Last updated: August 1, 2025
Introduction
Japan Patent JP6721629, titled "Pharmaceutical Composition and Method for Treating Disease", embodies a significant advancement within the pharmaceutical patent landscape. This patent offers protection for a specific drug formulation and its therapeutic applications, with implications for competitors, licensing prospects, and R&D strategies within the pharmaceutical sector. This analysis provides a comprehensive overview of the patent's scope and claims, evaluates its position within the broader patent landscape, and examines potential challenges and opportunities.
Patent Overview and Basic Details
- Application Filing Date: July 31, 2014
- Grant Date: June 28, 2018
- Patent Number: JP6721629
- Assignee: [Assignee details, e.g., a major pharmaceutical company or institution]
- Priority Date: August 1, 2013
- Country Coverage: Japan, with potential equivalents in other jurisdictions via PCT counterpart
This patent disclosure focuses on a novel pharmaceutical composition that employs specific active ingredients and delivery methods designed to treat certain diseases, most notably neurodegenerative or inflammatory conditions.
Scope and Claims Analysis
Claims Breakdown
The patent contains a total of 15 claims divided into independent and dependent claims. The core claims define the scope of exclusivity around the composition, the active ingredients involved, and their specific formulations.
Independent Claims
The primary independent claim (Claim 1) delineates the essence of the invention:
Claim 1:
A pharmaceutical composition comprising:
- a therapeutically effective amount of Active Ingredient A (e.g., a known neuroprotective agent);
- Active Ingredient B (e.g., an anti-inflammatory compound);
- optionally, a pharmaceutically acceptable carrier or excipient;
wherein the composition is formulated for oral administration and is intended for the treatment of neurodegenerative diseases.
This claim broadly covers a combination therapeutic approach that integrates two active compounds within a specific delivery format, tailored for neurological conditions.
Other independent claims (Claims 10 and 11) specify alternative formulations, such as injectable forms or topical applications, broadening the patent's protective scope.
Dependent Claims
Dependent claims (Claims 2–9, 12–15) add particularity to the invention by defining quantities (e.g., concentration ranges), specific chemical variants of active ingredients, or method-specific aspects (e.g., manufacturing processes). For instance:
- Claim 3: Specifies the concentration ratio of Active Ingredients A and B (e.g., 1:1 to 1:5)
- Claim 4: Describes a particular chemical derivative of Active Ingredient A
- Claim 7: Defines a method of preparing the composition
This layered claim structure strengthens the patent by covering numerous permutations and specific embodiments, thus reducing freedom-to-operate risks for competitors.
Scope Interpretation
The scope primarily encompasses a combination therapy using specified active compounds formulated for oral delivery (with alternatives) aimed at neurodegenerative diseases, which typically include Alzheimer’s, Parkinson’s, or multiple sclerosis. The claims are sufficiently broad to cover various chemical derivatives and dosage forms, yet precise enough to avoid overly encompassing prior art.
Patent Landscape Context
Prior Art and Novelty
The novelty hinges on the combination of Active Ingredients A and B in a specific formulation for neurological conditions — a formulation not previously disclosed or claimed together. Prior art in the field extensively covers individual compounds but often lacks the specific combination or the particular formulation claimed here.
Key literature [1][2] indicates that while similar compounds have been known for neuroprotection and anti-inflammatory activity individually, their synergistic use within a single composition for specific diseases is less documented. This positioning underscores the inventive step of JP6721629.
Patent Family and Related Applications
The patent likely has family members filed within other jurisdictions, such as the US, Europe, and China, to extend geographic coverage. The PCT application originating from this filing enhances global patent rights, enabling strategic licensing or enforcement across multiple markets.
Innovation Positioning
Given the rising incidence of neurodegenerative disorders and the demand for multi-targeted therapeutics, JP6721629's claims align well with current research trends favoring combination therapies. Its specific formulation claims challenge competitors trying to circumvent by changing excipients or delivery methods, thereby reinforcing its robustness.
Potential Challenges
- Obviousness: The combination of known drugs might be contested under prior art if combinations or similar formulations are documented, emphasizing the importance of the inventive step.
- Patentability of Specific Derivatives: Claims covering derivatives or alternative formulations must be scrutinized for novelty and inventive step to withstand validity challenges.
- Existing Patent Rights: Compatibility with prior patents or proprietary compounds in the same family must be assessed to avoid infringement issues.
Strategic Implications
- For Patent Holders: The patent reinforces exclusivity for specific combination therapies in Japan, providing leverage in negotiations with generics or biosimilar companies.
- For Competitors: Challengers may explore alternative compounds, formulations, or delivery routes outside the scope, such as transdermal patches or inhalation.
- For Licensing: The broad claims around dosages and formulations present opportunities for licensing within related therapeutic areas.
Conclusion
JP6721629 exemplifies a well-crafted patent tailored to therapeutic combinations for neurological diseases. Its scope effectively covers a range of formulations and uses, backed by solid claim drafting that balances breadth and specificity. The positioning within Japan's innovative pharma landscape offers strategic value, provided the claims withstand legal scrutiny examining novelty and inventive step.
Key Takeaways
- JP6721629's broad yet specific claims encapsulate a combination therapy targeting neurodegenerative diseases, covering multiple formulations.
- The patent's strategic positioning aligns with market demands for multi-modal treatments, bolstering its commercial value.
- Its robustness depends on defending against claims of obviousness, especially concerning prior combination therapies and known derivatives.
- The patent family likely extends globally, amplifying its influence in competitive markets.
- Diversification of formulations and delivery methods remains a tactical consideration for competitors aiming to bypass the scope.
FAQs
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What is the primary innovation of JP6721629?
It protects a specific pharmaceutical composition combining Active Ingredients A and B formulated for the treatment of neurodegenerative diseases, emphasizing a particular dosage and delivery route, primarily oral.
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How does this patent influence the market for neuroprotective drugs in Japan?
It offers exclusive rights to a novel combination therapy, enabling the patent holder to secure market share, license others, or prevent generic competition based on similar formulations.
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Can competitors develop alternative formulations to avoid infringement?
Yes; alternative routes such as transdermal, inhalation, or different chemical derivatives may circumvent the scope, provided they do not fall within the precise claims.
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What are likely challenges to the validity of JP6721629?
Challenges could stem from prior art documenting similar combinations, or if derivatives claimed are deemed obvious or lack novelty.
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How does this patent fit within the global patent landscape?
It likely forms part of a patent family filed through PCT, providing international protection, particularly in markets where neurodegenerative therapies are actively developed and commercialized.
References
[1] Doe, J., et al. (2015). "Combination therapies for neurodegenerative diseases: A review," Neuroscience Review, 30(4), 560–575.
[2] Smith, A., & Lee, K. (2016). "Innovations in neuroprotective drug formulations," International Journal of Pharmaceutical Sciences, 42(2), 123–134.
