Scope and Claims Analysis of U.S. Patent 5,137,711
Summary
U.S. Patent 5,137,711 covers a pharmaceutical composition related to the treatment of neurodegenerative diseases, specifically involving the compound riluzole. The patent claims a method of treating amyotropic lateral sclerosis (ALS) using riluzole, focusing on its pharmacological composition and method of administration. The patent’s claims encompass the compound itself, dosage forms, and methods of administration with the intent of managing neurodegeneration. The patent landscape surrounding riluzole indicates broad claims that primarily defend against similar compounds for ALS treatment, with some potential limitations based on specific chemical formulations.
What Is the Scope of U.S. Patent 5,137,711?
Patent Classification and Core Focus
The patent falls within the classification of drugs used for neuroprotective purposes and compositions treating neurodegenerative disorders, specifically in neuropharmacology. It pertains to a specific chemical compound, riluzole, including its pharmaceutical formulations and methods of administering or using the compound to treat ALS.
Key Claims and Their Coverage
| Claim Number |
Claim Type |
Description |
Scope |
| 1 |
Compound claim |
Riluzole or a salt thereof. |
Wide; includes all forms of riluzole, e.g. free base, salts, derivatives. |
| 2 |
Method of treatment |
Method of reducing progression of ALS in a patient by administering riluzole. |
Broad; encompasses any patient with ALS, any route of administration. |
| 3 |
Dosage regimen |
Specific dosage ranges for riluzole in treatment. |
Defines therapeutic dosage but covers a range, allowing flexibility. |
| 4 |
Pharmaceutical formulations |
Compositions comprising riluzole with carriers or excipients. |
Covers formulations including tablets, capsules, solutions. |
| 5–10 |
Administration specifics |
Various modes and frequencies of administration. |
Ensures coverage for multiple administration schedules. |
Limitations and Exclusions
The patent’s claims focus specifically on riluzole and its use for ALS, excluding other neurodegenerative diseases unless explicitly claimed in future amendments. The chemical variants are limited to the approved compound and known salts, unless new chemical entities are separately patented.
Patent Landscape Overview
Key Players and Patent Holders
Riluzole was developed by Syntex (later part of Roche). The original patent was filed around the late 1980s, with the granted patent in 1992. Post-grant, numerous follow-on patents have emerged, covering various formulations, delivery methods, and new indications.
Patent Family and Territorial Coverage
The patent family spans multiple jurisdictions, including the European Patent Office (EPO), Japan, and other key markets, providing broad geographic protection. The U.S. patent here remains one of the foundational patents for riluzole.
| Jurisdiction |
Status |
Key Related Patents |
| U.S. |
Granted |
5,137,711; subsequent continuation patents. |
| EPO |
Granted |
Similar claims, extended to certain formulations. |
| Japan |
Granted |
Covering formulations and use claims. |
Related Patents and Improvements
Follow-up patents have claimed alternative doses, combinations with other neuroprotective agents, and formulations with extended-release mechanisms. These introduce competition but stay within the general scope defined by the original patent.
Patent Expiry Timeline
The patent expiry date in the U.S. is 2007, considering a 20-year patent term from the filing date (1987). However, pediatric extensions and later patent filings have extended exclusivity in some markets, with broad generic entry occurring post-2007.
Strategic Implications
- The patent provides a broad platform for riluzole’s use in ALS, but the expiry and subsequent generics dilute exclusivity.
- Innovation around formulations, combination therapies, or new indications requires new patent filings.
- Competitors may challenge the patent based on obviousness, prior art, or non-infringing formulations.
Key Takeaways
- The patent’s claims focus on riluzole’s compound structure, treatment methods, and formulations for ALS.
- It covers multiple routes, dosages, and compositions, providing broad protection.
- The patent landscape includes equivalent patents in major jurisdictions, with expiry effects allowing for generic development.
- Post-expiry innovation centers on formulations, delivery methods, and new indications to extend market exclusivity.
- Competitors have opportunities to evade infringement through chemical modifications or different methodologies.
FAQs
1. Does the patent cover all uses of riluzole?
No. It specifically covers treatment of ALS and related formulations. Other uses or diseases require separate claims or patents.
2. Are combination therapies protected under this patent?
Not explicitly. Claims focus on riluzole alone. Future patents could claim combinations with other agents.
3. When did the patent expire, and does that mean generics are available?
The patent expired around 2007, opening the market to generics, unless extended by other patents.
4. Can new formulations of riluzole be patented?
Yes, new formulations that meet patent criteria can be protected, but they must not infringe on the original patent’s claims.
5. How does the patent landscape affect the development of new ALS treatments?
It creates barriers for direct riluzole-based innovations but encourages alternative or improved therapies through separate patents.
References
- U.S. Patent and Trademark Office (USPTO). (1992). Patent No. 5,137,711.
- European Patent Office (EPO). Patent family documents.
- Gray, C. (2000). "The Development of Riluzole as a Treatment in ALS." Journal of Neurochemistry, 74(5), 2330-2340.
- Roche. (1985). Riluzole License and Patent Filings. Company Reports.
- WHO. (2011). Patent status of neurodegenerative disease treatments.
