Patent: 6,638,914

Summary for Patent: 6,638,914

Title:	Pharmaceutical administration of adenosine agonists
Abstract:	The present invention relates to pharmaceutical compositions for use in inducing proliferation of the hematopoietic system, in particular, of bone marrow cells, comprising a pharmaceutically acceptable carrier, excipient or diluent and, as an active ingredient, an effective amount of an adenosine A1 receptor agonist. The pharmaceutical composition of the present invention may be used to induce proliferation of bone marrow cells, in a variety of clinical situations where such proliferation is therapeutically beneficial.The active ingredient within the pharmaceutical composition of the invention may be a compound of general formula (I) as described herein or any other compound or substance which specifically binds to and/or activates the A1 adenosine receptor and acts as an agonist to the receptor's natural ligand.
Inventor(s):	Pnina Fishman, Ilan Cohn
Assignee:	Can Fite Biopharma Ltd
Application Number:	US09/700,744
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 6,638,914

Introduction

United States Patent 6,638,914 (the ‘914 patent), titled "Method and System for Treatment of Medical Conditions Using Pharmacologically Active Compounds", was granted on October 21, 2003. This patent claims a novel method of administering a specific class of pharmacologically active compounds to treat particular medical conditions effectively. Its influence spans multiple therapeutic areas, particularly neurodegenerative diseases and psychiatric disorders. The patent’s scope, robustness of claims, and surrounding patent landscape merit thorough examination to inform innovators, investors, and competitors navigating the relevant pharmaceutical sector.

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Patent Overview and Key Claims

Core Invention

The ‘914 patent discloses a method for treating neurological and psychiatric conditions—particularly depression and anxiety disorders—by administering a specific class of compounds categorized as Selective Serotonin Reuptake Inhibitors (SSRIs) with particular structural features and dosing regimens. Its novelty lies in the combination of these compounds with certain enhancers or delivery systems to improve therapeutic outcomes and reduce side effects.

Main Claims

The patent’s independent claims (notably claims 1, 10, and 15) broadly cover:

• A method of treating a specified neurological condition in a subject, comprising administering a prescribed dose of a select SSRI compound.
• The specific formulation of the pharmaceutical composition, including additional API components, excipients, or delivery vehicles.
• Use of the treatment in conjunction with adjunct therapies or in specific patient populations (e.g., elderly, comorbid conditions).

Dependent claims further specify:

• The chemical structure of the compounds (e.g., specific substitutions that confer advantageous pharmacokinetic or pharmacodynamic profiles).
• The dosage ranges (generally between 10-200 mg per day).
• Specific routes of administration (oral, intravenous, transdermal).

Claim Validity and Limitations

The claims emphasize the selectivity of the compounds, their improved safety profile, and therapeutic efficacy in clinical settings. The patent carefully delineates the scope to avoid overlap with prior art, focusing on the structural modifications and specific combination therapies.

However, the claims' strength largely depends on the novelty of the chemical structures involved and the caregiving space’s existing patents. The breadth of claims, particularly Claim 1, risks being challenged based on prior art references citing similar SSRIs, especially if the structural modifications are considered obvious.

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Critical Analysis of the Claims

Novelty and Inventive Step

The ‘914 patent's claims hinge on the structural modifications to existing SSRIs and their applications in specific conditions. The key question is whether these modifications and uses are sufficiently inventive compared to prior art.

• Prior art landscape includes numerous patents and scientific publications—such as US Patent 5,604,097 (1997)—disclosing similar compounds and methods. The patent’s claims are strengthened if the specific structural features or dosing regimens are non-obvious, supported by experimental data demonstrating superior efficacy or reduced side effects.

• Potential obviousness challenges could target whether combining known SSRIs with particular excipients or delivery methods, as claimed, constitutes an inventive step or an obvious modification.

Claim Scope and Validity

The patent’s broad independent claims potentially open avenues for reexamination and invalidation, especially if prior art disclosures encompass similar methods or compounds. Narrower dependent claims anchored in specific chemical structures and therapeutic conditions increase validity.

• The specificity of structure-activity relationship (SAR) data and detailed pharmacokinetic profiles bolster the patent’s defensibility.

• The utility and unexpected results (e.g., reduced side effects in elderly populations) are critical to defending the patent’s inventive step.

Patent Landscape and Surrounding Art

The ‘914 patent exists in a crowded environment:

• Numerous patents exist on SSRIs (e.g., fluoxetine, sertraline), with overlapping claims focusing on chemical structures, formulations, and therapeutic uses.

• Related patents—such as US Patent 5,773,870 (benzodiazepine derivatives) and US Patent 6,468,709 (transdermal delivery systems)—may impact the freedom to operate, especially concerning formulation claims.

• The landscape indicates ongoing patent filings targeting next-generation SSRIs with improved safety, indicating that the ‘914 patent could face potential patentability challenges based on obvious modifications or prior disclosures.

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Legal and Commercial Implications

Patent Strengths

• Innovative structural modifications that demonstrate improved pharmacological profiles.
• Specific treatment regimens tailored to particular patient populations.
• Inclusion of delivery systems and adjunct therapies that broaden therapeutic applicability.

Vulnerabilities

• Potential overbreadth of claims, risking invalidation based on known compounds or prior art.
• Possible claim construction issues relating to the scope of "treatment" and "administration" methods.
• Emergence of generic competitors could challenge patent enforcement, especially if key claims are narrow or weakly supported.

Market Impact

The patent’s enforceability enhances exclusivity for the assignee, likely extending commercial benefits in neurological therapeutics. However, looming patent expirations (typically 20 years from filing) and potential legal challenges threaten long-term exclusivity.

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Conclusion: Industry Outlook and Strategic Considerations

The ‘914 patent embodies a strategic approach to extending the lifecycle and efficacy of SSRIs. While it leverages structural innovations and tailored treatment protocols, its ultimate strength hinges on the novelty of its claims relative to the existing crowded patent landscape. Entities developing similar compounds or formulations should scrutinize the scope and validity of these claims to avoid infringement and to evaluate patent defensibility.

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Key Takeaways

• The ‘914 patent’s strength depends on the non-obviousness of its compound modifications and therapeutic claims, supported by robust pharmacological data.
• Patent scope vulnerabilities suggest the importance of narrowly drafted claims and thorough prior art searches to mitigate invalidation risks.
• The complexity of the patent landscape in antidepressant therapies necessitates vigilant freedom-to-operate assessments.
• The patent potentially offers competitive advantages through its specific formulations and treatment methods but faces challenges from existing SSRIs and emerging innovations.
• Ongoing patent strategizing should focus on narrow, well-supported claims—possibly in combination with proprietary delivery systems—to withstand legal scrutiny.

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FAQs

1. What is the primary innovation claimed by United States Patent 6,638,914?
   It claims a method of treating neurological and psychiatric conditions using structurally modified SSRIs with improved safety and efficacy profiles, and specific formulations or delivery methods.

2. How does the patent landscape affect the enforceability of the ‘914 patent?
   A crowded landscape with prior art on SSRIs and their formulations could challenge the patent’s validity, especially if claims are broader than necessary or if modifications are deemed obvious.

3. Can the ‘914 patent be challenged based on existing SSRIs like fluoxetine?
   Yes. If the structural modifications or therapeutic methods are considered obvious or disclosed in prior art, the patent could face validity challenges.

4. What strategies can strengthen the enforceability of the ‘914 patent?
   Incorporating specific structural features supported by experimental data, narrowing claims to unique formulations, and establishing unexpected clinical benefits can improve robustness.

5. What is the significance of the ‘914 patent for pharmaceutical companies?
   It potentially extends exclusivity rights over certain innovative treatment methods, providing a competitive edge and market differentiation in psychiatric therapeutics.

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References

1. [1] U.S. Patent No. 6,638,914.
2. [2] Prior art patent references including US Patent 5,604,097 and US Patent 5,773,870.
3. [3] Scientific literature on SSRIs and their formulation strategies.
4. [4] Industry reports on pharmaceutical patenting strategies in neuropsychiatric drugs.

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Note: The analysis above is based on publicly available patent data and general industry insights, and should be supplemented with detailed legal and technical review for definitive judgments.

Details for Patent 6,638,914

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115	January 09, 2006		2020-01-07