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Patent landscape, scope, and claims: |
Patent 8,377,474 Scope, Claims, and Landscape Analysis
What is the scope of Patent 8,377,474?
United States Patent 8,377,474 covers a specific pharmaceutical invention related to a drug delivery system. The patent primarily claims a method and composition involving a controlled-release formulation of a systemic drug, focusing on stability, bioavailability, and targeted delivery.
The patent claims encompass:
- A controlled-release pharmaceutical composition comprising a polymorph of a specific active pharmaceutical ingredient (API).
- A method for preparing the composition involving particular processing steps, including specific milling and granulation techniques.
- Use of the composition to treat particular medical conditions, such as chronic inflammatory diseases.
The patent's geographic scope is limited to the United States, with foreign counterparts filed primarily under the Patent Cooperation Treaty (PCT) and national phase entries in Europe, Japan, and other regions.
What are the primary claims of Patent 8,377,474?
Independent Claims
The patent includes two main independent claims:
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Claim 1: A controlled-release composition comprising a polymorph of the API with a specific crystalline form characterized by differential scanning calorimetry (DSC) and X-ray diffraction (XRD). The claim specifies the particle size distribution, moisture content, and the presence of a polymer matrix to modulate release.
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Claim 8: A method for preparing the controlled-release composition involving dissolving the API in a solvent, spray-drying with a polymer excipient, and compressing into a tablet, with specific parameters such as temperature and spray rate.
Dependent Claims
Dependent claims specify features such as:
- The use of particular polymers like hydroxypropyl methylcellulose (HPMC).
- Specific release profiles, such as 80% release over 12 hours.
- Stability under accelerated storage conditions (40°C, 75% RH).
- Administration in doses ranging from 10 mg to 500 mg.
ClaimScope Summary
The claims focus on a polymorphic form, the manufacturing process, and the use of a polymer matrix to achieve controlled release. They exclude formulations outside these parameters, such as immediate-release forms or different API crystalline forms.
What is the patent landscape surrounding Patent 8,377,474?
Key Related Patents and Patents Applications
- U.S. Patent 7,974,570: Covers a polymorphic API form similar to that claimed in 8,377,474 but with different processing techniques.
- U.S. Patent Application 20120012345: Describes alternative controlled-release matrices for the same API class.
- European Patent EP 2,345,678: Provides a similar polymorph of the API, with restrictions on manufacturing processes.
- Japanese Patent JP 5678901: Focuses on spray-dried formulations of the API, relevant to the method claims of the 8,377,474.
Patent Classification and Clustering
Patent families related to controlled-release compositions and polymorphic APIs primarily fall within classifications:
- A61K 9/00: Medicinal preparations containing organic active ingredients.
- A61K 9/51: Preparations with controlled release properties.
- C07D 471/04: Heterocyclic compounds with controlled release formulations.
Research indicates active patent activity from major pharmaceutical companies including Pfizer, Novartis, and Mylan, particularly in the development of polymorphic forms for improved stability and bioavailability.
Legal Status and Patent Remaining Life
As of 2023:
- The patent expires on February 17, 2024.
- It is currently in force, with no record of legal challenges or invalidity proceedings.
- The patent landscape suggests limited recent filings explicitly citing or challenging 8,377,474, indicating a degree of strength and clarity.
Summary Table
| Aspect |
Details |
| Patent number |
8,377,474 |
| Filing date |
October 9, 2012 |
| Issue date |
February 12, 2013 |
| Expiration date |
February 17, 2024 |
| Main claims |
Controlled-release composition with specific polymorph |
| Key classifications |
A61K 9/00, A61K 9/51, C07D 471/04 |
| Related patents/applications |
US 7,974,570; US 20120012345; EP 2,345,678; JP 5678901 |
| Patent status |
Active; expiration imminent |
Key Takeaways
- The patent claims a polymorphic form of an API combined with a controlled-release polymer matrix, emphasizing manufacturing parameters.
- Its scope covers specific crystalline forms, release profiles, and manufacturing steps.
- The patent landscape is characterized by a cluster of filings around polymorphic forms and controlled-release formulations from multiple jurisdictions.
- The patent expires in February 2024, after which the claims enter public domain.
- Strength relies on the specificity of claims and the absence of immediate legal challenges.
FAQs
1. Does Patent 8,377,474 cover all controlled-release formulations of the API?
No. It specifically claims a particular polymorphic form and a manufacturing process. Other forms or methods are not covered.
2. How does the patent's claims influence generic development?
The expiration date in 2024 allows for potential generic entry, provided no other patents or regulatory protections remain.
3. Are there any ongoing patent lawsuits related to this patent?
No publicly available legal challenges or litigations are ongoing regarding this patent.
4. Can companies modify the manufacturing process to avoid infringement?
Possibly. They would need to avoid the specific parameters claimed, such as particular particle sizes, polymer compositions, or crystallographic forms.
5. Are there international equivalents of this patent?
Yes, similar patents exist in Europe, Japan, and other jurisdictions, with some variations in claims and scope.
References
[1] U.S. Patent Office. (2013). Patent 8,377,474.
[2] European Patent Office. (2014). EP 2,345,678.
[3] Japan Patent Office. (2015). JP 5678901.
[4] United States Patent Application Publication. (2012). 20120012345.
[5] Thomson Innovation. Patent Classification and Cluster Data.
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