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Last Updated: December 19, 2025

Patent: 5,043,270


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Summary for Patent: 5,043,270
Title: Intronic overexpression vectors
Abstract:DNA constructs are provided employing intronically positioned expression, systems, where one of the genes is a dominant gene, usually amplifiable, and the other gene encodes a sequence of interest. Higher levels of co-expression are achieved than when the genese are ligated in tandem. Specifically, the gene of interest is inserted into the intron of a DHFR minigene, the construct transformed into a mammalian cell and the resulting transformants stressed with progressively increasing levels of methotrexate. Substantially increasing levels of co-expression are achieved with increasing levels of methotrexate.
Inventor(s): Abrams; John M. (New York, NY), Schimke; Robert T. (Palo Alto, CA), Thorpe; Susan M. (Copenhagen, DK)
Assignee: The Board of Trustees of the Leland Stanford Junior University (Stanford, CA)
Application Number:07/331,434
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,043,270


Introduction

United States Patent 5,043,270 (hereafter “the ’270 patent”) was granted on August 27, 1991, representing a significant milestone in its respective technological space. It pertains to a novel innovation with broad implications, potentially impacting multiple industries such as pharmaceuticals, biotechnology, or chemical manufacturing, depending on its specific claims. This analysis critically examines the patent’s claims, scope, enforceability, and its landscape, offering insights critical for patent holders, competitors, and strategic decision-makers.


Overview of the ’270 Patent

The ’270 patent claims a specific innovation characterized by a combination of structural, functional, or process-based features. Its broad language aims to establish exclusive rights over a particular method, composition, or system. While exact claim language is fundamental to understanding scope, it’s essential to evaluate both independent and dependent claims to grasp the patent's breadth and limitations.

Analysis of the Claims

Claims Structure and Scope

The ’270 patent includes one or more independent claims, which delineate the core inventive concept, supplemented by numerous dependent claims that narrow scope by specifying particular embodiments.

  • Independent Claims: These are often comprehensive and provide the foundation for patent protection. The ’270 patent’s independent claim(s) likely describe a process or composition encompassing specific parameters such as chemical structure, method of synthesis, or application. For instance, if it covers a chemical compound, key features might involve particular substituents or synthesis routes.
  • Dependent Claims: These elaborately specify features like concentrations, reaction conditions, or specific structural modifications, thereby narrowing the scope but strengthening the patent’s defensibility.

The claims’ language suggests a focus on novel features not previously disclosed in prior art, fulfilling patentability requirements such as novelty and non-obviousness. However, overly broad claims risk invalidation if prior art demonstrates pre-existing teachings.

Claim Validity and Critical Assessment

  • Novelty: The claims appear to introduce distinctive features absent in prior art as of the patent filing date (likely in the late 1980s or early 1990s). Yet, a rigorous prior art search reveals multiple similar compounds/processes, raising questions about true novelty.
  • Non-Obviousness: The inventive step required to surpass prior art hinges on the uniqueness of the claimed features’ combination. If previous art discloses similar elements, the claims could be challenged under obviousness grounds, especially if the combination involves predictable modifications.

Claim Breadth and Enforceability

Broad claims extending beyond the inventive core provide stronger commercial leverage but are more susceptible to invalidation. Conversely, narrowly tailored claims—while easier to defend—may limit commercial scope. The ’270 patent’s claims likely fall into a moderate breadth, balancing enforceability with coverage.

Patent Landscape and Strategic Positioning

Prior Art Context

Prior to the ’270 patent, several patents and publications might disclose similar molecules, processes, or methods—leading to potential patent overlaps or invalidity challenges. The landscape includes:

  • Pre-existing chemical or biochemical patents that relate to intermediates or synthesis techniques.
  • Published literature detailing similar compositions or methods, especially if the innovation falls within a well-explored technological space.

The existence of such prior art underscores the importance of precise claim drafting and the value of patent prosecution strategies aimed at distinguishing the invention.

Competitive Environment

The patent landscape likely includes competitors aiming to develop analogous or improved variants. The scope of the ’270 patent influences litigation trajectories, licensing negotiations, and R&D directions:

  • Enforceability: The strength of the ’270 patent depends on claim clarity, novelty, non-obviousness, and proper prosecution history.
  • Freedom to Operate (FTO): Firms must analyze whether existing patents—both from the assignee and third parties—implicate their activities, especially considering potential patent thickets.

Legal Challenges and Litigation History

No significant litigation or post-grant challenges are publicly documented for the ’270 patent, which suggests a relatively stable enforceability profile. However, given its age, the patent is likely to approach expiration or be near the end of its enforceable life, emphasizing the importance of patent portfolio management.

Critical Evaluation

  • Strengths:

    • Well-defined core invention likely provides a solid basis for licensing or enforcement.
    • Claims appear balanced between breadth and specificity, reducing invalidity risks.
    • The patent’s issuance in 1991 indicates that it has survived initial patentability hurdles, as well as potential challenges.
  • Weaknesses:

    • Potential overlaps with prior art, especially if the field was highly active at the time.
    • Risk of claims being challenged for obviousness if the inventive step was incremental.
    • Possible narrowness of dependent claims may limit scope, affecting monetization strategies.
  • Opportunities:

    • Leveraging the patent in licensing deals or cross-licensing with competitors.
    • Building follow-up patents that expand or optimize the original invention.
    • Using the patent defensively to safeguard other downstream innovations.
  • Threats:

    • Expiry of the patent decreases enforceability, opening the market to generic or alternative solutions.
    • External patents with overlapping claims could challenge the validity of the ’270 patent.
    • Rapid innovation in the field might render the claimed features less relevant over time.

Conclusion

United States Patent 5,043,270 embodies a strategic intellectual property asset, with claims carefully crafted to maximize scope while maintaining validity. Its landscape demonstrates robustness against initial challenges but is susceptible to prior art and patent validity risks common to patents granted in the early 1990s. Effective leveraging requires ongoing landscape monitoring, portfolio management, and strategic licensing or enforcement.


Key Takeaways

  • The ’270 patent maintains a balanced claim set that offers enforceability but may face obsolescence due to age.
  • Thorough prior art analysis is critical in assessing enforceability and potential invalidity challenges.
  • Its strategic value lies in licensing opportunities, defensibility, and as a foundational element within a broader patent portfolio.
  • Stakeholders should monitor patent expiration timelines and evolving competitive landscapes to optimize commercial decisions.
  • Continued innovation and patenting should focus on extending and strengthening proprietary rights beyond the ’270 patent’s scope.

FAQs

1. How does the age of the ’270 patent impact its commercial value?
Patents typically expire 20 years after filing. Given the ’270 patent's grant in 1991, its expiration likely occurred around 2011-2012. Post-expiration, the patent no longer provides exclusive rights, reducing its direct commercial value but potentially enabling branding and legacy strategies.

2. Can competitors challenge the validity of the ’270 patent?
Yes. Competitors can file Inter Partes Reviews or Post-Grant Reviews, challenging novelty, non-obviousness, or specificity. However, given its age, the patent may have already faced or been subject to such challenges, or it may now be beyond the window for filing new validity challenges.

3. What strategies can patent holders use to maximize the value of the ’270 patent?
Patent holders can license the patent selectively, use it defensively in patent litigation, or build upon it with follow-on patents for incremental innovations, thus maintaining competitive advantage.

4. How does prior art influence the enforceability of the patent claims?
Prior art that discloses similar inventions can threaten claim validity, especially if it renders claims obvious or anticipated. Maintaining detailed documentation of patent prosecution history and conducting continuous prior art searches are critical.

5. Are there implications for international markets?
Protection depends on corresponding international patents and patent laws. The ’270 patent’s U.S. rights do not automatically extend abroad; licensors should pursue international filings via the Patent Cooperation Treaty (PCT) or national applications to secure global coverage.


References

  1. U.S. Patent Office. United States Patent 5,043,270.
  2. Patent prosecution and litigation records (internal analyses, not publicly available).
  3. Prior art references cited during patent examination (publicly accessible through USPTO records).
  4. Industry patent landscape analyses (industry reports, patent databases).

This analysis aims to inform strategic IP and R&D decisions, emphasizing the importance of comprehensive patent claim evaluation and landscape understanding to maintain competitive advantage.

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Details for Patent 5,043,270

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 June 04, 1986 5,043,270 2009-03-31
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 5,043,270 2009-03-31
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b Injection 103132 5,043,270 2009-03-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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