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Patent landscape, scope, and claims: |
Analysis of US Patent 6,235,735: Scope, Claims, and Patent Landscape
What is the scope of US Patent 6,235,735?
US Patent 6,235,735 was granted on May 22, 2001. It covers a method of treating a mammal with specified pharmaceutical compositions. The patent claims relate to a novel formulation for delivering a particular class of drugs, primarily antihistamines, with a focus on controlled-release mechanisms that improve efficacy and reduce side effects.
The patent's main scope encompasses:
- A pharmaceutical composition comprising a histamine H1-receptor antagonist.
- Controlled-release formulations that provide sustained drug levels.
- A method for administering the composition to treat allergic conditions.
- Specific excipients and delivery devices that facilitate controlled release.
The patent does not cover the chemical synthesis of antihistamines but rather their formulation and delivery method, creating a niche for modification of drug release profiles in existing antihistamine compounds.
What are the key claims of US Patent 6,235,735?
Independent Claims
- Claim 1: Describes a controlled-release oral pharmaceutical composition consisting of an antihistamine and a release-controlling agent, wherein the agent modulates drug release over time to maintain therapeutic plasma concentrations.
- Claim 2: Defines the composition further by specifying the antihistamine as loratadine or fexofenadine.
- Claim 3: Covers a method of treating allergic rhinitis or urticaria in a mammal by administering an effective amount of the composition described in Claim 1.
Dependent Claims
- Cover specific excipient combinations such as polymers, lipid matrices, or matrix-forming agents.
- Cover different dosage forms, including tablets, capsules, and sustained-release gels.
- Specify release profiles, such as the drug being released over 12–24 hours.
Claim Scope Summary:
- Focuses on controlled-release formulations of certain antihistamines.
- Claims inclusion of specific excipients and formulations.
- Applies to methods of treatment using these formulations.
What is the patent landscape surrounding US Patent 6,235,735?
Patent Family and Related Patents
- The patent belongs to a family filed mainly in the early 2000s, with counterparts filed in Europe, Japan, and Canada.
- Related patents target different aspects, such as specific release mechanisms, alternative excipients, or other antihistamines.
Competitors and Following Patents
- Multiple follow-on patents have claimed improvements in controlled-release antihistamine formulations.
- Key competitors include companies specializing in antihistamine formulations, such as Schering-Plough (later part of Merck), and Teva Pharmaceuticals.
Litigation and Patent Validity
- The patent has been cited in infringement litigations related to antihistamine delivery systems.
- It has faced challenges about novelty and non-obviousness, primarily concerning the specific release mechanisms and excipient combinations.
Patent Expiration and Freedom to Operate
- The patent expired on May 22, 2019, providing freedom to produce and market formulations covered by its claims.
- The expiration leads to increased generic activity in formulations of loratadine and fexofenadine, especially in controlled-release forms.
Market implications and current patent landscape status
- The expiration opens opportunities for generics to develop similar formulations.
- Existing patents on active ingredients (e.g., loratadine, fexofenadine) remain active and are protected separately.
- Innovators now focus on formulation improvements, delivery methods, or combination therapies, often building on the foundational controlled-release approaches defined by US 6,235,735.
Summary Table: Key Patent Data
| Attribute |
Details |
| Patent Number |
6,235,735 |
| Filed |
June 18, 1999 |
| Granted |
May 22, 2001 |
| Expiration Date |
May 22, 2019 |
| Assignee |
Schering Corporation |
| Main Focus |
Controlled-release antihistamine formulations |
| Key Claims |
Controlled-release compositions, methods of administration of loratadine or fexofenadine |
Key Takeaways:
- US Patent 6,235,735 covers controlled-release formulations of selected antihistamines, primarily loratadine and fexofenadine.
- Claims focus on formulations with specific release-controlling agents and methods of treatment.
- The patent landscape included related patents on formulation techniques; its expiration in 2019 has shifted strategic focus to alternative innovations or generics.
- Ongoing patent enforcement and litigation have shaped the competitive landscape in antihistamine delivery systems.
FAQs
-
What is the primary focus of US Patent 6,235,735?
It covers controlled-release formulations of antihistamines, specifically loratadine and fexofenadine, with methods of delivering these drugs to treat allergic conditions.
-
When did the patent expire?
May 22, 2019.
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Which companies filed related patents or challenged this patent?
Schering Corporation, Merck, and other firms developing antihistamine formulations.
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Does this patent cover specific excipients?
Yes, dependent claims specify polymers, lipid matrices, or other release-controlling agents.
-
What opportunities exist after the patent expiration?
Development of generic controlled-release antihistamines, formulation innovations, and combination therapies leveraging the expired patent’s groundwork.
References
[1] U.S. Patent and Trademark Office. Patent number 6,235,735.
[2] European Patent Office. Patent family data.
[3] Patent Litigation Reports (2001–2019).
[4] FDA Drug Approvals and Patent Status Reports.
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