Details for Patent: 10,562,934

Which drugs does patent 10,562,934 protect, and when does it expire?

Patent 10,562,934 protects ZILBRYSQ and is included in one NDA.

This patent has ninety-six patent family members in thirty-one countries.

Summary for Patent: 10,562,934

Title:	Modulation of complement activity
Abstract:	The present invention provides modulators of complement activity. Also provided are methods of utilizing such modulators as therapeutics.
Inventor(s):	Alonso Ricardo, Robert Paul Hammer
Assignee:	UCB Holdings Inc
Application Number:	US16/554,665
Patent Claim Types: see list of patent claims	Use;

US Patent 10,562,934: Scope, Claim Map, and U.S. Patent Landscape for Lysine-Conjugated Compounds and Modified Polypeptides

US Patent 10,562,934 claims a lysine-linked conjugate chemistry tied to a specific structural motif (the “compound comprising the structure of [formula]”), with both compound-level and polypeptide-level coverage. The estate is built around: (i) a defined chemical structure, (ii) lysine side-chain amine conjugation, (iii) integration of a modified lysine residue into polypeptides, and (iv) methods of modifying and synthesizing polypeptides using that modified lysine. This claim stack typically constrains design-around pathways by keeping both the conjugated compound and the resulting modified lysine residue within scope.

What patents protect the compound structure claimed in US 10,562,934?

Answer: US 10,562,934 protects a defined “compound comprising the structure of [specific formula],” plus its conjugation to lysine and incorporation as a modified lysine residue in polypeptides. The claims you provided are the core scope. Without the patent’s chemical structure text (the actual formula or substituents), downstream freedom-to-operate analysis cannot be completed at a molecular comparison level. Still, the claim architecture is sufficient to map the protection categories and likely adjacent prior-art and follow-on families.

Claim-scope categories in US 10,562,934

The provided claims define four scope buckets:

1. Compound claim (independent-style coverage)

   • Claim 1: “A compound comprising the structure of [formula].”
     This is the broadest chemical coverage because it does not require conjugation to lysine or incorporation into a polypeptide.

2. Conjugate claim (lysine-linked)

   • Claim 2: “The compound of claim 1, wherein the compound is conjugated to the side chain amine group of lysine to yield [conjugated structure].”
     This ties the structure to a specific attachment point: lysine ε-amino (side chain amine).

3. Polypeptide-modified residue claims

   • Claim 3: “The compound of claim 2, wherein the lysine residue is part of a polypeptide.”
   • Claim 4: “... wherein the lysine residue is the C-terminal residue of the polypeptide.”
     These add positional constraints (C-terminal lysine) that can narrow literal infringement but still capture products where the modified residue sits at the polypeptide terminus.

4. Method-of-use and method-of-manufacture claims

   • Claim 5: “A method of modifying a polypeptide, ... conjugating the polypeptide with a compound comprising the structure of [formula].”
   • Claim 6: “... wherein the compound is conjugated to the side chain amine group of lysine.”
   • Claim 7: “A method of synthesizing a polypeptide, ... incorporating a modified lysine residue into the polypeptide, wherein the modified lysine residue comprises the structure of [formula].”
     These capture both:
   • Post-synthesis modification (Claim 5/6) of lysine in a polypeptide
   • Incorporation during synthesis (Claim 7) via a modified lysine building block (or equivalent residue)

Practical claim-map: what must exist for infringement

For literal infringement on the method claims, the record must show at least one of:

• A polypeptide that contains lysine (for Claim 3/4; and for Claim 6 to be met, conjugation to lysine ε-amino is required), and
• Use of the claimed compound (Claim 5/6) that has the protected structural motif, or a
• Incorporation of a modified lysine residue with the motif (Claim 7).

Because Claim 4 specifically requires the lysine residue to be the C-terminal residue, many real-world products may fall between claims depending on the position of lysine in the relevant protein or peptide drug candidate.

How broad are the claims in US 10,562,934 compared with typical lysine-conjugate patents?

Answer: The claims are medium-to-broad at the chemical level (Claim 1) and medium at the conjugation level (Claims 2, 5, 6), then narrow at polypeptide positioning (Claim 4).

Breadth by claim type

• Claim 1 (compound): broadly covers the motif as such.
• Claim 2 (conjugate chemistry): narrows to conjugates where the lysine ε-amino is the attachment.
• Claim 3 (polypeptide): requires lysine residue present within a polypeptide.
• Claim 4 (C-terminal lysine): narrows to C-terminal lysine placement.
• Claim 5/6 (modification method): ties to conjugating a polypeptide with the compound motif, and specifies lysine ε-amino conjugation in dependent Claim 6.
• Claim 7 (synthesis method): narrows to incorporating a modified lysine residue with the motif during polypeptide synthesis.

Design-around pressure points

Given this claim stack, typical design-around strategies that reduce infringement risk include:

• Changing the attachment chemistry so the conjugate does not attach to lysine ε-amino (but this must be weighed against doctrine of equivalents and indirect infringement theory in litigation).
• Moving the modified lysine away from the C-terminal position, to avoid Claim 4 if that claim is asserted.
• Using a different residue concept (for example, substituting another amino acid conjugation strategy) that avoids using the “modified lysine residue” required by Claim 7.

Whether such strategies work depends on how the patent construes “compound comprising the structure of [formula]” and the exact conjugation and residue definitions.

What do the independent claims cover: compound, conjugate, modified polypeptide, or method?

Answer: US 10,562,934 covers all four, with the method claims anchored to the same structural motif used in compound and conjugate claims.

Claim 1: compound motif

• Coverage: the free compound motif regardless of conjugation partners.
• Litigation implication: if a competitor sells or uses that exact compound (or a substantially identical variant that still falls within “comprising the structure”), infringement risk is high.

Claim 2: lysine ε-amino conjugate

• Coverage: the lysine-conjugated form of the compound.
• Litigation implication: if a competitor performs conjugation of lysine residues with a similar motif but uses a different lysine attachment chemistry, the infringement analysis focuses on whether “conjugated to the side chain amine group of lysine” is satisfied.

Claim 3 and Claim 4: polypeptide context and C-terminal lysine

• Coverage: modified lysine residue present in a polypeptide; then further limited to C-terminal lysine.
• Litigation implication: many biologics and peptides contain lysines internally; Claim 4 can be a key narrowing constraint in claim construction and infringement analysis.

Claim 5 to Claim 7: modification and synthesis methods

• Coverage: two manufacturing routes:
  • post-synthesis conjugation to lysine ε-amino (Claim 5/6)
  • incorporation of modified lysine during synthesis (Claim 7)
• Litigation implication: a competitor can choose a manufacturing path. If a competitor uses a different route that avoids “incorporating a modified lysine residue comprising [motif],” Claim 7 risk is reduced, but Claim 5/6 risk may remain if post-synthesis conjugation uses the motif.

When does US 10,562,934 expire and what exclusivity does it interact with?

Answer: US patent term runs from the earliest effective filing date under 35 U.S.C. §§ 154, 156 adjustments, with possible regulatory adjustment depending on FDA marketing authorization and patent listed in Orange Book (if applicable).

Without the patent’s filing and priority dates, PTA/PTE, and any FDA regulatory listing tied to a specific NDA/BLA, the actual expiration date cannot be stated from the claim excerpt alone.

What is the Orange Book status of US 10,562,934?

Answer: Determination requires the specific FDA application (NDA/BLA) to which the patent is listed. The claim text alone does not identify the active ingredient, product, applicant, or Orange Book listing.

How many other U.S. patents likely cover the same lysine conjugate technology around US 10,562,934?

Answer: Patent estates for lysine-conjugation and modified amino-acid residue technologies commonly include a family of companion claims split across: the free compound, the conjugate reagent, modified amino-acid building blocks, peptide/protein conjugates, and methods of synthesis and conjugation.

However, a quantified count of “how many” and which specific US application numbers cannot be produced from the claim excerpt alone.

Which companies are likely challenging or licensing the lysine-conjugate patent estate?

Answer: Competitors in lysine-conjugated payload, linker-drug conjugates, and site-specific conjugation platforms are the likely parties to challenge or license.

A specific list of companies (and their Paragraph IV positions, if any) cannot be generated without tying the patent to a particular marketed product, investigational candidate, and Orange Book entry.

What patent litigation affects US 10,562,934?

Answer: Litigation impact depends on whether the patent is asserted against a specific NDA/BLA challenger or used in a direct infringement theory over reagent synthesis and conjugation steps.

No litigation docket can be tied to this patent from the claim excerpt alone.

What generic entry risks exist for products using lysine-linked conjugates covered by US 10,562,934?

Answer: Entry risk is strongest where a generic applicant must practice conjugation chemistry that uses the claimed motif and lysine ε-amino conjugation, especially where manufacture includes post-synthesis modification or incorporation of a modified lysine residue.

If the protected compound and the lysine ε-amino linkage are part of the generic product’s manufacturing or composition, the risk profile shifts:

• Composition-focused risk: if the generic has the same modified residue and conjugation pattern.
• Process-focused risk: if the generic’s manufacturing uses the patented modification or incorporation methods (Claims 5-7).

A product-level generic risk heatmap cannot be completed without knowing the active product composition and manufacturing route.

What formulations are protected by US 10,562,934?

Answer: The claims cover modified polypeptides that include a lysine residue conjugated with the claimed motif, with an additional constraint for C-terminal lysine in Claim 4.

Because the claims are not limited by dosage form (no tablet, injection, etc.) and are polypeptide-structure driven, the patent protection is composition-centric. Formulation protection is not explicit in the excerpt, so the estate likely does not claim excipient compositions unless there are additional claims not shown.

Method-of-use and manufacturing method: what does US 10,562,934 cover in practice?

Answer: It covers two operational workflows:

1. Modifying an existing polypeptide with the claimed conjugate reagent (Claims 5 and 6)
2. Synthesizing a polypeptide using a modified lysine residue that contains the claimed motif (Claim 7)

Operational risk for contract manufacturing organizations (CMOs)

CMOs handling conjugation often run batch records that can map to:

• “conjugating the polypeptide” (Claim 5/6)
• “incorporating a modified lysine residue” (Claim 7)

If the reagent corresponds to the claimed compound structure, manufacturing records become key evidence.

How does US 10,562,934 compare with other U.S. patents in lysine conjugation and modified amino-acid technologies?

Answer: Compared with broader lysine labeling patents, US 10,562,934 appears more specific because it anchors multiple claims to a single “compound comprising the structure of [formula]” and explicitly requires lysine side-chain amine conjugation. Compared with broader generic bioconjugation patents that allow multiple attachment chemistries, the specificity in Claim 2/6 narrows claim reach to the defined conjugate motif and lysine ε-amino attachment.

Likely adjacency patterns in the same technology space

Even without enumerating specific patents, typical adjacent IP in this space includes:

• Reagent synthesis routes for the conjugate motif (free compound preparation)
• Protected modified lysine building blocks used in solid-phase peptide synthesis
• Conjugation methods for site-specific labeling
• Protein or peptide payload conjugates where lysine position is specified (N-terminal, internal, or C-terminal)

US 10,562,934 most directly targets the building block motif and the lysine conjugation endpoint.

Key Takeaways

• US 10,562,934 claim scope centers on a defined chemical motif in Claim 1, then narrows to lysine ε-amino conjugation in Claim 2, and narrows further to C-terminal lysine in Claim 4.
• The patent also claims two manufacturing modes: post-synthesis modification of a polypeptide with the claimed motif (Claims 5/6) and synthesis using an incorporated modified lysine residue (Claim 7).
• The biggest design-around levers are changing the attachment chemistry away from lysine ε-amino and avoiding the C-terminal lysine feature for compositions that would otherwise match Claim 4.
• Expiration, Orange Book status, competitors, and litigation cannot be determined from the claim excerpt alone because they require the actual patent bibliographic data (priority/filing, assignee, cited families) and linkage to specific FDA applications.

FAQs

1) Does US 10,562,934 claim free lysine conjugates or only those on polypeptides?
Claim 1 covers the free compound motif. Claims 2-4 tie that motif to lysine conjugation and polypeptide context, with Claim 4 requiring C-terminal lysine.

2) Can a product avoid infringement by changing lysine position from C-terminal to internal?
Claim 4 requires the lysine residue be C-terminal. If infringement analysis relies on Claim 4 specifically, repositioning lysine may reduce Claim 4 risk, but Claims 2-3, 5-6, and 7 may still be implicated depending on the exact structures and methods used.

3) Do the method claims target conjugation manufacturing or only use of the final product?
They target manufacturing steps: Claim 5/6 cover modifying polypeptides by conjugating with the motif; Claim 7 covers synthesizing polypeptides by incorporating a modified lysine residue.

4) What is the strongest claim for blocking manufacture of conjugated polypeptides?
Claim 1 can be strongest if the exact compound is used or sold. If not, Claims 5-7 are strongest because they map to manufacturing workflows.

5) Is the patent likely relevant to drug-device conjugates or only peptide therapeutics?
The claims are polypeptide-structure driven, so relevance is strongest for peptide/protein therapeutics and polypeptide conjugates where lysine ε-amino modification occurs using the claimed motif.

References

1. U.S. Patent 10,562,934 (title, assignee, priority data not provided in prompt).

Drugs Protected by US Patent 10,562,934

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-001	Oct 17, 2023		RX	Yes	Yes	10,562,934			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	10,562,934			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes	10,562,934			Y

International Family Members for US Patent 10,562,934

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3154561		CA 2024 00021	Denmark
European Patent Office	3154561		301275	Netherlands
European Patent Office	3154561		PA2024514	Lithuania