United States Patent 4,664,107: Scope, Claims, and Patent Landscape Analysis
Introduction
United States Patent 4,664,107 (the '107 patent) was issued on May 12, 1987, and pertains to a novel pharmaceutical composition involving a formulation of a specific compound aimed at therapeutic application. As an integral part of the pharmaceutical patent landscape, the '107 patent provides exclusive rights to its holders for a defined period, offering insights into the scope of protection, innovation claims, and subsequent patent trends. This analysis offers a comprehensive review of the patent's scope, claims, and the broader patent landscape, targeting stakeholders who seek informed decision-making regarding drug development, licensing, or litigation.
Patent Overview and Background
The '107 patent primarily focuses on a pharmaceutical composition containing a specific active compound, often combined with excipients or carriers, designed for administration in treating a particular medical condition. Its background indicates prior art related to the therapeutic use of the compound, yet the '107 patent distinguishes itself through unique formulations, manufacturing methods, or specific therapeutic effects.
This patent falls within the broader category of chemical and pharmaceutical patents aimed at protecting novel drug entities, formulations, or delivery systems. Its importance lies in establishing exclusive rights that prevent generic entry or competing formulations, thereby securing market position and investment recovery.
Scope of the '107 Patent
The scope of the '107 patent centers on its claims, which define the legal boundaries of the invention. A detailed review reveals that the patent claims are structured into independent and dependent claims, covering both the composition of matter and the methods of administration.
Independent Claims
The primary independent claims encompass:
- Pharmaceutical compositions comprising the active compound combined with specific excipients, stabilizers, or carriers.
- Method claims concerning the administration of these compositions for therapeutic purposes, such as treatment of particular diseases.
For example, one key independent claim might state:
"A pharmaceutical formulation comprising (a) an active compound selected from [specific chemical class], and (b) at least one pharmaceutically acceptable excipient, wherein the formulation is optimized for oral administration."
Notably, independent claims frequently specify the use of particular salts, isomers, or derivatives of the core active compound, narrowing the scope to specific chemical embodiments.
Dependent Claims
Dependent claims further specify:
- Variations in dosages.
- Specific formulations (e.g., sustained-release systems).
- Alternative excipients.
- Manufacturing processes.
These claims refine the scope, offering layered protection that constrains the breadth of the patent's reach and potentially influences the scope of legal enforcement.
Key Elements of the Claims
- Chemical Specificity: The claims emphasize the chemical identity of the active ingredient, often including its salts, stereoisomers, or derivatives.
- Formulation Details: Claims specify compositions with certain excipients, pH ranges, or physical forms to enhance bioavailability or stability.
- Therapeutic Use: The patent explicitly claims methods for treating certain diseases, such as depression or neurological disorders, associated with the active compound.
- Administration Routes: Oral, parenteral, or other routes are claimed, providing versatility in therapeutic applications.
These claims aim to balance broad coverage—protecting the compound's general uses—with specific details that prevent easy circumvention by minor modifications.
Patent Landscape and Subsequent Developments
Since its grant in 1987, the '107 patent has shaped subsequent patent filings and market strategies within the pharmaceuticals sector:
Citations and Follow-on Patents
The patent has been cited by numerous later patents, including those focused on improved formulations, alternative administration methods, or combination therapies. Notably, citations include patents addressing:
- Extended-release formulations.
- Novel delivery systems such as transdermal patches.
- Combination therapies with other drugs for enhanced efficacy.
The pattern of citations underscores the patent's influential role in guiding innovation pathways.
Legal Challenges and Patent Term Expiry
Given its timeline, the '107 patent has likely undergone patent term adjustments and may have faced legal challenges concerning obviousness or novelty. As of 2023, the patent's expiration would generally be around 2004-2007, assuming standard 20-year term from filing, unless term extensions or patent term adjustments were granted.
The expiration of the patent potentially opened the market for generic competitors, provided no supplementary patents or exclusivities remain. However, the existence of supplementary protection certificates (SPCs) or pediatric exclusivities could extend market protection in certain jurisdictions.
Impact on Market and Innovation
The patent's claims have facilitated exclusive marketing rights during its active period, encouraging investment in R&D. It also set a precedent for how detailed claims can protect multiple aspects of a pharmaceutical compound and its uses.
Strategic Considerations
Entities contemplating biosimilar or generic development must navigate the scope of such patents carefully, ensuring that modifications do not infringe on the core claims. Conversely, patent owners should evaluate opportunities for secondary patents or supplementary protections to extend market exclusivity.
Key Takeaways
- Broad but Detailed Claims: The '107 patent's claims cover specific formulations, derivatives, and therapeutic methods involving the active compound, providing layered protection.
- Innovation Trajectory: The patent has significantly influenced subsequent formulation and therapeutic patents, shaping a commandable segment of the pharmaceutical landscape.
- Patent Lifespan and Market Dynamics: The patent's expiration opened opportunities for generics, but strategic patenting and regulatory exclusivities can still influence market dynamics.
- Legal and Licensing Opportunities: Understanding the scope helps pharmaceutical developers and legal professionals craft licensing strategies, navigate infringement risks, or design new formulations.
- Future Directions: Continued innovation in delivery systems or combination therapies can evolve around the foundational scope laid by the '107 patent, provided they avoid infringement.
FAQs
1. What is the core innovation of Patent 4,664,107?
The patent's core innovation lies in its specific pharmaceutical formulation comprising an active compound with particular excipients optimized for therapeutic use, along with methods of administration for treating specific diseases.
2. How does the scope of claims influence generic drug development?
The scope determines what formulations or uses can be legally copied. Broad claims may prevent even minor modifications, while narrower claims may be circumvented by formulators through alternative approaches.
3. Are there any legal challenges associated with this patent?
While specific legal challenges are not documented here, patents of this age often face validity challenges or expire, opening markets to generics unless extended by regulatory tools like data exclusivity.
4. What subsequent patents have cited the '107 patent?
Subsequent patents focusing on improved formulations, delivery systems, or combination therapies have cited the '107 patent, indicating its influence on ongoing innovation.
5. How does this patent fit into the larger pharmaceutical patent landscape?
It exemplifies a typical composition and method patent, serving as a foundational patent from which many derivative and improvement patents have emerged, thereby shaping therapeutic development strategies.
References
- United States Patent and Trademark Office [USPTO], Patent Database, Patent No. 4,664,107.
- Patent landscape reports and pharmaceutics literature referencing '107 patent.
- Legal case law involving patent infringement or validity related to similar formulations.
In conclusion, US Patent 4,664,107 exemplifies a strategic composition and method patent within the pharmaceutical field, shaping the innovation landscape, controlling market exclusivity, and serving as a reference point for subsequent innovation endeavors. Understanding its scope and claims enables stakeholders to make strategic decisions concerning drug development, patent litigation, and licensing opportunities.
