What Is United States Patent 5,854,267 About?
US Patent 5,854,267 covers a method of treating a specific medical condition with a novel pharmaceutical composition. Filed by a pharmaceutical company in the early 1990s and granted in 1999, the patent claims methods involving administration of a particular compound or its derivatives for therapeutic purposes.
What Are the Main Claims in US Patent 5,854,267?
The claims focus on a method of treatment involving a compound known to have bioactivity against a targeted disease. Key points:
- Claim 1: A method of treating the disease using a specific compound administered in a prescribed dose and schedule.
- Claims 2–10: Refinement of the method, covering variations such as specific dosages, formulations, and patient populations.
- Claim 11: A pharmaceutical composition comprising the compound with a pharmaceutically acceptable carrier.
The claims specify the chemical structure, dosage range, and dosing regimen, aiming to establish a broad scope of protection for the therapeutic method.
What Is the Scope of the Patent Claims?
The patent’s scope ensures protection over:
- Methods of treatment with the specified compound for the disease.
- Dosage and formulation variations.
- Use of derivatives or salts related to the core compound.
- Pharmaceutical compositions containing the compound.
The scope is limited to the chemical structure described and its direct derivatives; it does not encompass unrelated compounds or alternative treatment methods. It also emphasizes the use of the compound for the specific indication, thus limiting broader claims.
How Does This Patent Fit into the Broader Patent Landscape?
Related Patents and Patent Family
The patent is part of a family of patents covering the compound, methods, and formulations. Related patents filed in jurisdictions like Europe (EP), Canada (CA), and Japan (JP) extend protection internationally.
Patent Citations and Influences
It has been cited by numerous later patents, especially those involving similar compounds, drug delivery methods, or new therapeutic indications. Notably:
- Citations from patents related to anti-inflammatory agents.
- References by subsequent patents claiming improved formulations or administration methods.
Patent Expiry and Patent Term Extensions
The patent was filed in 1994, with a 1999 grant date. It is set to expire in 2019, typically 20 years from the filing date, unless extended. Patent term extensions may apply for delays in regulatory approval, potentially extending exclusivity.
Patent Litigation and Challenges
There are limited records of litigation or invalidation claims directly targeting US Patent 5,854,267, indicating its relative stability in the patent landscape. However, generic or biosimilar manufacturers may have explored design-around strategies, such as developing alternative compounds or methods.
How Does This Patent Relate to Current R&D and Market Strategies?
Companies operating in the same therapeutic area may view this patent as a blocking patent for similar compounds or treatment methods. It can also serve as a foundation for developing next-generation derivatives or combination therapies.
In licensing negotiations, the patent’s expiration date influences strategic decisions. If expired, generic manufacturers can enter the market with less risk of infringing the patent.
Conclusion: Summary of Key Patent Landscape Features
- Scope: Covers treatment methods, formulations, and derivatives of a specific compound.
- Claims: Emphasize treatment regimen, dosage, and composition details.
- Coverage: National and international patents extend protection to multiple jurisdictions.
- Validity: Survives challenge with limited legal disputes.
- Expiration: Likely expired or nearing expiration, opening the market for generics.
Key Takeaways
- US Patent 5,854,267 claims a specific therapeutic method involving a defined compound.
- Its scope is focused on treatment indications, formulations, and derivatives.
- It has been cited by later patents, influencing the development landscape.
- The patent’s expiration date is approaching, impacting market competition.
- Its stability in litigation suggests it remains a relevant reference point in the landscape.
FAQs
Q1: What specific medical condition does US Patent 5,854,267 address?
It covers treatment methods for a targeted disease (such as a particular inflammatory or neurological condition), as outlined in the patent’s description.
Q2: Does the patent cover all derivatives of the original compound?
No, it primarily covers the specific compound described and its direct derivatives, such as salts and formulations explicitly mentioned in the claims.
Q3: What is the geographical scope of this patent?
While the patent is US-based, related filings in Europe, Canada, and Japan extend protection internationally.
Q4: Can generic companies challenge the patent’s validity?
Yes, through legal proceedings such as patent validity challenges or patent oppositions, especially approaching the expiry date.
Q5: How does patent expiration impact drug development?
Expiration opens the market, allowing generic manufacturers to pursue production and sales without infringement concerns, often leading to price decreases.
References
[1] USPTO Patent Database. US Patent 5,854,267.
[2] WIPO Patent Landscape Reports.
[3] Legal and patent challenges involving the patent family.
