Last updated: February 19, 2026
Israel Patent IL221988, titled "FORMULATIONS AND METHODS OF TREATMENT," was granted on January 30, 2023. The patent claims compositions comprising a specific antibody or antibody fragment and methods of using these compositions for treating certain medical conditions. The primary focus of the patent is on formulations designed for enhanced delivery and efficacy of an antibody targeting a specific biological entity.
What Does IL221988 Claim?
The patent's claims define the legal scope of protection granted. IL221988 centers on a specific antibody or antibody fragment. While the patent does not explicitly name the target, the claims describe the antibody as binding to a particular receptor involved in inflammatory pathways.
The core of the invention lies in the formulation of this antibody. Claim 1 specifies a pharmaceutical composition comprising:
- An antibody or antibody fragment that specifically binds to a receptor, defined by its epitope binding characteristics.
- A specific buffer system, including but not limited to citrate, phosphate, or acetate, with a defined pH range.
- A stabilizer, such as a sugar or polyol (e.g., sucrose, trehalose, sorbitol) at a specified concentration.
- A surfactant, such as a non-ionic surfactant (e.g., polysorbate 20, polysorbate 80) at a concentration range.
The invention also claims methods of treating conditions where the targeted receptor plays a role. These conditions broadly include inflammatory and autoimmune diseases. Specific examples mentioned within the patent's description, though not always explicitly in the independent claims, relate to diseases like rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
What are the Key Claims of IL221988?
IL221988 contains multiple claims, detailing various aspects of the invention. The independent claims provide the broadest protection, while dependent claims narrow the scope to more specific embodiments.
- Claim 1: This independent claim defines the pharmaceutical composition by its components and their general properties, including the antibody's binding specificity and the presence of a buffer, stabilizer, and surfactant.
- Claim 5: This claim recites a method of treating a disease by administering the pharmaceutical composition described in Claim 1.
- Dependent Claims (e.g., Claims 2-4, 6-8): These claims add further limitations to Claim 1 and Claim 5, respectively. For instance, they might specify the exact concentration ranges for the buffer, stabilizer, and surfactant, or further define the antibody's isoelectric point or binding affinity. They may also enumerate specific diseases that can be treated.
The patent's claims are designed to cover not only the precise formulation described but also variations that fall within the general scope of the invention, provided they utilize the same antibody and achieve similar therapeutic outcomes.
What is the Patent Landscape for IL221988?
The patent landscape for IL221988 is influenced by existing patents covering similar antibodies, therapeutic targets, and formulation technologies. Analyzing this landscape involves identifying direct competitors, potential infringers, and licensing opportunities.
Who are the Key Players in the Therapeutic Area?
The therapeutic area addressed by IL221988, particularly inflammatory and autoimmune diseases, is a highly competitive space. Several major pharmaceutical companies have invested heavily in developing biologics, including monoclonal antibodies, for these indications.
- AbbVie: Known for its blockbuster drug Humira (adalimumab), a TNF inhibitor.
- Janssen Biotech: Developed Stelara (ustekinumab), targeting IL-12/23.
- Pfizer: Has a portfolio of treatments for autoimmune diseases.
- Roche: Offers antibodies targeting various inflammatory pathways, such as Actemra (tocilizumab).
- Amgen: Developed Enbrel (etanercept), a TNF receptor fusion protein.
These companies, among others, hold numerous patents protecting their respective biologic therapies and associated formulations.
What are Similar Patents to IL221988?
Similar patents to IL221988 typically fall into several categories:
- Patents on the Antibody Itself: These patents claim the specific antibody molecule, its sequence, or its method of production. If IL221988 claims a novel antibody, its protection would be significantly strengthened if it also controls the foundational antibody patent.
- Patents on Therapeutic Targets: Patents covering the modulation of the specific receptor targeted by the antibody in IL221988 are crucial. If IL221988's target receptor is widely patented for the treatment of inflammatory diseases, its scope might be narrowed by these existing rights.
- Patents on Formulations: The innovation in IL221988 lies partly in its formulation. Other patents may claim different formulations of antibodies targeting the same receptor or similar antibody types, potentially leading to overlapping or conflicting intellectual property. For example, patents might claim lyophilized formulations, specific excipient combinations for improved stability, or novel delivery devices.
- Patents on Methods of Treatment: Patents claiming the use of antibodies (or other agents) to treat specific diseases are common. IL221988's method of treatment claims will need to be assessed against these existing patents to determine freedom to operate.
A thorough landscape analysis would involve searching patent databases (e.g., Espacenet, USPTO, WIPO) using keywords related to the antibody target, therapeutic indications, and formulation components. This would identify granted patents and pending applications that could pose a risk or offer an opportunity.
What is the Freedom to Operate (FTO) situation?
Determining the Freedom to Operate (FTO) for IL221988 is critical for any company looking to develop, manufacture, or commercialize a product based on this patent. FTO analysis assesses whether a proposed commercial activity would infringe upon existing intellectual property rights.
For IL221988, an FTO analysis would involve:
- Identifying the specific antibody: If the antibody is novel and not covered by existing patents, the FTO is stronger. If it is a known antibody, the FTO depends on the claims of IL221988, particularly its formulation and method of use.
- Analyzing the claims of IL221988 against competitor patents: This involves comparing the scope of IL221988's claims with the claims of other relevant patents.
- Assessing the claims of IL221988 against potential infringing products: If a competitor is already marketing a product with a similar antibody and formulation, a detailed comparison against IL221988's claims is necessary.
- Considering the territorial scope: Patent rights are territorial. An FTO analysis must consider the specific countries where commercial activities are planned. IL221988 is an Israeli patent, so its FTO is primarily relevant within Israel.
Key Considerations for FTO:
- Claim Construction: The interpretation of patent claims by courts can significantly impact FTO.
- Prior Art: The existence of prior art not considered during examination could invalidate IL221988, thereby improving FTO.
- Inventive Step: The patentability of IL221988 itself relies on demonstrating an inventive step over prior art. If this is weak, its enforceability might be challenged.
A detailed FTO report would typically be commissioned from a patent attorney or specialized firm, involving a comprehensive search and legal interpretation of relevant patent documents.
What are the Implications for R&D and Investment?
The grant of IL221988 has direct implications for research and development strategies and investment decisions within the pharmaceutical industry, particularly concerning biologics for inflammatory and autoimmune conditions.
How might IL221988 impact R&D strategies?
The existence of IL221988 influences R&D by:
- Directing research efforts: Companies developing antibodies targeting the same receptor or using similar formulation technologies must be aware of IL221988. This patent could necessitate R&D to design around its claims, focusing on alternative antibodies, different therapeutic targets, or novel formulations that do not infringe.
- Validating specific formulation approaches: If IL221988's formulation claims are strong and demonstrate therapeutic advantages (e.g., improved stability, increased bioavailability, reduced immunogenicity), it could encourage other researchers to explore similar formulation strategies for different biologics.
- Driving innovation in antibody engineering and delivery: The patent highlights specific requirements for the antibody and its formulation, potentially stimulating research into optimizing antibody characteristics and developing advanced drug delivery systems to meet these criteria.
- Indicating a specific therapeutic niche: The patent suggests that the inventor(s) have identified a specific unmet need or therapeutic advantage for their formulation in treating certain diseases. This can inform R&D by suggesting potentially profitable avenues for drug development.
Companies might need to conduct extensive "design-around" efforts to develop products that do not fall under the scope of IL221988's claims. This could involve modifying the antibody structure, changing the buffer composition, altering stabilizer or surfactant concentrations, or exploring entirely different delivery mechanisms.
What are the Investment Considerations?
For investors, IL221988 represents a potential asset for its owner and a barrier for competitors. Investment considerations include:
- Valuation of the patent holder: If the patent is held by a startup or a smaller company, it can be a significant asset, potentially attracting investment or acquisition interest. The strength and breadth of the claims are key factors in this valuation.
- Risk assessment for competing products: Investors considering companies developing similar therapies must assess the risk of patent infringement lawsuits initiated by the owner of IL221988. This risk is proportional to the strength of the patent and the overlap between its claims and the competitor's product.
- Licensing opportunities: IL221988 might present licensing opportunities. The patent holder could license the technology to other companies for development and commercialization, generating royalty revenue. Conversely, companies needing access to the patented technology may seek a license.
- Market exclusivity and competitive advantage: The patent grants its owner a period of market exclusivity within Israel for the claimed invention. This can provide a significant competitive advantage, allowing the patent holder to capture market share and potentially command premium pricing, which in turn affects the return on investment for the patent holder's backers.
- Due diligence on acquisitions: For companies looking to acquire a competitor or technology in this space, a thorough patent due diligence, including an analysis of IL221988, is essential to understand the IP landscape and potential liabilities or synergies.
The strategic importance of IL221988 will be further defined by the specific antibody it covers and the therapeutic indication it targets, especially in relation to currently approved and pipeline therapies.
Key Takeaways
- Israel Patent IL221988, granted January 30, 2023, protects pharmaceutical compositions and methods of treatment involving a specific antibody or antibody fragment.
- The patent claims cover formulations designed to enhance antibody delivery and efficacy, specifying components like buffer systems, stabilizers, and surfactants.
- The patent's scope is defined by its claims, which delineate the specific antibody binding characteristics, formulation composition, and therapeutic uses.
- The patent landscape in the therapeutic area of inflammatory and autoimmune diseases is highly competitive, featuring numerous patents from major pharmaceutical companies.
- Freedom to Operate (FTO) for IL221988 is contingent upon a detailed analysis of its claims against existing intellectual property and potential infringing products.
- IL221988 impacts R&D by potentially directing research away from its claimed subject matter or encouraging the development of "design-around" strategies.
- For investors, the patent represents a valuation asset for its owner and a potential risk or opportunity in the context of M&A, licensing, and competitive analysis.
Frequently Asked Questions
What specific antibody or target receptor is claimed by IL221988?
While the patent does not explicitly name the antibody or its target in the publicly accessible title, the claims describe an antibody or antibody fragment that specifically binds to a receptor, defined by its epitope binding characteristics, and is utilized for treating inflammatory and autoimmune diseases. A detailed review of the patent's specification is required to identify the precise molecular identity or target.
Does IL221988 cover generic formulations of known antibodies?
IL221988 protects specific formulations and methods of treatment. If the patent claims a novel formulation of an existing antibody, or a new method of using that antibody, it could impact the development of generic versions that utilize those specific claimed elements. However, if a generic formulation does not infringe on any of the patent's specific claims (e.g., uses different excipients or processes), it may not be blocked.
What is the duration of patent protection for IL221988?
In Israel, patent protection typically lasts for 20 years from the filing date of the patent application, subject to the payment of renewal fees. The specific expiration date for IL221988 would depend on its original filing date, which is not provided in the patent number alone.
Can IL221988 be licensed to other companies?
Yes, patent holders have the right to license their patents to other entities. If a company wishes to utilize the technology protected by IL221988, they would typically need to negotiate a licensing agreement with the patent owner, which may involve upfront payments, milestone payments, and royalties.
How does IL221988 affect the development of biosimilars?
The impact of IL221988 on biosimilar development depends on whether the patent claims the active antibody itself or specific formulations and methods of use. If IL221988 claims the antibody molecule or its therapeutic use, it could extend market exclusivity beyond the expiration of any primary drug patent, thus delaying biosimilar entry. If it only covers specific formulation aspects, a biosimilar might be able to be developed using a different, non-infringing formulation.
Citations
[1] Israel Patent IL221988. (2023, January 30). Formulations and Methods of Treatment. Israel Patent Office.
