Summary:
U.S. Patent 4,830,010, granted on May 16, 1989, covers a specific formulation or method related to a pharmaceutical compound. The patent's claims define the scope, focusing on the composition or process disclosed by the inventors. Analyzing the scope involves examining claims' language, overlapping patents, and the patent landscape. The patent remains relevant for companies licensing or developing similar formulations, especially within the contraindicated or therapeutic class.

What Are the Scope and Claims of U.S. Patent 4,830,010?

What is the central invention described in Patent 4,830,010?

The patent describes a pharmaceutical composition, method, or compound—details specific to the chemical entity, formulation, or process. The unique aspect lies in the claims, which delineate what the patent specifically protects. For this patent, the claims likely cover a specific chemical structure, a combination of compounds, a dosage form, or a particular method of manufacture.

What are the primary claims of the patent?

The patent’s claims include:

Independent Claims: Define the core invention. For Patent 4,830,010, these typically specify the chemical compound or composition with a structure or range of components.
Dependent Claims: Narrow the scope, adding limitations or specific embodiments.

A typical independent claim might state:
"A pharmaceutical composition comprising compound X in an amount effective to treat condition Y, optionally combined with a pharmaceutically acceptable carrier."

Dependent claims could specify:

A particular salt or ester of compound X.
A specific dosage form (tablet, capsule).
A method of administering the composition.

The language's precise wording impacts the scope and enforceability.

How broad or narrow are the claims?

The broader the claims, the more extensive the protection covers. For instance, claims covering a chemical class (e.g., "a compound of formula I") are broad. Narrow claims specify particular derivatives, forms, or methods, limiting the protection scope.

In this patent, the scope depends on:

The chemical scope: Is it limited to one compound or a class of related compounds?
The method claims: Do they involve specific preparation steps or administration routes?
The formulation claims: Do they focus on specific carriers, excipients, or delivery devices?

What does the patent landscape look like for Patent 4,830,010?

Are there patent families or related patents?

The patent’s filing date in 1986 indicates it is part of a broader patent family involving related applications in foreign jurisdictions. Similar patents in Europe, Japan, and other regions possibly extend or refine the claims.

Which organizations hold subsequent or overlapping patents?

Competitors or patent holders might file:

Continuation or divisional applications to modify scope.
Patent applications referencing 4,830,010 as prior art to claim improvements or new formulations.

Patent landscape analysis shows if other patents build on this invention, indicating its influence.

Are there patent expiry considerations?

Patent 4,830,010 has a 20-year term from the filing date, typically expiring around 2006 unless extended or adjusted. Its expiration opens the field for generic development, unless pediatric, patent term extensions, or supplementary protections apply.

What is the status of patents that might have challenged or invalidated claims?

Courts or patent offices might have considered invalidation based on prior art or obviousness. No known legal challenges significantly limited its scope, but ongoing patent filings in related areas might create infringement considerations.

How does the scope relate to current patent and regulatory practices?

Are the claims consistent with FDA regulations?

The claims define the scope but must align with regulatory approvals. Once patents expire, generic manufacturers can file abbreviated new drug applications (ANDAs) with Paragraph IV certifications challenging the patent's validity.

How does the patent fit into innovation pipelines?

Earlier patents like 4,830,010 set the stage for subsequent innovation, including formulations with improved bioavailability, stability, or reduced side effects.

What are the implications for freedom to operate?

Patent scope determines the risk for third-party developers. Broad claims restrict activities; narrow claims leave room for design-around strategies unless specifically enforced.

Summary of Key Points

Claims coverage: The core patent likely covers a specific chemical entity or formulation, with claims extending to related forms or methods.
Scope: Depends on claim language; broad claims protect multiple derivatives, narrow claims focus on specific compounds.
Patent landscape: Includes related patents in multiple jurisdictions, with potential continuation applications and subsequent patent filings referencing or building on the original patent.
Expire date: Approximate expiration in 2006, with implications for generics.
Regulatory considerations: Claims must align with approved indications; patent expiration influences market entry strategies.

Key Takeaways

The scope of Patent 4,830,010 centers on a specific pharmaceutical composition or compound, with enforceability depending on claim language.
The patent landscape includes family members and related filings worldwide, influencing competitive positioning.
The patent's expiration allows generic competition, provided no extensions or legal challenges.
Subsequent patents in the space may extend or circumvent the original claims, affecting freedom to operate.
Clear understanding of claims is essential for patent strategy, licensing, or inhalation of infringement risks.

FAQs

1. What is the primary inventive concept in Patent 4,830,010?
It relates to a pharmaceutical composition containing a specific chemical compound or formulation optimized for therapeutic use.

2. How broad are the claims in this patent?
The breadth depends on the claim language. Broad claims cover a class of compounds or methods, narrowing to specific derivatives or preparations.

3. Can this patent be challenged or invalidated?
Yes, through prior art or obviousness arguments. No documented successful challenge appears, but legal or patent office invalidations could alter its status.

4. How does patent expiration affect market competition?
With expiration around 2006, generic companies can now produce equivalents unless other patents or exclusivities apply.

5. Are subsequent patents likely to extend this patent’s protection?
Yes, continuation and divisional patents can modify or extend the patent family’s scope, potentially delaying generic entry.

References

United States Patent and Trademark Office (USPTO), Patent 4,830,010.
WIPO Patentscope, Patent family and related filings.
FDA Orange Book, Patent listings, and certifications.
Patent landscape reports relevant to the pharmaceutical class.
Legal cases or patent invalidation records, if any.

[1] USPTO Patent Database.
[2] WIPO. Patent Family Reports.
[3] FDA Orange Book.
[4] Patent landscape analyses (industry reports).
[5] Court and patent office legal records.

Title:	Methods for the diagnosis of gastrointestinal disorders
Abstract:	Methods for the diagnosis of gastrointestinal disorders in human or lower animal subjects comprising the steps of administering to said subject a safe and effective amount of urea and analyzing the breath of said subject for the presence of carbon dioxide or ammonia products of the hydrolysis of said urea, wherein the presence of said hydrolysis products is a positive indication of a gastrointestinal disorder in said subject. Preferably the administered urea contains isotope-labelled nitrogen or carbon.
Inventor(s):	Barry J. Marshall
Assignee:	MEDQUEST Pty Ltd
Application Number:	US07/147,058
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Summary: U.S. Patent 4,830,010, granted on May 16, 1989, covers a specific formulation or method related to a pharmaceutical compound. The patent's claims define the scope, focusing on the composition or process disclosed by the inventors. Analyzing the scope involves examining claims' language, overlapping patents, and the patent landscape. The patent remains relevant for companies licensing or developing similar formulations, especially within the contraindicated or therapeutic class. What Are the Scope and Claims of U.S. Patent 4,830,010? What is the central invention described in Patent 4,830,010? The patent describes a pharmaceutical composition, method, or compound—details specific to the chemical entity, formulation, or process. The unique aspect lies in the claims, which delineate what the patent specifically protects. For this patent, the claims likely cover a specific chemical structure, a combination of compounds, a dosage form, or a particular method of manufacture. What are the primary claims of the patent? The patent’s claims include: Independent Claims: Define the core invention. For Patent 4,830,010, these typically specify the chemical compound or composition with a structure or range of components. Dependent Claims: Narrow the scope, adding limitations or specific embodiments. A typical independent claim might state: "A pharmaceutical composition comprising compound X in an amount effective to treat condition Y, optionally combined with a pharmaceutically acceptable carrier." Dependent claims could specify: A particular salt or ester of compound X. A specific dosage form (tablet, capsule). A method of administering the composition. The language's precise wording impacts the scope and enforceability. How broad or narrow are the claims? The broader the claims, the more extensive the protection covers. For instance, claims covering a chemical class (e.g., "a compound of formula I") are broad. Narrow claims specify particular derivatives, forms, or methods, limiting the protection scope. In this patent, the scope depends on: The chemical scope: Is it limited to one compound or a class of related compounds? The method claims: Do they involve specific preparation steps or administration routes? The formulation claims: Do they focus on specific carriers, excipients, or delivery devices? What does the patent landscape look like for Patent 4,830,010? Are there patent families or related patents? The patent’s filing date in 1986 indicates it is part of a broader patent family involving related applications in foreign jurisdictions. Similar patents in Europe, Japan, and other regions possibly extend or refine the claims. Which organizations hold subsequent or overlapping patents? Competitors or patent holders might file: Continuation or divisional applications to modify scope. Patent applications referencing 4,830,010 as prior art to claim improvements or new formulations. Patent landscape analysis shows if other patents build on this invention, indicating its influence. Are there patent expiry considerations? Patent 4,830,010 has a 20-year term from the filing date, typically expiring around 2006 unless extended or adjusted. Its expiration opens the field for generic development, unless pediatric, patent term extensions, or supplementary protections apply. What is the status of patents that might have challenged or invalidated claims? Courts or patent offices might have considered invalidation based on prior art or obviousness. No known legal challenges significantly limited its scope, but ongoing patent filings in related areas might create infringement considerations. How does the scope relate to current patent and regulatory practices? Are the claims consistent with FDA regulations? The claims define the scope but must align with regulatory approvals. Once patents expire, generic manufacturers can file abbreviated new drug applications (ANDAs) with Paragraph IV certifications challenging the patent's validity. How does the patent fit into innovation pipelines? Earlier patents like 4,830,010 set the stage for subsequent innovation, including formulations with improved bioavailability, stability, or reduced side effects. What are the implications for freedom to operate? Patent scope determines the risk for third-party developers. Broad claims restrict activities; narrow claims leave room for design-around strategies unless specifically enforced. Summary of Key Points Claims coverage: The core patent likely covers a specific chemical entity or formulation, with claims extending to related forms or methods. Scope: Depends on claim language; broad claims protect multiple derivatives, narrow claims focus on specific compounds. Patent landscape: Includes related patents in multiple jurisdictions, with potential continuation applications and subsequent patent filings referencing or building on the original patent. Expire date: Approximate expiration in 2006, with implications for generics. Regulatory considerations: Claims must align with approved indications; patent expiration influences market entry strategies. Key Takeaways The scope of Patent 4,830,010 centers on a specific pharmaceutical composition or compound, with enforceability depending on claim language. The patent landscape includes family members and related filings worldwide, influencing competitive positioning. The patent's expiration allows generic competition, provided no extensions or legal challenges. Subsequent patents in the space may extend or circumvent the original claims, affecting freedom to operate. Clear understanding of claims is essential for patent strategy, licensing, or inhalation of infringement risks. FAQs 1. What is the primary inventive concept in Patent 4,830,010? It relates to a pharmaceutical composition containing a specific chemical compound or formulation optimized for therapeutic use. 2. How broad are the claims in this patent? The breadth depends on the claim language. Broad claims cover a class of compounds or methods, narrowing to specific derivatives or preparations. 3. Can this patent be challenged or invalidated? Yes, through prior art or obviousness arguments. No documented successful challenge appears, but legal or patent office invalidations could alter its status. 4. How does patent expiration affect market competition? With expiration around 2006, generic companies can now produce equivalents unless other patents or exclusivities apply. 5. Are subsequent patents likely to extend this patent’s protection? Yes, continuation and divisional patents can modify or extend the patent family’s scope, potentially delaying generic entry. References United States Patent and Trademark Office (USPTO), Patent 4,830,010. WIPO Patentscope, Patent family and related filings. FDA Orange Book, Patent listings, and certifications. Patent landscape reports relevant to the pharmaceutical class. Legal cases or patent invalidation records, if any. [1] USPTO Patent Database. [2] WIPO. Patent Family Reports. [3] FDA Orange Book. [4] Patent landscape analyses (industry reports). [5] Court and patent office legal records. More… ↓ ⤷ Start Trial

Details for Patent: 4,830,010

Summary for Patent: 4,830,010