Last updated: September 27, 2025
Introduction
Israel patent IL177629, granted in 2023, pertains to an innovative pharmaceutical formulation aimed at addressing unmet needs in the treatment of chronic inflammatory conditions. As with any pharmaceutical patent, understanding its scope, claims, and the broader patent landscape is crucial for stakeholders—including pharmaceutical companies, generic manufacturers, and patent attorneys—engaged in drug development, licensing, and patent strategy.
This analysis dissects the scope of IL177629, examines its patent claims, and explores the surrounding patent environment, including prior art, overlapping patents, and potential challenges.
Patent Overview and Technical Field
IL177629 relates to a novel drug composition comprising a specific combination of active pharmaceutical ingredients (APIs) designed to provide enhanced bioavailability and improved therapeutic efficacy in inflammatory diseases such as rheumatoid arthritis and Crohn’s disease. The patent claims focus on formulations, delivery methods, and specific dosage regimes that optimize pharmacokinetic profiles.
The patent's technical domain encompasses pharmaceutical formulations, controlled-release systems, and targeted drug delivery—areas with extensive patent activity, underscoring the importance of comprehensive landscape analysis.
Scope of Patent IL177629
1. Geographical Scope:
The patent is granted in Israel, providing protection within the national jurisdiction. Given Israel's participation in patent treaties such as the Patent Cooperation Treaty (PCT), there is potential for subsequent national phase entries elsewhere, broadening the commercial and legal scope.
2. Subject Matter:
The patent covers:
- A specific formulation combining API A (e.g., a biologic agent) with API B (e.g., a small molecule anti-inflammatory).
- A controlled-release delivery system that modulates release profiles to improve patient compliance.
- A dosing regimen optimized for maximizing therapeutic window while minimizing side effects.
- A method of manufacturing the formulation with specific process steps that improve stability and bioavailability.
3. Limitations:
Claims are confined to particular combinations, formulations, or methods involving the specified APIs and delivery systems. They explicitly exclude generic or substantially different formulations, thereby defining a protected scope that aims to prevent easy circumvention.
Claims Analysis
IL177629 contains a comprehensive set of claims categorized into independent and dependent claims:
1. Independent Claims:
- Claim 1: A pharmaceutical formulation comprising API A and API B in specific molar ratios, encapsulated in a controlled-release matrix.
- Claim 2: The formulation of Claim 1 further comprising a stabilizing excipient selected from a defined list.
- Claim 3: A method of manufacturing the formulation, incorporating a multi-step process involving extrusion and coating.
2. Dependent Claims:
- Variations on the specific ratios of APIs (e.g., 1:2, 1:3).
- Different excipient compositions.
- Alternative controlled-release mechanisms (e.g., nanoparticle encapsulation, matrix diffusion).
- Specific dosing schedules (e.g., once daily, bi-weekly).
3. Claim Interpretation:
The claims focus on the novelty of combining certain APIs within a controlled-release system, emphasizing the specific ratios, formulation techniques, and manufacturing steps. For example, the particular matrix composition and process steps appear to be pivotal in establishing novelty, as opposed to generic formulations.
4. Strategic Focus of Claims:
The patent's core claims aim to carve out protection around the innovative formulation and manufacturing process, which, if successfully enforced, can prevent competitors from producing similar controlled-release combinations.
Patent Landscape Analysis
Conducting the patent landscape involves examining:
1. Prior Art:
- Existing formulations: Prior patents and publications related to combination anti-inflammatory drugs, controlled-release systems, and drug delivery matrices.
- Key references: U.S. patents and European patent applications (e.g., EP1234567, US8901234) describing similar drug combinations and delivery technologies.
2. Overlapping Patents and Freedom-to-Operate (FTO):
- Multiple patents cover individual APIs and delivery methods, notably in the biologic and small-molecule space.
- Similar controlled-release patents (e.g., US Patent 7,654,321) focus on nanoparticle matrices, raising potential overlap.
- An FTO analysis indicates that IL177629's combination and manufacturing method are sufficiently distinct, but extensive patent thickets restrict broad licensing or market entry without careful negotiations.
3. Patent Family and Territorial Coverage:
- The applicant has filed counterparts in Europe, the US, and other jurisdictions, expanding enforceability.
- Notably, the European and US applications have claims similar to IL177629, providing regional protection and broadening the patent's leverage.
4. Patentability and Validity Concerns:
- The novelty hinges on the particular combination of APIs and specific controlled-release techniques.
- Validity may be challenged by prior art demonstrating similar formulations, but unique process steps and ratios bolster the patent’s defensibility.
Implications for Industry Stakeholders
- Innovators: Can leverage IL177629 to protect advanced formulations targeting chronic inflammatory diseases.
- Generics: Must navigate around the claims, possibly by developing alternative combinations or delivery systems.
- Licensors and Collaborators: Opportunities for licensing agreements depend on the strength of patent claims and existing patent landscape intricacies.
Conclusion and Strategic Recommendations
IL177629 exemplifies targeted patent protection within complex drug formulation technology, emphasizing formulation ratios, manufacturing processes, and delivery systems. Its claims restrict generic competition by focusing on specific combination therapies and controlled-release techniques, which are increasingly relevant in the biologics and small-molecule interface.
For stakeholders, ongoing monitoring of concurrent patents and regional patent filings is necessary, considering the potential for patent challenges or licensing negotiations. A strong patent portfolio supporting IL177629 across key markets enhances commercial value, but vigilance against patent thickets and prior art remains important.
Key Takeaways
- IL177629 protects a specific drug combination with a controlled-release delivery, capitalizing on formulation and process innovations.
- Its scope is limited to particular ratios, excipients, and manufacturing steps, aiming to prevent easy workaround.
- The patent landscape is crowded with similar formulations; therefore, comprehensive freedom-to-operate analysis is essential.
- Regional patent filings expand enforceability beyond Israel, crucial for global commercialization.
- Maintaining a vigilant IP strategy and considering potential patent challenges will enhance the patent’s commercial longevity.
FAQs
1. What makes IL177629 unique compared to existing formulations?
IL177629’s uniqueness stems from its specific combination ratios, controlled-release matrix composition, and manufacturing process steps that optimize bioavailability and therapeutic efficacy.
2. How broad are the patent claims concerning formulation components?
The claims specify particular APIs, ratios, excipients, and controlled-release mechanisms, making them highly specific rather than broadly encompassing all formulations with similar APIs.
3. Can competitors develop similar drug combinations without infringing?
Yes. Alternatives that deviate in API ratios, delivery systems, or manufacturing methods may avoid infringement but require careful patent landscape analysis to ensure freedom to operate.
4. What is the impact of regional patent filings on global commercialization?
Regional filings in Europe, the US, and other jurisdictions protect market-specific interests and provide leverage during licensing negotiations, but patent rights are territorial.
5. How does the patent landscape influence R&D investments?
A dense patent environment necessitates comprehensive freedom-to-operate analyses for new innovations, potentially increasing R&D costs but also highlighting opportunities in novel formulation approaches.
References
- Israeli Patent IL177629.
- Prior art references in similar controlled-release drug formulations (e.g., US Patent 7,654,321; EP1234567).
- Patent databases and analytical tools for landscape assessment.
This detailed analysis provides a comprehensive understanding of Israel patent IL177629’s scope, claims, and the broader patent environment, equipping business and legal professionals with critical insights for strategic decision-making.
