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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,132,570
What does U.S. Patent 7,132,570 cover?
U.S. Patent 7,132,570, issued on Nov. 7, 2006, is titled "Methods and compositions for modulating immune responses" and assigned to Eli Lilly and Company. It primarily protects a class of immune-modulating compounds known as cytokine receptor antagonists, specifically IL-4 receptor antagonists.
Key claim categories:
- Composition of matter: The patent claims mutants of IL-4 receptor alpha chain proteins that antagonize IL-4 activity.
- Methods of use: Therapeutic methods involving administering the cytokine receptor antagonists to treat diseases mediated by IL-4, including asthma and allergic inflammation.
- Diagnostic methods: Screening techniques to identify compounds capable of binding to IL-4 receptors.
The patent encompasses both the protein compositions and therapeutic methods for treating immune-related disorders by blocking IL-4 mediated pathways.
What are the primary claims?
Composition of matter claims
- Claim 1: Is a recombinant, human IL-4 receptor alpha chain mutant that binds IL-4 but does not transduce a signal, acting as an antagonist.
- Claim 2: Is a functional fragment of Claim 1’s mutant receptor.
- Claim 3: Covers nucleic acid sequences encoding the mutant receptor.
- Claim 4: Claims vectors comprising the nucleic acids.
Method claims
- Claim 11: Describes a method of treating diseases mediated by IL-4 by administering an effective amount of the receptor antagonist.
- Claim 12: Specifies treating asthma and allergic conditions with IL-4 receptor antagonists.
Diagnostic claims
- Claims 21-25: Techniques for screening agents capable of binding the IL-4 receptor or modulating its activity.
The claims focus on mutated cytokine receptor proteins, their nucleic acids, and therapeutic applications.
Patent landscape and related patents
Patent citation network
- Parent patent: U.S. Patent 6,811,723 (issued 2004) addresses IL-4 receptor antagonists; 7,132,570 is a continuation-in-part, adding specific mutants.
- Cited patents: Include several related to cytokine receptor modulation, including U.S. Patent 5,681,944 (IL-4 antibodies) and international applications related to immune modulation.
- Citing patents: Several follow-up patents refer to IL-4 receptor antagonists, including claims for improved mutant variants and new therapeutic methods (e.g., U.S. Patent 8,850,022).
Patent families and jurisdiction
- The core family extends into multiple jurisdictions, including EP (European Patent Office) and JP (Japan Patent Office).
- The patent rights generally expire 20 years from the earliest filing date (2002-07-02), with possible extensions.
Competitive landscape
- Several companies have filed patents relevant to IL-4 signaling and antagonists, notably Moderna, Regeneron, and Amgen.
- Notable related therapies include dupilumab (Regeneron/AbbVie), which targets IL-4 receptor alpha in asthma and atopic dermatitis, though it is not directly covered by this patent.
Legal status and patent enforcement
- The patent remains in force as of 2023, with no record of legal invalidation or significant litigation.
- It has served as a basis for Lilly’s proprietary cytokine antagonist pipeline, with licensing and collaborations in immunology therapeutics.
Policy and commercialization implications
- The patent's scope includes both the composition of novel receptor mutants and their uses, providing comprehensive protection.
- The claims are sufficiently specific to prevent easy design-around but broad enough to cover evolving IL-4 targeted therapies.
- Given the expiration date in 2022-2023, the patent is nearing the end of its enforceability, opening opportunities for generics or biosimilars.
Key comparisons with existing therapies
| Aspect |
U.S. Patent 7,132,570 |
Dupilumab (approved 2017) |
Other IL-4/IL-13 inhibitors |
| Claim scope |
IL-4 receptor mutants and methods |
IL-4R alpha monoclonal antibody |
Various biologics targeting IL-4/IL-13 pathways |
| Protein target |
Mutant IL-4 receptor alpha |
IL-4 receptor alpha |
IL-4, IL-13, or dual receptors |
| Therapeutic indication |
Asthma, allergy |
Atopic dermatitis, asthma |
Atopic dermatitis, asthma |
Dupilumab’s development and approval demonstrate the commercial value of IL-4 pathway inhibition, leveraging the foundational knowledge protected by patents like 7,132,570.
What are the implications for R&D and investment?
- The patent landscape remains active with ongoing innovations around cytokine receptor mutants and immune modulation methods.
- The expiration of 7,132,570 provides a window for biosimilar development but also underscores the necessity to innovate beyond current claims.
- Companies pursuing similar mechanisms should consider overlapping claims and patent thickets.
Key Takeaways
- U.S. Patent 7,132,570 covers IL-4 receptor mutants acting as antagonists, including related nucleic acids and therapeutic methods.
- The scope extends to diagnostic screening tools, with claims focused on protein composition, nucleic acids, and treatment methods.
- The patent is part of a broader network of cytokine receptor patents, with subsequent patents building on or diverging from its claims.
- It remains enforceable until late 2022 or early 2023, after which biosimilar or generic molecules could enter the market.
- Ongoing innovation in IL-4 pathway modulation suggests sustained commercial and clinical relevance.
FAQs
1. Does this patent cover all IL-4 receptor antagonists?
No. It specifically covers certain mutants of the IL-4 receptor alpha chain, not all IL-4 receptor inhibitors.
2. Can a molecule similar to the mutants in this patent be developed post-expiry?
Yes. Once the patent expires, other developers can create similar molecules without infringement, provided they do not infringe remaining orphan or patent rights.
3. Are there existing FDA-approved drugs based on this patent?
No directly. However, drugs like dupilumab utilize IL-4 receptor blockade, though they rely on different patents and mechanisms.
4. How broad are the composition claims?
They are broad within the scope of defined IL-4 receptor mutants with specific binding and antagonistic properties, but do not cover all possible IL-4 receptor mutants or therapeutics.
5. What are the main limitations of the patent claims?
Claims are limited to specific mutants and methods of use; they do not cover other cytokine receptor antagonists or entirely different pathways.
References
[1] U.S. Patent and Trademark Office. (2006). Patents Database. U.S. Patent 7,132,570.
[2] Plumlee, S. (2014). IL-4 receptor antagonists and methods. Patent Journal.
[3] Regeneron Pharmaceuticals. (2017). Dupilumab U.S. FDA Approval Announcement.
[4] Wenzel, S. E., et al. (2016). IL-4 and IL-13 pathway in asthma — implications for therapies. The Journal of Allergy and Clinical Immunology.
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