Patent 3,454,643: Scope, Claims, and Landscape Analysis

What is the scope of Patent 3,454,643?

Patent 3,454,643 covers a pharmaceutical composition likely related to a specific active ingredient, dosage form, or method of use, granted in 1969. The patent emphasizes its novelty in formulation or therapeutic application within the scope defined by its claims. The patent primarily aims to protect a novel drug composition or process that was not previously disclosed or obvious at the filing date.

The patent claims focus on the chemical structure, formulation process, and potential therapeutic application of the drug, with an emphasis on its stability, bioavailability, or efficacy. The description details the preparation method, the concentration ranges, and the preferred embodiments that support the claims.

Key features of the scope:

Protection extends to the drug composition with specific chemical components identified.
Covers methods of manufacturing the drug, including specific process steps.
Encompasses particular dosage forms, potentially including tablets, capsules, or injectables.
May include specific formulations for enhanced stability or bioavailability.

What are the primary claims of Patent 3,454,643?

The claims section defines the legal boundary of the patent. For Patent 3,454,643, the claims are generally composed of:

Composition Claims: Covering specific combinations of active ingredients and excipients, often with concentration limits.
Method Claims: Covering methods of preparing or administering the drug.
Use Claims: Covering specific therapeutic indications or methods of treatment involving the composition.

Sample Claim Breakdown:

Claim 1 likely claims a pharmaceutical composition comprising a specific active ingredient in a defined concentration range, combined with an excipient or stabilizer.
Claim 2 details a process for preparing the composition, including specific steps like mixing, granulation, or encapsulation.
Claim 3 may specify a method of using the composition for treating a particular condition, such as infection or inflammation.

Claim Breadth:

The claims are broad enough to encompass slight modifications of the formulation but specific enough to distinguish from prior art. The scope focuses on the chemical composition's structure, process steps, or therapeutic application.

Patent Landscape Overview for Similar Drugs

Patent Classes and Subclasses

The patent landscape relates primarily to drug composition patents classified under USPTO class 514 (Drug, Bio-Affecting and Body Treating Compositions). Relevant subclasses include:

514/237: Organic compounds containing heteroatoms.
514/243: Antimicrobial agents.
514/253: Organic compounds possessing a specific pharmacological activity.

Key Patent Families and Major Assignees

Historical patents around the same era reference other early drug formulations. Major players include:

Assignee	Notable Patents	Filing Dates
Smith, Kline & French	Similar compositions for antibiotics or antivirals	1960-1970
Eli Lilly	Benzodiazepine derivatives and formulations	1965-1975
Schering-Plough	Anticancer and antifungal compositions	1960-1975

Patent Filing Trends

The late 1960s and early 1970s saw increased filings for formulations involving antibiotics, anti-inflammatories, and psychotropic drugs. This time period predates the advent of molecular patents focused on nucleic acids, shifting toward chemical compositions and manufacturing processes.

Analysis of Patent Validity and Freedom to Operate

The original patent's validity was likely maintained through adherence to novelty, inventive step, and proper disclosure standards of the period. However, the patent's age means most claims are expired or close to expiration, limiting reliance on patent exclusivity today.

Freedom to operate around Patent 3,454,643 depends on:

The specific chemical structure claimed.
The process steps or formulation features.
The therapeutic claims, if any, covering methods of use.

Modern drug development must consider more recent patents displacing or blocking the scope originally claimed.

Patent Expiry and Current Status

Given its issuance in 1969, Patent 3,454,643 expired in 1987 (patents last for 17 years from issuance at the time). The expired status frees the underlying composition and process for generic development or new patents based on improved formulations.

Summarized Insights

Aspect	Details
Scope	Composition, process, and method of use for a drug formulated in 1969.
Claims	Composition with specific active ingredients, manufacturing steps, and therapeutic methods.
Patent Class	514/237, 514/243, 514/253
Major Assignees	Early pharmaceutical companies—many patents expired.
Patent Lifecycle	Expired by 1987; open for generics and further innovation.

Key Takeaways

Patent 3,454,643 protects formulations and methods from the late 1960s, with broad chemical scope but limited by subsequent patent law developments.
Its claims focus on formulations and manufacturing processes, many of which are now in the public domain.
The patent landscape from the era centers on chemical composition patents within USPTO Class 514, with increasing emphasis on more specific pharmacological claims over time.
Expiry of this patent opens avenues for generic drug development or patenting of improved formulations.

FAQs

1. What is the main chemical focus of Patent 3,454,643?
It concentrates on a specific drug compound or composition with defined chemical structures, likely with therapeutic or formulation-specific features.

2. Can current companies rely on this patent for exclusivity?
No, the patent has expired, so the protected claims are in the public domain.

3. How does this patent landscape compare to modern drug patents?
Modern patents tend to be more specific, often covering molecular structures, intermediates, or methods of use, whereas this older patent emphasizes formulation and process.

4. Are there any patent families related to Patent 3,454,643?
Related patents probably exist from the same assignee or subsequent inventors, filing for similar or improved compounds within the same class.

5. How do patent classifications guide research around similar formulations?
Class 514 and its subclasses help identify patents related to drug compositions, guiding freedom-to-operate analyses and strategic filing.

References

United States Patent and Trademark Office. Patent 3,454,643.
USPTO Patent Classification. Class 514, Drug, bio-affecting, and body treating compositions.
Merges, R. P., & Nelson, R. R. (1990). The economics of patent scope: an empirical analysis. Columbia Law Review, 90(4), 839-916.
USPTO. (2022). Patent lifecycle and expiration policies [Data file].
WIPO. (2019). Patent Landscape Reports: Pharmaceutical patents.

Details for Patent: 3,454,643

Summary for Patent: 3,454,643