DCT
2:25-cv-15294
Pogona LLC v. Merck Sharp & Dohme LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Pogona, LLC (Delaware)
- Defendant: Merck Sharp & Dohme LLC (New Jersey)
- Plaintiff’s Counsel: Sills Cummis & Gross P.C.; Skiermont Derby LLP
- Case Identification: 2:25-cv-15294, D.N.J., 09/05/2025
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Merck resides and maintains its principal place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Capvaxive pneumococcal conjugate vaccine infringes a patent related to novel compositions of pneumococcal serotypes designed to combat emerging strains of bacteria.
- Technical Context: The technology lies in the field of pneumococcal conjugate vaccines (PCVs), which are critical for preventing invasive pneumococcal diseases such as pneumonia and meningitis, particularly as the prevalence of bacterial serotypes shifts in response to widespread vaccination.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the asserted patent and its underlying application. Specifically, it states that Plaintiff’s predecessor entity disclosed the patent application to Defendant during a meeting on October 25, 2017, and that the patent’s inventor later discussed the granted patent with Defendant on October 10, 2021. Defendant allegedly reviewed the intellectual property and declined to pursue a license on October 15, 2021, nearly three years before launching the accused product.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-31 | U.S. Patent No. 11,058,757 Priority Date |
| 2017-10-25 | Plaintiff’s predecessor allegedly discloses patent application to Defendant |
| 2021-07-13 | U.S. Patent No. 11,058,757 Issues |
| 2021-10-10 | Patent inventor allegedly discusses granted patent with Defendant |
| 2021-10-15 | Defendant allegedly informs Plaintiff it has no interest in the IP |
| 2024-06-17 | FDA approves Defendant’s Capvaxive Vaccine |
| 2024-06-27 | CDC advisory committee recommends Capvaxive |
| 2025-09-05 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,058,757 - "Saccharide-Polypeptide Conjugate Compositions and Methods of Use Thereof"
The Invention Explained
- Problem Addressed: The complaint asserts that widespread use of existing pneumococcal conjugate vaccines, such as PCV13, led to a phenomenon known as "serotype replacement" (Compl. ¶¶ 35, 39-40). This created a public health challenge where the bacterial serotypes not covered by existing vaccines began to account for an increasing percentage of invasive pneumococcal disease (IPD) (Compl. ¶40). Prior vaccine development had largely focused on adding more serotypes from an older, pre-existing vaccine backbone (PPSV23), an approach the patent’s inventors viewed as inadequate for addressing newly emerging pathogenic strains (Compl. ¶33).
- The Patented Solution: The ’757 patent discloses pharmaceutical compositions for vaccines that include specific pneumococcal serotypes selected to provide coverage against these emerging strains (Compl. ¶¶ 34, 37). Rather than building on the historical PPSV23 backbone, the invention claims combinations of serotypes—such as 23A, 23B, and 35B—that were identified through epidemiological surveillance as causing a significant share of modern IPD cases not covered by prior vaccines (’757 Patent, col. 4:36-50; Compl. ¶42). The complaint includes a table from the CDC ranking non-PCV13 serotypes causing IPD, which lists 23A, 35B, and 23B among the most prevalent strains in adults and children (Compl. ¶41).
- Technical Importance: The invention represents a strategic shift from expanding existing vaccine formulations to designing new ones based on current epidemiological data to target the most clinically relevant circulating serotypes (Compl. ¶¶ 34, 44).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3 and 12 (Compl. ¶72).
- Independent Claim 1 requires:
- A pharmaceutical composition
- comprising a plurality of at least two unique immunogenic saccharide-polypeptide conjugates,
- each comprising individually a capsular polysaccharide conjugated to a polypeptide,
- wherein each of the capsular polysaccharides is from a Streptococcus pneumoniae serotype selected from a group consisting of 23A, 23B, and 35B.
- The complaint expressly reserves the right to assert additional claims (Compl. ¶72, fn. 1).
III. The Accused Instrumentality
Product Identification
- Defendant’s Capvaxive™ (Pneumococcal 21-valent Conjugate Vaccine) (Compl. ¶1).
Functionality and Market Context
- Capvaxive is a vaccine indicated for active immunization for the prevention of invasive disease and pneumonia caused by 21 different serotypes of Streptococcus pneumoniae in adults (Compl. ¶75). The complaint alleges that the vaccine is a sterile solution containing purified capsular polysaccharides from each of the 21 serotypes, with each polysaccharide individually conjugated to a CRM197 carrier protein (Compl. ¶¶ 75-76, 80).
- The complaint quotes Defendant’s statements that Capvaxive was "specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults" and that it "targets serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over" (Compl. ¶46).
IV. Analysis of Infringement Allegations
11,058,757 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition... | The accused Capvaxive product is identified as a "(Pneumococcal 21-valent Conjugate Vaccine) Injection, for intramuscular use," which the complaint alleges is a pharmaceutical composition. | ¶75 | col. 4:56-62 |
| ...comprising a plurality of at least two unique immunogenic saccharide-polypeptide conjugates, each comprising individually a capsular polysaccharide conjugated to a polypeptide... | Capvaxive is described in its prescribing information as a "sterile solution of purified capsular polysaccharides from S. pneumoniae serotypes... individually conjugated to CRM197 carrier protein," constituting a plurality of unique conjugates. A screenshot of this description is provided in the complaint (Compl. ¶75). | ¶75, ¶76 | col. 7:1-6 |
| ...wherein each of the capsular polysaccharides is from a Streptococcus pneumoniae serotype selected from a group consisting of 23A, 23B, and 35B. | The prescribing information for Capvaxive, excerpted in the complaint, explicitly lists serotypes 23A, 23B, and 35B as being among the 21 serotypes included in the vaccine for which it provides active immunization (Compl. ¶77). | ¶77 | col. 51:39-41 |
Identified Points of Contention
- Scope Questions: The complaint’s infringement theory appears to rely on a direct, literal reading of the accused product's own descriptive materials against the claim language. A potential point of contention may arise from the open-ended "comprising" language of Claim 1. The claim recites a composition "comprising a plurality of at least two" conjugates selected from a three-member group, whereas the accused product is a 21-valent vaccine. This raises the question of whether the presence of 18 additional, unrecited serotypes in the accused product impacts the infringement analysis of the "wherein each" clause, which modifies the claimed "plurality."
- Technical Questions: The infringement allegations are primarily based on Defendant's prescribing information. A technical question for the court may be what evidence, beyond product labeling, confirms that the accused product as manufactured and sold contains separate and unique immunogenic conjugates for serotypes 23A, 23B, and 35B, as opposed to, for example, a multivalent conjugate or a formulation where the components do not function as claimed.
V. Key Claim Terms for Construction
- The Term: "a plurality of at least two unique immunogenic saccharide-polypeptide conjugates ... wherein each of the capsular polysaccharides is from a Streptococcus pneumoniae serotype selected from a group consisting of 23A, 23B, and 35B"
- Context and Importance: The construction of this phrase is central to the dispute. The accused product contains the three serotypes from the claim's Markush group but also contains 18 other serotypes. Practitioners may focus on this term because its interpretation will determine whether the claim requires a composition to only contain conjugates from the specified group or merely to include at least two conjugates from that group.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the transitional phrase "comprising" in the claim's preamble typically signals that the claim is open-ended and does not exclude additional, unrecited elements. The patent's specification discusses compositions with a large number of serotypes (e.g., "a plurality of at least 29 unique immunogenic... conjugates") (’757 Patent, col. 1:40-42), which may support an interpretation that the claims are intended to cover compositions that include the recited serotypes as part of a larger combination.
- Evidence for a Narrower Interpretation: A party might argue that the clause "wherein each of the capsular polysaccharides is from..." modifies the entire "plurality," thereby limiting that plurality to only members selected from the three-member group. Language in the specification emphasizing the novelty of combining these specific, previously-excluded serotypes could be cited to argue that the invention is the particular combination itself, not its inclusion in a broader vaccine.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement under 35 U.S.C. § 271(b), stating that Defendant’s prescribing information, dosage instructions, and other promotional materials instruct and encourage physicians and healthcare providers to administer the allegedly infringing vaccine (Compl. ¶¶ 84, 86, 88). The complaint provides a screenshot of the "HIGHLIGHTS OF PRESCRIBING INFORMATION" for Capvaxive as evidence of these instructions (Compl. ¶88). The complaint also alleges contributory infringement under § 271(c), asserting that the accused vaccine has no substantial non-infringing use (Compl. ¶¶ 89-90).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported pre-suit knowledge of the patent and its underlying application. The complaint alleges that Defendant was first made aware of the patent application on October 25, 2017, in a meeting with Plaintiff's predecessor, and was later notified of the granted patent on October 10, 2021, by the inventor (Compl. ¶¶ 85, 92). The complaint further alleges that Defendant reviewed the intellectual property and expressly declined to license it on October 15, 2021, yet proceeded to launch the accused product in 2024 (Compl. ¶¶ 63-65).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central legal question will be one of claim construction: does the language "comprising a plurality... wherein each... is from a group consisting of 23A, 23B, and 35B" read on a 21-valent vaccine that contains those three serotypes among 18 others, or does the "wherein each" clause limit the scope of the claimed "plurality" to only members of the recited group?
- A key factual issue will concern willfulness: given the detailed allegations of pre-suit notice, including disclosure of the patent application nearly seven years before launch and subsequent communications regarding the granted patent, the court will likely focus on whether Defendant’s decision to proceed without a license constituted egregious conduct sufficient to warrant enhanced damages.
- An underlying strategic question, prompted by the directness of the literal infringement allegations, will be one of validity: whether Merck's primary defense will be to challenge the patent's validity by arguing that the claimed combination of serotypes was anticipated or rendered obvious by prior art epidemiological data and vaccine development efforts preceding the patent’s March 2016 priority date.