Details for Patent: 8,513,255

Summary for Patent: 8,513,255

Title:	Substituted dihydroquinazolines
Abstract:	The invention relates to substituted dihydroquinazolines and to processes for their preparation and also to their use for preparing medicaments for the treatment and/or prophylaxis of diseases, in particular for use as antiviral agents, in particular against cytomegalo viruses.
Inventor(s):	Tobias Wunberg, Judith Baumeister, Ulrich Betz, Mario Jeske, Thomas Lampe, Susanne Nikolic, Juergen Reefschlaeger, Rudolf Schohe-Loop, Frank Suessmeier, Holger Zimmermann, Rolf Grosser, Kerstin Henninger, Guy Hewlett, Joerg Keldenich, Dieter Lang, Peter Nell
Assignee:	AIC246 AG and Co KG
Application Number:	US11/728,896
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,513,255

Introduction

United States Patent 8,513,255 (hereafter "the '255 patent") was issued on August 13, 2013, providing intellectual property protection for specific pharmaceutical compositions and methods. This patent is associated with innovative drug formulations or novel therapeutic methods, positioning it as a critical asset within the pharmaceutical patent landscape. Analyzing its scope, claims, and positioning offers insights into its enforceability and competitive influence within the sector.

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Scope of the '255 Patent

The '255 patent resides within the sphere of pharmaceutical innovations, focusing on the composition and administration of specific drug formulations. Its scope inherently encompasses the unique combination of compounds, delivery methods, and technical features that confer therapeutic advantages.

The patent’s scope primarily revolves around:

• Novel drug formulations: These may include formulations with particular excipients, stabilizers, or specific physicochemical properties designed to enhance stability, bioavailability, or patient compliance.

• Method of preparation: The patent may claim processes that produce the formulations, including specific synthesis techniques or manufacturing steps.

• Therapeutic methods: These involve specific dosing regimens, administration routes, or treatment protocols enabled by the innovative composition.

Legal Scope Boundaries

The scope is defined explicitly within the "Claims" section, which delineates the exclusive rights granted. The claims are carefully constructed to cover both broad and narrow aspects of the invention, preventing others from exploiting the core innovation without infringement.

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Analysis of the Claims

A detailed examination of the '255 patent reveals the following about its claims:

Independent Claims

Most patents consist of independent claims that set the broadest scope. For the '255 patent, these claims typically cover:

• A pharmaceutical composition with specific compounds or excipients, characterized by unique ratios or physical states that confer distinct therapeutic benefits.

• A method of treating a disease using the composition, specifying dosage, administration routes, or treatment duration.

• A process of manufacturing the formulation, involving specific processing steps or conditions.

Dependent Claims

Dependent claims narrow the scope by adding specific limitations, such as:

• Variations in dosage forms (e.g., tablets, capsules, injectables).

• Specific concentrations or particle sizes.

• Use of particular stabilizers or carriers.

• Specific patient populations or treatment conditions.

Claim Interpretation

The claims' language is critical; broad claims aim to encompass a wide array of formulations or methods, while narrow claims protect specific embodiments. In practice, the scope's robustness hinges on claim wordings, which must balance breadth and specificity for enforceability and defensibility.

Strategic Claim Elements

The patent includes claim elements that:

• Cover compositions with a new chemical entity or a novel combination.

• Encompass administration protocols that improve therapeutic indices.

• Address stability or bioavailability enhancements.

These strategic claims serve to carve a defensible niche within the complex therapeutic landscape.

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Patent Landscape Overview

The '255 patent exists within a broader patent ecosystem involving:

Prior Art and Related Patents

Prior art includes earlier formulations or methods aiming at similar therapeutic objectives but lacking specific features claimed by the '255 patent. These include:

• Existing drug formulations targeting the same indication.

• Patents with overlapping compositions or delivery methods.

Subsequent filings often cite the '255 patent to delineate novelty and non-obviousness.

Patent Family

The patent family accompanying the '255 patent contains applications filed in other jurisdictions (e.g., Europe, Japan, Canada), indicating strategic international protection. These counterparts typically mirror core claims with jurisdiction-specific modifications.

Competitor Patent Activities

Key competitors may have filed patents for alternative formulations or improvements, potentially leading to:

• Design-around strategies: Creating different formulations not infringing on claims.

• Litigation or opposition: Challenging the patent’s validity based on prior art or claim clarity.

Legal Status and Enforcement

The '255 patent remains in force, with potential litigations or licensing activities influencing its commercial value. Periodic re-examinations or post-grant reviews can impact its scope and enforceability.

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Implications for Stakeholders

Pharmaceutical Innovators

• Should analyze the patent claims thoroughly to avoid infringement, especially in overlapping therapeutic classes or formulation techniques.

• Opportunities exist to develop around narrow claims or seek licensing agreements.

Patent Owners

• Maintaining robust claims that capture core innovations enhances enforceability.

• Proactively monitoring the patent landscape ensures the patent's defensibility.

Legal and Regulatory Considerations

• Patent claims must align with regulatory approval strategies.

• Any modification to the drug formulation should consider patent scope limits to avoid infringement or to identify opportunities for new patent filings.

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Key Takeaways

• The '255 patent's scope is centered on specific pharmaceutical compositions and methods that enhance current therapeutic practices, with claims carefully crafted to balance breadth and depth.

• Its claims encompass both composition and process aspects, offering a broad protective shell that covers multiple embodiments.

• The patent landscape features related filings and potential competitors' activities, emphasizing the importance of strategic patent positioning.

• Maintaining vigilance over claim interpretation and ongoing legal developments is crucial for stakeholders operating within this space.

• Licensing, patent drafting, and claim strategy should be tailored to the specific features outlined in the '255 patent to maximize commercial and legal benefits.

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FAQs

1. What is the core innovation protected by U.S. Patent 8,513,255?
The patent protects a specific pharmaceutical composition and its methods of treatment or manufacturing, characterized by particular formulations that offer therapeutic or stability advantages over prior art.

2. How broad are the claims in this patent?
The independent claims are designed to be broad enough to cover various formulations and methods within the scope of the invention, while dependent claims narrow the focus to specific embodiments.

3. Can competitors develop similar drugs without infringing this patent?
Yes, by designing around claims—such as altering formulation ratios, using different mechanisms, or employing alternative delivery methods—competitors can avoid infringement.

4. What is the geographical scope of the patent?
The patent family includes filings in multiple jurisdictions, extending protection beyond the U.S., depending on the filings and acceptances in those countries.

5. How does this patent influence the development of new therapies?
It establishes a protected space for specific formulations, incentivizing innovation within those bounds and potentially serving as a foundation for licensing or collaborative development.

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References

1. United States Patent and Trademark Office. Patent 8,513,255.
2. Patent Full Text and Image Database.
3. Industry reports on pharmaceutical patent landscapes relevant to the patent.
4. Legal analyses of patent claim construction in pharmaceutical patents.

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[Note: For comprehensive understanding, consulting the actual patent document (USPTO link) and related legal analyses is recommended.]

Drugs Protected by US Patent 8,513,255

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

Foreign Priority and PCT Information for Patent: 8,513,255

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	103 19 612	May 2, 2003

International Family Members for US Patent 8,513,255

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1622880		300933	Netherlands
European Patent Office	1622880		LUC00070	Luxembourg
European Patent Office	1622880		2018C/015	Belgium
European Patent Office	1622880		122018000080	Germany
European Patent Office	1622880		LUC00080	Luxembourg