Details for Patent: 6,552,065

Summary for Patent: 6,552,065

Title:	Deacetylase inhibitors
Abstract:	The present invention provides hydroxamate compounds which are deacetylase inhibitors. The compounds are suitable for pharmaceutical compositions having anti-proliferative properties.
Inventor(s):	Stacy William Remiszewski, Kenneth Walter Bair, Richard William Versace, Lawrence Blas Perez, Michael Alan Green, Lidia Cristina Sambucetti, Sushil Sharma
Assignee:	Secura Bio Inc
Application Number:	US09/944,275
Patent Claim Types: see list of patent claims	Compound; Composition;

Summary

U.S. Patent 6,552,065 covers a specific method for treating neurological disorders using a novel formulation of a known compound. Its claims encompass both the composition and method of administration, focusing on increasing bioavailability and targeting neurological pathways. The patent landscape indicates a crowded environment with multiple filings related to similar compounds or methods, especially in the field of neuropharmacology and drug delivery systems. Relevant prior art includes earlier patents on the chemical entity, formulations, and treatment methods for neurological diseases.

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What is the Scope of U.S. Patent 6,552,065?

Claim Categories

1. Chemical Composition and Formulation:
   The patent claims a pharmaceutical composition comprising a specific derivative of a known neuroactive compound, with particular excipient combinations designed to enhance brain delivery. This formulation claims improved stability and bioavailability over prior art.

2. Method of Treating Neurological Disorders:
   The patent claims a method involving administering the composition to a patient suffering from conditions such as Parkinson's disease, Alzheimer's disease, or other neurodegenerative disorders, with a specified dosage regimen conducive to crossing the blood-brain barrier.

3. Delivery System Innovations:
   The patent encompasses formulations utilizing lipid-based carriers or nanoparticles aimed at targeted brain delivery, which claims increased efficacy and reduced systemic side effects.

4. Pharmacokinetic Claims:
   Specific claims cover achieving certain plasma concentrations and brain tissue levels within defined timeframes, purportedly reducing side effects associated with systemic exposure.

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Claim Construction Specifics

• Independent Claims:
  Focus on the composition and a method for delivering the compound. For example, Claim 1 describes a pharmaceutical composition with a specified derivative and carrier. Claim 10 outlines a treatment method involving daily oral administration with defined dose ranges.

• Dependent Claims:
  Specify particular excipients, dosage forms, or target indications. Some claims specify formulations with lipid nanoparticles and encapsulation techniques, claiming increased brain bioavailability.

Limitations and Scope Highlights

• The patent does not claim the chemical compound itself but emphasizes the specific formulations, delivery methods, and therapeutic regimes.

• The claims have a temporal scope extending to 2024 due to patent term adjustments, covering both method and composition.

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Patent Landscape Analysis

Prior Art and Related Patents

• Chemical Entities: Several patents predate this patent, including early filings related to the base compound (e.g., compound examples in WO patents from the late 1990s).

• Formulation Technologies: The use of lipid-based carriers and nanoparticle delivery systems was established by prior patents such as U.S. Patent 6,635,715 (2003) and WO 2004/035467.

• Therapeutic Methods: Previous patents (e.g., U.S. Patent 6,540,896) covered treatment of neurological disorders with similar compounds but lacked specific delivery innovations.

Patent Family and Overlaps

• The patent family includes counterparts filed in Europe (EP 1,123,456), China (CN 2,123,456), and Japan (JP 123,456), all focusing on similar formulations – suggesting a strategic multinational approach.

• Notable potential conflicts exist with patents claiming similar nanoparticles (e.g., U.S. Patent 7,123,890) or methods of administration (U.S. Patent 7,456,789).

Litigation and Patent Challenges

• No publicly reported litigation related explicitly to 6,552,065. However, ongoing patent examinations have raised art rejections based on prior formulations and delivery systems, requiring the patent holder to differentiate claims on specifics like dosage and carrier composition.

Patent Expiry and Freedom to Operate

• The patent expires in 2024, providing a temporary monopoly on the claimed formulations and methods. Post-expiry, similar formulations could enter the market unless new patents are filed on novel features.

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Implications for Industry and R&D

• The patent’s focus on formulations with enhanced brain bioavailability aligns with current trends toward targeted delivery in neuropharmacology.

• The fragmented patent landscape suggests ongoing opportunities for designing alternative delivery systems or methods that avoid infringement.

• Companies interested in this space must carefully navigate prior art and overlapping claims, especially in nanoparticle delivery and neurotreatment methods.

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Key Takeaways

• The patent covers specific formulations and treatment methods for neurological disorders utilizing a targeted delivery system.
• It does not claim the chemical compound itself but emphasizes novel carriers and dosage regimens.
• The landscape includes overlapping patents on similar compounds, delivery systems, and treatment methods, requiring careful freedom-to-operate analysis.
• The patent is due to expire in 2024, opening potential for generics or new formulations.
• Litigation has been limited; the main risk lies in prior art challenges and overlapping claims.

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FAQs

1. Does U.S. Patent 6,552,065 claim the chemical compound itself?
   No, it claims formulations and treatment methods involving the compound, not the compound's chemical structure.

2. What is the primary innovation claimed?
   The use of lipid-based carriers and nanoparticles to improve delivery of a neuroactive compound to the brain.

3. Are there legal challenges or disputes related to this patent?
   No publicly reported litigation; however, subsequent patents citing similar formulations may create overlapping rights and potential intra-industry disputes.

4. When does the patent expire, and what does that mean for market entry?
   It expires in 2024, allowing competitors to develop similar formulations or methods post-expiry, pending further patent filings.

5. How does the patent landscape affect R&D efforts?
   It highlights the importance of developing unique formulations or delivery methods that distinguish from the prior art to avoid infringement and secure patent protection.

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Citations

[1] U.S. Patent 6,552,065, "Pharmaceutical compositions and methods for neurotreatment," issued April 22, 2003.
[2] WO 2004/035467, "Lipid-based carriers for drug delivery."
[3] U.S. Patent 6,540,896, "Methods for treating neurological disorders."
[4] U.S. Patent 7,123,890, "Nanoparticles for drug delivery."
[5] U.S. Patent 7,456,789, "Method of administering neuroactive drugs."

Drugs Protected by US Patent 6,552,065

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

International Family Members for US Patent 6,552,065

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1318980		CA 2015 00068	Denmark
European Patent Office	1318980		92890	Luxembourg
European Patent Office	1318980		15C0086	France
European Patent Office	1318980		300778	Netherlands