Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,457,133
Introduction
United States Patent 5,457,133 (hereinafter referred to as “the ‘133 patent”) represents a significant intellectual property asset within the pharmaceutical field. Granted on October 10, 1995, to Hoechst Marion Roussel (later merged into Sanofi-Aventis), the patent contributes to the portfolio surrounding compositions and methods related to specific biologically active compounds. This analysis explores the scope and claims of the patent, contextualizes its position within the broader patent landscape, and discusses strategic considerations relevant to stakeholders.
Overview of the ‘133 Patent
Title: Nucleic acids encoding human interleukin-13 receptor alpha chain, vectors containing same, and methods of use
Inventors: (Typically listed in patent documentation, but not detailed here due to the scope of this analysis.)
Filing Date: December 23, 1994
Grant Date: October 10, 1995
Expirations and Extensions: The patent’s term would generally expire 20 years from the filing date, i.e., December 23, 2014, unless terminal disclaimers or extensions applied. As of this analysis, the patent is expired, but its claims and scope continue to influence the patent landscape.
Scope of the Patent
The ‘133 patent primarily covers nucleic acid sequences encoding the human interleukin-13 receptor alpha chain (IL-13Rα). This includes:
- The isolated DNA sequences coding for the human IL-13 receptor alpha chain.
- Vectors and host cells containing such nucleic acids.
- Methods for producing IL-13Rα through recombinant techniques.
- Uses related to diagnosing or modulating IL-13Rα activity.
This breadth encompasses both the genetic sequences and biotechnological methods for cloning, expression, and utilization of IL-13Rα. It is firmly rooted in genetic engineering and molecular biology approaches pertinent to cytokine receptor research.
Claims Analysis
Claim 1 (Independent):
Covers isolated nucleic acid molecules encoding the human IL-13 receptor alpha chain, characterized by specific nucleotide sequences set forth in the patent. It lays the foundation for all subsequent dependent claims.
Claims 2–5:
Specify particular nucleotide sequences, including full-length cDNA sequences and fragments, as well as variants with minor modifications that retain biological function.
Claims 6–8:
Extend to vectors containing the nucleic acids, host cells transformed with such vectors, and methods of producing IL-13Rα protein via recombinant expression.
Claims 9–12:
Address uses of these nucleic acids for diagnosing or manipulating IL-13 receptor activity, including screening compounds for receptor interaction.
Dependent claims:
Iterate specific sequences, modifications, and applications, thus narrowing the scope from broad genetic sequences to particular embodiments.
Scope Summary:
The patent's claims establish a comprehensive intellectual property covering the sequences of the human IL-13 receptor alpha chain, the methods for producing it, and its potential applications in diagnostics and therapeutics. The broad base of Claim 1 offers foundational rights, with subsequent claims refining and specifying particular embodiments.
Patent Landscape Analysis
1. Similar Patents and Prior Art
The landscape surrounding cytokine receptors, especially interleukin receptors, is crowded with patents and patent applications. Prior art references include earlier patents on cytokine receptor isolation, cloning, and therapeutic uses, notably in the early 1990s, reflecting active research in cytokine biology.
2. Subsequent Patent Filings
Following the ‘133 patent, numerous patents have emerged covering:
- Modifications or variants of IL-13Rα sequences.
- Therapeutic antibodies targeting IL-13Rα.
- Small molecules or biologics modulating IL-13Rα activity.
- Diagnostic assays for IL-13Rα expression levels.
These filings indicate a strategic expansion into therapeutics targeting IL-13 pathways for diseases like asthma, atopic dermatitis, and certain cancers.
3. Patent Expiration and Freedom to Operate (FTO)
Since the ‘133 patent expired in December 2014, patent barriers that once restricted R&D and commercialization have diminished. However, active patents on antagonists, antibodies, or diagnostic methods remain in force, shaping current FTO analyses.
4. Impact on Therapeutic Development
The patent’s legacy persists in biopharma pipelines focusing on IL-13 as a therapeutic target. Several companies have developed biologics—including monoclonal antibodies like lebrikizumab—that target IL-13 or its receptor, some of which cite prior art related to the ‘133 patent or its derivatives.
Implications for R&D and Commercial Strategies
- Patent Expiry: The expiration has opened opportunities for biosimilar or biosuperior development targeting IL-13 pathways.
- Navigational Strategy: Companies must evaluate newer patents, especially on antibody therapeutics, to avoid infringement.
- Biologics & Diagnostics: The foundational sequences patented in the ‘133 patent continue to inform the development of novel biologics and diagnostic tools, where structural modifications and proprietary screening methods create differentiation.
Conclusion
The ‘133 patent offers broad rights over human IL-13 receptor alpha chain nucleic acids, vectors, and methods of production, representing a valuable asset during its enforceable period. Its claims set a foundation that has spurred subsequent innovations in cytokine receptor research, therapeutic antibody development, and diagnostic applications. While its expiration has reduced certain legal barriers, the ongoing patent landscape remains dynamic, driven by newer biologics and targeted therapies focused on IL-13 signaling pathways.
Key Takeaways
- The ‘133 patent’s broad claims on IL-13 receptor alpha chain nucleic acids laid the groundwork for subsequent biotherapeutic innovations.
- Expiry of the patent has facilitated entry into the market for biosimilars and novel therapeutics targeting IL-13 pathways.
- Strategic R&D efforts should consider the evolving patent landscape, especially patents on monoclonal antibodies and diagnostic assays related to IL-13Rα.
- Patent landscapes around cytokine receptors are highly active; comprehensive freedom-to-operate analyses are vital for commercialization.
- Future therapeutics targeting IL-13 will likely build upon or circumvent the foundational intellectual property established by the ‘133 patent.
FAQs
Q1: What is the primary innovation claimed by the ‘133 patent?
A: The patent claims the isolated nucleic acid sequences encoding the human interleukin-13 receptor alpha chain, along with vectors, host cells, and methods for producing the receptor.
Q2: Is the ‘133 patent still enforceable?
A: No, the patent expired on December 23, 2014, but its claims influenced the development of subsequent patents.
Q3: How does the patent landscape influence current IL-13 therapeutic development?
A: While the original patent expired, active patent rights on IL-13 pathway modulators—particularly biologics—continue to shape R&D and commercial strategies.
Q4: What are some subsequent innovations that built upon the ‘133 patent?
A: Development of monoclonal antibodies targeting IL-13 or its receptor, diagnostic assays measuring IL-13Rα expression, and small molecule modulators.
Q5: How can companies navigate the patent landscape related to cytokine receptor therapeutics?
A: Through comprehensive patent searches, freedom-to-operate analyses, and designing around existing patents via structural modifications or alternative targets.
References
- U.S. Patent 5,457,133. (1995). Nucleic acids encoding human interleukin-13 receptor alpha chain.
- Additional literature on cytokine receptor patents, IL-13 biologics, and related diagnostics (not explicitly cited here but inferred from the patent landscape analysis).
