Untitled case

This patent infringement litigation, Pogona LLC v. Merck Sharp & Dohme LLC, concerns U.S. Patent No. 11,058,757, titled "Saccharide-polypeptide conjugate compositions and methods of use thereof." The patent broadly relates to pharmaceutical compositions, specifically pneumococcal conjugate vaccines (PCVs), utilizing novel combinations of Streptococcus pneumoniae serotypes conjugated to polypeptides to elicit an immune response. Plaintiff Pogona LLC is a biotechnology company focused on developing improved, next-generation PCVs, and claims to have developed a vaccine with a novel composition of serotypes aimed at preventing pneumococcal disease not covered by existing vaccines. Defendant Merck Sharp & Dohme LLC, a major multinational pharmaceutical company headquartered in Rahway, New Jersey, is accused of infringing the patent with its product, Capvaxive, a pneumococcal conjugate vaccine. Pogona alleges that Merck intentionally launched Capvaxive without the right to practice Pogona's PCV invention, asserting that without the '757 patent's invention, Merck would be unable to bring Capvaxive to market.

The case is currently active in the New Jersey District Court, case number 2:25-cv-15294. The assigned judge is Brian R. Martinotti, with Magistrate Judge James B. Clark, III, referred for discovery and other pre-trial matters. The District of New Jersey is a notable venue for patent litigation, particularly for pharmaceutical cases due to its specialized local patent rules designed to streamline and expedite such disputes, including specific provisions for Hatch-Waxman Act cases. This venue also frequently handles a high volume of patent cases, second only to Delaware, and its judges have developed expertise in the area. The procedural posture is early, with discovery stayed pending a decision on Merck's motion to stay the entire case.

This case is notable for several reasons. It involves an assertion by an operating biotechnology company, Pogona LLC, against a pharmaceutical giant, Merck, in the competitive pneumococcal vaccine market. The linkage to parallel inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) is also significant. Merck Sharp & Dohme LLC and Pfizer Inc. have both filed IPR petitions challenging the validity of the '757 patent, which could directly impact the district court litigation if claims are found unpatentable. The outcome of these IPRs and the motion to stay will be critical in determining the future trajectory of the infringement suit.

Key Legal Developments in Pogona LLC v. Merck Sharp & Dohme LLC

This patent infringement litigation, filed in the New Jersey District Court, involves U.S. Patent No. 11,058,757, which covers "Saccharide-polypeptide conjugate compositions and methods of use thereof". The case is currently active, with key developments focusing on initial pleadings, a motion to stay, and parallel proceedings at the Patent Trial and Appeal Board (PTAB).

Chronological Developments:

1. Filing & Initial Pleadings:

• Complaint Filed (2025-09-05): Plaintiff Pogona LLC initiated the lawsuit against Merck Sharp & Dohme LLC, alleging infringement of U.S. Patent No. 11,058,757.
• Answer and Counterclaims Filed (2025-11-24): Defendant Merck Sharp & Dohme LLC filed its answer to the complaint, which included counterclaims against Pogona LLC.

2. Pre-trial Motions of Substance & Discovery Milestones:

• Motion to Stay (Filed by Defendant, Date not specified but pending by February 2026): Merck Sharp & Dohme LLC filed a motion to stay the district court proceedings.
• Discovery Stayed (2026-02-25): United States Magistrate Judge James B. Clark, III, issued a letter order staying discovery in the case. This stay is pending the disposition of the Defendant's motion to stay the entire case.
• Briefing Schedule Adjustment (2026-03-02): Plaintiff Pogona LLC requested and was granted an adjustment to the briefing schedule for the motion to stay, with its opposition due March 16, 2026, and Defendant's reply due March 30, 2026.

3. Parallel PTAB IPR Proceedings:
Two Inter Partes Review (IPR) petitions have been filed against U.S. Patent No. 11,058,757 B2, potentially impacting the district court litigation:

• IPR2026-00189 (Filed 2025-12-23): Pfizer Inc. filed an IPR petition challenging the patent.
• IPR2026-00221 (Filed 2026-01-26): Merck Sharp & Dohme LLC, the defendant in the district court case, also filed an IPR petition challenging the patent.

As of the current date (2026-05-29), the district court case remains active, with discovery stayed pending the outcome of the motion to stay. No Markman hearing outcomes, trial events, or final dispositions have been recorded due to the early stage of the litigation and the pending motion to stay. The status of the IPR proceedings (e.g., institution decisions) would be a critical next development to monitor.

Plaintiff Pogona, LLC is represented by attorneys from Sills Cummis & Gross P.C. and Skiermont Derby LLP.

The counsel of record for Plaintiff Pogona, LLC are:

• Peter C. Urmston

  • Role: Local Counsel
  • Firm: Sills Cummis & Gross P.C., Newark, New Jersey
  • Note: Peter C. Urmston is an associate at Sills Cummis & Gross P.C. and is listed on the initial complaint. His firm, together with Skiermont Derby LLP, represents Pogona, LLC in this matter.

• Paul J. Skiermont

  • Role: Lead Counsel (pro hac vice)
  • Firm: Skiermont Derby LLP, Dallas, Texas
  • Note: Paul J. Skiermont is a founding partner of Skiermont Derby LLP and a prominent patent litigator. He is listed as pro hac vice counsel for the plaintiff in the complaint.

• Sarah E. Spires

  • Role: Counsel (pro hac vice)
  • Firm: Skiermont Derby LLP, Dallas, Texas
  • Note: Sarah E. Spires is an attorney at Skiermont Derby LLP and is listed as pro hac vice counsel for the plaintiff in the complaint.

• Ryan A. Hargrave

  • Role: Counsel (pro hac vice)
  • Firm: Skiermont Derby LLP, Dallas, Texas
  • Note: Ryan A. Hargrave is an attorney at Skiermont Derby LLP and is listed as pro hac vice counsel for the plaintiff in the complaint.

• Steven W. Hartsell

  • Role: Counsel (pro hac vice)
  • Firm: Skiermont Derby LLP, Dallas, Texas
  • Note: Steven W. Hartsell is an attorney at Skiermont Derby LLP and is listed as pro hac vice counsel for the plaintiff in the complaint.

Counsel of record representing defendant Merck Sharp & Dohme LLC in Pogona, LLC v. Merck Sharp & Dohme LLC, case number 2:25-cv-15294 in the New Jersey District Court, include attorneys from O'Melveny & Myers LLP as lead counsel, and FBT Gibbons (formerly Gibbons P.C.) as local counsel.

Lead Counsel (O'Melveny & Myers LLP)

• Robert F. Shaffer
  • Role: Partner, Lead Counsel (admitted pro hac vice)
  • Firm: O'Melveny & Myers LLP, Washington, D.C. office.
  • Experience Note: A first-chair trial attorney, Robert Shaffer specializes in complex patent litigation across pharmaceutical, medical device, and biologics technologies, with extensive experience in Hatch-Waxman disputes, International Trade Commission (ITC) actions, arbitrations, and Patent Trial and Appeal Board (PTAB) proceedings.
• Constance P. Lee
  • Role: Litigation Counsel, Lead Counsel (admitted pro hac vice)
  • Firm: O'Melveny & Myers LLP, Washington, D.C. office.
  • Experience Note: Constance Lee focuses on intricate patent and trade secret litigation in the chemical and pharmaceutical sectors, including cases under the Biologics Price Competition and Innovation Act (BPCIA) and Abbreviated New Drug Application (ANDA). She represents clients before federal district courts, the ITC, and the PTAB.
• Hassen A. Sayeed
  • Role: Partner, Co-Head of Life Sciences IP Litigation practice, Lead Counsel (admitted pro hac vice)
  • Firm: O'Melveny & Myers LLP, New York, NY office.
  • Experience Note: A Chambers-ranked trial lawyer with a medical degree, Hassen Sayeed specializes in life sciences patent litigation for pharmaceuticals, biotechnology, and medical devices. He has significant experience with Hatch-Waxman Act cases and biosimilars patent litigation.

Local Counsel (FBT Gibbons / Gibbons P.C.)

• Christine A. Gaddis
  • Role: Associate, Local Counsel
  • Firm: FBT Gibbons (formerly Gibbons P.C.), Red Bank, NJ office.
  • Experience Note: Christine Gaddis is an intellectual property litigation attorney recognized as a "Rising Star" for her work in New Jersey.
• Magnolia S. Joodi
  • Role: Attorney, Local Counsel
  • Firm: FBT Gibbons (formerly Gibbons P.C.), New Jersey office.
  • Experience Note: Magnolia Joodi focuses on complex commercial disputes, drawing on her extensive prior experience in marketing and strategy for major global corporations such as Nestlé Nutrition and Pfizer Consumer Healthcare.
• Derrick Neves
  • Role: Attorney, Local Counsel
  • Firm: FBT Gibbons (formerly Gibbons P.C.), New Jersey office.
  • Experience Note: Derrick Neves brings experience in civil litigation, including handling dispositive motions and discovery disputes, from his clerkships with the United States District Court for the District of New Jersey and the Superior Court of New Jersey.