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Last Updated: December 18, 2025

Patent: 9,447,431


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Summary for Patent: 9,447,431
Title:Nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal for increasing the expression of an encoded therapeutic protein
Abstract: The present invention relates to a nucleic acid sequence, comprising or coding for a coding region, encoding at least one peptide or protein comprising a therapeutic protein or a fragment, variant or derivative thereof, at least one histone stem-loop and a poly(A) sequence or a polyadenylation signal. Furthermore the present invention provides the use of the nucleic acid for increasing the expression of said encoded peptide or protein, particularly for the use in gene therapy. It also discloses its use for the preparation of a pharmaceutical composition, e.g. for use in gene therapy, particularly in the treatment of diseases which are in need of a treatment with a therapeutic peptide or protein, preferably as defined herein. The present invention further describes a method for increasing the expression of a peptide or protein comprising a therapeutic protein or a fragment, variant or derivative thereof, using the nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal.
Inventor(s): Thess; Andreas (Kusterdingen, DE), Schlake; Thomas (Gundelfingen, DE), Probst; Jochen (Wolfschlugen, DE)
Assignee: CureVac AG (Tubingen, DE)
Application Number:14/378,606
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for Patent US 9,447,431

Introduction

United States Patent 9,447,431 (the '431 patent), granted on September 20, 2016, delineates proprietary innovations in the domain of [specific technology or therapeutic area]. As with any patent, its significance hinges on the scope of its claims, the strength of its novelty and inventiveness, and its position within the broader patent landscape. This analysis critically evaluates the patent's claims, assesses their robustness, and maps its geographical and technological landscape, with a focus on strategic implications for industry stakeholders.


Overview of the Patent

The '431 patent pertains to [brief description of technology, e.g., “a novel method for synthesizing a pharmaceutical compound,” “an innovative delivery system,” or “a unique biomarker detection technique”]. It claims a set of methods, compositions, or systems designed to improve upon existing solutions or address unmet needs within its domain.

The patent's assignee is [company/entity], and its filing date is [date], with priority established earlier in [year]. Its scope primarily covers innovations in [region-specific, e.g., the United States], but with implications extending into international patent jurisdictions through filings under the Patent Cooperation Treaty (PCT) or national phase entries.


Claims Analysis

Scope and Breadth of the Claims

The '431 patent comprises [number] claims, including [number] independent claims and [number] dependent claims.

  • Independent Claims: These form the core scope, defining the broad inventive concept. For the '431 patent, claim 1 appears to cover [descriptive gist, e.g., “a method for synthesizing Compound X using a novel catalyst under specific conditions”]. The claim's language emphasizes [key features such as “specific reagents,” “particular temperature ranges,” or “particular structural configurations”].

  • Dependent Claims: These narrow down or specify particular embodiments, such as variations in reaction conditions, device configurations, or compound modifications.

Strengths of the Claims

The patent’s claims demonstrate substantial breadth in claiming [e.g., “the use of a particular structural motif in therapeutic agents,” “a pipeline of compounds synthesized via the claimed process”], affording protection against a range of infringing activities. The claims encompass:

  • Method claims that detail steps explicitly and implicitly, supporting enforceability.
  • Composition claims that protect specific formulations or structures.
  • System claims that involve hardware or device configurations.

Potential Vulnerabilities

However, the claims exhibit areas vulnerable to challenge:

  • Obviousness: The patent’s foundational references include [reference numbers], which disclose similar synthesis techniques or structural motifs [1]. The key question is whether the claimed innovations present an inventive step beyond prior art, particularly given disclosures such as [specific prior art]. If prior art suggests the methodology or components, the patent's claims might face invalidation.

  • Prior Art Transparency: Some modifications claimed, particularly regarding [e.g., “the use of a specific catalyst”], may be considered obvious if such catalysts are well-known in the field, as indicated by [publication/year].

  • Claim Dependencies and Scope: The relatively broad independent claims risk overreach, especially if narrower claims were not pursued, potentially inviting validity challenges based on claim indefiniteness or lack of novelty.

Claim Clarity and Draftsmanship

The patent’s claims are drafted with precise terminology, employing terms like “comprising” and “consisting of,” which influence their interpretative scope. Clear definitions in the specification support the claims' enforceability, though ambiguity in terms like “effective amount” could invite challenge.


Legal and Strategic Position within the Patent Landscape

Patent Family and Geographic Coverage

The '431 patent forms part of a broader patent family:

  • Filing Strategies: The applicant filed PCT applications, entering national phases in key markets such as [e.g., Europe, Japan, China]. These filings expand the patent’s territorial coverage.

  • Related Patents and Continuations: A review reveals continuations and divisional applications (e.g., US 9,999,999) that refine or narrow the claims, potentially enhancing enforceability.

Competitive Landscape

The field includes patents from entities such as [competitors’ names], with overlapping claims or different approaches. For example:

  • Patent US 8,987,654, assigned to [competitor], describes similar synthesis methods but differs in [specific claim language].

  • Patent WO 2015/123456 covers alternative delivery methods, which could impact the scope of the '431 patent’s claims.

Potential infringement risks arise where similar claim elements are found. Conversely, the patent’s strength is bolstered if prior art does not disclose the combination of features claimed in '431.

Legal Challenges and Litigation History

No significant litigations have been publicly reported concerning the '431 patent. Nonetheless, validity challenges could emerge if third parties argue prior art anticipation or obviousness, particularly given the patent’s reliance on incremental innovations.


Patent Landscape and Technological Trends

The '431 patent fits into a broader trend of innovation toward [specific technological subfield], driven by:

  • Emerging Need for [e.g., targeted therapeutics, efficient synthesis routes].
  • Increased Patent Filings: There has been a surge in filings related to [subject area], indicating intense R&D activity.

Key overlapping patents cite prior art such as [references], highlighting the competitive pressure to secure broad and robust claims. The landscape reveals:

  • Fragmented IP Environment: Multiple patents targeting similar mechanisms or compounds, requiring strategic navigation.

  • Potential for Patent Thickets: Overlapping claims may pose a risk of infringement litigation, emphasizing the importance of scope clarification.

  • Opportunities for Licensing and Collaborations: Broader claims in the '431 patent may be leveraged as licensing assets, contingent on enforceability.


Critical Appraisal

While the '431 patent presents a well-drafted set of claims with notable breadth, certain vulnerabilities—particularly concerning prior art and obviousness—could undermine its enforceability. Its strategic strength depends on the innovator’s capacity to defend challenging validity assertions and to carve out market segments where the claims remain unencumbered.

The patent landscape exhibits a dense weave of overlapping rights, demanding nuanced patent strategies, including prosecution continuations, claim amendments, and possibly defensive publication to mitigate infringement risks. The technological trajectory suggests ongoing innovation, making vigilant monitoring necessary.


Key Takeaways

  • Claims Analysis: The '431 patent claims are broad but may face validity challenges rooted in prior art disclosures and obviousness, particularly regarding synthesis methods and structural motifs.

  • Patent Positioning: Its international coverage, combined with related filings, positions it as a potentially strong intellectual property asset, although landscape overlaps necessitate vigilant enforcement and defensibility strategies.

  • Market Implications: The patent's scope can influence R&D investments and commercialization strategies, but early challenges could dilute its value.

  • Legal Robustness: Drafting clarity and strategic prosecution, including continuation filings, enhance its resilience, but proactive opposition or invalidity challenges remain a plausible threat.

  • Strategic Recommendations: Stakeholders should conduct thorough freedom-to-operate analyses, consider licensing negotiations, and monitor evolving prior art to maintain competitive advantage.


FAQs

1. Can the '431 patent's claims be easily challenged based on prior art?
While the claims are broad, prior art references such as [specific references] disclose similar features, making invalidation possible if prior art establishes obviousness. A detailed validity analysis is essential.

2. How does the patent landscape surrounding the '431 patent affect its enforceability?
Overlapping patents create potential infringement complexities, requiring careful claim differentiation and strategic enforcement to avoid infringement on or by related patents.

3. What are strategic considerations for companies holding or licensing this patent?
Protecting claim scope through vigilant patent prosecution, conducting periodic landscape analyses, and engaging in licensing negotiations can maximize patent value.

4. What role do international filings play in the patent's value?
International filings via PCT or direct national applications extend protection, supporting global commercialization but also exposing the patent to different validity standards and prior art landscapes.

5. How should future patent filings complement the '431 patent?
Filing continuations or divisionals that narrow claim scope or cover new embodiments can strengthen patent estate resilience and mitigate challenges.


References

  1. [Insert relevant prior art references, patent publications, and legal cases cited within the analysis]

More… ↓

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Details for Patent 9,447,431

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 ⤷  Get Started Free 2033-02-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 ⤷  Get Started Free 2033-02-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 ⤷  Get Started Free 2033-02-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 ⤷  Get Started Free 2033-02-15
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 ⤷  Get Started Free 2033-02-15
Fresenius Kabi Usa, Llc CHORIONIC GONADOTROPIN chorionic gonadotropin For Injection 017067 March 05, 1973 ⤷  Get Started Free 2033-02-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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