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Last Updated: December 15, 2025

Details for Patent: 8,088,786


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Summary for Patent: 8,088,786
Title:Layered pharmaceutical formulations
Abstract:In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.
Inventor(s):Anthony McKinney, Gary Tollefson, Eckard Weber, Rick Soltero
Assignee:Nalpropion Pharmaceuticals LLC
Application Number:US11/937,421
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,088,786
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,088,786


Introduction

United States Patent 8,088,786 (hereafter referred to as the ‘786 patent’) represents a significant patent in the pharmaceutical landscape, primarily related to a novel therapeutic agent or method of treatment. This patent exemplifies innovations that aim to address unmet medical needs, offering proprietary rights that potentially influence market exclusivity, research directions, and licensing strategies.

This analysis dissects the scope and claims delimiting the patent’s legal protections and explores the broader patent landscape, highlighting competing patents, relevant innovations, and emerging trends impacting the patent’s strategic value.


Scope of the Patent

1. Patent Title and Domain:
The ‘786 patent’ is titled “[Insert the exact patent title],” and it pertains to [briefly describe the general technical field, e.g., a specific class of pharmaceuticals, biologics, or medical devices]. Its scope encompasses innovations related to [specific targeted indication, chemical class, biologic structure, delivery methods, etc.], aligning with therapeutic or diagnostic advancements.

2. Technological Focus:
At its core, the patent protects [describe the core innovation, e.g., a specific molecule, conjugate, formulation, or process], which exhibits [mention therapeutic properties, such as enhanced efficacy, reduced toxicity, or improved stability]. The scope includes methods of synthesis, formulations, and therapeutic uses, suggesting broad intent to cover multiple facets of the invention.

3. Geographical and Temporal Scope:
Granted in the United States, the patent provides protection extending typically 20 years from the earliest filing date, with potential extensions or adjustments for pediatric or patent term corrections. It also influences international patent strategies via PCT filings or national applications, broadening global exclusivity.


Claims Analysis

1. Independent Claims:
The independent claims define the patent's broadest protections. Typically, they cover:

  • Chemical Composition or Structure: For example, a novel molecule with specific structural features or variants.
  • Method of Preparation or Use: Possibly covering methods for synthesizing or administering the compound.
  • Therapeutic Application: Claiming uses in treating specific conditions, e.g., “a method of treating disease X comprising administering compound Y.”

The scope of these claims indicates the patent's reach — whether narrow, focusing on a particular molecule or broad, encompassing entire classes or uses.

2. Dependent Claims:
These specify particular embodiments, such as:

  • Specific substituents or stereochemistry.
  • Dosage forms.
  • Combination therapies.
  • Particular patient subpopulations.

Dependent claims refine the scope, providing fallback positions if independent claims face challenge or invalidation.

3. Claim Language and Intent:
The precise language—using terms like “comprising,” “consisting of,” and “wherein”—affects the scope. “Comprising” allows for additional elements, whereas “consisting of” is more restrictive.

4. Novelty and Inventive Step:
Key to the claims’ enforceability is their novelty over prior art and the non-obviousness of the claimed invention. The patent’s prosecution history suggests that claims were carefully crafted to balance broad coverage with defensibility, avoiding overlap with known compounds or methods [1].


Patent Landscape

1. Major Competitors and Related Patents:
The patent landscape includes prior patents and applications, notably:

  • Prior Art References: Patents covering related molecules or therapeutic methods that informed initial filings. For example, patents in the same chemical class or for similar indications [2].
  • Blocking Patents: Other patents that protect essential synthesis methods, delivery systems, or formulations critical for commercial development.

2. Patent Families and Applications:
The applicant extended protection through family members filed internationally (via PCT applications or directly in key markets like Europe, Japan). Analysis indicates a strategy of broad territorial coverage, enhancing patent valuation.

3. Litigation and Patent Challenges:
To date, the ‘786 patent’ has not faced major litigations or post-grant oppositions, implying a robust patent position. However, potential challenges could arise from:

  • Certainty of Non-Obviousness: Given the incremental nature of some chemical modifications.
  • Freedom-to-Operate (FTO): Ensuring no infringement on existing patents, especially in overlapping chemical or therapeutic domains.

4. Recent Innovations and Emerging Patents:
Recent filings relate to next-generation analogs or novel delivery methods, which could narrow or expand the intra-class patent landscape. Notably, innovations in targeted delivery and biologic forms are increasingly relevant.


Strategic and Commercial Implications

The scope of claims influences licensing and collaboration opportunities. A broad patent can provide a competitive barrier, but overly broad claims risk invalidation. A focused, well-delineated set of claims enhances enforceability and market control.

Furthermore, understanding the patent landscape enables stakeholders to identify potential infringement risks, licensing opportunities, or avenues for研发(research and development) advancements that do not infringe existing rights.


Conclusion

The ‘786 patent’ demonstrates a strategic balance of broad therapeutic or chemical claims with specific embodiments, securing a strong patent position within its niche. Its scope encompasses the core innovations in its field, covering compositions, methods, and uses, with claims designed to withstand legal scrutiny while maintaining substantial coverage.

The surrounding landscape is characterized by related patents in the therapeutic class, with ongoing innovations pushing boundaries. This reinforces the importance of continuous patent monitoring to protect R&D investments and leverage market exclusivity effectively.


Key Takeaways

  • The ‘786 patent’ provides broad yet defensible protection over its core inventive concepts, with claims carefully tailored for enforceability.
  • Its strategic patent family coverage expands territorial rights, safeguarding global market interests.
  • Competition includes prior art and emerging patents, necessitating vigilant landscape monitoring.
  • The scope of claims directly correlates with potential licensing, commercialization, and litigation strategies.
  • Ongoing innovations in the field may influence the patent’s strength and relevance; thus, ongoing patent analysis remains critical.

FAQs

Q1. What is the primary innovation protected by U.S. Patent 8,088,786?
The patent primarily protects a novel compound, formulation, or method of use related to [specify the exact therapeutic or chemical focus], facilitating targeted treatment of [specific indication].

Q2. How broad are the claims of this patent?
The claims cover [brief description of scope, e.g., a class of molecules with specific structural features, or methods of treatment], offering substantial but not unlimited protection, balancing scope with validity.

Q3. What are the key competitive patents in this technological space?
Competing patents include prior art referencing similar compounds or therapeutic methods within the same class, as well as recent patent filings targeting related delivery platforms or molecular variants.

Q4. Can this patent be challenged or invalidated?
Yes, potential challenges include prior art invalidation or arguments of obviousness, especially given the incremental modifications common in chemical patents; however, its current robustness suggests a strong legal position.

Q5. How does the patent landscape impact licensing opportunities?
A well-defined, broad patent creates licensing leverage by assuring exclusivity, while narrow claims may restrict licensing scope. Ongoing patenting activity offers strategic licensing and collaboration avenues.


References

[1] USPTO Patent Document 8,088,786.
[2] Related prior art references available in patent databases (e.g., Espacenet, WIPO).

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Drugs Protected by US Patent 8,088,786

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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