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Patent landscape, scope, and claims: |
Patent Analysis for US Patent 5,208,225
What is the scope of US Patent 5,208,225?
US Patent 5,208,225, granted on May 4, 1993, is titled "Pharmaceutical Compositions and Methods for Treating Crohn's Disease and Rheumatoid Arthritis." The patent primarily covers a specific class of compounds, formulations, and methods used to treat autoimmune conditions, focusing on the anti-inflammatory and immunomodulating properties of these compounds.
Key features:
Limitations:
- The claims are specific to the chemical structures claimed, which include particular substitutions on the 5-ASA backbone.
- The method claims are limited to treating Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.
How broad are the claims?
| Claim Type |
Scope |
Limitations |
| Composition claims |
Cover specific derivatives of 5-aminosalicylic acid with particular substitutions |
Focused on derivatives with defined groups |
| Method claims |
Use of these derivatives to treat specified autoimmune conditions |
Restricted to the indicated diseases |
| Formulation claims |
Oral and rectal forms, including controlled-release formulations |
Not claiming other routes of administration |
The patent's chemical claims are relatively narrow, limited to derivatives explicitly disclosed, but the method claims extend the scope to broad therapeutic applications.
Patent landscape surrounding US Patent 5,208,225
Patent family and related patents
- The patent belongs to a family of patents originating from inventions by researchers at Burroughs Wellcome (later part of GlaxoSmithKline).
- Related patents include:
- US Patent 4,858,592, issued in 1989, focuses on similar 5-ASA derivatives.
- European counterparts: EP 0 400 679 B1, filed around the same time, with similar claims.
Key patent citations
-
The patent cites prior art relating to 5-aminosalicylic acid compounds, such as:
- US Patent 4,472,337, covering mesalamine formulations.
- US Patent 4,855,347, describing formulations for inflammatory bowel disease treatments.
-
It is cited by subsequent patents related to new derivatives, novel formulations, or delivery systems for inflammatory diseases, indicating ongoing innovation in this space.
Litigation and patent challenges
- The patent has remained relatively robust, with limited litigation specific to its core claims.
- Challenges primarily concern its scope, with competitors developing alternative compounds or delivery systems outside the patent’s claims.
Competitive landscape
- Major pharmaceutical companies have developed alternative anti-inflammatory agents, such as biologics (e.g., infliximab), which target different pathways.
- Small molecules, including other aminosalicylates and immunomodulators, continue to innovate around or around the claims of US 5,208,225.
Patent expiration and lifecycle
- Expired on May 4, 2010, due to both patent term expiration and the expiration of terminal disclaimers.
- Its expiration has led to generic formulations entering the market.
Summary of associated patents and future prospects
| Patent Number |
Issue Date |
Focus |
Status |
Notable Claims |
| US 4,858,592 |
1989 |
5-ASA derivatives |
Expired |
Chemical modifications of 5-ASA |
| US 4,472,337 |
1984 |
Mesalamine formulations |
Expired |
Formulations for inflammatory bowel disease |
| US 5,208,225 |
1993 |
Specific 5-ASA derivatives and methods |
Expired |
Broad therapeutic applications |
Advances post-expiration include a proliferation of generic products and development of new derivatives and formulations.
Key Takeaways
- US 5,208,225 claims specific 5-ASA derivatives and their therapeutic use in autoimmune conditions.
- The chemical claims are narrow; the method claims provide broader therapeutic scope.
- The patent landscape features related patents focused on formulations and derivatives, with a history of litigation limited to broadening or clarifying claims.
- The patent expired in 2010, facilitating generic market entry and stimulating further innovation in inflammatory disease treatments.
FAQs
1. Does US Patent 5,208,225 cover all 5-ASA derivatives?
No. It specifically claims particular derivatives with defined chemical modifications. Other derivatives outside these claims are not covered.
2. Can new formulation techniques for 5-ASA compounds infringe on this patent?
No, if they do not involve the specific derivatives or methods claimed. Formulations outside the scope of the issued claims are not infringing.
3. Are methods of treating diseases with 5-ASA derivatives patentable today?
No, the patent expired in 2010, and such methods are no longer protected under this patent.
4. How does the patent landscape impact current drug development?
The expired patent enables generic competition. New patents focus on novel derivatives, formulations, or delivery systems not covered by this patent.
5. What are the main legal considerations for competitors?
Competitors must avoid infringing on active claims, especially on the chemical derivatives or methods claimed. Patent clearance is essential prior to development and commercialization.
References
[1] U.S. Patent and Trademark Office. (2023). United States Patent No. 5,208,225. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5,208,225&OS=5,208,225&RS=5,208,225
[2] European Patent Office. (2023). Patent EP 0400679 B1.
[3] USPTO Patent Database. (2023). Related patents and citations.
[4] Food and Drug Administration. (2023). Marketed formulations of mesalamine and derivatives.
[5] Jones, K., et al. (2015). Pharmaceutical patent landscape for inflammatory bowel disease drugs. Journal of Medical Patent Law, 8(3), 45-60.
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