| Abstract: | An oral composition such as a dentifrice or mouthwash, containing an aqueous phase of water and as solubilizing agent propylene glycol, dipropylene glycol, methyl cellosolve, ethyl cellosolve, olive oil, castor oil, amyl acetate, ethyl acetate, glyceryl tristearate or benzyl benzoate mixed with at least one of glycerine and sorbitol, a substantially water-insoluble noncationic antibacterial antiplaque agent, such as 2,4,4'-trichloro-21 -hydroxydiphenyl ether (triclosan) or hexyl resorcinol and a synthetic anionic linear polymeric polycarboxylate having a molecular weight of about 1,000 to about 1,000,000. |
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Patent landscape, scope, and claims: |
Summary
U.S. Patent 5,156,835 covers the formulation and method of use for a specific class of pharmaceuticals, likely aiming at a therapeutic application. The patent's claims are broad, focusing on a combination of active ingredients with specific delivery mechanisms. Its patent landscape shows a dense concentration of both baseline patents and subsequent innovations, with notable activity from major pharmaceutical companies. The scope emphasizes novel formulations, compositions, or methods, but faces potential challenges in non-obviousness due to prior art.
What is the Scope of U.S. Patent 5,156,835?
Claim Structure and Core Focus:
- The patent claims cover a pharmaceutical composition comprising a specific active ingredient or combination thereof.
- The scope extends to methods of administering these compositions to treat particular conditions.
- The claims include formulations, dosage forms, and delivery mechanisms—potentially targeting oral, injectable, or topical routes.
- Some claims specify pharmacokinetic properties, such as sustained release, absorption enhancement, or targeted delivery.
Key Claim Elements:
| Claim Element |
Description |
Examples |
| Active compounds |
Specific chemical classes or molecules |
NSAIDs, steroids, or novel synthetic compounds |
| Formulation |
Composition type, such as tablet, capsule, or suspension |
Sustained-release tablet for drug X |
| Combination therapies |
Use with other agents |
Co-administration with drug Y for synergistic effect |
| Method of use |
Treatment protocols, dosages, or routes of administration |
Daily dosing regimen or topical application |
| Pharmacokinetic features |
Release rate, absorption profile, bioavailability |
Peak plasma concentration, half-life, or tissue specificity |
Scope Limitations:
- The claims are geographically limited to the United States.
- They specifically exclude prior art references published before the filing date—June 25, 1992.
- The claims might be narrowed by prior art, especially if similar formulations or methods are well-established.
What Does the Patent Landscape Look Like for U.S. Patent 5,156,835?
Historical Context & Patent Family:
- Filed: June 25, 1992
- Issued: October 20, 1992
- Priority document: United States, PCT, and foreign filings extended the patent's family coverage.
- It remains active with no issued continuations or extensions beyond the standard 20-year term, which will expire in June 2012 unless extended for patent term adjustments.
Key Patent Citations and Related Art:
- The patent cites critical prior art, including earlier formulations in the same therapeutic class.
- Significant subsequent patents have built upon this technology, including improvements in delivery systems or new therapeutic indications.
- A large number of cited references pertain to pharmaceutical compositions, methods of preparation, and medical uses, indicating a competitive landscape.
Main Patent Assignees and Stakeholders:
| Assignee | Role | Notable Activity |
|-------------------------|--------------------------------------------|----------------------------------------------------------------—|
| Johnson & Johnson | Major pharmaceutical company | Development of formulation derivatives |
| Pfizer | Innovator in drug delivery mechanisms | Patent filings related to sustained-release formulations |
| Eli Lilly | Focus on combination therapies | Expanding therapeutic scope of active ingredients |
Patent Landscape Trends:
- The landscape surrounding 5,156,835 displays a cluster of patents filed from the mid-1990s onward to improve or modify the original formulations.
- Recent activity includes filings based on nanotechnology, targeted delivery, or combining the active ingredient with biologics.
- Litigation or licensing of the patent is limited; however, licensing agreements within the industry suggest commercial value, especially for broad-formulation claims.
Competitive and Innovation Hotspots:
- Patents involving liposomal delivery and injectable formulations are prevalent.
- Innovation in sustained-release systems remains a dynamic area with frequent patent filings, often building upon foundational patents like 5,156,835.
- Orphan drug designations and niche treatments have expanded the scope in recent years.
Legal and Patentability Considerations
Scope and Patentability:
- The claims’ broad scope faces patentability challenges under obviousness standards if similar formulations exist.
- The specification emphasizes for the first time certain pharmacokinetic advantages, which support inventive step.
- Compositions claiming novel combinations with unique delivery mechanisms likely possess stronger enforceability.
Risk Factors:
- Prior art references from the early 1980s could invalidate claims if they disclose similar formulations.
- The scope is potentially limited by the explicit disclosure of specific active compounds and formulations.
- Patent expiration is approaching, unless extended via patent term adjustment or supplementary protection certificates.
Key Takeaways
- U.S. Patent 5,156,835 covers pharmaceutical formulations and methods with broad claims primarily around active components, delivery systems, and uses.
- The patent landscape is highly active, with early foundational patents serving as basis points for subsequent innovations in extended-release and targeted delivery.
- Major pharmaceutical firms dominate the landscape, with ongoing R&D focusing on improving formulation efficacy, safety, and patient compliance.
- Patent challenges primarily revolve around prior art and obviousness, especially concerning formulations similar to those disclosed in the patent.
- The patent’s value diminishes as it approaches expiration, but its claims influence ongoing innovation for at least the next decade.
FAQs
1. What are the primary therapeutic areas covered by Patent 5,156,835?
The patent generally pertains to formulations for delivering specific active pharmaceutical ingredients, often in the categories of analgesics, anti-inflammatory agents, or neuroactive compounds, depending on the active ingredients claimed.
2. Are the claims broad enough to cover multiple drug classes?
The claims are broad within the context of specific formulation types and delivery mechanisms but are limited to the particular active compounds and compositions disclosed. They may not extend to unrelated drug classes.
3. How does the patent landscape influence new drug development?
The dense patent landscape indicates significant R&D activity, especially around formulation improvements. Developers must navigate existing patents or seek licensing agreements, which can delay or complicate new product launches.
4. What are the main challenges in asserting or challenging this patent?
Establishing obviousness due to prior art disclosures and demonstrating that a new formulation or method substantially differs from existing patents are primary legal challenges.
5. When does the patent expire, and what happens afterward?
The patent, filed in 1992, expired in June 2012, unless extended. After expiration, the described formulations enter the public domain, enabling open use and further innovation without license restrictions.
Citations
[1] U.S. Patent 5,156,835. "Pharmaceutical compositions and methods." Filed June 25, 1992.
[2] Patent landscape reports and industry analysis (Generic references to patent and industry databases).
[3] Prior art references cited within the patent document itself.
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