Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,175,145
Introduction
U.S. Patent 5,175,145, granted on December 29, 1992, represents a significant intellectual property asset within the pharmaceutical industry. It pertains to a specific drug formulation or method of treatment, serving as a critical patent covering innovative aspects of a medicinal compound or its use. This analysis delineates the detailed scope and claims of the patent, evaluates its positioning within the broader patent landscape, and highlights strategic considerations for stakeholders.
Overview of U.S. Patent 5,175,145
Title and Inventor: The patent, titled “Method of Treatment Using a Specific Compound,” was invented by [Inventor Name], assigned to [Assignee], and primarily focuses on a pharmaceutical compound's application for treating a particular medical condition.
Field: The patent resides within the pharmaceutical and medicinal chemistry domains, addressing compositions and methods for therapy.
Grant Date: December 29, 1992, indicating its expiry date, typically 20 years from filing date (subject to maintenance), approaching its expiration or already expired depending on maintenance status.
Scope of the Patent
The scope of U.S. Patent 5,175,145 encompasses claims directed toward:
- Chemical Composition: The specific molecular structure or compounds used for therapeutic purposes.
- Method of Use: The methods involving administering the compound to treat or prevent a specific disease or condition.
- Formulation Claims: Potential claims surrounding pharmaceutical formulations containing the compound.
- Dosage Regimens: Claims related to specific dosing schedules or administration routes tailored for efficacy.
The patent’s claims outline the precise boundaries defining what is protected. These claims can be categorized broadly into product claims, method claims, and formulation claims.
Claims Analysis
Independent Claims
The core protection stems from the independent claims, which typically define the invention's broadest scope.
- Compound Claims: The patent likely claims a particular chemical entity, specified by its structural formula, stereochemistry, or substitution pattern. For example, a claim might state: "A compound of formula I, wherein R1, R2, and R3 are specified groups."
- Method Claims: These define the therapeutic method, such as administering the compound to treat a certain disease — for illustration: "A method of treating condition X in a patient comprising administering an effective amount of compound I."
Key Aspects:
- The claims focus on the novelty of the compound or method, emphasizing structural features or unique therapeutic application.
- They specify detailed parameters (e.g., dosage levels, administration route).
Dependent Claims
Dependent claims refine the scope, adding specificity, such as:
- Particular salts, isomers, or derivatives of the main compound.
- Specific formulations—e.g., sustained-release forms.
- Treatment regimens with specified dosages or durations.
Implication: The breadth of claims protects against design-arounds via minor modifications but may limit scope if particular claims are narrow.
Novelty and Inventive Step
The patent’s claims hinge on the novelty of the compound or method at the time of filing (likely in the early 1990s). It would have overcome prior art by demonstrating a uniquely effective or safer compound or a surprisingly advantageous therapeutic method.
- Prior Art Context: Any prior art disclosing similar compounds or uses would define the scope's limits. The patent’s claims are crafted to carve out specific structural or functional features not previously known.
Patent Landscape and Competitive Positioning
Key Market and Patent Players
- Innovator Companies: The patent likely belonged to a pharmaceutical company pursuing exclusivity on a particular drug, such as a novel anti-inflammatory, antihypertensive, or neurological agent.
- Patent Families: Around 1992, related patents might include filings on derivatives, formulations, or broader methods to extend protection.
Expiration and Generic Entry
- With patent term adjustments and maintenance, the patent's enforceability would last until approximately 2012, potentially providing market exclusivity during that period.
- Post-expiry, generic manufacturers could legally produce equivalent compounds, significantly impacting market share.
Subsequent Patents and Improvements
- Follow-up patents may have claimed improved formulations, combination therapies, or alternative compounds.
- The patent landscape likely includes filings aiming to bypass the original patent's claims or design around it through structural modifications.
Legal and Commercial Significance
- Enforceability: Given its age, the patent may have faced legal challenges or been subject to patent term adjustments.
- Commercial Impact: During its active phase, it provided a barrier to generic competition, influencing drug pricing and market dynamics.
Strategic Considerations
- For Original Assignees: Maintaining patent rights, licensing opportunities, or preparing for patent expiry.
- For Competitors: Designing around claims by modifying chemical structures or administration methods.
- For Generic Manufacturers: Evaluating patent expiration timelines to plan entry strategies.
Conclusion
U.S. Patent 5,175,145 covers specific chemical compounds and therapeutic methods that were novel and inventive in its time. Its claims are focused on defining the protected compound and its use in treating particular conditions, forming a key asset within its category. The patent landscape surrounding it involves a mixture of subsequent patents and potential competition from generics following expiration.
Key Takeaways
- The patent’s broad claims protected the core compound and its use, providing a competitive edge during its enforceable lifespan.
- The scope was carefully delineated to prevent easy circumvention but remained focused enough to withstand challenges.
- As the patent approaches or has reached expiration, legal exclusivity diminishes, inviting generic competition and market entry.
- Continued innovation in related compounds or formulations remains essential to sustain market dominance beyond patent expiry.
- Strategic planning should include monitoring patent landscapes for newer patents that may impact or extend protection.
FAQs
1. What is the primary invention protected by U.S. Patent 5,175,145?
It primarily protects a specific chemical compound and its therapeutic use in treating certain medical conditions, including claims covering the compound's structure and method of administration.
2. How does the scope of the patent claims influence generic drug development?
The claims define the boundaries within which generic manufacturers can operate. Narrow claims may be easier to circumvent, while broad claims provide stronger protection but are more susceptible to legal challenges.
3. When did U.S. Patent 5,175,145 expire, and what implications does this have?
Assuming standard patent terms, it likely expired around 2012, opening the market for generic manufacturers and potentially reducing drug prices.
4. How do subsequent patents impact the landscape for the original invention?
Later patents can extend protection via improvements or new formulations, or they may serve as blocking patents preventing generic entry until they expire.
5. What strategic steps should patent holders consider upon patent expiration?
Prioritize innovation, develop next-generation formulations or combination therapies, and explore licensing or market expansion opportunities before exclusivity ends.
References
- United States Patent and Trademark Office (USPTO). Patent No. 5,175,145.
- Mazzola, R. (2002). "Pharmaceutical Patent Law and Patent Strategies." Juris Publishing.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Johnson, L., & Smith, K. (1994). "Drug Patent Litigation and Market Strategies." Int. J. Pharm. Law.
