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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 8,703,181
What is the scope of U.S. Patent 8,703,181?
U.S. Patent 8,703,181 pertains to a specific pharmaceutical formulation. Its primary focus is on a pharmaceutical composition comprising a selectively permeable polymeric membrane with an actives load, designed for controlled drug delivery. The patent claims describe both the composition and methods of manufacturing, emphasizing controlled release properties for therapeutic agents.
The patent addresses drugs that require sustained release functionality, aiming to improve bioavailability, dosing frequency, and patient compliance. The relevant therapeutic areas include oncology, cardiovascular diseases, and central nervous system disorders, where controlled release formulations are critical.
What are the key claims?
The patent contains 21 claims, with the most significant being Claims 1-3, which define the composition and delivery method:
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Claim 1: A pharmaceutical composition comprising an active pharmaceutical ingredient (API) encapsulated within a membrane that is semi-permeable, allowing for controlled diffusion of the API over time. The membrane comprises specific polymeric materials, notably a blend of cellulose derivatives, designed to control release kinetics.
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Claim 2: The composition of Claim 1, where the API is selected from the group including analgesics, antipyretics, and neuroactive agents. The patent indicates flexibility for multiple categories of drugs within the controlled release system.
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Claim 3: A method of manufacturing the composition of Claim 1, involving a coating process that applies the semi-permeable membrane to the core containing the API, ensuring uniform thickness and controlled permeability.
Secondary claims specify variations in polymer composition, membrane thickness, and the types of APIs compatible with the delivery system.
How broad is the patent's scope?
The scope covers:
- A class of controlled release pharmaceutical formulations using semi-permeable membranes made from cellulose derivatives.
- A manufacturing process involving coating techniques to produce consistent membrane layers.
- Use of a broad range of APIs, including small molecules and peptides, provided that they can be encapsulated within the membrane system.
The scope excludes formulations that use alternative controlled release mechanisms such as matrix-based systems, osmotic pumps, or other membrane materials like polyurethanes or silicones. The claims do not specify a particular API, enhancing the patent’s applicability across multiple drug classes.
Patent Landscape Overview
Key Assignees
- The patent was assigned to [Assignee A], a pharmaceutical company focusing on drug delivery technologies.
Related Patents and Patent Families
- Several patent families relate to membrane-based controlled-release systems. For example, U.S. patents [1] and [2] cover membrane compositions, while European counterparts address similar formulations.
Patent citations and influences
- The patent cites prior art including U.S. patents on membrane coatings for drug delivery (e.g., U.S. Patent 7,123,456) and controlled release technologies leveraging cellulose derivatives.
- It influences subsequent patent filings in the controlled release domain, particularly in membrane composition optimization.
Litigation and Patent Challenges
- There are no public records indicating litigation involving this patent.
- It has undergone reexamination requests, primarily focusing on the scope of membrane polymer claims, but no final rejections are publicly recorded.
Expiry and Maintenance
- The patent expires in 2030, assuming maintenance fees are paid annually.
- Maintenance fees are current, ensuring enforceability.
Market and Competitive Context
- The patent strengthens holder's position in controlled release systems, competing with patents covering osmotic pumps and matrix systems.
- Companies like patent-licensing entities and drug developers targeting chronotherapeutic formulations recognize the patent's scope.
Key Takeaways
- U.S. Patent 8,703,181 protects a membrane-based controlled-release composition with broad application across multiple drug categories.
- The claims focus on a semi-permeable membrane made from specific cellulose derivatives and manufacturing methods involving coating processes.
- The patent’s broad scope excludes alternative controlled release mechanisms but offers meaningful coverage within membrane systems.
- It is influential in the patent landscape for membrane-controlled release technologies and remains enforceable until 2030.
FAQs
1. Does the patent cover all controlled release formulations? No. It specifically pertains to membrane semi-permeable systems using cellulose derivatives.
2. Are there similar patents using different polymer materials? Yes. Patents using polyurethanes, silicones, or other polymers exist outside this patent’s scope.
3. Can the patent be challenged for breadth? Potentially. Claims related to specific membrane compositions or manufacturing could be scrutinized in reexamination or litigation.
4. What therapeutic areas could benefit from this patent? Oncology, cardiovascular, CNS disorders, and any field requiring controlled drug release.
5. When does the patent expire? In 2030, assuming proper maintenance and no legal challenges.
References
- Johnson, L. (2017). Membrane coatings in controlled release. Journal of Pharmaceutical Sciences, 106(4), 1101–1112.
- Smith, R., & Lee, J. (2019). Advances in cellulose derivative membranes. International Journal of Pharmaceutics, 567, 118434.
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