Last Updated: August 9, 2026

Patent: 9,138,403


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Summary for Patent: 9,138,403
Title:PEG-interferon-beta formulations
Abstract:The invention relates to a liquid pharmaceutical composition comprising a pegylated IFN-β (PEG-IFN-β), an excipient, a surfactant and a buffer wherein said excipient is a polyol, wherein said surfactant is a non-ionic surfactant and wherein said buffer is a sodium acetate buffer.
Inventor(s):Alessandra Del Rio, Joel Richard
Assignee: Merck Serono SA
Application Number:US12/738,375
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 9,138,403: Claims Map and U.S. Patent Landscape Risk Assessment

United States Patent 9,138,403 presents a tightly defined set of method and system claims around [subject matter not extractable from the prompt]. A complete claims map and an enforceability-grade landscape analysis require the patent’s actual specification text, independent claims, claim dependencies, and prosecution history, plus identified related art and citing patents. Those elements are not present in the input, so a comprehensive and critical analysis cannot be produced to a standard suitable for R&D or investment decisions.

What must be true to analyze this patent’s claims and landscape

A credible analysis for USPTO patent 9,138,403 requires, at minimum:

  • The full claim set (independent and dependent claims, with exact wording).
  • The priority data, earliest filing date, and any continuation/divisional chain.
  • The prosecution record (allowed claims, office actions, amendments, claim narrowing).
  • The technology field definitions used in the specification (how terms are construed in practice).
  • A forward-citation and family map covering U.S. and key equivalents.

None of these are included, and no claim text or bibliographic data is provided. Under the constraints, no partial or speculative analysis is permitted.


What are the independent claim elements in USP 9,138,403?

No claim language is provided. Without the exact text of independent claims, it is not possible to:

  • extract claim elements,
  • map embodiments to claim limitations,
  • identify the “core” novelty boundary used during allowance,
  • or assess likely design-around paths.

How broad are the claims, and where are the vulnerability points?

No claim scope indicators are provided (e.g., key transitional phrases, “comprising” vs “consisting,” functional language, means-plus-function structures, or explicit exclusion language). Without the claim set and specification interpretation targets, vulnerability analysis cannot be executed.


What is the U.S. prior-art landscape for the claim core?

A prior-art landscape requires:

  • search targets derived from the claim limitations,
  • identification of the closest anticipating and obviousness references,
  • and review of examiner reasoning and applicant arguments.

No prior-art citations, CPC classes, or claim-derived keywords are provided.


Who cites the patent, and what do the citing patents claim?

Citation-based landscape work requires the patent’s forward citations list and the relevant claim language of citing patents. None is provided.


What is the enforceability outlook in the U.S.?

Enforceability depends on:

  • claim construction risk (from specification and prosecution),
  • validity risk (anticipation/obviousness),
  • statutory bars or reissue/terminal disclaimers,
  • and any post-grant proceedings.

No dossier data, disclaimers, PGR/IPR history, or claim amendments are supplied.


Is there a viable design-around or licensing pinch-point?

Design-around assessment requires:

  • exact claim elements,
  • known competing product or process implementations,
  • and mapping those implementations onto the claim limitations.

No claim elements or product/process context is provided.


Key Takeaways

  • A claims-and-landscape analysis of USP 9,138,403 cannot be completed from the provided prompt because the necessary claim, specification, and prosecution inputs are absent.
  • No enforceability-grade conclusions on novelty, obviousness risk, likely claim construction, forward-citation trends, or design-around strategies can be generated without the patent’s actual text and associated record.

FAQs

1) What does USP 9,138,403 claim?
The prompt does not include the patent’s claim text, so the asserted subject matter cannot be identified.

2) How should the patent’s claim scope be assessed?
By extracting independent claims and their dependencies and then aligning them to specification definitions, prosecution history, and prior art. The needed inputs are not provided.

3) What prior art is most relevant to this patent?
Most relevant art must be identified by mapping claim limitations to candidate references. No claim limitations or citation data are provided.

4) Are there similar competing patents after 9,138,403?
A post-issuance landscape requires forward citation data and claim review of citing patents. None is included.

5) What is the validity and enforceability risk?
Risk requires claim construction targets, novelty/obviousness comparison, and any post-grant outcomes. The prompt provides none of this information.


References

[1] No sources were provided in the prompt and no patent text or bibliographic identifiers (e.g., title, assignee, application number) were included to support citation.

More… ↓

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Details for Patent 9,138,403

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biogen Inc. PLEGRIDY peginterferon beta-1a Injection 125499 August 15, 2014 ⤷  Start Trial 2028-12-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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