Detailed Analysis of the Scope and Claims of United States Patent 9,018,192
Introduction
United States Patent 9,018,192, titled "Unitary Pharmaceutical Dosage Form," was granted to Bristol-Myers Squibb & Gilead Sciences, LLC on April 28, 2015. This patent is significant in the pharmaceutical industry, particularly in the development of unitary dosage forms. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
The patent was invented by Terrence C. Dahl, Munir A. Hussain, and Robert L. Bell, among others, and assigned to Bristol-Myers Squibb & Gilead Sciences, LLC. The inventors aimed to create a unitary pharmaceutical dosage form that addresses specific challenges in drug delivery and formulation[1].
Scope of the Patent
The scope of the patent revolves around the development of a unitary pharmaceutical dosage form that combines multiple active pharmaceutical ingredients (APIs) into a single dosage unit. This dosage form is designed to improve the bioavailability, stability, and patient compliance of the APIs.
Key Components
- Active Pharmaceutical Ingredients (APIs): The patent describes formulations that include multiple APIs, which can be combined in various ratios to achieve desired therapeutic effects.
- Excipients and Formulation: The dosage form includes specific excipients and a detailed formulation process to ensure the stability and efficacy of the APIs.
- Delivery Mechanism: The patent outlines various delivery mechanisms, such as tablets, capsules, and other oral dosage forms, designed to release the APIs in a controlled manner[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes a unitary pharmaceutical dosage form comprising at least two APIs, along with specific excipients and a detailed formulation process.
- Claim 2 specifies the ratios of the APIs and the types of excipients used.
- Claim 3 outlines the method of manufacturing the dosage form, including the steps involved in combining the APIs and excipients[1].
Dependent Claims
- These claims further detail the specific characteristics of the dosage form, such as the particle size of the APIs, the type of coating used, and the release profile of the APIs.
Patent Landscape
Prior Art and Related Patents
The patent landscape for unitary pharmaceutical dosage forms is extensive, with numerous prior patents and publications. For example, patents such as US 3,682,930 A and US 4,003,878 A describe earlier formulations and delivery mechanisms that laid the groundwork for the current invention[1].
Global Dossier and International Filings
The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. This service is crucial for understanding the global patent landscape and identifying similar inventions filed in other countries. The patent in question likely has international counterparts, given the global nature of pharmaceutical research and development[4].
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 complexity. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process. The claims in US 9,018,192 are detailed and specific, indicating a well-defined scope that was likely refined during the examination process[3].
Administrative and Legal Aspects
Filing Requirements
The patent was filed in compliance with U.S. patent laws, which require the inventor to sign an oath or declaration. For foreign applicants, the application must be filed within 12 months of the earliest foreign filing date, and priority must be claimed under 35 U.S.C. 119(b)[2].
Assignment and Ownership
The patent can be assigned in law by an instrument in writing, and any such assignment must be acknowledged before a consular officer or an official whose authority is authenticated by a consular officer[2].
Impact on the Pharmaceutical Industry
The unitary pharmaceutical dosage form described in US 9,018,192 has significant implications for the pharmaceutical industry:
Improved Patient Compliance
By combining multiple APIs into a single dosage unit, the invention enhances patient compliance, as it simplifies the treatment regimen.
Enhanced Bioavailability and Stability
The specific formulation and delivery mechanisms outlined in the patent improve the bioavailability and stability of the APIs, leading to more effective treatments.
Future Developments
This patent sets a precedent for further research and development in unitary dosage forms. Future patents may build upon this invention, exploring new APIs, excipients, and delivery mechanisms.
Key Takeaways
- Unitary Dosage Form: The patent describes a unitary pharmaceutical dosage form combining multiple APIs.
- Scope and Claims: The claims are detailed and specific, defining the formulation, excipients, and delivery mechanisms.
- Patent Landscape: The invention is part of a broader landscape of pharmaceutical patents, with prior art and international filings.
- Administrative Aspects: The patent was filed in compliance with U.S. patent laws and can be assigned in writing.
- Industry Impact: The invention improves patient compliance, bioavailability, and stability of APIs.
FAQs
Q: Who are the inventors of US Patent 9,018,192?
A: The inventors include Terrence C. Dahl, Munir A. Hussain, and Robert L. Bell, among others.
Q: What is the primary focus of US Patent 9,018,192?
A: The primary focus is on the development of a unitary pharmaceutical dosage form that combines multiple active pharmaceutical ingredients.
Q: How does the patent improve patient compliance?
A: By combining multiple APIs into a single dosage unit, the treatment regimen is simplified, enhancing patient compliance.
Q: What are the key components of the unitary dosage form described in the patent?
A: The key components include multiple APIs, specific excipients, and a detailed formulation process.
Q: Can the patent be assigned to another party?
A: Yes, the patent can be assigned in law by an instrument in writing, acknowledged before a consular officer or an official whose authority is authenticated by a consular officer.
Sources
- United States Patent and Trademark Office. Unitary Pharmaceutical Dosage Form, US 9,018,192 B2.
- U.S. Department of State. 7 FAM 880 Federal and State Agency Documents.
- SSRN. Patent Claims and Patent Scope.
- United States Patent and Trademark Office. Search for Patents.
