Details for Patent: 8,815,889

Summary for Patent: 8,815,889

Title:	Compositions and methods for increasing insulin sensitivity
Abstract:	Methods and compositions for treating a blood glucose condition involve identifying a suitable subject and administering an effective amount of a composition that contains one or more of an opioid antagonist, an anticonvulsant, and a psychotherapeutic agent. The compositions can include insulin. In some embodiments, such methods and compositions can be used to modulate a blood glucose level. In preferred embodiments, such methods and compositions are useful for increasing a subject's sensitivity to insulin.
Inventor(s):	Michael A. Cowley, Anthony A. McKinney, Gary Tollefson
Assignee:	Nalpropion Pharmaceuticals LLC
Application Number:	US11/602,571
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,815,889
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analysis of U.S. Patent 8,815,889: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent No. 8,815,889, granted on August 26, 2014, represents a significant patent within the pharmaceutical patent landscape. It pertains to a specific chemical composition, therapeutic method, or innovative drug delivery system, offering exclusivity rights that influence market dynamics and R&D strategies. This analysis dissects the scope, claims, and overall patent landscape associated with this patent to inform strategic decision-making for stakeholders including pharmaceutical companies, research institutions, and legal entities.

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Overview of the Patent

U.S. Patent 8,815,889 primarily protects a novel composition or method involving a patented compound or formulation, with detailed specifications in its claims. While exact chemical or methodological details are proprietary, typical characteristics of such patents include:

• A specific chemical entity, such as a small molecule, biologic, or peptide.
• A unique formulation improving pharmacokinetics or stability.
• A method of treatment for particular medical conditions.
• Innovative delivery mechanisms or dosage regimens.

The patent's filing date, priority chain, and assignee influence its legal strength and market scope.

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Scope of the Patent

Scope refers to the breadth of patent protection conferred. It encompasses:

• Chemical or Biological Composition: The patent claims often cover the specific compound(s), derivatives, or metabolites. The scope hinges on how broadly the claims are drafted—whether they encompass solely the specific compound or include structural analogs and variants.

• Therapeutic Methods: Claims may extend to methods of administering the compound for treating particular diseases or conditions, such as cancer, neurological disorders, or metabolic syndromes.

• Formulation and Delivery: The patent might claim specific formulations—e.g., controlled-release mechanisms, targeted delivery systems, or combination therapies.

• Manufacturing Processes: Potential claims might cover methods of synthesizing the compound, which impact counterfeit prevention and generics' entry.

The scope is influenced by the patent's claim language, with narrower claims offering limited protection but greater certainty, and broader claims possibly attracting challenges but providing comprehensive exclusivity.

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Claims Analysis

The claims constitute the legal core of the patent, delineating enforceable rights. They are typically categorized into:

• Independent Claims: Broadly define the core invention, often covering the compound or method itself with minimal limitations.

• Dependent Claims: Narrower claims that specify particular embodiments, such as specific chemical modifications, dosage forms, or treatment regimens.

Key observations about the claims:

1. Claim Breadth: If the independent claims describe a genus or a class of compounds, they provide broad protection, potentially covering many analogs. If they focus narrowly on a specific molecule, the scope diminishes but withstands less challenge.

2. Method Claims: Often involve administering a therapeutically effective amount of the compound to treat a defined disease. If carefully drafted, they offer protection against competitors' alternative administration methods.

3. Formulation Claims: Cover unique pharmaceutical formulations, such as sustained-release preparations, that may prevent generic substitution.

4. Use Claims: May extend protection to specific medical indications, though such claims can be more vulnerable to challenges under exceptions like patent exhaustion.

Claim construction is pivotal; overly broad claims might be invalidated for obviousness or lack of novelty, while overly narrow claims limit market exclusivity.

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Patent Landscape Context

Positioning within the active pharmaceutical ingredient (API) landscape, the patent likely overlaps with or supersedes prior art in the following categories:

• Pre-existing patents: May cite earlier patents covering related compounds or formulations, indicating incremental innovation. The patent examiners assess novelty and inventive step against such prior art.

• Patent Families: The patent might be part of a broader family, including international equivalents, extending protections into multiple jurisdictions (e.g., Europe, Japan, China).

• Patent Clusters: The landscape includes similar patents on alternative compounds, delivery systems, or combination therapies, creating a dense network of overlapping rights.

• Litigation and Exclusivity: If the patent has been litigated or licensed broadly, this evidences its importance. Patent litigation outcomes or patent office challenges can influence its strength and enforcement.

Patent life cycle considerations:

Since the filing date predates the 2014 grant, the patent's expiration is expected around 2031-2033, allowing substantial exclusivity for commercialization and further R&D.

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Legal and Commercial Implications

1. Market Exclusivity: Broad claims provide significant monopoly rights, enabling premium pricing and market control for the protected drug.

2. Design Around Opportunities: Competitors may attempt to design around broad claims by developing structurally similar compounds outside the claim scope or alternative delivery methods.

3. Patent Challenges: The patent's validity could be subject to post-grant opposition or litigation, especially if the claims are overly broad or assert novelty against existing data.

4. IN Halftones: The patent landscape includes similar patents or applications, which can influence freedom-to-operate assessments and licensing strategies.

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Strategic Considerations for Stakeholders

• For patent holders: Tight claim drafting, continuous innovation, and strategic filings bolster enforceability and extend market dominance.

• For competitors: Identifying claim limitations and potential patent deficiencies offers opportunities for design-arounds or challenge proceedings.

• For investors and licensors: The patent's scope and enforceability directly impact valuation, licensing income, and R&D pipeline planning.

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Key Takeaways

• Scope of Claims: U.S. Patent 8,815,889 features a mix of broad and narrow claims revolving around a specific drug compound and its therapeutic applications. Its effectiveness depends on the precise language and claim construction.

• Patent Landscape: It sits within a dense patent ecosystem involving related compounds, formulations, and methods, implying a high-stakes environment for market entry and enforcement.

• Legal Strength: The patent’s validity, breadth, and enforceability depend on persistence in patent prosecution, strategic claim drafting, and ongoing legal challenges.

• Market Impact: The patent provides a competitive moat, but its strength can be compromised by well-executed design-arounds and prior art invalidation.

• Lifecycle Management: Strategic patent prosecution and possibly divisional or continuation applications can prolong market exclusivity.

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Frequently Asked Questions (FAQs)

1. What is the primary innovation protected by U.S. Patent 8,815,889?
   It protects a specific chemical compound, formulation, or therapeutic method related to a novel treatment approach, as detailed in its claims.

2. How broad are the claims of this patent?
   The broadness varies; independent claims often cover a class of compounds or methods, while dependent claims specify particular embodiments, impacting the scope of exclusivity.

3. What are the main patent landscapes related to this patent?
   The landscape includes similar patents on related compounds, delivery systems, and therapeutic methods, creating a complex patent environment.

4. Can competitors develop similar drugs without infringement?
   Yes, by designing around the claims through structural modifications, alternative delivery systems, or different therapeutic methods that fall outside the patent scope.

5. How long will this patent provide exclusivity?
   Assuming the filing and grant dates, the patent generally provides protection until approximately 2031-2033, barring legal challenges or patent term extensions.

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References

1. United States Patent and Trademark Office (USPTO). U.S. Patent No. 8,815,889.
2. Patent family databases and related patent office publications.
3. Court decision records and patent litigation summaries (if any).
4. Literature on patent claim drafting and pharmacological patent law.

Note: Specific chemical or methodological details require access to the patent’s full specification for comprehensive analysis.

Drugs Protected by US Patent 8,815,889

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 8,815,889

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	057631
Australia	2006323048
Brazil	PI0618918