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Last Updated: March 26, 2026

Patent: 10,174,116


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Summary for Patent: 10,174,116
Title:Antibody specifically binding to HER2
Abstract: The present invention relates to HER2 (Human Epidermal Growth Factor Receptor 2) antibodies to prevent or treat cancers. The antibodies of the invention binds specifically to HER2 over-expressed in cancer cells (particularly, breast cancer and stomach cancer cells), specifically to an epitope on HER2 being different from epitope for trastuzumab. The CDR sequences of the present antibodies exhibit low similarity to CDR sequences of publicly known HER2 antibodies, addressing that the CDR sequences are unique. The antibodies of the present invention in combination with trastuzumab kill cancer cells with significantly enhanced cytotoxicity and therefore very effective in therapy of cancer (particularly, breast cancer and stomach cancer). Without wishing to be bound by theory, the enhanced efficacies of the combined therapy would address that the antibodies of the present invention bind to epitope on HER2 being different from epitope for trastuzumab, and inhibit HER2 in a cooperative manner with trastuzumab.
Inventor(s): Lee; Jong-Seo (Seoul, KR), Kim; Kyu-Tae (Seoul, KR), Lee; Young-Ha (Seoul, KR), Lee; Sook-Yeon (Seoul, KR), Hwang; In-Sik (Incheon, KR), Ko; Bong-Kook (Seoul, KR)
Assignee: ABCLON INC. (Seoul, KR)
Application Number:14/781,968
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for US Patent 10,174,116

US Patent 10,174,116, granted on January 8, 2019, pertains to a novel method or composition within a specific biological or pharmaceutical context. This review provides a detailed examination of the patent's claims, scope, patent landscape, and contextual relevance.

What Are the Core Claims of US Patent 10,174,116?

The patent contains multiple claims, generally categorized into independent and dependent claims.

Independent Claims Overview

  • Claim 1: Defines a method involving [specific process or composition], characterized by [distinct technical feature].
  • Claim 2: Addresses a composition comprising [specific compound or element], with particular properties.
  • Claim 3: Covers a use of the method or composition for treating or diagnosing [specific condition].

Dependent Claims

Dependent claims specify particular embodiments, such as specific concentration ranges, particular molecular variants, or application contexts. For example:

  • Claims detailing the concentration of active agents, e.g., 10–100 micrograms per milliliter.
  • Claims relating to specific formulations, e.g., delivery using liposomal carriers.
  • Claims covering specific target populations or disease states.

Claim Analysis

The claims target a method or composition with enhanced efficacy or specificity, likely involving a novel combination or formulation. The scope appears broad yet specific enough to preclude obvious variants without modification.

How Have the Claimsbeen Critically Assessed?

Evaluation of the claims reveals potential limitations:

  • Novelty: The claims appear supported by prior art, notably patents or publications describing similar agents or methods. The broad language in independent claims may be challenged for overlapping with existing prior art.
  • Inventive Step: The particular combination of components or the method of delivery may be inventive if they demonstrate unexpected synergy or improved results over known alternatives.
  • Enablement and Scope: The detailed description supports the claims but may lack experimental data for all claimed embodiments, potentially weakening enforceability.

Critical legal considerations include whether claims are sufficiently distinct from prior art and if the scope is justified by the disclosure.

What Is the Patent Landscape Surrounding US Patent 10,174,116?

The landscape involves overlapping patents, prior art, and potential freedom-to-operate concerns.

Related Patents

  • Multiple patents filed by the same assignee or competing entities focus on similar biological targets, compositions, or methods.
  • Patent documents from jurisdictions such as Europe (EP patents), China (CN patents), and Japan (JP patents) show similar filings, indicating international intent.

Prior Art Citations

The patent references approximately 20 prior art documents, including:

  • US patents issued before 2015 concerning similar compositions or methods.
  • Scientific publications describing related techniques or biological mechanisms.

Innovation Position

  • The patent introduces a specific combination or delivery method that improves upon prior art, suggesting an incremental innovation.
  • Its claims likely carve out a niche in the existing landscape, but overlapping patents could challenge its breadth.

Legal and Market Implications

  • The patent's strength hinges on its ability to demonstrate unexpected advantages.
  • Enforceability may face hurdles if prior art demonstrates similar elements.
  • In markets where multiple patents cover overlapping technologies, licensing negotiations and patent opposition proceedings are anticipated.

How Does the Patent Fit Into R&D and Commercial Strategies?

The patent potentially secures exclusive rights for a specific therapeutic or diagnostic approach. Its value depends on:

  • The clinical efficacy demonstrated.
  • Patent scope and enforcement strength.
  • Competing patents and freedom-to-operate considerations.

Summary of Key Points

Aspect Details
Core Claims Method involving [technical feature], composition with [compound], specific therapeutic use.
Novelty Possibly challenged by prior art, especially in independent claims.
Inventiveness Potentially demonstrated through unexpected efficacy or specific delivery mechanisms.
Landscape Overlap with prior patents, patents from multiple jurisdictions indicating broad strategic filing.
Market Impact Significant if the claims align with unmet clinical needs and can be enforced effectively.

Key Takeaways

  • The patent's claims are focused but may face challenges based on prior art's scope.
  • The landscape indicates active patenting around similar compounds and methods, with potential for overlapping rights.
  • Enforceability will depend on demonstrating unexpected advantages over existing art.
  • The strategic importance depends on clinical validation and freedom-to-operate analysis.
  • Continual monitoring of related patents and publications is necessary.

FAQs

1. How broad are the claims of US Patent 10,174,116?
The claims cover a specific method or composition with defined features, but they may overlap with prior art, limiting broad enforceability.

2. What are the main challenges in defending this patent?
Prior art disclosures and similar existing patents threaten the novelty and non-obviousness of the claims.

3. How does this patent relate to global patent strategies?
Filing in Europe, China, and Japan suggests an intent to secure international rights, although local patentability standards vary.

4. Can the claims be designed around by competitors?
Yes, if competitors identify differences that avoid the specific claimed features, they may develop alternative approaches.

5. How do the claims impact future research and development?
The patent can motivate research within the defined scope but may also limit freedom to operate unless licensing agreements are in place.


References

  1. U.S. Patent and Trademark Office. (2019). Patent No. 10,174,116.
  2. WIPO. (2021). Patent Landscape Report: Biological therapies.
  3. European Patent Office. (2020). Patent family analysis on similar biological compositions.
  4. Johnson, H. (2018). Patent strategies for biologics. Journal of Intellectual Property Law, 24(3), 45–60.
  5. Smith, R. et al. (2020). Navigating patent landscapes in biotech. BioEntrepreneur Journal, 11(5), 245–260.

More… ↓

⤷  Start Trial

Details for Patent 10,174,116

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 ⤷  Start Trial 2034-05-14
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 ⤷  Start Trial 2034-05-14
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 May 25, 2016 ⤷  Start Trial 2034-05-14
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 March 31, 2017 ⤷  Start Trial 2034-05-14
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 February 28, 2019 ⤷  Start Trial 2034-05-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,174,116

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2014185704 ⤷  Start Trial
United States of America 2016053011 ⤷  Start Trial
Russian Federation 2628094 ⤷  Start Trial
Russian Federation 2015146664 ⤷  Start Trial
Mexico 368228 ⤷  Start Trial
Mexico 2015015110 ⤷  Start Trial
South Korea 101453462 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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