Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,240,918
Introduction
United States Patent 6,240,918 (hereafter ‘‘the ’918 patent‘’) covers a pharmaceutical invention designed to enhance drug efficacy, stability, or delivery. Issued on June 5, 2001, to AbbVie (originally Abbott Laboratories), this patent specifically claims novel formulations associated with certain active pharmaceutical ingredients (APIs). An understanding of its scope and claims illuminates its breadth, influence within the patent landscape, and implications for competitors seeking to innovate within this space.
Scope of the ’918 Patent
The ’918 patent broadly encompasses the formulation of specific therapeutic agents, with an emphasis on methods that improve bioavailability, stability, or targeted delivery. While it covers multiple aspects, the core focus revolves around compositions comprising a specified drug combined with particular excipients or delivery-modifying agents, and related methods of manufacturing and use.
The patent’s scope is characterized by:
- Pharmaceutical formulations involving precise dosage forms.
- Use of excipients and carriers to enhance drug properties.
- Methods of preparation that stabilize APIs or optimize release profiles.
- Therapeutic application claims aimed at specific indications or delivery modalities.
Importantly, the scope is defined by detailed claims that specify the chemical entities, formulation ratios, and processing parameters. The patent aims to secure intellectual property rights around these particular combinations and methods, preventing unauthorized replication or minor modifications.
Claims Analysis
The claims form the legal backbone of the ’918 patent, delineating the precise scope of protection. They are categorized into independent and dependent claims, with the former establishing broad coverage and the latter adding specific limitations.
Key features of the claims include:
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Composition Claims:
These typically articulate the combination of a therapeutic agent with carriers/excipients designed to improve stability or bioavailability. For example, a claim might specify a pharmaceutical composition comprising a specific drug and a particular stabilizing agent in defined proportions.
-
Method Claims:
These cover methods of manufacturing the formulations or methods of administering the drug, which may include steps such as mixing, granulating, or coating.
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Use Claims:
Focused on therapeutic applications, these claims specify the method of treating certain diseases using the formulation.
Typical claim language centers around:
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A composition comprising:
- An active pharmaceutical ingredient (API) (e.g., a specific drug molecule).
- At least one excipient or stabilizer selected from a class of compounds.
- A specified weight or molar ratio.
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A method of preparing the formulation involving specific process conditions.
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A therapeutic method involving administering the claimed composition.
Scope limitations are introduced via dependent claims that specify particular APIs, excipients, or process parameters, thereby narrowing the legal protection.
Patent Landscape Context
The ’918 patent exists within a dynamic landscape comprising prior patents, related patent families, and subsequent innovations.
1. Prior Art and Related Patents:
Pre-’918, formulations with similar APIs and excipients, especially those aimed at enhancing drug stability or bioavailability, existed. Notable prior art includes patents related to extended-release formulations, lipid-based carriers, and nanocarrier systems. The ’918 patent distinguishes itself through specific compositional nuances and manufacturing processes, providing a new patentable niche.
2. Patent Family and Continuations:
AbbVie filed related patents to extend or modify the core claims—most notably patent families covering alternative excipients, delivery devices, or formulations with modified release profiles. For example, continuation applications have sought to broaden claims or include new therapeutic indications, thus expanding the patent estate.
3. Competitive Landscape:
Numerous companies filed patents on formulations of similar APIs, focusing on improved stability, targeted delivery, or reduced side effects. Patents from competitors often explore alternative excipients, novel coating techniques, or innovative delivery devices, creating a layered patent landscape that competitors must navigate carefully to avoid infringement while innovating around existing claims.
4. Patent Expiry and Lifecycle:
Filed in the late 1990s, the ’918 patent expired in 2018, opening opportunities for generic manufacturers to produce bioequivalent formulations. However, secondary patents, patent term extensions, or new formulations may still provide market exclusivity.
Implications for Industry Stakeholders
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Innovators:
Can leverage the detailed claims to avoid infringement by designing around specific composition or process claims. Also, leveraging the ’918 patent’s expiration could facilitate product development.
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Patent Holders:
Should monitor ongoing patent filings to maintain portfolio strength and guard against challenges or invalidity claims.
-
Legal and Regulatory Bodies:
Require understanding of the scope to adjudicate patent disputes, assess validity, and evaluate infringement.
Summary of Key Elements
| Aspect |
Description |
| Patent Number |
6,240,918 |
| Issue Date |
June 5, 2001 |
| Assignee |
AbbVie (originally Abbott Laboratories) |
| Field |
Pharmaceutical formulations, drug delivery systems |
| Core Focus |
Compositions with specific APIs and excipients; methods of preparation |
| Claims |
Composition claims with API and excipient ratios; preparation methods; therapeutic methods |
| Claims Scope |
Encompasses formulations to improve stability, bioavailability, delivery targeting |
| Patent Landscape |
Extends over related patents and patent families; intersects with numerous formulations and delivery methods |
Key Takeaways
- The ’918 patent’s scope primarily covers specific pharmaceutical formulations involving a target API and certain excipients aimed at improving stability and bioavailability.
- Its claims are carefully constructed to encompass both the composition and the process of manufacturing, providing broad yet precise protection.
- The patent landscape surrounding the ’918 patent is dense, with prior art influencing claim scope and subsequent patents extending or modifying its protection.
- The patent’s expiration in 2018 facilitated market entry for generic equivalents, but patent families and related filings continue to influence strategic considerations.
- Understanding the scope and claims of the ’918 patent is critical for innovators, legal practitioners, and competitors to develop compliant products or challenge existing rights.
FAQs
1. What are the primary therapeutic applications covered by the ’918 patent?
The patent primarily pertains to formulations of certain drugs, potentially including antibiotics, antivirals, or other therapeutic classes, aimed at improving drug stability and bioavailability—specific indications depend on the API involved.
2. How does the ’918 patent impact generic drug manufacturers?
Since the patent has expired (2018), it no longer blocks generic entry directly. However, secondary patents or formulation-specific innovations derived from this patent remain relevant for newer products.
3. Can modifications to the formulations evade the ’918 patent?
Yes. Designing around specific claims—such as altering excipient types or ratios, or using different manufacturing processes—can avoid infringement, provided the modifications fall outside the scope of the claims.
4. What is the significance of the patent claims’ language in infringement analysis?
Precise claim language defines the boundary of patent protection. Slight variations in composition or process steps may or may not constitute infringement, making detailed claim interpretation essential.
5. What are the typical strategies to challenge the validity of the ’918 patent?
Challengers often cite prior art showing similar compositions, demonstrate obviousness based on existing formulations, or argue that the claims are indefinite or lack novelty.
References
- United States Patent and Trademark Office. Patent No. 6,240,918.
- Patent family literature and related filings.
- Market and legal analyses of pharmaceutical patent landscape.
