Merck Sharp & Dohme LLC v. Pogona LLC

This case involves an inter partes review (IPR) filed by Merck Sharp & Dohme LLC against a patent held by Pogona LLC at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. Merck Sharp & Dohme LLC, known as Merck & Co., Inc. in the United States and Canada, is a global biopharmaceutical operating company that develops and manufactures a wide range of prescription medicines, vaccines, and biologic therapies, with a strong focus on oncology, infectious diseases, and vaccines. Pogona LLC is the owner of U.S. Patent No. 11,058,757 and has asserted this patent against Merck in a parallel district court action. Pogona's principals, including its CSO and Manager, Bruce D. Forrest, are listed as the inventors of the patent, and the company is actively engaged in developing and asserting intellectual property related to next-generation vaccines.

The patent at issue, U.S. Patent No. 11,058,757, titled "Saccharide-polypeptide conjugate compositions and methods of use thereof," generally relates to pharmaceutical compositions that include at least two distinct immunogenic saccharide-polypeptide conjugates. Specifically, the patent focuses on the selection of particular capsular polysaccharides from Streptococcus pneumoniae serotypes 23A, 23B, and/or 35B for use in vaccine compositions designed to elicit an immune response. In the related district court litigation, Pogona LLC alleges that Merck's Capvaxive Vaccine infringes the '757 patent through its manufacture, use, offer for sale, and sale within the United States.

The procedural posture of this case is an Inter Partes Review (IPR2026-00221) filed on January 26, 2026, before the PTAB. The PTAB declined to institute the review, with a status of "Not Instituted - Procedural." This outcome signifies that the PTAB did not proceed to a full trial on the merits of the patentability arguments, but rather dismissed the petition based on a procedural ground. Merck's petition for IPR specifically argued against discretionary denial under Fintiv, claiming that no trial schedule was set in the parallel district court litigation (Pogona LLC v. Merck Sharp & Dohme LLC, Civil Action No. 2:25-cv-15294, filed September 5, 2025, in the District of New Jersey), suggesting that the IPR would likely conclude before any district court trial. This case is notable because it involves a major pharmaceutical company challenging a patent related to critical vaccine technology, highlighting the ongoing interplay between pharmaceutical innovation and patent validity challenges, particularly in the context of the PTAB's discretionary denial policies for parallel litigation.

Key Legal Developments and Outcome for Pogona LLC v. Merck Sharp & Dohme LLC

This analysis details the key legal developments and outcome for the patent infringement litigation involving US Patent 11,058,757, primarily in the U.S. District Court for the District of New Jersey, and a related inter partes review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB).

District Court Patent Infringement Litigation

Caption: Pogona LLC v. Merck Sharp & Dohme LLC
Case number: 2:25-cv-15294
Court: U.S. District Court for the District of New Jersey
Filed: 2025-09-05
Status: Open
Patents at issue: US Patent No. 11,058,757 ("the '757 patent")

1. Filing & Initial Pleadings:

• Complaint for Patent Infringement: On September 5, 2025, Pogona LLC ("Pogona") filed a complaint against Merck Sharp & Dohme LLC ("Merck") in the District of New Jersey, alleging infringement of U.S. Patent No. 11,058,757. Pogona alleges that Merck's Capvaxive Vaccine infringes one or more claims of the '757 patent. The patent relates to pneumococcal saccharide-polypeptide conjugate vaccines.
• Answer and Counterclaims: Merck Sharp & Dohme LLC filed an Answer to the Complaint and asserted Counterclaims against Pogona LLC. The due date for Merck's answer was extended to November 24, 2025.

2. Pre-trial Motions of Substance:

• Motion to Stay Pending IPR: A letter from Peter C. Urmston to Magistrate Judge James B. Clark, III, regarding a "MOTION to Stay" was filed on March 2, 2026. This motion likely sought to stay the district court litigation pending the outcome of the parallel IPR proceeding. The outcome of this specific motion is not explicitly detailed in the provided search results but is implicitly impacted by the IPR's status.

3. Claim Construction (Markman) Outcomes:

• No specific claim construction (Markman) outcomes or hearing dates are available in the provided information for the district court case.

4. Discovery Milestones:

• No specific discovery milestones with strategic significance are detailed in the provided search results.

5. Trial Events, Verdict, and Post-Trial Motions:

• The case is currently listed as "Open," indicating it has not reached trial or a final verdict. No trial events, verdict, or post-trial motions have occurred.

6. Settlement, Dismissal, Judgment, or Appeal:

• The case remains active and open in the District of New Jersey. There has been no final disposition such as settlement, dismissal, or judgment.

Parallel PTAB IPR Proceedings

Caption: Merck Sharp & Dohme LLC v. Pogona LLC
Case number: IPR2026-00221
Court: PTAB (United States Patent and Trademark Office)
Filed: 2026-01-26
Status: Not Instituted - Procedural
Patents at issue: US Patent No. 11,058,757

1. IPR Filing:

• On January 26, 2026, Merck Sharp & Dohme LLC filed an inter partes review petition, IPR2026-00221, challenging the patentability of claims of US Patent No. 11,058,757.
• Merck argued that prior art references, specifically Porro and Mekalanos, anticipated or rendered obvious all 19 claims of the '757 patent. The petitioner contended that the original examiner of the '757 patent had erroneously concluded the claimed serotypes were free of prior art.

2. IPR Outcome and Effect on Litigation:

• The PTAB issued a decision on May 19, 2026, denying institution of IPR2026-00221 on "Procedural" grounds. This means the PTAB did not proceed to a full review of the challenged patent claims.
• The "Not Instituted - Procedural" status indicates that the PTAB declined to initiate the IPR for reasons other than the merits of the patentability challenge, such as timeliness, standing, or other discretionary factors.
• Given the denial of institution, the IPR proceeding did not result in any invalidated claims and therefore did not directly impact the scope of the asserted claims in the ongoing district court litigation. The district court case would likely continue without a stay based solely on the IPR.

Merck Sharp & Dohme LLC is represented by attorneys from O'Melveny & Myers LLP and in-house counsel in IPR2026-00221.

Counsel of Record for Merck Sharp & Dohme LLC:

• Benjamin Haber

  • Role: Lead Counsel
  • Firm: O'Melveny & Myers LLP, Los Angeles, CA
  • Note: O'Melveny & Myers has a patent litigation practice that regularly represents clients in IPR proceedings and has experience in technology and life sciences industries.

• William M. Fink

  • Role: Back-Up Counsel
  • Firm: O'Melveny & Myers LLP, Washington, DC
  • Note: O'Melveny & Myers has a patent litigation practice that regularly represents clients in IPR proceedings and has experience in technology and life sciences industries.

• Robert F. Shaffer

  • Role: Back-Up Counsel (Pro Hac Vice Pending)
  • Firm: O'Melveny & Myers LLP, Washington, DC
  • Note: Robert F. Shaffer has also appeared as counsel for Merck Sharp & Dohme LLC in other related patent litigation, such as Pogona LLC v. Merck Sharp & Dohme LLC in the District of New Jersey. O'Melveny & Myers has a patent litigation practice that regularly represents clients in IPR proceedings and has experience in technology and life sciences industries.

• Caitlin P. Hogan

  • Role: Back-Up Counsel
  • Firm: O'Melveny & Myers LLP, New York, NY
  • Note: O'Melveny & Myers has a patent litigation practice that regularly represents clients in IPR proceedings and has experience in technology and life sciences industries.

• Constance P. Lee

  • Role: Back-Up Counsel
  • Firm: O'Melveny & Myers LLP, Washington, DC
  • Note: Constance P. Lee has also appeared as counsel for Merck Sharp & Dohme LLC in other related patent litigation, such as Pogona LLC v. Merck Sharp & Dohme LLC. O'Melveny & Myers has a patent litigation practice that regularly represents clients in IPR proceedings and has experience in technology and life sciences industries.

• Mark Stewart

  • Role: Back-Up Counsel (In-house)
  • Firm: Merck Sharp & Dohme LLC, Rahway, New Jersey
  • Note: Mark Stewart is an in-house counsel for Merck, focusing on patent matters.

• Aaron G. Clay

  • Role: Back-Up Counsel (In-house)
  • Firm: Merck Sharp & Dohme LLC, Rahway, New Jersey
  • Note: Aaron G. Clay is a Director of Intellectual Property Litigation at Merck. Merck regularly hires patent counsel to work with its internal R&D team on patentability assessments, drafting and prosecuting patent applications, and conducting freedom-to-operate analyses.

Pogona LLC is represented by attorneys from Skiermont Derby LLP and Sills Cummis & Gross P.C. in the District of New Jersey patent infringement case.

Counsel of Record for Pogona LLC:

• Peter C. Urmston

  • Role: Lead Counsel (Local Counsel)
  • Firm: Sills Cummis & Gross P.C., Newark, New Jersey
  • Note: Mr. Urmston is an associate in the firm's Litigation Department with experience in commercial disputes and antitrust matters. He previously clerked for a U.S. District Court Judge for the District of New Jersey.

• Paul J. Skiermont

  • Role: Lead Counsel (Pro Hac Vice forthcoming at the time of initial filing)
  • Firm: Skiermont Derby LLP, Dallas, Texas
  • Note: Skiermont Derby LLP is known for its patent litigation practice.

• Sarah E. Spires

  • Role: Back-Up Counsel (Pro Hac Vice forthcoming at the time of initial filing)
  • Firm: Skiermont Derby LLP, Dallas, Texas

• Ryan A. Hargrave

  • Role: Back-Up Counsel (Pro Hac Vice forthcoming at the time of initial filing)
  • Firm: Skiermont Derby LLP, Dallas, Texas

• Steven W. Hartsell

  • Role: Back-Up Counsel (Pro Hac Vice forthcoming at the time of initial filing)
  • Firm: Skiermont Derby LLP, Dallas, Texas

It is worth noting that Bruce D. Forrest, listed as an inventor of the '757 patent and a principal of Pogona LLC, is a medical doctor with extensive global leadership experience in pharmaceutical development, particularly in vaccines and biopharmaceuticals. He serves as President of Hudson Innovations, LLC, and Co-Head of Life Sciences Investment Banking at Young America Capital, LLC.