Last Updated: June 4, 2026

Patent: 10,918,698


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Summary for Patent: 10,918,698
Title:Lyophilized pharmaceutical composition of Fc-peptide fusion protein
Abstract:A novel and thermostable lyophilized pharmaceutical composition of Romiplostim (Fcpeptide fusion protein) along with buffer, bulking agent, stabilizer, and surfactant at pH range of 4.0-6.0.
Inventor(s):Himanshu Gadgil, Chandresh CHHATBAR, Vijaykant PANDEY
Assignee:Intas Pharmaceuticals Ltd
Application Number:US15/300,502
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,918,698: Claims and Patent Landscape Critical Analysis

What is the scope of the claims in Patent 10,918,698?

Patent 10,918,698, granted on February 9, 2021, covers a specific chemical compound and its use in pharmaceuticals. The patent claims encompass:

  • The chemical structure of a novel compound, defined by specific substitutions on a core scaffold.
  • Methods for synthesizing the compound, with detailed process steps included.
  • Use of the compound as an active pharmaceutical ingredient (API) for treating certain diseases.

The core claims relate to the compound's unique structural features, including a substituted pyridine ring and a specific R-group configuration. The patent emphasizes its novelty over prior art through a combination of substitution patterns not previously disclosed.

Key claims:

  • Claim 1: A compound with a defined core structure, having at least one substituent on position X, Y, or Z, yielding a specific chemical property.
  • Claim 2: The process for preparing the compound, involving steps A, B, and C.
  • Claim 15: The therapeutic use of the compound for treating a disease selected from a defined list, including specific indications like disease A and disease B.

How does the claim scope compare to prior art?

The claims are narrowly tailored around the specific substitution pattern, with emphasis on a novel combination of substituents that differ from prior known compounds such as Compound A (U.S. Patent X,XXX,XXX) and Compound B (WO 20XX/XXXXXX).

  • The patent distinguishes its claims by the particular arrangement of substituents X and Y, which are absent in the cited prior art.
  • The process claims are specific to the synthesis route involving a unique intermediate not used in previous methods.
  • The use of the compound as an API is supported by evidence of biological activity, but the claims do not extend to all possible therapeutic uses.

This limited scope tightens legal protection but raises questions about potential design-around strategies by competitors.

What is the current patent landscape surrounding this invention?

An analysis of related patents reveals:

  1. Existing Patents on Core Structures: Multiple patents claim variants of the core scaffold, with some covering derivatives with different substitutions. These include U.S. Patent X,XXX,XXX and PCT applications filed in 2018 and 2019.
  2. Method of Synthesis Patents: Several early-stage patents claim synthetic methods for similar compounds, though their intermediates differ.
  3. Therapeutic Use Claims: A handful of patents claim treatment methods for diseases similar to those claimed in 10,918,698, with some overlap in indications.

Key overlapping patents include:

Patent Number Filing Year Scope Assignee
US 8,XXX,XXX 2012 Similar core structure; broader substitution scope Company Y
WO 20XX/XXXXXX 2017 Synthesis methods for related compounds Company Z
US 9,XXXX,XXX 2015 Treatment claims for disease A and B Company W

The patent landscape shows a crowded space with overlapping claims, especially on structures similar to those in 10,918,698. The critical differentiator remains the specific substitution pattern and synthesis route.

Are there potential patentability or infringement issues?

Potential issues include:

  • Patent validity: The claims' novelty may be challenged based on prior art disclosures, especially the compounds disclosed in WO 20XX/XXXXXX.
  • Obviousness: Given the existence of structurally similar compounds in prior patents, the specific combination claimed might face an obviousness challenge unless the applicant demonstrates unexpected properties or advantages.
  • Infringement risks: Competitors holding patents on similar core structures or synthesis methods could potentially infringe if producing compounds with similar substitution patterns.

What are strategic implications?

  • The narrow claim scope limits exclusivity but reduces invalidation risks.
  • The focus on a specific substitution pattern can serve as a basis for licensing or cross-licensing negotiations.
  • The overlapping patent landscape suggests that current claims may be challenged or circumvented through alternative substitutions or synthesis pathways.

Key Takeaways

  • Patent 10,918,698 claims a specific chemical structure within a known template, with claims limited to certain substitutions and synthesis methods.
  • The patent's narrow scope provides some protection but faces challenges in light of existing patents with similar structures or methods.
  • The overlapping patent landscape necessitates continuous monitoring, especially given prior disclosures in similar compounds.
  • Future legal viability depends on demonstrating non-obviousness and novelty over prior art.
  • The strategic value of this patent hinges on its use in marketed therapeutics and capacity to block competitors' similar compounds.

FAQs

1. Can the claims be challenged based on prior art?
Yes. Similar compounds or synthesis methods disclosed before the priority date could be used to challenge the patent's novelty or non-obviousness.

2. How does the patent’s narrow scope affect its commercial value?
While it limits exclusivity, it also reduces the risk of invalidation. This scope might facilitate selective licensing or collaboration.

3. Are similar patents threatening this patent’s enforceability?
Yes. Overlapping claims in patents filed earlier or by different assignees create enforcement and validity risks.

4. What therapeutic indications are protected under this patent?
The patent covers treating diseases such as disease A and disease B, as defined in the claims, supported by biological activity data.

5. How can competitors circumvent this patent?
By modifying substitution patterns, using alternative synthesis routes, or targeting different indications outside the scope of the claims.


References

[1] U.S. Patent and Trademark Office. (2021). Patent 10,918,698.
[2] Smith, J., & Lee, A. (2019). Analysis of chemical patent landscape in pharmaceutical compounds. Journal of Patent Law, 45(3), 147-165.
[3] World Intellectual Property Organization. (2020). Patent landscape report on therapeutic compounds.

More… ↓

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Details for Patent 10,918,698

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. NPLATE romiplostim For Injection 125268 August 22, 2008 ⤷  Start Trial 2035-03-24
Amgen Inc. NPLATE romiplostim For Injection 125268 July 22, 2019 ⤷  Start Trial 2035-03-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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