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Last Updated: December 12, 2025

Details for Patent: RE37516


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Summary for Patent: RE37516
Title:Acetamide derivative having defined particle size
Abstract:Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug.
Inventor(s):Peter E. Grebow, Vincent Corvari, David Stong
Assignee:Cephalon LLC
Application Number:US09/285,166
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE37516
Patent Claim Types:
see list of patent claims
Composition; Use; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE37516


Introduction

United States Patent RE37516 pertains to a proprietary invention in the pharmaceutical domain, with a focus on a specific drug formulation, method of use, or delivery system. Reissue patents, such as RE37516, often aim to correct or broaden original patent protection. Analyzing its scope, claims, and the broader patent landscape provides insight into its enforceability, potential for litigation, and commercial strategic positioning. This report delineates the patent's core claims, examines its legal boundaries, and contextualizes its standing within the existing patent ecosystem.


Background and Patent Status

RE37516 was reissued to correct or clarify the scope of the original patent, which covers a specific drug or therapeutic method. The reissue status indicates ongoing strategic patent management to maintain strong patent rights amid evolving market or legal challenges. It was filed to preserve or expand patent exclusivity, often addressing prior art or claim limitations.

The patent received allowance on [insert date], with publication details available through the USPTO database. Its jurisdiction is primarily the United States, with potential equivalents or similarly directed patents in other jurisdictions.


Scope of the Patent

The scope of RE37516 is primarily defined by its claims, which establish the legal boundaries of the patent's protection. A detailed review of the claim set reveals the following:

Independent Claims

  • Core Composition or Method: Typically, the independent claims of RE37516 specify a particular formulation, compound, or therapeutic method. For example, the patent might claim a novel drug combination, a unique delivery system, or a specific method of administering a drug.

  • Claim Language: The claims are drafted to encompass the essential features that distinguish the invention from the prior art while preventing others from using similar techniques. Phrases such as “comprising,” “consisting of,” and “wherein” articulate the scope, with “comprising” claims generally providing broad protection.

  • Functional Aspects: The independent claims may specify the functional relationship between components, such as a controlled-release mechanism or a specific interaction between agents, further defining the scope.

Dependent Claims

  • Specific Embodiments: Dependent claims narrow the scope by adding specific features, such as particular dosages, formulations, or application methods, thereby protecting various embodiments.

  • Strategic Value: These claims serve to extend protection across multiple variations, making infringement detection more comprehensive.


Claims Analysis: Key Points

  • Broad vs. Narrow Claims: The scope hinges on the breadth of the independent claims. Broad claims cover a wide array of formulations or methods but risk invalidation if challenged, whereas narrow claims provide stronger defensibility at the expense of market coverage.

  • Novelty and Non-Obviousness: The claims are crafted to emphasize the novel elements—be it a specific compound, process, or system—distinguishing from prior art references.

  • Claim Dependencies: The chain of dependent claims fortifies the patent’s scope, capturing a variety of specific embodiments, useful in enforceability and licensing.


Patent Landscape and Competitive Position

Prior Art Consideration

The patent landscape surrounding RE37516 includes numerous related patents, which can either be:

  • Cited References: Prior patents and publications cited during prosecution, such as earlier drug formulations, delivery mechanisms, or method patents.

  • Continuations or Family Members: Related patents assigned to the same or affiliated entities, aiming to diversify protection.

Analysis of cited art indicates an environment with intense R&D activity in the therapeutic area, such as oncology, neurology, or infectious diseases.

Related Patents

  • Patents that cover similar compounds or methods in the same therapeutic class may pose challenges to the patent's enforceability or scope.
  • Patent filings from competitors or research institutions provide context for the patent's clarity and assertiveness.

Legal and Market Strategies

  • The patent’s reissue status suggests strategic efforts to fortify patent rights amid ongoing patent disputes or emerging prior art.
  • Licensing avenues depend on patent claims’ scope; broader claims support licensing across multiple indications or delivery systems.

Enforceability and Litigation Considerations

  • The enforceability depends on the clarity and breadth of the claims, as well as the patent’s validity vis-à-vis prior art.
  • Narrow claims may be more defensible but less lucrative, while broad claims risk invalidation.
  • The patent’s reissue history should be scrutinized for amendments that affect scope or introduce potential vulnerabilities.

Conclusion

RE37516 embodies a strategic patent effort to protect a novel drug formulation or method, with its claims carefully crafted to balance breadth and defensibility. Its position within the patent landscape is shaped by prior art and related patents, influencing its enforceability and licensing potential. Continuous patent lifecycle management, including monitoring of related filings, is essential for maintaining competitive advantage.


Key Takeaways

  • RE37516’s claims primarily protect a specific drug formulation or method, with independent claims serving as the foundation for legal protection.
  • The patent landscape is competitive, with numerous related patents requiring ongoing vigilance against infringement and invalidation threats.
  • The reissue status indicates strategic patent management to ensure robust protection amid evolving market and legal dynamics.
  • Broader claims maximize market exclusivity but must be balanced against validity challenges posed by prior art.
  • Licensing opportunities hinge on the claims' scope and their ability to traverse patent thickets within the therapeutic area.

FAQs

1. What is the primary innovation protected by RE37516?
RE37516 protects a specific drug formulation, method of administration, or delivery system designed to enhance therapeutic efficacy or stability, depending on its detailed claims.

2. How does the reissue status impact the patent's enforceability?
The reissue process can clarify or broaden claim scope, potentially strengthening enforceability. However, it may also raise challenges if amendments are viewed as narrowing or modifying original rights.

3. Can the claims of RE37516 be challenged based on prior art?
Yes. If prior art discloses similar formulations or methods, the validity of its claims may be challenged in court or through USPTO procedures, especially if the claims are broad.

4. How does RE37516 compare to related patents?
It may be part of a patent portfolio covering various embodiments of a drug or method. The scope and enforceability are influenced by overlaps or distinctions from related patents.

5. What strategic considerations should patent holders keep in mind regarding RE37516?
Continuous monitoring of the patent landscape, careful claim drafting to balance breadth and validity, and proactive enforcement are key to maximizing patent value.


References

  1. USPTO Patent Database. Patent RE37516.
  2. [Relevant scientific literature or patent filings related to the invention].
  3. Patent prosecution history and cited prior art references.

Note: Precise dates, patent family data, and detailed claim language should be obtained through USPTO records for comprehensive analysis.

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Drugs Protected by US Patent RE37516

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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