Last updated: February 19, 2026
This report details the scope and claims of Chilean drug patent application CL2024003470, examining its patent landscape and potential implications for the pharmaceutical industry. The application, filed on March 25, 2024, by Innovapharm S.A. and assigned to BioGenerics Pharma, claims a novel pharmaceutical formulation for treating chronic inflammatory conditions. The core of the patent application lies in a specific composition of a biological agent, identified as BG-452, combined with a proprietary stabilizing excipient, Epsilon-Z.
What is the Subject Matter of CL2024003470?
The patent application CL2024003470 seeks to protect a pharmaceutical formulation and its method of use. The primary subject matter is a liquid pharmaceutical composition comprising an active pharmaceutical ingredient (API), BG-452, and a specific stabilizing agent, Epsilon-Z. BG-452 is described as a recombinant humanized monoclonal antibody targeting the interleukin-17 (IL-17) pathway. Epsilon-Z is a complex carbohydrate derivative not previously disclosed in prior art related to IL-17 inhibitors. The application specifies a concentration range for BG-452 between 50 mg/mL and 200 mg/mL and a weight ratio of Epsilon-Z to BG-452 between 2:1 and 5:1.
The claimed invention is differentiated by its ability to maintain BG-452's structural integrity and biological activity for a prolonged period under standard storage conditions (2-8 degrees Celsius). Prior formulations of similar biological agents have exhibited degradation issues when stored at ambient temperatures, necessitating cold chain logistics. CL2024003470 asserts that its formulation overcomes this limitation, offering enhanced stability and a reduced reliance on strict temperature control.
What Are the Key Claims of CL2024003470?
The patent application presents several key claims, broadly categorized into composition, method of use, and manufacturing aspects.
Claim 1: Pharmaceutical Composition
This independent claim defines the core of the invention: "A liquid pharmaceutical composition comprising: a) BG-452, a recombinant humanized monoclonal antibody that binds to IL-17A, wherein the concentration of BG-452 is from 50 mg/mL to 200 mg/mL; and b) Epsilon-Z, a stabilizing excipient, wherein the weight ratio of Epsilon-Z to BG-452 is from 2:1 to 5:1." This claim is central to protecting the specific combination and ratio of the API and excipient.
Claim 2: Specific Antibody Sequence
This dependent claim further defines BG-452 by referencing a specific amino acid sequence for its variable regions, designated SEQ ID NO: 1 for the heavy chain variable region and SEQ ID NO: 2 for the light chain variable region. This provides a definitive identifier for the therapeutic antibody.
Claim 3: Concentration Range
This dependent claim reiterates and specifies the concentration of BG-452, stating: "The liquid pharmaceutical composition of claim 1, wherein the concentration of BG-452 is 150 mg/mL." This narrows the scope to a preferred concentration.
Claim 4: Weight Ratio Range
This dependent claim focuses on the stabilizing excipient: "The liquid pharmaceutical composition of claim 1, wherein the weight ratio of Epsilon-Z to BG-452 is 3:1." This defines a preferred ratio for optimal stabilization.
Claim 5: Additional Excipients
This independent claim broadens the composition to include common pharmaceutical additives: "The liquid pharmaceutical composition of claim 1, further comprising one or more pharmaceutically acceptable excipients selected from the group consisting of buffers, tonicity modifiers, and surfactants." This allows for standard formulation components commonly found in injectable drug products.
Claim 6: Method of Treating Inflammatory Conditions
This independent claim addresses the therapeutic application of the formulation: "A method of treating a chronic inflammatory condition in a subject, the method comprising administering to the subject an effective amount of the pharmaceutical composition of claim 1." The "chronic inflammatory condition" is further specified in subsequent dependent claims.
Claim 7: Specific Inflammatory Conditions
This dependent claim enumerates specific target diseases: "The method of claim 6, wherein the chronic inflammatory condition is selected from the group consisting of psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease." This highlights the intended therapeutic areas.
Claim 8: Administration Route
This dependent claim specifies the delivery method: "The method of claim 6, wherein the pharmaceutical composition is administered via subcutaneous injection." This is a common route for monoclonal antibody therapies.
Claim 9: Manufacturing Process
This independent claim pertains to the production method: "A process for manufacturing the liquid pharmaceutical composition of claim 1, the process comprising steps of formulating BG-452 with Epsilon-Z under controlled pH and temperature conditions." This claim aims to protect the specific manufacturing protocol that achieves the desired stability.
What is the Patent Landscape for IL-17 Inhibitors and Stabilizing Excipients?
The patent landscape for IL-17 inhibitors is highly competitive, with significant activity from major pharmaceutical companies. Existing patents in this domain primarily focus on:
- Novel Antibody Sequences: Patents protecting specific antibody molecules targeting IL-17A, IL-17F, or their receptors. Examples include Sekisui Diagnostics, Ltd.'s patents on anti-IL-17 antibodies and AbbVie Inc.'s extensive patent portfolio for their IL-17 inhibitor, secukinumab.
- Therapeutic Indications: Patents covering the use of IL-17 inhibitors for specific autoimmune and inflammatory diseases, such as psoriasis, psoriatic arthritis, and inflammatory bowel disease.
- Formulation Technologies: Patents related to specific delivery systems, such as auto-injectors, pre-filled syringes, and methods for enhancing bioavailability.
- Manufacturing Processes: Patents claiming specific methods for producing recombinant antibodies, including cell culture, purification, and downstream processing.
The inclusion of Epsilon-Z as a novel stabilizing excipient in CL2024003470 is a key differentiator. While numerous patents exist for formulations of biological drugs, the specific composition and use of Epsilon-Z for stabilizing IL-17 antibodies appear to be a novel aspect. Prior art typically involves standard excipients like polysorbates, sugars (e.g., sucrose, trehalose), and amino acids to improve protein stability. The identification and patented use of Epsilon-Z suggest a potentially strong proprietary position for BioGenerics Pharma in this specific formulation.
Key players in the IL-17 inhibitor market, including Novartis (cosentyx), Eli Lilly and Company (taltz), and UCB (bimzelx), all hold substantial patent portfolios. However, these patents are often directed towards different aspects of their respective drugs, such as distinct antibody sequences, specific therapeutic uses, or alternative formulation approaches. The novelty of Epsilon-Z positions CL2024003470 to potentially carve out a distinct intellectual property space, particularly concerning long-term storage and handling benefits.
A preliminary search of patent databases for "Epsilon-Z" combined with "IL-17" or "monoclonal antibody" does not reveal immediate direct overlaps, suggesting that this specific stabilizing agent may indeed represent a novel contribution. However, a comprehensive freedom-to-operate analysis would be required to confirm the absence of any indirect blocking patents or potential infringement issues.
What is the Current Status and Likely Examination Trajectory of CL2024003470?
As of its filing date on March 25, 2024, CL2024003470 is in the very early stages of the patent examination process in Chile. The Chilean National Institute of Industrial Property (INAPI) will conduct a formal examination to determine if the application meets the criteria for patentability, including novelty, inventiveness (non-obviousness), and industrial applicability.
The examination process typically involves:
- Formalities Examination: Verifying that all necessary documents and fees have been submitted.
- Substantive Examination: This is the core of the process. An examiner will conduct prior art searches to assess novelty and inventiveness. They will analyze the claims against existing patents and publications.
- Office Actions: If the examiner identifies any objections or rejections, they will issue an "Office Action" detailing these issues. The applicant then has a period (typically 60 days, extendable) to respond by amending the claims, providing arguments, or submitting further evidence.
- Grant or Final Rejection: If the applicant successfully overcomes all objections, the patent will be granted. If objections remain unresolved, the application may face a final rejection.
Given the claims' focus on a specific combination of a known class of API (IL-17 antibody) with a novel excipient (Epsilon-Z), the examination will likely scrutinize:
- Novelty of Epsilon-Z: The examiner will search extensively to determine if Epsilon-Z, or a functionally similar compound used for protein stabilization, has been previously disclosed.
- Inventive Step: Even if Epsilon-Z is novel, the examiner will assess whether its use in stabilizing BG-452 would have been obvious to a person skilled in the art of pharmaceutical formulation. The claimed benefits of enhanced stability and reduced cold chain requirements will be critical here. Evidence demonstrating a clear advantage over existing stabilization methods will be crucial.
- Clarity and Sufficiency of Disclosure: The application must adequately describe the invention, including the structure of Epsilon-Z and how it is formulated and used.
BioGenerics Pharma's success will depend on its ability to demonstrate that Epsilon-Z is a novel and non-obvious component that provides a significant and unexpected improvement in the stability of BG-452. The company's strategy likely involves robust experimental data supporting the claimed stability benefits.
What are the Potential Market and Business Implications?
The grant of patent CL2024003470 could have significant market and business implications for BioGenerics Pharma and the broader pharmaceutical industry.
- Market Exclusivity: A granted patent would provide BioGenerics Pharma with exclusive rights to market and sell the specific BG-452 formulation in Chile for a period of 20 years from the filing date, subject to patent term extensions in certain jurisdictions. This exclusivity is crucial for recouping R&D investments and generating profits.
- Competitive Advantage: The claimed enhanced stability could translate into a significant competitive advantage. Reduced reliance on cold chain logistics can lower distribution costs, improve product accessibility in regions with less developed infrastructure, and offer greater convenience to healthcare providers and patients.
- Licensing Opportunities: If the formulation proves successful, BioGenerics Pharma could explore licensing agreements with other pharmaceutical companies for markets where they lack direct commercialization capabilities.
- Barriers to Entry for Generics: The patent would act as a substantial barrier for generic manufacturers seeking to produce biosimilars or follow-on versions of BG-452 with the same stabilizing formulation.
- Strategic Value for Innovapharm S.A.: As the assignee, BioGenerics Pharma's investment in this patent underscores its strategy to develop differentiated drug products. The patent contributes to their intellectual property portfolio and potential market valuation.
For competitors developing IL-17 inhibitors, the patent would necessitate careful consideration of their own formulations and potential infringement. They may need to develop alternative stabilization methods or seek licensing agreements if their products are found to infringe on the claims of CL2024003470.
Key Takeaways
- Chilean patent application CL2024003470, filed March 25, 2024, by Innovapharm S.A. and assigned to BioGenerics Pharma, claims a novel liquid pharmaceutical formulation for treating chronic inflammatory conditions.
- The core invention is a composition of BG-452, an IL-17A monoclonal antibody, stabilized by a proprietary excipient, Epsilon-Z, at specified concentrations and ratios.
- Key claims cover the composition, specific antibody sequences, concentration and ratio ranges, inclusion of additional excipients, methods of treating inflammatory conditions (e.g., psoriasis, psoriatic arthritis), and manufacturing processes.
- The patent landscape for IL-17 inhibitors is crowded, but the specific stabilizing agent Epsilon-Z appears to be a novel differentiator for BioGenerics Pharma.
- The application is in the early examination phase at INAPI, with the patentability hinging on the novelty and inventiveness of Epsilon-Z and its stabilizing effect.
- A granted patent would provide BioGenerics Pharma with market exclusivity in Chile, a competitive advantage through enhanced stability, and potential licensing opportunities.
Frequently Asked Questions
-
What is the primary therapeutic target of the BG-452 antibody mentioned in CL2024003470?
The BG-452 antibody is designed to target and bind to the interleukin-17A (IL-17A) pathway, a key mediator in various inflammatory and autoimmune diseases.
-
What specific benefit does the Epsilon-Z excipient offer according to the patent application?
Epsilon-Z is claimed to be a proprietary stabilizing excipient that enhances the structural integrity and biological activity of the BG-452 antibody, allowing for prolonged stability under standard storage conditions (2-8 degrees Celsius) and potentially reducing reliance on strict cold chain logistics.
-
Which chronic inflammatory conditions are explicitly mentioned as treatable by the claimed formulation?
The patent application explicitly lists psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease as target chronic inflammatory conditions.
-
What is the significance of the assignee, BioGenerics Pharma, in relation to this patent application?
BioGenerics Pharma is the assignee of the patent application, meaning it is the entity to which the rights of the invention will accrue if the patent is granted. This signifies their ownership and commercial interest in the claimed formulation.
-
How does the filing date of March 25, 2024, affect the patent term for CL2024003470?
The patent term in Chile, as in many jurisdictions, is typically 20 years from the filing date. Therefore, if granted, CL2024003470 would provide patent protection until March 25, 2044, subject to potential patent term adjustments or extensions that may be applicable.
Citations
[1] Innovapharm S.A. (2024). Pharmaceutical Composition and Method of Use. Chilean Patent Application No. CL2024003470. Filed March 25, 2024.
