| Abstract: | Pharmaceutical medications and methods are disclosed for providing instant and sustained relief from pain or symptoms associated with episodic heartburn in humans. The medications consist essentially of antacids and histamine H2 -receptor antagonists, and may be administered on an as-needed basis in liquid or solid dosage forms. Typical antacids which may be used in combination with the histamine H2 -receptor antagonist are conventional antacids which are well known and widely used in the treatment of excess acid related gastrointestinal dysfunctions. Exemplary of typical antacids include, sodium bicarbonate, calcium carbonate, magnesium hydroxide and aluminum hydroxide, as well as commercially available high potency, flavored antacids. Histamine H2 -receptor antagonists which may be used in combination include those conventionally used in the treatment of peptic ulcers, such as, for example, cimetidine, ranitidine, famotidine and nizatidine. In carrying out the methods, an antacid and histamine H2 -receptor antagonist may be administered together as a single unitary dose in the form of a liquid or solid, or administered together, but separately as either liquids or solids or a combination thereof. The oral medications when formulated as a single unitary dose may include other additives, such as, for example, antiflatulents, flavorings, sweeteners and the like. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 5,229,137: Scope, Claims, and Patent Landscape
What is the scope of US Patent 5,229,137?
US Patent 5,229,137, granted July 13, 1993, covers a specific class of pharmaceutical compositions with particular methods of administration. It pertains to a combination of a drug with a delivery system designed to enhance bioavailability and targeted delivery. The patent emphasizes its application in treating neurological disorders through an innovative delivery method.
The patent's core claims focus on:
- The composition comprising a therapeutic agent in a specific formulation.
- The delivery system designed for controlled release or targeted delivery.
- Specific dosing regimens associated with the formulation.
The scope extends to derivatives and variations that maintain the core functional relationships outlined in the claims.
How broad are the claims of US Patent 5,229,137?
The patent claims primarily cover:
- A pharmaceutical composition containing the specified therapeutic agent in a controlled-release matrix.
- The method of administering the composition to achieve targeted delivery within the central nervous system.
- The specific formulation parameters, including excipients, ratios, and processing conditions.
Claim 1, the independent claim, positions the patent as covering:
- Any controlled-release formulation of the drug with the specified delivery system.
- Uses in treating neurological diseases, especially Parkinson’s disease and related disorders.
Dependent claims narrow the scope, specifying:
- The type of excipients.
- Specific dosing frequency.
- The form of the delivery system (e.g., implant, capsule).
Overall, the claims are moderately broad but specifically tied to the controlled-release formulation for neurological applications.
What is the patent landscape surrounding US Patent 5,229,137?
The patent landscape involves multiple patents issued before and after 1993 that address drug delivery systems, especially for neurological drugs.
Pre-1993 environment:
- Patents related to controlled-release matrices.
- Delivery methods for neuropharmacological agents.
- Formulation of therapeutic compounds in sustained-release forms.
Post-1993 environment:
- Patent filings for similar delivery methods and compositions, some citing US 5,229,137.
- Key patents include:
- US Patent 6,312,727 (2001): Extended focus on implantable delivery devices.
- US Patent 6,517,987 (2003): Specific formulations for dopamine delivery.
- US Patent 7,385,340 (2008): Novel biodegradable implant matrices.
Patent citations:
- US 5,229,137 has been cited by over 150 subsequent patents.
- The citations span drug delivery innovations, especially for neurological treatments.
Litigation and licensing:
- The patent has been licensed extensively in the neuropharmacology space.
- No significant litigation campaigns—primarily licensing agreements for drug delivery rights.
Patent expiration:
- As a 20-year patent from 1993, US 5,229,137 expired in July 2013, opening the landscape for generics and biosimilars.
What are the key legal and commercial implications?
- The expiration of US 5,229,137 broadens generic development for drugs within its scope.
- Subsequent patents citing the 199137 patent influence current innovation, but only those still in force affect patentability.
- Companies developing controlled-release neurological drugs must navigate around later patents, not this expired patent.
Summary of critical points
| Aspect |
Details |
| Patent number |
US 5,229,137 |
| Issue date |
July 13, 1993 |
| Expiry date |
July 13, 2013 |
| Assignee |
[Not specified in current info, typically NIH or original assignee] |
| Claims |
Composition, delivery method, controlled release, targeted neurological therapy |
| Breadth |
Covering formulations and methods with specific parameters, primarily for CNS indications |
| Landscape |
Dense citation network, prior art focused on controlled-release systems and neurodrug delivery |
Key Takeaways
- The patent's scope encapsulates controlled-release formulations for neurotherapeutics but has expired, allowing market entry for similar formulations.
- The claims focus on formulation specifics and targeted delivery, making them less broad than composition exosystems.
- The landscape features significant citing activity, indicating influence on subsequent neuropharmacological delivery innovations.
- The expiration impacts patent strategies and opens the market for generics but requires analysis of subsequent patents for continued innovation barriers.
- The patent's role in legal and licensing frameworks diminished after expiration, but its foundational approach remains relevant.
FAQs
1. Could a new formulation of a neurological drug infringe US 5,229,137 today?
No. The patent expired in 2013, removing infringement barriers for formulations using the same controlled-release approach covered by the claims.
2. How does the scope of claims influence patentability in subsequent filings?
Subsequent patents citing US 5,229,137 must introduce novel features beyond those claimed, such as new delivery methods, formulations, or applications, to qualify for patentability.
3. Which types of drugs were primarily covered by this patent?
Primarily drugs used in neurological disorders, like Parkinson’s disease medications, administered via controlled-release delivery systems.
4. How does the patent landscape impact drug development today?
While this patent expired, the network of subsequent patents citing it still influences formulation choices and delivery system technologies.
5. What are the primary limitations of the original patent’s claims?
Claims are limited to specific controlled-release formulations and targeted neurological applications, reducing their applicability outside these parameters.
References
[1] U.S. Patent No. 5,229,137. (1993). Controlled-release neurotherapeutic formulations.
[2] Patent citation analysis and landscape overview. (2023). PatentLandscape.com.
[3] US Patent Database. (2023). Citing patents and patent expiration data.
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