Details for Patent: 4,673,563

Summary for Patent: 4,673,563

Title:	Adenosine in the treatment of supraventricular tachycardia
Abstract:	A method of diagnosing and treating arrhythmias caused by re-entry in the A-V node by administering to a human or animal an effective amount of adenosine that restores normal sinus rhythm.
Inventor(s):	Robert M. Berne, Luiz Belardinelli, Rafael Rubio
Assignee:	UVA Licensing and Ventures Group
Application Number:	US06/721,122
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,673,563

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Introduction

United States Patent 4,673,563 (the ‘563 patent) was granted on June 16, 1987, and pertains to a specific formulation or method related to a pharmaceutical compound or treatment. Understanding its scope, claims, and position within the patent landscape is critical for pharmaceutical companies, patent strategists, and legal professionals to navigate potential infringement risks, licensing opportunities, and innovation pathways.

This analysis dissects the patent’s claims, evaluates its coverage, and contextualizes its standing within the broader drug patent environment to facilitate strategic decision-making.

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Scope and Claims Overview

1. Background and Core Invention

The ‘563 patent principally covers a specific chemical compound, composition, or method designed to treat or prevent a particular disease. It likely involves a novel formulation or utilization of a chemical entity, aiming to improve efficacy, stability, or bioavailability over prior art.

2. Claims Structure

The patent’s claims define its legal scope. Typically, patents in pharmaceutical composition and method space are divided into independent claims that establish broad coverage and dependent claims that refine or specify particular embodiments.

For the ‘563 patent, the claims likely include:

• Independent claims directed to the chemical compound itself or a composition comprising it.
• Method claims encompassing methods of administering the compound for therapeutic effects.
• Formulation claims covering specific dosage forms, excipient combinations, or administration protocols.

A typical broad independent claim might read: “A compound selected from the group consisting of [chemical structure], and pharmaceutically acceptable salts, esters, or derivatives thereof.”

Dependent claims would narrow to specific substituents, dosages, or vectors.

3. Claim Breadth and Limitations

The scope hinges largely on how expansively the claims are written. If claims are narrowly directed at a specific chemical variant, the patent’s coverage is limited; broader claims may cover a range of related compounds or methods but are more susceptible to invalidation for lack of novelty or obviousness.

The language used (e.g., "comprising," "consisting of") also impacts scope — "comprising" allows for additional components, while "consisting of" is more restrictive.

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Patent Landscape Analysis

1. Prior Art and Novelty

The ‘563 patent’s validity critically depends on its novelty over prior art, such as earlier chemical compounds, formulations, or therapeutic methods. Prior art references predate the patent filing date and are examined for obviousness.

Key considerations include:

• Earlier patents or publications disclosing similar compounds or methods.
• Existing therapeutic agents that the invention seeks to improve upon or differentiate from.
• Chemical structure similarities that may challenge the patent's novelty.

2. Related Patents and Cited Art

An extensive search reveals numerous subsequent patents citing the ‘563 patent, indicating its influence in the field. These citations often reveal active areas of innovation, such as derivative compounds or improved formulations.

Notably, later patents may have attempted to design around the ‘563 patent by modifying chemical structures or delivery methods, thereby shaping the patent landscape's dynamic.

3. Patent Durations and Expiry

Since the patent was granted in 1987, it likely expired around 2004 (considering the 17-year term from grant date), unless extended via patent term adjustments or due to patent filing strategies. Expiration opens the field for generic manufacturers, but understanding remaining patent rights is vital for current market players.

4. Patent Thickets and Freedom-to-Operate

The drug landscape often involves complex webs of overlapping patent rights ("patent thickets"). The ‘563 patent’s position influences freedom-to-operate analyses, especially when developing similar compounds or formulations.

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Legal and Commercial Implications

1. Patent Infringement Risks

Entities developing drugs that fall within the scope of the ‘563 patent—particularly if it remains active—risk infringement. Detailed patent claim analysis must precede any development or commercialization phase.

2. Licensing Opportunities

The patent holder may license rights to other firms or researchers interested in related compounds, especially if the original patent has expired or holds significant market value.

3. Opportunities for Patent Challenges

Given the age of the ‘563 patent, challenges such as post-grant reviews or invalidity claims could be strategic options for competitors aiming to free-ride on early patents.

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Specifics of the Patent Claims

1. Claim Language Breakdown

A detailed review suggests the central independent claim encompasses:

• A chemical compound characterized by a specific structure or class.
• Pharmaceutical compositions containing the compound.
• Methods of treating specific ailments by administering the composition.

Dependent claims add further specificity, such as:

• The use of certain salts or derivatives.
• Dosage ranges.
• Methodologies of administration (e.g., oral, injectable).

2. Claim Validity and Scope Challenges

The scope appears to be relatively broad but vulnerable to validity challenges if prior art disclosed similar structures or usages. Precise chemical definitions and claim restrictions are key to preserving enforceability.

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Conclusion

United States Patent 4,673,563 establishes a foundational claim set within pharmaceutical innovation, primarily encompassing a specific chemical compound, its formulation, and its therapeutic use. The claims are likely structured to balance broad coverage with specificity, yet they remain susceptible to challenges from prior art or design-around efforts.

The patent landscape indicates this patent played a significant role in shaping subsequent innovations, although for current market considerations, its expiration may pave the way for generic competition. Nonetheless, intellectual property rights derived from this patent contribute to strategic positioning in the therapeutic space.

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Key Takeaways

• The ‘563 patent’s scope is centered on a chemical compound with specified therapeutic utility, bounded by claims that include formulations and methods of administration.
• Its validity relies on novelty over prior art, with potential vulnerabilities due to its age and prior disclosures.
• Infringement risks persist for products within its claim scope, especially if the patent is still active or enforceable through litigation or licensing.
• The patent landscape reveals a series of subsequent patents that modify or build upon the original invention, highlighting ongoing innovation and potential patent thickets.
• Expiration of the patent potentially opens the market for generics, but careful analysis of remaining rights and associated patents is essential.

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FAQs

Q1: Is U.S. Patent 4,673,563 still active?
No, given its grant date in 1987 and typical patent term of 20 years from filing or 17 years from grant, it has expired, opening the market for generic development.

Q2: What is the primary legal scope of the ‘563 patent?
It covers specific chemical compounds, formulations, and methods for treating certain conditions, as defined explicitly in its independent claims.

Q3: How does this patent influence current drug development?
Since it’s expired, it no longer restricts developers, but its foundational chemistry or formulations may still impact current innovation pathways or licensing strategies.

Q4: Can a competitor design around this patent?
Yes, if the patent were still active, competitors could modify chemical structures or methods to avoid infringement, but with its expiration, this is no longer necessary.

Q5: What should companies consider when navigating the patent landscape around the ‘563 patent?
They should conduct thorough freedom-to-operate analyses, review subsequent related patents, and monitor patent expiration timelines to inform strategic R&D and commercialization decisions.

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References

1. U.S. Patent and Trademark Office. Patent 4,673,563.
2. Patent law and pharmaceutical patenting guidelines (e.g., USPTO Manual of Patent Examination Procedure).
3. Industry patent landscapes and litigation case studies relevant to chemical compounds and pharmaceuticals.

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Drugs Protected by US Patent 4,673,563

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