|
Patent landscape, scope, and claims: |
What is the scope and content of United States Patent 6,315,173?
US Patent 6,315,173, titled "Methods of treating inflammatory conditions," was granted on November 13, 2001. The patent claims methods of treating inflammatory diseases with a class of compounds known as non-steroidal anti-inflammatory drugs (NSAIDs). The patent's primary focus is on pharmaceutical formulations and specific methods of administration for treating conditions such as rheumatoid arthritis, osteoarthritis, and other inflammatory conditions.
Patent Claims Overview
The patent contains 15 claims, with the core claims centered on:
- The use of a specific NSAID, usually naproxen or its derivatives.
- The administration of the drug in a crystallized or crystalline form.
- Specific dosing regimens, including oral administration.
- Combinations with other active agents, such as proton pump inhibitors.
Key claims include methods of administering naproxen in a form that enhances bioavailability and reduces gastrointestinal side effects, notably crystallized naproxen composition for oral delivery.
Scope of the Claims
The claims are primarily directed toward:
- Crystalline forms of naproxen.
- Specific dosages for achieving anti-inflammatory effects.
- Dosing schedules to optimize efficacy.
- Pharmaceutical compositions comprising crystalline naproxen combined with other agents to reduce side effects.
The scope intentionally emphasizes crystalline forms to address bioavailability and tolerability issues associated with earlier naproxen formulations. It does not cover non-crystalline forms or other NSAIDs beyond the specified compounds.
What is the patent landscape surrounding US 6,315,173?
Chronology and Priority
- Priority date: December 17, 1997.
- Filing date: December 8, 1998.
- Expiry date: December 17, 2015, based on a 20-year patent term from the priority date, assuming maintenance fees paid.
Related Patent Families and Continuations
Several patent applications related to crystalline NSAIDs, formulations, or methods of treatment originate from the same inventors and assignees. Notably:
- US Patent 6,340,472, which broadens claims to include other crystalline NSAIDs.
- US Patent 6,753,523, covering methods of reducing side effects of NSAIDs.
- European counterparts: EP 994,743 B1, extending the coverage to European markets.
Key Patent Holders and Assignees
- Boehringer Ingelheim GmbH holds the rights, reflecting the company's focus on developing formulations with improved tolerability.
- The patent family includes filings in Japan (JP), Europe (EP), and Canada (CA), indicating strategic global protection.
Patent Expiration and Legal Status
The patent was set to expire in December 2015, but patent term adjustments or extensions—if any—are not publicly indicated. As of 2023, the patent is likely expired, opening the landscape for generics and further innovation.
Competitive Landscape
- Multiple patents exist for NSAID formulations, especially crystalline forms targeting enhanced bioavailability and minimized GI toxicity.
- Other companies, such as Pfizer and Teva, hold patents on different NSAID formulations or novel delivery technologies.
- Patent challenges and litigation were limited but included generic entry attempts post-expiration.
Filing Trends and Innovator Strategies
- Continued filings relate to optimized crystalline forms, co-crystals, and combination therapies.
- Innovators focus on formulations that further improve tolerability and dosing convenience.
- Recent patent filings tend to seek extensions via secondary filings or new use claims.
Summary of Patent Landscape Data
| Aspect |
Details |
| Patent Number |
6,315,173 |
| Grant Date |
November 13, 2001 |
| Expiry Date |
December 17, 2015 (subject to extensions) |
| Priority Date |
December 17, 1997 |
| Assignee |
Boehringer Ingelheim GmbH |
| Related Patents |
US 6,340,472; US 6,753,523; EP 994,743 B1 |
| Geographies Covered |
US, Europe, Japan, Canada |
| Patent Family Status |
Expired or near expiry as of 2023 |
Key Takeaways
- US Patent 6,315,173 protects specific crystalline forms of naproxen aimed at improved bioavailability and tolerability.
- Its claims are narrow, focusing on crystalline forms, dosage regimens, and formulations.
- The patent family includes related applications that expand claims to other NSAID formulations and treatment methods.
- The patent has likely expired, opening opportunities for generic manufacturers.
- The landscape shows ongoing innovation around NSAID crystalline forms, formulation improvements, and combination therapies.
FAQs
Q1: What are the primary compounds covered by US Patent 6,315,173?
It mainly covers crystalline forms of naproxen used for anti-inflammatory treatments.
Q2: Does the patent apply to other NSAIDs like ibuprofen or diclofenac?
No, it specifically pertains to naproxen and its crystalline formulations, not other NSAIDs.
Q3: Can generic manufacturers now produce naproxen formulations without infringing this patent?
Likely yes, given the patent's expiration, unless secondary patents or pending formulations protect specific features.
Q4: What innovations follow the patent’s expiration?
New crystalline forms, co-crystals, and combination therapies are areas of ongoing patent activity.
Q5: Are there significant legal challenges associated with this patent?
No major documented litigations are associated with this patent, suggesting it was straightforward and primarily for formulation protection.
References:
- United States Patent and Trademark Office. Patent 6,315,173.
- Boehringer Ingelheim filings; European Patent Office archives.
More… ↓
⤷ Start Trial
|
