BioMarin Pharmaceutical Inc. v. Unknown Defendant

This litigation, BioMarin Pharmaceutical Inc. v. Unknown Defendant, case number 1:26-cv-01005, is a patent infringement suit filed in the District of New Jersey by BioMarin Pharmaceutical Inc., a global biotechnology company specializing in therapies for rare genetic diseases. BioMarin develops and commercializes treatments for conditions such as achondroplasia, phenylketonuria, and mucopolysaccharidosis. The "Unknown Defendant" nomenclature strongly suggests this is an Abbreviated New Drug Application (ANDA) litigation under the Hatch-Waxman Act, where a generic drug manufacturer has filed an ANDA seeking to market a generic version of a BioMarin drug. The accused product is therefore likely a generic formulation of one of BioMarin's therapies for skeletal dysplasias, with BioMarin's VOXZOGO® (vosoritide), a C-type natriuretic peptide analog approved for achondroplasia, being a strong candidate.

The sole patent at issue is U.S. Patent 12,233,106, titled "C-type natriuretic peptide variants to treat skeletal dysplasia in children." This patent broadly covers methods of treating skeletal dysplasias in children, including improving symptoms such as long bone growth or growth velocity, by administering specific variants of C-type natriuretic peptide (CNP). The patent was granted on February 25, 2025, and has an adjusted expiration date of July 11, 2042. The case is in its early procedural posture, having been filed in 2026 in the District of New Jersey, a frequently chosen venue for pharmaceutical patent disputes due to its specialized expertise in complex drug litigation.

This case is notable for several reasons. As a Hatch-Waxman litigation, it represents the typical challenge to a brand-name pharmaceutical company's market exclusivity by a generic competitor. The relatively recent grant date of the asserted patent (February 25, 2025) suggests BioMarin is actively defending its intellectual property for a potentially valuable drug targeting rare genetic conditions like achondroplasia, where treatments can have significant market impact. Furthermore, the patent is currently facing a Post-Grant Review (PGR2026-00013) initiated by Ascendis Pharma A/S at the Patent Trial and Appeal Board (PTAB), which commenced on November 24, 2025. This parallel PTAB challenge directly scrutinizes the validity of the patent-in-suit and will likely influence the district court proceedings.

BioMarin Pharmaceutical Inc. initiated a patent infringement lawsuit against Zydus Lifesciences Limited, Zydus Lifesciences Global FZE, and Zydus Pharmaceuticals (USA) Inc. in the District Court for the District of New Jersey. The case, numbered 1:26-cv-01005, was filed on February 2, 2026.

Key Legal Developments and Outcome:

• Filing & Initial Pleadings:

  • Complaint Filed (2026-02-02): BioMarin Pharmaceutical Inc. filed a patent infringement complaint under the Hatch-Waxman Act. The plaintiff alleges that the defendants' submission of Abbreviated New Drug Application (ANDA) No. 220670, seeking FDA approval to market a generic version of BioMarin's drug VOXZOGO®, constitutes an act of patent infringement. The ANDA included a Paragraph IV certification against US Patent 12233106, asserting that the patent is invalid, unenforceable, or will not be infringed by the generic product. The complaint was filed within the 45-day period following receipt of the defendants' notice letter, triggering an automatic 30-month stay on FDA approval of the ANDA. As of the current date (May 29, 2026), given the recent filing, the case is in its early stages, and there are no public records of an answer or counterclaims having been filed yet.

• Pre-trial motions of substance:

  • No substantial pre-trial motions to dismiss, transfer, or for summary judgment have been publicly recorded due to the nascent stage of the litigation.

• Claim Construction (Markman) outcomes:

  • The case has not yet reached the claim construction stage.

• Discovery milestones:

  • No significant discovery milestones have been publicly recorded.

• Trial events, verdict, and post-trial motions:

  • The case has not proceeded to trial.

• Settlement, dismissal, judgment, or appeal:

  • The case is currently active and is still in its early procedural stages. There has been no final disposition, settlement, dismissal, or judgment recorded.

• Parallel PTAB IPR/PGR proceedings:

  • Post-Grant Review (PGR) Petition Filed (2025-11-24): A Post-Grant Review (PGR) petition, PGR2026-00013, was filed on November 24, 2025, challenging US Patent 12233106, the patent at issue in the District Court litigation. The Patent Owner (BioMarin Pharmaceutical Inc.) may file a preliminary response to the petition no later than three months from the notice date, arguing why the requested review should not be instituted. This PGR proceeding is ongoing and could potentially affect the district court litigation if the PTAB decides to institute review.
  • Mandatory Notices: Patent Owner is required to submit mandatory notice information, including identifying any other judicial or administrative matter that would affect or be affected by a decision in the PGR proceeding, within 21 days of service of the petition. This would include the ongoing District Court litigation.

BioMarin Pharmaceutical Inc., as the plaintiff in the patent infringement case 1:26-cv-01005 in the District of New Jersey, is represented by attorneys from Jones Day. This firm has consistently represented BioMarin in numerous patent infringement and Hatch-Waxman (ANDA) litigations, including previous cases in the District of New Jersey. The case involves U.S. Patent 12233106 and the defendant is identified as Zydus Lifesciences Ltd..

Based on their extensive experience with BioMarin and Hatch-Waxman litigation, the following attorneys from Jones Day are likely counsel of record for the plaintiff:

• Anthony M. Insogna

  • Role: Likely Lead Counsel, given his position as Practice Leader of Jones Day's Global Intellectual Property Practice.
  • Firm: Jones Day, San Diego office.
  • Experience Note: A Chambers-ranked life sciences patent lawyer with over 30 years of experience enforcing and defending patents worldwide, driving portfolio strategy for therapeutic products, and conducting due diligence. He has specifically represented BioMarin in patent infringement actions against Par Pharmaceutical, Inc. and Dr. Reddy's Laboratories in the District of New Jersey.

• Matthew J. Hertko

  • Role: Likely Lead Counsel or key litigation counsel.
  • Firm: Jones Day, Chicago office.
  • Experience Note: Represents clients in high-stakes patent litigation, with a particular emphasis on representing innovator pharmaceutical companies in actions brought under the Hatch-Waxman Act. He successfully represented BioMarin Pharmaceutical, Inc. in a patent infringement action against Dr. Reddy's Laboratories.

• Gasper J. LaRosa

  • Role: Likely Lead Counsel or key litigation counsel.
  • Firm: Jones Day (office not specified in readily available results, but typically involved in D.N.J. matters due to expertise).
  • Experience Note: A leading pharmaceutical and biotechnology patent lawyer specializing in Hatch-Waxman (ANDA), biosimilar (BPCIA), and other patent litigation. He has represented major pharmaceutical companies in the enforcement of patents covering successful drug products and has experience in the District of New Jersey.

• John J. Normile

  • Role: Likely Lead Counsel or key litigation counsel.
  • Firm: Jones Day, New York office.
  • Experience Note: A leading Hatch-Waxman patent litigator with over 35 years of experience representing innovative pharmaceutical companies, acting as trial counsel before various federal district and appellate courts.

• Kevin V. McCarthy

  • Role: Likely key litigation counsel.
  • Firm: Jones Day (office not specified, but has experience in D.N.J. matters).
  • Experience Note: Represents plaintiffs and defendants in patent litigation cases, with a particular focus on Hatch-Waxman matters, and has litigated cases in the District of New Jersey.

• Jason G. Winchester

  • Role: Likely Litigation Counsel.
  • Firm: Jones Day, Chicago office.
  • Experience Note: Listed as a contact for BioMarin's patent infringement cases against Par Pharmaceutical and Dr. Reddy's Laboratories in the District of New Jersey.

• Timothy J. Heverin

  • Role: Of Counsel.
  • Firm: Jones Day, Chicago office.
  • Experience Note: Also listed as a contact for BioMarin's patent infringement cases against Par Pharmaceutical and Dr. Reddy's Laboratories in the District of New Jersey.

• Tamera M. Weisser Ph.D.

  • Role: Likely supporting counsel in a strategic or advisory capacity.
  • Firm: Jones Day (office not specified, but leads the global patent prosecution group).
  • Experience Note: Leader of Jones Day's global patent prosecution group, with over 25 years of experience in global patent portfolio development. She established a worldwide patent portfolio for BioMarin's Palynziq®.

• Kunyong Yang

  • Role: Likely Litigation Counsel.
  • Firm: Jones Day (office not specified).
  • Experience Note: Focuses on developing and managing global patent portfolios involving pharmaceutical and biotechnology innovations and has experience in Hatch-Waxman litigation.

Due to the lack of direct PACER access for the specific case docket, the precise designation of "lead counsel," "local counsel," or "of counsel" for each attorney in this specific case cannot be definitively stated. However, the listed attorneys are highly experienced in patent and Hatch-Waxman litigation and have a strong track record of representing BioMarin in similar matters, particularly in the District of New Jersey, making them highly probable candidates for the plaintiff's legal team. BioMarin also has internal legal leadership, such as G. Eric Davis, Executive Vice President, Chief Legal Officer, who would oversee the external counsel.

As of May 29, 2026, the counsel of record representing the defendant(s) in BioMarin Pharmaceutical Inc. v. ZYDUS LIFESCIENCES LIMITED et al, Case No. 1:26-cv-01005 in the District of New Jersey, could not be definitively identified through publicly available web search results.

The defendants in this patent infringement case are ZYDUS LIFESCIENCES LIMITED, ZYDUS LIFESCIENCES GLOBAL FZE, and ZYDUS PHARMACEUTICALS (USA) INC.. The lawsuit, an Abbreviated New Drug Application (ANDA) patent infringement action, was filed on February 2, 2026. While the docket indicates that waivers of service were executed and answer deadlines have passed (April 13, 2026, and May 12, 2026), meaning counsel should have appeared, specific attorneys representing the defendants are not listed in the available public snippets.

For context, law firms frequently involved in defending generic pharmaceutical companies in ANDA litigation in the District of New Jersey include:

• Saul Ewing LLP: Known for representing generic pharmaceutical companies in ANDA litigation and having attorneys regularly appear before judges in the District of New Jersey.
• Shelhoff Canfield & Chin LLC: Their attorneys Dmitry Shelhoff and Ken Canfield are ranked among "Top Attorneys in ANDA Litigation" for their work on the defendant side, and the firm litigated primarily in the District of New Jersey.
• Stamoulis & Weinblatt LLC: Represents both brand and generic pharmaceutical companies in ANDA litigation, with experience in the District of New Jersey.
• Caesar Rivise, PC: Offers extensive experience in ANDA litigation for generic pharmaceutical companies, including in the District of New Jersey.
• Duane Morris LLP: Handles pharmaceutical patent litigations and Hatch-Waxman practice, with attorneys experienced in the District of New Jersey.

However, without specific docket entries confirming their appearances in 1:26-cv-01005, these firms and attorneys cannot be confirmed as counsel of record for the defendants in this particular case.