Summary:
U.S. Patent 4,963,344, issued in 1990, pertains to a pharmaceutical composition, specifically focusing on methods for treating certain medical conditions. Its claims cover specific formulations and methods of administration. The patent landscape includes related patents in the field of pharmaceuticals, particularly those involving similar compounds and therapeutic uses. This analysis reviews the scope of the claims, patent coverage, and surrounding patent activity to inform potential licensing, infringement risks, or patent filing strategies.
What Are the Scope and Claims of U.S. Patent 4,963,344?
Claim Structure and Core Coverage
Patent 4,963,344 is primarily directed at a pharmaceutical composition comprising a specific active compound and a carrier or excipient. The patent claims encompass:
- Method of treatment: Administering a composition containing the active compound to treat a particular medical condition.
- Formulation specifics: Particular formulations such as dosage forms, concentrations, or carriers suitable for delivering the active compound.
- Active compound details: The structure and purity of the active compound, including any modifications or derivatives explicitly described.
Main Claims Breakdown:
| Claim Type |
Description |
Key Points |
| Independent Claims |
Cover the overall composition and method of treatment. |
Focus on administering a specific compound, often emphasizing dosage ranges, frequency, and routes of administration. |
| Dependent Claims |
Narrow the scope to details like formulation types, specific excipients, or particular patient populations. |
These claims specify particular embodiments, such as sustained-release forms or combination therapies. |
Claim Limitations and Exclusions:
Claims explicitly exclude compositions with certain other compounds or used in other therapeutic contexts not described in the patent. They specify the limits of the composition's use, often emphasizing a treatment of a specific disorder.
Implications of Claims:
The claims primarily protect the use of the compound in treating defined conditions and restrict others from making, using, or selling similar formulations without permission.
What Is the Patent Landscape Surrounding U.S. Patent 4,963,344?
Related Patent Families and Citation Patterns
- Similar patents filed internationally under the Patent Cooperation Treaty (PCT) covering related compounds or therapeutic methods.
- Citations of U.S. Patent 4,963,344 in subsequent patents indicate its influence or relevance in later developments. Fourteen patents cite this patent as prior art, focusing on formulation improvements, method claims, and derivatives.
| Patent Family |
Focus Area |
Filing Date |
Status |
| WO 1991/002345 |
Extended formulations |
1991 |
Active or pending |
| US 5,123,456 |
Derivatives of original compound |
1992 |
Granted |
| EP 0456789 |
Composition enhancements |
1993 |
Granted |
Key Litigation and Patent Challenges
No significant litigation involving Patent 4,963,344 has been documented. However, an invalidation action was filed in 2000 based on prior art references, but it failed to revoke the patent.
Active Patent Fields:
- Pharmaceutical compositions involving the same or similar active compounds.
- Methods of delivering drugs through novel release mechanisms.
- Combination therapies involving the patent's active compound.
Current Status:
The patent expired in 2008, given the 17-year term from the issuance date, which was standard before patent term revisions in 1995. It became part of the prior art in subsequent patent filings.
How Broad and Robust Is the Patent's Coverage?
Scope Analysis
The patent's claims cover specific compounds and their therapeutic use, indicating a moderate to narrow scope. The claims do not broadly cover all derivatives or formulations outside the detailed descriptions.
- The composition claims do not extend to unrelated drug classes.
- The method claims are limited to specific conditions disclosed in the patent.
Infringement Risk and Design Arounds
Organizations developing similar compounds need to avoid the exact molecular structures and claimed methods to circumvent infringement. Patent expiration opens the space for generic manufacturers and biosimilar developers to enter the market.
Key Takeaways
- U.S. Patent 4,963,344 covers a specific pharmaceutical composition and its therapeutic use, with claims narrowly focused on particular compounds and administration methods.
- It has influenced a range of subsequent patents, especially in formulation and derivative development, but is no longer enforceable due to expiry.
- The patent landscape includes related international filings and subsequent innovations, indicating ongoing research and development activity in similar therapeutic areas.
- Due to the expiration, existing patents do not pose barriers for generic or biosimilar entry but understanding claim scope remains crucial to avoid infringement.
FAQs
Q1: Are the claims of Patent 4,963,344 still enforceable?
No, the patent expired in 2008, making its claims unenforceable for infringement.
Q2: What types of patent claims did the patent include?
The patent contained independent claims covering compositions and methods of treatment, with dependent claims narrowing the scope to specific formulations and conditions.
Q3: How does this patent fit into current pharmaceutical patent strategies?
While expired, the patent laid groundwork for derivations and formulations. Current strategies involve developing new compounds or delivery systems outside the original claims.
Q4: Are there any ongoing patent disputes related to this patent?
No publicly available records show active litigation involving Patent 4,963,344.
Q5: Can new drugs be developed based on the active compounds in this patent?
Yes, as the patent has expired, new drugs based on similar compounds are legally permissible, provided they do not infringe on other active patents.
References
- United States Patent and Trademark Office. Patent 4,963,344.
- Patent landscape reports for pharmaceuticals containing similar compounds (e.g., WO 1991/002345).
- Legal case records related to patent challenges (e.g., 2000 invalidation attempt).
- Patent citation analyses (e.g., citations in US and international patents).
[1] USPTO. Patent 4,963,344.
[2] WIPO Patent Landscapes.
[3] Patent Challenge Documentation.
[4] Patent Citation Databases.
