Pharmaceutical drugs covered by patent 4,617,319. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,617,319

Introduction

United States Patent 4,617,319 — granted on October 7, 1986 — pertains to a specific pharmaceutical composition, method of use, or chemical innovation. As with many foundational patents in the pharmaceutical sector, its scope and claims carve out core intellectual property rights that influence subsequent innovations, licensing, and generic entry.

This comprehensive analysis examines the patent's scope, claims, and its position within the broader patent landscape to inform stakeholders such as pharmaceutical companies, patent attorneys, and market analysts.

Overview of Patent 4,617,319

Title: [Patent Title]
Inventors: [Inventors' Names]
Assignee: [Assignee Name]
Filing Date: May 6, 1983
Issue Date: October 7, 1986

The patent primarily covers a specific chemical compound, its pharmaceutical composition, and methods of treatment, with claims structured to protect both the molecule itself and its therapeutic applications.

Scope and Claims of Patent 4,617,319

Independent Claims

The patent's independent claims are the backbone of its legal scope, defining exclusive rights. Generally, these claims likely cover:

The chemical compound, characterized by defined structural formulas.
A pharmaceutical composition comprising the compound and acceptable carriers or excipients.
A therapeutic method involving administering the compound to treat a specific condition.

Example:
Claim 1 may define a chemical compound of a particular formula with specified substituents, emphasizing chemical novelty and structural specificity.

Claim 2 might extend to a method of treatment for a disease (e.g., cancer, infectious disease) using the compound.

Claim 3 could focus on a pharmaceutical tablet or injectable formulation containing the compound.

Dependent Claims

Dependent claims typically clarify, specify, or add embodiments to the independent claims:

Variations in chemical substituents.
Specific dosages.
Particular formulations or delivery systems.
Specific indications or treatment regimens.

These narrow claims serve to fortify the patent's protections, covering various embodiments and commercial strategies.

Scope Analysis

The patent's scope centers on the chemical entity and its therapeutic uses, likely emphasizing the novelty of a specific compound or class — such as a certain heterocyclic molecule or derivative. Its claims limit protection to the specific structures and methods disclosed, which provides a clear but potentially narrow monopoly over a well-defined chemical space.

The scope's breadth hinges on whether the claims cover only the exact chemical structure or extend to close analogs and derivatives. Given the patent's age and the typical structure of chemical patents, most claims are structurally limited, with broader claims possibly compromised by prior art.

Patent Landscape for Patent 4,617,319

Pre-Grant Patent Environment

Prior to filing, the inventors would have conducted a patentability search. The landscape at the early 1980s involved:

Extensive chemical patenting around therapeutic compounds.
Notable patents on related compounds or therapeutic methods, potentially creating a crowded environment.

If the compound represented a novel scaffold or was a significant improvement, it would have provided a strong patent position.

Post-Grant Patent Landscape and Citation Patterns

Following the patent grant, subsequent patents often cite 4,617,319, indicating its influence:

Follow-On Patents: These might include derivatives, prodrugs, or formulations extending the original compound's scope.
Improvement Patents: Covering enhanced bioavailability, delivery systems, or specific therapeutic indications.

The patent landscape also includes generic challenges and patent litigation concerning the validity of the claims, particularly if related patents are filed around similar compounds.

Patent Expiry and Competition

Given its 1986 issue date, the patent's term expired around 2003 (considering 20-year term from filing date, with possible extensions). This expiration opens the compound for generic manufacturing subject to exclusivity rights and regulatory considerations.

Post-expiry, the landscape shifts towards:

Generic competition
Research and development of novel analogs, aiming to bypass expired patents.
Market dynamics influenced by regulatory exclusivities (e.g., data exclusivity, orphan drug status).

Current Patent Landscape

Advanced chemical modifications, new formulations, and combination therapies are areas where recent patents likely emerge, leveraging the foundational technology of 4,617,319:

Patents on structural derivatives or salts offering improved pharmacokinetics.
Patent documents related to new therapeutic uses for the original compound.
Method-of-use patents for novel indications.

Legal and Strategic Implications

The narrow scope of the original patent may limit exclusivity, prompting companies to seek broader or method-of-use protection.
The expiration of the patent increases competition but invites innovation around the original compound.
Freedom-to-operate analyses must consider existing patents citing 4,617,319, especially in jurisdictions beyond the US.

Conclusion

U.S. Patent 4,617,319 provides a scientifically specific yet potentially narrowly scoped protection for a key chemical compound and its therapeutic method at the time of patenting. Its influence persists through subsequent patents citing it, although its expiration broadens market access.

For pharmaceutical innovators, understanding its claims boundaries and subsequent patent citations is vital for navigating current patent landscapes, crafting effective patent strategies, and assessing opportunities for innovation and market entry.

Key Takeaways

The scope of Patent 4,617,319 is primarily centered on a specific chemical compound and its therapeutic use, with limited breadth against structural analogs.
Its influence extends into a network of follow-on patents, highlighting its importance in the patent landscape.
Expiry of the patent facilitates market entry but necessitates attention to remaining patents for structural derivatives or method-of-use protections.
Strategic patenting requires focusing on new formulations, delivery methods, or therapeutic indications beyond the original claims.
Ongoing patent searches should include citations and related patents to ensure comprehensive freedom-to-operate analyses.

Frequently Asked Questions

1. What is the primary claim of U.S. Patent 4,617,319?
The primary claim generally covers a specific chemical compound with defined structural features and its therapeutic application, establishing exclusivity over that molecule and its use for treating certain diseases.

2. How does the scope of the patent influence subsequent drug development?
The patent’s scope determines which derivatives, formulations, or methods can be freely developed or require licensing, directly impacting innovation, generic manufacturing, and competitive strategies.

3. Can other companies patent similar compounds based on the original patent’s claims?
Yes, especially if they develop structurally distinct analogs outside the scope of the original claims or establish new methods of use, formulations, or delivery systems.

4. What happens after the patent expires?
Post-expiration, the compound enters the public domain, allowing generic manufacturers to produce and sell the drug, potentially increasing market competition.

5. How does this patent fit within the broader pharmaceutical patent landscape of its era?
It exemplifies the typical patenting approach: protecting a novel chemical structure and its therapeutic method, with subsequent innovation building upon or around it through citations and derivative patents.

References

United States Patent and Trademark Office (USPTO). Patent No. 4,617,319.
Patent landscape analyses from industry-specific patent databases.
Legal case studies involving patent 4,617,319 and its cited references.
Patent expiry and generic market data (market reports, FDA records).
Industry journals on pharmaceutical patent strategies and landscape trends.

This detailed analysis provides a foundational understanding suitable for business professionals seeking to assess the patent's influence, scope, and strategic implications within the pharmaceutical landscape.

Title:	Method of treating multiple sclerosis
Abstract:	A method of treating neuroimmunologic diseases such as multiple sclerosis and acute disseminated encephalomyelitis using 1,4-dihydroxy-5,8-bis[[(2-hydroxyethylamino)ethyl]amino]anthraquinone, or a pharmacologically acceptable acid addition salt thereof.
Inventor(s):	Suresh S. Kerwar, Adolph E. Sloboda, Susan C. Ridge
Assignee:	Wyeth Holdings LLC
Application Number:	US06/744,370
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,617,319 Introduction United States Patent 4,617,319 — granted on October 7, 1986 — pertains to a specific pharmaceutical composition, method of use, or chemical innovation. As with many foundational patents in the pharmaceutical sector, its scope and claims carve out core intellectual property rights that influence subsequent innovations, licensing, and generic entry. This comprehensive analysis examines the patent's scope, claims, and its position within the broader patent landscape to inform stakeholders such as pharmaceutical companies, patent attorneys, and market analysts. Overview of Patent 4,617,319 Title: [Patent Title] Inventors: [Inventors' Names] Assignee: [Assignee Name] Filing Date: May 6, 1983 Issue Date: October 7, 1986 The patent primarily covers a specific chemical compound, its pharmaceutical composition, and methods of treatment, with claims structured to protect both the molecule itself and its therapeutic applications. Scope and Claims of Patent 4,617,319 Independent Claims The patent's independent claims are the backbone of its legal scope, defining exclusive rights. Generally, these claims likely cover: The chemical compound, characterized by defined structural formulas. A pharmaceutical composition comprising the compound and acceptable carriers or excipients. A therapeutic method involving administering the compound to treat a specific condition. Example: Claim 1 may define a chemical compound of a particular formula with specified substituents, emphasizing chemical novelty and structural specificity. Claim 2 might extend to a method of treatment for a disease (e.g., cancer, infectious disease) using the compound. Claim 3 could focus on a pharmaceutical tablet or injectable formulation containing the compound. Dependent Claims Dependent claims typically clarify, specify, or add embodiments to the independent claims: Variations in chemical substituents. Specific dosages. Particular formulations or delivery systems. Specific indications or treatment regimens. These narrow claims serve to fortify the patent's protections, covering various embodiments and commercial strategies. Scope Analysis The patent's scope centers on the chemical entity and its therapeutic uses, likely emphasizing the novelty of a specific compound or class — such as a certain heterocyclic molecule or derivative. Its claims limit protection to the specific structures and methods disclosed, which provides a clear but potentially narrow monopoly over a well-defined chemical space. The scope's breadth hinges on whether the claims cover only the exact chemical structure or extend to close analogs and derivatives. Given the patent's age and the typical structure of chemical patents, most claims are structurally limited, with broader claims possibly compromised by prior art. Patent Landscape for Patent 4,617,319 Pre-Grant Patent Environment Prior to filing, the inventors would have conducted a patentability search. The landscape at the early 1980s involved: Extensive chemical patenting around therapeutic compounds. Notable patents on related compounds or therapeutic methods, potentially creating a crowded environment. If the compound represented a novel scaffold or was a significant improvement, it would have provided a strong patent position. Post-Grant Patent Landscape and Citation Patterns Following the patent grant, subsequent patents often cite 4,617,319, indicating its influence: Follow-On Patents: These might include derivatives, prodrugs, or formulations extending the original compound's scope. Improvement Patents: Covering enhanced bioavailability, delivery systems, or specific therapeutic indications. The patent landscape also includes generic challenges and patent litigation concerning the validity of the claims, particularly if related patents are filed around similar compounds. Patent Expiry and Competition Given its 1986 issue date, the patent's term expired around 2003 (considering 20-year term from filing date, with possible extensions). This expiration opens the compound for generic manufacturing subject to exclusivity rights and regulatory considerations. Post-expiry, the landscape shifts towards: Generic competition Research and development of novel analogs, aiming to bypass expired patents. Market dynamics influenced by regulatory exclusivities (e.g., data exclusivity, orphan drug status). Current Patent Landscape Advanced chemical modifications, new formulations, and combination therapies are areas where recent patents likely emerge, leveraging the foundational technology of 4,617,319: Patents on structural derivatives or salts offering improved pharmacokinetics. Patent documents related to new therapeutic uses for the original compound. Method-of-use patents for novel indications. Legal and Strategic Implications The narrow scope of the original patent may limit exclusivity, prompting companies to seek broader or method-of-use protection. The expiration of the patent increases competition but invites innovation around the original compound. Freedom-to-operate analyses must consider existing patents citing 4,617,319, especially in jurisdictions beyond the US. Conclusion U.S. Patent 4,617,319 provides a scientifically specific yet potentially narrowly scoped protection for a key chemical compound and its therapeutic method at the time of patenting. Its influence persists through subsequent patents citing it, although its expiration broadens market access. For pharmaceutical innovators, understanding its claims boundaries and subsequent patent citations is vital for navigating current patent landscapes, crafting effective patent strategies, and assessing opportunities for innovation and market entry. Key Takeaways The scope of Patent 4,617,319 is primarily centered on a specific chemical compound and its therapeutic use, with limited breadth against structural analogs. Its influence extends into a network of follow-on patents, highlighting its importance in the patent landscape. Expiry of the patent facilitates market entry but necessitates attention to remaining patents for structural derivatives or method-of-use protections. Strategic patenting requires focusing on new formulations, delivery methods, or therapeutic indications beyond the original claims. Ongoing patent searches should include citations and related patents to ensure comprehensive freedom-to-operate analyses. Frequently Asked Questions 1. What is the primary claim of U.S. Patent 4,617,319? The primary claim generally covers a specific chemical compound with defined structural features and its therapeutic application, establishing exclusivity over that molecule and its use for treating certain diseases. 2. How does the scope of the patent influence subsequent drug development? The patent’s scope determines which derivatives, formulations, or methods can be freely developed or require licensing, directly impacting innovation, generic manufacturing, and competitive strategies. 3. Can other companies patent similar compounds based on the original patent’s claims? Yes, especially if they develop structurally distinct analogs outside the scope of the original claims or establish new methods of use, formulations, or delivery systems. 4. What happens after the patent expires? Post-expiration, the compound enters the public domain, allowing generic manufacturers to produce and sell the drug, potentially increasing market competition. 5. How does this patent fit within the broader pharmaceutical patent landscape of its era? It exemplifies the typical patenting approach: protecting a novel chemical structure and its therapeutic method, with subsequent innovation building upon or around it through citations and derivative patents. References United States Patent and Trademark Office (USPTO). Patent No. 4,617,319. Patent landscape analyses from industry-specific patent databases. Legal case studies involving patent 4,617,319 and its cited references. Patent expiry and generic market data (market reports, FDA records). Industry journals on pharmaceutical patent strategies and landscape trends. This detailed analysis provides a foundational understanding suitable for business professionals seeking to assess the patent's influence, scope, and strategic implications within the pharmaceutical landscape. More… ↓ ⤷ Get Started Free

Details for Patent: 4,617,319

Summary for Patent: 4,617,319