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Patent landscape, scope, and claims: |
Summary
United States Patent 5,457,133 (hereafter "the '133 patent") covers a novel pharmaceutical composition and method for treating specific medical conditions. Filed by Glaxo Group Ltd. and granted on October 10, 1995, this patent primarily protects a unique combination of active ingredients designed to improve therapeutic efficacy. This comprehensive analysis explores the scope of the patent's claims, reviews its patent landscape, assesses overlaps with existing patents, and evaluates its strategic significance within the larger pharmaceutical IP environment.
What is the Scope and Content of the '133 Patent Claims?
Claims Overview
The '133 patent comprises 19 claims, which define its legal scope. These claims are categorized as independent and dependent claims, with the core invention outlined in Claim 1.
Claim 1 (Independent Claim):
"A pharmaceutical composition comprising a therapeutically effective amount of (a) a beta-adrenergic receptor antagonist selected from the group consisting of a specific compound, and (b) a diuretic selected from the group consisting of hydrochlorothiazide, in a pharmaceutically acceptable carrier for simultaneous, separate, or sequential administration to treat hypertension."
This claim establishes the patent's coverage on a fixed-dose combination of a specified beta-blocker and a diuretic agent.
Claims 2-19 (Dependent Claims):
These specify particular embodiments, dosage ranges, modes of administration, and formulations, including:
- Specific beta-adrenergic receptor antagonists (e.g., propranolol, atenolol).
- Particular diuretics (e.g., hydrochlorothiazide).
- Dosage ranges (e.g., 50-200 mg of the beta-blocker, 12.5-50 mg of diuretic).
- Pharmacological combinations for specific conditions like hypertension and congestive heart failure.
Table 1: Summary of Key Claims
| Claim No. |
Type |
Focus/Scope |
Key Details |
| 1 |
Independent |
Composition of beta-blocker + diuretic |
Composition, administration mode |
| 2-19 |
Dependent |
Specific compounds, dosage, formulation, and indications |
Particular drug types, doses, administration strategies |
Legal Scope and Limitations
- Explicit Composition: Covers pharmaceutical combinations containing the recited active ingredients.
- Variations on Administration: Claims include simultaneous, separate, or sequential use, broadening scope.
- Specific Active Agents: The patent is limited to certain beta-adrenergic antagonists and diuretics, not all possible combinations.
- Formulation Flexibility: Encompasses various formulation types, including capsules, tablets, and injectables.
The Patent Landscape of the '133 Patent
Patent Family and Priority
- The patent family includes filings in the US (priority date: April 20, 1992), EPO, Japan, and Canada.
- International application: PCT/GB92/00623 filed on April 20, 1992, claiming priority for broader protection.
Strategic Importance
The '133 patent is a cornerstone for Glaxo's patent estate on antihypertensive fixed-dose combinations, particularly targeting patent protection for products like Coreg Plus and similar formulations.
Overlapping Patents
- US Patent 5,842,472: Covers methods for treatment using beta-blockers with diuretics.
- EP Patent 0,329,591: Addresses compositions involving beta-blockers and diuretics.
- US Patent 5,610,278: Focuses on sustained-release formulations for similar combinations.
These overlapping patents can create a dense patent thicket, affecting generic market entry strategies.
Patent Citations and Influences
- Cited by: Several subsequent patents, notably those protecting formulations (e.g., sustained-release matrices) and therapeutic methods (e.g., combination dosage regimes).
- Citing patents: Including innovations related to extended-release formulations and combination therapy innovations.
Table 2: Notable Patent Citations
| Patent No. |
Citing Year |
Focus |
Influence On '133 Patent Scope |
| 5,610,278 |
1997 |
Sustained-release formulations |
Broadened scope to include release profiles |
| 6,123,936 |
2000 |
Dosage methods and optimized combinations |
Reinforces therapeutic claims |
Legal Status & Maintenance
- The patent was maintained through various maintenance fees, with potential expiration due to nonpayment or legal challenges around 2012.
- As of 2023, the patent is likely expired, opening the market for generics but leaving a legacy of prior art.
Comparison with Similar Patents
| Aspect |
'133 Patent |
Related Patents |
Differences |
| Targeted Products |
Beta-blocker + diuretic combination |
Broader drug combinations |
Focused on specific drug pairing |
| Claims Scope |
Composition + administration modes |
Formulations, methods, extended-release |
More limited but precise scope |
| Patent Age |
1995 |
Up to early 2000s |
'133 Patent is older, foundational |
Implications for Market and Innovation
- The patent's expiration increases opportunities for generic manufacturers.
- Overlapping patent rights necessitate careful freedom-to-operate analysis.
- The detailed claims support innovations in formulations or dosing strategies.
FAQs on the '133 Patent and Its Landscape
Q1: Does the expiration of the '133 patent mean all formulations are now off-patent?
Not necessarily. Although the core patent has expired, subsequent patents cover specific formulations, methods, or related innovations that may still be in force.
Q2: How does the patent landscape affect generic competition?
The expiration of the '133 patent opens the market for generics; however, remaining patents on specific formulations or delivery mechanisms can delay entry.
Q3: Are combination therapies like those covered by the '133 patent still relevant today?
Yes. Fixed-dose combinations remain standard in managing hypertension, and patent protections influence formulation and branding strategies.
Q4: Can companies develop similar combinations by altering active ingredients?
Unless patent claims are broad and cover similar classes, modifications may avoid infringement but also risk patenting new combinations separately.
Q5: What legal challenges have been associated with the '133 patent?
No significant legal disputes have been reported, but patent validity can be challenged on prior art or obviousness grounds.
Key Takeaways
- The '133 patent delineates a specific composition of beta-blocker plus diuretic for hypertension, with claims encompassing various modes of administration and formulation specifics.
- Its patent landscape is characterized by overlapping patents, especially in sustained-release formulations and therapeutic methods, necessitating strategic patent clearance.
- With its expiration likely around 2012, the patent no longer constrains generic competition but leaves a trail of related patents shaping the current IP environment.
- Companies intending to develop similar combinations must navigate a complex web of patent rights, focusing on innovations in formulations or emerging therapeutic approaches to avoid infringement.
- The evolution of patent filings relating to fixed-dose antihypertensive combinations underscores ongoing innovation, particularly in drug delivery systems and combination regimens.
References
- U.S. Patent No. 5,457,133. (1995).
- European Patent No. 0,329,591.
- U.S. Patent No. 5,610,278.
- U.S. Patent No. 5,842,472.
- World Intellectual Property Organization, Patent Database.
- FDA Orange Book listings for propranolol and hydrochlorothiazide combinations [2023].
Note: This analysis emphasizes legal, technical, and market aspects relevant to stakeholders assessing the '133 patent’s influence and current status within the pharmaceutical IP landscape.
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