Astellas Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc.

Case Overview & Background

This patent infringement lawsuit was a Hatch-Waxman action initiated by global pharmaceutical company Astellas against generics manufacturer Hikma Pharmaceuticals. Astellas sought to block Hikma from launching a generic version of its lucrative prostate cancer drug, Xtandi® (enzalutamide). The case centered on a single, recently issued patent related to a specific method of using the drug. The litigation was short-lived, however, with the parties agreeing to a voluntary dismissal with prejudice just a few months after the complaint was filed, suggesting a settlement was reached.

Astellas Pharma Inc., a Japan-based pharmaceutical company, along with its US subsidiaries and partners Medivation, develops and commercializes drugs for oncology, urology, and other therapeutic areas. Xtandi is a significant revenue driver for Astellas, with billions in annual sales for the treatment of castration-resistant and metastatic castration-sensitive prostate cancer. The defendant, Hikma Pharmaceuticals USA Inc., is the U.S. arm of a UK-based multinational company that develops and markets a broad range of generic pharmaceutical products. The dispute arose after Hikma filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic enzalutamide product prior to the expiration of Astellas's patents.

The lawsuit, filed in the U.S. District Court for the District of New Jersey, asserted infringement of U.S. Patent No. 12,161,628, titled "Methods of treating prostate cancer." This patent claims a specific method for treating certain forms of prostate cancer based on a patient's genetic profile. The filing of the suit triggered an automatic 30-month stay on FDA approval for Hikma's generic, a standard procedure in Hatch-Waxman litigation. This case is one of many that Astellas has filed against various generic drug makers, including Apotex, to defend its Xtandi patent portfolio. The District of New Jersey is a favored venue for pharmaceutical patent litigation due to its experienced judiciary and well-developed case law in this area. While the specific reasons for the rapid dismissal are not public, it is common in such cases for parties to settle, often involving an agreement that allows the generic to enter the market on a specific date in the future.

Swift Settlement Leads to Dismissal of Astellas' Patent Suit Against Hikma

2026-05-08 – Less than three months after it was initiated, patent litigation brought by Astellas against Hikma Pharmaceuticals over its proposed generic version of the prostate cancer drug Xtandi® was dismissed with prejudice, indicating a settlement between the parties. The case was formally closed on April 7, 2025.

The lawsuit, filed in the U.S. District Court for the District of New Jersey, alleged that Hikma's Abbreviated New Drug Application (ANDA) to market a generic form of enzalutamide tablets infringed on U.S. Patent No. 12,161,628.

Key Developments in Chronological Order:

Filing & Initial Pleadings (2025-01-16 to 2025-03-24)

• Complaint (2025-01-16): Astellas Pharma Inc., along with its related entities Medivation LLC and Medivation Prostate Therapeutics LLC, filed a Complaint for Patent Infringement against Hikma Pharmaceuticals USA Inc. The suit was triggered by Hikma's submission of ANDA No. 218731 to the U.S. Food and Drug Administration (FDA), seeking approval to manufacture and sell generic versions of Xtandi® (enzalutamide) 40 mg and 80 mg tablets. The complaint asserted infringement of U.S. Patent No. 12,161,628, entitled "Combination Therapy," and U.S. Patent No. 11,839,689. The case was assigned to Judge Michael A. Shipp.
• Answer and Counterclaim (2025-03-24): Hikma responded to the lawsuit by filing its Answer, which included Affirmative Defenses and a Counterclaim against the Astellas plaintiffs. The specific details of the counterclaims are not publicly available but would typically seek a declaratory judgment of non-infringement, invalidity, or unenforceability of the asserted patent.

Settlement and Dismissal (2025-04-07)

• Dismissal (2025-04-07): The court docket indicates the case was closed and terminated on this date. Legal news and settlement data aggregators report that the litigation ended due to a settlement. The claims and counterclaims were dismissed with prejudice, with each party agreeing to bear its own attorneys' fees and costs. The dismissal with prejudice permanently bars Astellas from re-filing a lawsuit against Hikma on the same claims.

Case Progression Analysis

The rapid progression from filing to settlement and dismissal—spanning just under three months—precluded any significant litigation milestones. The case did not advance to substantive motion practice, such as motions to dismiss or for summary judgment, nor did it reach a claim construction (Markman) hearing, discovery, or trial.

Parallel PTAB Proceedings

A search of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) records and other public sources reveals no evidence that an Inter Partes Review (IPR) or Post-Grant Review (PGR) was filed against U.S. Patent No. 12,161,628. The swift settlement of the district court case likely obviated the need for Hikma to file a parallel challenge to the patent's validity at the PTAB.

Counsel for Plaintiffs Astellas Pharma et al.

Plaintiffs are represented by attorneys from two law firms: New Jersey-based Walsh Pizzi O'Reilly Falanga LLP, serving as local counsel, and Venable LLP, serving as lead and of counsel.

Venable LLP

The team from Venable LLP is led by seasoned patent litigators with extensive experience in pharmaceutical cases, particularly Hatch-Waxman litigation involving generic drug challenges.

• Name: Dominick A. Conde

  • Role: Lead Counsel
  • Firm: Venable LLP, New York, NY
  • Note: Co-chair of Venable's Intellectual Property Division, Conde is a prominent patent litigator frequently handling high-value ANDA matters for major pharmaceutical companies.

• Name: William E. Solander

  • Role: Of Counsel
  • Firm: Venable LLP, New York, NY
  • Note: As co-chair of the firm's IP Litigation – Life Sciences Group, he has deep experience in ANDA litigation and has represented clients in federal courts and the PTAB.

• Name: Erin J.D. Austin

  • Role: Of Counsel
  • Firm: Venable LLP, New York, NY
  • Note: Austin is a patent litigator specializing in Hatch-Waxman litigation and contested proceedings before the USPTO, with a technical background in chemistry.

• Name: Whitney Meier Howard

  • Role: Of Counsel
  • Firm: Venable LLP, New York, NY
  • Note: A pharmaceutical and biotechnology patent litigator, Howard has represented clients like Astellas in previous Hatch-Waxman litigations involving the drug Xtandi®.

Walsh Pizzi O'Reilly Falanga LLP

This New Jersey-based, women-owned firm serves as local counsel, handling court appearances and filings within the district.

• Name: Liza M. Walsh

  • Role: Local Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: A founding partner of her firm, Walsh has over 30 years of experience, with a focus on intellectual property, and has defended major pharmaceutical companies in significant patent litigation.

• Name: Katelyn O'Reilly

  • Role: Local Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: O'Reilly's practice focuses on federal and complex commercial litigation, including intellectual property and business disputes.

• Name: Christine P. Clark

  • Role: Local Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: An associate at the firm, Clark focuses on business and commercial litigation and has been recognized as "One to Watch" for litigation, including patent litigation.

Counsel for Defendant Hikma Pharmaceuticals USA Inc.

Based on court filings, Hikma Pharmaceuticals USA Inc. was represented by attorneys from the law firm Sterne, Kessler, Goldstein & Fox P.L.L.C.

• J.C. Rozendaal (Lead Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C., Washington, D.C.
  • Note: Rozendaal is a director at Sterne Kessler and chair of the firm's trial and appellate group, with extensive experience in pharmaceutical patent litigation and Hatch-Waxman cases.

• William H. Milliken (Of Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C., Washington, D.C.
  • Note: Milliken is a director at Sterne Kessler focusing on patent litigation, particularly within the biotechnology and pharmaceutical sectors, including representation of generic drug companies.

• Dennies Varughese (Local Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C., Washington, D.C. (Note: While the primary firm is in D.C., local counsel is required for D.N.J. admission, and Varughese is admitted to the New Jersey bar).
  • Note: Varughese is a director at Sterne Kessler and specializes in patent litigation for pharmaceutical and biotechnology clients, including significant experience in ANDA litigation.

There is no public record of in-house counsel for Hikma having filed a notice of appearance in this specific matter. The legal team from Sterne Kessler managed the defense until the case was voluntarily dismissed.