Last updated: July 31, 2025
Introduction
European Patent EP1884242, titled "Method and composition for treatment of autoimmune diseases", represents a significant patent in the pharmaceutical landscape, particularly in the realm of immunomodulatory therapies. Issued by Novartis AG in 2014, this patent covers compositions and methods related to the treatment of autoimmune conditions using specific receptor modulators. This analysis dissects the patent’s scope, claims, and overall landscape to inform stakeholders on its strategic importance.
Patent Overview
Patent Number: EP1884242
Filing Date: May 29, 2006
Publication Date: October 29, 2008 (grant granted in 2014)
Applicant: Novartis AG
Priority: Several priority dates, notably from US and WO applications, indicating a broad initial filing.
The patent primarily addresses novel immunomodulating agents that target specific cytokine pathways implicated in autoimmune diseases. Its claims focus on compounds, pharmaceutical compositions, and methods of treatment involving these compounds.
Scope of the Patent
Field and Intended Use
EP1884242 encompasses therapeutic methods for autoimmune diseases, including multiple sclerosis (MS), rheumatoid arthritis (RA), and other inflammatory conditions. The patent specifically relates to selective receptor modulators, aiming to suppress pathological immune responses while minimizing systemic immunosuppression.
Core of the Patent
The central theme involves modulating cytokine receptor activity—specifically targeting pathways integral to immune cell activation and proliferation. Such pathways include IL-2, IL-4, IL-13, and others, using novel compounds that act as either agonists or antagonists.
Claims Analysis
The patent comprises a series of specific claims, which can be broadly classified into:
1. Composition Claims
These claims define specific chemical compounds or classes of compounds, often with detailed structures, substituents, and stereochemistry. They cover compounds designed as receptor modulators, with variations allowing broad coverage over related analogs.
Example:
"Compounds of Formula I, wherein the R groups are selected from ..."
2. Methods of Use Claims
These claims specify methods of treating autoimmune diseases using the compounds described. They include specific dosages, routes of administration, and treatment regimens.
Example:
"A method of treating multiple sclerosis comprising administering an effective amount of a compound of Formula I."
3. Pharmaceutical Composition Claims
Claims also cover compositions comprising the compounds with carriers, excipients, or in combination with other agents.
4. Manufacturing Claims
Procedural claims describe methods of preparing the compounds or formulations.
Scope of Claims
Breadth and Specificity
- The patent claims both broad classes of compounds and specific molecular embodiments, providing a wide ceiling for potential infringing products.
- Claim language indicates a focus on receptor binding affinity and functional activity, covering both agonist and antagonist actions.
- Method claims extend the patent's scope into clinical and therapeutic applications, asserting proprietary rights over treatment regimens.
Limitations and Download Points
While broad, the claims are carefully delineated by structural formulas, which may restrict their scope if competitors develop similar compounds outside the claimed structures. Some claims specify particular stereochemistry, which can influence the scope.
Patent Landscape Context
Related Patents and Continuations
- Prior art includes earlier filings related to immunomodulators and cytokine receptor antagonists—such as WO2006077035 (Novartis), which aimed at IL-2 receptor modulation.
- Novartis has filed continuation and divisional applications aimed at narrowing or expanding claim scope, indicating strategic patent portfolio development.
Competitor Landscape
Key players, including F. Hoffmann-La Roche, Biogen, and Teva, hold patents on similar cytokine receptor modulators. The competitive landscape involves both small molecule and biologic therapeutics targeting autoimmune pathways.
Legal and Patent Management Considerations
- The patent's expiry date is projected around 20 years from filing (2026), meaning it remains relevant for ongoing research and development.
- Novartis likely maintains patent families spanning jurisdictions, broadening protection against generics.
Market and Strategic Implications
EP1884242’s scope supports Novartis’s positioning in autoimmune disease therapeutics. Its claims extend protections over novel receptor modulators that could be integrated into multi-product pipelines for MS, RA, and potentially other inflammatory conditions.
Protection of such compounds discourages competitors from entering the space with similar receptor-targeted therapies, consolidating Novartis’s market share.
Conclusion
EP1884242 leverages a strategic combination of detailed chemical claims and broad method claims to secure comprehensive protection over specific receptor modulators and autoimmune treatment methods. Its scope aligns with Novartis’s pipeline and research interests, effectively covering novel compounds and their clinical application. The patent landscape suggests ongoing patent family development, emphasizing the relevance of this patent for both infringement risks and potential licensing.
Key Takeaways
- EP1884242 covers a broad class of receptor modulators targeting cytokine pathways pivotal in autoimmune diseases.
- The patent claims include specific compounds, treatment methods, and pharmaceutical formulations, providing multi-layered protection.
- Its strategic value lies in solidifying Novartis’s position within immunomodulatory therapeutics, especially for diseases like MS and RA.
- The patent landscape indicates active development through continuations and related applications, maintaining competitive advantage.
- Stakeholders should monitor competing patents in cytokine receptor modulation to navigate potential infringement or licensing opportunities.
FAQs
1. What types of compounds are protected under EP1884242?
The patent primarily protects small-molecule receptor modulators, particularly those targeting cytokine receptors involved in immune regulation, such as IL-2, IL-4, and IL-13 pathways.
2. How broad are the patent claims concerning autoimmune diseases?
The claims encompass methods of treating various autoimmune diseases using the specified compounds, including MS and RA, with potential applicability to other inflammatory conditions.
3. Does EP1884242 protect only the chemical compounds or also the treatment methods?
It protects both chemical entities (compounds) and methods of treatment, including dosing and administration protocols, expanding its enforceable scope.
4. Can competitors develop similar receptor modulators outside the scope of this patent?
Potentially, if they design non-structurally similar compounds or target different pathways, they might circumvent the patent. Careful claim interpretation and patent landscaping are essential.
5. What is the strategic significance of this patent for Novartis?
It fortifies Novartis’s intellectual property portfolio in the immunology sector, discourages competitors, and supports ongoing development of next-generation therapies for autoimmune conditions.
References:
- European Patent Office, EP1884242.
- Novartis Annual Reports and Patent Filings.
- WIPO Patent Database.
- Patent landscape reports on cytokine receptor modulators.
