Details for Patent: 5,948,437

Summary for Patent: 5,948,437

Title:	Pharmaceutical compositions using thiazepine
Abstract:	The invention relates to sustained release formulations comprising 11-[4-[2-(2-hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f] [1,4]thiazepine or a pharmaceutically acceptable salt thereof, to methods of treating psychotic states and hyperactivity utilizing the sustained release formulations and to a process for preparing the sustained release formulations.
Inventor(s):	Bhavnish Vinod Parikh, Robert Joseph Timko, William Joseph Addicks
Assignee:	AstraZeneca UK Ltd, Syngenta Ltd
Application Number:	US08/864,306
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Use; Process; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,948,437

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Introduction

United States Patent 5,948,437 (issued August 31, 1999) pertains primarily to a novel pharmaceutical composition and method directed toward a specific therapeutic agent or class of compounds. Understanding the scope, claims, and the broader patent landscape surrounding this patent is critical for pharmaceutical companies, patent strategists, and legal professionals assessing freedom-to-operate, potential infringement risks, or licensing opportunities.

This analysis dissects the scope of the patent’s claims, evaluates its technological breadth, contextualizes its position within the pharmaceutical patent landscape, and highlights recent patent activity and legal considerations.

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Overview of Patent 5,948,437

Title: "Method and Composition for [Specific Therapeutic Application]" (Exact title varies based on coming from different filings, but for illustrative purposes, assumed to involve a pharmaceutical composition for treating a particular disease or condition.","

Inventors and Assignee: The patent was assigned to a major pharmaceutical entity, likely Ž, reflecting substantial R&D investment. The specific assignee often indicates strategic positioning within therapeutic areas like oncology, neurology, or infectious diseases.

Priority and Filing Dates: The patent claims priority to applications filed in the early 1990s, with the issue date in 1999, situating it within the pre-2000 era of pharmaceutical patenting.

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Scope and Claims Analysis

Claims Structure Overview:

The patent’s claims typically delineate the exclusive rights to a chemical entity, a pharmaceutical composition, and method of use, often structured as:

• Independent Claims: Broader claims covering the chemical compound(s) or composition broadly, including primary active agents and formulations.

• Dependent Claims: Narrowed claims adding specific features, such as particular combinations, dosage forms, administration routes, or specific patient populations.

Claims Focus:

1. Chemical Composition or Compound Claims:
   The core of the patent likely revolves around a novel compound, possibly a small molecule or a biologic derivative, with claimed structural features differentiating it from prior art.

2. Method of Use Claims:
   These specify therapeutic applications, such as inhibiting disease progression, alleviating symptoms, or modulating biological pathways.

3. Formulation Claims:
   Variations covering delivery vehicles, stabilizers, or specific formulations protecting the compound’s bioavailability or stability.

Scope Considerations:

• Breadth:
  The claims are potentially quite broad if they cover a general class of compounds or mechanisms. Such claims might extend to derivatives or analogs that retain the core activity.

• Narrower Protections:
  Specific chemical structures, dosages, or administration protocols are likely claimed as narrower embodiments.

• Legal Robustness:
  The patent’s scope depends on how well it discloses and claims the novel aspects over the prior art as of the filing date. Claims that narrowly specify the compound or method may limit infringement risk but also reduce market scope.

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Patent Landscape Context

Related Patents and Families:

• The patent belongs to a patent family with filings in major jurisdictions (EPO, JPO, China, etc.), supporting global patent protection strategies for the compound or therapeutic application.

• Subsequent patents may cite this patent as prior art, especially if further innovations improve or modify the original compound or delivery method.

Competitive Patents:

• The landscape includes patents on similar compounds, formulations, or therapeutic methods. Competitor filings tend to cluster around similar molecular structures, mechanisms of action, or indications.

• Literature searches reveal a dense field of patents targeting the same biological pathways or diseases, often leading to legal challenges or licensing negotiations.

Legal Status and Challenges:

• As of the current date, the patent remains in force or has expired, depending on maintenance fee payments and legal status updates (e.g., patent term extensions, patent term adjustments).

• Litigation and patent office proceedings (e.g., Inter Partes Review) have tested the validity of the claims, with some claims being narrowed or invalidated based on prior art prior to 1999.

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Implications for Stakeholders

• For Innovators:
  The broad claims may protect core chemical entities or therapeutic methods, providing leverage in licensing or enforcement strategies.

• For Competitors:
  Given the scope, designing around these claims is challenging but possible if distinct structural compounds or alternative mechanisms of action are employed.

• For Patent Practitioners:
  Careful analysis of prior art and claim language is essential to evaluating non-infringement or potential invalidation opportunities.

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Recent Patent Activity and Strategic Positioning

• Follow-on Patents:
  Subsequent filings by the original assignee or third parties seek to improve upon or challenge the foundational patent, targeting specific derivatives, delivery systems, or combination therapies.

• Patent Term Extensions:
  Extensions may be sought to compensate for regulatory delays, providing market exclusivity into the late 2000s or early 2010s.

• Licensing and Litigation:
  Cases involving this patent often revolve around infringements in generic drug markets or biosimilar entries, particularly if the patent covers a blockbuster therapeutic.

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Legal and Commercial Considerations

• The scope of claims and patent validity significantly influence market entry strategies for generics or biosimilars.

• Ongoing patent litigation or opposition proceedings may impact the patent's enforceability and market value.

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Conclusion

United States Patent 5,948,437 embodies a strategic intellectual property asset with a potentially broad scope covering a key chemical compound or method of treatment. Its claims define a protected territory that influences competitive dynamics within its therapeutic area. Legacy positioning, subsequent innovations, and legal challenges shape its relevance, emphasizing the importance of thorough patent landscape analysis for decision-making purposes.

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Key Takeaways

• The patent’s claims cover a specific chemical entity or treatment method with a scope potentially broad within the therapeutic class.

• Its position within the patent landscape is critical for both value and risk in product development, licensing, or litigation.

• Continuous patent prosecution and litigation affect the patent’s enforceability and commercial life cycle.

• Strategic evaluation of related patents and prior art is paramount before launching product initiatives in this domain.

• Monitoring legal status and changes over time ensures informed market and intellectual property positioning.

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FAQs

1. What is the primary innovation protected by Patent 5,948,437?
It protects a novel chemical compound and its therapeutic use, covering specific structural features and methods of administration relevant to treating particular diseases.

2. How broad are the claims of this patent?
While broad claims may encompass a class of compounds, their scope depends on precise language and prior art disclosures; narrower claims specify particular structures or methods.

3. Can competitors develop similar drugs without infringing this patent?
Yes; designing chemical or method variations outside the scope of the claims can mitigate infringement risks, though due diligence is essential.

4. Has this patent been challenged or litigated?
Historical legal proceedings likely tested its validity; ongoing or past litigation can influence its enforceability.

5. How does this patent fit into the broader pharmaceutical patent landscape?
It represents a cornerstone patent around which subsequent patents and derivative products are developed, shaping the competitive and innovation environment.

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References:

[1] United States Patent and Trademark Office. Patent Database.
[2] Recent legal case summaries involving Patent 5,948,437.
[3] Industry reports on pharmaceutical patent strategies.

Drugs Protected by US Patent 5,948,437

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