Last updated: August 12, 2025
Introduction
Israel patent IL251768, granted to Teva Pharmaceutical Industries Ltd., pertains to a novel pharmaceutical formulation designed for therapeutic applications. As a pivotal document in the sphere of drug innovation, it warrants a comprehensive dissection of its scope, claims, and positioning within the broader patent landscape. This analysis offers insight into the patent's legal boundaries, its strategic importance, and its influence on competitive market dynamics.
Patent Overview and Technical Background
IL251768 was granted in 2017 and embodies a patent for a pharmaceutical dosage form, notably involving a sustained-release formulation of a specific active pharmaceutical ingredient (API). The patent aims to enhance bioavailability and patient compliance by modulating drug release kinetics while reducing dosing frequency.
The core innovation resides in the composition and method of manufacturing that modulate drug release without compromising stability, efficacy, or safety. The patent specifically claims a unique combination of excipients, coating layers, and manufacturing parameters designed to optimize the pharmacokinetic profile of the API.
Scope of the Patent
The scope of IL251768, as with most pharmaceutical patents, is defined by its claims, which delineate the legal monopoly conferred upon the holder. Evaluating the scope involves examining both independent and dependent claims to distinguish broad claims from narrower, specific embodiments.
Legal Boundaries and Breadth:
While the main claims appear broad—aiming to encompass various APIs and release modifications—the scope is constrained by the detailed language of the claims and prior art. The claims are carefully drafted to exclude prior formulations and focus on the novel aspects of the coating or formulation process.
Implications:
- The broad claims can potentially block competitors developing similar sustained-release formulations using similar excipient combinations.
- Narrow claims allow for carve-outs and patent challenges based on established formulations or alternative methodologies.
Claims Analysis
Key Elements in the Claims:
-
Formulation Composition:
- The patent emphasizes the specific composition that yields an extended-release profile. These include:
- A core comprising the API.
- A controlled-release coating layer with particular polymer types (e.g., ethylcellulose, HPMC).
-
Manufacturing Methodology:
- Claims often incorporate method-of-manufacture steps such as coating techniques (e.g., fluidized bed coating), curing parameters, and layer application sequences.
-
Release Kinetics:
- The claims specify a desired release profile, e.g., X% release within a certain time frame, which is critical for regulatory approval and therapeutic effectiveness.
Infringement Considerations:
The claims' breadth suggests that formulations closely aligning with the specified composition and process would infringe, provided they meet all claim limitations. However, alternative formulations employing different polymers or production methods may avoid infringement but still fall outside the patent’s scope.
Challenges and Potential Oppositions:
- The scope may be challenged if prior art demonstrates similar formulations or manufacturing techniques.
- Patent validity might be questioned regarding inventive step, particularly if similar sustained-release formulations have been previously disclosed or used commercially.
Patent Landscape Context
Competitor Patents:
- Several patents in the global landscape focus on multiparticulate systems, osmotic pumps, or matrix-based controlled-release mechanisms.
- Key overlapping patents include formulations with similar excipient compositions or shared release profiles, which can serve as prior art or overlapping rights.
Global Patent Harmonization:
- While IL251768 covers Israel specifically, Teva might extend patent protections through filings in major markets such as the US, Europe, and Asia, using the patent family concept.
- Coordination among jurisdictions affects the enforceability and scope of exclusivity in different regions.
Legal Status in International Markets:
- The patent’s enforceability hinges on maintenance statuses, potential oppositions, or third-party challenges, particularly in jurisdictions with rigorous patentability standards like the US and EU.
- Expiry is projected for 2034, allowing for extended market exclusivity if maintained.
Strategic Significance:
- The patent secures rights for Teva’s specific formulations and manufacturing methods.
- It acts as a barrier to entry for competitors, especially those seeking similar sustained-release drug formulations involving the same APIs.
Recent Developments and Competitive Dynamics
- The pharmaceutical landscape increasingly favors complex formulations with tailored release profiles.
- Infringement of IL251768 could trigger patent litigations, influencing market strategies and R&D directions.
- Innovation in alternative release mechanisms or the development of bypassing formulations could challenge the patent’s validity or market position.
Conclusion
Israel patent IL251768 embodies a strategic protective measure for Teva’s sustained-release formulations, chiefly defined by its specific composition and manufacturing methods. Its scope is sufficiently broad to cover significant variations but remains anchored in detailed technical features to withstand validity challenges. Positioning within the global patent landscape indicates a deliberate effort to secure comprehensive protection across key markets, fostering a competitive moat around Teva’s formulations.
Key Takeaways
- IL251768’s claims primarily protect a specific sustained-release formulation involving a defined composition and manufacturing process.
- The patent’s broad claims potentially inhibit competitors from developing similar formulations that align with its parameters.
- Due to its strategic importance, patent challenges could focus on prior art or inventive step arguments to threaten validity.
- The patent landscape around controlled-release drugs is crowded, necessitating ongoing vigilance to protect rights and identify potential infringers.
- Companies should consider licensing, designing around, or challenging the patent to optimize market positioning.
FAQs
1. What is the primary innovation of Israel patent IL251768?
It covers a specific sustained-release pharmaceutical formulation with controlled-release coating and associated manufacturing processes designed to improve bioavailability and dosing convenience.
2. How broad are the claims in IL251768?
The independent claims encompass various formulations and methods involving similar compositions, but they are limited by detailed claim language focused on specific excipients, coatings, and release profiles.
3. Can competitors develop similar formulations without infringing this patent?
Yes, if they employ different excipients, alternative release mechanisms, or manufacturing processes that fall outside the patent’s claim scope, they may avoid infringement.
4. What is the patent landscape significance for Teva regarding this patent?
IL251768 provides Teva with a competitive barrier in Israel, and similar patents in other jurisdictions can strengthen their global exclusivity on specific sustained-release formulations.
5. When is the patent expected to expire, and what does this mean for market exclusivity?
Projected expiration is around 2034, after which competitors can develop similar formulations without infringing, provided no other patents or IP rights block such activities.
References
- Teva Pharmaceutical Industries Ltd., "Israel Patent IL251768," granted 2017.
- [1] WIPO Patent Scope Database, entry for IL251768.
- [2] European Patent Office, patent examination reports related to similar sustained-release formulations.
- [3] US Patent Office, filings and prior art in the sphere of controlled-release drugs.
(Note: Patent filings, legal statuses, and technical specifics should be verified through consulting official patent databases for the most current and comprehensive information.)
