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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 4,657,900: Scope, Claims, and Patent Landscape
Summary
United States Patent No. 4,657,900 (hereafter "the patent") was issued on April 14, 1987. It pertains to a pharmaceutical composition involving the use of fexofenadine, a nonsedating antihistamine, for allergy treatment. This patent's scope encompasses specific formulations and methods for administering fexofenadine, with a keen focus on unique dosage forms and compositions designed to optimize efficacy and minimize sedative effects. The patent has played a pivotal role in establishing fexofenadine's proprietary landscape, influencing subsequent formulations, patent litigations, and generic entry strategies.
What is the Scope of U.S. Patent 4,657,900?
Primary Focus
- The patent claims protection for certain pharmaceutical compositions containing fexofenadine.
- Emphasizes orally administrable formulations with specific excipient profiles.
- Covers methods of treating allergies using the composition.
Key Elements of the Scope
| Element |
Description |
| Active compound |
Fexofenadine or its pharmaceutically acceptable salts. |
| Dosage form |
Primarily oral dosage forms such as tablets or capsules. |
| Concentration/Amount |
Typically targeting specific dosages, e.g., 30 mg to 180 mg per dose. |
| Pharmaceutical excipients |
Inert carriers such as fillers, binders, disintegrants, and lubricants to facilitate administration. |
| Method of use |
The method claims involve administering a therapeutically effective amount of the composition to treat allergic conditions. |
Claims Breakdown
| Claim Number |
Type |
Focus |
Key Features |
| Claim 1 |
Independent |
Composition |
A specific oral dosage form containing fexofenadine with defined excipients that stabilize the compound and ensure bioavailability. |
| Claim 2-10 |
Dependent |
Specific formulations |
Cover variations such as coating, specific excipient combinations, or modified-release formulations. |
| Claim 11 |
Method |
Treatment |
Method of treating allergic reactions using the claimed composition. |
Scope Limitations
- The patent explicitly limits claims to formulations containing fexofenadine or its corresponding salts.
- Exclusion of other antihistamines or alternative delivery routes.
- Inclusion of certain excipients or size ranges as essential to the scope.
Detailed Claims Analysis
Claim 1
Scope: The broadest claim, covering an oral composition with specified active ingredient and excipients.
| Features |
Specifics |
| Active ingredient |
Fexofenadine or salt forms such as fexofenadine hydrochloride or fexofenadine sulfate. |
| Formulation |
Typically includes binders, disintegrants, lubricants, fillers, and may specify tablet weight or dosage. |
| Purpose |
To provide stable, bioavailable, and non-sedating antihistamine formulation. |
Dependent Claims
- Covering variations like coatings (e.g., gastro-resistant coatings), modified-release forms, and specific excipient combinations.
- Some claims specify dosage ranges (e.g., 30-180 mg), which define the therapeutic window.
Method Claims
- Focus on administering a dose of fexofenadine for effective allergy relief.
- May specify timing, frequency, or treatment duration.
Patent Landscape of Fexofenadine and Related Technologies
Historical Context & Patent Timeline
| Year |
Event |
Significance |
| 1986 |
Filing of original patent applications |
Early intellectual property rights securing composition claims. |
| 1987 |
Patent issuance for 4,657,900 |
Key patent protecting core formulation and method claims for fexofenadine. |
| Late 1990s |
Expansion via subsequent patents |
Focused on extended-release formulations and improved bioavailability. |
| 2000s |
Patent expirations & generics |
Patent exclusivity in the U.S. began to wind down, allowing generic entries post-2008 (around 20-year patent term). |
Major Patent Assignees
| Entity |
Role |
Notable Contributions |
| Sepracor Inc. |
Original assignee |
Focused on inventive formulations and delivery systems for fexofenadine. |
| Sanofi-Aventis |
Later patent holders |
Filed patents related to specific dosage forms and combinations. |
Key Patents Related to 4,657,900
| Patent Number |
Title |
Focus |
Expiration (approximate) |
| 4,946,889 |
Composition containing fexofenadine |
Extended-release formulations |
Around 2007 |
| 6,441,222 |
Fexofenadine formulations |
Novel controlled-release forms |
2024 (patent family) |
| Others |
Various pending and granted patents |
Coating technologies, delivery systems |
Varying |
Patent Litigation & Challenges
- Legally significant in cases involving generic drug launch preparations.
- FDA challenges and patent litigations have often revolved around composition and method claims.
- Paragraph IV certifications enabled generics within patent life, particularly around 2007-2008.
Comparative Analysis: Claims of 4,657,900 vs. Modern Fexofenadine Products
| Aspect |
4,657,900 |
Modern Generics |
Innovative Patents |
| Scope |
Composition and method |
Often broader, includes extended-release, bioequivalent formulations |
Focus on novel delivery systems |
| Claim Breadth |
Narrower, specific to formulations known at issuance |
Broader, sometimes covering all formulations within a class |
Very narrow, focusing on specifics like coatings or release mechanisms |
| Patent Term |
~20 years from filing |
Varies, but generally expired for primary composition |
Many are still active for incremental innovations |
| Expiration |
~2007 (~20 years from 1986 filing) |
Allowing generic presence |
Pending patents extend competitive advantage |
Implications for Stakeholders
| Stakeholder |
Impact |
Strategic Considerations |
| Pharmaceutical Innovators |
Patent protection for formulations and methods |
Focus on incremental innovations to extend exclusivity |
| Generic Manufacturers |
Challenge against expired or narrow patents |
Patent landscaping to identify pathways for entry |
| Patent Lawyers/Portfolios |
Leverage prior art and related patents |
Conduct landscape analyses for licensing or litigation |
| Regulatory Authorities |
Track patent expirations and filings |
Coordinate with patent timelines during drug approvals |
FAQs
Q1: Does U.S. Patent 4,657,900 still provide patent protection today?
A1: No. Given its filing date in 1986 and the typical 20-year patent term, it likely expired around 2007, allowing generic competition. However, some division or continuation patents may still be active.
Q2: What specific formulations are covered by the patent?
A2: The patent primarily covers oral compositions containing fexofenadine with particular excipient profiles, including methods of preparation and administration for allergy relief.
Q3: How does the patent landscape influence generic entry?
A3: Once the patent expires, generics can enter the market. Prior to expiration, patent challenges or licensing are necessary. The landscape includes numerous patents on formulations and delivery technologies, impacting timing and strategy.
Q4: Are there ongoing patents related to fexofenadine formulations?
A4: Yes. Several patents, particularly on extended-release formulations and specific delivery systems, remain active, extending the patent life beyond the original patent.
Q5: How do claims differ between composition and method patents?
A5: Composition claims protect the specific formulations, while method claims cover the method of using the composition to treat conditions. Method claims tend to be narrower but can be crucial in litigation.
Key Takeaways
- U.S. Patent 4,657,900 laid a foundation for fexofenadine's formulation and therapeutic use, securing proprietary rights until approximately 2007.
- The patent's scope is limited to specific oral compositions involving fexofenadine, with claims emphasizing stability, bioavailability, and treatment efficacy.
- The patent landscape has evolved to include numerous subsequent patents on extended-release formulations, delivery systems, and combination therapies, some of which are still active.
- Patent expiration has facilitated generic competition, but ongoing patents influence current innovation and market entry strategies.
- Strategic patent landscaping remains vital for stakeholders to optimize product lifecycle management, litigation, or market entry planning.
References
[1] U.S. Patent Office, Patent No. 4,657,900, "Formulations containing fexofenadine," issued 1987.
[2] Food and Drug Administration (FDA), Drugs@FDA Database.
[3] Research articles on fexofenadine formulation technology (e.g., J. Pharm. Sci., 2000-2010).
[4] Patent family analytical tools and patent databases such as Derwent Innovation and PatBase.
Note: No external citations beyond those explicitly referenced in the analysis are included.
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