United States Patent 4,849,228: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,849,228, hereafter referred to as the '228 patent, is a significant patent in the pharmaceutical sector, particularly related to sustained-release formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '228 patent, titled "Sustained Release Pharmaceutical Composition," was granted to TAP Pharmaceutical Products, Inc., and its affiliated companies. This patent is part of a series of patents related to pharmaceutical formulations, specifically those used in treating conditions such as prostate cancer[2][5].
Scope of the Patent
The '228 patent is directed to certain biodegradable high molecular polymers that have good aging stability and are useful as excipients in pharmaceutical preparations. These polymers are crucial in the formulation of sustained-release drugs, ensuring a controlled and prolonged release of the active pharmaceutical ingredient[2].
Key Aspects of the Scope
- Biodegradable Polymers: The patent focuses on biodegradable polymers, which are essential for creating formulations that can degrade over time, releasing the drug in a controlled manner.
- Aging Stability: The polymers described must have good aging stability, ensuring that the formulation remains effective over its shelf life.
- Excipients: The polymers are used as excipients, which are inactive ingredients that help in the delivery of the active pharmaceutical ingredient.
Claims of the Patent
The '228 patent includes multiple claims that define the scope of the invention. Here are some key claims:
Claim 1
Claim 1 typically sets the broadest scope of the invention and is often the most critical claim. For the '228 patent, Claim 1 involves a sustained-release pharmaceutical composition comprising a biodegradable polymer matrix and an active pharmaceutical ingredient[2].
Claims 2-4
These claims further specify the characteristics of the biodegradable polymer matrix, such as its molecular weight, the type of polymer used, and the method of preparation. These claims help to narrow down the scope and ensure that the invention is clearly defined[2].
Patent Landscape
The '228 patent is part of a larger patent landscape involving pharmaceutical formulations and sustained-release technologies.
Related Patents
- U.S. Patent No. 4,728,721: This patent, also owned by TAP, is related to the same field and involves similar biodegradable polymers. The two patents often appear together in litigation and are crucial for TAP's intellectual property portfolio[2][5].
- Other Takeda Patents: The '228 patent is part of a suite of patents owned or co-owned by Takeda, including U.S. Patent Nos. 4,652,441, 4,677,191, 4,917,893, 5,476,663, 5,575,987, 5,631,020, 5,631,021, and 5,716,640. These patents collectively protect various aspects of TAP's pharmaceutical formulations[5].
Litigation and Enforcement
The '228 patent has been involved in several significant litigation cases, highlighting its importance in the pharmaceutical industry.
TAP vs. OWL Pharmaceuticals
In a notable case, TAP sued OWL Pharmaceuticals and Oakwood Laboratories for infringement of several patents, including the '228 patent. The court found that OWL infringed claim 1 of the '228 patent and claims 1-4 of U.S. Patent No. 4,728,721. The case underscored the enforceability of these patents and their impact on competition in the pharmaceutical market[2][5].
Impact on Competition and Innovation
The '228 patent, along with other related patents, has significant implications for competition and innovation in the pharmaceutical sector.
Deterrence of Competition
False marking or the misuse of expired patents can deter competition by making potential competitors believe that certain products are still under patent protection. This can lead to reduced innovation and increased costs for companies trying to navigate the patent landscape[1].
Encouraging Innovation
On the other hand, valid and enforceable patents like the '228 patent can encourage innovation by providing a clear framework for what is protected and what is in the public domain. This clarity can foster further research and development in related areas[3].
Metrics for Measuring Patent Scope
To understand the scope and impact of the '228 patent, metrics such as independent claim length and independent claim count can be used. These metrics help in assessing the breadth and clarity of the patent claims, which are crucial for determining the patent's scope and its potential impact on innovation[3].
Global Patent System Integration
The '228 patent is part of a global patent system that is increasingly integrated. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of patent applications across different jurisdictions, making it easier to understand the global patent landscape surrounding this patent[4].
Key Takeaways
- Scope and Claims: The '228 patent is focused on biodegradable polymers used in sustained-release pharmaceutical formulations, with specific claims defining the characteristics of these polymers.
- Patent Landscape: The patent is part of a broader portfolio owned by TAP and Takeda, protecting various aspects of pharmaceutical formulations.
- Litigation and Enforcement: The patent has been enforced in significant litigation cases, highlighting its importance in the pharmaceutical industry.
- Impact on Competition and Innovation: The patent can both deter and encourage competition and innovation, depending on its use and the clarity of its claims.
- Global Integration: The patent is part of an increasingly integrated global patent system, facilitated by tools like the Global Dossier and CCD.
FAQs
What is the main subject of U.S. Patent 4,849,228?
The main subject of U.S. Patent 4,849,228 is a sustained-release pharmaceutical composition using biodegradable high molecular polymers.
Who owns U.S. Patent 4,849,228?
U.S. Patent 4,849,228 is owned by TAP Pharmaceutical Products, Inc., and its affiliated companies.
What are the key claims of the '228 patent?
The key claims include the composition of the biodegradable polymer matrix and the active pharmaceutical ingredient, as well as specific characteristics of the polymers used.
Has the '228 patent been involved in any significant litigation?
Yes, the '228 patent has been involved in significant litigation, particularly in the case of TAP vs. OWL Pharmaceuticals, where it was found that OWL infringed on this patent.
How does the '228 patent impact competition and innovation?
The '228 patent can deter competition by protecting specific formulations, but it also encourages innovation by providing a clear framework for what is protected and what is in the public domain.
What tools are available for analyzing the global patent landscape of the '228 patent?
Tools such as the Global Dossier and the Common Citation Document (CCD) are available for analyzing the global patent landscape of the '228 patent.
Sources
- UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT - Federal patent policy and false marking[1].
- U.S. Court of Appeals for the Federal Circuit - TAP Pharmaceutical Products, Inc. vs. OWL Pharmaceuticals, L.L.C.[2].
- SSRN - Patent Claims and Patent Scope[3].
- USPTO - Search for patents and Global Dossier[4].
- UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT - TAP Pharmaceutical Products, Inc. vs. OWL Pharmaceuticals, L.L.C.[5].
