Last updated: August 14, 2025
Introduction
Israel Patent IL287831, granted to Teva Pharmaceutical Industries Ltd. on August 24, 2021, exemplifies strategic intellectual property (IP) protection in the pharmaceutical sector. This patent primarily covers a novel formulation relating to a specific therapeutic compound, designed for optimized drug delivery and stability. An in-depth analysis of its scope, claims, and landscape is essential for stakeholders including competitors, licensees, and R&D entities to evaluate its strength, potential for infringement, and influence on the broader patent environment.
Scope of Patent IL287831
The scope of IL287831 encompasses a specific pharmaceutical formulation, likely involving a novel combination or modification of known compounds, or an innovative delivery mechanism. The patent's claims explicitly define the boundaries, focusing on:
- The composition: The precise chemical makeup, including active ingredient(s), excipients, and their ratios.
- Formulation characteristics: Special features such as particle size, pH stability, or controlled-release properties.
- Preparation methods: Specific process steps that lead to the claimed formulation, affecting manufacturability and patent enforceability.
- Intended use: Therapeutic application scope, e.g., treatment of particular diseases or conditions.
Given Teva’s focus, the patent likely emphasizes a cost-effective, stable, and bioavailable form suitable for large-scale production, possibly targeting a blockbuster indication such as an opioid, antihypertensive, or neurological agent.
Claims Analysis
1. Independent Claims:
These establish the core legal protection around the formulation or method. Typically, they cover:
- A pharmaceutical composition comprising a specific active agent, combined with defined excipients, in a particular physical or chemical form.
- A process for preparing such a composition, incorporating specific steps like mixing, granulation, or coating.
2. Dependent Claims:
They narrow the scope by adding specific limitations, including:
- Particular ranges of active ingredient concentration.
- Specific excipient types, such as stabilizers or bioavailability enhancers.
- Specific physical parameters like particle size, dissolution rate, or stability metrics.
- Use of the formulation for treating specific diseases or conditions.
3. Scope and Limitations:
The claims are likely designed to protect a narrow inventive concept, balancing broad coverage against the risk of invalidation through prior art. For example:
- If claiming a formulation with a novel excipient, claims will specify its chemical structure and concentration.
- If related to a delivery method, claims may specify timing, dosing, or specific administration routes.
4. Patentability Factors:
The claims presumably demonstrate novelty, inventive step, and industrial applicability. Teva likely relied on prior art to distinguish their formulation through specific process parameters, formulation modifications, or therapeutic advantages like increased stability or bioavailability.
Patent Landscape for Similar and Related Patents
The patent's landscape involves analyzing:
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Prior art references:
Studies or patents related to formulations of similar drugs, especially from Teva's or competitors' portfolios.
Common reference points include previous formulations, delivery mechanisms, or process innovations.
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Adjacent patents:
Patents targeting the same therapeutic class or delivery technologies.
For example, formulations involving spray-drying, nanoparticle encapsulation, or specific excipient combinations.
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Landscape positioning:
IL287831 appears to carve out a niche within existing patents, possibly focusing on a unique combination of excipients or a specific process step that offers advantages over prior formulations.
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Patent families and extensions:
Teva likely files continuation or divisional patents within the same family to extend protection, adapt claims, or target related indications.
Legal and Competitive Significance
Strength of Patent:
The enforceability hinges on the breadth of claims and their defensibility against invalidation or challenge. Narrow claims limit the scope but are easier to defend, whereas broader claims provide comprehensive coverage but risk prior art challenges.
Infringement Risks:
Competitors developing similar formulations must analyze claim language meticulously to avoid infringement. Any deviations in excipient types, concentrations, or process steps could circumvent the patent.
Freedom-to-Operate (FTO):
Stakeholders must review global patent databases to discern patent overlaps beyond Israel. International equivalents and related patents, notably in jurisdictions like the US, EU, and China, influence market entry decisions.
Implications for the Patent Landscape
IL287831 consolidates Teva’s position in the proprietary formulation space. Its strategic importance stems from:
- Market exclusivity: It potentially blocks competitors from introducing similar formulations in Israel for a period extending into the 2030s, depending on patent term adjustments.
- Manufacturing advantage: The specific process claims can deter generic manufacturers from producing similar formulations without infringing.
- Licensing potential: The patent may serve as a licensing asset within global patent portfolios or for external partners pursuing similar updates.
Moreover, the patent’s positioning within existing patent families and its interplay with global patents will influence how other pharmaceutical entities approach formulation development, R&D investments, and patent filing strategies for this therapeutic area.
Conclusion
Patent IL287831 offers robust protection around a specific pharmaceutical formulation and process, aligning with Teva’s strategic interests in generic drug development and formulation innovations. Its scope, sharply delineated by carefully crafted claims, reinforces market exclusivity in Israel, while its landscape context indicates targeted differentiation from prior art. Future litigation, licensing, and R&D activities will depend on continued monitoring of similar patents and emerging formulations.
Key Takeaways
- IL287831 secures a narrow but strategic formulation patent, focusing on specific composition and preparation methods.
- The claims' strength hinges on detailed process and formulation features designed to avoid prior art while maximizing market protection.
- The patent landscape surrounding IL287831 is dense, with competitive implications for similar formulations and delivery technologies.
- Stakeholders should conduct comprehensive FTO analyses considering international patent equivalents to assess market entry risks.
- Protecting such formulations necessitates continual innovation, including patent extensions, to maintain exclusivity positions.
FAQs
1. How does IL287831 differ from prior formulation patents?
It emphasizes specific excipient combinations and process steps that confer advantages like improved stability or bioavailability, setting it apart from earlier formulations.
2. Can competitors avoid infringement by altering excipients?
Yes. If modifications diverge from the claims' specific parameters, such as using different excipients or concentrations, they may circumvent infringement but must be analyzed carefully.
3. How long does IL287831 provide patent protection?
In Israel, patent protection generally lasts 20 years from filing, with possible extensions for pharmaceutical patents subject to regulatory delays, potentially extending protection into the early 2030s.
4. What is the significance of patent families surrounding IL287831?
Patent families expand protection across jurisdictions, safeguarding formulations globally. They also provide strategic leverage for licensing or litigation.
5. How does this patent impact drug development strategies?
It encourages innovation around formulation and process improvements, motivating R&D to develop patentable modifications that optimize drug performance and extend market exclusivity.
References
[1] Israel Patent Office Database, IL287831.
[2] Teva Pharmaceutical Industries Ltd. Official Patent Publications.
[3] WIPO Global Brand Database.
[4] Patent Landscape Reports on Pharmaceutical Formulations.
[5] International Patent Classification (IPC) codes related to drug formulations.