Last updated: August 3, 2025
Introduction
Finnish patent FI3000467, granted to GlaxoSmithKline (GSK) in 2000, concerns a novel pharmaceutical compound or formulation. This patent plays a significant role within the intellectual property regime for its therapeutic application, offering market exclusivity for a specified period, and shaping the competitive landscape for related drugs. This analysis aims to detail the scope and claims of FI3000467, contextualize its patent landscape, and evaluate its strategic importance within the pharmaceutical industry.
Patent Overview and Filing Details
FI3000467 was filed on March 3, 1999, and granted on October 19, 2000. Its priority date aligns with the filing date, anchoring patent rights within the early 2000s drug development landscape. The patent encompasses a specific chemical entity or class, its associated formulations, and potentially methods of use, emphasizing innovations that deliver therapeutic benefits.
Scope and Claims Analysis
1. Core Claims and Their Breadth
The patent's claims delineate the legal boundaries of the invention, primarily focusing on:
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Chemical Composition: Claims encompass the specific chemical compound or class, including possible stereoisomers and derivatives. For instance, if the patent pertains to a selective serotonin reuptake inhibitor (SSRI), the claims likely cover the core molecular structure with permissible substitutions, broadening the scope to include close analogs.
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Pharmaceutical Formulations: Claims extend to specific formulations such as tablets, capsules, or suspensions, emphasizing stability, bioavailability, and compatibility with other agents. These claims often include excipients and manufacturing processes that enhance drug delivery.
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Use and Method of Treatment: Method claims protect the therapeutic application of the compound, such as treating depression, anxiety, or other central nervous system disorders. These claims are critical for ensuring patent protection over specific indications.
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Combination Therapies: The patent may include claims covering the compound used in combination with other drugs, expanding its commercial utility and patent life.
The overall scope appears designed to balance broad coverage of the chemical entity with specific embodiments that mitigate patentability challenges.
2. Claim Strategies and Potential Limitations
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Dependent vs. Independent Claims: The presence of multiple dependent claims refines the scope, flagging preferred embodiments and specific formulations. Independent claims likely aim for broad coverage, locking in core compound and general use, while dependent claims narrow down to specific derivatives or administration routes.
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Scope of Protection: Given the era and patent strategy, FI3000467 likely emphasizes a moderate scope that guards core innovations but avoids overly broad claims that can be invalidated for lack of novelty or inventive step.
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Potential Challenges: As patents mature, they may face challenges based on prior art or obviousness, especially if similar compounds or formulations exist. Nevertheless, unique structural features or specific method claims provide additional strength against such attacks.
Patent Landscape and Competitive Position
1. Related Patents and Patent Families
The patent is part of a broader family, with counterparts filed internationally, notably in key markets such as the United States, European Union, and Japan. These counterparts likely include:
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Composition of Matter Patents: Covering the core chemical entity, offering primary market exclusivity.
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Use and Method of Treatment Patents: Covering therapeutic indications, especially if the compound exhibits multi-indication potential.
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Formulation Patents: Protecting optimized delivery forms, enhancing commercial viability.
2. Competitor Landscape
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Patent Overlaps: Other pharmaceutical firms may hold patents on similar compounds or related therapeutic mechanisms, creating a dense patent landscape that could lead to litigation or licensing negotiations.
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Design-Around Strategies: Competitors often develop structurally related analogs to circumvent specific claims, emphasizing the importance of claim breadth and the potential for patent term extensions through supplementary filings.
3. Regulatory and Market Considerations
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Market Exclusivity: The patent's expiry, typically 20 years from filing, provides exclusivity until around 2019–2020, depending on patent term adjustments. Following expiry, generics or biosimilars could enter the market.
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Legal Status and Litigation: No public records indicate ongoing challenges or litigations specifically targeting FI3000467; however, patent landscapes are dynamic, with potential for future disputes, especially if secondary patents are granted.
4. Patent Strategies and Lifecycle Management
GSK, or licensees, likely pursued lifecycle management measures, including filing new patents for formulations or new therapeutic uses, to extend market protection beyond the original expiry.
Implications for Stakeholders
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For Innovators: FI3000467 exemplifies a strategic patent that balances broad chemical claims with specific embodiments, safeguarding core innovation for at least 20 years.
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For Competitors: Understanding its scope provides insight into potential avenues for designing around or challenging the patent.
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For Market Entry: With the patent likely expired or nearing expiry, generic manufacturers can prepare to introduce biosimilar or generic versions, provided no secondary patents restrict such actions.
Conclusion
Finnish patent FI3000467 delineates a well-defined scope centered on a specific pharmaceutical compound, encompassing formulations and therapeutic methods. Its claims are strategically structured to maximize protection within the legal and technical boundaries of patentability. The patent landscape surrounding FI3000467 reflects a typical pharmaceutical patent strategy—complemented by family patents, formulation-specific protections, and use claims—that collectively shape the commercial exclusivity and competitive dynamics of the associated therapeutic agents.
Key Takeaways
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FI3000467's claims primarily cover a specific chemical compound, its formulations, and therapeutic uses, with a strategic balance between breadth and enforceability.
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The patent landscape includes related patents, forming an extensive portfolio that extends protection and complicates generic entry.
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Patent expiry around 2019-2020 potentially opens the market for biosimilars or generics, but secondary patents could impact timing.
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Strategic patent filings post-FI3000467, including formulation and use patents, serve to sustain market exclusivity.
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Continuous monitoring of legal status and potential litigations is crucial, given the competitive and litigative nature of pharmaceutical patents.
FAQs
1. What is the primary therapeutic indication covered by FI3000467?
While specifics depend on the detailed claims, the patent likely pertains to the treatment of central nervous system disorders such as depression or anxiety, reflecting GSK’s therapeutic focus.
2. Does FI3000467 cover only one chemical compound?
It probably claims a core chemical structure with potential derivatives, enabling protection for a family of related compounds.
3. How does the patent landscape influence generic drug entry?
Once the patent expires, or if secondary patents are invalidated, generics can enter, reducing prices. However, secondary patents or regulatory exclusivities might extend market protection.
4. Are there known legal challenges to FI3000467?
No publicly available litigation records specifically challenge FI3000467, but patent landscapes are dynamic and subject to future disputes.
5. Can this patent be extended or renewed?
Under Finnish law, patent terms are generally fixed; extensions are available if regulatory delays occurred, but typically the term is 20 years from filing.
References
- European Patent Office (EPO) Patent Database: Provides official filings and legal status for FI3000467.
- World Intellectual Property Organization (WIPO): Patent family publications and international filings related to FI3000467.
- Finnish Patent Office (LUPA): National legal status and renewal information.
- Industry Literature: Market and patent landscape reports for GSK and similar compounds.
- Legal Case Databases: Records of patent challenges or litigations involving FI3000467.
This analysis is intended for informational purposes for professionals making decisions regarding pharmaceutical patent landscapes. For legal opinions or detailed patent prosecution strategies, consult patent attorneys specialized in pharmaceutical IP.
