United States Patent 8,623,410: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,623,410, titled "Modified release compositions comprising tacrolimus," is a significant patent in the pharmaceutical field, particularly in the area of immunosuppressive drugs. This patent, assigned to a pharmaceutical company, outlines a specific formulation and method for the controlled release of tacrolimus, a crucial drug used to prevent organ rejection in transplant patients.
Patent Overview
Publication Number and Authority
The patent number is US8623410B2, and it was issued by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
Tacrolimus is a well-known immunosuppressive drug, and various formulations have been developed to optimize its delivery. The background of this patent involves the need for a formulation that provides a controlled and extended release of tacrolimus to maintain therapeutic levels over a longer period, reducing the frequency of dosing and improving patient compliance.
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims focus on the composition and method of preparing the modified release formulation. Here are some key aspects:
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Composition: The patent claims a pharmaceutical composition comprising tacrolimus, a polymer such as hydroxypropyl methyl cellulose, and other excipients like polyethylene glycol and magnesium stearate. The composition is designed to release less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test[4].
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Method of Preparation: The claims also cover the method of preparing the composition, which involves mixing the active ingredient with the polymers and other excipients, followed by a coating process to achieve the desired release profile[4].
Dependent Claims
Dependent claims further specify the details of the composition and method, including the types and amounts of excipients, the coating process, and the physical form of the final product (e.g., tablets or capsules).
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and clarity. For US8623410B2, the independent claims are detailed but not overly broad, suggesting a well-defined scope. Studies indicate that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Examination Process and Patent Quality
Narrowing of Claims
The examination process for this patent likely involved narrowing the scope of the claims to ensure clarity and validity. This is consistent with research findings that the examination process tends to narrow the scope of patent claims in terms of both claim length and claim count[3].
International and Global Context
Global Dossier and International Search
To understand the global landscape of this patent, tools like the Global Dossier provided by the USPTO can be useful. This service allows users to see the patent family for a specific application, including related applications filed at participating IP Offices, along with dossier, classification, and citation data[1].
Search in International Patent Offices
Searching databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can provide insights into whether similar patents exist or have been filed in other jurisdictions[1].
Technical Details and Innovations
Controlled Release Mechanism
The patent describes a controlled release mechanism that ensures the active ingredient, tacrolimus, is released in a manner that maintains therapeutic levels over an extended period. This is achieved through the use of specific polymers and excipients that control the dissolution rate of the drug[4].
Excipients and Formulation
The formulation includes hydroxypropyl methyl cellulose, polyethylene glycol, and magnesium stearate, among other ingredients. These excipients play a crucial role in achieving the desired release profile and ensuring the stability of the formulation[4].
Commercial and Practical Implications
Patient Compliance and Therapeutic Efficacy
The modified release composition of tacrolimus can significantly improve patient compliance by reducing the frequency of dosing. This can lead to better therapeutic outcomes and reduced side effects associated with fluctuating drug levels[4].
Market Competition
In the pharmaceutical market, having a patented controlled release formulation can provide a competitive edge. This patent protects the specific formulation and method of preparation, preventing other companies from producing identical or very similar products.
Legal Status and Expiration
Current Status
As of the current date, the legal status of the patent is important to note. The patent has expired, which means that the exclusive rights to the invention are no longer in effect, and the technology can be freely used by others[4].
Conclusion
United States Patent 8,623,410 represents a significant advancement in the formulation of tacrolimus, a critical immunosuppressive drug. The patent's scope and claims are well-defined, reflecting a clear and narrow focus on the controlled release mechanism. The use of specific polymers and excipients ensures a therapeutic release profile, enhancing patient compliance and efficacy.
Key Takeaways
- Controlled Release Mechanism: The patent describes a formulation that releases less than 20% w/w of tacrolimus within 0.5 hours, ensuring a controlled and extended release.
- Specific Excipients: Hydroxypropyl methyl cellulose, polyethylene glycol, and magnesium stearate are key excipients in achieving the desired release profile.
- Patient Compliance: The formulation improves patient compliance by reducing the frequency of dosing.
- Expired Patent: The patent has expired, allowing others to use the technology freely.
- Global Context: Tools like the Global Dossier and international patent databases can provide insights into similar patents globally.
FAQs
Q: What is the main focus of United States Patent 8,623,410?
A: The main focus is on a modified release composition comprising tacrolimus, designed to release the active ingredient in a controlled manner.
Q: What are the key excipients used in this formulation?
A: The key excipients include hydroxypropyl methyl cellulose, polyethylene glycol, and magnesium stearate.
Q: How does this formulation improve patient compliance?
A: By providing a controlled and extended release of tacrolimus, the formulation reduces the frequency of dosing, improving patient compliance.
Q: What is the current legal status of this patent?
A: The patent has expired, meaning the exclusive rights to the invention are no longer in effect.
Q: How can one search for similar patents globally?
A: Tools like the Global Dossier and databases from international intellectual property offices such as the EPO, JPO, and WIPO can be used to search for similar patents globally.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- PubChem - Solid dispersions comprising tacrolimus: https://pubchem.ncbi.nlm.nih.gov/patent/US7994214
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - Modified release compositions comprising tacrolimus: https://patents.google.com/patent/US8623410B2/en
- PubChem - Sustained release formulation containing tacrolimus: https://pubchem.ncbi.nlm.nih.gov/patent/US-6884433-B2
