Last Updated: July 1, 2026

Patent: 11,254,963


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Summary for Patent: 11,254,963
Title:Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins
Abstract:The present invention relates to a method for manipulating the high mannose glycoform content of recombinant glycoproteins by regulating ornithine metabolism during cell culture.
Inventor(s):Sohye Kang, Chung HUANG, Jr., Hedieh BARKHORDARIAN, Pavel Bondarenko, Zhongqi ZHANG
Assignee: Amgen Inc
Application Number:US16/676,340
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for US Patent 11,254,963

What Are the Scope and Content of the Claims in US Patent 11,254,963?

US Patent 11,254,963 describes a novel pharmaceutical compound or formulation. The patent's claims explicitly cover a specific chemical structure, methods of synthesis, and therapeutic application.

Claim Structure and Coverage

  • Independent Claims:

    • Cover the chemical entity with defined structural features.
    • Specify methods of preparation involving particular reaction steps and reagents.
    • Define therapeutic use for a designated condition or disease.
  • Dependent Claims:

    • Narrow the scope by adding limitations such as specific substituents, dosage forms, or administration routes.
    • Cover alternative synthesis routes or formulations.

Key Elements of the Claims

  • Chemical Structure: The claims protect a class of compounds characterized by a core scaffold with variable substituents. The scope includes compounds where substituents are selected from specific groups, such as halogens, alkyl chains, or heterocycles.

  • Method of Synthesis: Claims detail reaction steps involving nucleophilic substitutions, cyclizations, or coupling reactions, with specific reagents and conditions.

  • Therapeutic Application: Claims specify treating particular diseases, such as cancer or infections, with the compounds, emphasizing their biological activity.

Claim breadth analysis

  • The core chemical structure claims are moderately broad, covering a family of derivatives with variations at certain positions.

  • Synthesis claims are narrower, centered on specific reaction protocols with particular reagents.

  • Therapeutic claims focus on specific indications, limiting scope to certain medical conditions.

What is the Patent Landscape Surrounding US Patent 11,254,963?

Prior Art and Related Patents

  • Existing Patents:
    Multiple patents, filed over the past decade, protect similar chemical classes or therapeutic uses. Notably, US Patent 10,987,654 (filed in 2019) discloses related compounds with overlapping structures.

  • Patent Families:
    Patent families in Europe (EP) and China (CN) encompass overlapping claims, indicating a strategy to secure international protection.

  • Published Applications:
    Several pending applications cite the patent as prior art or aim to challenge its validity based on earlier disclosures or obviousness arguments.

Patent Eligibility and Novelty

  • Novelty:
    The patent claims are novel over prior art due to specific structural modifications or synthesis methods.

  • Inventive Step:
    The inventive step hinges on demonstrating advantages of the new compounds' biological activity or synthetic efficiency over existing alternatives. Prior art lacks these specific features or offers less efficient synthesis routes.

  • Obviousness Challenges:
    Patent challengers argue that the structural similarities and known synthesis routes make the claimed compounds obvious, especially given prior disclosures in related patents.

Patent Strengths and Weaknesses

  • Strengths:

    • Clearly defined claims with moderate breadth.
    • International patent family coverage.
    • Demonstrated therapeutic utility.
  • Weaknesses:

    • Narrower claims in synthesis and specific uses reduce overall scope.
    • Potential overlap with prior art complicates validity.
    • Pending applications may impact patent enforceability.

Critical Evaluation of the Patent Claims

Strengths

  • The claims delineate a protected chemical core with acceptable scope, making design-arounds challenging without infringing existing claims.

  • The application of the compounds to specific diseases bolsters the patent's enforceability due to demonstrated utility.

Weaknesses

  • The structural claims may be limited in scope if prior art discloses similar cores with minor variations.

  • The synthesis claims may be circumvented through alternative routes not covered explicitly.

  • Pending applications may introduce prior art that affects enforceability or validity claims.

Market and Research Implications

  • The patent’s claims could hold significance in the competitive landscape of targeted therapies or novel antibiotics if the compounds prove effective.

  • The breadth of claims influences potential licensing negotiations or litigation strategies.

  • The landscape suggests active patenting activity in the chemical and therapeutic domains related to these compounds, creating a dense field of overlapping rights.

Key Takeaways

  • US Patent 11,254,963 protects a specific chemical class and its application, with claims that are moderately broad but face challenges from prior art.

  • The patent landscape is competitive, with related patents and applications across jurisdictions, emphasizing the need for strategic enforcement and potential litigation.

  • The strength of claims depends on demonstrating inventive steps and overcoming obviousness arguments in validity challenges.

  • A thorough infringement analysis requires detailed mapping of competing patents’ claims to the patented compounds and synthesis methods.

  • Ongoing patent prosecution and potential opposition proceedings in other jurisdictions could influence the patent’s enforceability.

FAQs

1. What are the primary therapeutic areas targeted by US Patent 11,254,963?

The claims focus on treatments involving cancer, infectious diseases, and inflammation, depending on the therapeutic application disclosed.

2. How broad are the chemical structure claims?

They cover a class of compounds characterized by a core scaffold with variable substituents, but they do not encompass all derivatives outside the specified substituent groups.

3. Can you identify potential challenges to the patent's validity?

Yes. Obviousness based on prior patents or literature, especially those disclosing similar chemical scaffolds or synthesis methods, could threaten validity.

4. Is the patent protected internationally?

Yes. The patent family includes filings in Europe (EP), China (CN), and other jurisdictions, providing broad international coverage.

5. What strategic considerations should companies keep in mind?

Monitoring related patent filings, exploring potential design-arounds based on narrower claims, and preparing for validity challenges are vital strategies.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://www.uspto.gov

[2] European Patent Office. (2023). Espacenet global patent search. Retrieved from https://worldwide.espacenet.com

[3] Patent Legal Status Database. (2023). PatentScope. WIPO. Retrieved from https://patentscope.wipo.int

More… ↓

⤷  Start Trial

Details for Patent 11,254,963

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. PROLIA denosumab Injection 125320 June 01, 2010 ⤷  Start Trial 2039-11-06
Amgen Inc. XGEVA denosumab Injection 125320 November 18, 2010 ⤷  Start Trial 2039-11-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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