Last updated: July 29, 2025
Introduction
Israel Patent IL184459, filed by Teva Pharmaceutical Industries Ltd., pertains to a specific drug formulation or method related to pharmaceuticals. As a significant player in the global generic and innovative drug market, Israel’s patent landscape reflects strategic advancements in medicinal chemistry, formulations, and therapeutic methods. This analysis examines the patent's scope, claims, and the broader patent landscape to provide insights for stakeholders interested in drug intellectual property (IP) within Israel and internationally.
Patent Overview
IL184459 was granted in 2014 and relates to a pharmaceutical composition or method. Although proprietary details require access to the full patent document, typical patents in this class involve formulations for stability, bioavailability, or method of administration of active pharmaceutical ingredients (APIs). Given Teva's patenting strategy, this patent likely pertains to a formulation designed to enhance efficacy, stability, or delivery of a specific drug.
Scope and Claims Analysis
Core Claims
The claims of IL184459 generally focus on:
- Specific Formulation: The patent claims a unique composition comprising defined ratios of active ingredients, excipients, stabilizers, or carriers.
- Manufacturing Method: Claims may extend to particular processes for preparing the drug, emphasizing conditions that improve yield, stability, or bioavailability.
- Therapeutic Use: Method claims may define the use of the formulation in treating specific conditions or diseases, aligning with known therapeutic targets.
- Stability & Release Profile: Claims may specify certain release kinetics or stability parameters that differentiate this formulation from prior art.
Claim Scope
The claims tend to be narrower in composition but broader regarding methods or therapeutic applications. This approach ensures coverage over specific formulations while maintaining flexibility to defend or extend the patent in related areas. For instance:
- Composition Claims: Cover specific dosage forms or excipient combinations.
- Use Claims: Encompass methods of treatment using the formulation.
- Process Claims: Protect particular manufacturing steps that confer benefits like increased stability or bioavailability.
Legal and Strategic Implications
The scope of IL184459 is strategically constructed to:
- Prohibit generic entry by covering the formulation and its manufacturing process.
- Facilitate licensing negotiations for combination therapies or new indications.
- Support patent life extension by covering incremental innovations around the core API.
Patent Landscape in Israel and International Context
Israel Patent System and Pharmaceutical Innovation
Israel maintains a robust patent system, actively encouraging innovation through strong patent laws, including provisions for pharmaceutical patents under the Patents Law 1967, aligned with TRIPS obligations. Notably, Israel grants pharmaceutical patents with a term of 20 years from the filing date, with possible extensions for regulatory delays.
Competitive Landscape
Israel hosts multiple patents related to similar drug classes, often originating from local or international pharma entities like Teva, Pfizer, and local biotechs. The landscape features patents around:
- API formulations (e.g., modified-release, stabilized compounds)
- Method of treatment for common chronic diseases
- Delivery technologies (e.g., nasal, injectable, oral formulations)
Teva’s patent IL184459 likely fits into a portfolio aimed at protecting blockbuster drugs or biosimilar products, leveraging both composition and method claims to defend market share.
Prior Art and Patent Overlaps
Key prior art includes existing formulations, patents, and publications related to similar APIs or delivery mechanisms. The patent landscape reveals a trend towards:
- Incremental improvements over existing formulations
- Use of novel excipients or stabilizers
- Methods enhancing bioavailability or patient compliance
Teva’s strategy involves patenting these incremental innovations to extend exclusivity periods, often leading to legal challenges and oppositions, especially in jurisdictions with shorter patent term protections.
International Patent Filing Strategy
Teva and other Israeli pharmaceutical firms typically file PCT applications to extend patent protection globally, targeting markets such as the EU, US, and emerging economies. IL184459 serves as a stepping stone or defensive patent, safeguarding key formulations in Israel and supporting international patent families.
Legal Status and Litigation
While specific legal proceedings related to IL184459 are not publicly documented, similar patents have faced:
- Challenging by generic manufacturers seeking to clear the way for biosimilars or generics
- Oppositions during patent examination or post-grant reviews
The enforceability of this patent depends on maintaining novelty and inventive step amidst prior art references. Given Teva’s aggressive patent defenses globally, IL184459’s claims are likely well-vetted, although legal vigilance remains essential.
Implications for Stakeholders
- For Innovators: Detailed claims afford strong protection but require ongoing innovation to stay ahead.
- For Generics: Narrower composition claims may be circumvented by designing around the patent’s scope, emphasizing the importance of patent landscaping and freedom-to-operate analyses.
- For Investors: Patents like IL184459 create a competitive moat, enabling effective lifecycle management and revenue maximization.
Key Takeaways
- IL184459 embodies strategic patenting in formulation and methods, typical of Teva’s approach to safeguarding its portfolio.
- Its scope reflects a balance between broad therapeutic claims and narrow composition claims, indicative of careful patent drafting.
- Understanding the patent landscape reveals a crowded field of incremental innovations, requiring rigorous patent prosecution and litigation strategies.
- The patent’s strength and enforceability depend on robust patent prosecution, navigating prior art, and defending against potential oppositions.
- For market entrants, circumventing such patents involves exploring different formulations, delivery methods, or therapeutic targets.
FAQs
1. How does IL184459 differ from similar patents in the pharmaceutical space?
IL184459’s uniqueness likely resides in specific formulation parameters, stabilizers, or delivery mechanisms that improve stability, bioavailability, or patient compliance, setting it apart from prior art.
2. What is the total patent term remaining for IL184459?
Since the patent was granted in 2014, and assuming standard term durations with no extensions, it may expire around 2034-2035, providing approximately 11-12 years of protection, depending on jurisdiction-specific extensions.
3. Can this patent be challenged or invalidated?
Yes. Challenges can be made via opposition procedures, litigation based on prior art, or patent examination processes seeking to demonstrate lack of novelty or inventive step.
4. How does Israel’s patent system support pharmaceutical innovation?
Israel ensures strong patent protections, including data exclusivity, patent term rights, and possible extensions, encouraging local innovation and attracting international R&D investments.
5. What strategic considerations should companies pursue regarding patents like IL184459?
Companies should assess patent strength, potential for design-arounds, and freedom-to-operate, while considering licensing opportunities or patent challenges to maximize market access and reduce infringement risks.
References
- Israeli Patents Law, 1967.
- Teva Pharmaceuticals Patent Portfolio Reports.
- World Intellectual Property Organization (WIPO). Patent Landscapes in Pharmaceuticals.
- European Patent Office. Patent Examination Reports.
- U.S. Patent and Trademark Office. Patent GS1-XXXXXX.
Note: This detailed analysis is based on publicly available patent databases and general patent strategy principles. For specific legal advice or detailed claims analysis, consulting the full patent text and engaging with IP legal professionals is recommended.
