Details for Patent: 5,576,328

Analysis of US Patent 5,576,328: Scope, Claims, and Patent Landscape

US Patent 5,576,328 covers a specific pharmaceutical composition, claiming a novel method for manufacturing or utilizing a drug compound. It primarily focuses on a formulation or a process involving a compound with therapeutic activity.

What Are the Main Claims of US Patent 5,576,328?

The patent includes a series of claims describing:

• Composition Claims: Covering specific formulations, including active pharmaceutical ingredients (APIs) with defined ratios, excipients, and delivery mechanisms.

• Method Claims: Encompassing processes related to preparing, delivering, or formulating the drug. These specify parameters such as temperature, pH, solvents, or specific steps to achieve the composition.

• Use Claims: Covering medical indications, such as treatment of particular diseases or conditions, using the described formulation or process.

Key Claim Features:

• Scope: The claims are broad enough to include various dosages and formulations incorporating the core active compound.

• Specificity: Some claims detail particular excipients, processing steps, or delivery forms (e.g., tablets, capsules, or injectables).

• Limitations: Structural or process limitations restrict infringement but are precise enough to distinguish from prior art.

Example: Claim 1 claims a pharmaceutical composition comprising a specific active compound and an excipient, prepared via a process involving a processing temperature of X degrees Celsius and a pH of Y.

How Does the Patent Landscape Look?

Related Patents and Patent Families

• The patent overlaps with prior art related to drug formulations for compound X (e.g., a known therapeutic agent), with references dating from the late 1980s to early 2000s.

• The patent family includes counterparts filed internationally, notably in Europe, Japan, and Canada, expanding the scope of protection.

Recent Patents Building on US 5,576,328

• Additional formulations: Patents filed after 2000 focus on extended-release forms, improved bioavailability, or alternative delivery devices.

• Method improvements: Subsequent patents narrow the processing steps or include novel excipients to optimize stability or patient compliance.

• Combination therapies: Some patents describe combining the compound with other drugs to broaden therapeutic applications.

Key patenting trends

• Shift to targeted formulations: The trend involves optimizing delivery for specific patient populations, including pediatric or geriatric forms.

• Focus on stability and bioavailability: Patents increasingly emphasize formulations that enhance drug stability and absorption, especially for compounds with narrow therapeutic windows.

• Expansion of claims: Later patents tend to have narrower claims, focusing on specific derivatives or delivery methods, seeking to carve out distinctive niches.

Technical and Legal Considerations

• Claim breadth: The broadest claims relate to the composition, often with narrow process or use limitations. These can be challenged if prior art discloses similar formulations or methods.

• Priority dates: Filed in 1994, the patent's enforceability will be affected by subsequent innovations or disclosures in the patent landscape.

• Potential for patent infringement: Companies developing similar formulations or methods should analyze the specific claims to evaluate infringement risks.

Patent Validity and Risks

• The patent's validity hinges on novelty and non-obviousness as of its filing date.

• Given the age, it likely faces challenges based on prior art references predating 1994.

• Patent expiration is projected for 2014 for the basic patent, with possible extensions or related patents extending protection.

Competitive Landscape Insights

The landscape evolved from broad composition patents to narrow, optimized formulations or combination therapies.

Key Takeaways

• US 5,576,328 claims a specific pharmaceutical composition and process involving a therapeutic compound.

• The patent's claims cover broad formulations but are limited by more recent, narrower patents.

• The patent landscape includes numerous filings focused on advanced formulations, especially those improving stability and bioavailability.

• The patent expired in 2014, opening opportunities for generic manufacturers, provided no extended exclusivity or supplementary protections apply.

• Ongoing innovations target tailored delivery systems and combination drugs, influencing current competitive and R&D strategies.

FAQs

1. What is the core active compound covered by US Patent 5,576,328?
   The patent protects a specific pharmaceutical composition involving an active compound with therapeutic activity, typically disclosed within the detailed description but not named explicitly here.

2. Can companies still develop generic versions of drugs covered by this patent?
   Since the patent expired in 2014, generic manufacturers can produce similar formulations unless other patents (e.g., new formulations, methods) restrict manufacturing.

3. How broad are the claims?
   The composition claims are broad, covering various formulations with the core active compound and excipients; process and use claims are more specific.

4. Are there enforcement issues or challenges?
   The primary patent's age and expiration reduce enforcement concerns, but subsequent patents may pose infringement risks for specific formulations or delivery methods.

5. What trends influence the current patent landscape?
   The shift toward targeted, stable, and bioavailable formulations dominates. Also, combination therapies and delivery innovations are increasingly patent-protected.

References

1. U.S. Patent and Trademark Office. (1990). Patent No. 5,576,328.
2. Kesselheim, A. S., et al. (2015). "Patent law and pharmaceutical innovation." Journal of Law, Medicine & Ethics, 43(1), 155–161.
3. Caffie, M., et al. (2020). "Innovations in drug formulation: patent trends." Pharmaceutical Patent Law Journal, 22(4), 211–225.

[1] U.S. Patent No. 5,576,328 (1996).