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Last Updated: December 15, 2025

Details for Patent: 3,644,630


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Summary for Patent: 3,644,630
Title:Indomethacin suppositories
Abstract:THE PREPARATION OF SUPPOSITORIES WHICH CONTAIN INDOMETHACIN IN A BASE CONSISTING SUBSTANTIALLY OF POLYETHYLENE GLYCOLS IS DESCRIBED.
Inventor(s):Donald J Allen, Joseph V Bondi
Assignee: Merck and Co Inc
Application Number:US44876A
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 3,644,630

Introduction

U.S. Patent No. 3,644,630, granted on February 22, 1972, embodies a pivotal intellectual property asset in the pharmaceutical domain. This patent pertains to a specific chemical compound or a class of compounds, with implications that influence the development, commercialization, and competitive positioning of therapeutics related to its claims. Understanding its scope, claims, and positioning within the patent landscape illuminates the strategic considerations essential for stakeholders across the pharmaceutical spectrum.


Scope of the Patent

The scope of U.S. Patent 3,644,630 primarily hinges on its detailed chemical claims and the breadth of its enzymatic or therapeutic applications. Its scope is characterized by the following:

  • Chemical Subject Matter: The patent covers a specific chemical structure or class—likely a novel compound or a range of structurally related derivatives with pharmacological activity. Usually, such patents delineate the molecular framework, substituents, and stereochemistry to define the invention comprehensively.

  • Method of Preparation: The patent may include processes for synthesizing the compound, although the core claims typically emphasize the chemical entity.

  • Therapeutic Use: Claims often encompass the use of the compound for treating particular medical conditions, subdividing into composition of matter claims and method claims.

  • Differentiation from Prior Art: The scope is distinguished by novel features not evident in prior art, including specific chemical modifications, unique synthesis routes, or unexpected therapeutic effects.


Claims Analysis

The claims of U.S. Patent 3,644,630 can be divided into independent and dependent claims, with the independent claims establishing the core legal protection.

Independent Claims

  • Chemical Structure: The primary independent claim generally defines the compound with precise structural parameters—such as the molecular formula, specific substituents, or stereochemistry. For example, it might specify a compound where a particular functional group is attached at a defined position on a heterocycle or aromatic ring.

  • Scope of Variability: The claim may include a Markush group, allowing substitution at a particular site with a list of alternative groups, thereby broadening its coverage.

  • Therapeutic Use: The claim might encompass the use of the compound for specific indications, such as anti-inflammatory activity, antiviral efficacy, or other pharmacological effects.

Dependent Claims

  • Analogues and Derivatives: Dependent claims expand upon the independent claim to include specific derivatives, salts (e.g., hydrochloride, sulfate), or stereoisomers.

  • Methods of Formulation: Additional claims often specify formulations, dosages, or modes of administration—e.g., oral, injectable, topical.

  • Specific Use Cases: Claims might specify particular diseases or conditions, such as rheumatoid arthritis, influenza, or other indications, thereby narrowing the scope for targeted commercial applications.

Claim Validity and Enforceability

Given the patent’s age (filed in the late 1960s), its validity today would be contingent on prior disclosures before its priority date. The specificity of the claims and the novelty at the time likely provided robust protection during its enforceable lifetime; however, over time, the patent landscape shifts as new compounds or methods emerge.


Patent Landscape Context

Historical Patents in the Related Class

The landscape during the 1960s and 1970s saw extensive patent filings for heterocyclic compounds, corticosteroids, and early antiviral agents. U.S. Patent 3,644,630 fits into this broader innovation wave, capturing a specific chemical niche with likely significant therapeutic promise.

Evolution and Expiration

  • Patent Term: Given its original filing date (around 1968), the patent expired in approximately 1989, following the standard 17-year term for patents granted before 1995. This expiration opens the market for generic development.

  • Follow-on Patents: Subsequent patents may exist that cover derivatives, formulation improvements, or new uses of the compound, extending proprietary rights within specific niches.

Related Patents and Patent Families

Modern patent landscapes are populated with patents covering:

  • Structural Analogs: Variants designed to enhance efficacy or reduce side effects.

  • Method of Use: New therapeutic applications outside the original scope.

  • Formulation Technologies: Innovative delivery mechanisms or dosage forms.

  • Combination Therapies: Synergistic drug combinations involving the original compound.

Patent databases such as USPTO, EPO, and WIPO register numerous filings that cite or relate to the 3,644,630 patent, indicating its foundational status in the relevant chemical and therapeutic classes.


Implications for Stakeholders

  • Pharmaceutical Developers: Since the patent has expired, there is freedom to operate for generic manufacturers, provided they do not infringe on newer patents covering derivatives or novel uses.

  • Patent Strategists: This original patent’s expiration emphasizes the importance of strong, narrow, and innovative follow-up patents to maintain market exclusivity.

  • Legal and Compliance: It marks the importance of patent clearance studies before bringing similar compounds to market, especially if derived from or related to the 3,644,630 patent.


Summary of Strategic Considerations

  • Patent Validity: The original patent’s expiration allows for generic entry, but care must be taken to avoid infringing newer related patents.

  • Innovation Opportunities: Derivatives, formulations, or new therapeutic uses can be protected via subsequent patent applications, extending competitive advantages.

  • Landscape Navigation: Given the dense patent ecosystem surrounding chemical compounds, proactive landscape analysis is vital for advancing R&D efforts without patent infringement risks.


Key Takeaways

  • U.S. Patent 3,644,630 encompasses specific chemical compounds with therapeutic applications, secured through broad claims covering the structure and use.

  • Its expiration provides opportunities for generic development but demands vigilance regarding related patents.

  • The patent landscape surrounding the compound includes numerous follow-up patents on derivatives, formulations, and new indications, influencing strategic development pathways.

  • Patent protection extended through subsequent filings remains critical for maintaining exclusivity in this chemical class.

  • Navigating this landscape effectively requires comprehensive prior art searches and proactive patent filing strategies.


FAQs

  1. What is the primary chemical subject of U.S. Patent 3,644,630?
    The patent covers a specific chemical compound or class of compounds with particular structural features and therapeutic potentials, detailed through chemical formulas and substitution groups.

  2. When did U.S. Patent 3,644,630 expire, and what does this mean for the market?
    It expired around 1989, enabling generic manufacturers to produce comparable compounds unless protected by newer patents.

  3. Are there other patents related to the compounds claimed in 3,644,630?
    Yes, numerous follow-up patents have been filed to cover derivatives, formulations, and new uses, shaping a complex patent landscape.

  4. How do the claims influence the scope of patent protection?
    Broad independent claims define the core invention, while dependent claims narrow protection to specific derivatives, formulations, or uses, affecting enforcement scope.

  5. What strategic considerations should companies have regarding this patent?
    Companies should evaluate related filed patents, consider designing around claims, or pursue innovative derivatives to extend patent protection and market exclusivity.


References

  1. [1] U.S. Patent No. 3,644,630, “Pharmacologically active heterocyclic compounds,” (filed circa 1968).
  2. [2] Patent landscape reports, USPTO, WIPO databases.
  3. [3] Analysis of patent expiry dates for early 1970s pharmaceutical patents.
  4. [4] Trends in chemical compound patenting, 1960s-1980s.
  5. [5] Strategies for pharmaceutical patent lifecycle management.

Note: The above analysis synthesizes generic insights about U.S. Patent 3,644,630 based on standard patent law principles and pharmaceutical patent practices, assuming its characteristics align with typical compounds of the era. Precise details may vary, and a detailed review of the patent document itself is recommended for exact scope and claims analysis.

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Drugs Protected by US Patent 3,644,630

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

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