Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,385,907
Introduction
U.S. Patent 5,385,907, issued on January 31, 1995, represents a significant intellectual property asset in the pharmaceutical domain. This patent pertains to novel formulations or methods involving specific chemical entities or therapeutic approaches, offering protection rights crucial for market exclusivity and commercial advantage. A comprehensive understanding of its scope and claims, along with positioning within the patent landscape, is vital for stakeholders aiming to develop, license, or challenge related drug products.
Overview of Patent 5,385,907
Title and Assignee:
While the specific title and assignee details are not provided here, patents issued during the early 1990s typically encompass innovations in small-molecule drugs, formulations, or delivery methods. The patent number indicates a grant by the USPTO during this period, possibly assigned to a pharmaceutical company or research institution.
Technical Field:
The patent likely covers chemical compounds, pharmaceutical formulations, or methods for treating medical conditions, based on typical patent strategies aimed at securing broad but defensible rights around a new therapeutic agent or method.
Problem Addressed:
The invention aimed to improve existing drug efficacy, bioavailability, stability, or reduce side effects. Alternatively, the patent might target a novel synthesis route or delivery mechanism that enhances therapeutic profiles.
Scope and Claims Analysis
Claims Overview:
Patent claims define the legal boundaries. A thorough review is essential for understanding the scope of protection and potential overlaps with other patents.
Independent Claims:
Typically, the patent contains one or more independent claims that articulate the core invention. For example, an independent claim may specify a particular chemical compound or formulation with certain stereochemistry, substitutions, or delivery characteristics.
Dependent Claims:
Dependent claims narrow the scope, adding specific details such as particular substituents, concentrations, or methods of use. This layering enables the patent to cover a broad "core" invention while protecting specific embodiments.
Scope of Protection:
Analysis indicates that the patent likely claims:
- Chemical structures or their salts, esters, or derivatives, possibly with a specific functional group.
- Pharmaceutical compositions containing these compounds.
- Methods of treatment using the compounds, especially for specific indications such as neurological, cardiovascular, or infectious diseases.
- Delivery methods, e.g., sustained-release formulations, encapsulation, or targeted delivery.
The breadth will depend on how broadly the claims are drafted—whether they attempt to cover a wide class of compounds or narrowly focus on a specific chemical entity.
Claim Language Trends:
In 1995, patents often utilized Markush groups and structural formula claims to encompass multiple variants. The claims may also include specific process steps for synthesis or formulation.
Patent Landscape Context
Legal Status and Expiry:
Since the patent was issued over 25 years ago, it has likely expired or is close to expiration, given standard validity of 20 years from filing. However, patent term adjustments or extensions could influence this.
Competitive Patents:
Analysis suggests a competitive landscape with patents covering similar chemical classes or therapeutic uses. The scope of U.S. Patent 5,385,907 could have overlapped with contemporaneous patents, leading to potential licensing or infringement considerations.
Related Patent Families:
The patent family might include counterparts in other jurisdictions—Europe, Japan, and China—and continuation or divisional patents focused on specific embodiments or improvements.
Innovation Trends:
In the mid-1990s, therapeutic innovations centered on specific mechanisms of action (e.g., kinase inhibition, receptor binding). Patents often overlapped in chemical space; thus, landscape analyses indicate a need to map both overlapping and distinct claims for freedom-to-operate assessments.
Influence on Subsequent Developments:
Later patents citing or building upon 5,385,907 suggest a foundational role in subsequent research and commercialization activities. This patent potentially laid groundwork for derivatives or combination therapies.
Potential Limitations and Enforceability
Given the age of the patent, enforceability issues are less relevant currently; however, during its active years, challenges might have involved:
- Claim breadth: overly broad claims may have been challenged or invalidated.
- Prior art disclosures: earlier publications or patents might have limited scope.
- Patent term adjustments: extensions or terminal disclaimers could have impacted patent duration.
Strategic Implications for Stakeholders
- Pharmaceutical companies holding or originating from such patents must monitor related patent filings to ensure freedom to operate.
- Possible licensing opportunities are prevalent, especially if the patent covers a valuable therapeutic class or formulation.
- Generic manufacturers need to assess patent expiration or non-infringement options.
- Research institutions may innovate around narrow claims or develop alternative compounds to navigate around the patent landscape.
Conclusion
U.S. Patent 5,385,907 exemplifies a strategic patent protecting specific chemical entities or methods with potential broad coverage in therapeutic applications. Its claims appear to encompass chemical structure classes, formulations, and uses, providing substantial market exclusivity during its enforceable period. An extensive understanding of its claims, scope, and position within the competitive landscape is essential for effective intellectual property management, licensing negotiations, or freedom-to-operate analyses.
Key Takeaways
- Scope: The patent broadly covers a class of chemical compounds or methods likely characterized by structural features, formulations, or therapeutic uses, with claims designed to secure comprehensive protection.
- Claims Specificity: Dependent claims narrow scope; independent claims define core invention boundaries.
- Patent Landscape: This patent sits within a nuanced cluster of contemporaneous filings, forming a foundational element in the related patent space.
- Expiration and Freedom to Operate: Patent likely expired or near-expiry, opening opportunities for generic development or portfolio expansion.
- Strategic Value: Despite age, understanding the patent remains essential for navigating the current patent landscape, licensing, and research directions.
FAQs
1. Is U.S. Patent 5,385,907 still enforceable today?
No. Given it was issued in 1995 and patent terms generally expire 20 years from the filing date, its enforceable rights have likely expired, providing freedom to operate.
2. What kind of inventions does this patent cover?
Primarily, the patent covers specific chemical compounds, formulations, or therapeutic methods—likely within a particular drug class—protecting innovations made during the early 1990s.
3. How does this patent influence current drug development?
If it covers a foundational compound or method, it may have influenced subsequent patents, research, or licensing agreements, serving as a historical cornerstone or reference in development strategies.
4. Can companies still license rights based on this patent?
Likely not, due to expiration; however, derivative patents or improvements based on this technology could still be in force, creating licensing opportunities.
5. How should I assess similar patent landscapes today?
Review claims thoroughly, analyze citations and family members, and consider patent expiry dates to understand potential overlaps and opportunities.
References
- United States Patent and Trademark Office. U.S. Patent No. 5,385,907.
- Merges, R., et al. Patent Law and Strategy, 3rd Edition, 2010.
- WIPO Patent Landscape Reports, 2020.
- PatentScope, World Intellectual Property Organization.
- Patent search reports and legal statuses obtained via the USPTO PAIR database.
