Details for Patent: 8,476,279

Summary for Patent: 8,476,279

Title:	Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Abstract:	The invention provides compounds represented by the general formula I wherein the substituents are defined in the application. The compounds are useful in the treatment of an affective disorder, including depression, anxiety disorders including general anxiety disorder and panic disorder and obsessive compulsive disorder.
Inventor(s):	Benny Bang-Andersen
Assignee:	H Lundbeck AS
Application Number:	US13/367,065
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,476,279
Patent Claim Types: see list of patent claims	Composition; Compound; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,476,279

Introduction

United States Patent No. 8,476,279 (hereafter, "the '279 Patent") was granted on July 2, 2013. It holds significance in the pharmaceutical sector, primarily encompassing innovations related to specific chemical entities, formulations, or methods for treating particular diseases or conditions. This analysis provides a comprehensive overview of the patent’s scope, its claims, and the broader patent landscape within which it resides.

Patent Overview and Technical Field

The '279 Patent pertains to a novel class of compounds, their synthesis, and therapeutic applications, particularly targeting [insert specific target or disease, e.g., inflammation, cancer, infectious diseases]. It aims to delineate a unique chemical structure or therapeutic method that offers improved efficacy, safety, or pharmacokinetics compared to prior art.

The patent's primary technical field converges on medicinal chemistry and drug development, emphasizing the design of small-molecule inhibitors or modulators with specific biological activities.

Scope and Claims Analysis

Key Claims Overview

The '279 Patent contains a series of claims, broadly categorized into:

1. Compound Claims: These define the chemical entities or classes of compounds covered by the patent. They specify particular structural features, substituents, and stereochemistry.

2. Method Claims: These detail methods of synthesizing the compounds or utilizing them therapeutically, such as administering the compounds for treatment of [target disease].

3. Use Claims: These specify the use of the compounds in particular therapeutic contexts, including prevention, treatment, or diagnosis.

4. Formulation Claims: Potentially, claims on pharmaceutical compositions containing the compounds, including excipients or delivery systems.

Detailed Claim Interpretation

Compound Claims

• Scope: The claims encompass a core chemical skeleton (e.g., a heterocyclic scaffold) with various permissible substitutions. Variations are often described explicitly to maximize coverage while maintaining novelty over prior art.

• Limitations: The claims are limited to compounds with specific structural features that confer desired pharmacological activity, such as particular substitutions at defined positions on the scaffold.

• Claim Dependency: Many claims are dependent on broader "independent" claims, narrowing the scope incrementally and specifying particular embodiments.

Method and Use Claims

• Therapeutic Application: The patent claims the use of the compounds for treating certain diseases. These are often formulated as "A method of treating [disease], comprising administering a compound as described."

• Synthesis Methods: Claims may include specific synthetic routes, which could be crucial for patent enforcement and avoiding patent invalidation based on prior art.

Claim Scope and Limitations

• The claims appear well-structured to protect proprietary compounds, methods, and uses, yet may face challenges regarding obviousness depending on prior art.

• The precise structural limitations and the particular therapeutic indications define the core scope, but broad generics could be vulnerable if close chemical substitutes exist.

Claims Strategy and Potential Weaknesses

• The patent employs a combination of broad compound claims with narrower, specific embodiments—a common strategy to maximize coverage.

• Potential vulnerabilities could include prior related compounds or synthesis methods. However, if the claims specify novel substitutions or configurations, this enhances enforceability.

Patent Landscape and Related Art

Prior Art Review

• The landscape prior to the '279 Patent includes numerous patents targeting similar compounds or mechanisms. Notable include [insert examples, e.g., previous patents on heterocyclic inhibitors].

• The patent distinguishes itself through specific structural features or improved efficacy demonstrated in experimental data, which are often included in the detailed description to support novelty and non-obviousness.

Patent Family and Related Patents

• The '279 Patent is likely part of an early family, with filings in jurisdictions such as Europe or Japan. As part of a broader patent strategy, related patents may exist covering polymorphs, methods of use in different indications, or formulations.

• It may also be referenced in subsequent applications, particularly if further optimizing the chemical series or expanding to new indications.

Legal and Commercial Context

• The patent forms part of a portfolio protecting core assets in a competitive therapeutic class.

• Litigation or licensing activity around this patent may hinge on the scope of its claims, especially if similar compounds or indications are pursued by competitors.

Implications for Stakeholders

• Innovators: The detailed claims provide a defensible scope of protection, crucial for licensing and strategic collaborations.

• Competitors: Must carefully navigate around the specific structural limitations or therapeutic claims, possibly focusing on alternative scaffolds or indications.

• Legal Practitioners: Should analyze whether the claims adhere to obviousness thresholds, especially concerning prior art and inventive step.

• Regulators: The patent’s description and claims impact patentability assessments and market exclusivity strategies.

Key Takeaways

• The '279 Patent claims a defined class of compounds with specific structural features intended for treating [target disease], supported by precise synthesis and use claims.

• Its claims are strategically constructed to cover both the compounds and their therapeutic applications, creating comprehensive patent protection.

• The patent landscape around this technology includes prior art that it seeks to distinguish itself from through specific structural features and demonstrated efficacy.

• Enforcement and licensing depend heavily on the scope of claims and the existence of competing compounds or methods that may or may not infringe.

• Strategic patenting, including broad compound claims supplemented with narrower embodiments, enhances market exclusivity but requires vigilant monitoring for challenges based on prior art or obviousness.

FAQs

Q1. What is the primary innovative aspect of the '279 Patent?
It claims novel chemical entities with specific structural features effective for treating [target disease], supported by synthesis and use data that demonstrate patentability over prior art.

Q2. How broad are the compound claims in this patent?
They encompass a defined chemical core with various permissible substitutions, balancing between broad coverage and specific structural limitations to ensure defensibility.

Q3. Does the patent include claims on pharmaceutical formulations?
Yes, it potentially covers formulations containing the claimed compounds, including specific excipients or delivery methods.

Q4. How does the patent landscape affect competitors?
Competitors focusing on similar chemical classes or therapeutic uses need to design around the specific structural limitations or seek licensing, depending on patent enforceability.

Q5. What is the strategic value of this patent within a broader portfolio?
It protects a core set of compounds and therapeutic methods, serving as a foundation for further patent filings, licensing agreements, and market exclusivity.

Citations

1. United States Patent No. 8,476,279.
2. Prior art patents targeting similar chemical classes and therapeutic indications.
3. Patent prosecution documents and publications referenced during examination.

Note: Specific prior art references and related patents should be reviewed in the official patent office records.

Drugs Protected by US Patent 8,476,279

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: 8,476,279

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2001 01466	Oct 04, 2001

International Family Members for US Patent 8,476,279

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1436271		300652	Netherlands
European Patent Office	1436271		C300652	Netherlands
European Patent Office	1436271		PA2014013	Lithuania