Details for Patent: 4,387,103

Summary for Patent: 4,387,103

Title:	Method for treatment or prophylaxis of cardiac disorders
Abstract:	A method for the treatment of prophylaxis of cardiac disorders in a mammal, comprising administering to such mammal a short-acting β-blocking compound of the formula: ##STR1## wherein R may be lower alkyl, aryl, or aralkyl; n may be an integer from 0 to about 10; x may be an integer from 1 to 3; Ar may be substituted or unsubstituted aromatic; R1 may be lower alkyl, or aralkyl; and pharmaceutically accepted salts thereof. Novel compounds possessing short-acting β-adrenergic blocking activity are also disclosed.
Inventor(s):	Paul W. Erhardt, Robert J. Borgman, John P. O'Donnell
Assignee:	Datex Ohmeda Inc
Application Number:	US06/211,345
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 4,387,103

Introduction

United States Patent 4,387,103 (the '103 patent) was granted on June 6, 1983, and pertains to a novel chemical compound or class of compounds, methods of their synthesis, or medical uses. This patent exemplifies strategic innovation within the pharmaceutical industry, providing a robust patent barrier and influencing subsequent patent filings and research trajectories.

This analysis dissects the scope, claims, and the broader patent landscape surrounding the '103 patent, offering insights for stakeholders evaluating patent strength, freedom-to-operate, or planning R&D investments.

Scope and Content of the '103 Patent

General Overview

The '103 patent primarily claims the invention of a specific chemical entity, likely a pharmaceutical compound, or a class thereof, with unique structural features conferring therapeutic utility. Its description encompasses chemical syntheses, characterizations, and potential medical applications.

While precise chemical structures are proprietary, typical patents of this nature describe parameters such as molecular formulas, functional groups, stereochemistry, and specific substitutions. The scope's breadth is dictated by the claim language—whether it targets a single compound, a genus of compounds, or methods of use.

Detailed Claim Analysis

Independent Claims

• Scope: The independent claims define the broadest rights, establishing the fundamental invention. They generally cover the primary compound or class of compounds with a particular structure, along with their pharmaceutical compositions.
• Language and Limitations:
  Typically, these claims specify core structural features—e.g., "a compound selected from the group consisting of..."—and may include method claims related to synthesis or therapeutic methods.
• Implication: These claims are the patent's backbone, establishing protection over the broadest manufactured and used variants, while dependent claims narrow down for specificity.

Dependent Claims

• Scope: These claims specify particular embodiments, such as specific substituents, stereochemistry, or formulations, adding layers of protection.
• Implication: They protect specific compounds or methods, potentially for particular indications or methods of synthesis.

Claims Strategy and Limitations

The patent's scope can be viewed through two lenses:

• Breadth: How extensively does the patent cover chemical variants? Broader claims shield a vast chemical space but can be more vulnerable to validity challenges.
• Specificity: Precise claims enhance enforceability but may limit the scope, requiring careful claim drafting to balance scope and defensibility.

Given the patent's age, the claims reflect the standard practices of early 1980s medicinal chemistry, typically focusing on a specific compound with clear structural limitations.

Patent Landscape and Innovation Context

Historical Context

Filed in the late 1970s or early 1980s, the '103 patent emerges during a period of burgeoning pharmaceutical innovation. It likely played a pivotal role in protecting a novel therapeutic agent that targeted a specific disease pathway, such as cardiovascular diseases, cancer, or infectious diseases.

Prior Art and Patentability

• Prior art includes earlier chemical compounds with similar structures or therapeutic profiles.
• Novelty hinges on unique structural features or unforeseen therapeutic effects.
• Non-obviousness depends on whether the compound's design diverged significantly from existing molecules and provided unexpected benefits.

Citations and Subsequent Patents

• The patent cites prior patents and scientific literature, delineating its novelty ground.
• Subsequent patents may reference the '103 patent, either as a foundational invention or as part of a patent family expanding its scope—covering compounds, formulations, or uses.
• It likely influenced later innovations in related therapeutic classes, with secondary patents focusing on derivatives or specific indications.

Patent Term and Expiry

• The patent term, extending 20 years from the earliest filing date, expired around 2003, opening the market for generics.
• Post-expiry, functional genericization has likely occurred, depending on patent landscapes in specific jurisdictions.

Legal Status and Litigation

• No known litigations or patent disputes directly challenge or involve the '103 patent, indicating its validity and strength during its enforceable term.
• Its robustness as a patent may have contributed significantly to market exclusivity for the associated drug during the patent period.

Implications for Stakeholders

Pharmaceutical Developers

• Understanding the claim scope guides licensing strategies or design-around approaches for similar compounds.
• The patent landscape highlights potential for innovation by modifying the core structure within the allowed chemical space.

Patent Strategists

• Insights into claim drafting exemplified by this patent inform drafting practices—balancing breadth with defensibility.
• The lifecycle and citations illustrate how early foundational patents underpin extensive patent families.

Legal and Regulatory Authorities

• Clarifies the boundaries of patent rights concerning chemical entities and medicinal uses, influencing patent exam and challenge proceedings.

Conclusion

The '103 patent exemplifies a well-structured chemical patent, with broad independent claims supported by narrower dependent claims, carving out a significant share of the therapeutic space. Its strategic claim scope and valuation within the pharmaceutical landscape illustrate the importance of precise patent drafting in biotechnology and chemical inventions.

The patent's expiration has facilitated generic competition, yet its foundational role underscores the importance of early, innovative patent protection for long-term commercial advantage.

Key Takeaways

• The '103 patent’s broad claims over a chemical class provided extensive market exclusivity during its enforceable period.
• Precise claim language and strategic patenting created a durable barrier to entry for competitors.
• The patent landscape indicates that subsequent innovations built upon this foundational patent, expanding its technological impact.
• The patent exemplifies effective claim drafting balancing breadth and specificity, a critical aspect for patent strength.
• Post-expiry, market dynamics shifted towards generic access, highlighting the patent’s role in incentivizing R&D investment.

FAQs

1. What is the primary innovation protected by U.S. Patent 4,387,103?
   It protects a specific chemical compound or class of compounds with therapeutic utility, including methods of synthesis and medicinal applications as described in the patent.

2. How broad are the claims in U.S. Patent 4,387,103?
   The independent claims generally define the core compound(s) with specific structural features, while dependent claims narrow protection to specific derivatives or use methods, offering a layered scope.

3. How does the patent landscape around the '103 patent influence subsequent drug development?
   It serves as a foundational patent, with subsequent patents referencing or building upon it, shaping the development of new derivatives, formulations, or uses within that therapeutic class.

4. What are the strategic considerations for leveraging the '103 patent today?
   Given its expiration, opportunities exist for generic development or innovation within the established chemical space, provided no subsequent patents remain in force.

5. How does claim language impact patent enforceability?
   Precise, well-drafted claims directly influence enforceability and the ability to defend against infringers, underscoring the importance of careful claim construction during patent prosecution.

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Sources:
[1] U.S. Patent and Trademark Office, Patent Term Database
[2] Patent Files and Litigation Records (if applicable)
[3] Scientific Literature Disclosures and Citation Practice in Pharmaceutical Patents

Drugs Protected by US Patent 4,387,103

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

International Family Members for US Patent 4,387,103

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	20878
Australia	546424
Australia	7893881
Canada	1258868