BioMarin Pharmaceutical Inc. v. Zydus Lifesciences Ltd

BioMarin Pharmaceutical Inc., a global biotechnology company headquartered in San Rafael, California, specializes in developing and commercializing therapies for rare genetic diseases, including enzyme replacement therapies and gene therapies. They are known for products treating conditions like achondroplasia, phenylketonuria, and hemophilia. The defendant, Zydus Lifesciences Ltd, an Indian multinational pharmaceutical company with a significant U.S. generic drug division, Zydus Pharmaceuticals (USA) Inc. in Pennington, New Jersey, is a fully integrated healthcare provider engaged in the research, development, production, marketing, and distribution of a broad portfolio of pharmaceutical products, including active pharmaceutical ingredients (APIs), human formulations, and animal health products. Zydus is a major player in the generic drug market in the U.S..

This patent infringement suit, filed by BioMarin against Zydus Lifesciences, is an Abbreviated New Drug Application (ANDA) litigation initiated under the Hatch-Waxman Act. The accused product is a generic version of BioMarin's VOXZOGO® (vosoritide), which is used for the treatment of achondroplasia, the most common type of dwarfism, in children. Zydus submitted ANDA No. 220670 seeking FDA approval to market its generic vosoritide product, including a Paragraph IV certification asserting that BioMarin's asserted patent is invalid, unenforceable, or will not be infringed. The sole patent at issue is U.S. Patent No. 12,233,106, titled "C-Type Natriuretic Peptide Variants to Treat Skeletal Dysplasia in Children," which issued on February 25, 2025. This patent generally describes methods for treating skeletal dysplasias in children, and improving symptoms such as long bone growth or growth velocity, by administering variants of C-type natriuretic peptide (CNP).

The case, BioMarin Pharmaceutical Inc. v. Zydus Lifesciences Ltd, is active in the U.S. District Court for the District of New Jersey, under case number 2:26-cv-01005. The District of New Jersey is a common venue for ANDA litigation due to the presence of many pharmaceutical companies' U.S. operations or principal places of business within the state, including Zydus Pharmaceuticals (USA) Inc. being located in Pennington, New Jersey. This case is notable as it concerns VOXZOGO®, a significant and relatively new drug (the first FDA-approved treatment for achondroplasia) for a rare genetic disease, indicating the high commercial stakes involved in bringing a generic version to market. Additionally, there's an indication of a related Patent Trial and Appeal Board (PTAB) case, PGR2026-00013, which was filed and is pending, suggesting parallel invalidity challenges to the '106 patent. BioMarin has also been involved in similar litigation regarding CNP variants in Europe.BioMarin Pharmaceutical Inc., a global biotechnology company based in California, focuses on developing and commercializing therapies for rare genetic diseases, including enzyme replacement and gene therapies for conditions such as achondroplasia and phenylketonuria. Conversely, Zydus Lifesciences Ltd, an Indian multinational pharmaceutical company with a substantial U.S. generic drug division in New Jersey, is a fully integrated healthcare provider known for its extensive portfolio of generic drugs, active pharmaceutical ingredients, and other pharmaceutical products. This suit pits an innovator company against a major generic drug manufacturer.

The litigation stems from Zydus Lifesciences' filing of an Abbreviated New Drug Application (ANDA) No. 220670 with the FDA, seeking approval to market a generic version of BioMarin's VOXZOGO® (vosoritide). VOXZOGO® is a pioneering drug, being the first and only FDA-approved treatment for achondroplasia, the most common form of dwarfism, in children. Zydus's ANDA included a Paragraph IV certification, challenging the validity, enforceability, or infringement of BioMarin's patent. The sole patent asserted in this infringement suit is U.S. Patent No. 12,233,106, titled "C-Type Natriuretic Peptide Variants to Treat Skeletal Dysplasia in Children," which issued on February 25, 2025. This patent generally covers methods for treating skeletal dysplasias in children by administering variants of C-type natriuretic peptide (CNP) to improve symptoms like long bone growth.

The case, BioMarin Pharmaceutical Inc. v. Zydus Lifesciences Ltd, is currently active in the U.S. District Court for the District of New Jersey under case number 2:26-cv-01005. The District of New Jersey is a frequently utilized venue for ANDA litigation, often selected due to the significant presence of pharmaceutical companies, including generic manufacturers like Zydus Pharmaceuticals (USA) Inc., within the state. This litigation is notable given the substantial market significance of VOXZOGO® as a groundbreaking treatment for a rare genetic condition. The case also features parallel proceedings, with a Patent Trial and Appeal Board (PTAB) petition for inter partes review (PGR2026-00013) having been filed against the '106 patent, indicating a multifaceted challenge to the patent's validity.

The patent infringement lawsuit, BioMarin Pharmaceutical Inc. v. Zydus Lifesciences Ltd (Case No. 2:26-cv-01005, D. New Jersey), is active ANDA litigation concerning U.S. Patent 12233106.

Here's a breakdown of the key legal developments:

1. Filing & Initial Pleadings:

• Complaint Filed: BioMarin Pharmaceutical Inc. filed the complaint against Zydus Lifesciences Ltd in the District of New Jersey on February 2, 2026. This case is likely related to a generic drug application, characteristic of ANDA litigation.

2. Parallel PTAB IPR/PGR Proceedings:

• PGR Filed: A Post-Grant Review (PGR) proceeding, PGR2026-00013, was filed against U.S. Patent 12233106 on November 24, 2025. The petitioner in this PGR is Ascendis Pharma A/S.
• Effect on Litigation: PGRs, like other America Invents Act (AIA) trial proceedings before the Patent Trial and Appeal Board (PTAB), can impact district court litigation. These proceedings offer a different standard of proof for invalidating patents ("preponderance of the evidence" in PTAB vs. "clear and convincing evidence" in district court) and can lead to claims being cancelled as unpatentable. The PTAB encourages parties to consider settlement or alternative dispute resolution in these proceedings. A Final Written Decision in a PGR could significantly influence the district court case regarding the validity of the patent.

As of May 29, 2026, the case remains active. There is no publicly available information regarding answers, counterclaims, substantive pre-trial motions, claim construction, discovery milestones, trial events, or a final disposition.

It appears that detailed counsel information for BioMarin Pharmaceutical Inc. in case 2:26-cv-01005 is not yet broadly available through public web searches of the docket. The case was filed recently, on February 2, 2026, in the District of New Jersey, and is an Abbreviated New Drug Application (ANDA) litigation with a pending judge assignment.

However, based on BioMarin's past patent litigation representation and known counsel in similar ANDA cases, the following attorneys and firms are likely involved or have a strong history of representing BioMarin in such matters:

• Kevin E. Warner (Likely Lead Counsel)

  • Firm: RMMS Legal (Chicago, IL)
  • Experience: Mr. Warner serves as lead counsel for clients in the life sciences industry, with a particular focus on Hatch-Waxman disputes, biosimilar litigation, and medical device lawsuits. He has extensive experience representing clients as trial counsel in jury trials, bench trials, and private arbitrations. Prior to joining RMMS, he was a partner at Winston & Strawn LLP, specializing in life sciences patent and intellectual property litigation.

• Saul Ewing LLP (Likely Local Counsel in New Jersey)

  • Firm: Saul Ewing LLP (various offices, including New Jersey)
  • Experience: Saul Ewing is recognized as a "Go-To New Jersey Counsel for Brand Pharmaceutical Companies" and has a history of representing BioMarin Pharmaceutical Inc. in ANDA litigation. Their team advises brand pharmaceutical companies in all phases of ANDA cases, including those involving small molecule and polymorph patents as well as large molecule (biologics) patents.

• Jones Day (Likely Lead or Co-Counsel)

  • Firm: Jones Day (various offices, including Chicago and San Diego, with intellectual property attorneys active in patent litigation)
  • Experience: Jones Day has successfully represented BioMarin Pharmaceutical Inc. in past patent infringement actions, including a notable resolution against Par Pharmaceutical, Inc., related to a generic version of Kuvan®. Attorneys such as Jason G. Winchester (Chicago), Timothy J. Heverin (Chicago), and Anthony M. Insogna (San Diego) are noted for their intellectual property practice.

• Anand Viswanathan (In-house Counsel)

  • Firm: BioMarin Pharmaceutical Inc. (Novato, CA)
  • Experience: Mr. Viswanathan is listed as in-house legal counsel for BioMarin. In-house counsel typically manage external legal teams and provide internal strategic guidance on litigation matters.

As of the current date, the specific appearances for case 2:26-cv-01005 have not been readily identified in public search results. Filings can sometimes be sealed, or counsel appearances might not be immediately reflected in all public databases.

As of May 29, 2026, the counsel of record representing Zydus Lifesciences Ltd (including Zydus Lifesciences Global FZE and Zydus Pharmaceuticals (USA) Inc.) in BioMarin Pharmaceutical Inc. v. Zydus Lifesciences Ltd, D. New Jersey, case number 2:26-cv-01005, has not been identified through public web searches.

While initial docket entries confirm the parties involved, publicly available aggregate docket information (such as Justia Dockets, last updated February 27, 2026) lists counsel only for the plaintiff, BioMarin Pharmaceutical Inc.. No specific attorneys or firms have been named as representing the defendant(s) in this particular case in the search results.

Zydus Lifesciences Ltd is a frequent litigant in Hatch-Waxman patent infringement cases, and firms such as Kasowitz LLP have represented Zydus in past patent actions, including those in the District of New Jersey. However, these are general firm representations and do not confirm their involvement in the specific BioMarin case. Without direct access to recent PACER filings or more detailed public docket updates, the specific counsel of record for the defendant cannot be definitively identified at this time. It is possible that appearances have been filed since the last public update of these aggregate services, or are not publicly disclosed through these channels.