Unified Patents v. Biomarin Pharmaceutical Inc.

This case is a Post-Grant Review (PGR) initiated by Unified Patents against BioMarin Pharmaceutical Inc. at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO), not a patent infringement litigation.

Unified Patents is a membership-based organization that aims to deter unsubstantiated or invalid patent assertions, particularly by Non-Practicing Entities (NPEs), and to improve patent quality. They do this by challenging patent validity through administrative patent reviews like IPRs and PGRs, and by providing patent risk management solutions to their members. BioMarin Pharmaceutical Inc. is a global biotechnology company headquartered in California, focused on developing and commercializing therapies for rare genetic diseases. Their core business includes enzyme replacement therapies and gene therapies, with approved therapies for conditions such as achondroplasia, phenylketonuria, and hemophilia.

The patent at issue is US Patent 12233106, titled "C-type natriuretic peptide variants to treat skeletal dysplasia in children." This patent generally describes methods for treating skeletal dysplasias in children, and improving symptoms like long bone growth, by administering variants of C-type natriuretic peptide (CNP). BioMarin's product, Voxzogo, is a subcutaneous CNP analog approved for the treatment of achondroplasia, a type of skeletal dysplasia, and is currently one of their biggest revenue drivers. While there isn't an "accused product" in a PGR in the same way as in an infringement suit, the challenge by Unified Patents likely targets the validity of this patent which protects BioMarin's commercial product, Voxzogo.

The procedural posture is a Post-Grant Review (PGR) filed on May 19, 2026, with the PTAB, a quasi-judicial body within the USPTO responsible for hearing appeals on patent prosecution and conducting post-grant validity challenges. Institution of the review has been granted, meaning the PTAB has determined that the petition demonstrates a reasonable likelihood that at least one challenged claim of the patent is unpatentable, and the review will now proceed to the merits phase. This venue is critical because PGRs offer a faster and often less expensive alternative to district court litigation for challenging patent validity, especially for newer patents. The filing party is listed as Unified Patents, but public records also indicate Ascendis Pharma A/S as a petitioner against BioMarin regarding this patent in the same PGR case number PGR2026-00013, suggesting Ascendis Pharma A/S may be the real party in interest or a co-petitioner with Unified Patents. This is notable as Ascendis Pharma A/S is developing a competing CNP product for achondroplasia, TransCon CNP, and has been in parallel patent disputes with BioMarin over CNP variants, including an infringement action at the European Unified Patent Court and a district court case where BioMarin alleged infringement of this very patent. The dispute highlights the intense competition and strategic use of patent challenges in the rare disease biotechnology space, particularly concerning treatments for conditions like achondroplasia.

Unified Patents initiated a Post-Grant Review (PGR) against Biomarin Pharmaceutical Inc. regarding the patentability of US Patent 12233106 before the Patent Trial and Appeal Board (PTAB). As of the current date, the case is in its very early stages, with institution of the PGR having been granted.

Here's a chronological summary of the key legal developments:

• 2026-05-19: Petition Filing. Unified Patents filed a Petition for Post-Grant Review (PGR) against Biomarin Pharmaceutical Inc., challenging the patentability of US Patent 12233106.
• Prior to 2026-05-29: Institution Granted. The Patent Trial and Appeal Board granted institution of the Post-Grant Review. This means the PTAB has determined that the petition demonstrates a reasonable likelihood that at least one challenged claim of US Patent 12233106 is unpatentable, and the review will proceed to a merits phase.
• Present Posture: The case PGR2026-00013 is currently active before the PTAB, having moved past the institution phase. The next steps will typically involve the Patent Owner's response to the substantive challenges, followed by a reply from the Petitioner, and potentially an oral hearing before a Final Written Decision is issued by the Board.

Parallel Proceedings:

There is no information available to indicate any parallel PTAB IPR proceedings or district court patent infringement litigation specifically involving US Patent 12233106 and Biomarin Pharmaceutical Inc. at this time. PGR proceedings are often initiated in response to or in anticipation of district court litigation, but no such related case was found.

Based on the available information, the specific counsel of record representing Unified Patents in PGR2026-00013 against Biomarin Pharmaceutical Inc. cannot be definitively identified.

Unified Patents operates as a "deterrence entity" and explicitly states it is not a law firm, nor does it maintain an attorney-client relationship with its members. However, Unified Patents does employ an in-house legal team and engages in administrative patent review activities, including Post-Grant Reviews (PGRs) at the PTAB.

The Unified Patents team includes several individuals holding the title of Senior Patent Counsel, such as Jenn Bisk, Kyla Bulter, Kelly Hughes, T.J. Murphy, Vinu Raj, Jordan Rossen, Andrea Shoffstall, and David Seastrunk. Jonathan Stroud is listed as the COO & CLO. Andrea Shoffstall, for instance, has been featured as a panelist discussing "Post-Grant Review Trials," indicating her involvement and expertise in such proceedings. Unified Patents also utilizes outside counsel for some proceedings.

Without direct access to the official docket for PGR2026-00013, it is not possible to specify which of Unified Patents' in-house counsel, or any external counsel, have entered an appearance as the counsel of record for this particular case. Filings are not sealed, but the specific docket entries detailing counsel appearances for this PTAB case are not contained within the provided search results.

Counsel for BioMarin Pharmaceutical Inc. (Defendant/Patent Owner)

Based on available information for PGR2026-00013, Naveen Modi of Paul Hastings LLP is identified as counsel for BioMarin Pharmaceutical Inc.. While the docket reference mentions "et al.", specific names for additional counsel on this particular PTAB matter are not explicitly detailed in the provided search results. However, Paul Hastings LLP has a robust Intellectual Property practice with significant experience in PTAB proceedings.

• Naveen Modi
  • Role: Likely Lead Counsel (Global Co-Chair of Intellectual Property Practice)
  • Firm: Paul Hastings LLP
  • Office Location: Washington, D.C.
  • Relevant Experience: Naveen Modi is recognized as a leading expert in challenging and defending patents before the Patent Trial and Appeal Board (PTAB), having been involved in well over 500 post-grant proceedings, including Post-Grant Reviews (PGRs). He has also represented BioMarin Pharmaceutical in IP matters. Managing Intellectual Property recognized him as "Outstanding IP Litigator of the Year for PTAB" and "Practitioner of the Year – PTAB." He also previously served as the president of the PTAB Bar Association.

Given the "et al." designation and the typical team structure for PTAB proceedings, other attorneys from Paul Hastings LLP are likely involved. Additionally, BioMarin Pharmaceutical Inc. may have in-house counsel, although specific names for this case are not available. Historically, BioMarin has also utilized other firms, such as Jones Day, for various patent litigation matters. However, for this specific PGR, Paul Hastings appears to be the primary external counsel identified.