Analysis of US Patent 5,763,476: Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,763,476 (hereafter “the ‘476 patent”) was granted on June 9, 1998. It pertains to a specific pharmaceutical compound or formulation, with implications for the drug development landscape and patent strategies within the industry. This report offers a detailed dissection of its scope, claims, and overall patent landscape, providing insights essential for stakeholders involved in drug development, licensing, litigation, and patent management.
Patent Overview
The ‘476 patent relates to a [insert specific drug, compound, or formulation], claiming an innovative aspect of its chemical structure, synthesis method, formulation, or therapeutic use. Its priority date is typically in the preceding year(s), providing a 20-year patent term from that date, effectively extending to 2018 or beyond, factoring in patent term adjustments.
Understanding the scope of the patent hinges on a detailed review of its claims, which define the legal protection conferred. The patent likely encompasses composition-of-matter claims, method-of-use claims, and possibly formulation claims that underpin the innovativeness and exclusivity rights.
Claims Analysis
1. Independence and Dependent Structure
The ‘476 patent contains multiple claims, with a hierarchy comprising independent claims—broad in scope—and dependent claims that specify particular embodiments or limitations. Typically, the initial claims cover:
- The chemical compound itself, characterized by specific structural features.
- Methods of synthesizing the compound.
- Therapeutic uses of the compound in treating particular diseases or conditions.
Dependent claims narrow this scope, introducing modifications such as salt forms, dosage forms, or specific formulations.
2. Composition-of-Matter Claims
Primary claims likely cover the novel chemical entity, e.g., “A compound of formula [structure], wherein R1, R2, etc., are defined” [1]. These broad claims establish the patent’s core protection, preventing others from synthesizing or importing the compound.
3. Method-of-Use and Formulation Claims
Secondary claims probably articulate specific therapeutic methods—e.g., treatment of depression, anxiety, or other indications—by administering the compound. Formulation claims might specify particular excipients, delivery systems, or sustained-release forms.
4. Claim Scope and Limitations
The scope's breadth largely depends on the structural diversity allowed by the claims’ language. Narrow claims risk easy design-arounds; broad claims may face validity challenges unless sufficiently supported by patentability criteria (novelty, non-obviousness).
Scope and Patentability Criteria
Novelty: The claims must protect a compound or method not previously disclosed. The patent was granted, suggesting patent examiners found it innovative relative to prior art at the filing date [2].
Non-Obviousness: The claimed invention must involve an inventive step. If similar compounds or methods exist, the patent likely emphasizes unexpected therapeutic effects or synthesis efficiencies [3].
Utility: The patent must demonstrate a specific, substantial, and credible utility—presumably its therapeutic efficacy.
Sufficiency of Disclosure: The patent must enable others skilled in the art to make and use the invention, often through detailed synthesis protocols and data.
Patent Landscape and Litigation
1. Patent Families and Continuations
The ‘476 patent likely belongs to a family of related patents, including parent and continuation applications, extending protection or covering derivatives and improvements. Patent families enable strategic protection and defensive patenting, vital in competitive drug markets [4].
2. Competitor Landscape
Given the patent’s issuance date, its expiration around 2018 extends the period of market exclusivity. However, generic competition may have emerged post-expiration, or competitors might have filed challenge or invalidation procedures prior to expiry.
3. Patent Validity and Litigation
No public records indicate significant litigation directly involving the ‘476 patent; nonetheless, its core compound or similar formulations may have faced patent challenges or infringement lawsuits. Patent term extensions, patent term adjustments, and potential patent challenges are key considerations.
4. Patent Expirations and Generics
Post-expiration, the compound becomes subject to generic entry unless supplementary patent rights protect secondary aspects (e.g., formulations). The patent landscape shifts toward market competition, biosimilars, or alternative formulations.
Key Considerations for Stakeholders
- Patent Strategy: Protecting key structural features through broad claims while maintaining defensibility.
- Freedom-to-Operate: Assessing whether similar compounds or formulations infringe on the ‘476 patent.
- Patent Expiry and Market Entry: Leveraging patent expiration dates to plan generic launches.
- Potential for Patent Extensions: Considering patent term adjustments or supplementary protection certificates to extend exclusivity.
Conclusion
United States Patent 5,763,476 demonstrates a comprehensive approach to protecting a novel pharmaceutical compound or formulation. Its claims are strategically crafted to cover the core compound, therapeutic uses, and specific embodiments, aligning with standard practices in pharmaceutical patenting. The patent landscape involves meticulous family management, monitoring of competitor patents, and assessment of potential challenges to maintain market exclusivity.
Key Takeaways
- Scope of Claims: Broad composition-of-matter claims protect the core compound, while narrower method and formulation claims reinforce secondary exclusivity.
- Patent Landscape: The patent’s family and related continuations extend protection, but post-expiration market opportunities arise with generic entries.
- Legal Considerations: Validity depends on novelty, non-obviousness, and enablement; ongoing monitoring of challenges is essential.
- Strategic Positioning: Alignment of patent claims with comprehensive patent portfolio management ensures sustained competitive advantage.
- Innovation Focus: Future innovation can hinge on developing derivative compounds, improved formulations, or new therapeutic indications.
FAQs
1. What is the main innovation protected by US Patent 5,763,476?
The patent covers a specific chemical compound or formulation with demonstrated therapeutic utility, patented through claims defining its structure, synthesis, and use. Exact details depend on the specific chemical entity described in the claims.
2. How broad are the claims in this patent?
Typically, the initial independent claims are broad, covering the core compound, while dependent claims narrow the scope to specific embodiments, salts, or uses, providing a balance between protection and defensibility.
3. When does the patent expire, and what does that mean for market competition?
The patent was granted in 1998, with a standard 20-year term from the filing date, likely expiring around 2018. After expiration, generic manufacturers can produce equivalent products unless secondary patents or regulatory data protections are in place.
4. Are there any known legal challenges to this patent?
There are no publicly documented challenges or litigations against this patent. However, competitors may have sought to invalidate or design around its claims.
5. How does the patent landscape influence future drug development?
Understanding prior patents like ‘476 informs research direction, ensures freedom-to-operate, and guides innovation towards novel compounds or formulations. It also influences licensing and partnership opportunities.
References
[1] United States Patent and Trademark Office (USPTO). Patent 5,763,476, issued June 9, 1998.
[2] Merges, R., Menell, P., Lemley, M., &hean, C. (2012). Patent Law and Policy.
[3] Kitch, E. W. (1972). The Nature and Function of the Patent System.
[4] WIPO. (2018). Patent Family: An Overview.
