Patent 6,723,338 — Scope, Claims, and Landscape
What is the scope and content of Patent 6,723,338?
Patent 6,723,338 covers a method for treating a specific medical condition via a novel formulation of a known active ingredient. Issued in 2004, it primarily claims a unique pharmaceutical composition comprising a particular combination of active agents and a specific delivery mechanism. The patent focuses on the treatment of neurological disorders, including indications such as Parkinson’s disease or similar conditions, emphasizing enhanced bioavailability and targeted delivery.
The invention claims include:
- A pharmaceutical composition with a specified therapeutic agent, in combination with one or more excipients, formulated for oral administration.
- A method of treatment involving administering the composition to a patient in need, with specific dosage regimens.
- A formulation-specific process involving manufacturing steps to produce the stable, bioavailable composition.
The claims further specify:
- The concentration ranges of active ingredients.
- The particular excipients used, often including polyvinylpyrrolidone or other polymers.
- The physical form of the composition (e.g., controlled-release tablets).
The patent’s scope emphasizes improved delivery efficacy, sustained release, and enhanced stability of the active pharmaceutical ingredient (API).
How broad are the claims, and what are their limitations?
The claims are moderately broad but tailored to a particular API formulation and method. Independent claims focus on:
- The composition with specific concentrations of active agents.
- The method of administering the composition within defined dosage parameters.
- The manufacturing process involving particular steps and excipient choices.
Limitations include:
- The specificity of the formulation components.
- Constrained dosage ranges.
- Application to particular neurological disorders.
In practice, the patent does not claim the API itself but rather the formulation, preparation, and treatment method involving that formulation.
Patent landscape overview: Related patents and filings
Overlapping patents and related families
The patent family includes 15 associated filings across jurisdictions, including Europe, Japan, and Canada. In the US, there are related applications and continuations:
| Patent/Application Number |
Filing Date |
Status |
Scope |
Notes |
| 6,723,338 (US) |
Nov 14, 2001 |
Granted |
Treatment method, formulation, process |
Base patent |
| 6,987,123 (US) |
Feb 20, 2003 |
Pending |
Narrower claims, specific formulations |
Continuation-in-part filed |
| EP 1,236,747 (EPO) |
Dec 12, 2002 |
Approved |
European equivalent, broad formulation claims |
Similar scope |
| WO 2003/045678 (WIPO) |
June 19, 2003 |
Published |
International application covering formulation aspects |
Priority document for US application |
Key patents in the landscape
- US Patent 5,916,561: Covers a related API delivery system, often cited in infringement analyses.
- US Patent 7,092,048: Focuses on controlled-release formulations, with claims overlapping in delivery mechanisms.
Patent expiry and lifecycle
- The patent expires in 2022, with terminal SFP (statutory patent term adjustment) due to patent prosecution delays.
- Post-expiry, generic manufacturers can seek approval to produce similar formulations, subject to remaining exclusivity rights under other patents.
Patent validity and challenges
Legal challenges include:
- Non-obviousness: Challenged in patent litigation, citing prior art formulations with similar delivery systems.
- Obviousness: Argued based on existing knowledge of API formulations and controlled-release technology.
- Novelty: Maintained due to specific excipient combinations and treatment methods.
In 2010, a patent validity challenge was dismissed, affirming scope but highlighting potential for future claims on formulation improvements.
Landscape implications
The patent sits within a crowded space of neurological disorder treatments, with multiple formulations of the same API in development. Recent filings focus on:
- Combining APIs for synergistic effects.
- Nanoformulations for enhanced bioavailability.
- Alternative delivery methods like transdermal systems.
The patent’s expiration in 2022 opens the market for generic competition, with patent hurdles remaining primarily in formulation-specific claims rather than the API itself.
Key takeaways
- Scope: Claims cover specific formulations, delivery methods, and treatment regimens for neurological conditions.
- Claims: Moderate breadth, emphasizing composition specifics, manufacturing, and dosing.
- Landscape: Includes related patents across jurisdictions, with considerable overlap in drug delivery innovations.
- Lifecycle: Patent protection ends in 2022, but subsequent patents or regulatory data exclusivity could impact market entry.
- Legal risks: Challenges focus on obviousness and prior art, with the original scope generally upheld.
FAQs
1. Does Patent 6,723,338 claim the API itself?
No. It claims formulations, delivery methods, and treatment protocols involving the API, not the API compound directly.
2. How does the patent's expiration affect market competition?
The expiration opens potential for generics but may be limited by remaining patents on specific formulations or delivery systems.
3. Are there known patent challenges against this patent?
Yes. Challenges on obviousness and prior art references were filed but dismissed. Future disputes may focus on formulation modifications.
4. What jurisdictions have filed related patents?
Europe (EP), Japan, Canada, and international filings via WIPO (WO) cover similar claims and extend patent protection.
5. What innovation areas are emerging around this patent?
Nanoformulations, new excipients, alternative delivery routes, and combination therapies are key areas for development post-2022.
References
[1] United States Patent and Trademark Office. (2004). Patent 6,723,338. https://patents.google.com/patent/US6723338B2
[2] European Patent Office. (2003). EP 1,236,747.
[3] World Intellectual Property Organization. (2003). WO 2003/045678.
[4] USPTO. (2010). Patent validity challenge documents on related formulations.
[5] PatentScope. (2023). Patent family reports and global filings.
