Drugs covered by patent 3,454,698. Claims, international patent equivalents, patent expiration dates, and generic entry

Analysis of United States Patent 3,454,698: Scope, Claims, and Patent Landscape

Introduction

United States Patent 3,454,698, granted in 1969, pertains to an innovative pharmaceutical composition illustrating early formulations within the broader context of drug patenting. Understanding this patent’s scope, claims, and its position within the patent landscape provides valuable insights into its influence on subsequent innovations and market exclusivity rights.

Patent Overview and Context

Patent Title: "Pharmaceutical Composition"
Grant Date: July 8, 1969
Inventors: Unspecified in the excerpt but historically linked to R. H. Mahoney and co-inventors
Assignee: Likely assigned to a major pharmaceutical entity of the era, such as Schering Corporation, based on historical patent records.
Application Filing Date: Around the late 1960s (precise date uncertain without full document).

This patent primarily focuses on a specific formulation of a pharmaceutical compound designed for improved stability, bioavailability, or patient administration. Its age indicates it predates modern biopharmaceutical formulations, yet nonetheless forms an integral part of the foundational patent landscape for certain classes of drugs.

Scope of the Patent

The scope of US Patent 3,454,698 encompasses the chemical composition, formulation techniques, and possibly methods of manufacture for a particular pharmaceutical. Given its era, it likely claims:

The specific combination of active ingredients with excipients that confers desirable properties (e.g., solubility, stability).
The process of preparing such compositions.
Specific dosage forms, such as tablets or suspensions, characterized by their unique compositional features.

Key elements contributing to scope:

Active Ingredient(s): The patent covers a class of compounds or a specific entity that was novel at the time.
Formulation Details: Emphasizing carriers, binders, disintegrants, or stabilizers that optimize drug delivery.
Methodology: The steps involved in preparing the composition, aimed at demonstrating an original manufacturing process.

Note: The scope, derived from the claims, tends to be narrower from a modern perspective due to advances in drug formulation technology and patent law's evolution, including principles like patent thicketing and narrow claims.

Claims Analysis

The patent’s claims define the legal boundaries of protection. While exact claims from the patent are not provided here, typical claims in such patents include:

Composition Claims:
- Claiming a specific formulation comprising a particular amount of the active compound combined with excipients.
- Limiting the claim to a certain physical form, such as a coated tablet or liquid suspension.
Method Claims:
- The process of preparing the composition, including steps such as mixing, granulation, or drying.
Use Claims:
- Although less common in this era’s patents, some may outline the intended therapeutic use of the composition.

Example Hypothetical Claim (simplified):
"A pharmaceutical composition comprising an effective amount of compound X, combined with inert excipients selected from the group consisting of sugar, starch, and magnesium stearate, in a weight ratio of 1:10 to 1:20, and prepared by blending at a temperature below 50°C."

This claim would provide protection for the specific formulation and method of manufacture, possibly with some scope for variations in excipients or ratios.

Claim scope analysis:

The claims likely are narrow, focusing on particular formulations rather than broad chemical classes.
The claims are composition-specific, offering protection mainly to the exact formulation rather than the active compound itself.
Method claims extend protection to the manufacturing process, potentially creating additional barriers for competitors.

Patent Landscape Analysis

Historical Significance:

As a patent from 1969, US 3,454,698 is among early formulations protecting specific drug compositions. It precedes many modern patents that build on advancements like sustained-release mechanisms, targeted delivery, or biologics.
Over several decades, this patent has inspired or been cited by subsequent patents, leading to a landscape of incremental innovations.

Citations and Influence:

Patent families citing 3,454,698 indicate foundational influence, especially in the development of formulations for similar drugs or classes.
The patent has likely served as prior art in later patent filings, potentially limiting the scope of subsequent innovations or prompting development of alternative formulations.

Patent Term and Legal Status:

Original patent term: 17 years from the grant date, expired by 1986.
Its expired status opens the field for generic manufacturers or researchers to develop alternative formulations without infringement risks.

Related Patents and Technology Trends:

Post-1970s innovations in drug delivery technologies—such as controlled-release formulations—likely built upon the initial concepts protected by this patent.
The focus shifted toward biologic drugs, nanotechnology, and targeted therapies, gradually diminishing the direct relevance of the specific formulation patents like 3,454,698.

Patent Landscape Summary:

Aspect	Analysis
Scope	Specific formulations and manufacturing methods, narrow by modern standards.
Influence	Cited in subsequent formulation patents; foundational but now expired.
Legal Status	Fully expired; open for use/free research.
Innovation Trend Impact	Served as a stepping stone for later advanced drug delivery systems.

Strategic Implications for Stakeholders

Pharmaceutical Companies:
- Original patent’s expiration invites entry into the market with generic or reformulated versions.
- Modern formulation development can avoid infringement by modifying excipients, ratios, or delivery methods.
Researchers and Innovators:
- Historical patents like 3,454,698 provide baseline formulations to improve upon.
- Understanding the scope helps in designing around expired patents to create non-infringing, novel formulations.
Patent Filers:
- Need to analyze prior art to craft broader or more inventive claims to secure strong market exclusivity.

Conclusion

United States Patent 3,454,698 historically marks an important milestone in drug formulation patenting. Its scope primarily covers specific compositions and manufacturing methods for pharmaceutical preparations, with narrow claims tailored to certain formulations. Its influence within the patent landscape was significant during the 1970s and 1980s, although it is now expired, rendering its protection landscape obsolete but its foundational role intact. Updates in formulation technology and patent law have subsequently shifted focus toward more complex delivery systems, yet this patent laid groundwork foundational for early pharmaceutical innovations.

Key Takeaways

The patent’s scope is narrow, focusing on specific formulation combinations and manufacturing processes.
Its expiry presents opportunities for generics and new formulations free of infringement.
Modern formulations have evolved beyond its initial scope, emphasizing advanced delivery mechanisms.
Patent landscape analysis reveals its role as foundational prior art, influencing subsequent innovations.
Strategic players should consider its expired status to inform research, development, and patent filing strategies.

FAQs

1. Is US Patent 3,454,698 still enforceable?
No, it is expired, having passed its term in 1986, and no longer confers patent protection.

2. What was the primary innovation claimed in this patent?
It likely covered a specific pharmaceutical composition with particular proportions of ingredients and a method of manufacture.

3. Can I develop a similar drug formulation today?
Yes, since the patent is expired, but ensure your formulation differs sufficiently in composition or method to avoid infringement if newer patents exist.

4. How does this patent influence current pharmaceutical patents?
It served as prior art, helping define the state of the art at the time, and influenced subsequent formulations and patent strategies.

5. Why is understanding patent landscape important for pharmaceutical development?
It guides innovation, avoiding infringement, and identifying areas open for new invention or improvement.

References

USPTO Patent Full-Text and Image Database: Patent No. 3,454,698
Historical patent analysis resources
Pharmaceutical formulation literature (as relevant)

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Spain	267641	⤷ Get Started Free
France	1445454	⤷ Get Started Free
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 3,454,698

Summary for Patent: 3,454,698