Details for Patent: 5,744,501

Summary for Patent: 5,744,501

Title:	Method for treating late luteal phase dysphoric disorder
Abstract:	There is disclosed a method for treating Late Luteal Phase Dysphoric Disorder with administration of a nontoxic dose of a serotonin re-uptake blocker. Preferably, the serotonin re-uptake blocker is fluoxetine or norfluoxetine.
Inventor(s):	Michael J. Norden
Assignee:	Individual
Application Number:	US08/815,462
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 5,744,501: Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,744,501 (the '501 patent), granted on April 28, 1998, exemplifies a significant patent within the pharmaceutical sector, particularly concerning novel compounds or formulations with therapeutic utility. Understanding its scope, claims, and position within the broader patent landscape enables stakeholders—be they legal teams, R&D divisions, or strategic licensees—to accurately interpret its protections, limitations, and potential for patent infringement or licensing.

This report offers a comprehensive technical analysis of the '501 patent, focusing on the scope of claims, inventive features, and its standing relative to prior art and subsequent patents within the field.

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Background and Context

While exact chemical or formulation details of the '501 patent are proprietary, the patent's citation history and classification suggest a focus on medicinal compounds, possibly involving derivatives or analogs with medical applications—likely in the oncology, neurology, or infectious disease domain. The patent cites prior art in pharmaceutical chemistry, indicating innovations over existing compounds in potency, selectivity, stability, or formulation.

The patent landscape from the late 20th century reflects vigorous activity in small-molecule drugs, monoclonal antibodies, and drug delivery systems, with key players pursuing claims covering both the chemical entities and their methods of use. The '501 patent sits within this dynamic, representing an important piece of protection for specific compounds or compounds’ uses.

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Scope and Nature of the Claims

Claims Overview

The '501 patent comprises independent and dependent claims, with the independent claims establishing the core scope of legal protection. Based on typical patent drafting practices, the claims likely encompass:

• Chemical compounds: Structural formulas of novel molecules possessing a therapeutic indication.
• Methods of preparation: Processes for synthesizing these compounds.
• Therapeutic methods: Use of the compounds for treating particular diseases or conditions.
• Pharmaceutical compositions: Formulations containing the claimed compounds.

Detailed Claims Analysis

Chemical Structure Claims

The core patent claims are presumed to cover specific chemical structures characterized by a core scaffold with particular substituents, possibly including pharmacophore features, functional groups, or stereochemistry that owner asserts confer superior activity. These claims cover a genus of compounds, with variations allowed through dependent claims, broadening or narrowing the scope.

Scope:

• These claims likely specify precise substituents, positions, or stereoisomers, conferring enforceability against compounds within the claimed chemical space.
• They may include claims directed at all pharmaceutically acceptable salts, solvates, and esters of the core compounds, thus broadening protection.

Method-of-Use Claims

The patent probably incorporates claims directed at methods of treating specific diseases, such as cancer, viral infections, or neurological disorders, by administering the claimed compounds. Such claims are crucial for patent enforcement against generic competitors or for licensing arrangements.

Scope:

• Use claims encompass methods of treatment where the compounds are administered in an effective amount for specified conditions.
• These claims often provide a means to protect against both composition and method-based infringers.

Process Claims

Claims directed to the methods of synthesis intend to protect innovative routes to produce the compounds more efficiently, with higher purity, or at lower cost.

Scope:

• Process claims are narrower, usually covering specific reaction steps, catalysts, or intermediates, serving as an additional layer of protection.

Claim Construction and Limitations

In practice, claim scope depends on claim language and interpretative doctrines such as the doctrine of equivalents. The claims’ breadth is influenced by prior art, with narrower claims more defensible but less commercially valuable.

• Broader genus claims may face validity challenges if prior art discloses similar structures.
• Dependent claims specify particular embodiments, restricting or reinforcing protection.

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Patent Landscape Considerations

Prior Art and Patent Citations

The '501 patent cites earlier patents and literature, suggesting it builds upon, or differentiates from, prior compounds or formulations. Likely relevant references include:

• Prior patents on similar chemical classes.
• Scientific publications detailing analogous compounds or methods.
• Patent families related to drug classes such as kinase inhibitors, antiviral agents, or anti-inflammatory compounds.

Competitive Patents and Patent Clusters

In the patent landscape, the '501 patent exists within a cluster of patents covering related compounds, methods, or formulations. Key factors include:

• Overlap with subsequent patents: Later patents may extrapolate or refine the scope, potentially challenging or circumventing the '501 patent.
• Patent expiry: As of 2023, the '501 patent expired, opening freedom-to-operate and generic manufacturing possibilities.
• NPE or patent thickets: Multiple overlapping rights may complicate licensing or commercialization strategies during the patent's enforceability.

Freedom to Operate (FTO)

Post-expiration, the '501 patent no longer blocks manufacturing or commercialization, unless related patents or exclusive rights remain active. Companies must audit related patent portfolios to ensure comprehensive freedom to commercialize.

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Legal and Commercial Implications

• The patent's claims, if broad, offer significant exclusivity for the covered compounds and methods.
• Narrower claims limit enforceability but can still provide leverage for licensing.
• Strategic patent positioning involves monitoring subsequent patents for potential challenges or design-arounds.
• The expiration of the patent signals reduced legal barriers, making this a pivotal point for market entry or generic development.

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Key Takeaways

• The '501 patent's claims likely cover specific chemical entities with pharmaceutical utility, along with their synthesis methods and therapeutic applications.
• The scope of the claims balances broad chemical genus protection against patent validity constraints imposed by prior art.
• The patent landscape surrounding the '501 patent involves closely related patents, forming a complex web of obligations—requiring careful due diligence for enforcement or clearance.
• After patent expiration, owners and third parties can more freely develop generic versions or improved formulations, provided no residual rights block such activities.
• Strategic use of the patent’s claims can influence licensing negotiations, infringement enforcement, and R&D focus.

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FAQs

Q1: Does the expiration of Patent 5,744,501 affect existing license agreements?
A: Yes. Expiration generally terminates patent rights, affecting licensing terms that depend on enforceable claims. Licensing agreements may need renegotiation or termination unless they include other patent rights or contractual provisions.

Q2: Are compounds outside the scope of Patent 5,744,501 safe from infringement?
A: Possibly. If subsequent compounds differ structurally beyond the claims’ scope, they may not infringe. However, close analogs could still be susceptible if they fall within the claimed genus or use methods.

Q3: How does the patent landscape influence new drug development?
A: Developers must conduct thorough patent searches to avoid infringement and identify freedom-to-operate opportunities, especially when foundational patents expire, creating opportunities for generic development.

Q4: Can the patent claims be challenged for validity?
A: Yes. Due to prior art or obviousness arguments, patent claims can be challenged via administrative procedures (e.g., inter partes review) or litigation.

Q5: What strategies protect innovative improvements over expired patents?
A: Filing new patents on novel compounds, formulations, or methods can extend protection and provide market exclusivity beyond the original patent's lifespan.

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References

1. USPTO. United States Patent 5,744,501.
2. Relevant patent classifications and pharmaceutical patenting guidelines.
3. Anonymized patent family and citation data (where applicable).
4. Pharmaceutical patent law and jurisprudence resources.
5. Recent literature on patent strategies in drug development.

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Note: Specific structural and claim language of Patent 5,744,501 was not included due to lack of access to detailed patent text. The analysis provided draws on typical patent characteristics, landscape considerations, and strategic insights suited to a patent of this nature.

Drugs Protected by US Patent 5,744,501

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