United States Patent 4,980,173: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,980,173, titled "Pharmaceutical Composition and Method for the Treatment of Colitis Ulcerosa and Crohn's Disease by Oral Administration," was granted on December 25, 1990. This patent, invented by Soren Halskov and assigned to Farmaceutisk Laboratorium Ferring A/S, is significant in the field of pharmaceuticals, particularly for the treatment of inflammatory bowel diseases (IBD).
Background and Context
Colitis ulcerosa and Crohn's disease are chronic inflammatory bowel diseases that affect millions of people worldwide. The treatment of these conditions often involves complex pharmaceutical regimens. The patent in question addresses a specific approach to treating these diseases through oral administration of a pharmaceutical composition.
Scope of the Patent
The patent describes a pharmaceutical composition useful for the treatment of colitis ulcerosa and Crohn's disease. The composition includes derivatives of salicylic acid, particularly meta- (or 5-) aminosalicylic acid and its esters, which are known for their anti-inflammatory properties[1].
Key Components
- Salicylic Acid Derivatives: The patent highlights the use of meta- (or 5-) aminosalicylic acid and its esters. These compounds are effective in treating inflammatory bowel diseases due to their ability to reduce inflammation in the gastrointestinal tract.
- Pharmaceutically Acceptable Salts: The composition can include alkali metal salts (e.g., sodium, potassium) and alkaline earth metal salts (e.g., calcium, magnesium) of the salicylic acid derivatives.
- Esters: The patent mentions various esters, such as straight chain or branched C1-C18 alkyl esters (e.g., methyl, ethyl, propyl), which can be used to enhance the delivery and efficacy of the active ingredients.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1
- A pharmaceutical composition for the treatment of colitis ulcerosa and Crohn's disease, comprising a therapeutically effective amount of a meta- (or 5-) aminosalicylic acid derivative or its ester, and a pharmaceutically acceptable carrier.
Claim 2
- The composition of claim 1, where the derivative is in the form of a salt, preferably a sodium or calcium salt.
Claim 3
- The composition of claim 1, where the ester is a straight chain or branched C1-C18 alkyl ester.
Patent Landscape
The patent landscape surrounding US 4,980,173 is complex and involves several related patents and publications.
Related Patents
- Continuation and Divisional Patents: This patent is part of a series of continuations and divisionals, starting from the original PCT application PCT/DK/81/00027. This indicates a long history of development and refinement of the invention[1].
- Other Relevant Patents: Patents such as US 9,539,265 B2, which also deal with pharmaceutical formulations for treating inflammatory conditions, highlight the ongoing research and innovation in this field[2].
Citations and References
The patent cites several earlier patents and publications, including those related to the use of salicylic acid derivatives and other anti-inflammatory compounds. For example, the patent references Danish patent application No. 1270/77, which discloses esters of salicylic acid useful as ultraviolet ray screening compounds[1].
Impact and Significance
The patent has significant implications for the treatment of colitis ulcerosa and Crohn's disease. The use of oral administration of meta- (or 5-) aminosalicylic acid derivatives and their esters provides a targeted and effective treatment option for patients suffering from these conditions.
Clinical Relevance
- Efficacy: The composition described in the patent has been shown to be effective in reducing inflammation and improving symptoms in patients with IBD.
- Convenience: Oral administration makes the treatment more convenient and potentially increases patient compliance compared to other forms of administration.
Industry Expert Insights
Industry experts emphasize the importance of targeted therapies in managing IBD. For instance, Kathleen A. Head et al., in their review on inflammatory bowel disease, highlight the conventional and alternative treatment options, including the use of aminosalicylates like those described in this patent[2].
Statistical Significance
The prevalence of IBD is significant, with millions of people worldwide affected. Effective treatments like the one described in this patent can improve the quality of life for these patients. For example, a study might show that patients treated with this composition experience a reduction in symptoms and an improvement in their overall health outcomes.
Future Developments
The patent landscape continues to evolve with new formulations and delivery methods being developed. For instance, modified release formulations, as described in other patents, aim to enhance the efficacy and convenience of IBD treatments[5].
Key Takeaways
- Pharmaceutical Composition: The patent describes a pharmaceutical composition using meta- (or 5-) aminosalicylic acid derivatives and their esters for treating colitis ulcerosa and Crohn's disease.
- Oral Administration: The composition is administered orally, making it a convenient treatment option.
- Efficacy: The treatment has been shown to be effective in reducing inflammation and improving symptoms in IBD patients.
- Patent Landscape: The patent is part of a broader landscape of related patents and ongoing research in IBD treatments.
FAQs
1. What is the main active ingredient in the pharmaceutical composition described in US 4,980,173?
The main active ingredient is meta- (or 5-) aminosalicylic acid or its esters.
2. How is the composition administered?
The composition is administered orally.
3. What are the benefits of using this composition for treating IBD?
The benefits include targeted anti-inflammatory action, convenience of oral administration, and improved patient compliance.
4. Are there other related patents in this field?
Yes, there are several related patents and ongoing research in the field of IBD treatments, including modified release formulations and other pharmaceutical compositions.
5. What is the significance of this patent in the context of IBD treatment?
This patent provides a specific and effective treatment option for patients with colitis ulcerosa and Crohn's disease, contributing to the broader arsenal of therapies available for managing IBD.
Cited Sources
- United States Patent 4,980,173: "Pharmaceutical Composition and Method for the Treatment of Colitis Ulcerosa and Crohn's Disease by Oral Administration."
- United States Patent 9,539,265 B2: "Pharmaceutical Formulation."
- Alternative Medicine Review: "Inflammatory bowel disease Part 1: ulcerative colitis-pathophysiology and conventional and alternative treatment options."
- Google Patents: "Modified release formulations for treating inflammatory bowel disease."
