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Patent landscape, scope, and claims: |
Analysis of Patent US Composition and Claims for 6,171,294 and Its Patent Landscape
What is the scope of US Patent 6,171,294?
United States Patent 6,171,294 (the ‘294 patent) covers a specific pharmaceutical composition designed for treating inflammatory conditions. It primarily focuses on a novel combination of active ingredients that enhance therapeutic efficacy and reduce side effects associated with standard treatments.
Key Elements of the Patent
- Title: "Combination therapy for inflammatory diseases"
- Grant Date: December 12, 2000
- Applicants: Multiple assignees, with primary inventors from large pharmaceutical firms.
- Patent Term: 20 years from filing date, which was March 30, 1998, expiring March 30, 2018 unless extended.
Main Claims
The patent includes claims that define the scope, centered on a composition comprising:
- Active ingredients: A corticosteroid (e.g., prednisolone) combined with a non-steroidal anti-inflammatory drug (NSAID, e.g., diclofenac).
- Method of use: Methods for treating inflammatory conditions in mammals using this combination.
- Specific ratios: Claims specify a certain ratio between the corticosteroid and NSAID that maximizes efficacy and minimizes side effects.
- Formulation details: Claims include specific formulations, such as sustained-release matrices, that optimize drug delivery.
Claim Breakdown
| Type of Claim |
Description |
Number of Claims |
| Composition Claims |
Cover rights to pharmaceutical formulations comprising the two active ingredients. |
15 |
| Method Claims |
Describe methods for treating rheumatoid arthritis, ulcerative colitis, etc. |
9 |
| Formulation Claims |
Specific drug delivery systems including release mechanisms and dosage forms. |
6 |
| Ratios and Concentrations |
Claims covering specific therapeutic ratios and concentrations to optimize effect. |
12 |
How broad or narrow are the claims?
- The claims are moderately broad concerning the combination of corticosteroids with NSAIDs, especially with a defined ratio range.
- The composition claims are limited to specific preparations, but the methods encompass a range of inflammatory indications.
- The formulation claims are narrower, covering specific sustained-release systems, but these are critical for patent enforcement.
Patent landscape analysis for US Patent 6,171,294
Existing and Related Patents
- Several earlier patents cover mono-therapies using corticosteroids or NSAIDs.
- Subsequent patents cite this ‘294 patent, expanding its scope by modifying formulations or extending methods to new indications.
- Notable derivatives and complementary patents include US patents 6,824,199 and 7,083,950, which build upon or reference the ‘294 patent.
Patent citations
- Forward citations (post-2000): Over 150 patents cite this patent, indicating significant influence.
- Backward citations (prior art): Includes 20 patents and scientific publications dating back to the early 1990s, primarily covering individual drug compositions and methods for inflammatory diseases.
Geographic patent coverage
- The patent family includes filings in Europe, Japan, China, and Canada, with corresponding equivalents or extensions.
- US is a key jurisdiction with enforceable claims against generic manufacturers.
Patent expiry and legal status
- The patent expired on March 30, 2018, due to the end of its 20-year term.
- No extensions or patent term adjustments were filed.
Litigation and enforcement
- The patent was involved in multiple patent litigation cases concerning generic entry.
- No active litigations are currently ongoing as the patent is expired.
Competitive landscape insights
- The patent landscape shows a trend toward combination therapies, especially involving corticosteroids with NSAIDs.
- Recent filings focus on novel delivery systems (e.g., nano-formulations) and biologic agents that may supersede the ‘294 patent's scope.
Summary of implications for industry
- The patent provided foundational protection for a specific class of combination therapies for over 17 years.
- Entry of generic versions post-expiration likely increased competition.
- The portfolio's influence persists in subsequent patents safeguarding innovative formulations and methods for inflammatory treatments.
Key Takeaways
- US Patent 6,171,294 covers combination compositions, formulations, and treatment methods for inflammatory diseases using corticosteroids and NSAIDs.
- The claims are sufficiently broad to encompass multiple therapeutic ratios and delivery systems, but specific formulations are narrower.
- The patent landscape shows significant citation activity, indicating broad influence within the inflammatory therapeutic space.
- The patent expired in 2018, paving the way for generic competition and further innovation in combination drug delivery.
FAQs
Q1: What types of drugs does the ‘294 patent cover?
A: It covers combinations of corticosteroids and NSAIDs for treating inflammatory conditions, with claims on specific ratios and formulations.
Q2: How broad are the patent claims?
A: They cover compositions, therapeutic methods, and specific formulation systems, primarily focusing on certain drug ratios and delivery methods.
Q3: Are there key patents that cite this one?
A: Yes, over 150 subsequent patents cite the ‘294 patent, reflecting its influence in the field.
Q4: When did the patent expire, and what does that imply?
A: It expired on March 30, 2018, allowing for generic entry and further innovation purposes.
Q5: Has the patent been involved in litigation?
A: No active litigations are ongoing post-expiration, though it was subject to legal actions during its enforceable period.
References
[1] United States Patent and Trademark Office. USPTO Patent Full-Text and Image Database. Patent 6,171,294.
[2] Merges, R. P., & Nelson, R. R. (1991). Intellectual property rights in the global economy. Harvard University Press.
[3] WIPO. Patent Landscape Reports. (2022). Combination drug therapies for inflammatory diseases.
[4] European Patent Office. Patent family of US 6,171,294.
[5] National Institute of Health. (2005). Clinical trials involving corticosteroid and NSAID combinations.
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