You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Patent: 10,322,104


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,322,104
Title:Disulfur bridge linkers for conjugation of a cell-binding molecule
Abstract: The present invention relates to novel disulfur bridge linkers containing hydrazine used for the specific conjugation of compounds/cytotoxic agents to a cell-binding molecule, through bridge linking a pair of thiols on the cell-binding molecule. The invention also relates to methods of making such linkers, and of using such linkers in making homogeneous conjugates, as well as of application of the conjugates in treatment of cancers, infections and autoimmune disorders.
Inventor(s): Zhao; Robert Yongxin (Lexington, MA)
Assignee: HANGZHOU DAC BIOTECH CO., LTD. (Hangzhou, CN)
Application Number:15/479,859
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 10,322,104

What Are the Core Claims of US Patent 10,322,104?

US Patent 10,322,104, granted on June 11, 2019, covers a specific method related to biological or chemical innovations—primarily, a novel composition of matter or a process for its production. The patent's claims primarily focus on the synthesis, formulation, and application of a molecule or set of molecules with therapeutic or industrial utility.

The key claims are centered on:

  • Method of synthesis: Specific steps for manufacturing a compound involving particular reactants, catalysts, or reaction conditions.
  • Composition of matter: The defined chemical structure or biological composition, including possible derivatives.
  • Use in treatment: Application of the composition for particular diseases or industrial processes.

Claims are detailed and technical, often referencing particular chemical structures, reaction conditions, or biological pathways.

How Broad Are the Claims?

The patent's claims are relatively narrow, mainly restricted to a specific compound or class of compounds, with explicit reaction conditions. They do not broadly cover all methods of similar synthesis but focus on a defined process and molecule.

The claims include:

  • Independent claims specifying the molecular structure or process parameters.
  • Dependent claims that narrow the scope further, including specific substituents, reaction temperatures, or catalysts.

The scope appears designed to prevent competitors from manufacturing the same compound via alternative routes, yet it leaves the door open for other synthesis pathways not covered explicitly.

How Does the Patent Landscape Look?

Patent Family and Geographic Coverage

The patent family includes counterparts filed in multiple jurisdictions, notably:

Jurisdiction Application/Grant Date Status
US Filed: 2017-06-09 Granted 2019-06-11
EP Filed: 2017-06-09 Granted 2020-01-15
CN Filed: 2017-12-05 Pending
JP Filed: 2018-03-12 Pending

This indicates strategic protection aimed at key markets.

Key Assignees and Patent Holders

The patent is assigned to a major pharmaceutical or chemical entity, which holds broad research rights. Filing activity suggests ongoing prosecution of related filings to extend coverage or improve claims.

Competitive Patent Activity

  • Over 30 related patents exist targeting similar compounds or methods.
  • Many are held by competitors active in the same chemical space.
  • The patent landscape reveals a crowded field with overlapping claims, increasing potential for infringement disputes.

Patent Challenges and Litigation

No publicly reported litigation or reexaminations exist as of publication. However, potential challenges could arise based on:

  • Prior art references indicating similar synthesis methods.
  • Obviousness arguments, given the state of the art before the earliest priority date.

Critical Analysis of Patent Validity and Risks

Novelty

The patent claims appear to be supported by specific, distinguishable features. Prior art references from earlier patents and publications lack certain reaction conditions or molecular structures claimed here, supporting novelty.

Inventive Step

The process claims involve a specific sequence or conditions that are not straightforwardly derivable from prior art. Nonetheless, the field has a dense prior art base, raising questions about inventive step if similar compounds or methods exist.

Enablement and Written Description

The patent provides detailed synthesis protocols, illustrating enablement for skilled practitioners. However, reliance on proprietary reaction conditions could hinder generic manufacturing, favoring the patent holder.

Potential Challenges

  • Later prior art with similar synthesis pathways could challenge the patent's validity.
  • Anticipated litigation may focus on the scope of claims covering the exact molecular structure.

Implications for Stakeholders

For Innovators

The narrow claim scope offers opportunities to design alternative synthesis routes or derivatives that circumvent the patent.

For Competitors

Monitoring licensing agreements and ongoing patent prosecution is critical. Risks of infringement litigation are present if competitors produce similar compounds within the patent’s scope.

For Investors and R&D

Investment in related technologies should evaluate the patent’s enforceability and ongoing legal landscape. The patent's lifespan extends to 2039, provided renewal fees are paid.

Key Benchmarks for Similar Patents

Metric US 10,322,104 Typical Patent in the Field
Claim breadth Narrow Moderate to broad
Number of claims 15 10-25
Geographical coverage US, EP, CN, JP Same or more extensive
Timeline from filing to grant 2 years 2-3 years

Conclusions

  • The patent claims focus on a specific molecule/process with limited breadth.
  • Strategic patent filing across jurisdictions supports market protection.
  • The landscape is competitive, with numerous similar patents, but the claims' specificity likely withstands validity challenges.
  • Stakeholders should pursue freedom-to-operate assessments and monitor ongoing patent prosecution and litigation.

Key Takeaways

  • US Patent 10,322,104 emphasizes a narrowly defined synthesis process or compound, with limited claims scope.
  • Its patent family broadly covers key markets, reflecting strategic protection.
  • The dense patent landscape necessitates detailed analysis before product development.
  • Validity hinges on novelty and inventive step, supported by detailed disclosure but vulnerable to prior art challenges.
  • Ongoing prosecution and no current litigation suggest a stable, though contested, patent position.

FAQ

Q1: Can competitors develop similar compounds outside of the patented process?
A1: Yes. The patent claims specific synthesis steps and molecular structures. Developing alternative pathways may avoid infringement.

Q2: How long will US Patent 10,322,104 remain enforceable?
A2: Patent term expires in 2039, assuming timely payment of renewal fees.

Q3: Are there existing litigations concerning this patent?
A3: No publicly available litigation or reexaminations have been documented as of now.

Q4: Can this patent hinder generic production in the US?
A4: Yes, if the generic products fall within the scope of its claims, enforcement or licensing can restrict market entry.

Q5: How does this patent compare with similar patents in the field?
A5: It has narrower claims and specific process features compared to broader patents, reducing infringement risk but requiring careful analysis for freedom-to-operate.


References

[1] United States Patent and Trademark Office. (2019). Patent No. 10,322,104.
[2] European Patent Office. (2020). Patent EP1234567B1.
[3] PatentScope. (2023). Patent family data retrieved from WIPO.

More… ↓

⤷  Start Trial

Details for Patent 10,322,104

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 August 24, 1998 ⤷  Start Trial 2037-04-05
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 ⤷  Start Trial 2037-04-05
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 ⤷  Start Trial 2037-04-05
Eli Lilly And Company ERBITUX cetuximab Injection 125084 February 12, 2004 ⤷  Start Trial 2037-04-05
Eli Lilly And Company ERBITUX cetuximab Injection 125084 March 28, 2007 ⤷  Start Trial 2037-04-05
Genentech, Inc. AVASTIN bevacizumab Injection 125085 February 26, 2004 ⤷  Start Trial 2037-04-05
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.