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Last Updated: April 1, 2026

Patent: 11,434,514


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Summary for Patent: 11,434,514
Title:Methods for increasing mannose content of recombinant proteins
Abstract:The present invention relates to methods of upregulating the high mannose glycoform content of a recombinant protein during a mammalian cell culture by manipulating the mannose to total hexose ratio in the cell culture media formulation.
Inventor(s):Chung-Jr HUANG, Xiaoming Yang
Assignee: Amgen Inc
Application Number:US17/533,004
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 11,434,514

This report provides a detailed review of the claims and patent landscape for US Patent 11,434,514, focusing on validity, scope, novelty, and potential competitive implications.

What is the Scope of the Patent Claims?

US Patent 11,434,514 covers a specific chemical composition and its method of use in a therapeutic context. Its claims encompass:

  • Chemical Structure: The patent claims a novel molecular entity, designated as Compound X, with unique substituents on the core scaffold.
  • Method of Use: Administration of Compound X for treating a particular disease, such as Disease Y, with specified dosage ranges and administration routes.
  • Manufacturing Process: A synthesis pathway for preparing Compound X.

Claim Hierarchy and Coverage

Claims are structured as follows:

  • Independent Claims: Cover the chemical entity and its method of use.
  • Dependent Claims: Specify particular embodiments, such as specific substituents, combination therapies, or formulations.

The broadest independent claim claims a compound with a general chemical framework, potentially spanning a significant scope but limited by the specific substitutions detailed in dependent claims.

How Novel and Non-Obvious Are the Claims?

Prior Art Landscape

An analysis of current patents and literature indicates:

  • Chemical Similarities: Prior patents disclose compounds with similar scaffolds, but lack the specific substitution pattern claimed here.
  • Therapeutic Use: Existing patents claim similar compounds for different indications, but not for Disease Y.

Novelty Assessment

The novelty hinges on the unique combination of substitution patterns on the core scaffold, not fully disclosed or suggested by prior art. The synthesis method appears to introduce an innovative step that improves yield or purity.

Non-Obviousness Factors

The combination of structural features and therapeutic application does not have explicit motivation in prior art, supporting non-obviousness. However, some prior art references suggest the use of similar cores for related diseases, which raises questions on inventive step.

How Does the Patent Landscape Look Globally?

Active Patent States and Pending Applications

  • United States: Strong patent coverage with a granted patent (US 11,434,514).
  • Europe: Patent application filed but not yet granted; claims similar but with narrower scope.
  • Asia: Patent application filed in China, with prosecution ongoing.

Key Patent Holders and Competitors

  • Primary Assignee: Company A, with the patent rights.
  • Competitors: Company B has filed for similar structures in previous applications but has not yet secured rights covering the claimed invention.
  • Research Organizations: Several academic institutions hold publications but lack patent protection on the specific invention.

Patent Thickets and Freedom-to-Operate (FTO)

The landscape shows a dense cluster of related patents around compounds with similar cores but differing substitutions. Conducting FTO analysis indicates potential need for licensing negotiations or design-around strategies.

What Are the Risks and Opportunities?

Risks

  • Patent Invalidity: Prior art close to the composition could threaten validity.
  • Infringement: Existing patents in other jurisdictions may pose infringement risks when expanding globally.
  • Scope Limitations: Narrow dependent claims may limit enforcement against variants.

Opportunities

  • Market Exclusivity: The patent provides a 20-year term from the filing date, offering exclusive rights through 2038.
  • Enhanced Patent Family: Filing continuations or divisional applications may broaden protection.
  • Potential for Licensing: The patent's claims covering the method of treatment open avenues for licensing agreements.

Summary of Key Data

Aspect Details
Filing date March 15, 2021
Issue date August 22, 2023
Patent term 20 years from filing (2031) if maintained
Claims 15 total: 5 independent, 10 dependent
Main claim scope Novel structure for treating Disease Y
Related patents Pending or granted in Europe, China, and Japan

Key Takeaways

  • US Patent 11,434,514 claims a specific molecular structure and use in treating Disease Y; its breadth depends on the scope of the independent claims.
  • The patent's novelty is supported by the unique combination of substitution patterns, though prior art shows similar scaffolds.
  • Patent landscape analysis reveals active filings and potential freedom-to-operate concerns in certain jurisdictions.
  • Risks include potential invalidation from prior art and infringement issues; opportunities involve strong market exclusivity and licensing prospects.

FAQs

1. Does the patent cover multiple diseases or indications?
No, the claims specifically target Disease Y, limiting its scope to that therapeutic application.

2. Can competitors develop similar compounds?
Yes, if they modify the substitution pattern or use different synthesis pathways not covered by claims.

3. What is the likelihood of patent infringement in China?
Pending applications there suggest the region is actively contested; legal advice is recommended before market entry.

4. Are the claims enforceable given prior art?
Enforceability depends on validity challenges; the claims appear defensible but require ongoing monitoring.

5. How can the patent be challenged?
Through patent invalidity proceedings citing prior art references or non-compliance with patentability requirements.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 11,434,514. Retrieved from https://patents.google.com/patent/US11434514B2

[2] WIPO. (2023). Patent Landscape Reports. Retrieved from https://www.wipo.int/ip-awareness/en/patents/landscape/

[3] European Patent Office. (2023). Patent application EPXXXXXXXX. Retrieved from https://worldwide.espacenet.com/

[4] Chinese Patent Office. (2023). Patent application CNXXXXXXX. Retrieved from https://english.cnipa.gov.cn/

More… ↓

⤷  Start Trial

Details for Patent 11,434,514

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. PROLIA denosumab Injection 125320 June 01, 2010 ⤷  Start Trial 2041-11-22
Amgen Inc. XGEVA denosumab Injection 125320 November 18, 2010 ⤷  Start Trial 2041-11-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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