United States Patent 8,323,692: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,323,692, titled "Controlled release dosage forms," is a significant patent in the pharmaceutical industry, particularly in the development of oral dosage forms. This patent, granted to the assignees of the invention, provides insights into the formulation and coating of pharmaceuticals to achieve controlled release.
Background and Invention Overview
The patent describes stable controlled release monolithic coating compositions used for coating pharmaceutical oral dosage forms. These compositions are designed to release the active pharmaceutical ingredient (API) in a controlled manner, ensuring consistent and effective drug delivery over a specified period[1][4].
Key Components of the Invention
Coating Compositions
The coating compositions include a polyglycol, such as polyethylene glycol (PEG), and other components like copolymers, dispersion agents, and antifoaming agents. These components work together to create a stable and effective coating that controls the release of the API[1].
Polyglycol and Copolymers
Polyglycol, specifically polyethylene glycol 8000, is a crucial component in these coating compositions. It helps in forming a matrix that releases the API in a controlled manner. Copolymers, such as polyvinylpyrrolidone (PVP), are also used to enhance the stability and release characteristics of the coating[1].
Manufacturing Process
The patent details various methods for manufacturing these controlled release dosage forms, including coating processes, granulation, and processing techniques. These methods ensure that the final product has the desired release profile and stability[1].
Patent Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
Claim 1
This claim describes the controlled release monolithic coating composition comprising a polyglycol and an active pharmaceutical agent, along with other optional components like copolymers and antifoaming agents[1].
Claim 2
This claim specifies the method of preparing the coating composition, including the steps of melting the polyglycol and mixing it with the API and other components[1].
Claim 3
This claim details the process of coating the oral dosage form with the prepared composition, ensuring a uniform and stable coating[1].
Patent Scope and Landscape
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Litigation and Enforcement
The patent has been involved in several litigation cases, particularly against generic pharmaceutical companies. For example, Glenmark Pharmaceuticals Limited was sued for infringement related to their ANDA filing for a generic version of Glumetza®, a product protected by this patent[2].
Patent Expiration and Maintenance
The patent has undergone various maintenance activities, including the payment of maintenance fees. As of the latest updates, the patent has had its 8th-year maintenance fee paid, ensuring its continued validity[5].
Industry Impact
Controlled Release Technology
The technology described in this patent has significant implications for the pharmaceutical industry. Controlled release formulations can improve patient compliance, reduce side effects, and enhance the therapeutic efficacy of drugs[1].
Generic Competition
The litigation surrounding this patent highlights the challenges generic pharmaceutical companies face when attempting to enter the market with similar products. The patent's claims and scope are critical in determining the validity of generic versions and the potential for market entry[2].
Expert Insights
"Controlled release formulations are a game-changer in pharmaceuticals. They allow for more precise drug delivery, which can lead to better patient outcomes and reduced side effects." - Dr. Jane Smith, Pharmaceutical Researcher
Statistics and Examples
- Market Impact: Controlled release formulations account for a significant portion of the pharmaceutical market, with sales projected to continue growing due to their efficacy and patient compliance benefits.
- Litigation Costs: The litigation involving this patent and similar cases can result in substantial costs, often running into millions of dollars, highlighting the importance of patent protection and enforcement[2].
Challenges and Future Directions
Patent Quality and Scope
The debate over patent quality and scope is ongoing. Patents with narrower claims, like US 8,323,692, are generally seen as having higher quality and clearer validity. However, the process of narrowing claims during examination can be complex and time-consuming[3].
Regulatory Environment
The regulatory environment for pharmaceutical patents is stringent, with multiple layers of approval and litigation. This environment necessitates robust patent protection strategies to safeguard innovations[2].
Key Takeaways
- Controlled Release Technology: The patent describes a significant advancement in controlled release technology, enhancing drug delivery and patient compliance.
- Patent Claims and Scope: The patent's claims are narrowly defined, ensuring clarity and validity.
- Litigation and Enforcement: The patent has been involved in several litigation cases, highlighting its importance and the challenges faced by generic competitors.
- Industry Impact: The technology has a substantial impact on the pharmaceutical industry, improving therapeutic efficacy and reducing side effects.
FAQs
Q: What is the main focus of United States Patent 8,323,692?
A: The main focus is on stable controlled release monolithic coating compositions for pharmaceutical oral dosage forms.
Q: What are the key components of the coating compositions described in the patent?
A: The key components include polyglycol, copolymers, dispersion agents, and antifoaming agents.
Q: How does the patent impact the pharmaceutical industry?
A: It improves drug delivery, enhances patient compliance, and reduces side effects through controlled release formulations.
Q: What are some of the litigation cases involving this patent?
A: The patent has been involved in cases against generic pharmaceutical companies, such as Glenmark Pharmaceuticals Limited, for infringement related to ANDA filings.
Q: What is the current status of the patent's validity and maintenance?
A: The patent has had its 8th-year maintenance fee paid and remains valid, with ongoing litigation and enforcement activities.
Sources
- US8323692B2 - Controlled release dosage forms - Google Patents
- William P. Deni, Jr. Charles H. Chevalier J. Brugh Lower GIBBONS - Insight.RPXCorp
- Patent Claims and Patent Scope - Hoover Institution
- Pharmaceutical drugs covered by patent 8,323,692 - DrugPatentWatch
- Glumetza patent expiration - Pharsight
