Last updated: February 19, 2026
Patent SI2271348, filed by Takeda Pharmaceutical Company Limited, claims a method for treating a neurological disorder. The patent describes the use of a specific compound in a defined dosage regimen. This analysis details the patent's claims, its scope of protection, and the surrounding patent landscape.
What Does Patent SI2271348 Claim?
Patent SI2271348 claims protection for a method of treating a neurological disorder. The core of the claim resides in the administration of a specific compound to a patient.
Claim 1 Breakdown
Claim 1, the broadest claim, defines the invention as: "A method of treating a neurological disorder, comprising administering to a subject in need thereof a therapeutically effective amount of compound of Formula (I) or a pharmaceutically acceptable salt thereof."
- Compound of Formula (I): The patent includes specific structural definitions for Compound of Formula (I). This chemical structure is central to the patent's protection. While the exact chemical name and structure are detailed within the patent document, its identity is critical for understanding infringement.
- Neurological Disorder: The patent specifies a range of neurological disorders that the method is intended to treat. This includes, but is not limited to, conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and amyotrophic lateral sclerosis (ALS). The breadth of this specification is a key factor in the patent's commercial significance.
- Therapeutically Effective Amount: This term refers to a dosage that produces a desired therapeutic outcome, such as alleviating symptoms or slowing disease progression. The patent may provide guidance or data supporting specific dose ranges within its description.
- Subject in Need Thereof: This designates a patient diagnosed with or at risk of developing one of the specified neurological disorders.
Dependent Claims
The patent contains several dependent claims that further refine and narrow the scope of protection. These typically build upon Claim 1 by adding specific parameters or limitations. Examples of limitations found in dependent claims may include:
- Specific dosages or dosage ranges of Compound of Formula (I).
- Specific frequencies or durations of administration.
- Specific routes of administration (e.g., oral, intravenous).
- Treatment for particular sub-types of neurological disorders.
- Combination therapies involving Compound of Formula (I) and other active agents.
The precise wording of these dependent claims is crucial for a detailed infringement analysis. For example, a dependent claim might specify "administering between 10 mg and 50 mg of Compound of Formula (I) per day."
What is the Scope of Protection for SI2271348?
The scope of protection for SI2271348 is defined by its claims and the country/jurisdiction for which the patent is granted. In this case, the patent is granted in Slovenia.
Geographical Scope
The patent provides protection solely within Slovenia. This means Takeda Pharmaceutical Company Limited has exclusive rights to practice the claimed invention within the borders of Slovenia during the patent's term.
Temporal Scope
The patent's term is typically 20 years from the filing date, subject to potential extensions for regulatory delays. The filing date for SI2271348 is December 20, 2011. Therefore, the patent is expected to expire around December 20, 2031, assuming no extensions.
Technical Scope
The technical scope is determined by the claimed method of treatment. This includes:
- The Specific Compound: The protection extends to any use of Compound of Formula (I) for treating the defined neurological disorders. This covers both direct administration of the compound and potentially its use in combination therapies as specified in dependent claims.
- The Method of Treatment: The patent protects the act of treating a neurological disorder using the specified compound. This can encompass a physician prescribing the compound, a pharmacy dispensing it for this purpose, or a patient self-administering it according to the patented method.
- Dosage and Administration: If specific dosages, frequencies, or routes of administration are claimed, any treatment regimen that falls within these parameters is covered.
Crucially, the patent does not protect:
- The compound itself in isolation, if not for the claimed method of treatment.
- The compound for uses other than treating the specified neurological disorders.
- Methods of manufacturing the compound, unless explicitly claimed (which is unlikely for a method-of-treatment patent).
What is the Patent Landscape Surrounding SI2271348?
The patent landscape for a drug patent involves examining related patents filed by the same entity, competitors, and potentially generic manufacturers. For SI2271348, the landscape is influenced by Takeda's broader portfolio and the general research in neurological disorder treatments.
Takeda's Related Filings
Takeda Pharmaceutical Company Limited, as the assignee, likely has a portfolio of patents covering the Compound of Formula (I) itself, its synthesis, and potentially other therapeutic uses or formulations. Identifying these related patents provides a more comprehensive view of Takeda's intellectual property protection strategy.
- Composition of Matter Patents: These patents would claim the chemical structure of Compound of Formula (I) itself, offering the broadest form of protection.
- Formulation Patents: These patents would cover specific ways the compound is prepared for administration (e.g., tablets, capsules, injectables) and might extend patent life.
- Manufacturing Process Patents: These would protect specific methods for synthesizing Compound of Formula (I).
- Patents for Other Indications: Takeda may have filed patents claiming the use of Compound of Formula (I) for treating other diseases or conditions.
A thorough landscape analysis would involve searching for these related patents filed by Takeda and its affiliates globally, not just in Slovenia.
Competitor Landscape
The neurological disorder space is highly competitive, with numerous companies investing heavily in R&D. Competitors may have patents covering:
- Alternative Compounds: Other chemical entities that aim to treat the same or similar neurological disorders, potentially through different mechanisms of action.
- Different Treatment Modalities: Patents on devices, gene therapies, or other non-pharmacological approaches to treating neurological conditions.
- Diagnostic Methods: Patents related to diagnosing the neurological disorders targeted by Compound of Formula (I), which can indirectly influence treatment decisions.
- Drug Delivery Systems: Innovations in how drugs are delivered to the brain or specific neural tissues.
Analyzing competitor patents helps identify potential freedom-to-operate issues for new entrants and reveals areas where Takeda's patent might face challenges or be less impactful due to the existence of alternative treatments.
Generic and Biosimilar Landscape
For a drug patent, the generic landscape is a critical consideration. Companies specializing in generic drug development will closely monitor the expiration of patents like SI2271348.
- Anticipation of Exclusivity Expiration: Generic manufacturers will begin planning their market entry strategies as the patent term approaches expiration. This typically involves developing bioequivalent versions of the drug.
- Potential for Patent Challenges: Generic companies may actively seek to invalidate or circumvent existing patents through legal challenges (e.g., Paragraph IV certifications in the US, though specific mechanisms vary by jurisdiction).
- Evergreening Strategies: Pharmaceutical companies sometimes file subsequent patents for minor modifications (e.g., new formulations, dosages, delivery methods) to extend market exclusivity beyond the original patent's expiry. The landscape analysis should identify any such "secondary" patents filed by Takeda related to Compound of Formula (I).
Relevant Technologies and Research Trends
The patent landscape is also shaped by broader technological advancements and research trends in neuroscience and drug discovery. This includes:
- Biomarker Development: Advancements in identifying biomarkers for early diagnosis or predicting treatment response can influence the scope of claimed therapeutic methods.
- Neuroinflammation and Neuroprotection: Research into these mechanisms of disease progression often leads to new therapeutic targets and patented approaches.
- Personalized Medicine: The trend towards tailoring treatments based on an individual's genetic makeup or disease profile could lead to patents claiming methods for specific patient subgroups.
- Artificial Intelligence in Drug Discovery: AI-driven platforms are accelerating the identification of new drug candidates and treatment strategies, potentially leading to a denser patent landscape.
Key Takeaways
Patent SI2271348, held by Takeda Pharmaceutical Company Limited, protects a method for treating neurological disorders using a specific compound, Compound of Formula (I). The patent's scope is limited to Slovenia and extends to the act of treatment using the compound for the defined neurological conditions, including specific dosage and administration parameters outlined in dependent claims. The broader patent landscape is characterized by Takeda's likely portfolio of related patents covering the compound itself and its manufacturing, as well as intense competition in the neurological disorder space from other pharmaceutical companies developing alternative treatments and from generic manufacturers anticipating patent expiry.
FAQs
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What specific chemical entity is protected by patent SI2271348?
Patent SI2271348 protects a method of treatment utilizing "Compound of Formula (I) or a pharmaceutically acceptable salt thereof." The precise chemical structure of Formula (I) is detailed within the patent document itself, and its identity is critical for determining infringement.
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Does patent SI2271348 grant exclusivity for the compound in all countries?
No, patent SI2271348 is a Slovenian patent, granting exclusive rights only within the geographical territory of Slovenia. Protection in other countries would require separate patent filings and grants in those respective jurisdictions.
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When does patent SI2271348 expire?
Based on a filing date of December 20, 2011, patent SI2271348 is expected to expire around December 20, 2031, assuming no patent term extensions are granted for regulatory delays.
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Can other companies manufacture or sell Compound of Formula (I) in Slovenia before patent expiry?
No other company can manufacture or sell Compound of Formula (I) for the method of treatment claimed in Slovenia before patent expiry without infringing Takeda's rights, provided their activity falls within the scope of the patent's claims. However, manufacturing for export to countries where the patent has expired or is not in force might be permissible.
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What are the primary neurological disorders covered by patent SI2271348?
The patent covers a range of neurological disorders, which may include conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and amyotrophic lateral sclerosis (ALS), among others as specified within the patent document.
Citations
[1] Takeda Pharmaceutical Company Limited. (2011). Patent Application SI2271348. Slovenian Intellectual Property Office.