filings and associated public records, the counsel of record representing the plaintiff, Takeda Pharmaceutical Co. Ltd., in case 2:26-cv-04939 is:

  • Charles M. Lizza
    • Role: Lead Counsel
    • Firm: Saul Ewing LLP, with New Jersey offices in Princeton and Newark. While he may practice from either, he is frequently noted as New Jersey litigation counsel.
    • Experience: Mr. Lizza brings over 40 years of litigation experience, with a significant focus on Hatch-Waxman Abbreviated New Drug Application (ANDA) litigation and protecting intellectual property for branded pharmaceutical and medical device companies. He leads Saul Ewing's nationally recognized patent litigation team and is consistently listed among "America's Leading Lawyers in Intellectual Property Law" by Chambers USA.

In addition to Mr. Lizza, other attorneys from Saul Ewing LLP frequently represent Takeda Pharmaceutical Co. Ltd. in similar patent litigation, particularly against Sun Pharmaceutical Industries Ltd., and are likely involved in this case:

  • Alexander Lee Callo

    • Role: Counsel
    • Firm: Saul Ewing LLP (New Jersey offices in Princeton and Newark).
    • Experience: Mr. Callo represents clients in the life sciences industry in patent litigation, with particular strength in ANDA litigation and disputes regarding obviousness. He is recognized by Chambers USA as an "Associate to watch" in Intellectual Property in New Jersey.
  • Sarah Ann Sullivan

    • Role: Counsel
    • Firm: Saul Ewing LLP (New Jersey offices in Princeton and Newark).
    • Experience: Ms. Sullivan focuses her practice on complex, high-stakes patent litigation, specifically Hatch-Waxman ANDA cases and intellectual property disputes for branded pharmaceutical companies. She is recognized by Chambers USA for her growing practice in this area.

Saul Ewing LLP is a prominent firm in pharmaceutical patent litigation, known for representing branded pharmaceutical companies in ANDA cases. The firm's patent litigation team has been nationally recognized for its work for patentees and ANDA plaintiffs.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

As of June 1, 2026, the specific counsel of record representing Sun Pharmaceutical Industries Ltd. in case 2:26-cv-04939 in the District of New Jersey has not been explicitly identified in publicly available search results directly pertaining to this case's docket. Given the recent filing date of May 1, 2026, it is possible that initial appearances have not yet been widely publicized beyond the official PACER system, which is not directly accessible through this tool.

However, based on a closely related and recently filed patent infringement case in the same court involving Sun Pharmaceutical Industries Ltd. (specifically, SUN PHARMACEUTICAL INDUSTRIES, LTD. et al v. SOLARIS PHARMA CORPORATION, case number 2:26-cv-04286, filed April 22, 2026), the following attorneys from Rivkin Radler LLP have filed Notices of Appearance on behalf of Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd.:

Firm: Rivkin Radler LLP

  • Timothy P. Gonzalez
    • Role: Likely lead counsel or significant counsel in patent litigation.
    • Office Location: Implied to be associated with their patent litigation practice, potentially New York or New Jersey offices.
    • Experience: Appears as counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd. in a recent ANDA patent infringement case in the District of New Jersey, indicating experience in pharmaceutical patent litigation.
  • Catherine Salerno
    • Role: Counsel.
    • Office Location: Implied to be associated with their patent litigation practice.
    • Experience: Appears as counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd. in a recent ANDA patent infringement case in the District of New Jersey.
  • Gregory D. Miller
    • Role: Counsel.
    • Office Location: Implied to be associated with their patent litigation practice.
    • Experience: Appears as counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd. in a recent ANDA patent infringement case in the District of New Jersey.
  • Gene Y. Kang
    • Role: Counsel.
    • Office Location: Implied to be associated with their patent litigation practice.
    • Experience: Appears as counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd. in a recent ANDA patent infringement case in the District of New Jersey.
  • Kaitlyn Piechnik
    • Role: Counsel.
    • Office Location: Implied to be associated with their patent litigation practice.
    • Experience: Appears as counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries, Ltd. in a recent ANDA patent infringement case in the District of New Jersey.

Given the proximity in filing dates and the nature of the litigation, it is highly probable that Sun Pharmaceutical Industries Ltd. will utilize the same or a similar legal team from Rivkin Radler LLP for 2:26-cv-04939.

Other Firms/Attorneys Representing Sun Pharmaceutical in Past Patent Litigation:

While not directly linked to the current case, Sun Pharmaceutical Industries Limited has been represented by other firms in prior patent litigation, which may indicate their broader network of legal counsel:

  • Dominick T. Gattuso
    • Firm: Heyman Enerio Gattuso & Hirzel LLP
    • Office Location: Wilmington, DE.
    • Experience: Represented Sun Pharmaceutical Industries Limited as defendant's counsel in ALLERGAN USA INC LLC v. SUN PHARMACEUTICAL INDUSTRIES LIMITED (District of Delaware, 2022), an ANDA patent infringement case.
  • Charles B. Klein
    • Firm: Winston & Strawn LLP
    • Office Location: Washington, DC.
    • Experience: Represented Sun Pharmaceutical Industries Limited as defendant's counsel in ALLERGAN USA INC LLC v. SUN PHARMACEUTICAL INDUSTRIES LIMITED (District of Delaware, 2022).
  • Jovial Wong
    • Firm: Winston & Strawn LLP
    • Office Location: Washington, DC.
    • Experience: Represented Sun Pharmaceutical Industries Limited as defendant's counsel in ALLERGAN USA INC LLC v. SUN PHARMACEUTICAL INDUSTRIES LIMITED (District of Delaware, 2022).
  • Kevin J. Boyle
    • Firm: Winston & Strawn LLP
    • Office Location: Chicago, IL.
    • Experience: Represented Sun Pharmaceutical Industries Limited as defendant's counsel in ALLERGAN USA INC LLC v. SUN PHARMACEUTICAL INDUSTRIES LIMITED (District of Delaware, 2022).