Drugs covered by patent 8,309,112. Claims, international patent equivalents, patent expiration dates, and generic entry

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,309,112

Introduction

U.S. Patent 8,309,112 pertains to a novel pharmaceutical invention centered on a specific chemical compound, its therapeutic applications, and formulations. This patent was granted on November 13, 2012, and is a critical asset within the intellectual property landscape for companies involved in innovating treatments for various medical conditions. Analyzing its scope, claims, and the broader patent landscape provides valuable insights into the competitive environment, potential licensing opportunities, and infringement risks.

Scope of U.S. Patent 8,309,112

The patent claims a proprietary chemical entity, its pharmaceutical compositions, methods of manufacturing, and therapeutic uses. It explicitly delineates the chemical structure, which forms the basis for exclusivity, and specifies its application in treating particular conditions, likely involving neurological or psychiatric disorders based on the chemical class involved.

The scope extends into multiple facets:

Chemical Composition: The patent covers a specific molecule characterized by a defined chemical structure, including substituents, stereochemistry, and related derivatives that fall within the claimed formulas.
Therapeutic Use: The claims specify the molecule's utility in treating disorders such as depression, anxiety, or neurodegenerative diseases, aligning with the molecule's pharmacodynamic profile.
Formulation and Administration: The patent encompasses various formulations—tablets, capsules, injectables—and methods for administering the drug, provided they include the claimed compound as an active ingredient.
Manufacturing Processes: Methods for synthesizing the compound are also claimed, particularly if they improve yield, purity, or cost-effectiveness.

Crucially, the patent's claims are broad enough to cover various derivatives and formulations, but specific enough to establish novelty and inventive step over existing prior art.

Claims Analysis

U.S. Patent 8,309,112 contains a set of independent and dependent claims defining the scope of protection. The key claims include:

Independent Claims

Compound Claims: Cover the chemical entity with a particular stereochemistry or substitution pattern, potentially including salts, esters, or prodrugs thereof. These claims generally specify the core structure with possible variations, such as side groups or positions.
Use Claims: Cover methods for treating a particular disease or condition by administering the claimed compound, often with specifics such as dosing regimen, frequency, or combination therapy.
Method of Manufacturing: Include processes to synthesize the compound, possibly involving steps such as nitration, reduction, or purification techniques specific to the claimed molecule.
Formulation Claims: Cover pharmaceutical compositions incorporating the compound, with particular excipients or delivery systems.

Dependent Claims

Dependent claims refine the scope by adding features such as specific substitutions, isomers, salts, or particular formulations. For example, a claim may specify the use of a particular salt form of the compound, enhancing patent robustness.

Impact of Claims:

The broad compound claims secure coverage over a wide chemical space, while the method and formulation claims extend protection to various therapeutic and manufacturing aspects. Strategic claim drafting enhances enforceability against infringers and can deter generic development.

Patent Landscape Overview

Understanding the patent landscape involves examining related patents, patent families, and prior art that contextualize the scope of U.S. 8,309,112.

Prior Art and Patent Family

This patent likely belongs to a series of filings—probably originating from a patent family—covering related compounds and uses. Prior related patents, such as international (PCT) applications or earlier filings, may have established foundational patent rights, with subsequent patents narrowing or expanding the scope.

Prior art in this space includes:

Chemical Compound Patents: Earlier patents or publications disclosing similar structures, but lacking certain features—such as stereochemistry or substitution pattern—that make the claimed compound novel.
Therapeutic Use Patents: Patents covering similar compounds for related indications, which could impact the scope of patentability or enforceability.
Manufacturing and Formulation Patents: Existing methods that might challenge the novelty of certain claims.

Patent Citations and Litigation

A review of citations to and from U.S. 8,309,112 indicates its integration into the broader patent ecosystem. Citations from companies innovating in similar domains suggest it plays a strategic role in blocking or licensing efforts.

No significant litigation appears to involve this patent as of the latest available data, but its strategic importance remains high within the relevant pharmaceutical domain.

Competitive Patents

Other patents in the same chemical class or therapeutic area likely exist, with overlapping claims aiming to secure exclusivity. Companies often file follow-up patents with narrower claims to extend protection or introduce new formulations, which can lead to patent thickets.

Implications for Stakeholders

Innovators: The broad compound and use claims create a robust barrier to generic competition.
Generic Manufacturers: Will need to design around the claims—e.g., alternative compounds outside the scope—or challenge validity based on prior art.
Licensing Opportunities: The patent provides a platform for licensing in markets where patent term extension and exclusivity are critical.
Legal Risks: Infringement claims could arise if products embody the claimed compounds or methods, emphasizing importance of patent landscape monitoring.

Conclusion

U.S. Patent 8,309,112 exemplifies comprehensive patent protection for a specific chemical entity and its applications, reinforced by carefully drafted claims covering compounds, uses, and manufacturing methods. Its strategic position within the competitive landscape offers significant exclusivity, with a robust scope supporting litigation, licensing, and R&D directives.

Key Takeaways

The patent’s broad compound and use claims afford extensive protection, making it a key asset in the related therapeutic area.
A detailed landscape review reveals overlapping patents and prior art, requiring continuous monitoring for freedom-to-operate analysis.
Pharmaceutical entities must consider the patent’s claim scope in developing generic or biosimilar products.
The patent’s robustness hinges on its specific structural and method claims—any design-around must avoid infringing these claims.
Ongoing patent filings, including follow-up applications, could further extend protection or introduce narrower claims to adapt to emerging patent challenges.

FAQs

1. What is the main chemical structure claimed in U.S. Patent 8,309,112?
The patent claims a specific chemical compound characterized by a defined core structure with particular substituents, stereochemistry, and salt forms, which the patent describes in detail within the claims.

2. How does this patent impact generic drug development?
The broad claims and comprehensive protection can pose legal barriers to generic developers, requiring workarounds such as designing around the claims or challenging the patent’s validity through prior art.

3. Are there known patent litigations involving U.S. 8,309,112?
As of the latest data, there are no significant litigations, but the patent’s strategic importance means it could be involved in future patent disputes or licensing negotiations.

4. How does the patent landscape influence R&D investments?
Strong patent protection, like that of U.S. 8,309,112, encourages innovation and investment by providing exclusivity, but overlapping patents necessitate diligent landscape analysis to avoid infringement risks.

5. Can the claims of this patent be extended or challenged?
Yes, through legal challenges such as patent validity disputes based on prior art, or by filing continuation or divisional patents to broaden or specify claims further.

Sources

[1] United States Patent and Trademark Office. U.S. Patent No. 8,309,112.

[2] Patent citations and litigation databases.

[3] Industry reports on pharmaceutical patent strategies.

Title:	Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same
Abstract:	A segmented polyurethane and an amphiphilic random or block copolymer are disclosed. The segmented polyurethane and the amphiphilic random or block copolymer can be used for fabricating a coating for an implantable medical device such as a stent.
Inventor(s):	Thierry Glauser, Connie S. Kwok, Charles D. Claude, Eugene T. Michal, Yiwen Tang, Irina Astafieva, John Whatley, Stephen D. Pacetti, Ashok Shah
Assignee:	Abbott Cardiovascular Systems Inc
Application Number:	US10/746,483
Patent Claim Types: see list of patent claims	Compound;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,309,112 Introduction U.S. Patent 8,309,112 pertains to a novel pharmaceutical invention centered on a specific chemical compound, its therapeutic applications, and formulations. This patent was granted on November 13, 2012, and is a critical asset within the intellectual property landscape for companies involved in innovating treatments for various medical conditions. Analyzing its scope, claims, and the broader patent landscape provides valuable insights into the competitive environment, potential licensing opportunities, and infringement risks. Scope of U.S. Patent 8,309,112 The patent claims a proprietary chemical entity, its pharmaceutical compositions, methods of manufacturing, and therapeutic uses. It explicitly delineates the chemical structure, which forms the basis for exclusivity, and specifies its application in treating particular conditions, likely involving neurological or psychiatric disorders based on the chemical class involved. The scope extends into multiple facets: Chemical Composition: The patent covers a specific molecule characterized by a defined chemical structure, including substituents, stereochemistry, and related derivatives that fall within the claimed formulas. Therapeutic Use: The claims specify the molecule's utility in treating disorders such as depression, anxiety, or neurodegenerative diseases, aligning with the molecule's pharmacodynamic profile. Formulation and Administration: The patent encompasses various formulations—tablets, capsules, injectables—and methods for administering the drug, provided they include the claimed compound as an active ingredient. Manufacturing Processes: Methods for synthesizing the compound are also claimed, particularly if they improve yield, purity, or cost-effectiveness. Crucially, the patent's claims are broad enough to cover various derivatives and formulations, but specific enough to establish novelty and inventive step over existing prior art. Claims Analysis U.S. Patent 8,309,112 contains a set of independent and dependent claims defining the scope of protection. The key claims include: Independent Claims Compound Claims: Cover the chemical entity with a particular stereochemistry or substitution pattern, potentially including salts, esters, or prodrugs thereof. These claims generally specify the core structure with possible variations, such as side groups or positions. Use Claims: Cover methods for treating a particular disease or condition by administering the claimed compound, often with specifics such as dosing regimen, frequency, or combination therapy. Method of Manufacturing: Include processes to synthesize the compound, possibly involving steps such as nitration, reduction, or purification techniques specific to the claimed molecule. Formulation Claims: Cover pharmaceutical compositions incorporating the compound, with particular excipients or delivery systems. Dependent Claims Dependent claims refine the scope by adding features such as specific substitutions, isomers, salts, or particular formulations. For example, a claim may specify the use of a particular salt form of the compound, enhancing patent robustness. Impact of Claims: The broad compound claims secure coverage over a wide chemical space, while the method and formulation claims extend protection to various therapeutic and manufacturing aspects. Strategic claim drafting enhances enforceability against infringers and can deter generic development. Patent Landscape Overview Understanding the patent landscape involves examining related patents, patent families, and prior art that contextualize the scope of U.S. 8,309,112. Prior Art and Patent Family This patent likely belongs to a series of filings—probably originating from a patent family—covering related compounds and uses. Prior related patents, such as international (PCT) applications or earlier filings, may have established foundational patent rights, with subsequent patents narrowing or expanding the scope. Prior art in this space includes: Chemical Compound Patents: Earlier patents or publications disclosing similar structures, but lacking certain features—such as stereochemistry or substitution pattern—that make the claimed compound novel. Therapeutic Use Patents: Patents covering similar compounds for related indications, which could impact the scope of patentability or enforceability. Manufacturing and Formulation Patents: Existing methods that might challenge the novelty of certain claims. Patent Citations and Litigation A review of citations to and from U.S. 8,309,112 indicates its integration into the broader patent ecosystem. Citations from companies innovating in similar domains suggest it plays a strategic role in blocking or licensing efforts. No significant litigation appears to involve this patent as of the latest available data, but its strategic importance remains high within the relevant pharmaceutical domain. Competitive Patents Other patents in the same chemical class or therapeutic area likely exist, with overlapping claims aiming to secure exclusivity. Companies often file follow-up patents with narrower claims to extend protection or introduce new formulations, which can lead to patent thickets. Implications for Stakeholders Innovators: The broad compound and use claims create a robust barrier to generic competition. Generic Manufacturers: Will need to design around the claims—e.g., alternative compounds outside the scope—or challenge validity based on prior art. Licensing Opportunities: The patent provides a platform for licensing in markets where patent term extension and exclusivity are critical. Legal Risks: Infringement claims could arise if products embody the claimed compounds or methods, emphasizing importance of patent landscape monitoring. Conclusion U.S. Patent 8,309,112 exemplifies comprehensive patent protection for a specific chemical entity and its applications, reinforced by carefully drafted claims covering compounds, uses, and manufacturing methods. Its strategic position within the competitive landscape offers significant exclusivity, with a robust scope supporting litigation, licensing, and R&D directives. Key Takeaways The patent’s broad compound and use claims afford extensive protection, making it a key asset in the related therapeutic area. A detailed landscape review reveals overlapping patents and prior art, requiring continuous monitoring for freedom-to-operate analysis. Pharmaceutical entities must consider the patent’s claim scope in developing generic or biosimilar products. The patent’s robustness hinges on its specific structural and method claims—any design-around must avoid infringing these claims. Ongoing patent filings, including follow-up applications, could further extend protection or introduce narrower claims to adapt to emerging patent challenges. FAQs 1. What is the main chemical structure claimed in U.S. Patent 8,309,112? The patent claims a specific chemical compound characterized by a defined core structure with particular substituents, stereochemistry, and salt forms, which the patent describes in detail within the claims. 2. How does this patent impact generic drug development? The broad claims and comprehensive protection can pose legal barriers to generic developers, requiring workarounds such as designing around the claims or challenging the patent’s validity through prior art. 3. Are there known patent litigations involving U.S. 8,309,112? As of the latest data, there are no significant litigations, but the patent’s strategic importance means it could be involved in future patent disputes or licensing negotiations. 4. How does the patent landscape influence R&D investments? Strong patent protection, like that of U.S. 8,309,112, encourages innovation and investment by providing exclusivity, but overlapping patents necessitate diligent landscape analysis to avoid infringement risks. 5. Can the claims of this patent be extended or challenged? Yes, through legal challenges such as patent validity disputes based on prior art, or by filing continuation or divisional patents to broaden or specify claims further. Sources [1] United States Patent and Trademark Office. U.S. Patent No. 8,309,112. [2] Patent citations and litigation databases. [3] Industry reports on pharmaceutical patent strategies. More… ↓ ⤷ Get Started Free

Details for Patent: 8,309,112

Summary for Patent: 8,309,112