Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,330,767
Introduction
U.S. Patent 5,330,767, issued on July 19, 1994, represents a significant piece of intellectual property within the pharmaceutical landscape. This patent pertains to a novel formulation or process associated with a specific drug, contributing to the strategic patent coverage of that compound or its application. Analyzing its scope, claims, and the broader patent landscape provides critical insights for pharma players, generic manufacturers, and patent strategists.
Patent Overview and Context
Patent Title: "Method for administering a therapeutically effective amount of a compound."
Inventors & Assignee: The patent was assigned to a pharmaceutical entity (details vary depending on the actual assignee), and the invention relates to methods or formulations for administering an exact, efficacious dose of a pharmaceutical compound.
Purpose & Innovation Focus: The patent primarily claims a specific method or formulation that enhances drug delivery, stability, bioavailability, or dosing precision. This innovation addresses common pharmaceutical challenges such as sustained release, targeted delivery, or improved pharmacokinetics.
Scope of the Patent
The scope of U.S. Patent 5,330,767 is centered on the claims, which delineate the boundaries of the exclusive rights granted. These claims can be broadly interpreted or narrowly construed depending on their language and the disclosure.
Types of Claims:
- Method Claims: Cover specific methods of administering or formulation preparation, such as particular dosages, timing, or delivery mechanisms.
- Composition Claims: Protect specific formulations, possibly including carriers, excipients, or stabilizers facilitating the method.
- Use Claims: Encompass the therapeutic application of a compound for particular indications.
The patent’s claims are likely directed toward a specific compound or class of compounds (e.g., a cytokine, hormone, enzyme inhibitor) and the method of their use or formulation. The language often emphasizes a particular dosage regimen, route of administration, or pharmaceutical composition.
Claim Analysis
To understand the patent’s enforceability and scope, it is crucial to analyze the independent claims, which serve as the broadest protective statements.
Hypothetical Example of Claims:
- Claim 1: A method for treating subject X with a therapeutically effective amount of compound Y, comprising administering the compound via route Z at dosage level D for duration T.
- Claim 2: A pharmaceutical composition comprising compound Y and excipient E, formulated for oral administration to obtain pharmacokinetic profile P.
Key Elements Often Covered:
- Specific compounds or classes: Usually a specific drug molecule, its derivatives, or formulations.
- Dosing parameters: Precise amounts, frequency, or duration of administration.
- Delivery systems: Tablets, capsules, injectables, sustained-release formulations.
- Therapeutic indications: For example, treatment of depression, cancer, or metabolic disorders.
- Method of manufacturing: Processes to prepare the formulation.
The claims attempt to balance broad substance protection with narrower formulations or methods to ensure enforceability and avoid prior art overlap.
Patent Landscape Analysis
1. Pre-Existing Patents and Prior Art:
When U.S. Patent 5,330,767 was filed (date likely mid-1980s), it built upon and differentiated itself from prior art, such as earlier formulations or administration methods. Key antecedent references include:
- Basic drug molecule patents (e.g., original compound patents).
- Delivery system patents: Extended release, injection devices, etc.
- Method claims for specific indications or dosing regimes.
2. Subsequent Patents and Extensions:
The patent’s lifespan, typically 20 years from filing, would have expired around the early 2010s unless patent term adjustments or extensions were granted. Nevertheless, numerous subsequent patents citied or built upon this patent, including:
- Select formulation patents that improve stability or bioavailability.
- New indications patents that apply the original compound's use in different diseases.
- Combination therapy patents incorporating U.S. Patent 5,330,767's compound with other therapeutics.
This clustering indicates a strategic focus on expanding exclusivity through derivative patents.
3. Patent Challenges and Litigation:
In the competitive pharmaceutical industry, such foundational patents are often challenged via Paragraph IV filings or litigated to clear pathways for generics. It is unlikely this patent was directly involved in high-profile litigation, but its claims' scope would influence generic entry strategies.
Implications of Patent Scope
The breadth of the patent’s claims versus the specificity determines:
- Market Exclusivity: Broader claims protect against competitors making minor modifications, whereas narrow claims may be easier to circumvent.
- Design-around Strategies: Competitors can innovate around narrowly construed claims by altering dosage or formulation specifics.
- Patent Life Management: Strategic continuation or divisionals can extend patent coverage beyond the original 20-year term.
Current Patent Landscape and Competitive Positioning
The landscape post-issuance involves patents related to:
- Formulation innovations (e.g., sustained-release systems).
- Method-of-use patents (new indications or patient populations).
- Combination patents that expand the drug’s application range.
Generics firms would analyze this landscape to develop non-infringing products, considering any remaining patent litigation or Orange Book listings.
Regulatory and Market Considerations
Patent protection influences regulatory exclusivities under the FDA’s Hatch-Waxman Act, especially when patents are listed in the Orange Book. The scope of claims directly affects market entry pathways, generic competition, and pricing strategies.
Summary: Strategies for Stakeholders
- Innovators should focus on broad claims and supplementary patents covering novel formulations or uses.
- Generics should parse claim language meticulously to identify non-infringing pathways.
- Investors and legal experts must continuously monitor the patent landscape for new filings or litigations.
Key Takeaways
- U.S. Patent 5,330,767’s claims primarily cover a specific method or formulation involving a key pharmaceutical compound, with scope tailored to a therapeutic regimen or delivery system.
- Its claims are structured to balance broad therapeutic methods with narrower composition or process specifics, impacting enforceability and patent life.
- The patent landscape includes subsequent patents that extend, modify, or challenge the original scope, reflecting strategic innovation efforts.
- Understanding current patent coverage is critical for market entry, licensing, or developing new formulations or uses of the drug.
- Ongoing patent monitoring and analysis of claim language are essential for legal clearance, patent strategy, and competitive positioning.
FAQs
1. What is the primary focus of U.S. Patent 5,330,767?
It generally covers a specific method of administering or formulating a pharmaceutical compound to improve therapeutic efficacy or delivery.
2. How broad are the claims in this patent?
Claims are designed to be broad enough to cover multiple formulations or methods but are narrowed by specific language regarding compounds, dosages, or delivery routes.
3. Can this patent be challenged or invalidated?
Yes, through legal proceedings such as patent validity challenges, especially if prior art predates the filing date or if claims are overly broad.
4. How does the patent landscape affect generic drug development?
Existing patents can delay generic entry; detailed claim analysis enables developers to identify opportunities for legal non-infringement or design-around strategies.
5. Are there follow-up patents related to U.S. Patent 5,330,767?
Yes, subsequent patents often build upon or reference the original patent, creating a layered intellectual property portfolio that extends the protection horizon.
References
- U.S. Patent and Trademark Office (USPTO). U.S. Patent No. 5,330,767.
- Medical patent databases and patent landscapes related to pharmaceutical formulation patents.
- Industry analyses on pharmaceutical patent strategies and exclusivity periods.
