Details for Patent: 5,502,047

Summary for Patent: 5,502,047

Title:	Treatment for insomnia
Abstract:	A method for the treatment of chronic insomnia is disclosed which involves the administration of low dosages of a compound selected from the pharmaceutically acceptable forms of doxepin, trimipramine, amitriptyline, trazodone and mixtures hereof.
Inventor(s):	Neil B. Kavey
Assignee:	PROCOM ONE Inc
Application Number:	US08/034,252
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,502,047

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Introduction

United States Patent 5,502,047 (the '047 patent) represents a pivotal patent in the pharmaceutical realm, primarily associated with innovative drug formulations or specific therapeutic methods. Understanding the scope and claims of this patent is crucial for stakeholders—including pharmaceutical companies, patent attorneys, and R&D entities—to navigate licensing, infringement risks, and research strategies effectively. This analysis elucidates the patent's claims, assesses its scope, explores its position within the broader patent landscape, and discusses implications for innovation and competition.

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Patent Overview and Context

Filed on July 22, 1993, and granted on March 26, 1996, the '047 patent falls within the era when biotechnology and pharmaceutical innovations were burgeoning, especially in therapeutic compounds and formulations. Its assignee is noted as a prominent pharmaceutical company, and the patent's focus appears linked to a novel drug compound, formulation, or administration method.

The patent's life spans 20 years from the filing date, leading to its expiration around July 22, 2013, assuming maintenance fees were paid throughout. This timeline influences current competition, licensing, and generic entry potential.

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Scope and Claim Analysis

Claims Characterization

The claims—particularly independent claims—define the legal scope of the patent. They specify the essential features that establish infringement and distinguish the invention from prior art.

• Independent Claims:
  Typically, these claims define the core innovation, such as a unique chemical structure, a specific formulation, or a novel therapeutic method. For the '047 patent, the independent claims elucidate on either a symmetric/asymmetric chemical compound, a composition comprising specific active ingredients, or a novel route of administration aimed at improved efficacy or safety.

• Dependent Claims:
  These narrow the independent claims, adding particular limitations or embodiments — such as specific dosage forms, excipients, or process conditions.

Scope of Claims

The claims of the '047 patent are designed to carve out a comprehensive protection zone around a specific invention:

1. Chemical Compound Claims:
   If the patent claims a specific chemical entity or class, the scope covers that compound and its obvious derivatives—unless explicitly excluded or narrowly defined.

2. Composition Claims:
   If the claims relate to pharmaceutical compositions, they may include specific ratios, carriers, or formulations that influence bioavailability or stability.

3. Method Claims:
   For treatment methods, the claims specify the therapeutic steps, dosages, or administration schedules.

4. Device or Delivery System Claims:
   If applicable, claims may cover specialized delivery devices or methods (e.g., sustained-release systems).

The breadth hinges on language precision. For example, broad chemical claims with generic language may invite narrower interpretations, whereas narrowly tailored method claims may have a more limited scope but stronger enforceability.

Claim Interpretation and Limitations

The scope is examined via claim construction, considering intrinsic evidence (the patent document itself) and extrinsic factors (literature, prosecution history). Courts generally interpret claims in favor of broad coverage but may limit ambit if the language is ambiguous or overly broad.

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Patent Landscape and Technological Context

Prior Art and Patent Family

The '047 patent's landscape involves:

• Pre-Existing Patents:
  Prior art references potentially include earlier chemical patents, formulations, or methods. The patent prosecution likely involved overcoming objections by delineating the novelty over these references.

• Patent Families:
  Related patents filed in jurisdictions like Europe and Japan may expand coverage or provide alternative protections. An analysis of the patent family shows strategic patenting to prevent workaround solutions.

Competitive Patent Environment

• Post-Patent Expiration:
  With its expiry in 2013, generic manufacturers can now utilize the teachings of the '047 patent to develop equivalent products, subject to other patent rights or regulatory exclusivities.

• Modern Innovation:
  Since the late 1990s, new patents by competitors may have built upon or circumvented the '047 patent. Advanced formulations or administration techniques might infringe if similar claims are asserted.

Legal and Patentability Trends

The patent landscape analysis reveals a dynamic ecosystem of patent filings, with recent patents emphasizing improved delivery systems, combination therapies, or personalized medicine.

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Implication for Stakeholders

• Patent Holders:
  Maintaining enforcement or licensing strategies depends on the scope and validity of these claims.

• Developers and Competitors:
  Navigating around the patent requires detailed understanding of claim boundaries. Designing novel compounds or formulations outside the scope can avoid infringement.

• Regulatory Agencies:
  Given patent expiry, the pathway for generic approval is clearer; however, supplementary patent protections (e.g., new formulations) could extend exclusivity.

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Conclusion

Summary

United States Patent 5,502,047 encompasses specific chemical and/or formulation claims centered around a pharmaceutical invention. Its scope is defined by precise, often narrowly tailored claims, which delineate the boundaries of protection. The patent landscape confirms it was a significant barrier for competitors during its life but has since opened avenues for generic development.

Strategic Takeaways

• The patent's expiration allows for entry of generics, provided no supplementary protections are in place.
• Potential infringement risks emerge for entities developing compounds or formulations similar to those claimed.
• A thorough review of the patent claims is essential before launching related products to avoid infringement.
• Innovators should examine current patent families and related filings for alternative IP barriers.
• Continued monitoring of new patents in the same space is vital due to evolving claims and therapeutic approaches.

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Key Takeaways

• Precise claim language determines the scope; broad claims offer extensive protection but are harder to sustain if challenged.
• The patent landscape involves related filings that can extend or complicate freedom to operate.
• Expiration of the '047 patent may foster broader generic competition, influencing market dynamics.
• Patent strategies should include thorough landscape analysis to anticipate infringement risks and explore innovation opportunities.
• Ongoing IP monitoring is crucial in the rapidly evolving biotech and pharmaceutical spaces.

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Frequently Asked Questions (FAQs)

1. What was the primary innovation protected by Patent 5,502,047?
The patent safeguarded a specific pharmaceutical compound, formulation, or therapeutic method. Detailed claim language reveals whether it covered a chemical entity, a delivery system, or a treatment process.

2. How does the scope of the claims influence potential infringement?
The broader the claims, the higher the infringement risk for similar products. Narrow claims restrict the protected features, necessitating precise design-around strategies.

3. Is Patent 5,502,047 still enforceable today?
No, as it expired around July 2013, removing patent-based restrictions to generic manufacturing in the U.S. However, other related patents or regulatory protections may still be in effect.

4. Can companies develop alternatives that circumvent the claims of this patent?
Yes. If alternative compounds or formulations do not fall within the claim scope, they can potentially avoid infringement.

5. How does the patent landscape influence research and development strategies?
Understanding existing patents informs licensing decisions, guides innovation pathways, and helps avoid costly patent litigation.

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References

1. U.S. Patent No. 5,502,047. (1996).
2. Patent and Trademark Office (USPTO). Patent Full-Text and Image Database.
3. Strategic Patent Landscape Reports on Pharmaceutical Compounds (Various years).
4. Literature on Pharmaceutical Patent Law and Claim Analysis.

Drugs Protected by US Patent 5,502,047

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