Last updated: February 19, 2026
This analysis examines Israel patent IL232103, focusing on its technical scope, asserted claims, and the surrounding patent landscape. The patent covers a specific formulation of secukinumab, a human monoclonal antibody targeting interleukin-17A (IL-17A), used in the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. The examination provides a foundation for assessing market exclusivity, potential infringement risks, and strategic positioning for competitors and investors.
What is the Technical Scope of IL232103?
Patent IL232103, filed on September 26, 2016, and granted on December 19, 2022, describes a pharmaceutical composition of secukinumab with specific concentration, buffer, and excipient characteristics. The core innovation lies in a stable liquid formulation designed for subcutaneous injection.
The claimed formulation is characterized by:
- Secukinumab Concentration: The patent asserts a concentration of secukinumab between 20 mg/mL and 100 mg/mL.
- Buffer System: The composition utilizes a histidine-acetate buffer system.
- pH Range: The formulation has a pH of 5.0 to 6.0.
- Stabilizing Excipients: The composition includes specific stabilizing agents. These are identified as:
- Sucrose (e.g., 5% w/v)
- Polysorbate 20 (e.g., 0.05% w/v)
- Isotonicity Agent: An isotonicity agent is present to ensure physiological compatibility.
- Water for Injection: The balance of the composition is water for injection.
The specific example provided in the patent (Example 1) details a formulation with 75 mg/mL of secukinumab, 5% sucrose, 0.05% polysorbate 20, and a histidine-acetate buffer at pH 5.5. This formulation is designed for enhanced stability and ease of administration [1].
The patent also covers the use of this specific pharmaceutical composition for treating conditions mediated by IL-17A, including plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
What are the Key Claims of IL232103?
The granted claims of IL232103 define the protected intellectual property. Claim 1, the primary independent claim, recites:
"A pharmaceutical composition comprising:
a) secukinumab, wherein the concentration of secukinumab is between 20 mg/mL and 100 mg/mL;
b) a buffer system comprising histidine and acetate;
c) sucrose;
d) polysorbate 20; and
e) water for injection;
wherein the pH of the composition is from 5.0 to 6.0." [1]
Dependent claims further refine the scope by specifying ranges and preferred embodiments:
- Claim 2: Specifies the concentration of secukinumab as being 75 mg/mL.
- Claim 3: Defines the concentration of sucrose as 5% w/v.
- Claim 4: Defines the concentration of polysorbate 20 as 0.05% w/v.
- Claim 5: Specifies the pH as 5.5.
- Claim 6: Claims the use of the composition for treating psoriasis.
- Claim 7: Claims the use of the composition for treating psoriatic arthritis.
- Claim 8: Claims the use of the composition for treating ankylosing spondylitis.
The claims are narrowly drafted to encompass a specific liquid formulation and its therapeutic applications. They do not cover secukinumab as a molecule itself, nor do they broadly claim all secukinumab formulations. The protection is tied to the particular combination of secukinumab concentration, buffer, pH, and specific excipients (sucrose and polysorbate 20).
What is the Patent Landscape for IL232103?
The patent landscape for IL232103 is situated within the broader intellectual property surrounding secukinumab and its therapeutic applications. Secukinumab is marketed by Novartis under the brand name Cosentyx. The development and commercialization of Cosentyx have been supported by a robust patent portfolio, with IL232103 representing a formulation-specific patent granted in Israel.
Key elements of the secukinumab patent landscape include:
- Composition of Matter Patents: Initial patents covering the secukinumab antibody itself as a novel biological entity. These are foundational patents and have a significant impact on the initial market exclusivity.
- Formulation Patents: Patents like IL232103 that claim specific formulations of the active pharmaceutical ingredient (API). These are crucial for extending market exclusivity beyond the initial composition of matter patents, particularly for biopharmaceuticals where formulation can impact stability, efficacy, and administration.
- Method of Use Patents: Patents claiming specific therapeutic uses of secukinumab for particular indications (e.g., psoriasis, psoriatic arthritis, ankylosing spondylitis).
- Manufacturing Process Patents: Patents related to the methods used to produce secukinumab, including cell culture, purification, and formulation processes.
- Secondary Patents: Patents covering combinations with other drugs, new dosage regimens, or specific delivery devices.
Analysis of IL232103 within this landscape:
- Novartis's Strategy: IL232103 is consistent with the typical strategy of originators like Novartis to secure multiple layers of patent protection around a successful biologic. Formulation patents are critical for lifecycle management and creating barriers against biosimilar competition by protecting improved or alternative versions of the drug product.
- Geographic Scope: IL232103 is specific to Israel. Novartis likely has similar formulation patents in other major markets (e.g., U.S., Europe, Japan) covering the same or related liquid formulations. The strength and duration of protection will vary by jurisdiction.
- Biosimilar Competition: The expiration of primary composition of matter patents for biologics often triggers the entry of biosimilars. However, formulation patents, manufacturing patents, and method of use patents can provide significant remaining market exclusivity. For IL232103, this patent provides protection for a specific liquid formulation in Israel until its expiration. The exact expiry date for IL232103 is September 26, 2036, assuming no extensions or prior invalidation [1].
- Freedom to Operate (FTO) for Competitors: Any company seeking to market a secukinumab product in Israel would need to conduct thorough FTO analysis. This would involve assessing whether their proposed formulation and method of use infringe upon the claims of IL232103 and other relevant patents. If a competitor intends to market a product with a formulation similar to that claimed in IL232103, they would likely face an infringement risk. They might need to develop a different formulation that does not fall within the claims of IL232103 or challenge the validity of the patent.
- Patent Term Extension: In some jurisdictions, patent terms can be extended to compensate for regulatory delays. The granted term of IL232103 (September 26, 2036) reflects the patent term in Israel and any applicable extensions or adjustments.
The patent landscape demonstrates that IL232103 is one component of a comprehensive IP strategy for secukinumab. Its importance lies in protecting a specific, commercially relevant liquid formulation in the Israeli market.
What are the Potential Implications of IL232103 for Market Exclusivity and Competition?
Patent IL232103 has direct implications for market exclusivity and competition within Israel for secukinumab-based therapies.
- Market Exclusivity Extension: For Novartis, IL232103 extends market exclusivity for the specific liquid formulation of secukinumab beyond the expiry of the primary composition of matter patents. This provides a legal barrier against the introduction of biosimilar products that utilize the same or a substantially similar formulation in Israel.
- Protection of Commercialized Products: The formulation described in IL232103 is likely representative of or very similar to the formulation of Cosentyx (secukinumab) currently marketed in Israel. The patent thus protects this commercially successful drug product from direct replication by competitors using the same formulation.
- Biosimilar Development Hurdles: Companies developing biosimilars of secukinumab for the Israeli market must either:
- Develop a formulation that falls outside the scope of IL232103 and any other relevant Israeli patents.
- Challenge the validity of IL232103 and other formulation patents.
- Wait for the expiry of IL232103 and any other applicable patents.
- Risk Assessment for Investors and Manufacturers:
- For Investors: Understanding the IP protection, including patents like IL232103, is crucial for assessing the long-term revenue potential of a drug and the risks associated with biosimilar entry. The existence of this patent suggests a continued period of reduced competition for Novartis in Israel for this specific formulation.
- For Manufacturers (Originator): IL232103 reinforces the company's ability to maintain market share and pricing power for its secukinumab product in Israel until patent expiry.
- For Manufacturers (Biosimilar/Generic): This patent represents a significant obstacle. A competitor would need to carefully navigate around its claims or seek its invalidation. The costs and timelines associated with patent litigation or developing a non-infringing formulation are critical considerations.
- Therapeutic Indications: The patent also claims the use of the formulation for specific indications. This reinforces Novartis's exclusivity for these uses with this particular formulation in Israel. Competitors looking to market secukinumab for these indications would need to ensure their product and intended use do not infringe.
- Limited Scope vs. Broad Impact: While the claims of IL232103 are specific to a particular formulation, the impact on market exclusivity can be substantial. Biologic formulations are complex and often represent significant technical advancements in stability, delivery, and patient convenience. Replicating these without infringement is challenging.
The expiry date of IL232103, September 26, 2036, is a critical date for competitive analysis in the Israeli market. Prior to this date, any introduction of a secukinumab product using the claimed formulation faces direct patent protection.
Key Takeaways
- IL232103 protects a specific liquid formulation of secukinumab in Israel, characterized by defined concentration ranges, a histidine-acetate buffer, a specific pH range, and the inclusion of sucrose and polysorbate 20.
- The patent grants Novartis protection for this formulation and its use in treating psoriasis, psoriatic arthritis, and ankylosing spondylitis until its expiry on September 26, 2036.
- This formulation patent is a key component of Novartis's intellectual property strategy to extend market exclusivity for Cosentyx (secukinumab) in Israel and serves as a barrier against biosimilar competition for this specific product configuration.
- Companies developing secukinumab biosimilars for the Israeli market must either design non-infringing formulations, challenge patent validity, or wait for the patent's expiry.
Frequently Asked Questions
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What is the primary indication protected by patent IL232103?
Patent IL232103 claims the use of the secukinumab formulation for treating psoriasis, psoriatic arthritis, and ankylosing spondylitis.
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Does patent IL232103 cover secukinumab as a molecule?
No, IL232103 is a formulation patent. It does not cover the secukinumab molecule itself, but rather a specific pharmaceutical composition containing it.
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What is the expiration date of patent IL232103 in Israel?
The patent IL232103 is set to expire on September 26, 2036.
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Can a biosimilar using a different secukinumab concentration infringe on IL232103?
Infringement depends on whether the biosimilar's formulation falls within the literal scope of the claims. If a biosimilar uses a concentration outside the 20 mg/mL to 100 mg/mL range specified in claim 1, it may not directly infringe that claim but could still infringe other claims if other elements of the formulation match.
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What are the key excipients specified in the IL232103 formulation?
The key excipients specified in the formulation are sucrose and polysorbate 20, along with a histidine-acetate buffer system.
Citations
[1] Israel Patent IL232103. (2022). Pharmaceutical composition containing secukinumab. State of Israel, Ministry of Justice, Patent Office.
