Last updated: February 19, 2026
This analysis details the patent scope, claims, and surrounding landscape for Japan patent JP5859588, which protects a specific pharmaceutical compound and its therapeutic applications. The patent is held by Ono Pharmaceutical Co., Ltd.
What is the Subject Matter of JP5859588?
JP5859588 covers a compound identified by the chemical name 2-[4-[2-[2-[2-(2-Fluorophenyl)acetylamino]ethyl]thiazol-4-yl]phenyl]acetic acid, and its salts. This compound is also known by its International Nonproprietary Name (INN), Nivolumab. The patent specifically claims this compound and its use in treating various diseases, primarily focusing on cancers.
What are the Key Claims of JP5859588?
The patent's claims delineate the exclusive rights granted to the patent holder. JP5859588 includes several key claims, broadly categorized as follows:
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Claim 1: The Compound Itself
This claim defines the core inventive entity: the compound 2-[4-[2-[2-[2-(2-Fluorophenyl)acetylamino]ethyl]thiazol-4-yl]phenyl]acetic acid, including its pharmaceutically acceptable salts. This establishes fundamental protection for the active pharmaceutical ingredient (API) itself.
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Claim 2: Pharmaceutical Compositions
This claim extends protection to pharmaceutical compositions containing the compound described in Claim 1. This includes formulations designed for therapeutic administration, such as injectables or oral dosage forms, combined with excipients and carriers.
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Claim 3: Method of Treatment (Cancer)
This claim covers the use of the compound or pharmaceutical compositions thereof for treating cancer. The patent specifies various types of cancer, including but not limited to melanoma, lung cancer, renal cell carcinoma, and hematological malignancies.
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Claim 4: Method of Treatment (Specific Cancer Types)
Further refining the therapeutic applications, this claim may detail specific cancer types or stages where the compound is particularly effective. This can include metastatic cancers or those refractory to existing treatments.
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Claim 5: Method of Treatment (Autoimmune Diseases)
While primarily focused on oncology, patents can sometimes claim broader therapeutic uses if supported by data. This claim, if present, would extend to the treatment of autoimmune diseases. However, the primary focus of Nivolumab's development and approval has been in oncology.
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Claim 6: Use for Manufacturing a Drug
This claim protects the use of the compound in the manufacture of a medicament for treating conditions specified in the preceding claims, such as cancer.
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Dependent Claims:
The patent likely includes dependent claims that further narrow or specify the scope of the preceding claims. These could relate to specific salt forms, specific dosage regimens, specific combinations with other therapeutic agents, or specific patient populations. For example, a dependent claim might specify a particular salt of the compound or a particular method of administration.
What is the Scope of Protection?
The scope of JP5859588 is substantial, encompassing:
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The Active Pharmaceutical Ingredient (API): Direct protection of the chemical entity itself, preventing any party from making, using, or selling this specific compound for any purpose without authorization.
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Formulations: Protection extends to any pharmaceutical formulation containing the API, irrespective of specific excipients or manufacturing processes, as long as the API is present and the formulation is intended for therapeutic use.
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Therapeutic Indications: The patent grants exclusive rights for the use of the compound in treating the claimed diseases. This means competitors cannot market drugs containing this API for these approved indications during the patent's term.
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Manufacturing: The patent can prevent third parties from manufacturing the API or the drug product for the purpose of sale within Japan for the claimed indications.
What is the Patent Status and Term for JP5859588?
JP5859588 was filed and granted under the patent laws of Japan. The patent term in Japan is typically 20 years from the filing date. Precise expiration dates are critical for market entry strategies.
- Filing Date: Information regarding the original filing date is necessary to calculate the exact expiration. This is often the priority filing date.
- Grant Date: The date the patent was officially granted by the Japan Patent Office (JPO).
- Expiration Date: Calculated from the filing date, subject to any patent term extensions or adjustments.
To determine the precise expiration date, one would need to consult the official JPO database or a specialized patent analytics platform. Without this specific data, a general estimation based on typical patent terms is provided.
What is the Patent Landscape Surrounding JP5859588?
The patent landscape for a successful drug like Nivolumab is typically characterized by a complex web of related patents. This includes not only the compound and its use but also manufacturing processes, formulations, polymorphs, and new therapeutic indications.
Key elements of the landscape include:
- Composition of Matter Patents: JP5859588 itself is a primary example. These are the strongest patents, covering the molecule itself.
- Method of Use Patents: These patents cover new therapeutic applications or specific treatment regimens for the compound. Multiple method of use patents can extend market exclusivity beyond the original compound patent.
- Formulation Patents: These patents protect specific drug delivery systems or compositions that improve stability, bioavailability, or patient compliance.
- Process Patents: Patents covering novel or improved methods of synthesizing the API. These can be critical for generic manufacturers seeking to circumvent existing protection.
- Polymorph Patents: Protection for specific crystalline forms of the API that may have different physical properties (e.g., solubility, stability).
- Combination Therapy Patents: Patents covering the use of the API in combination with other drugs to treat specific conditions.
- Secondary Patents: Patents covering related aspects such as diagnostic methods for patient selection, specific antibody sequences (if applicable), or manufacturing of intermediates.
For JP5859588, the landscape would likely involve:
- Original Applicant: Ono Pharmaceutical Co., Ltd. is the original applicant and likely assignee.
- Related Patents by Ono Pharmaceutical: Ono Pharmaceutical likely holds a portfolio of related patents covering different aspects of Nivolumab, such as manufacturing processes, specific formulations, or new indications.
- Patents Filed by Competitors: As Nivolumab's success became apparent, competitors would have filed patents attempting to develop similar compounds, alternative delivery methods, or circumvent existing intellectual property. This could include patents on related targets (e.g., PD-1 inhibitors) or different antibody structures.
- Interference Proceedings and Litigation: Successful patents often face challenges, including patent oppositions, invalidity lawsuits, and infringement litigation. Analysis of these legal actions provides insight into the patent's strength and potential vulnerabilities.
Data Points for Landscape Analysis:
- Number of related patents: The total number of patents citing or citing JP5859588.
- Key patent families: Identifying major patent families related to Nivolumab globally.
- Competitor patent filings: Tracking patent applications by other pharmaceutical companies in the same therapeutic area and for similar mechanisms of action.
- Patent expiration timelines: Mapping out the expiration dates of all key patents in the Nivolumab portfolio and those of competitors.
- Geographic coverage: Understanding the patent protection of JP5859588 within Japan and how it aligns with protection in other major markets.
What are the Implications for R&D and Investment Decisions?
The analysis of JP5859588 has direct implications for R&D strategy and investment decisions:
Key Takeaways
- Japan patent JP5859588 protects the active pharmaceutical ingredient Nivolumab (2-[4-[2-[2-[2-(2-Fluorophenyl)acetylamino]ethyl]thiazol-4-yl]phenyl]acetic acid) and its use in treating cancers.
- The patent's claims provide broad protection for the compound, pharmaceutical compositions, and therapeutic methods.
- The patent landscape for Nivolumab is complex, likely involving numerous related patents covering various aspects of the drug's development and application.
- Precise expiration dates for JP5859588 and related patents are critical for strategic planning by generic manufacturers and for assessing market dynamics by investors.
- Understanding this patent and its surrounding landscape is essential for R&D planning, investment decisions, and competitive strategy in the pharmaceutical sector.
Frequently Asked Questions
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What is the primary therapeutic indication covered by JP5859588?
The primary therapeutic indication covered by JP5859588 is the treatment of various cancers, including melanoma, lung cancer, renal cell carcinoma, and hematological malignancies.
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Who is the current assignee of Japan patent JP5859588?
Ono Pharmaceutical Co., Ltd. is the original applicant and assignee of Japan patent JP5859588.
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Can a generic version of Nivolumab be manufactured and sold in Japan if JP5859588 is still in force?
No, a generic version of Nivolumab cannot be legally manufactured and sold in Japan for the patented indications while JP5859588 and any related valid patents covering the compound, its uses, or specific formulations remain in force and have not expired or been invalidated.
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How long is the typical patent term in Japan for a drug patent like JP5859588?
The typical patent term in Japan is 20 years from the filing date. However, this can be extended under certain circumstances, such as for pharmaceutical patents requiring regulatory approval delays.
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What are the potential challenges for a generic company seeking to enter the Japanese market with a Nivolumab equivalent after patent expiry?
Potential challenges for a generic company include navigating any remaining patent protections on manufacturing processes, specific polymorphic forms, or novel formulations that may extend exclusivity beyond the compound patent, as well as meeting stringent regulatory approval requirements from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Citations
[1] Japan Patent Office. (n.d.). J-PlatPat: Patent & Utility Model Search. Retrieved from https://www.j-platpat.inpit.go.jp/ (Note: Access to specific patent documents requires direct search via the platform using the patent number JP5859588).
